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.

Impact of Calcification on the Outcomes of Femoropopliteal Artery Endovascular Treatment Using a Polymer Coated Drug-Eluting Stent.

PURPOSE: The aim of this study was to analyze the impact of calcification on the 12 and 24 months outcomes of the Eluvia™ (Boston Scientific®) drug-eluting stent (DES) for femoropopliteal occlusive disease using three different calcium scoring systems. MATERIAL AND METHODS: A single-center, retrospective cohort-study (March-2016 to December-2018) of patients treated with the Eluvia™ DES for femoropopliteal atherosclerosis was performed. Outcomes included primary and secondary patency rates and freedom from target lesion revascularization (FTLR) and were analyzed by comparing the impact of calcium burden according to the following calcium scores: Peripheral Arterial Calcium Scoring System (PACSS) score, number of vessel quadrants affected (0-4) and calcification score per Peripheral Academic Research Consortium (PARC) definitions. RESULTS: In total, 111 Patients were included (mean age: 71.2 ± 7.9; 64% male). Most patients presented with Rutherford class 3 (79.9%), followed by class 5 (12.7%), class 4 (10%) and class 6 (6.4%). The mean lesion length was 197.6 ± 108.5 mm and 74.3% of patients had chronic total occlusions. There were no differences in primary patency between the calcification scores at 12 months (PACSS, LogRank = 0.28; quadrants, LogRank = 0.29; PARC, LogRank = 0.42) and 24 months (PACSS, LogRank = 0.13; quadrants, LogRank = 0.42; PARC, LogRank = 0.13). FTLR was significantly lower at 12 months in patients with calcification affecting 3 or 4 quadrants (LogRank = 0.022) but not at 24 months (LogRank = 0.36). CONCLUSIONS: In this study, the Eluvia™ DES showed promising performance in calcified disease and the analysis according to the quadrant model predicted an increased risk for TLR at 12 months.

Use of Secondary Iliac Branch Devices after Previous Endovascular Abdominal and Thoraco-Abdominal Aortic Aneurysm Repair.

OBJECTIVE: To assess the safety and effectiveness of iliac branch devices (IBDs), as secondary procedure, for the treatment of type Ib endoleak or evolution of iliac artery disease after prior endovascular aortic repair (EVAR) for thoraco-abdominal (TAAAs) or abdominal aortic aneurysms (AAAs). METHODS: A multicentre observational study of three European centres. The study included 75 patients (age 71 ± 9 years, 96% men) with previous EVAR (n = 64, 85%) or fenestrated or branched (FB) EVAR (n = 11, 15%). Overall, 88 IBDs were implanted to treat aneurysmal iliac artery evolution in 40 (53%) and type Ib endoleak in 35 (47%) cases, respectively. Thirteen (17%) patients received bilateral IBDs. Internal iliac artery (IIA) catheterisation was done through a transaxillary access (n = 82, 93%) or up and over (n = 6, 7%) technique. The primary endpoint was technical success. Secondary endpoints were 30 day major adverse event, early and long term freedom from re-intervention and target vessel instability. RESULTS: All procedures were technically successful (100%). During hospitalisation, there were four (5%) major adverse events and three (4%) early re-interventions, but no death, stroke, or damage to previous endografts. The median follow up was 47 (interquartile range 42) months, and the five year survival rate was 78 ± 6% with no aortic related death. Cox's regression analysis showed pre-operative renal function impairment (hazard ratio [HR] 3.4; 95% confidence interval [CI] 1.1 - 10.1; p = .033), and primary TAAA repair (HR 6.1; 95% CI 1.6-22.3; p = .006) as independent factors for long term mortality. Freedom from re-interventions was 85 ± 4% at five years with 11 (12%) cases (five endoleaks, four IBD thromboses, two stenoses). IIA instability was reported in three (3%) limbs and freedom from IIA instability was 95 ± 3% after 60 months. CONCLUSION: Secondary IBD after EVAR is a safe and effective procedure with high technical success and low complication rates. The technique of choice to revascularise the IIA seems not to affect early and follow up results. Long term durability of IBD repair is acceptable with low rates of IIA re-intervention.

Long-term Results of Angulated Versus Hyperangulated Neck in Endovascular Aneurysm Repair With Endurant Endoprosthesis.

PURPOSE: Patients with a hyperangulated (>60°) proximal aortic neck and at high risk of open surgery have been treated with endovascular aortic repair (EVAR). However, long-term outcomes are not well reported. The aim of this study is to compare the technical and clinical success of EVAR in angulated (45°-60°) and hyperangulated (>60°) proximal neck angulation. MATERIALS AND METHODS: The data of all consecutive patients undergoing EVAR treated between November 2007 and February 2020 were collected. A retrospective analysis of this prospective database was performed. The primary measure outcome was technical and clinical success. In addition, we evaluated sack evolution, type IA endoleak, secondary procedures, aneurysm rupture, mortality, aneurysm-related mortality, and migration. RESULTS: In all, 246 of 1353 EVAR patients presented with an angulation of the proximal neck >45°, 130 patients presented with an infrarenal angulation >60°, while 116 patients had an angulation between 45° and 60°. Patients with a hyperangulated infrarenal aortic neck were significantly more often women (8.6% vs 26.9%), older (73.9 vs 76.7 years), and had less often diabetes mellitus (20.7% vs 10.8%). Suprarenal neck angulation and reversed tapered neck were significantly more frequent in the hyperangulated group so that propensity scores were generated using these anatomical parameters to create a matched cohort group. No significant differences in technical (87.9% vs 94.8%) and clinical success (66.4% vs 69.8%) were observed. After a mean clinical follow-up of 58.9 months significantly more secondary procedures were performed in the hyperangulated group (23.3% vs 12.9% p=0.04); however, neck-related secondary procedures were comparable (1.7% vs 6.0%; p=0.09). Also, all-cause and aneurysm-related mortality, sack evolution, type IA endoleak, aneurysm rupture, and migration were comparable for both groups. CONCLUSION: Compared with less angulated proximal aortic neck, hyperangulated neck anatomy did not reduce the technical and clinical success of EVAR but increased the risk of secondary procedures. In patients who are not good candidates for open surgery, EVAR is a reasonable alternative.

Efficacy analysis following polymer coated drug eluting stent and bare metal stent deployment for femoropopliteal arterial disease.

OBJECTIVES: The objective is to assess the performance of the Eluvia polymer coated drug eluting stent (DES) compared to a bare metal stent (BMS) platform in patients with femoropopliteal arterial disease. METHODS: This is a retrospective, single-center analysis. Patients treated with the Eluvia DES (group Eluvia) or the EverFlex BMS (group BMS) for femoropopliteal disease between January 2013 and December 2019 were included. Primary measure outcome of this analysis was the overall mortality. The PTX specific mortality, the primary patency, the amputation free survival (AFS), and the target lesion revascularization (TLR) rates were additionally evaluated. RESULTS: A total of 124 patients were treated by BMS deployment, while the Eluvia platform was preferred in 75 subjects. In both groups the majority presented with lifestyle limiting claudication (BMS: 84% vs Eluvia: 73%, p = 0.73). Chronic total occlusions were more frequent in patients treated by BMS (BMS: 71% vs Eluvia: 84%, p = 0.027), whereas the calcification burden (BMS: 81% vs Eluvia: 76%, p = 0.43) and the median lesion length (in mm, IQR) (BMS: 160 (100 to 240) vs Eluvia: 140 (80 to 229), p = 0.17) were comparable. At 24 months, the overall survival (BMS: 93% vs Eluvia: 89%, hazard ratio (HR): 1.20, 95% confidence interval (CI): 0.55 to 2.64, p = 0.64) and the PTX specific survival (BMS: 95% vs Eluvia: 95%, HR: 1.28, 95% CI: 0.41 to 4.02, p = 0.67) did not differ significantly between the two platforms. No significant difference was observed regarding the 24 months primary patency rate (BMS: 66% vs Eluvia: 78%, HR: 0.65, 95% CI: 0.37 to 1.15, p = 0.18), the freedom from TLR (BMS: 83% vs Eluvia: 89%, HR: 0.81, 95% CI: 0.39 to 1.68, p = 0.572), and the AFS (BMS: 93 vs Eluvia: 89%, HR: 1.20, 95% CI: 0.55 to 2.64). The Cox regression analysis revealed a higher mortality risk among patients with chronic limb-threatening ischemia (CLTI) (HR: 3.14, 95% CI: 1.61 to 6.14, p = 0.008), chronic obstructive pulmonary disease (COPD) (HR: 4.65, 95% CI: 2.14 to 10.09, p = 0.001), in octagenerians (HR: 4.40, 95% CI: 1.92 to 10.44, p = 0.005), and in patients not on statins at baseline (HR: 2.44, 95% CI: 1.19 to 4.99, p=0.014). CONCLUSIONS: In this cohort, the use of the Eluvia DES did not increase the risk for mortality compared to BMS deployment. CLTI, COPD, advanced age, and the lack of statin therapy at baseline were associated with a higher risk for death.

A meta-analysis of safety and efficacy of endovascular aneurysm repair in aneurysm patients with severe angulated infrarenal neck.

OBJECTIVES: A growing number of abdominal aortic aneurysms with severe angulated neck anatomy is treated by endovascular means. However, contradictory early and late outcomes have been reported. Our review and outcome analysis attempted to evaluate the available literature and provide clinicians with a base for clinical implementation and future research. MATERIALS AND METHODS: A systematic review of the literature was undertaken to identify the outcomes of endovascular aneurysm repair in patients with severe infrarenal neck angulation (SNA ≥ 60°) vs non-severe neck angulation (NSNA). Outcome measures included perioperative complications, type 1a endoleak, neck-related secondary procedures, stent graft migration, aneurysm rupture, increase (>5mm) in sac diameter, all-cause and aneurysm-related mortality (PROSPERO Nr.: CRD42021233253). RESULTS: Six observational studies reporting on 5981 patients (1457 with SNA and 4524 with NSNA) with a weighted mean follow-up period of 1.8 years were included. EVAR in SNA compared with NSNA was associated with a higher rate of type 1a endoleak at 30 days (4.0% vs 1.8%; p< 0.00001), at 1 year (2.8% vs 1.9%; p<0.03), at 2 years (4.9% vs 2.1%; p< 0.0002), at 3 years (5.6% vs 2.6%; p< 0.0001). The rate of neck-related secondary procedures was significantly higher at 1 year (6.6% vs 3.9%; p<0.05) and at 3 years (13.1% vs 9%; p<0.05). Graft migration, aneurysm sack increase, aneurysm rupture and all-cause mortality were not statistically different at mid-term. CONCLUSIONS: The use of EVAR in severely angulated infrarenal aortic necks is associated with a high rate of early and mid-term complications. However, aortic related and all-causes mortality are not higher compared to patients with NSNA. Therefore, EVAR should be cautiously used in patients with SNA.

Use of Chimney Technique Does Not Improve the Outcome of Endovascular Aneurysm Repair in Patients With a Hyperangulated and Short Proximal Aortic Neck.

PURPOSE: We hypothesized that extending the proximal landing zone with the chimney technique could be beneficial in patients with a hyperangulated proximal aortic neck, defined as more > 60 degrees. MATERIAL AND METHODS: We retrospectively analyzed the outcome of prospectively collected data of patients treated by endovascular aneurysm repair (EVAR) for infrarenal aortic aneurysm with a hyperangulated proximal aortic neck. In all, 104 out of 130 patients were treated without (Group A) and 24 with the chimney endovascular aortic repair (ChEVAR, Group B). Primary outcome was technical and clinical success according to the reporting standards of the Society of Vascular Surgery. RESULTS: The use of the chimney technique was associated with a significantly longer operation duration (167 vs. 93 min, p < .001), longer fluoroscopy time (44 vs.30 min, p = < .001), and larger amount of contrast medium used (149 vs. 127 ml, p = .03) but did not significantly improve technical (79.2% vs. 87.7%) and clinical success (54.2% vs. 68.9%). Aneurysm-related mortality was higher in group B (8.3% vs. = 0%, p < .001). Type IA endoleak was high in both groups at completion angiography (11.3% in Group A vs. 12.5% in Group B) and at follow-up (10.4% in Group A vs. 4.5% in Group B) without significant difference between the groups. CONCLUSIONS: Our data did not show a benefit of the primary use of the chimney technique in patients with a hyperangulated and short neck, although more studies are required to support this conclusion. Other strategies or new technologies are required for improving EVAR results in aneurysm patients with severe angulated proximal and short neck.

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.

Preliminary Clinical and Radiologic Outcome of Matched Patients with Thoracoabdominal Aortic Aneurysms Treated by Low-Profile vs Standard Profile Branched Aortic Endografts.

BACKGROUND: Durability of low-profile branched aortic stent-grafts (LPSG) in the treatment of patients with thoracoabdominal aortic aneurysms (TAAA) remains unclear. Objective of this study is to compare the outcomes of LPSG with standard profile branched aortic stent-grafts (SPSG). METHODS: Between January 2016 and January 2020, 225 consecutive patients with TAAA were treated by branched endovascular aortic repair (BEVAR). Twenty-four patients who were treated with a LPSG were compared to 24 patients who received SPSG as a control group. Control patients were selected according to aneurysm size (maximum aneurysm diameter) and extension (Crawford classification) as well as availability of adequate preoperative and postoperative CT-angiograms at 24 months. The primary endpoint was ongoing clinical success defined as successful implantation and freedom from aneurysm- or procedure-related death, secondary intervention, type I or III endoleak, infection, thrombosis, aneurysm expansion or rupture and conversion. Secondary endpoints were radiological changes of the branched endograft (migration, shortening, scoliosis, lordosis, and fracture). RESULTS: After a median follow-up of 22.6 (LPSG) and 26.2 months (SPSG), no significant difference was found in terms of technical success (100% in both groups), late mortality (4.2% vs 0%), aneurysm diameter increase (4.2% in both groups) and reinterventions (25% vs 37.5%). Infection, thrombosis, aneurysm expansion or rupture and conversion were not observed. Radiological analysis of aortic graft remodeling showed no fracture and no significant migration, shortening, scoliosis and lordosis of the LPSG (6.1 mm, 7.5 mm, 12.8° and 6.1°) compared to SPSG (3.9 mm, 5.1 mm, 7.9° and 5.6°) after 2 years. CONCLUSION: The clinical and radiological findings of the present study showed no increased mortality and complications for the matched patients who underwent treatment with low-profile vs standard-profile BEVAR. This study provides preliminary evidence of safety and efficacy of low-profile branched endografts in patients with demanding iliac access vessels.

Aortic endograft and bridging stent-graft remodeling after branched endovascular aortic repair.

OBJECTIVES: The results of branched endovascular repair of thoracoabdominal aneurysms are mainly dependent on durability of the graft used. The purpose of this study was to evaluate postoperative aortic main body and bridging stent-graft remodeling, and their impact on bridging stent-graft instability at one year. METHODS: Computed tomoangiographies of 43 patients (43 aortic main body mated with 171 bridging stent-grafts) were analyzed before and after branched endovascular repair as well as after a follow-up of 12 months. Primary endpoint was aortic main body remodeling (migration >5 mm, shortening >5 mm, scoliosis >5° or lordosis >5°). Shortening was defined as a reduced length in the long axis, scoliosis as left-right curvature, and lordosis as antero-posterior curvature. Aortic main body remodeling, aneurysm sac changes, and bridging stent-graft tortuosity were evaluated to study their correlations and the impact on the bridging stent-graft instability. RESULTS: At 12 months, aortic main body remodeling was observed in 72% of the cases, migration in 39.5% (mean 5.21 mm), shortening in 41.9% (mean 5.79 mm), scoliosis in 58.1%, (mean 10.10°), lordosis in 44.2% (mean 5.78°). Migration, shortening, and scoliosis were more frequent in patients with larger aneurysms (p = .005), while scoliosis was significantly more frequent in type II thoracoabdominal aneurysm (p = .019). Aortic main body remodeling was significantly associated to bridging stent-graft remodeling (r: 0.3-0.48). The bridging stent-graft instability rate was 9.3%. Despite a trend toward significance (p = .07), none of the evaluated aortic main body and bridging stent-graft changes were associated with bridging stent-graft instability at 12 months. CONCLUSIONS: Aortic main body remodeling is frequent especially in large and extended thoracoabdominal aneurysm aneurysms. Aortic main body and bridging stent-graft remodeling was significantly correlated. While these geometric changes had no significant impact on bridging stent-graft instability at one year, a close long-term follow-up after branched endovascular repair could predict bridging stent-graft failures.

Long-term Results of Thoracic Endovascular Aortic Repair Using a Low-Profile Stent-Graft.

PURPOSE: To evaluate the long-term results associated with the Zenith Alpha thoracic stent-graft, which was designed to address challenging access vessel anatomy. MATERIALS AND METHODS: A retrospective analysis was conducted of 44 consecutive patients (mean age 72.5±8.3 years; 25 men) treated in a single center between August 2010 and October 2014 with a minimum follow-up of 5 years in survivors. The Zenith Alpha thoracic stent-graft was used to treat thoracic aortic aneurysms (n=37), thoracoabdominal aortic aneurysm (n=5), or penetrating aortic ulcer (n=2). Ten patients (23%) were American Society of Anesthesiologists class IV, and 9 (20%) had nonelective procedures. Access vessel anatomy was demanding (mean minimum diameter 5.4 mm, tortuosity index 1.3). The primary endpoint at 5 years was ongoing clinical success (freedom from aneurysm-/procedure-related death, secondary intervention, type I or III endoleak, infection, thrombosis, aneurysm expansion, rupture, or conversion). Secondary endpoints were freedom from all-cause mortality, device migration, stent fractures, fabric erosions, endoleaks, neurological events, and access vessel complications. RESULTS: The ongoing clinical success was 84% (37 of 44 patients) owing to 4 aneurysm-related deaths (9%), 3 type I or III endoleaks (1 in a deceased patient), and 1 aneurysm expansion without detectable endoleak. There were 3 access vessel complications (7%), and no postoperative neurological events. Migration was observed in 2 cases (5%). There were no stent fractures or fabric tears. CONCLUSION: Despite the alterations in stent-graft design and material to reduce profile, the Zenith Alpha thoracic stent-graft showed favorable long-term results even in multimorbid patients with demanding iliac anatomy.

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.

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.

Outcomes of bridging stent grafts in fenestrated and branched endovascular aortic repair.

OBJECTIVE: Until today, no dedicated bridging stent graft (BSG) has been available for use in fenestrated and branched endovascular aneurysm repair (F/BEVAR). The purpose of this study was to evaluate the clinical performance of the well-known Advanta/iCast V12 (Getinge Maquet, Rastatt, Germany) and the new Viabahn VBX (W. L. Gore & Associates, Flagstaff, Ariz) balloon-expandable stent graft in F/BEVAR. METHODS: Retrospective analysis of prospectively collected data was performed. Inclusion criteria were treatment with fenestrated or branched endografts for complex aortic diseases, implantation of at least one VBX stent graft as a BSG in one of the target vessels, and clinical or radiologic follow-up of 6 months. The primary end point of the study was technical success of all BSGs, defined as placement of the BSG in the desired position with absence of endoleak on final angiography. Secondary end points were freedom from perioperative major adverse events and freedom from reinterventions and mortality at 6 months. Procedural and postoperative data were analyzed. RESULTS: Between December 2017 and July 2018, there were 50 patients (40 male; mean age, 71 years) included. A total of 145 VBX stent grafts were implanted, followed by 57 Advanta V12, 29 Viabahn, and 28 bare-metal stents. There were 126 branches (celiac trunk, 27; superior mesenteric artery, 25; renal arteries, 74) sealed exclusively with VBX. Technical success rate was 98.6%. There were six device-related reinterventions due to type IC endoleaks (n = 4), target vessel stenosis distal to the BSG, and stent graft occlusion in a left renal artery in one case. The perioperative and aneurysm-related mortality was 0%; the 6-month all-cause mortality was 2%. CONCLUSIONS: The used BSGs demonstrated promising preliminary results in F/BEVAR. Further evaluation is mandatory to determine durability of the VBX.

Multicenter Registry about the Use of EndoAnchors in the Endovascular Repair of Abdominal Aortic Aneurysms with Hostile Neck Showed Successful but Delayed Endograft Sealing within Intraoperative Type Ia Endoleak Cases.

BACKGROUND: The durability of endovascular aortic aneurysms repair (EVAR) is highly related to several anatomical constraints. The term "hostile neck" describes several anatomical features that usually make EVAR treatment technically demanding despite having higher risk of failure. The aim of the study was to describe a multicenter experience with EVAR and an adjunctive use of EndoAnchors in hostile neck anatomies. METHODS: Data were prospectively collected from 4 academic vascular centers including 46 patients with a hostile neck treated by standard EVAR with the adjunctive use of EndoAnchors. Twenty-two of them (47.8%, group A) had an intraoperative type Ia endoleak, and 24 (52.2%) patients were treated in a preventive manner (group B). Primary endpoints were technical and procedural success. Secondary endpoints were regression of the aneurysm sac, freedom from type Ia endoleak, and reinterventions. RESULTS: Neck length and diameter showed no statistical difference in preoperative measures, 9.1 ± 6.9 mm and 8.6 ± 2.8 mm and 25.4 ± 4.7 mm and 27.3 ± 4.7 mm, in group A and B, respectively. Aneurysm sac diameter decreased from 58.2 ± 8 mm and 57.9 ± 9.8 mm to 55.7 ± 8.5 mm and 53.8 ± 10.4 mm in group A and B; respectively, at the last computed tomography scan. Technical and procedural success was 97.8% and 100%, respectively, for group B. Group A showed persistence of type Ia endoleak at completion angiogram in 9 (40.9%) patients. Five of them showed early spontaneous sealing at the first (30 days) computed tomography angiography (CTA), and in the remaining 4, a delayed spontaneous sealing was diagnosed at 12-month CTA. No neck-related secondary procedures were performed. Overall survival was 91%. CONCLUSIONS: Our study shows that additional use of EndoAnchors can successfully improve the sealing of abdominal endografts in case of intraoperative type Ia endoleaks in hostile neck anatomies, representing a safe and effective endovascular alternative in our armamentarium. However, meticulous radiological follow-up is necessary because complete resolution of all observed intraoperative type Ia endoleaks was not observed until the 12-month CTA follow-up.

In vitro study for the evaluation of transluminal aspiration as a novel treatment option for thrombosis in the HeartWare HVAD.

INTRODUCTION:: Pump thrombosis of left ventricular assist devices remains a devastating complication with high morbidity and mortality. Despite the improvements made, the matter affects many patients and the treatment options are limited to thrombolysis and surgical replacement. An alternative approach using the aspiration Indigo catheter was tested. METHODS:: An Indigo thrombectomy catheter was used within an in vitro model to assess the direct aspiration of prefabricated clots from three different positions within the HeartWare HVAD (inlet, outlet, and housing). The experiments were conducted with a straight and an angled catheter. The aspiration pressure was constant. The flow, power consumption, and pressure head of the left ventricular assist devices were measured at pre-defined measuring points. RESULTS:: The device was more effective (success rate 71%) at inlet and outlet of the left ventricular assist device. In addition, the duration of aspiration and the aspiration volume were shorter in comparison to the aspiration in the housing (inlet M = 19.75 s, outlet M = 60.50 s, and housing M = 38.75 s). Moreover, the aspiration volume was associated with the aspiration duration and the weight of thrombi but not with their volume. Noteworthy, the angled catheter showed an improved performance compared to the straight one (67%-33%). The recorded parameters showed no major changes during the use of the catheter. After application of the Indigo catheter, flow and pressure head of the pump could be restored. CONCLUSIONS:: The aspiration system showed promising results under specific conditions for the treatment of pump thrombosis in an in vitro model. However, further examination, including in vivo experiments, will justify its effectiveness.

1-Year All-Comers Analysis of the Eluvia Drug-Eluting Stent for Long Femoropopliteal Lesions After Suboptimal Angioplasty.

OBJECTIVES: The aim of this study was to assess the performance of the fluoropolymer-based paclitaxel-eluting stent (PES) in long femoropopliteal lesions. BACKGROUND: The new-generation fluoropolymer-based PES showed promising outcomes in short femoropopliteal lesions. The main feature of the stent is its controlled and sustained paclitaxel release over 12 months. However, the safety and efficacy of this technology in longer femoropopliteal lesions remain unclear. METHODS: Between March 2016 and March 2017, 62 patients were included in this analysis. Indications for fluoropolymer-based PES deployment were insufficient luminal gain or flow-limiting dissection after plain old balloon angioplasty in a femoropopliteal lesion. Primary patency, freedom from target lesion revascularization, amputation-free survival, and paclitaxel-related adverse events were retrospectively analyzed for up to 1 year of follow-up. RESULTS: Lesions were de novo in 84% of patients. Mean lesion length was 20 ± 12 cm, and 79% of the lesions (n = 49) were chronic total occlusions. Moderate or severe calcification was present in 42% of the lesions (n = 26). Stent implantation involved the distal superficial femoral artery and the proximal popliteal artery in 76% (n = 47) and 44% (n = 27) of patients, respectively. The Kaplan-Meier estimate of primary patency and freedom from target lesion revascularization was 87%. Amputation-free survival was 100% for patients with claudication (n = 32 [52%]) and 87% in patients with critical limb ischemia (n = 30 [48%]) (hazard ratio: 6.3; 95% confidence interval: 1.25 to 31.54; p = 0.052). Five aneurysm formations of the treated segments (8%) were thought to be attributable to paclitaxel. CONCLUSIONS: The fluoropolymer-based PES showed promising 1-year clinical and angiographic outcomes in real-world long femoropopliteal lesions. The long-term impact of aneurysm formation remains to be further investigated.

Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Common Femoral Artery Atherosclerotic Disease.

PURPOSE: To report an experience using directional atherectomy (DA) with antirestenotic therapy (DAART) in the form of drug-coated balloon (DCB) angioplasty vs DCB angioplasty alone in common femoral artery (CFA) occlusive lesions. METHODS: A retrospective review was conducted of 47 consecutive patients (mean age 71 years; 26 men) treated between October 2011 and July 2016 using either DCB angioplasty alone (n=26) or DAART (n=21) for CFA lesions. The majority of patients had lifestyle-limiting claudication (14 DCB and 15 DAART). Mean lesion length (39±14 mm DCB and 34±16 mm DAART) and vessel calcification (17/26 DCB and 11/21 DAART) were comparable between the groups. There were 4 chronic total occlusions, all in the DAART group. The main outcome measure was primary patency. Key secondary outcomes were technical success, secondary patency, and freedom from clinically-driven target lesion revascularization (TLR). RESULTS: Technical success rates were 89% following DCB angioplasty and 95% for DAART (p=0.41). The 88% 12-month primary patency and 89% freedom from TLR for DAART were higher than the 68% and 75% estimates following DCB angioplasty alone, but neither difference was statistically significant. However, the secondary patency estimate at 12 months was significantly higher in the DAART group (100% vs 81% for DCB, p=0.03). Bailout stenting (1 DCB vs 1 DAART), vessel perforation (1 DCB vs 0 DAART), access site complications (4 DCB vs 3 DAART), and distal embolization (0 DCB vs 1 DAART) were comparable, whereas DCB angioplasty had more non-flow-limiting dissections (8 vs 1 for DAART, p=0.02). CONCLUSION: Preparation of the atherosclerotic CFA with directional atherectomy was not associated with statistically significantly higher primary patency or freedom from TLR compared to DCB angioplasty alone at 12 months. Nonetheless, both modalities had promising outcomes in a primarily surgically treated vascular territory.

Initial Experience With the 6-F and 8-F Indigo Thrombectomy System for Acute Renovisceral Occlusive Events.

PURPOSE: To examine the safety and effectiveness of the new large-bore Indigo thrombectomy catheters to treat patients with acute renovisceral occlusion without the need of thrombolytic agents. METHODS: Between November 2015 and 2016, 7 consecutive patients (mean age 65±5 years; 5 men) with acute renovisceral artery occlusion were treated with the new large-bore (6-F and 8-F) vacuum-assisted thrombectomy catheters. The occluded vessels were 6 renal arteries and 3 superior mesenteric arteries (SMAs); 5 of the 9 thromboses were in bridging stent-grafts associated with branched endografts. Mean lesion length was 63±36 mm. For the SMA and all bridging stent-grafts, 8-F catheters are routinely used through a brachial access, whereas 6-F aspiration catheters were used in native renal arteries. Technical success was defined as restoration of antegrade blood flow without the need of lysis or alternative thrombectomy/revascularization strategies. Safety endpoints were any in-hospital major adverse events. Pre- and postoperative hemoglobin and hematocrit levels were compared. RESULTS: Technical success was 100% with no major adverse events or fatal bleeding. The mean amount of aspirated blood was 219±97 mL. The mean hemoglobin and hematocrit values were 13.1±2.1 g/dL and 39%±6% prior to and 11.6±2.2 g/dL (p=0.001) and 34%±6% (p<0.0001) directly after the intervention, respectively. CONCLUSION: The first assessment of the new large-bore Indigo thrombectomy catheters showed them to be an effective and safe lysis-free frontline therapy for acute renovisceral artery occlusion in a small cohort of patients. New users should be fully aware of the potential blood loss during aspiration.

Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Isolated Popliteal Artery Lesions.

PURPOSE: To report a single-center study comparing drug-coated balloon (DCB) angioplasty vs directional atherectomy with antirestenotic therapy (DAART) for isolated lesions of the popliteal artery. METHODS: Seventy-two patients were treated with either DCB angioplasty alone (n=31) or with DAART (n=41) for isolated popliteal artery stenotic disease between October 2009 and December 2015. The majority of patients presented with lifestyle-limiting claudication (74% vs 86%, respectively). Vessel calcification (29% vs 29%, respectively), mean lesion length (47 vs 42 mm, respectively), and number of runoff vessels were comparable between the groups. The primary outcome measure was primary patency; secondary outcomes were technical success (<30% residual stenosis or bailout stenting), secondary patency, and freedom from clinically driven target lesion revascularization (TLR). RESULTS: The technical success rate following DCB was 84% vs 93% (p=0.24) after DAART. The 12-month primary patency rate was significantly higher in the DAART group (65% vs 82%; hazard ratio 2.64, 95% confidence interval 1.09 to 6.37, p=0.021), while freedom from TLR did not differ between the 2 treatment strategies (82% vs 94%, p=0.072). Secondary patency at 12 months was identical for both groups (96% vs 96%). Although not statistically significant, bailout stenting was more common after DCB angioplasty (16% vs 5% for DAART, p=0.13) and aneurysmal degeneration of the popliteal artery was seen more often after DAART (7% vs 0% for DCB alone, p=0.25). Popliteal artery injury was observed in 2 patients treated using DAART (5% vs 0% for DCB alone, p=0.5), whereas distal embolization rates were comparable between the groups (3% for DCB alone vs 5% for DAART, p=0.99). CONCLUSION: In this study, the use of DAART was associated with a higher primary patency rate compared with DCB angioplasty for isolated popliteal lesions. Nonetheless, both treatment options were associated with excellent 12-month secondary patency. Aneurysmal degeneration of the popliteal artery and increased bailout stenting could compromise the outcomes of DAART and DCB, respectively.