Early multicentric outcomes of the on-label and CE-marked combination of the Endurant with the Radiant chimney graft for the chimney endovascular aortic repair (EnChEVAR): The LaMuR Registry.

BACKGROUND: The aim of this study was to evaluate the early results of the CE-marked standardized device combination consisting of Endurant and the Radiant chimney graft (En-ChEVAR) for the treatment of juxtarenal aortic aneurysms. METHODS: We analyzed multicentric non-industry sponsored case series evaluating the EnChEVAR technique for patients treated between December 2022 and February 2024. Clinical, perioperative procedure-related and radiological data were collected. The primary outcome measure was the freedom of a type Ia gutter-related endoleak at postoperative computed tomography angiography (CTA). Secondary outcome measures included early type Ia endoleak-related reinterventions, target vessel complications including dissection or loss of target vessel, major adverse events, and mortality. Continuous variables were presented as median (interquartile range [IQR]) and categorical variables as count and percentage. RESULTS: Ten patients were included in the present study. Eight (80%) were males, in nine cases a single chimney was implanted, and the other one was a double chimney graft placement. The treated aneurysms had an infrarenal neck length of 3.4 (1.2) mm. The rate of main body oversizing was 30%. The new neck length after chimney graft placement was 18 (3) mm. The median procedural time was 130 (17) mm, contrast medium use was 109 (26) mL, radiation time was 45 (12) min. The technical success was 100%. No type Ia endoleak was detected at the postoperative CTA. There were no target vessel issues. No major adverse events or death were observed. CONCLUSIONS: First reported cohort of patients treated with EnChEVAR demonstrated reproducible clinical and procedural outcomes within the 3 vascular centers with total exclusion of the aneurysms, patent renal arteries, and no evidence of gutter-related type IA endoleak. Further evidence with larger sample size of treated patients and longer follow-up are needed.

Latest evidence on chimney endovascular repair of abdominal aortic aneurysms and the renal artery angulation pitfall.

This article summarizes the key findings in literature up to date on the endovascular treatment of complex abdominal aortic aneurysms (AAAs) employing the chimney technique. Additionally, an unexplored pitfall is described regarding the target vessel angulation. Although balloon-expandable covered stents present more favorable configuration in downward-oriented target vessels, transverse and upward-oriented target vessels may benefit from other endovascular techniques imploring careful case planning and further investigation on the topic.

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.

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.

Assessment of Sirolimus- vs. paCLitaxEl-coated balloon angioPlasty In atherosclerotic femoropopliteal lesiOnS (ASCLEPIOS Study): preliminary results.

BACKGROUND: There appears to be an association between paclitaxel-coated devices and increased 5-year all-cause mortality. METHODS: We are conducting a prospective, randomized, controlled, single-center, noninferiority study. All consecutive patients with femoropopliteal arterial disease who fulfilled the inclusion/exclusion criteria are sequentially and consecutively assigned to either paclitaxel (Ranger, Boston Scientific) or sirolimus (MagicTouch, Concept Medical) coated balloon angioplasty treatment. The primary outcome are procedural success and primary vessel patency at index procedure. The secondary outcomes are 30-day and 12-month freedom from MAEs (amputation, death, TLR/TVR, MI, distal embolization that requires a separate intervention or hospitalization), procedural success (≤30% residual diameter stenosis or occlusion after the procedure), Rutherford category improvement (reduction ≤1 category) and ABI improvement (increase ≥0.10 from baseline). RESULTS: A total of six patients have been enrolled in the present study up to now. The mean age was 72.6 years old and five were male. All patients had angiographic evidence of isolated occlusion in the transition segment of the distal femoral superficial artery in the popliteal artery. The mean length was 109 mm. Three patients were treated by sirolimus-coated (group A) and three by paclitaxel coated balloon angioplasty (group B). The primary patency and procedural success was in two of three and three of three patients, for group A and B, respectively. CONCLUSIONS: Preliminary results show safety and feasibility of the Sirolimus-coated balloon angioplasty. Further investigation and increase of sample size will allow for more sustained conclusions regarding patency and procedural success of this type of balloons for the endovascular treatment of peripheral arterial disease.

Technical performance and reproducibility following rotational atherectomy of femoropopliteal artery occlusive lesions: analysis of the multicenter MORPHEAS Registry.

BACKGROUND: The purpose of this study was to define patient and anatomical factors associated with technical results specific to rotational atherectomy. Controversy exists surrounding appropriate utilization of atherectomy to treat femoral-popliteal atherosclerosis. Importantly, the existence of different atherectomy devices and lack of technical reports highlighting variables that impact outcomes obscures the ability to assess perioperative performance. METHODS: The nonindustry sponsored, Multicentric National Registry on the use of rotational atherectomy in femoral-popliteal occlusive atherosclerotic disease (MORPHEAS) database was queried. The MORPHEAS investigators included experienced providers at four centers who previously had not utilized rotational atherectomy. The primary endpoint was flow-limiting dissection and/or >50% recoil resulting in stent-placement while a secondary endpoint included peripheral thromboembolism incidence. RESULTS: One hundred thirteen patients were enrolled. Only femoropopliteal occlusions were included in the analysis and anatomic distribution and calcification severity were depicted separately. The most common adjunctive therapy was drug-coated balloon angioplasty (84%; N.=96). Flow-limiting dissection was identified in 16% (N.=18) and thromboembolism occurred in 4% (N.=4). Diabetes increased risk of thromboembolism (P=0.03) while lesion length ≥8.0 cm (P=0.07) and SFA-popliteal adductor canal location (P=0.01) were associated with flow-limiting dissection. In multivariable analysis, SFA-popliteal adductor canal occlusion had a 4.7-fold risk of perioperative complications (OR=4.7, 95%CI: 1.1-21.0; P=0.04). CONCLUSIONS: Rotational atherectomy was characterized by reproducible performance among four centers; however, diabetic patients, as well as those with long-segment, heavily calcified SFA-popliteal adductor canal occlusion present greatest risk of complications.

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.

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.

Outcomes of endosutured aneurysm repair with the Heli-FX EndoAnchor implants.

OBJECTIVE: Endovascular aneurysm repair has gained field over open surgery for the treatment of abdominal aortic aneurysm. However, type Ia endoleak represents a common complication especially in hostile neck anatomy that is recently faced using endoanchors. We conducted a systematic review and meta-analysis to collect and analyse all the available comparative evidence on the outcomes of the endosuture aneurysm repair in patients with or without hostile neck in standard endovascular aneurysm repair. METHODS: The current meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All the prospective and retrospective studies reporting primary use of the Heli-FX EndoAnchor implants were considered eligible for inclusion in this study. The main study outcomes (technical success of endoanchor implantation, incidence of type Ia endoleak, aortic stent graft migration and the percentage of patients who presented regression or expansion of aneurysm sac throughout the follow-up) were subsequently expressed as proportions and 95% confidence intervals. RESULTS: Eight studies with a total of 968 patients were included in a pooled analysis. The technical success of the primary endoanchor fixation was 97.12% (95%CI: 92.98-99.67). During a mean six months follow-up period, a pooled rate of 6.23% (95%CI: 0.83-15.25) of the patients developed a persistent type Ia endoleak despite the primary implantation. Migration of the main graft was reported in five studies, in which a 0.26% (95%CI = 0.00-1.54) of the patients required an additional proximal aortic cuff. Regression of the aneurysm sac was observed at 68.82% (95%CI: 51.02-84.21). An expansion of the aneurysm sac was found in 1.93% (95%CI: 0.91-3.24) of the participants. The overall survival rate was 93.43% (95%CI: 89.97-96.29) at a mean six months follow-up period. CONCLUSIONS: Endosuture aneurysm repair with the Heli-FX EndoAnchor implants seems to be technically feasible and safe either for prevention or for repair of intraoperative type Ia endoleak. Despite the primary implants of endoanchors, few cases of persistent type Ia endoleak and migration are still conspicuous. Long-term follow up is needed to determinate the role of this therapeutic option in the treatment of aortic aneurysms.

Cost-effectiveness analysis of chimney/snorkel versus fenestrated endovascular repair for high-risk patients with complex abdominal aortic pathologies.

BACKGROUND: The aim of this study was to evaluate the cost-effectiveness of chimney (ch-EVAR) vs. fenestrated aneurysm repair (f-EVAR) for treatment of complex abdominal aortic pathologies. Endovascular repair of complex abdominal aortic pathologies with involvement of renal arteries includes use of f-EVAR as first line treatment. However, lack of availability and suitability has necessitated an alternative strategy employing parallel or snorkel/chimney grafts (ch-EVAR). METHODS: Between January 2013 and January 2017, prospectively collected data of elective and symptomatic patients with complex aortic pathologies treated by single or double ch-EVAR (N.=111) or by f-EVAR with three fenestrations (N.=37) were evaluated. The primary endpoint was cost-effectiveness analysis defined as the summary of material costs, in-hospital costs and additional costs due to procedure-related reinterventions during a follow-up period averaging 37.2 months. RESULTS: No differences between both groups were found in terms of demographics (P=0.32), age (P=0.058) and hospital stay at initial procedure (P=0.956). Index procedure and hospitalization median costs were € 22,171 for ch-EVAR and € 42,116 for f-EVAR, respectively (P<0.001). The median overall costs including costs after reinterventions during follow-up were € 22,872 for ch-EVAR and € 42,128 for f-EVAR (P<0.001). Six patients (5.4%) in the ch-EVAR group required readmission compared to three patients (8.1%) required readmission for reinterventions in the f-EVAR group (P=0.69). CONCLUSIONS: Ch-EVAR is significantly more cost-effective compared to f-EVAR. The two procedures have comparable readmission rates for reinterventions.

Partial Renal Coverage after Endovascular Aortic Aneurysm Repair with Suprarenal Fixation Seems Not to be Associated with Early Renal Impairment.

BACKGROUND: Efforts to achieve optimal seal during endovascular aortic aneurysm repair (EVAR) may produce partial coverage of the lowest renal artery and in some cases even occlusion. This coverage might alter the renal ostial flow, which could finally affect renal function. We sought to evaluate the incidence of renal ostium coverage and its possible effects on renal function. METHODS: All patients undergoing elective EVAR with suprarenal fixation devices between January 2014, and December 2017, at our institution were identified. Patients with preoperative and postoperative computed tomography angiography (CTA), as well as the preoperative, postoperative, and one year postintervention creatinine levels and estimated glomerular filtration rate (eGFR) were included in the present study. Patients in hemodialysis, with a preoperative eGFR <30 mL/min, urgent EVAR, neck adjunctive procedures, excessive aortic thrombus, or procedure-related reintervention were excluded. RESULTS: A total of 127 patients received EVAR for aortoiliac aneurysmatic pathologies between January 2014, and December 2017. Forty-three of them met the inclusion criteria having a median follow-up of 18.8 months (range; 12.0-53.9). Twenty-six (60.5%) patients presented at least one criterion of hostile neck condition and 23 (53.5%) had a preoperative eGFR <60 mL/min. The average distance from the proximal endograft fabric to the lower renal artery was 1.5 mm (range, 0.0-6.0) while a total of 15 renal ostia (34.9%) suffered unintended partial coverage (range, 20 to 75% of the renal ostium) in the postoperative CTA. Nine of these patients (60%) had a hostile neck condition. Eight patients (18.6%) suffered significant deterioration (>20% of the eGFR), 27 patients (62.8%) maintained their renal function and 8 (18.6%) presented an improvement of the eGFR in the latest available blood sample. Renal function impairment showed no significant association with renal ostium coverage (P = 0.561), hostile neck condition (P = 0.973), or the diameter of the renal artery (P = 0.835). In the subgroup analysis, patients with the eGFR <60 mL/min did not show significantly greater renal function deterioration (P = 0.568). CONCLUSIONS: Partial renal coverage is not an uncommon phenomenon occurring in one-third of the treated patients. However, it was not associated with renal function impairment in the early term. Further studies with longer follow-up are needed to confirm our results in the long haul.

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.

Coexisting hypogastric aneurysms worsen the outcomes of endovascular treatment by the iliac branch devices within the pELVIS Registry.

OBJECTIVE: Hypogastric aneurysms (HAs) frequently coexist with aortoiliac aneurysms (AIAs). However, the presence of an HA is a contraindication to endovascular aneurysm treatment by iliac branch devices (IBDs) because of the risk of distal sealing-related endoleaks. No robust evidence exists in the published literature, and therefore we sought to evaluate the performance of IBDs in the presence of HAs within a multicenter registry of nine vascular centers. METHODS: Clinical and radiographic information of 804 patients with AIAs treated by IBDs was retrospectively reviewed and analyzed using prearranged, defined, and documented protocols. The treatment period was between January 2005 and April 2017. RESULTS: HA was present in 315 (32.6%) of the overall 910 deployed IBDs. Mean radiologic follow-up was 32 months. The incidence of incomplete aneurysm exclusion and type I endoleak was 3% in the HA group vs 0.7% in the non-HA group (P = .019). The 5-year freedom from IBD-related type I endoleak was 93% vs 98% in the HA group vs the non-HA group, respectively (P = .006). Subgroup analysis of the HA group revealed that use of a single distal bridging stent graft vs multiple bridging devices led to higher rate of type I endoleak (9.6% vs 2.8%; P = .031), branch occlusions (8.3% vs 0.9%; P = .009), and buttock claudication (7.6% vs 1.9%; P = .038). CONCLUSIONS: This series of AIAs with HAs is the largest reported. It shows that HAs coexisting with AIAs, when treated with IBDs, have significantly worse outcomes. Lengthening the distal landing zone with more than one bridging stent graft into the distal healthy hypogastric artery or one of its main branches improves outcomes.