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  • 1
    In: Annals of Vascular Surgery, Elsevier BV, Vol. 60 ( 2019-10), p. 61-69
    Type of Medium: Online Resource
    ISSN: 0890-5096
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2019
    detail.hit.zdb_id: 1473891-0
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  • 2
    In: Vascular, SAGE Publications, Vol. 29, No. 2 ( 2021-04), p. 213-219
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1708-5381 , 1708-539X
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2021
    detail.hit.zdb_id: 2143006-8
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  • 3
    Online Resource
    Online Resource
    SAGE Publications ; 2021
    In:  Journal of Endovascular Therapy Vol. 28, No. 1 ( 2021-02), p. 56-62
    In: Journal of Endovascular Therapy, SAGE Publications, Vol. 28, No. 1 ( 2021-02), p. 56-62
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1526-6028 , 1545-1550
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2021
    detail.hit.zdb_id: 2049858-5
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  • 4
    In: Journal of Endovascular Therapy, SAGE Publications, Vol. 30, No. 1 ( 2023-02), p. 91-97
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1526-6028 , 1545-1550
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
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  • 5
    In: Vascular, SAGE Publications, Vol. 28, No. 5 ( 2020-10), p. 568-576
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1708-5381 , 1708-539X
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
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  • 6
    In: Vascular, SAGE Publications, Vol. 29, No. 6 ( 2021-12), p. 808-816
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1708-5381 , 1708-539X
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2021
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  • 7
    In: PLOS ONE, Public Library of Science (PLoS), Vol. 17, No. 2 ( 2022-2-24), p. e0264327-
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1932-6203
    Language: English
    Publisher: Public Library of Science (PLoS)
    Publication Date: 2022
    detail.hit.zdb_id: 2267670-3
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  • 8
    In: Journal of Endovascular Therapy, SAGE Publications, Vol. 24, No. 4 ( 2017-08), p. 604-610
    Type of Medium: Online Resource
    ISSN: 1526-6028 , 1545-1550
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2017
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  • 9
    In: Journal of Endovascular Therapy, SAGE Publications, Vol. 25, No. 1 ( 2018-02), p. 92-99
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1526-6028 , 1545-1550
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2018
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  • 10
    In: Vasa, Hogrefe Publishing Group, Vol. 50, No. 5 ( 2021-09), p. 356-362
    Abstract: Summary: 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.
    Type of Medium: Online Resource
    ISSN: 0301-1526 , 1664-2872
    Language: English
    Publisher: Hogrefe Publishing Group
    Publication Date: 2021
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