53 results on '"Torsello GF"'
Search Results
2. 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
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D'Oria, M., Pitoulias, G. A., Torsello, G. F., Pitoulias, A. G., Fazzini, S., Masciello, F., Verzini, F., Donas, K. P., Taneva, G. T., Austermann, M., Bosiers, M., Dorigo, W., Cao, P., Ferrer, C., Ippoliti, A., Barbante, M., Parlani, G., Simonte, G., Kolbel, T., Tsilimparis, N., Haulon, S., Branzan, D., Schmidt, A., Pratesi, C., Fargion, A., Pratesi, G., D'Oria, M, Pitoulias, Ga, Torsello, Gf, Pitoulias, Ag, Fazzini, S, Masciello, F, Verzini, F, and Donas, Kp
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medicine.medical_specialty ,business.industry ,Clinical effectiveness ,medicine.disease ,Abdominal aortic aneurysm ,Center volume ,abdominal aortic aneurysm ,aortoiliac disease ,center volume ,iliac branch device ,Settore MED/22 ,medicine.anatomical_structure ,medicine ,Radiology, Nuclear Medicine and imaging ,Surgery ,Radiology ,Cardiology and Cardiovascular Medicine ,business ,Aortoiliac disease ,Pelvis ,Volume (compression) - Abstract
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.
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- 2021
3. Atherectomy Followed by Drug-Coated Balloon Angioplasty Versus Surgery for Symptomatic Deep Femoral Artery Arteriosclerotic Disease.
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Torsello GB, Gouveia E Melo R, Zeller T, Böhme T, Korosoglou G, Coscas R, Stavroulakis K, Kapetanios D, Torsello GF, and Nasr B
- Abstract
Purpose: Limited data are available regarding endovascular therapy of arteriosclerotic lesions of the deep femoral artery (DFA). In this study, we compare the outcomes of atherectomy combined with drug-coated balloon (DCB) angioplasty and open repair of DFA lesions., Methods: This is a multicenter retrospective registry of patients with peripheral artery occlusive disease Rutherford categories 2 to 5 treated by surgical profundaplasty (SP) or atherectomy followed by DCB for DFA lesions (symptomatic DFA). The primary endpoint was clinically driven target lesion revascularization (CD-TLR). Overall mortality, target limb reinterventions, major amputation, and major adverse limb events (MALEs) were additionally analyzed., Results: A total of 373 patients treated for an arteriosclerotic lesion of the DFA between February 2015 and August 2021 were included, 301 treated by SP and 72 with atherectomy and DCB. The rates of chronic limb threatening ischemia (CLTI) were 42.2% and 22.2% (p<0.002) for the surgical and endovascular groups, respectively. A previous DFA intervention was more frequent in the endovascular group (30.6% vs 15.3%; p<0.003). Patients who had an open repair were more likely to have an occlusion of the profunda (34.9% vs 19.7%, p=0.014), severe calcified lesions (26.5% vs 5.6%, p=0.001), and lesions longer than 20 mm (95.7% vs 88.7%, p=0.024). After propensity score matching, no significant differences were found with regard to technical and hemodynamic success. At 24 months, no difference was found in terms of freedom from CD-TLR (95.7% vs 96.8%), freedom from all-cause mortality (94.2% vs 98.5%), freedom from MALE (90.4% vs 93.9%), and amputation-free survival (93.8% vs 97%). Following endovascular therapy, length of stay was significantly lower (p<0.001) and any reintervention on the index limb was more frequent (p=0.039)., Conclusion: Patients with CLTI, occlusion of profunda, severe calcified lesions, and longer lesions are more frequently treated by open surgery, while reinterventions are more commonly treated by atherectomy and DCB. In patients with comparable clinical and lesion characteristics after matching, endovascular and surgical reconstruction of DFA lesions showed similar mid-term clinical outcomes. However, the risk of reintervention at the index limb is higher after endovascular treatment. Randomized studies are now warranted to compare both techniques in terms of medical and financial aspects., Clinical Impact: Atherectomy followed by DCB of symptomatic DFA is safe and effective. In patients with comparable clinical and lesion characteristics, outcomes are comparable with surgery. However, the risk of reintervention at the index limb is higher after endovascular treatment. Therefore, whenever possible an additional outflow vessel revascularization should be performed by the time of the primary intervention. Randomized studies are warranted to compare endovascular techniques and open surgery also under economic aspects., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Raphael Coscas received speaking fees from Boston Scientific, Abbott, Medtronic and BD. All other authors declare no conflict of interest.
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- 2024
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4. Transprosthetic Fenestration With Electrified Wires. Experimental Evaluation of Three Multifilament Endografts.
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Torsello GB, Silvano M, Torsello GF, Seçer R, Grambow E, Ormandzhieva TK, and Elger F
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Purpose: In situ fenestration of aortic endografts is an alternative endovascular technique for treatment of complex aortic aneurysms. While this technique has been carried out also to pass stent-grafts in individual cases, its feasibility and safety using different stent-grafts needs to be evaluated., Methods: In a saline bath at water temperature of 37°C, a 0.018" Astato 30 guidewire was advanced through 3 different stent-grafts (RelayPro, Zenith and Endurant II) by applying external current of 180 W via an electrosurgery pencil. Puncture efficacy and quality of the fenestration after ballooning with a 6 mm percutaneous transluminal angioplasty (PTA) catheter were assessed. Then, balloon-expandable covered stents were deployed in the fenestrations and evaluated for stenosis, using microscopy and radiography., Results: Crossing of the electrified guidewire was instantaneous in the Zenith (n:10) and RelayPro (n:10) groups but not in 3 of 10 punctures in the Endurant group (p<.05). The fenestration area created after PTA was significantly larger in the RelayPro (5.3 mm
2 ± 1.8, interquartile range [IQR] 1.6) and Zenith group (6.7 mm2 ± 0.7, IQR 0.5) compared to Endurant (2.3 mm2 ± 0.4, IQR 0.5, p<.001). Fraying was observed in all groups while graft shredding was found in 8 cases after PTA of the Zenith and Endurant endografts and in 5 of the RelayPro group, but the difference was not significant. Vertical tearing was detected after RelayPro (2 out of 10) and Zenith (6 out of 10) fenestrations, no damage was found in the Endurant group (p<.01). Residual stenosis at the level of the fenestration after implantation of a 6 × 79 mm VBX stent had to be corrected in all Endurant cases with a high-pressure PTA catheter. No stenosis was found in the RelayPro and Zenith groups before and after flaring., Conclusions: The "electrified wire" technique is a feasible tool that can be used to perform in situ fenestration by perforation of the endograft fabric. Based on this experimental evaluation the "ideal graft" for this technique could not be identified. Long-term fatigue tests and comparison with other fenestration techniques are required., Clinical Impact: In situ endograft fenestration can be a useful technique in emergent aortic repair. Recently, the electrified wire technique has been proposed as alternative option to laser, radiofrequency and needle-based techniques. In comparison to these methods, the use of electrified wires can be performed without modifications of routine equipment. Additionally, the material costs can be substantially reduced. However, the effectiveness of this approach for fenestration of different prosthetic grafts is unknown. Based on our experimental studies, the electrified wire technique is feasible but the Endurant endograft requires more attempts, and the placement of a bridging stent should be completed with high-pressure balloons., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.- Published
- 2024
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5. IVUS-Guided Intravascular Lithotripsy of the Juxtarenal and Visceral Coral Reef Aorta.
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Elger F, Secer R, Silvano M, Grambow E, Torsello GF, and Torsello GB
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A patient with coral reef aorta at the level of the renal and visceral arteries was treated endovascularly. We used intravascular lithotripsy for improving stent expansion and intravascular ultrasound as an intraoperative diagnostic tool. The renal artery periscope technique maintained renal perfusion after placement of the aortic endograft., Competing Interests: The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)
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- 2024
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6. [Management of Injuries to the Parenchymal Abdominal Organs].
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Schild-Suhren S, Yilmaz E, Biggemann L, Seif A, Torsello GF, Uhlig A, Ghadimi M, and Bösch F
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- Humans, Wounds, Nonpenetrating surgery, Wounds, Nonpenetrating diagnostic imaging, Wounds, Nonpenetrating therapy, Wounds, Nonpenetrating diagnosis, Spleen injuries, Spleen diagnostic imaging, Tomography, X-Ray Computed, Multiple Trauma surgery, Multiple Trauma diagnostic imaging, Multiple Trauma diagnosis, Laparotomy, Kidney injuries, Kidney diagnostic imaging, Abdominal Injuries surgery, Abdominal Injuries diagnostic imaging, Abdominal Injuries therapy, Abdominal Injuries diagnosis, Liver injuries, Liver diagnostic imaging, Liver surgery, Pancreas injuries, Pancreas surgery, Pancreas diagnostic imaging
- Abstract
The most common organs affected by abdominal trauma are the spleen and the liver, often in combination. Pancreatic injuries are rare. In the case of blunt abdominal trauma, which is much more common, a clinical and laboratory examination as well as sonography should be performed. In the initial assessment, the circulatory situation must be screened. If there is haemodynamic instability and presentation of free fluid, an emergency laparotomy is indicated. If the situation is stable or stabilised and a pathological sonography is present, it is essential to perform triphasic contrast enhanced computed tomography, which is also mandatory in polytraumatised patients. If a renal injury is suspected, a late venous phase should be attached. In addition to the classification of the injury, attention should be paid to possible vascular injury or active bleeding. In this case, angiography with the possibility of intervention should be performed. Endoscopic treatment is possible for injuries of the pancreatic duct. If the imaging does not reveal any intervention target and a circulation is stable, a conservative approach is possible with continuous monitoring using clinical, laboratory and sonographic controls. Most injuries can be successfully treated by non-operative management (NOM).There are various surgical options for treating the injury, such as local and resecting procedures. There is also the option of "damage control surgery" with acute bleeding control and second look. Complex surgical procedures should be performed at centres. Postoperative complications arise out of elective surgery.In the less common case of penetrating abdominal trauma, the actual extent of the injury cannot be estimated from the visible wound. Here again, the circulatory situation determines the next steps. An emergency laparotomy should be carried out in case of instability. If the condition is stable, further diagnostics should be performed using contrast enhanced computed tomography. If penetration through the peritoneum cannot be clearly excluded, diagnostic laparoscopy should be performed., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)
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- 2024
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7. Role of liver augmentation prior to hepatic resection - a survey on standards, procedures, and indications in Germany, Switzerland, and Austria.
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Yilmaz E, Torsello GF, Hosseini ASA, Zygmunt AC, Lorf T, Keck J, Schild-Suhren S, Wellge B, Oberhuber R, Kollmar O, Ghadimi M, and Bösch F
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- Humans, Austria, Switzerland, Germany, Surveys and Questionnaires, Liver Transplantation, Embolization, Therapeutic, Hepatectomy methods, Liver Neoplasms surgery, Liver Neoplasms pathology
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Purpose: For primary and secondary liver tumors oncological resection remains a chance of cure. Augmentation of functional liver tissue may be necessary to preserve sufficient future liver remnant (FLR). Clinical decision-making on liver augmentation techniques and indications may differ internationally. Thus, this study aims to identify standards of liver augmentation in hepato-pancreatico-biliary (HPB) centers in Germany, Switzerland, and Austria., Methods: Using a web-based survey, 48 hospitals in Germany, Switzerland, and Austria were invited to report their surgical indication, standard procedures, and results of liver augmentation., Results: Forty (83.3%) of the hospitals invited participated. Most of the hospitals were certified liver centers (55%), performing complex surgeries such as liver transplantation (57.5%) and ALPPS (80%). The standard liver augmentation technique in all countries was portal vein embolization (PVE; 56%), followed by ALPPS (32.1%) in Germany or PVE with hepatic vein embolization (33.3%) in Switzerland and Austria. Standard procedure for liver augmentation did not correlate with certification as liver center, performance of liver transplantation or ALPPS. Surgical indication for PVE varied depending on tumor entity. Most hospitals rated the importance of PVE before resection of cholangiocarcinoma or colorectal metastases as high, while PVE for hepatocellular carcinoma was rated as low., Conclusion: The survey gives an overview of the clinical routine in HPB centers in Germany, Austria, and Switzerland. PVE seems to dominate as standard technique to increase the FLR. However, there is a variety in the main indication for liver augmentation. Further studies are necessary evaluating the differing PVE techniques for liver augmentation., (© 2024. The Author(s).)
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- 2024
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8. Cost Analysis of Target Lesion Revascularisation in Patients With Femoropopliteal In Stent Re-Stenosis or Occlusion: The COSTLY-TLR Study.
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Saratzis A, Torsello GB, Cardona-Gloria Y, Van Herzeele I, Messeder SJ, Zayed H, Torsello GF, Chisci E, Isernia G, D'Oria M, and Stavroulakis K
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- Humans, Female, Aged, Male, Retrospective Studies, Europe, Cost-Benefit Analysis, Treatment Outcome, Aged, 80 and over, Hospital Costs statistics & numerical data, Constriction, Pathologic economics, Peripheral Arterial Disease economics, Peripheral Arterial Disease surgery, Peripheral Arterial Disease therapy, Peripheral Arterial Disease mortality, Femoral Artery surgery, Popliteal Artery surgery, Endovascular Procedures economics, Endovascular Procedures adverse effects, Endovascular Procedures instrumentation, Stents economics
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Objective: To report the cost of target lesion revascularisation procedures (TLR) for femoropopliteal peripheral artery disease (PAD) following stenting, from a healthcare payer's perspective., Methods: European multicentre study involving consecutive patients requiring femoropopliteal TLR (January 2017 - December 2021). The primary outcome was overall cost (euros) associated with a TLR procedure from presentation to discharge. Exact costs per constituent, clinical characteristics, and early outcomes were reported., Results: This study included 482 TLR procedures (retrospectively, 13 hospitals, six countries): 56% were female, mean age was 75 ± 2 years, 61% were Rutherford class 5 or 6, 67% had Tosaka class 3 disease, and 16% had common femoral or iliac involvement. A total of 52% were hybrid procedures and 6% involved open surgery only. Technical success was 70%, 30 day mortality rate was 1%, and the 30 day major amputation rate was 4%. Most costs were for operating time during the TLR (healthcare professionals' salaries, indirect and estate costs), with a mean of: €21 917 ± €2 110 for all procedures; €23 337 ± €8 920 for open procedures; €12 903 ± €3 108 for endovascular procedures; and €22 806 ± €3 977 for hybrid procedures. In a regression analysis, procedure duration was the main parameter associated with higher overall TLR costs (coefficient, 2.77; standard error, 0.88; p < .001). The mean cost per operating minute of TLR (indirect, estate costs, all salaried staff present included) was €177 and the mean cost per night stay in hospital (outside intensive care unit) was €356. The mean cost per overnight intensive care unit stay (minimum of 8 hours per night) was €1 193., Conclusion: The main driver of the considerable peri-procedure costs associated with femoropopliteal TLR was procedure time., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)
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- 2024
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9. Percutaneous drainage and combined praziquantel-albendazole therapy: a novel approach for the treatment of simple echinococcal liver cysts.
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Richter J, Lindner AK, Geisel D, Fleckenstein FN, Torsello GF, Millet Pascual-Leone B, Ivanov O, Zöllner C, Wilde AB, and Equihua Martinez G
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- Humans, Albendazole therapeutic use, Praziquantel therapeutic use, Neoplasm Recurrence, Local, Drainage, Ethanol, Liver, Echinococcosis drug therapy, Echinococcosis, Hepatic diagnosis, Echinococcosis, Hepatic drug therapy, Cysts drug therapy
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Cystic echinococcosis (CE) is a worldwide helminthic zoonosis causing serious disease in humans. The WHO Informal Working Group on Echinococcosis recommends a stage-specific treatment approach of hepatic CE that facilitates the decision on what therapy option is most appropriate. Percutaneous aspiration, instillation of a scolicide, e.g., ethanol or hypertonic saline, and subsequent re-aspiration (PAIR) have been advocated for treating medium-size unilocular WHO-stage CE1 cysts. PAIR can pose a risk of toxic cholangitis because of spillage of ethanol in the case of a cysto-biliary fistula or of life-threatening hypernatriaemia when hypertonic saline is used. The purpose of our study is to develop an alternative, safe, minimally invasive method to treat CE1 cysts, avoiding the use of toxic topic scolicides.We opt for percutaneous drainage (PD) in four patients: the intrahepatic drainage catheter is placed under CT-fluoroscopy, intracystic fluid is aspirated, and the viability of intracystic echinococcal protoscolices is assessed microscopically. Oral praziquantel (PZQ) is added to albendazole (ABZ) instead of using topical scolicidals.Protoscolices degenerate within 5 to 10 days after PZQ co-medication at a cumulative dosage of 250 to 335 mg/kg, and the cysts collapse. The cysts degenerate, and no sign of spillage nor relapse is observed in the follow-up time of up to 24 months post-intervention.In conclusion, PD combined with oral PZQ under ABZ coverage is preferable to PAIR in patients with unilocular echinococcal cysts., Competing Interests: The authors declare that they have no conflict of interest., (Thieme. All rights reserved.)
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- 2024
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10. Treatment of Femoropopliteal Artery Disease with Polymer-Coated Drug-Eluting Stent: 5-Year Results of a Prospective, Non-Randomized Study Including the Halo Phenomenon.
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Torsello GF, Stavroulakis K, Bisdas T, Cardona Y, Wichmann K, and Torsello GB
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- Humans, Femoral Artery diagnostic imaging, Femoral Artery pathology, Popliteal Artery diagnostic imaging, Popliteal Artery pathology, Follow-Up Studies, Treatment Outcome, Paclitaxel therapeutic use, Prospective Studies, Polymers, Vascular Patency, Drug-Eluting Stents, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease therapy
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Purpose: To investigate the long-term results of the Eluvia drug-eluting stent (DES) implantation for femoropopliteal arterial disease, including the 'halo' phenomenon. Long-term data of DES is scarce. A focal reaction ('halo') following Eluvia DES deployment has been described. However, the long-term clinical impact of this phenomenon remains unclear., Methods: This prospective, non-randomized, single-arm study included 130 consecutive patients treated with an Eluvia DES for symptomatic femoropopliteal disease between March 2016 and December 2018. Clinical outcomes and imaging were assessed after 6 months and annually thereafter for up to 5 years. The primary outcome measure was primary patency. Secondary outcomes were freedom from clinically driven target lesion revascularization (CD-TLR), freedom from major amputation, overall survival and amputation-free survival rates., Results: The primary patency was 65% at 5 years. The freedom from CD-TLR and from major amputation at 5 years was 79 and 96%, respectively. The overall survival and amputation-free survival rates were 88 and 83% at 60 months, respectively. Out of the 27 patients with a halo sign, two showed an increased (7.4%) and 6 (22.2%) a decreased diameter. In 19 cases (70.4%), the diameter remained unchanged at the latest follow-up. The presence of the 'halo' sign was associated with increased primary patency (87% versus 59%, HR: 2.48, 95%CI 1.19-5.16, P = .015)., Conclusions: The presented patient cohort treated with the Eluvia DES for femoropopliteal artery lesions indicates durable efficacy and a good safety profile regardless of the halo phenomenon. The results need to be confirmed in a larger patient cohort., Level of Evidence Iii: Non-randomized controlled cohort/follow-up study., (© 2024. The Author(s).)
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- 2024
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11. Association of Genetic Polymorphisms with Abdominal Aortic Aneurysm in the Processes of Apoptosis, Inflammation, and Cholesterol Metabolism.
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Nugroho NT, Herten M, Torsello GF, Osada N, Marchiori E, Sielker S, and Torsello GB
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- Humans, Male, Aged, Aged, 80 and over, Female, Case-Control Studies, Polymorphism, Single Nucleotide genetics, Risk Factors, Inflammation, Apoptosis, Cholesterol, ras GTPase-Activating Proteins genetics, Genetic Predisposition to Disease, Aortic Aneurysm, Abdominal genetics
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Background and Objectives : This study aims to identify the minor allele of the single nucleotide polymorphisms (SNPs) DAB2IP rs7025486, IL6R rs2228145, CDKN2BAS rs10757278, LPA rs3798220, LRP1 rs1466535, and SORT1 rs599839 in order to assess the risk of abdominal aortic aneurysm (AAA) formation and define the linkage among these SNPs. Materials and Methods : A case-control study with AAA patients (AAA group) and non-AAA controls (control group) was carried out in a study population. DNA was isolated from whole blood samples; the SNPs were amplified using PCR and sequenced. Results: In the AAA group of 148 patients, 87.2% of the patients were male, 64.2% had a history of smoking, and 18.2% had relatives with AAA. The mean ± SD of age, BMI, and aneurysmal diameter in the AAA group were 74.8 ± 8.3 years, 27.6 ± 4.6 kg/m
2 , and 56.2 ± 11.8 mm, respectively. In comparison with 50 non-AAA patients, there was a significantly elevated presence of the SNPs DAB2IP rs7025486[A], CDKN2BAS rs10757278[G], and SORT1 rs599839[G] in the AAA group ( p -values 0.040, 0.024, 0.035, respectively), while LPA rs3798220[C] was significantly higher in the control group ( p = 0.049). A haplotype investigation showed that the SNPs DAB2IP , CDKN2BAS , and IL6R rs2228145[C] were significantly elevated in the AAA group ( p = 0.037, 0.037, and 0.046) with minor allele frequencies (MAF) of 25.5%, 10.6%, and 15.4%, respectively. Only DAB2IP and CDKN2BAS showed significantly higher occurrences of a mutation ( p = 0.028 and 0.047). Except for LPA , all SNPs were associated with a large aortic diameter in AAA ( p < 0.001). Linkage disequilibrium detection showed that LPA to DAB2IP , to IL6R , to CDKN2BAS , and to LRP1 rs1466535[T] had D' values of 70.9%, 80.4%, 100%, and 100%, respectively. IL6R to LRP1 and to SORT1 had values for the coefficient of determination ( r2 ) of 3.9% and 2.2%, respectively. Conclusions : In the investigated study population, the SNPs CDKN2BAS rs10757278, LPA rs3798220, SORT1 rs599839, DAB2IP rs7025486, and IL6R rs2228145 were associated with the development of abdominal aortic aneurysms. Individuals with risk factors for atherosclerosis and/or a family history of AAA should be evaluated using genetic analysis.- Published
- 2023
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12. Evaluation of Different Registration Algorithms to Reduce Motion Artifacts in CT-Thermography (CTT).
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Kostyrko B, Rubarth K, Althoff C, Zibell M, Neizert CA, Poch F, Torsello GF, Gebauer B, Lehmann K, Niehues SM, Mews J, Diekhoff T, and Pohlan J
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Computed tomography (CT)-based Thermography (CTT) is currently being investigated as a non-invasive temperature monitoring method during ablation procedures. Since multiple CT scans with defined time intervals were acquired during this procedure, interscan motion artifacts can occur between the images, so registration is required. The aim of this study was to investigate different registration algorithms and their combinations for minimizing inter-scan motion artifacts during thermal ablation. Four CTT datasets were acquired using microwave ablation (MWA) of normal liver tissue performed in an in vivo porcine model. During each ablation, spectral CT volume scans were sequentially acquired. Based on initial reconstructions, rigid or elastic registration, or a combination of these, were carried out and rated by 15 radiologists. Friedman's test was used to compare rating results in reader assessments and revealed significant differences for the ablation probe movement rating only ( p = 0.006; range, 5.3-6.6 points). Regarding this parameter, readers assessed rigid registration as inferior to other registrations. Quantitative analysis of ablation probe movement yielded a significantly decreased distance for combined registration as compared with unregistered data. In this study, registration was found to have the greatest influence on ablation probe movement, with connected registration being superior to only one registration process.
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- 2023
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13. Long-term Results of Angulated Versus Hyperangulated Neck in Endovascular Aneurysm Repair With Endurant Endoprosthesis.
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Özdemir-van Brunschot DMD, Torsello GB, Bernardini G, Litterscheid S, Torsello GF, and Beropoulis E
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- Humans, Female, Blood Vessel Prosthesis adverse effects, Retrospective Studies, Endovascular Aneurysm Repair, Endoleak diagnostic imaging, Endoleak etiology, Stents adverse effects, Treatment Outcome, Risk Factors, Aortography methods, Time Factors, Blood Vessel Prosthesis Implantation adverse effects, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Abdominal complications, Endovascular Procedures adverse effects
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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.
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- 2023
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14. Transaneurysmal Occlusion of Complicated Common Femoral Artery Pseudoaneurysms Using the Angio-Seal Closure Device-A Promising Technique.
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Auer TA, Fehrenbach U, Torsello GF, Collettini F, Wieners G, Günther RW, and Gebauer B
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- Humans, Femoral Artery diagnostic imaging, Femoral Artery surgery, Hemostatic Techniques, Punctures, Japan, Treatment Outcome, Aneurysm, False diagnostic imaging, Aneurysm, False therapy
- Abstract
Purpose: Pseudoaneurysm (PSA) developing after catheter examinations is one of the most frequent vascular complications and a nonsurgical technique with utmost low risk of complications is warranted. Our aim was to investigate the technical feasibility, success, and safety of transaneurysmal occlusion of complicated post-interventional common femoral artery (CFA) PSA using the Angio-Seal Closure Device (ASCD) and a technique that we describe as the transaneurysmal (TA) maneuver., Material and Methods: We used the Angio-Seal (Terumo, Tokyo, Japan) Closure System to manage complicated PSAs in patients who would otherwise have needed surgery after failure of all conservative therapies. The TA maneuver was performed in 14 consecutive patients from July 2021 to July 2022. After ultrasound-guided puncture of the PSA close to its neck, the CFA was entered radiographically with micro-guidewires, and the neck of the PSA was closed with the ASCD after changing the sheaths and wires. All patient had to wear a pressure dressing until the next day, when successful closure was verified by sonography., Results: All procedures were performed with technical success and without any complications. No patient had to undergo surgery. All sonographies on the next day confirmed complete absence of perfusion within the PSA and normal flow conditions of the CFA and vessels below., Conclusion: The TA maneuver a promising minimally invasive procedure for closing complicated PSA of the CFA after catheter examination., (© 2022. The Author(s).)
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- 2023
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15. Percutaneous Large-Bore Pulmonary Thrombectomy with the FlowTriever Device: Initial Experience in Intermediate-High and High-Risk Patients.
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Luedemann WM, Zickler D, Kruse J, Koerner R, Lenk J, Erxleben C, Torsello GF, Fehrenbach U, Jonczyk M, Guenther RW, De Bucourt M, and Gebauer B
- Subjects
- Humans, Adult, Middle Aged, Aged, Retrospective Studies, Treatment Outcome, Thrombectomy methods, Thrombolytic Therapy methods, Pulmonary Embolism diagnostic imaging, Pulmonary Embolism therapy, Pulmonary Embolism etiology, Thrombosis etiology
- Abstract
Objectives: This retrospective cohort study investigates outcomes of patients with intermediate-high and high-risk pulmonary embolism (PE) who were treated with transfemoral mechanical thrombectomy (MT) using the large-bore Inari FlowTriever aspiration catheter system., Material and Methods: Twenty-seven patients (mean age 56.1 ± 15.3 years) treated with MT for PE between 04/2021 and 11/2021 were reviewed. Risk stratification was performed according to European Society of Cardiology (ESC) guidelines. Clinical and hemodynamic characteristics before and after the procedure were compared with the paired Student's t test, and duration of hospital stay was analyzed with the Kaplan-Meier estimator. Procedure-related adverse advents were assessed., Results: Of 27 patients treated, 18 were classified as high risk. Mean right-to-left ventricular ratio on baseline CT was 1.7 ± 0.6. After MT, a statistically significant reduction in mean pulmonary artery pressures from 35.9 ± 9.6 to 26.1 ± 9.0 mmHg (p = 0.002) and heart rates from 109.4 ± 22.5 to 82.8 ± 13.8 beats per minute (p < 0.001) was achieved. Two patients died of prolonged cardiogenic shock. Three patients died of post-interventional complications of which a paradoxical embolism can be considered related to MT. One patient needed short cardiopulmonary resuscitation during the procedure due to clot displacement. Patients with PE as primary driver of clinical instability had a median intensive care unit (ICU) stay of 2 days (0.5-3.5 days). Patients who developed PE as a complication of an underlying medical condition spent 11 days (9.5-12.5 days) in the ICU., Conclusion: In this small study population of predominantly high-risk PE patients, large-bore MT without adjunctive thrombolysis was feasible with an acceptable procedure-related complication rate., (© 2022. The Author(s).)
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- 2023
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16. Correction to: Sex Differences in Endovascular Treatment of Isolated Popliteal Lesions.
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Özdemir-van Brunschot DMD, Torsello GB, Litterscheid S, Berchiolli R, Troisi N, and Torsello GF
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- 2022
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17. Sex Differences in Endovascular Treatment of Isolated Popliteal Lesions.
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Özdemir-van Brunschot DMD, Torsello GB, Litterscheid S, Berchiolli R, Troisi N, and Torsello GF
- Subjects
- Female, Femoral Artery pathology, Humans, Male, Popliteal Artery diagnostic imaging, Popliteal Artery pathology, Popliteal Artery surgery, Retrospective Studies, Risk Factors, Stents, Treatment Outcome, Vascular Patency, Peripheral Arterial Disease therapy, Sex Characteristics
- Abstract
Purpose: Sex-based differences in peripheral arterial disease are well-known. Aim of this study was to evaluate sex-related disparities in patients undergoing endovascular treatment of isolated popliteal artery lesions., Material and Methods: Between 1th January 2004 and 1th January 2021 304 patients underwent endovascular treatment of an isolated popliteal artery lesion at three vascular centers. A retrospective analysis was performed comparing the outcomes in female versus male patients., Results: The majority of the patients were female (51.3%). Male patients were younger (70.4 vs. 76.8 years, p < 0.01). Hyperlipidemia (62.2% vs. 45.5%, p < 0.01) and diabetes (62% vs. 40%, p < 0.01) were more common in male group. There were more current and former smokers in the male group (p = 0.04 and p = 0.01). There were no differences regarding lesion length (mean 94.5 mm) nor location of the lesion. Technical success was comparable in both groups 94.6% vs. 97.4%), no differences in terms of in-hospital complications (9.5% vs. 7.7%) were found. At 3 years estimates did not demonstrate any difference in terms of clinically driven target lesion revascularization (23% vs. 34%), secondary patency (86% vs. 96%), and all-cause mortality (77% vs. 67%) between the two groups., Conclusion: In our experience the female sex showed clinical signs of popliteal artery lesion at higher age with less aggressive atherosclerotic risk factors. However, during the follow-up no sex-related significant differences were found in terms of morphological and clinical outcomes after endovascular revascularization., (© 2022. Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).)
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- 2022
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18. Cannulation of Visceral Vessels Using a Steerable Sheath in Fenestrated and Branched Aortic Endografts.
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Kapahnke S, Bürger M, Torsello GF, Omran S, Hinterseher I, Greiner A, and Frese JP
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- Aged, Blood Vessel Prosthesis adverse effects, Catheterization adverse effects, Humans, Male, Postoperative Complications etiology, Prosthesis Design, Retrospective Studies, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects
- Abstract
Background: A critical step in the endovascular treatment of complex aortic aneurysms is the cannulation and stenting of renovisceral vessels, especially in cases with a complex anatomy or atherosclerotic lesions. This study aimed to demonstrate the results of renovisceral vessel cannulation using a steerable sheath in fenestrated or branched endovascular aortic procedures (FB-EVAR)., Methods: Patients undergoing elective FB-EVAR for asymptomatic thoracoabdominal or juxtarenal aneurysm at a single tertiary referral center from 2016 to 2019 were included in this study. Underlying pathologies, renovisceral target vessels (TV), technical success (TS), freedom from reintervention (FFR), and TV patency were assessed. Target vessels were categorized as challenging or nonchallenging TV., Results: Fifty-three patients (median age 73 (Q1, Q3 (68-80)); 43 male (81%)) who underwent elective FB-EVAR were included. Indications comprised thoracoabdominal aneurysms (Crawford I-IV) (n = 26; 49%), juxtarenal aneurysms (n = 23; 43.5%) and penetrating aortic ulcers (PAU) (n = 4; 7.5%). Two patients (4%) had prior open aortic surgery, and three patients (6%) had undergone a failed standard EVAR before. Of the 196 treated TV, 131 (67%) were categorized as challenging. Cannulation was successful in 194 of 196 vessels (99%). A total of 3 TV (1.5%) showed periprocedural complications. No significant difference was found in the rate of intraoperative complications between challenging versus nonchallenging TV (P = 0.457). One patient died within 30 days of the procedure (1.9%). No stroke or intestinal ischemia occurred. After 12, 24, and 36 months, the survival rate was 87%, 87%, and 81%, respectively. Primary patency after 12 months was 98.6%, and 97.9% of vessels remained FFR during follow-up., Conclusions: Transfemoral, retrograde cannulation of renovisceral vessels using a steerable sheath is feasible and safe and provides good mid-term results, especially in cases with challenging renovisceral vessels. The potential complications of antegrade vascular access can be avoided., (Copyright © 2022 Elsevier Inc. All rights reserved.)
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- 2022
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19. CT fluoroscopy-guided percutaneous gastrostomy (CT-PG) - A single center experience in 233 patients.
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Segger L, Auer TA, Fleckenstein FN, Fehrenbach U, Torsello GF, Frisch A, Jonczyk M, Hamm B, and Gebauer B
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- Ascites, Fluoroscopy, Humans, Retrospective Studies, Tomography, X-Ray Computed methods, Gastroscopy, Gastrostomy methods
- Abstract
Purpose: To investigate the feasibility and complications of computed tomography-guided percutaneous gastroscopy (CT-PG) using two procedural techniques (trocar technique and Seldinger technique) in all patients and in a subgroup of patients with ascites as a relative contraindication., Material and Methods: In this single-center study a total of 233 patients who underwent CT-PG (55 in trocar group and 178 in Seldinger group) between 2012 and 2021 were analyzed retrospectively. Success and complications were determined for both techniques and compared in the total study population and in the subgroup of patients with ascites. Complications were classified using the Common Terminology Criteria for Adverse Events (CTCAE) Protocol for procedural complications., Results: Feeding tube placement was successful in 93.6% of cases (218/233). In the trocar group, placement was successful in 98.2% (54/55) with a complication rate of 7.4% (4/54) including one grade 5 complication. In the Seldinger group, placement was successful in 92.1% (164/178) with a complication rate of 6.7% but no grade 4 or 5 complication. Preprocedural paracentesis for ascites was performed in 6.9% of patients (16/233). In this subgroup, CT-PG was successful in 87.5% (14/16) and only complications rated as grade 1 or 2 occurred., Conclusion: CT-PG is a safe interventional procedure, which also applies to patients with ascites if paracentesis is performed beforehand. Specifically, our findings show the Seldinger technique to be safe, as no severe complications occurred in this subgroup., (Copyright © 2022. Published by Elsevier B.V.)
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- 2022
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20. [Endovascular aneurysm repair (EVAR) : Update D].
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Torsello GF
- Subjects
- Elective Surgical Procedures methods, Humans, Aortic Aneurysm, Abdominal surgery, Aortic Rupture, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects
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Background: Abdominal aortic aneurysms can either be treated by open surgery or endovascular repair. In both cases, prostheses are implanted to prevent potentially lethal aortic ruptures., Objectives: Studies seeking to identify the optimal treatment came to diverging conclusions. The goal of this article is to shed light on the discussion of which treatment option is to be preferred., Materials and Methods: This article summarizes the relevant studies on elective and emergency abdominal aortic aneurysm repair. The presented studies are discussed, and results are interpreted and compared., Results: While most studies indicate lower short-term mortality rates in endovascular aneurysm repair (EVAR), mortality rates converged in multiple trials and even showed a lower mortality rate for open repair in mid-term analyses. Most recent studies indicate long-term equivalence in terms of mortality and a higher rate of secondary interventions in EVAR patients., Conclusions: The current body of literature indicates no real advantage of one therapy over another. The choice of therapy should depend on anatomic, clinical, and logistic criteria., (© 2022. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)
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- 2022
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21. [Update on thoracic endovascular aneurysm repair : New stent graft designs].
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Torsello GF
- Subjects
- Blood Vessel Prosthesis adverse effects, Humans, Postoperative Complications etiology, Prosthesis Design, Retrospective Studies, Stents adverse effects, Treatment Outcome, Aortic Aneurysm, Abdominal complications, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects
- Abstract
Background: In the last decade, new stent graft designs have evolved to tackle challenges in thoracic endovascular aortic repair. A specific focus on access vessel issues has led to the introduction of new low-profile endograft designs for most of the major products., Objective: The main objective of this article is to provide an overview of the available publications on new stent graft designs., Materials and Methods: Assessing recent publications on the major reiterations of thoracic endografts, benefits and drawbacks are discussed., Results: Recent reiterations of major endografts for thoracic aortic endovascular repair have focused mainly on the development of low-profile devices. Through alterations on graft fabric as well as stent material and design, delivery systems were reduced in profile, thus, reducing access vessel complications or enabling an endovascular procedure altogether. Long-term data are already available for one endoprosthesis. Other refinements include in situ adaptation of the stent graft to the aortic arch curvature as well as the option of staged deployment to allow more precision and reduce manipulation close to supra-aortic branches., Conclusions: Especially in the case of low-profile endografts, preliminary and long-term results of access vessel complications are promising. In order to draw final conclusions as to how durable the results of aneurysm exclusion are, more long-term studies are warranted., (© 2022. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)
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- 2022
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22. Short- and long-term evaluation of disease-specific symptoms and quality of life following uterine artery embolization of fibroids.
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Psilopatis I, Fleckenstein FN, Collettini F, Can E, Frisch A, Gebauer B, Fehrenbach U, Torsello GF, Schnapauff D, David M, and Wieners G
- Abstract
Background: The purpose of this study is to evaluate uterine artery embolization (UAE) for the management of symptomatic uterine leiomyomas regarding changes in quality of life after treatment in a large patient collective. This study retrospectively analyzed prospectively acquired standardized questionnaires of patients treated with UAE. Clinical success was evaluated before and after embolization. Patients were stratified into short- (≤ 7 months) and long-term (> 7 months) follow-up groups depending on the time of completion of the post-interventional questionnaire. Uterine leiomyomas were furthermore divided into small (< 10 cm) and large (≥ 10 cm) tumors based on the diameter of the dominant fibroid., Results: A total of 245 patients were included into the final data analysis. The Kaplan-Meier analysis showed a cumulative clinical success rate of 75.8% after 70 months until the end of follow-up (9.9 years). All questionnaire subscales showed a highly significant clinical improvement from baseline to short- and long-term follow-up (p < 0.001). Patients with small fibroids showed a significantly better response to UAE in multiple subcategories of the questionnaire than patients with fibroids ≥ 10 cm who had a twofold higher probability of re-intervention in the Cox-regression model., Conclusions: UAE is an effective treatment method for symptomatic fibroids that leads to quick relief of fibroid-related symptoms with marked improvement of quality of life and is associated with a low risk for re-interventions. Patients with small fibroids tend to show a better response to UAE compared to patients with large fibroids. Trial registration Charité institutional review board, EA4/167/20. Registered 27 November 2020-Retrospectively registered. https://ethikkommission.charite.de/., (© 2022. The Author(s).)
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- 2022
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23. Use of Chimney Technique Does Not Improve the Outcome of Endovascular Aneurysm Repair in Patients With a Hyperangulated and Short Proximal Aortic Neck.
- Author
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Özdemir-van Brunschot DMD, Torsello GB, Bernardini G, Litterscheid S, Torsello GF, and Beropoulis E
- Subjects
- Blood Vessel Prosthesis, Endoleak surgery, Humans, Retrospective Studies, Risk Factors, Treatment Outcome, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation, Endovascular Procedures
- Abstract
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.
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- 2022
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24. [67/m-Incidental finding of a solitary pulmonary nodule : Preparation for the medical specialist examination: part 145].
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Nunninger M and Torsello GF
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- Humans, Incidental Findings, Tomography, X-Ray Computed, Lung Neoplasms diagnosis, Solitary Pulmonary Nodule diagnosis
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- 2022
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25. A meta-analysis of safety and efficacy of endovascular aneurysm repair in aneurysm patients with severe angulated infrarenal neck.
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Bernardini G, Litterscheid S, Torsello GB, Torsello GF, Beropoulis E, and Özdemir-van Brunschot D
- Subjects
- Aortic Aneurysm, Abdominal mortality, Aortic Aneurysm, Abdominal pathology, Humans, Postoperative Complications, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Endovascular Procedures adverse effects, Endovascular Procedures mortality
- Abstract
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., Competing Interests: The authors have declared that no competing interests exist.
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- 2022
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26. Combining Transarterial Radioembolization (TARE) and CT-Guided High-Dose-Rate Interstitial Brachytherapy (CT-HDRBT): A Retrospective Analysis of Advanced Primary and Secondary Liver Tumor Treatment.
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Fleckenstein FN, Roesel MJ, Krajewska M, Auer TA, Collettini F, Maleitzke T, Böning G, Torsello GF, Fehrenbach U, and Gebauer B
- Abstract
Purpose: Treatment of patients with primary and secondary liver tumors remains challenging. This study analyzes the efficacy and safety of transarterial radioembolization (TARE) combined with CT-guided high-dose-rate interstitial brachytherapy (CT-HDRBT) for the treatment of primary and secondary liver tumors., Patients and Methods: A total of 77 patients (30 female) with various liver malignancies were treated. Primary endpoints were median overall survival (OS) and time to untreatable progression (TTUP). Additionally, subgroup analyses were performed in consideration of diagnosis and procedure sequence. Median OS and TTUP prediction were estimated using Kaplan-Meier analysis and hazard ratios (HR) were calculated using a multivariate Cox proportional hazard model., Results: A total of 115 CT-HDRBT and 96 TARE procedures were performed with no significant complications recorded. Median OS and TTUP were 29.8 (95% CI 18.1-41.4) and 23.8 (95% CI 9.6-37.9) months. Median OS for hepatocellular carcinoma (HCC)-, cholangiocarcinoma carcinoma (CCA) and colorectal cancer (CRC) patients was 29.8, 29.6 and 34.4 months. Patients starting with TARE had a median OS of 26.0 (95% CI 14.5-37.5) compared to 33.7 (95% CI 21.6-45.8) months for patients starting with CT-HDRBT. Hazard ratio of 1.094 per month was shown for patients starting with CT-HDRBT., Conclusion: Combining TARE and CT-HDRBT is effective and safe for the treatment of advanced stage primary and secondary liver tumors. Our data indicate that early TARE during the disease progression may have a positive effect on survival.
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- 2021
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27. Aortic endograft and bridging stent-graft remodeling after branched endovascular aortic repair.
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Fazzini S, Torsello G, Austermann M, Beropoulis E, Munaò R, and Torsello GF
- Subjects
- Aged, Aorta diagnostic imaging, Aorta physiopathology, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic physiopathology, Blood Vessel Prosthesis Implantation adverse effects, Databases, Factual, Endovascular Procedures adverse effects, Female, Foreign-Body Migration etiology, Humans, Male, Middle Aged, Prosthesis Design, Prosthesis Failure, Retrospective Studies, Time Factors, Treatment Outcome, Aorta surgery, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Stents, Vascular Remodeling
- Abstract
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.
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- 2021
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28. Performance of the Gore VBX Balloon Expandable Endoprosthesis as Bridging Stent-Graft in Branched Endovascular Aortic Repair for Thoracoabdominal Aneurysms.
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Torsello GB, Pitoulias A, Litterscheid S, Berekoven B, Torsello GF, Austermann M, and Bosiers MJ
- Subjects
- Blood Vessel Prosthesis, Humans, Prosthesis Design, Retrospective Studies, Stents, Time Factors, Treatment Outcome, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects
- Abstract
Purpose: Bridging stent stability is crucial for efficacy and safety of branched aortic endovascular repair (bEVAR) of thoracoabdominal aortic aneurysms (TAAAs). In this study, we assess the performance of the new Viabahn Balloon-Expandable endoprosthesis (VBX) in bEVAR. Based on our learning curve we give recommendations for a safe and effective use of the device., Materials and Methods: We prospectively collected the data of patients with TAAAs undergoing bEVAR between December 2017 and December 2019. All patients with implantation of at least 1 VBX stent-graft as bridging stent were included in our single-center analysis. Demographic, comorbidity, and computed tomography angiography (CTA) data of 112 patients were retrospectively evaluated. Primary endpoint was a composite of branch-related technical success and freedom from target vessel instability. Secondary endpoints were clinical and ongoing clinical success., Results: Primary endpoint: technical success was achieved in all patients (100%) with a freedom from target vessel instability of 96.3% after a median follow-up of 18 months. Overall mortality was 13.4% (n=15) and 13 patients underwent secondary interventions, 12 of them are still alive and 1 suffered from aneurysm sac expansion, consequently an ongoing clinical success of 75.9% was reached. After modification of the implantation technique during the course of the study by selecting longer stent lengths after accurate estimation of vessel curvature and expected adaptation of the flexible endoskeleton to the specific anatomical conditions, no type Ic endoleaks were observed in the last 70 cases., Conclusions: The VBX stent-graft can be safely used as bridging stent for branched thoracoabdominal repair. However, learning curve should be considered to avoid type Ic endoleak and edge stenosis. Based on this experience longer landing zones and 2-step deployment of VBX are useful for successful bridging also of challenging target vessels.
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- 2021
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29. Preliminary Clinical and Radiologic Outcome of Matched Patients with Thoracoabdominal Aortic Aneurysms Treated by Low-Profile vs Standard Profile Branched Aortic Endografts.
- Author
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Puta B, Fazzini S, Torsello G, Pipitone MD, Austermann M, Beropoulis E, and Torsello GF
- Subjects
- Aged, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic mortality, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation mortality, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Female, Humans, Male, Middle Aged, Postoperative Complications diagnostic imaging, Predictive Value of Tests, Prosthesis Design, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Aortic Aneurysm, Thoracic surgery, Aortography, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Computed Tomography Angiography, Endovascular Procedures instrumentation, Stents
- Abstract
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., (Copyright © 2021 Elsevier Inc. All rights reserved.)
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- 2021
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30. 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.
- Author
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D'Oria M, Pitoulias GA, Torsello GF, Pitoulias AG, Fazzini S, Masciello F, Verzini F, and Donas KP
- Abstract
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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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- 2021
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31. Fatigue Resistance of the Advanta V12/iCast and Viabahn Balloon-Expandable Stent-Graft as Bridging Stents in Experimental Fenestrated Endografting.
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Torsello G, Müller M, Litterscheid S, Berekoven B, Austermann M, and Torsello GF
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- Humans, Prosthesis Design, Stents, Treatment Outcome, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation adverse effects
- Abstract
Purpose: Bridging stents undergo millions of cycles during respiratory movements of the kidneys throughout the patient's life. Thus, understanding the response of fabric and endoskeleton of the stent to cyclic loading over the time is crucial. In this study, we compare the fatigue resistance of the Viabahn Balloon-Expandable stent-graft (VBX) with the widely used Advanta V12/iCast under prolonged stress induction., Materials and Methods: A polyester test sheet with 10 fenestrations was used simulating a fenestrated endograft. Five 6×59 mm VBX stent-grafts and five 6×58 mm Advanta stent-grafts were implanted into 6×6 mm fenestrations. The stents were flared with a 10×20 mm PTA (percutaneous transluminal angioplasty) catheter and connected with a fatigue stress machine. All stent-grafts were evaluated by microscopy and radiography at baseline and after regular intervals until 50,000,000 cycles were applied, simulating a life span of approximately 75 months. Freedom from fracture (FF), freedom from initial polytertafluoroethylene (PTFE) changes (FIC), and from PTFE breakpoint (FBP, all-layer defect) were calculated., Results: Digital radiographic images did not show any stent fracture in both groups after 50,000,000 cycles. The VBX stent-graft was free from any all-layer defects at the conclusion of 50,000,00 cycles resulting in a significant higher FBP compared with Advanta V12 (50,000,000 vs 33,400,000; p<0.01). All-layer defects were observed only in the Advanta group. Two of 5 Advanta stents showed early penetration of the nitinol ring causing a defect of PTFE. Regarding FIC, there was no significant difference between the stents (3,400,000 in VBX vs 3,200,000 in Advanta)., Conclusions: In fatigue tests simulating respiration movements, VBX and Advanta V12 performed equally well in terms of fracture resistance and freedom from initial PTFE changes. VBX maintained freedom from PTFE breakpoint throughout the full 50,000,000 cycles. All-layers defects were detected only in Advanta and were mainly caused by penetration of the nitinol ring through the PTFE.
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- 2021
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32. Treatment of a giant hepatic echinococcal cyst with percutaneous drainage and in vivo assessment of the protoscolicidal effect of praziquantel.
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Richter J, Lindner AK, Geisel D, Torsello GF, Martinez GE, Isner C, Schürmann D, Pfäfflin F, Orhun A, Manciulli T, and Brunetti E
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- Animals, Drainage, Humans, Praziquantel, Cysts drug therapy, Echinococcosis, Hepatic drug therapy, Echinococcosis, Hepatic surgery, Echinococcus
- Abstract
Therapy choices for cystic echinococcisis (CE) are stage-specific: surgical, minimally invasive, medical or observation without intervention. PAIR (percutaneous aspiration, instillation of a scolicide, and re-aspiration) has been considered the treatment of choice for uncomplicated echinococcal liver cysts. However, PAIR carries the risk of toxic cholangitis or hypernatremia and that the cyst frequently refills with bile after withdrawing the catheter. We treated a patient with a giant CE 1 liver cyst with puncture drainage (PD) under albendazole coverage. Drainage enabled us to monitor the morphology of protoscolices under praziquantel (PZQ) co-medication. Protoscolices degenerated within 5 days of PZQ 50 mg/kg/d. The cyst cavity solidified with no evidence of reactivation or secondary spread. Percutaneous treatments can replace surgery in a significant number or cases with hepatic CE. PD allows to assess microscopically the viability of protoscolices under co-medication with PZQ-albendazole and to avoid the instillation of topical scolicides.
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- 2021
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33. Treatment of iliac atherosclerotic lesions using the balloon-expandable dynamic bare metal stent: One-year outcomes of the BIODYNAMIC single-center retrospective analysis.
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Torsello GF, Doerr B, Donas K, Berekoven B, Torsello GB, and Beropoulis E
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- Aged, Amputation, Surgical, Angioplasty, Balloon adverse effects, Angioplasty, Balloon mortality, Female, Germany, Humans, Limb Salvage, Male, Middle Aged, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease mortality, Prosthesis Design, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Angioplasty, Balloon instrumentation, Iliac Artery diagnostic imaging, Metals, Peripheral Arterial Disease therapy, Plaque, Atherosclerotic, Stents
- Abstract
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.
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- 2021
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34. The PROTAGORAS 2.0 Study to Identify Sizing and Planning Predictors for Optimal Outcomes in Abdominal Chimney Endovascular Procedures.
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Fazzini S, Martinelli O, Torsello G, Austermann M, Pipitone MD, Torsello GF, Irace L, and Donas KP
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- Aged, Aged, 80 and over, Aorta, Abdominal diagnostic imaging, Aorta, Abdominal physiopathology, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal physiopathology, Aortography, Blood Vessel Prosthesis Implantation adverse effects, Computed Tomography Angiography, Databases, Factual, Endoleak etiology, Endoleak prevention & control, Endovascular Procedures adverse effects, Female, Graft Occlusion, Vascular etiology, Graft Occlusion, Vascular prevention & control, Humans, Male, Prosthesis Design, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Vascular Patency, Aorta, Abdominal surgery, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Stents
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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., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)
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- 2021
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35. Long-term Results of Thoracic Endovascular Aortic Repair Using a Low-Profile Stent-Graft.
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Beropoulis E, Fazzini S, Austermann M, Torsello GB, Damerau S, and Torsello GF
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- Aged, Aged, 80 and over, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis, Female, Humans, Male, Middle Aged, Prosthesis Design, Retrospective Studies, Treatment Outcome, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects, Stents
- Abstract
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.
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- 2021
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36. Outcomes of bridging stent grafts in fenestrated and branched endovascular aortic repair.
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Torsello GF, Beropoulis E, Munaò R, Trimarchi S, Torsello GB, and Austermann M
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- Aged, Aged, 80 and over, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal mortality, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic mortality, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation mortality, Endoleak etiology, Endoleak therapy, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Female, Humans, Male, Middle Aged, Prosthesis Design, Retreatment, Retrospective Studies, Time Factors, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Stents
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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., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2020
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37. Late outcomes of different hypogastric stent grafts in aortoiliac endografting with iliac branch device: Results from the pELVIS Registry.
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Verzini F, Parlani G, Varetto G, Gibello L, Boero M, Torsello GF, Donas KP, and Simonte G
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- Adult, Aged, Aged, 80 and over, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal mortality, Aortic Aneurysm, Abdominal physiopathology, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation mortality, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Europe, Female, Humans, Iliac Aneurysm diagnostic imaging, Iliac Aneurysm mortality, Iliac Aneurysm physiopathology, Male, Middle Aged, Postoperative Complications mortality, Postoperative Complications surgery, Prosthesis Design, Registries, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Vascular Patency, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Iliac Aneurysm surgery, Stents
- Abstract
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., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2020
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38. Successful aspiration thrombectomy in a patient with submassive, intermediate-risk pulmonary embolism following COVID-19 pneumonia.
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Pohlan J, Kamel SN, Torsello GF, Zickler D, Kruse JM, Eckardt KU, and Gebauer B
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A 64-year-old female patient presented with severe dyspnea shortly after apparent recovery from COVID-19 disease. Chest computed tomography revealed central pulmonary embolism and ultrasonography showed a deep vein thrombosis of her right leg. The patient was tachycardiac with evidence of right ventricular strain on echocardiography. An interdisciplinary decision for interventional therapy was made. Angiographic aspiration thrombectomy resulted in a significant reduction of thrombus material and improved flow in the pulmonary arteries and immediate marked clinical improvement and subsequent normalization of functional echocardiographic parameters. This case adds to the emerging evidence for severe thromboembolic complications following COVID-19 and suggests aspiration thrombectomy can be considered in pulmonary embolism of intermediate risk., Competing Interests: None., (© 2020 The Authors. Published by Elsevier Inc. on behalf of University of Washington.)
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- 2020
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39. One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System.
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Torsello GF, Argyriou A, Stavroulakis K, Bosiers MJ, Austermann M, and Torsello GB
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- Adult, Aged, Aged, 80 and over, Aorta, Thoracic diagnostic imaging, Aorta, Thoracic physiopathology, Aortic Diseases diagnostic imaging, Aortic Diseases mortality, Aortic Diseases physiopathology, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation mortality, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Female, Humans, Male, Middle Aged, Postoperative Complications etiology, Product Surveillance, Postmarketing, Prospective Studies, Prosthesis Design, Risk Factors, Time Factors, Treatment Outcome, Aorta, Thoracic surgery, Aortic Diseases surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Stents
- Abstract
Purpose: To report the outcomes from the observational SURPASS registry, which was created to assess the performance of the Conformable TAG (CTAG) stent-graft with the Active Control System (ACS) in patients undergoing thoracic endovascular aortic repair (TEVAR) in a real-world setting. Materials and Methods: The SURPASS registry ( ClinicalTrials.gov ; identifier NCT03286400) was an observational, prospective, single-arm, post-market, international study that enrolled patients undergoing TEVAR using the CTAG with ACS for both acute and chronic thoracic aortic disease between October 2017 and July 2018. The CTAG with ACS features 2-stage deployment of the stent-graft and an optional angulation mechanism that modifies only the proximal end of the stent-graft. During the observation period, 127 patients (mean age 67.1±12.1 years, range 27-86; 92 men) were enrolled and treated for an array of aortic pathologies, including chronic and acute lesions and 4 ruptured descending thoracic aneurysms. The primary outcome of this study was technical success; secondary outcomes were clinical success and major adverse events at 30 days and 12 months. The numbers of 2-stage device deployments and applications of the angulation mechanism were recorded, along with the reasons for use. Results: Technical success of the TEVAR was 97.6% owing to unintentional partial coverage of supra-aortic branches in 3 cases (the vessels were patent on imaging). The stent-graft was repositioned at its intermediate diameter in 79 patients (62.2%), and the angulation feature was applied in 64 cases (50.4%), mainly to improve proximal wall apposition and orthogonality in the aorta. The desired effect was achieved in 60 cases (93.8%). There was no device compression, bird-beak configuration, fracture, or graft occlusion. The 30-day and 12-month clinical success rates were 97.6% and 92.9%, respectively. There were 3 aorta-related deaths at 30 days and a further 3 at 12 months. Fatalities were due to a retrograde type A dissection (0.8%), paraplegia, bowel ischemia, sepsis in the setting of a mycotic aneurysm, aneurysm rupture post aortoesophageal fistula, and multiorgan dysfunction syndrome. Three endoleaks (2 type Ia and 1 type III) required reintervention. Conclusion: In the SURPASS registry, the use of the CTAG device with ACS showed promising outcomes despite the challenging pathologies. The new delivery system enables a controlled staged delivery with in situ adjustments during positioning, facilitating the treatment of complex aortic disease.
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- 2020
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40. Comparison of the Biomechanical Properties of the Advanta V12/iCast and Viabahn Stent-Grafts as Bridging Devices in Fenestrated Endografts: An In Vitro Study.
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Torsello GF, Herten M, Müller M, Frank A, Torsello GB, and Austermann M
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- Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects, Equipment Failure Analysis, Foreign-Body Migration etiology, Materials Testing, Prosthesis Design, Prosthesis Failure, Risk Factors, Stress, Mechanical, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Stents
- Abstract
Purpose: To compare experimentally the biomechanical properties of the Viabahn Balloon-Expandable Stent Graft (VBX) with the widely used Advanta V12/iCast in the role of bridging stent-grafts for fenestrated endovascular aortic repair. Materials and Methods: Test sheets made of polyester having 2 rows of 5 fenestrations in 6-mm and 8-mm diameters were used to simulate a commercially made fenestrated aortic endograft. In total, 40 stent-grafts measuring 6×39 mm and 8×39 mm (10 of each size for each stent-graft) were implanted in fenestration sheets immersed in a 37°C water bath. After flaring, all stent-grafts were evaluated using microscopy and radiography. Biomechanical evaluation included pullout and the shear stress force testing; results are reported in Newtons (N) as the median (minimum-maximum). Results: After flaring, no damage or fracture to the stent-graft structures were detected. Pullout forces for the 6-mm stent-grafts were 27.1 N (20.0-28.9) for the VBX and 16.6 N (14.7-19.2) for the Advanta (p=0.008). Pullout forces for the 8-mm stent-grafts were 20.1 N (14.8-21.5) for the VBX and 15.8 N (12.4-17.5) for the Advanta (p=0.095). The shear stress forces necessary to dislocate the device at 150% stent diameter displacement was 12.5 N (VBX) vs 14.7 N (Advanta) for the 6-mm devices and 23.3 N (VBX) vs 20.2 N (Advanta) for the 8-mm stents (p>0.99 and p=0.222, respectively). Conclusion: In vitro tests simulating external pull and shear forces on bridging stent-grafts implanted in fenestrations showed that the VBX had resistance to dislocation equivalent to a well-known control device.
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- 2020
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41. Performance of BeGraft and BeGraft+ Stent-Grafts as Bridging Devices for Fenestrated Endovascular Aneurysm Repair: An In Vitro Study.
- Author
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Torsello GF, Herten M, Frank A, Müller M, Jung S, Torsello GB, and Austermann M
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- Angioplasty, Balloon adverse effects, Aorta diagnostic imaging, Aorta physiopathology, Aortic Aneurysm diagnostic imaging, Aortic Aneurysm physiopathology, Blood Vessel Prosthesis Implantation adverse effects, Chromium Alloys, Equipment Failure Analysis, Humans, Materials Testing, Polytetrafluoroethylene, Prosthesis Design, Prosthesis Failure, Stress, Mechanical, Angioplasty, Balloon instrumentation, Aorta surgery, Aortic Aneurysm surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Stents
- Abstract
Purpose: To investigate 2 generations of balloon-expandable covered stents as potential bridging devices using an in vitro model of stent-graft fenestrations. Materials and Methods: Twenty BeGraft and 20 BeGraft+ cobalt-chromium stents covered in expanded polytetrafluoroethylene (ePTFE) in 6- and 8-mm diameters were tested in sheets mimicking stent-graft fenestrations. Microscopy and radiography were employed to evaluate stent morphology after flaring. In vitro bench tests measured maximum pullout (perpendicular displacement) and the shear stress (axial displacement) forces needed to dislocate the stents. Results: No alteration of ePTFE coverage was detected in the flared stents. Digital radiography and computed tomography showed marked alteration of the stent geometry, which was more pronounced in the BeGraft group. No fractures were detected. Median (minimum-maximum) pullout forces for the 6-mm stent-grafts were 17.1 N (15.8-19.6) for the BeGraft device and 30.4 N (20.2-31.9) for the BeGraft+ device (p=0.006). Median (minimum-maximum) pullout forces for the 8-mm stent-grafts were 11.3 N (11-12.1) for the BeGraft device and 21.8 N (18.2-25.5) for the BeGraft+ device (p<0.001). The shear stress test showed median forces of 10.5 vs 15.28 N at 150% of the stent diameter for the 6-mm BeGraft and BeGraft+ stent-grafts, respectively, and 15.23 vs 20.72 N at 150% stent diameter for the 8-mm models (p=0.016 and 0.017, respectively). Conclusion: Flaring changed the stent geometry but did not provoke stent fractures. The BeGraft+ is superior to the BeGraft in terms of pullout and shear stress forces, demonstrating greater resilience.
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- 2019
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42. In Vitro Evaluation of Balloon-Expandable Chimney Grafts in the Renal Arteries Combined With the Endurant Endograft.
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Taneva GT, Donas KP, Torsello GB, Seifarth H, de Azevedo FM, Austermann M, and Torsello GF
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- Angioplasty, Balloon adverse effects, Aorta, Abdominal diagnostic imaging, Aorta, Abdominal physiopathology, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal physiopathology, Blood Vessel Prosthesis Implantation adverse effects, Hemodynamics, Humans, Models, Anatomic, Models, Cardiovascular, Prosthesis Design, Renal Artery diagnostic imaging, Renal Artery physiopathology, Renal Circulation, Angioplasty, Balloon instrumentation, Aorta, Abdominal surgery, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Renal Artery surgery, Stents
- Abstract
Purpose: To compare balloon-expandable covered stents (BECS) available for use as renal chimney grafts to the Advanta V12 approved for use with the Endurant endograft. Materials and Methods: A silicone model was manufactured based on preoperative computed tomography angiography (CTA) scans of a patient with a 7-cm juxtarenal aneurysm treated with an Endurant bifurcated endograft and an Advanta V12 covered stent for the 6-mm-diameter right renal artery. The model was placed in a flow box filled with a 37°C blood-mimicking solution equipped with a pulsatile pumping system (140/60 mm Hg). The tested BECS were the Advanta V12, the VBX, and the BeGraft+. A 36-mm-diameter Endurant II endograft with a 16-mm-diameter contralateral limb and a 6×59-mm BECS chimney graft were used in 9 consecutive tests (3 for each combination). After each implantation, the model was placed in the CT scanner, and 2 radiologists blinded to the test device independently measured the gutter areas and the patent chimney graft lumen at the level of the Endurant's suprarenal stent, at the level of the chimney's maximum curvature, and 10 mm inside the renal artery. The intraclass correlation coefficients (ICC) were calculated to assess interreader reliability. Results: The mean gutter areas were 19.3±7, 20.2±8, and 22.3±8 mm
2 for the Advanta, VBX, and BeGraft+, respectively (all p>0.05). At the level of the aortic endograft's suprarenal stent struts, the mean diameter of the Advanta V12, VBX, and BeGraft+ were 4.46±0.3, 4.12±0.4, and 4.12±0.3 mm, respectively (all p>0.05). At the level of the maximum chimney graft angulation, the mean diameters were 3.77±0.3, 4.16±0.1, and 3.74±0.3 mm, respectively (all p>0.05). In the right renal artery, the mean diameters were 3.91±0.2, 4.05±0.9, and 4.3±0.4 mm, respectively (all p>0.05). The ICCs varied between 0.7 and 0.9, indicating good agreement between readers. Conclusion: These in vitro findings showed comparable results between the Advanta V12 and the available BECS used in conjunction with the Endurant endograft according to the instructions for use. Further clinical evaluation is needed to confirm these results.- Published
- 2019
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43. CTA Assessment of Midterm Morphological Changes to Chimney Grafts Used in the Treatment of Juxtarenal Aortic Aneurysms.
- Author
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Hahtapornsawan S, Lazaridis K, Criado FJ, Torsello GF, Bisdas T, Austermann M, and Donas KP
- Subjects
- Aged, Aged, 80 and over, Aortic Aneurysm, Abdominal diagnostic imaging, Blood Vessel Prosthesis Implantation adverse effects, Endoleak etiology, Endovascular Procedures adverse effects, Female, Foreign-Body Migration etiology, Humans, Male, Predictive Value of Tests, Prosthesis Design, Retrospective Studies, Time Factors, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Aortography, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Computed Tomography Angiography, Endoleak diagnostic imaging, Endovascular Procedures instrumentation, Foreign-Body Migration diagnostic imaging, Stents
- Abstract
Purpose: To evaluate chimney stent-graft position and morphological changes of the aneurysm sac as visualized by postoperative computed tomography angiography (CTA) over a minimum 24-month follow-up period. Materials and Methods: Twenty-one patients (mean age 75.7±8.6 years; 20 men) with juxtarenal aortic aneurysms who underwent successful chimney endovascular aneurysm repair (ch-EVAR) with the Endurant stent-graft and had 2 postoperative CTAs separated by at least 24 months were included in the study. CTA-based measurements of aortic stent-graft migration, target vessel angle, and chimney angle were compared between the serial scans. Results: During a mean follow-up of 34.9 months (range 24-69.2), the mean migration of the aortic stent-grafts was under 5 mm (2.76±2.4 mm). The average migration distance per year was 1.15 mm. The aneurysm diameter reduced a mean 3.25 mm (p=0.048). The right renal artery angle moved significantly upward 6.72° (p=0.025), while the right renal chimney stent-graft moved significantly downward 7.83° (p=0.042). The left renal artery angle also moved upward 1.87° (p=0.388) and the corresponding chimney moved downward 5.68° (p=0.133). During the study period, no type I/III endoleak or chimney occlusion was observed. Conclusion: Midterm morphometric assessment of ch-EVAR using CTA showed significant aneurysm sac shrinkage and a stable 3-year position of the abdominal devices, with the mean downward migration of the aortic stent-graft being <5 mm in the majority of cases. The chimney grafts seem to be prone to take an oblique rather than parallel configuration during follow-up. However, there was no relevant clinical consequence related to this phenomenon.
- Published
- 2019
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44. In Vitro Evaluation of the Gore Viabahn Balloon-Expandable Stent-Graft for Fenestrated Endovascular Aortic Repair.
- Author
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Torsello GF, Herten M, Müller M, Frank A, Torsello GB, and Austermann M
- Subjects
- Angioplasty, Balloon adverse effects, Aortic Aneurysm physiopathology, Blood Vessel Prosthesis Implantation adverse effects, Hemodynamics, Humans, Materials Testing, Permeability, Prosthesis Design, Prosthesis Failure, Stress, Mechanical, Angioplasty, Balloon instrumentation, Aortic Aneurysm surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Stents
- Abstract
Purpose: To evaluate the safety and integrity of a new stent-graft as a potential bridging device in fenestrated stent-grafts using an in vitro fenestrated model., Materials and Methods: Polyester test sheets with ten 6-mm- or 8-mm-diameter fenestrations were used to simulate a fenestrated main body endoprosthesis. In total, 50 Viabahn balloon-expandable (VBX) stent-grafts of varying lengths (29 and 39 mm) and diameters (6, 7, and 8 mm) were implanted in the fitting fenestrations. After release, the 6- and 7-mm-diameter stent-grafts were flared with a 10×20-mm angioplasty balloon; a 12×20-mm balloon was used in the 8-mm-diameter devices. Safety of the devices was defined as absence of fractures detected on radiography or computed tomography (CT), as well as material failure detected by microscopy and water permeability testing. The forces (in Newtons, N) needed for perpendicular dislocation (pullout force) and axial dislocation (shear stress force) were also evaluated., Results: Forty VBX stent-grafts were subjected to digital radiographic imaging and multiplanar CT. None showed any stent fracture. Subsequent microscopy indicated no damage to the fabric or separation of the graft after flaring. Ten VBX stent-grafts underwent water permeability testing after flaring; no water passed through the graft wall during a 10-minute period under an intraluminal pressure at 120 mm Hg. Testing of 25 VBX stent-grafts revealed initial pullout forces between 11.3 and 31 N. Shear stress tests showed that the average force needed to dislocate the stent-grafts by 50% of their diameter ranged between 5.75 and 6.91 N (mean 6.1±0.5 N) for the 6-mm stents and between 3.31 and 5.4 N (mean 4.4±0.8) for the 8-mm stents., Conclusion: This preliminary study demonstrated the applicability of the VBX as a bridging stent-graft in a simulated fenestration model. A comparison with other stent-grafts and clinical assessment are required.
- Published
- 2019
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45. Multicenter experience with endovascular treatment of aortic coarctation in adults.
- Author
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Erben Y, Oderich GS, Verhagen HJM, Witsenburg M, van den Hoven AT, Debus ES, Kölbel T, Arko FR 3rd, Torsello GB, Torsello GF, Lawrence PF, Harlander-Locke MP, Bacharach JM, Jordan WD Jr, Eskandari MK, and Hagler DJ
- Subjects
- Adult, Aged, Aortic Coarctation diagnostic imaging, Aortic Coarctation mortality, Aortic Coarctation physiopathology, Blood Vessel Prosthesis, Female, Graft Occlusion, Vascular etiology, Graft Occlusion, Vascular physiopathology, Graft Occlusion, Vascular therapy, Humans, Male, Middle Aged, Progression-Free Survival, Recurrence, Retreatment, Retrospective Studies, Risk Assessment, Risk Factors, Stents, Time Factors, Vascular Patency, Young Adult, Angioplasty, Balloon adverse effects, Angioplasty, Balloon instrumentation, Angioplasty, Balloon mortality, Aortic Coarctation therapy, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation instrumentation, Blood Vessel Prosthesis Implantation mortality
- Abstract
Objective: The objective of this study was to evaluate outcomes of endovascular treatment of aortic coarctation in adults., Methods: Clinical data and imaging studies of 93 consecutive patients treated at nine institutions from 1999 to 2015 were reviewed. We included newly diagnosed aortic coarctation (NCO), recurrent coarctation, and aneurysmal/pseudoaneurysmal degeneration (ANE) after prior open surgical repair (OSR) of coarctation. Primary end points were morbidity and mortality. Secondary end points were stent patency and freedom from reintervention., Results: There were 54 (58%) male and 39 (42%) female patients with a mean age of 44 ± 17 years. Thirty-two patients had NCO (mean age, 48 ± 16 years) and 61 had endovascular reinterventions after prior OSR during childhood (mean, 30 ± 17 years after initial repair), including 50 patients (54%) with recurrent coarctation and 11 (12%) with ANE. Clinical presentation included asymptomatic in 31 patients (33%), difficult to control hypertension in 42 (45%), and lower extremity claudication in 20 (22%). Endovascular treatment was performed using balloon-expandable covered stents in 47 (51%) patients, stent grafts in 36 (39%) patients, balloon-expandable uncovered stents in 9 (10%) patients, and primary angioplasty in 1 (1%) patient. Mean lesion length and diameter were 64.5 ± 50.6 mm and 19.5 ± 6.7 mm, respectively. Mean systolic pressure gradient decreased from 24.0 ± 17.5 mm Hg to 4.4 ± 7.4 mm Hg after treatment (P < .001). Complications occurred in nine (10%) patients, including aortic dissections in three (3%) patients and intraoperative ruptures in two patients; type IA endoleak, renal embolus, spinal headache, and access site hemorrhage occurred in one patient each. The aortic dissections and ruptures were treated successfully by deploying an additional covered stent proximal to the site of dissection or rupture. Two patients died within 30 days of the index procedure. After a mean follow-up of 3.2 ± 3.1 years, nearly all patients (98%) were clinically improved and all stents were patent. Reintervention was needed in 10 (11%) patients. Freedom from reintervention at 5 years was 85%. Two additional patients died during follow-up of coarctation-related causes, including rupture of an infected graft and visceral ischemia. Patient survival at 5 years was 89%., Conclusions: Endovascular repair is effective with an acceptable safety profile in the treatment of NCO and postsurgical complications of coarctation after initial OSR. Aortic rupture is an infrequent (2%) but devastating complication with high mortality. Balloon-expandable covered stents are preferred for NCO, whereas stent grafts are used for ANE. The rate of reinterventions is acceptable, with high procedural and long-term clinical success., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2019
- Full Text
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46. Radiation doses for endovascular aortic repairs performed on mobile and fixed C-arm fluoroscopes and procedure phase-specific radiation distribution.
- Author
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Schaefers JF, Wunderle K, Usai MV, Torsello GF, and Panuccio G
- Subjects
- Aged, Aged, 80 and over, Angiography, Digital Subtraction adverse effects, Aortography adverse effects, Blood Vessel Prosthesis, Equipment Design, Female, Fluoroscopy, Humans, Male, Predictive Value of Tests, Radiation Monitoring, Radiography, Interventional adverse effects, Retrospective Studies, Risk Factors, Stents, Time Factors, Treatment Outcome, Angiography, Digital Subtraction instrumentation, Aorta diagnostic imaging, Aorta surgery, Aortography instrumentation, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures adverse effects, Endovascular Procedures instrumentation, Radiation Dosage, Radiation Exposure adverse effects, Radiography, Interventional instrumentation, Tomography Scanners, X-Ray Computed
- Abstract
Objective: The objective of this study was to analyze radiation risk to patients during endovascular aneurysm repair (EVAR) using mobile C-arm (MA) or fixed C-arm (FA) fluoroscopes and to describe the dose distribution during the different phases of the procedure., Methods: Patients treated with EVAR using a single stent graft system between November 2009 and June 2016 were included in this study. The patients were divided into one of two groups (MA or FA) according to the type of C-arm used in the procedure. Data regarding patients' demographics and the total amount of contrast agent (CA) used, dose-area product, and fluoroscopy time for the procedures were prospectively recorded. Based on the dose report from the FA system, five standard and two optional phases of the procedure were identified to determine the dose distribution., Results: Overall, 160 patients were included (mean age, 73.30 ± 8.97 years; 146 men); of these, 107 were treated with an MA system and 53 were treated with an FA system. The mean amounts of CA used were 108.55 ± 42.28 mL in the MA group and 85.37 ± 38.79 mL in the FA group (P = .0014). The mean total dose-area product values were 49.93 ± 38.06 Gy·cm
2 in the MA group and 168.34 ± 146.92 Gy·cm2 in the FA group (P < .0001). There was no significant difference in fluoroscopy time between the groups. Per-phase analysis demonstrated that identification of the proximal landing zone and main body deployment required the most radiation, accounting for 24% of the total radiation dose. Overall, 47.6% of the exposure was due to digital subtraction angiography., Conclusions: Use of an FA system can significantly reduce the amount of CA needed but may also lead to higher radiation doses in EVAR procedures. Dose monitoring remains crucial for the safety of both patients and operators. A detailed analysis of dose distribution is possible with modern systems, which may improve the quality of monitoring in the future., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)- Published
- 2018
- Full Text
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47. Durability of a low-profile stent graft for thoracic endovascular aneurysm repair.
- Author
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Torsello GF, Inchingolo M, Austermann M, Torsello GB, Panuccio G, and Bisdas T
- Subjects
- Aged, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic mortality, Aortic Diseases diagnostic imaging, Aortic Diseases mortality, Aortography methods, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation mortality, Computed Tomography Angiography, Endoleak etiology, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Female, Foreign-Body Migration etiology, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Predictive Value of Tests, Prosthesis Design, Prosthesis Failure, Retrospective Studies, Risk Factors, Time Factors, Treatment Outcome, Ulcer diagnostic imaging, Ulcer mortality, Aortic Aneurysm, Thoracic surgery, Aortic Diseases surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Stents, Ulcer surgery
- Abstract
Objective: The introduction of lower profile endografts expanded the application of aortic endovascular repair. However, evidence about their durability is still scarce. The objective of this study was to assess longer term durability of the Zenith Alpha Thoracic Stent Graft (Cook Inc, Bloomington, Ind) after thoracic endovascular aortic repair., Methods: Prospectively collected data of all patients treated for thoracic aortic aneurysms or penetrating aortic ulcers and having computed tomography angiography-based follow-up of ≥12 months were retrospectively analyzed. The primary end point was ongoing clinical success. Among the secondary end points, stent graft migration and fracture were analyzed., Results: Between August 2010 and October 2015, 70 consecutive patients were treated in a single center with the Zenith Alpha stent graft. With computed tomography angiography-based follow-up of 22.3 ± 15.9 months, ongoing clinical success was 87.1%. There were three cases of type IA endoleak (4.3%), two cases of type IB endoleak (2.9%), and one case of aneurysm sac enlargement (1.4%). Five patients died postoperatively (7.1%). No type III or type IV endoleak was detected; there was one case of distal stent graft migration and no stent fracture. Reintervention was necessary in one case (1.4%) of a combined type IA and type II endoleak. There were no conversions to open repair and no ruptures or intraoperative deaths. All-cause mortality was 17.1% at 76 months., Conclusions: The Zenith Alpha Thoracic Stent Graft appears to maintain favorable results in a longer time frame with a low incidence of aneurysm sac growth and migration. Results from multicenter prospective trials are needed to validate these data., (Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2017
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48. Factors Influencing Decision Making in the Treatment of Complex Pararenal Aortic Pathologies: The APPROACH Concept.
- Author
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Donas KP, Torsello GF, and Torsello GB
- Subjects
- Blood Vessel Prosthesis, Decision Making, Humans, Stents, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation, Endovascular Procedures
- Published
- 2017
- Full Text
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49. Postmarket Clinical Experience with the INCRAFT AAA Stent Graft System for Challenging Access Routes.
- Author
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Sugimoto M, Torsello GF, Torsello GB, Austermann M, Stachmann A, and Bisdas T
- Subjects
- Aged, Aged, 80 and over, Angiography, Aortic Aneurysm, Abdominal complications, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal mortality, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation mortality, Clinical Trials as Topic, Disease-Free Survival, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Female, Humans, Male, Middle Aged, Peripheral Arterial Disease complications, Peripheral Arterial Disease diagnostic imaging, Postoperative Complications etiology, Product Surveillance, Postmarketing, Prosthesis Design, Retrospective Studies, Risk Factors, Time Factors, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Stents
- Abstract
Background: The INCRAFT system is a new device that has become available in Europe in September 2014 after the announcement of the 2-year results of the INNOVATION trial. However, no data in the "real-world" practice exist. Herein, we report our early series of consecutive patients treated with the INCRAFT after its launch on the market., Methods: Prospectively collected data of patients enrolled in the INNOVATION trial (group IT) and consecutive patients from CE Mark approval to April 2015 (group CM) were retrospectively evaluated and compared. Main outcomes were any device- or procedure-related major adverse event (MAE) within 30 days and survival and reinterventions during follow-up., Results: Seventeen patients were included in group IT (median follow-up [95% CI]; 60.4 months [55-63]), and 24 patients were in group CM (12.5 [6.6-13.5]). The patients' comorbidities were comparable between the groups. The average diameter of aortic bifurcation and the bilateral external iliac arteries was significantly smaller in group CM. Adjunctive interventions for iliac artery disease were performed in 8 patients (33%) in group CM, whereas no adjunctive was required in group IT. MAEs within 30 days were not significantly different between 2 groups. Survival and reintervention rates were also equivalent after a median follow-up of 13 months., Conclusions: Compared to our patients recruited for the INNOVATION trial, the patients after CE Mark approval had significantly more challenging access routes reflecting the difficulties of "real-world" conditions. Despite frequent adjunctive procedures in group CM, the early performance of the endograft was encouraging so far. Long-term surveillance of those patients remains mandatory., (Copyright © 2016 Elsevier Inc. All rights reserved.)
- Published
- 2017
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50. Computer-aided endovascular aortic repair using fully automated two- and three-dimensional fusion imaging.
- Author
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Panuccio G, Torsello GF, Pfister M, Bisdas T, Bosiers MJ, Torsello G, and Austermann M
- Subjects
- Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Thoracic diagnostic imaging, Automation, Fluoroscopy, Humans, Multimodal Imaging, Predictive Value of Tests, Prospective Studies, Reproducibility of Results, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Thoracic surgery, Aortography methods, Blood Vessel Prosthesis Implantation methods, Computed Tomography Angiography, Endovascular Procedures methods, Imaging, Three-Dimensional, Radiographic Image Interpretation, Computer-Assisted, Surgery, Computer-Assisted methods
- Abstract
Objective: To assess the usability of a fully automated fusion imaging engine prototype, matching preinterventional computed tomography with intraoperative fluoroscopic angiography during endovascular aortic repair., Methods: From June 2014 to February 2015, all patients treated electively for abdominal and thoracoabdominal aneurysms were enrolled prospectively. Before each procedure, preoperative planning was performed with a fully automated fusion engine prototype based on computed tomography angiography, creating a mesh model of the aorta. In a second step, this three-dimensional dataset was registered with the two-dimensional intraoperative fluoroscopy. The main outcome measure was the applicability of the fully automated fusion engine. Secondary outcomes were freedom from failure of automatic segmentation or of the automatic registration as well as accuracy of the mesh model, measuring deviations from intraoperative angiography in millimeters, if applicable., Results: Twenty-five patients were enrolled in this study. The fusion imaging engine could be used in successfully 92% of the cases (n = 23). Freedom from failure of automatic segmentation was 44% (n = 11). The freedom from failure of the automatic registration was 76% (n = 19), the median error of the automatic registration process was 0 mm (interquartile range, 0-5 mm)., Conclusions: The fully automated fusion imaging engine was found to be applicable in most cases, albeit in several cases a fully automated data processing was not possible, requiring manual intervention. The accuracy of the automatic registration yielded excellent results and promises a useful and simple to use technology., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2016
- Full Text
- View/download PDF
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