Midterm outcomes of rotational atherectomy-assisted endovascular treatment of severe peripheral arterial disease.

OBJECTIVE: We evaluated the midterm results of atherectomy-assisted angioplasty for the treatment of femoropopliteal lesions and the identification of possible subgroups of patients with superior outcomes. METHODS: We conducted a single-center, physician-initiated, nonindustry-sponsored retrospective analysis of patients with Rutherford category ranging from II to V and de novo occlusive or stenotic lesions of the superficial femoral (SFA) and/or popliteal arteries treated with atherectomy-assisted angioplasty (Jetstream rotational atherectomy + drug-eluting ballooning). In cases of subintimal recanalization or patients without an SFA stamp, with previous ipsilateral bypass surgery, systemic coagulopathy, end-stage renal disease requiring hemodialysis, life expectancy of <12 months, and intolerance to aspirin, clopidogrel, and/or heparin were excluded. RESULTS: In a total of 103 enrolled patients, the median SFA and/or popliteal lesion length was 80 mm (interquartile range, 61.2 mm) with 73 lesions being occlusive (70.9%) and 84 (81.5%) classified as Fanelli calcification score 3 and 4. Technical success was met in 96.1% of cases (n = 99) at a median operative time of 108 minutes. Adjunctive stenting was needed in 10 patients (9.8%). At a median follow-up of 18.0 ± 10.8 months, Rutherford class clinical improvement was present in 77 patients (74.8%), and 7 patients (6.79%) presented target lesion occlusion needing reintervention in 6 cases (5.82%). The primary patency rates were 97% at 12 months and 83% at 24 months with secondary patency rates of 99% at 12 months and 91% at 24 months of follow-up. There were no significant differences when treating differently located lesions, diabetic vs nondiabetic patients, or comparing experienced vs nonexperienced operators. CONCLUSIONS: The use of rotational atherectomy and drug-eluting balloons for the treatment of severe femoropopliteal disease showed relatively low need for bailout stenting and good midterm primary patency rates. The influence of lesion location, diabetes mellitus, or operator experience did not show statistically different results in terms of patency. Longer term outcomes and comparative analysis are needed to consolidate further clinical evidence.

Systematic Review of the Current In Vitro Experience of the Endovascular Treatment of Juxtarenal Abdominal Aortic Aneurysms by Fenestrated and Parallel Endografting.

OBJECTIVE: To identify and analyze the published in vitro benchtop experiments for the assessment of endovascular techniques used for the treatment of juxtarenal abdominal aortic aneurysms (jAAAs). DATA SOURCES: Scopus, PubMed, and Web of Science. REVIEW METHODS: A systematic literature search was carried out throughout March 2021 following PRISMA guidelines. Two investigators independently performed title and abstract screening to reveal all benchtop testing evaluating the endovascular treatment of jAAA. RESULTS: A total of 19 studies were included, 8 evaluating fenestrated (FEVAR) and 11 parallel grafts (PGs). FEVAR studies used different custom testing apparatus (n=7) or 3D-printed models (n=1) to analyze dislodgement and migration resistance, misalignment consequences and causation, and bridging stents' radial force, flareability, fatigue, and fracture resistance. All PG studies used silicone-based models to analyze optimal oversizing, sealing length, gutter behavior, and possible reduction. Test evaluation in FEVAR in vitro testing was based on pullout force analysis (N=5), photo evaluation (n=1), fluoroscopy (n=1), X-rays (n=4), CT analysis (n=3), macro- and microscopic evaluation (n=4), water permeability (n=1), and fatigue simulator testing (n=1), while it was based on CT analysis in all PG studies adding ECG-gate in one study. The most frequently tested devices were Zenit (Cook) (n=7), Endurant (Medtronic) (n=5), and Excluder (Gore) (n=5) as main grafts, and Advanta V12 (n=14) as the bridging device. CONCLUSIONS: This systematic review presents a broad analysis of the current in vitro methods evaluating the endovascular treatment of jAAA. Fundamental issues have been benchtop tested in both FEVAR and PGs. The analysis of the included studies allowed to recommend an optimal testing design. In vitro testing is a potential tool to further elucidate points of attention hard to investigate in vivo to finally enhance the endovascular treatment outcomes. Future in vitro studies are needed to evaluate the in vitro performance of all indistinctively used devices in the clinical practice.

In Vitro Radiological Evaluation of Different Types of Chimney Stents Using a Silicon Flow Model with Adjustable Physiological Simulating Conditions.

OBJECTIVE: To evaluate in vitro the performance of in vivo published covered or bare metal chimney stents (ChSs) in combination with the Endurant II abdominal endograft (Medtronic) as the only CE approved main graft (MG) in the treatment of juxtarenal abdominal aortic aneurysms with the chimney endovascular aneurysm repair (chEVAR) technique. METHODS: Bench top experimental study. A silicon flow model with adjustable physiological simulating conditions and patient based anatomy was used to test nine different MG-ChS combinations: Advanta V12 (Getinge); BeGraft+ (Bentley); VBX (Gore & Associates Inc.); LifeStream (Bard Medical); Dynamic (Biotronik); Absolute Pro (Abbott); double Absolute Pro; Viabahn (Gore) lined with Dynamic; and Viabahn lined with EverFlex (Medtronic). Angiotomography was performed after each implantation. DICOM data were analysed blindly twice per observer by three independent experienced observers. Each blinded evaluation was performed at one month intervals. The main analysed parameters were the area of gutters, MG and ChS maximum compression, and the presence of infolding. RESULTS: Bland-Altman analysis confirmed adequate results correlation (p < .05). Each employed ChS showed significantly different performance favouring the balloon expandable covered stent (BECS). The smallest gutter area was seen in the combination with Advanta V12 (0.26 cm2). MG infolding was observed in all tests. The lowest ChS compression was observed in the combination with BeGraft+ (compression 4.91%, D ratio 0.95). In our model, BECSs showed higher angulations than bare metal stents (BMSs) (p < .001). CONCLUSION: This in vitro study shows the variability of performance with each theoretically possible ChS and explains the divergent ChS outcomes in the published literature. BECS in combination with the Endurant abdominal device confirms their superiority vs. BMS. The presence of MG infolding in each test underlines the need for prolonged kissing ballooning. Angulation evaluation and comparison with other in vitro and in vivo publications demands the need for further investigation in transversely or upwardly oriented target vessels.

What we have learned from in-vitro studies of the chimney endovascular technique for treatment of complex abdominal aortic aneurysms: A systematic review.

BACKGROUND: A considerable number of patients with abdominal aortic aneurysms (AAA) is not eligible for standard endovascular repair. These complex cases require alternative surgical approaches including the readily available chimney graft endovascular aneurysm repair (Ch-EVAR) or sealing (Ch-EVAS). The optimal configuration for Ch-EVAR or Ch-EVAS is important for success but not yet known. OBJECTIVE: The aim of the present study was to analyze current data of the outcomes of in-vitro chimney graft treatment in complex AAA. METHODS: A systematic review following PRISMA guidelines was conducted including studies reporting on gutter size, main graft compression, and chimney graft compression in in-vitro configurations. RESULTS: The search resulted in 285 articles. 11 studies considering 219 individual tests could be included. Gutter size was comparable between Ch-EVAR and Ch-EVAS configurations. In Ch-EVAR set-ups, the deployed BECG were Advanta V12, VIABAHN®, and BeGraft. One type of SECG was used: VIABAHN®. The four types of main grafts (MG) deployed were: Endurant™ I/II; EXCLUDER Conformable AAA Endoprosthesis and AAA Endoprosthesis, and AFX™ Endovascular AAA Delivery System. In the EVAS-configurations, the Nellix® EVAS system was deployed. In general, SECG presented smaller gutters with higher chimney graft compression. 30% main grafts oversizing seems to give the smallest gutters without high risk of infolding of MG. Oversizing, EndoAnchors, and secondary endobag filling (in Ch-EVAS) reduced gutter sizes. CG ballooning during the entire polymer injection in Ch-EVAS prevented CG compression. CONCLUSION: In-vitro investigations provide insight in optimal Ch-EVAR and Ch-EVAS configurations for simulated complex AAA repair. The findings above might aid physicians in their planning to potential CG set-ups and can be used in future research to refine the most optimal configuration for chimney graft technique in complex AAA.

A systematic review and meta-analysis of stroke rates in patients undergoing thoracic endovascular aortic repair for descending thoracic aortic aneurysm and type B dissection.

OBJECTIVE: We performed a systematic review and meta-analysis to assess the stroke rates after thoracic endovascular aortic repair (TEVAR) for descending thoracic aortic aneurysms and/or dissections. METHODS: A systematic search of all the literature reported until September 2021 was performed according to the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines. The pooled perioperative stroke rates and corresponding 95% confidence intervals (CIs) were estimated using fixed or random effect methods. RESULTS: A total of 878 study titles were identified by the initial search strategy, of which 43 were considered eligible for inclusion in the meta-analysis. A total of 5764 patients (63.5% male) were identified among the eligible studies. The pooled any stroke rate was 4.4% (95% CI, 3.60%-5.28%). However, after procedures without left subclavian artery (LSA) ostial coverage (eg, TEVAR deployed within or distal to zone ≥3), the stroke rate was 3.15% (95% CI, 2.21%-4.22%). For the patients with LSA coverage, the pooled stroke rate was 2.8% (95% CI, 1.69%-4.14%) for patients receiving left subclavian artery revascularization. However, the patients without LSA revascularization had a pooled estimated stroke incidence of 11.8% (95% CI, 5.85%-19.12%). CONCLUSIONS: Stroke has been a common finding after TEVAR, especially with LSA coverage without revascularization, validating current clinical practice guidelines recommending routine revascularization, when feasible. Additional studies with larger patient numbers that provide separate data regarding the aortic pathology treated, the anatomic location of the stroke and their association with functional recovery and survival are needed.

Multicenter Mid-Term Outcomes of the Chimney Technique in the Elective Treatment of Degenerative Pararenal Aortic Aneurysms.

PURPOSE: Chimney endovascular abdominal aortic aneurysm repair (CHEVAR) has predominantly been described as an alternative technique for the management of urgent presentations of degenerative pararenal aortic aneurysms (dPAAs). However, the role of CHEVAR in the treatment of asymptomatic patients remains unknown. The aim of current multinational study was to evaluate the outcomes of elective CHEVAR of dPAAs. MATERIAL AND METHODS: Retrospective analysis of 267 consecutive dPAA patients treated with elective CHEVAR at 13 European and US centers from 2008 to 2014. Primary endpoints were 30 days and out of hospital CHEVAR-related mortality. Secondary endpoints included persistent type Ia endoleak or endotension, angiographically confirmed occlusion and/or high-grade chimney graft (CG) or involved splanchnic vessel stenosis identified at index procedure and/or during follow-up, as well as CHEVAR-related re-intervention. RESULTS: Mean follow-up time was 25.5±13.3 months. The 442 visceral vessels were involved and mean number of CGs per patient was 1.63±0.7. 436 targeted vessels were successfully cannulated. The aortic graft intentionally covered 6 renal arteries and immediate technical success was 98.6%. The 30 days mortality was 1.9% (n=5), while the in-hospital complication rate was 10.1% (n=27) including 3 strokes, 1 permanent dialysis, and 1 intestinal ischemia. No 30 day type Ia endoleaks were detected and 3.2% of CGs (n=14, including the intentionally covered) had evidence of occlusion and/or stenosis. The overall CHEVAR-related mortality was 2.2% (n=6). Freedom from primary and secondary type Ia endoleak/endotension rates at 3 years was 93.0% and 98.0%, respectively. Primary and secondary CG patency was 87.0% and 89.0%. Primary and secondary endovascular freedom from any endpoint at 3 years was 81.0% and 94.0% respectively. CONCLUSION: Elective use of CHEVAR in the management of dPAAs seems to be durable. These results are comparable to published outcomes with other total endovascular strategies, which justifies an expanded role for CHEVAR in the treatment of asymptomatic patients presenting with dPAAs.

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.

Systematic review with pooled data analysis reveals the need for a standardized reporting protocol including the visceral vessels during fenestrated endovascular aortic repair (FEVAR).

OBJECTIVES: To collect and analyse the available evidence in the outcomes of patients treated with fenestrated endovascular aortic repair (f-EVAR) technique focusing specifically on visceral vessel outcomes. METHODS: The current meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All the studies reporting the f-EVAR technique for the management of degenerative pararenal and/or type IV thoracoabdominal aortic aneurysms (TAAA) were considered eligible for inclusion in the study. The main study outcomes (technical success, type I endoleaks, fracture or occlusion of the bridging stents, overall aneurysm-related mortality, and the reintervention rate) were subsequently expressed as proportions and 95% confidence intervals. RESULTS: Fourteen studies with a total of 1804 patients were included in a pooled analysis. The technical success of the procedure was 95.97% (95%CI = 92.35-98.60). Intraoperatively, the pooled proportion of reported type I endoleak was 7.6% (95%CI = 2.52-14.60) while during a median follow-up of 41 months (range 11-96) follow-up period the pooled rate of fracture and occlusion of the bridging stents was 2.79% (95%CI = 0.00-8.52) and 4.46% (95%CI = 1.93-7.77), respectively. The overall aneurysm-related mortality was detected to be 0.63% (95%CI = 0.04-1.63), and the pooled estimate for re-intervention rate was 15.69%. CONCLUSIONS: Fenestrated endovascular repair for p-AAA is an effective and safe treatment. Target vessel complications and endoleaks remain the two most important concerns for fenestrated endovascular procedures, contributing to most of the secondary interventions. The lack of computed tomography angiography follow-up evaluation does not allow us to draw robust conclusions about the complication rates for the superior mesenteric artery during f-EVAR. Due to the potential implications of SMA complications on aneurysm-related mortality, standardized reporting of short- and long-term target visceral vessel outcomes is required.

First report of intravascular ultrasound-guided intravascular lithotripsy to treat an underexpanded stent in the superficial femoral artery.

BACKGROUND/OBJECTIVE: To evaluate the safety and utility of a new in Europe intravascular ultrasound (IVUS) catheter in a case of peripheral arterial disease caused by in-stent restenosis of the superficial femoral artery. METHOD: Pre-therapeutic computed tomographic angiography identified severe stent restenosis related to device underexpansion, which was caused by an underlying eccentric severely calcified stenosis leading to suboptimal device deployment. The OptiCross 18 (30 MHz Peripheral Imaging Catheter, Boston Scientific, USA) is a short rail imaging catheter. It consists of two main assemblies: The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking 30 MHz ultrasonic transducer at the distal tip. An electro-mechanical connector interface at the proximal end of the catheter makes the connection to the Motordrive Unit (MDU5 PLUSTM) Instrument. The MDU5 PLUS-catheter interface consists of an integrated mechanical drive socket and electrical connection. RESULTS: The use of the IVUS-guided imaging revealed in-stent restenosis, fracture, and protrusion of the calcified plaque in the stent and confirmed the preoperative computed tomography angiography which showed stent compression. Use of intravascular litotripsy catheter (intravascular lithotripsy Shockwave Medical, Santa Clara, California) and drug coated balloon led to improvement in stent expansion, having minimal patent diameter of 5.77 mm. The patient's subsequent clinical course was uneventful, and clinically had palpable pulses in the foot and ankle-brachial index of 1. CONCLUSIONS: Whether acoustic pulse application might affect device structure in the long term remains to be determined, use of the novel IVUS system demonstrated excellent visibility of the etiology of the in-stent restenosis improving the perioperative diagnostic modalities of suboptimal endovascular outcome.

Outcomes of elective use of the chimney endovascular technique in pararenal aortic pathologic processes.

OBJECTIVE: In the treatment of pararenal abdominal aortic aneurysms and aortic pathologic processes, chimney endovascular aneurysm repair (CHEVAR) represents an alternative technique for urgent cases. The aim of the study was to evaluate the outcomes of CHEVAR in the elective setting. METHODS: We performed a retrospective analysis of prospectively collected records of 165 consecutive asymptomatic CHEVAR patients who were treated between March 2009 and January 2018 with the Endurant stent graft (Medtronic, Santa Rosa, Calif). A total of 244 chimney grafts (CGs) were implanted. The primary end point was clinical success, defined as freedom from procedure-related mortality, persistent type IA endoleak, occlusion or high-grade stenosis (>70%) of CGs, and any chimney technique-related secondary procedure for the entire follow-up period. Secondary clinical success included patients with successful treatment of a primary end point with a secondary endovascular procedure. RESULTS: All 244 targeted chimney vessels were successfully cannulated. Total perioperative morbidity was 7.8% (n = 13), including 3 (1.8%) cases of bowel ischemia, 1 (0.6%) patient with renal ischemia, and 1 patient (0.6%) with stroke. Median follow-up was 25.5 ± 2.2 months. Both 30-day and follow-up procedure-related mortality rates were 1.8% (n = 3). Primary and secondary freedom from persistent type IA endoleak rates were 96.4% (n = 159) and 99.4% (n = 164), respectively. Primary and secondary CG patency rates were 92.2% (n = 225) and 95.9% (n = 234), respectively. The rate of reinterventions related to the chimney technique was 10.9% (n = 18), and 83.3% of them were performed by endovascular means. The estimated cumulative primary patency and freedom from persistent type IA endoleak were 87.5% and 95.3%, respectively, and the primary and secondary clinical successes rates at midterm were 80.3% and 87.5%, respectively. CONCLUSIONS: The elective use of CHEVAR with the Endurant stent graft in our series showed favorable midterm clinical results, which are similar to the published results of other total endovascular modalities. A prospective randomized trial of elective treatment of pararenal abdominal aortic aneurysms and aortic pathologic processes with current endovascular options is needed to assess the value of CHEVAR in the elective setting.

Long-term chimney/snorkel endovascular aortic aneurysm repair experience for complex abdominal aortic pathologies within the PERICLES registry.

OBJECTIVE: The early and short-term efficacy of the snorkel/chimney technique for endovascular aortic aneurysm repair (ch-EVAR) have been previously reported. However, long-term ch-EVAR performance, vessel patency, and patient survival remain unknown. Our study evaluated the late outcomes to identify possible predictors of failure within the PERICLES (performance of the chimney technique for the treatment of complex aortic pathologies) registry. METHODS: Clinical and radiographic data from patients who had undergone ch-EVAR from 2008 to 2014 in the PERICLES registry were updated with an extension of the follow-up. Regression models were used to evaluate the relevant anatomic and operative characteristics as factors influencing the late results. We focused on patients with ≥30 months of follow-up (mean, 46.6 months; range, 30-120 months). RESULTS: A total of 517 patients from the initial PERICLES registry were included in the present analysis, from which the mean follow-up was updated from 17.1 months to 28.2 months (range, 1-120 months). All-cause mortality at the latest follow-up was 25.5% (n = 132), with an estimated patient survival of 87.6%, 74.4%, and 66.1% at 1, 3, and 5 years, respectively. A subgroup of 244 patients with 387 chimney grafts placed (335 renal arteries, 42 superior mesenteric arteries, 10 celiac arteries) and follow-up for ≥30 months was used to analyze specific anatomic and device predictors of adverse events. In the subgroup, the technical success was 88.9%, and the primary patency was 94%, 92.8%, 92%, and 90.5% at 2.5, 3, 4, and 5 years, respectively. The mean aneurysm sac regression was 7.8 ± 11.4 mm (P < .0001). Chimney graft occlusion had occurred in 24 target vessels (6.2%). Late open conversion was required in 5 patients for endograft infection in 2, persistent type Ia endoleak in 2, and endotension in 1 patient. The absence of an infrarenal neck (odds ratio, 2.86; 95% confidence interval, 1.32-6.19; P = .007) was significantly associated with long-term device-related complications. A sealing zone diameter >30 mm was significantly associated with persistent or late type Ia endoleak (odds ratio, 4.86; 95% confidence interval, 1.42-16.59; P = .012). CONCLUSIONS: The present analysis of the PERICLES registry has provided the missing long-term experience for the ch-EVAR technique, showing favorable results with more than one half of the patients surviving for >5 years and a chimney graft branch vessel patency of 92%. The absence of an infrarenal neck and treatment with a sealing zone diameter >30 mm were the main anatomic long-term limits of the technique, requiring adequate preoperative planning and determination of the appropriate indication.

Results of Iliac Branch Devices in Octogenarians Within the pELVIS Registry.

Purpose: To evaluate if the elderly could benefit from the implantation of iliac branch devices (IBDs) to preserve the patency of the internal iliac artery (IIA) in aneurysms involving the iliac bifurcation. Materials and Methods: From January 2005 to April 2017, 804 patients enrolled in the pELVIS registry underwent endovascular aneurysm repair with 910 IBDs due to aneurysmal involvement of the iliac bifurcation. Among the 804 patients, 157 (19.5%) were octogenarians (mean age 82.9±2.5 years; 157 men) with 171 target IIAs for preservation. Outcomes at 30 days included technical success, death, conversion to open surgery, and major complications. Outcomes evaluated in follow-up were patency of the IBD and target vessels, type I and type III endoleaks, aneurysm-related reinterventions, aneurysm-related death, and overall patient survival. Kaplan-Meier analyses were employed to evaluate the late outcome measures; the estimates are presented with the 95% confidence interval (CI). Results: Technical success was 99.4% with no intraoperative conversions or deaths (1 bridging stent could not be implanted, and the IIA was sacrificed). Perioperative mortality was 1.9%. The overall perioperative aneurysm-related complication rate was 8.9% (14/157), with an early reintervention rate of 5.1% (8/157). Median postoperative radiological and clinical follow-up were 21.8 months (range 1-127) and 29.3 months (range 1-127), respectively. Estimated rates of freedom from occlusion of the IBD, the IIA, and the external iliac artery at 60 months were 97.7% (95% CI 96.1% to 99.3%), 97.3% (95% CI 95.7% to 98.9%), and 98.6% (95% CI 97% to 99.9%), respectively. Estimated rates of freedom from type I and type III endoleaks and device migration at 60 months were 90.9% (95% CI 87% to 94.3%), 98.7% (95% CI 97.5% to 99.8%), and 98% (95% CI 96.4% to 99.6%), respectively. Freedom from all cause reintervention at 60 months was 87.4% (95% CI 82.6% to 92.2%). The estimated overall survival rate at 60 months was 59% (95% CI 52.4% to 65.6%). Conclusion: IBD implantation in octogenarians provided acceptable perioperative mortality and morbidity rates, with satisfying long-term freedom from IBD-related complications and should be considered a feasible repair option for selected elderly patients affected by aneurysms involving the iliac bifurcation.

Bilateral Use of Iliac Branch Devices for Aortoiliac Aneurysms Is Safe and Feasible, and Procedural Volume Does Not Seem to Affect Technical or Clinical Effectiveness: Early and Midterm Results From the pELVIS International Multicentric Registry.

OBJECTIVE: To evaluate early and follow-up outcomes following bilateral use of iliac branch devices (IBD) for aortoiliac endografting and assess the impact of center volume. We used data from the pELVIS international multicentric registry. METHODS: For the purpose of this study, only those patients receiving concomitant bilateral IBD implantation were analyzed. To assess the impact that procedural volume of bilateral IBD implantation could have on early and follow-up outcomes, participating institutions were classified as Site(s) A if they had performed >10 and/or >20% concomitant bilateral IBD procedure, otherwise they were classified as Site(s) B. Endpoints of the analysis included early (ie, 30-day) mortality and morbidity, as well as all-cause and aneurysm-related mortality during follow-up. Additional endpoints that were evaluated included IBD-related reinterventions, IBD occlusion or stenosis requiring reintervention (ie, loss of primary patency), and IBD-related type I endoleak. RESULTS: Overall, 96 patients received bilateral IBD implantation (out of 910 procedures collected in the whole pELVIS cohort), of whom 65 were treated at Site A (ie, Group A) and 31 were treated at Site(s) B (ie, Group B). In total, only 1 death occurred within 30 days from bilateral IBD implantation, and 9 patients experienced at least 1 major complication without any significant difference between subjects in Group A versus those in Group B (10.8% vs 6.5%, p=0.714). In the overall cohort, the 2-year freedom from IBD-related type I endoleaks and IBD primary patency were 96% and 92%, respectively; no significant differences were seen in those rates between Group A or Group B (95% vs 100%, p=0.335; 93% vs 88%, p=0.470). Freedom from any IBD-related reinterventions was 83% at 2 years, with similar rates between study groups (85% vs 83%, p=0.904). CONCLUSIONS: Within the pELVIS registry, concomitant bilateral IBD implantation is a safe and feasible technique for management of aortoiliac aneurysms in patients with suitable anatomy. Despite increased technical complexity, effectiveness of the repair is satisfactory with low rates of IBD-related adverse events at mid-term follow-up. Procedural volume does not seem to affect technical or clinical outcomes after bilateral use of IBD, which remains a favorable treatment option in selected patients.

The PROTAGORAS 2.0 Study to Identify Sizing and Planning Predictors for Optimal Outcomes in Abdominal Chimney Endovascular Procedures.

OBJECTIVE: The aim was to identify predictors of adequate pre-operative sizing and planning for chimney endovascular aortic repair (ChEVAR) in order to reduce the incidence of persistent type Ia endoleaks (IaELs) without influencing chimney graft (CG) patency. METHODS: Consecutive patients who underwent ChEVAR between January 2009 and December 2017 at a single centre were evaluated retrospectively. Included were patients treated with one device combination (Medtronic Endurant mated with Getinge Advanta V12/iCast) and placement of single or double CG. The freedom from IaEL related re-interventions and primary CG patency was estimated by measuring aortic stent graft oversizing (OS), total neck length (TNL), and a composite parameter (L-OS: TNL [mm] + OS [%]). RESULTS: Seventy-three patients who underwent placement of 101 CGs (45 single, 28 double) met the inclusion criteria. The median radiological follow up was 25.5 (interquartile range [IQR] 12-48) months. Freedom from IaEL related re-intervention was achieved in 94.6% with a median OS of 38.5% (IQR 30%-44%, p = .004), TNL 19 mm (16-25 mm, p = .62), and L-OS 59 (51-65, p = .018). Primary CG patency was achieved in 95% of the cases with a median OS of 36% (29%-42%, p = .008), TNL 19 mm (15.5-26 mm, p = .91), and L-OS 57 (50-64, p = .005). By using the receiver operating characteristic curve, an optimal cut off to prevent IaEL related re-interventions was identified by an OS of 30% (p < .001; L-OS 55, p = .006) and to avoid CG stenosis/occlusions by OS 42% (p < .001; L-OS 65, p < .001). In multivariable analysis, aortic endograft OS was the only independent parameter preventive for IaEL related re-intervention (odds ratio, 0.78; 95% confidence interval, 0.61-0.99). CONCLUSION: With the Endurant-Advanta V12/iCast combination, an aortic stent graft OS of at least 30% (range 30%-42%) should be used to avoid type Ia endoleaks and likewise to ensure CG patency.

Treatment of iliac atherosclerotic lesions using the balloon-expandable dynamic bare metal stent: One-year outcomes of the BIODYNAMIC single-center retrospective analysis.

OBJECTIVES: Endovascular therapy using balloon expandable stents has become the treatment standard for most iliac atherosclerotic lesions. We aimed to assess the safety and performance of the Dynamic stainless-steel balloon-expanding stent system in this location. METHODS: BIODYNAMIC is a retrospective single center study including consecutive patients with iliac lesions treated with the Dynamic stent system. Not included were implantations inside an endograft. The primary endpoint was freedom from major adverse limb events (MALE) at 12 months, defined as index limb amputation or target lesion revascularization (TLR). Secondary endpoints were procedure success, ankle brachial index (ABI) and Rutherford class change, mortality and freedom from TLR after 12 months. RESULTS: Within two years, 182 patients with 234 lesions in the common iliac artery were enrolled. Rutherford class 5 and 6 were present in 11.5% of patients, average stent diameter was 8.0 ± 0.5 mm and stented length 40.0 ± 15.3 mm. The primary endpoint was reached in 96.2% (225/234) of the cases, with six TLR (2.6%) and three target limb amputations (1.3%). Procedure success was obtained in all but three patients (98.4%). In paired analysis, ABI improved by 0.25 ± 0.21 from baseline to 0.90 ± 0.16 post-procedure and Rutherford class improved by -1.75 ± 1.53. There were four non-device-related deaths (2.2%). Freedom from TLR was 97%, 95.3%, 94% and 92.7% at 24, 36, 48 and 60 months, respectively. CONCLUSION: The Dynamic balloon-expandable stent system proved to be safe and effective in a population with common iliac artery lesions.

The role of surgical and total endovascular techniques in the treatment of ruptured juxtarenal aortic aneurysms.

Background: Ruptured juxtarenal aortic aneurysms (RJAAA) represent a special challenge in clinical practice, but the evidence to guide therapeutic decision-making is scarce. The aim of this study was to present two different approaches, open surgical (OAR) and chimney endovascular repair (CHEVAR), for treating patients with RJAAA. Patients and methods: This retrospective two-center study included all patients per center undergoing OAR or CHEVAR for RJAAA between February 2008 and January 2020. Juxtarenal aortic aneurysms were defined as having an infrarenal neck of 2-5 mm, measured after three-dimensional reconstruction of the computed tomography angiography scan. Results: 12 OAR patients (10 male, median age 73 years [58-90 years]) and 6 CHEVAR patients (all male, median age 74 years [59-83 years]) were included. In the OAR group, the proximal aortic clamping was suprarenal in 7 and interrenal in 5 patients. Cold renal perfusion was used in 4 patients, in 2 with suprarenal aortic clamping and in 2 with interrenal aortic clamping. 3 CHEVAR patients received a single renal chimney, the other 3 received double renal chimneys. Technical success was 12/12 in the OAR group 5/6 in the CHEVAR group. In-hospital mortality and 30-day mortality were 3/12 after OAR and 0/6 after CHEVAR. 2 OAR patients required transient dialysis. Median in-hospital stay was 14 (10-63) and 8 (6-21) days and median follow-up (FU) was 20 (3-37) and 30 (7-101) months, respectively. No further deaths occurred during FU. One OAR patient and 4 CHEVAR patients required aortic reinterventions. Conclusions: RJAAAs are rare. Both OAR and CHEVAR can represent adequate treatments for RJAAAs. OAR is the traditional approach, but CHEVAR has - in a high-volume center - promising early results with nonetheless a need for continuous FU to prevent reinterventions. Defining the studied aortic pathology precisely is essential for future research in order to draw valid conclusions.

Late outcomes of different hypogastric stent grafts in aortoiliac endografting with iliac branch device: Results from the pELVIS Registry.

OBJECTIVE: The objective of this study was to evaluate long-term results of self-expanding vs balloon-expandable hypogastric stent grafts in conjunction with iliac branch devices (IBDs) for aortoiliac aneurysm repair in a multicenter experience (pErformance of iLiac branch deVIces for aneurysmS involving the iliac bifurcation [pELVIS] Registry). METHODS: All patients electively treated for aortoiliac aneurysm with the Cook IBD (Cook Medical, Bloomington, Ind) in nine European centers were reviewed. Clinical and imaging data were prospectively collected in each center, and a multicenter database was created and interrogated. The primary outcome was the primary patency of the IBDs. For the purpose of this investigation, three subgroups were identified: patients receiving a hypogastric balloon-expandable stent graft (BESg); those with a self-expanding stent graft (SESg); and those with any stent graft plus relining with a bare-metal stent (RESg). RESULTS: Between 2005 and 2017, there were 691 patients who underwent 747 elective endovascular repairs of aortoiliac aneurysms (n = 518 [75.0%]) or isolated iliac aneurysms (n = 173 [25.0%]) with Cook IBDs (n = 56 bilateral) in nine European centers. Mean age was 72 years (range, 41-93 years); 658 (95.2%) patients were male. In 364 patients (52.7%), BESg was used; in 127 (18.4%), SESg; and in 200 (28.9%), RESg. At 30 days, there were 3 (0.4%) perioperative deaths, 3 (0.4%) technical failures, 7 (1.0%) graft thromboses, 30 (4.3%) reinterventions, and 1 (0.1%) conversion to open repair. After a mean follow-up of 32 months (range, 0-128 months), 28 (3.7%) IBD occlusions and 17 (2.3%) IBD-related endoleaks occurred. In 10 patients, iliac diameter increased >5 mm (1.4%). Overall primary patency was 99.2% at 1 month, 97.9% at 12 months, and 95.1% at 72 months. Primary patency was not significantly different in the BESg vs SESg or RESg cohorts (P = .4). During follow-up, there were 126 (18.2%) reinterventions, 93 (13.5%) of which were IBD related, including 11 (1.6%) conversions. Overall, freedom from reintervention and conversion was 90.4% at 12 months and 71.0% at 72 months. IBD-related reinterventions during follow-up in the three cohorts were not significantly different (P = .3) Overall survival was 71.3% at 72 months without differences between the subgroups. At multivariate analysis, aneurysmal hypogastric artery (P < .001; Exp [B] = 4.44) and bilateral treatment (P = .02; Exp [B] = 1.87) were associated with an increase in late failure. CONCLUSIONS: In this wide real-world experience, long-term results of endovascular treatment of aortoiliac aneurysms with the IBD are favorable, with a low rate of late graft occlusion and aneurysm-related death. No significant differences in clinical outcomes were observed in patients receiving hypogastric BESg vs SESg or endovascular relining.

Results of chimney endovascular aneurysm repair as used in the PERICLES Registry to treat patients with suprarenal aortic pathologies.

BACKGROUND: The prevailing evidence calls for using chimney/snorkel endovascular repair (ch-EVAR) with one or two chimney grafts. No studies up to now focus on its applicability and results for the treatment of suprarenal aortic pathologies (SRAP). Hence, we evaluated the clinical and radiologic results of ch-EVAR treatment for SRAP placing three or more chimney grafts within the PERICLES Registry. METHODS: Data from 517 patients suffering complex aortic pathologies treated by ch-EVAR between 2008 and 2014 at 13 European and U.S. centers were retrospectively reviewed and analyzed. RESULTS: Sixty-seven ch-EVAR-treated patients (12.9% of the entire PERICLES cohort) presented SRAP (83.5% elective, 16.5% urgent). The majority of patients (95.5%) received three chimney grafts; four patients received four chimney grafts. The Endurant device was the most commonly used (35.8%) followed by the Zenith abdominal endograft (19.4%). Overall, 204 chimney grafts were placed (56.7% covered self-expandable, 40.3% covered balloon-expandable stents, and 10.4% bare metal balloon-expandable stents). At a median follow-up of 24 months (range, 0.1-67.0 days), 30-day mortality was 6.1% (4 patients), and the overall mortality was 16.4% (11 patients). Overall survival was 87.4% (range, 79.5%-96.0%) at 1 year, 81.8% (range, 72.2%-92.2%) at 2 years and thereafter. Type IA endoleak was noted in nine patients (13.4%) intraoperatively and successfully treated in seven cases (97.1% technical success). Aneurysm sac diameter significantly decreased from 70.5 ± 19.3 mm to 66.9 ± 20.6 mm (P < .001) at last follow-up. Ischemic stroke or transient ischemic attack were noted in two patients (2.9%). Chimney occlusion was detected in six renal arteries (9.5%) and two superior mesenteric arteries (3.2%). No patients required chronic hemodialysis. All occluded superior mesenteric artery grafts were successfully rescued using endovascular approaches. CONCLUSIONS: The midterm use of ch-EVAR for the treatment SRAP seems to be safe, highlighting its applicability for the treatment of rupture threatening pathologies and seal zone lengthening as in type IA endoleaks after EVAR. However, the incidence of type IA endoleaks, chimney graft occlusions, and ischemic stroke rates is higher compared with the prevailing single chimney evidence. Longer follow-up with more cases is needed to establish the exact performance of this treatment in SRAP.

Prognosis review and time-to-event data meta-analysis of endovascular aneurysm repair outside versus within instructions for use of aortic endograft devices.

BACKGROUND: Our objective was to investigate whether patients undergoing standard endovascular aneurysm repair (EVAR) outside the instructions for use (IFU) have worse outcomes than patients treated within IFU. METHODS: We conducted a systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Electronic bibliographic sources were searched up to January 2019 using a combination of controlled vocabulary (thesaurus) and free-text terms to identify studies comparing outcomes of EVAR in patients treated outside versus within IFU. Pooled estimates of dichotomous outcomes were calculated using odds ratio (OR) or risk difference (RD) and 95% confidence interval (CI). We conducted a time-to-event data meta-analysis using the inverse-variance method and reported the results as summary hazard ratio (HR) and associated 95% CI. Random-effects methods of meta-analysis were applied. We formed meta-regression models to explore heterogeneity as a result of changes in practice over time. RESULTS: We identified 17 observational cohort studies published between 2011 and 2017, reporting a total of 4498 patients. The pooled prevalence of EVAR performed outside the IFU was 40% (95% CI, 33-48). Nonadherence to IFU was not associated with increased risk of perioperative mortality (RD, 0.01; 95% CI, -0.00 to 0.01; P = .23), aneurysm rupture (HR, 1.34; 95% CI, 0.30-5.93; P = .70), aneurysm-related mortality (HR, 0.88; 95% CI, 0.20-3.84; P = .86), technical failure (RD, 0.01; 95% CI, -0.03 to 0.05; P = .56), requirement for adjunctive procedures (OR, 1.48; 95% CI, 0.81-2.71; P = .20), type I endoleak (HR, 2.28; 95% CI, 0.58-8.91; P = .24), aneurysm sac expansion (HR, 0.86; 95% CI, 0.55-1.33; P = .49), or aneurysm-related reintervention (HR, 1.04; 95% CI, 0.81-1.34; P = .74). The overall mortality was significantly higher in patients treated outside the IFU (HR, 1.20; 95% CI, 1.02-1.42; P = .03). Meta-regression showed that the prevalence of EVAR performed outside the IFU has increased over time (P = .019). CONCLUSIONS: Standard EVAR outside the IFU was not found to have worse aneurysm-related outcomes than treatment within the IFU. Standard EVAR outside the IFU could be considered in selected patients who are deemed high risk for complex open or endovascular surgery.

Use of Stainless-Steel, Balloon-Expandable Chimney Grafts Is Durable Though Caution Is Required When Lining Angulated Renal Arteries.

PURPOSE: To analyze the overall performance of flexible nitinol stents used to line chimney grafts (CGs) during chimney endovascular aneurysm repair (chEVAR) of pararenal pathologies. MATERIALS AND METHODS: A retrospective review was conducted of all 116 elective patients (mean age 74.3±7.2 years; 103 men) who underwent chEVAR with balloon-expandable Advanta V12/iCAST CGs in combination with the Endurant stent-graft between January 2009 and December 2017 at a single center. CG lining with a nitinol stent was electively performed in 43 target vessels of 32 patients. The Kaplan-Meier method was used to estimate the primary outcomes of CG patency and freedom from reintervention (FFR) at the patient level and according to the use of a stent to line the CG. Estimates are reported with the 95% confidence interval (CI). Adjusted odds ratios (ORs) were calculated to identify any confounding effect between the presence/absence of a stent lining or according to the number of CGs. RESULTS: The mean radiological follow-up was 27.3 months (range 22.1-32.6). During this time, 8 CGs (4.7%) became occluded, 6 of them were lined with stents. Restoration of patency was possible in 3 of the 4 occluded stents that were associated with symptoms. First-year primary patency estimates were 96.9% (95% CI 92.5% to 100%) for the unlined group vs 77.1% (95% CI 58% to 95.3%; p=0.001) for the lined group, while FFR was 87.6% (95% CI 79.9% to 95.2%) vs 83.4% (95% CI 68.1% to 98.6%; p=0.82), respectively. Lining represented an independent risk factor for CG occlusion (OR 9.9, p=0.006). CONCLUSION: CG lining performed mainly in angulated renal arteries during chEVAR was significantly associated with CG occlusion. These findings highlight the importance of not having the distal part of the CG impinge on the angulated segment of the target vessel.