75 results on '"PINI, RODOLFO"'
Search Results
2. List of Contributors
- Author
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Abi-Aad, Karl, primary, Abu-Halimah, Shadi, additional, AbuRahma, Ali F., additional, Acharya, Yogesh, additional, Anain, Paul, additional, Aridi, Hanaa Dakour, additional, Asciutto, Giuseppe, additional, Atwal, Gursant S., additional, Avgerinos, Efthymios D., additional, Ayad, Micheal T., additional, Beecher, Jeffrey S., additional, Bendok, Bernard R., additional, Brinster, Clayton J., additional, Cantos, Andrew J., additional, Carpenter, Jeffrey P., additional, Chaer, Rabih A., additional, Chang, Jason, additional, Cherr, Gregory S., additional, Cheun, Tracy J., additional, Chuter, Timothy A.M., additional, Curl, Richard, additional, Dake, Michael D., additional, Darling, R. Clement, additional, Davies, Mark G., additional, Doshi, Dolly Thakkar, additional, Dosluoglu, Hasan H., additional, D’Souza, Ashwini, additional, Dryjski, Maciej L., additional, Edwards, Jeffrey B., additional, Eijkenboom, Quirine L., additional, Faggioli, Gianluca, additional, Farber, Mark A., additional, Farnsworth, Joseph B., additional, Fennell, Vernard S., additional, Feyko, Jared T., additional, Flohr, Tanya R., additional, Fontenot, Danielle, additional, Gallitto, Enrico, additional, Gargiulo, Mauro, additional, Gillespie, David L., additional, Go, Catherine C., additional, Hall, Michael R., additional, Harris, Linda M., additional, Hnath, Jeffrey C., additional, Hynes, Niamh, additional, Illig, Karl A., additional, Jayakumar, Lalithapriya, additional, Kapadia, Samir R., additional, Kärkkäinen, Jussi M., additional, Kasprzak, Piotr M., additional, Kavanagh, Edel P., additional, Khan, Sikandar Z., additional, Kostun, Zachary W., additional, Koudoumas, Dimitrios, additional, Krishna, Chandan, additional, Krishnaswamy, Amar, additional, Lal, Brajesh K., additional, Lehrman, Evan D., additional, Levy, Elad I., additional, Liang, Patric, additional, Lim, Jaims, additional, Malas, Mahmoud B., additional, Marone, Luke, additional, McKinsey, James F., additional, McMackin, Katherine K., additional, Mehta, Manish, additional, Meier, George H., additional, Milner, Ross, additional, Montross, Brittany C., additional, Morrison, John F., additional, Mouawad, Nicolas J., additional, Mousa, Albeir Y., additional, Oderich, Gustavo S., additional, O’Donnell, Thomas F.X., additional, Oikonomou, Kyriakos, additional, Ou, Christine, additional, Panneton, Jean M., additional, Patra, Devi P., additional, Pfister, Karin, additional, Pini, Rodolfo, additional, Powell, Richard J., additional, Raffetto, Joseph D., additional, Ramdon, Andre R., additional, Rathore, Animesh, additional, Ravin, Reid, additional, Reed, Amy B., additional, Reilly, Brendon, additional, Resch, Timothy, additional, Rhee, Robert, additional, Rivero, Mariel, additional, Sattur, Mithun G., additional, Schermerhorn, Marc L., additional, Shakir, Hakeem J., additional, Shames, Murray L., additional, Shih, Michael, additional, Shivapour, Daniel M., additional, Siddiqui, Adnan H., additional, Snyder, Kenneth V., additional, Stella, Andrea, additional, Stoner, Michael C., additional, Sultan, Sherif, additional, Sywak, Michael, additional, Tallarita, Tiziano, additional, Tan, Tze-Woei, additional, Tenorio, Emanuel R., additional, TerBush, Matthew J., additional, Tian, Fucheng, additional, Tran, Kenneth, additional, Ullery, Brant W., additional, Vakharia, Kunal, additional, Waldman, David L., additional, Wang, Sophie, additional, Weintraub, Joshua L., additional, Welz, Matthew E., additional, Woo, Karen, additional, Wooster, Mathew, additional, Wu, Winona, additional, Yacoub, Michael, additional, Zacharias, Nikolaos, additional, and Zhang, Wayne W., additional
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- 2022
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3. Unheralded Lower limb threatening ischemia in a COVID-19 patient
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Vacirca Andrea, Faggioli Gianluca, Pini Rodolfo, Teutonico Paolo, Pilato Alessandro, and Gargiulo Mauro
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COVID-19 ,SARS-CoV-2 infection ,Acute limb ischemia ,Thrombosis ,Infectious and parasitic diseases ,RC109-216 - Abstract
Acute thromboembolic events appear to be frequent in patients with SARS-CoV-2 infection. We report a case of an intubated patient, who developed a threatening lower limb ischemia. Intra-arterial fibrinolysis and intravenous heparin infusion did not lead to complete recanalization of the tibial arteries, which were successfully treated by surgical embolectomy.
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- 2020
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4. An international, expert-based, Delphi consensus document on controversial issues in the management of abdominal aortic aneurysms.
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Paraskevas KI, Schermerhorn ML, Haulon S, Beck AW, Verhagen HJM, Lee JT, Verhoeven ELG, Blankensteijn JD, Kölbel T, Lyden SP, Clair DG, Faggioli G, Bisdas T, D'Oria M, Mani K, Sörelius K, Gallitto E, Fernandes E Fernandes J, Katsargyris A, Lepidi S, Vacirca A, Myrcha P, Koelemay MJW, Mansilha A, Zeebregts CJ, Pini R, Dias NV, Karelis A, Bosiers MJ, Stone DH, Venermo M, Farber MA, Blecha M, Melissano G, Riambau V, Eagleton MJ, Gargiulo M, Scali ST, Torsello GB, Eskandari MK, Perler BA, Gloviczki P, Malas M, and Dalman RL
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- Humans, Female, Male, Risk Factors, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation standards, Treatment Outcome, Smoking adverse effects, Aged, Aortic Aneurysm, Abdominal surgery, Delphi Technique, Consensus, Endovascular Procedures adverse effects, Endovascular Procedures standards
- Abstract
Objective: As a result of conflicting, inadequate or controversial data in the literature, several issues concerning the management of patients with abdominal aortic aneurysms (AAAs) remain unanswered. The aim of this international, expert-based Delphi consensus document was to provide some guidance for clinicians on these controversial topics., Methods: A three-round Delphi consensus document was produced with 44 experts on 6 prespecified topics regarding the management of AAAs. All answers were provided anonymously. The response rate for each round was 100%., Results: Most participants (42 of 44 [95.4%]) agreed that a minimum case volume per year is essential (or probably essential) for a center to offer open or endovascular AAA repair (EVAR). Furthermore, 33 of 44 (75.0%) believed that AAA screening programs are (probably) still clinically effective and cost effective. Additionally, most panelists (36 of 44 [81.9%]) voted that surveillance after EVAR should be (or should probably be) lifelong. Finally, 35 of 44 participants (79.7%) thought that women smokers should (or should probably/possibly) be considered for screening at 65 years of age, similar to men. No consensus was achieved regarding lowering the threshold for AAA repair and the need for deep venous thrombosis prophylaxis in patients undergoing EVAR., Conclusions: This expert-based Delphi consensus document provides guidance for clinicians regarding specific unresolved issues. Consensus could not be achieved on some topics, highlighting the need for further research in those areas., Competing Interests: Disclosures A.K. has received speaker fees from Cook Inc., & W.L. Gore & Associates, and is a consultant for Bentley Innomed. M.A.F. has received clinical trial support and is a Consultant for Cook, W. L. Gore & Associates, Getinge, and ViTAA. He has received research support from Cook and has stock options in Centerline Biomedical. M.E. is a paid consultant for W. L. Gore & Associates and Silk Road Medical. M.G. is a consultant for Cook Medical, W. L. Gore & Associates and Medtronic and a proctor for Cook Medical., (Copyright © 2024 Society for Vascular Surgery. All rights reserved.)
- Published
- 2025
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5. T-branch by partial deployment technique in the endovascular repair of complex aortic and thoracoabdominal aneurysms with narrow or severe angulated para-visceral aorta.
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Gallitto E, Faggioli G, Lodato M, Caputo S, Cappiello A, Di Leo A, Pini R, Vacirca A, Acquisti E, and Gargiulo M
- Abstract
Introduction/aim: The partial deployment technique (PDT) is an unconventional option of T-branch deployment to allow target arteries (TAs) cannulation/stenting from the upper arm access, in case of narrow (NPA: <25mm) or severely angulated (APA: >60°) aorta. Aim of this study was to report outcomes of the endovascular repair of complex aortic (c-AAAs) and thoracoabdominal (TAAAs) aneurysms by T-branch and PDT., Methods: All consecutive patients underwent urgent endovascular repair of c-AAAs and TAAAs by T-branch (Cook-Medical, Bloomington, IN, US) and PDT from 2021 to 2023 were analyzed. Technical success (TS), 30-days mortality, TAs-instability within 30-days and 1-year as well as reinterventions were assessed as primary endpoints. Time of intraoperative pelvic/lower limb ischemia, spinal cord ischemia (SCI) and perioperative stroke were assessed as secondary endpoints., Results: Thirty-three cases were analyzed. There were 6(18%) type I endoleaks in failed EVAR, 9(28%) juxta/para-renal aneurysms, 6(18%) post-dissection and 12(36%) degenerative TAAAs, respectively. The median para-visceral aortic lumen diameter was 23(IQR:19-27) mm and 10(30%) cases had APA. Out of 128 TAs, 111(87%) were cannulated/stented with distally captured aortic graft. The median time of pelvic/lower limb ischemia was 120 (IQR:90-150) minutes. TS was achieved in all patients. One (3%) patient suffered SCI and there were no cases of stroke. An asymptomatic renal artery occlusion was detected at postoperative imaging which was recanalized by thrombus-aspiration/relining. This was the only case of TAs-instability (1/128-0.8%) and reintervention (1/33-3%) within 30-day. Two (6%) patients died within 30-days. Median follow-up was 14(IQR:6-22) months. One (3%) case of bilateral renal artery occlusion occurred at 6-months. No superior mesenteric artery or celiac trunk events occurred, with an overall TAs-instability rate of 2% (3/128). Eighteen (55%) patients completed the radiological follow-up at 1-year with no new case of TAs-instability. Freedom from TAs-instability was 91% at 1-year., Conclusion: T-branch by PDT seems to be safe and effective in the management of c-AAAs/TAAAs with NPA or APA. Results were satisfactory in terms of TS and mid-term TAs-instability, suggesting a possible enlargement of the anatomical feasibility criteria for outer branches in urgent cases., Competing Interests: Conflict of interest Prof M Gargiulo, GL Faggioli and E Gallitto are clinical proctors for F/B-EVAR with Cook platform., (Copyright © 2025. Published by Elsevier Inc.)
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- 2025
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6. A Dedicated Algorithm for Endovascular Approach as a First-Line Treatment Option for Visceral Artery Aneurysms.
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Pomatto S, Pini R, Faggioli G, Poliseno C, Shyti B, and Gargiulo M
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- Humans, Retrospective Studies, Male, Treatment Outcome, Female, Aged, Middle Aged, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation instrumentation, Computed Tomography Angiography, Aged, 80 and over, Predictive Value of Tests, Risk Factors, Adult, Endovascular Procedures adverse effects, Aneurysm surgery, Aneurysm diagnostic imaging, Algorithms, Viscera blood supply, Clinical Decision-Making, Decision Support Techniques
- Abstract
Objectives: Few data are reported in literature about visceral artery aneurysms (VAAs) management. The aim of the present study was to analyze VAAs management in a single institution, with a dedicated algorithm for endovascular approach as the first line treatment., Methods: A single-center retrospective cohort study was performed. Patients with a VAA submitted to either endovascular repair or open surgery from 2016 to 2023 were included. A dedicated algorithm was used to evaluate the endovascular approach feasibility assessing on the preoperative computed tomography angiography the following parameters: (a) the tortuosity of the involved artery (<150°), (b) the healthy arterial diameter (>4 mm), (c) the VAA proximity to the hilum and/or the presence of a bifurcation of the aneurysmatic artery, and (d) the circumferential calcium presence. An endovascular approach was chosen if (a) and (b) criteria were satisfied without (c) and (d) ones. Otherwise, it was deemed a challenging anatomy, and an open surgical treatment was considered. In the absence of (a) and/or (b) criteria open surgery was the preferred option., Results: Thirty-one asymptomatic aneurysms (28 patients) were treated electively. The most frequent VAA location was the splenic artery (18 cases; 58%), followed by the renal arteries (6 cases; 19%), the common hepatic artery (5 cases; 16%), the gastroepiploic artery (1 case, 3.2%) and the pancreatoduodenal artery (1 case; 3%). Twenty-two aneurysms (71%) were initially treated by an endovascular approach (stent-graft deployment and/or transcatheter embolization) with 3 (13%) of them needing a surgical conversion. Nine aneurysms (29%) were submitted directly to a surgical treatment (aneurysm resection with or without interposition bypass) with no peri-operative and long-term complications. Technical success was 90.3%., Conclusions: Endovascular management as a first line approach is safe and effective in most cases. A preoperative dedicated algorithm is useful to identify suitable cases. Open surgery can be considered an alternative option in specific challenging anatomical situations or in case of endovascular failure., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2025
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7. An International, Expert-Based Delphi Consensus Document on Controversial Issues about TransCarotid Artery Revascularization (TCAR).
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Paraskevas KI, AbuRahma AF, Abularrage CJ, Clair DG, Eldrup-Jorgensen J, Kashyap VS, Dardik A, de Borst GJ, Dermody M, Faggioli G, Hicks CW, Kwolek CJ, Lyden SP, Mansilha A, Van Herzeele I, Myrcha P, Leal Lorenzo JI, Jim J, Pini R, Secemsky EA, Spinelli F, Capoccia L, Stone DH, Stoner MC, Zeebregts CJ, Lal BK, Schneider PA, Malas MB, and Schermerhorn ML
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- Humans, Treatment Outcome, Patient Selection, Risk Factors, Time Factors, Risk Assessment, Endarterectomy, Carotid adverse effects, Endarterectomy, Carotid standards, Delphi Technique, Carotid Stenosis surgery, Carotid Stenosis therapy, Carotid Stenosis diagnostic imaging, Consensus, Endovascular Procedures adverse effects, Endovascular Procedures standards, Stents, Clinical Decision-Making
- Abstract
Background: Transcarotid artery revascularization (TCAR) has emerged as an alternative therapeutic modality to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TFCAS) for the management of patients with carotid artery stenosis. However, certain issues regarding the indications and contraindications of TCAR remain unanswered or unresolved. The aim of this international, expert-based Delphi consensus document was to attempt to provide some guidance on these topics., Methods: A 3-round Delphi consensus process was performed, including 29 experts. The aim of round 1 was to investigate the differing views and opinions of the participants. Round 2 was carried out after the results from the literature on each topic were provided to the participants. During round 3, the participants had the opportunity to finalize their vote., Results: Most participants agreed that TCAR can or can probably or possibly be performed within 14 days of a cerebrovascular event, but it is best to avoid it in the first 48 hr. It was felt that TCAR cannot or should not replace TFCAS or CEA, as each procedure has specific indications and contraindications. Symptomatic patients >80 years should probably be treated with TCAR rather than with TFCAS. TCAR can or can probably be used for the treatment of restenosis following CEA or TFCAS. Finally, there is a need for a randomized controlled trial (RCT) to provide better evidence for the unresolved issues., Conclusions: This Delphi consensus document attempted to assist the decision-making of physicians or interventionalists or vascular surgeons involved in the management of carotid stenosis patients. Furthermore, areas requiring additional research were identified. Future studies and RCTs should provide more evidence to address the unanswered questions regarding TCAR., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2025
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8. Cook Zenith Alpha Endograft: A Protocol to Minimise Limb Graft Occlusion.
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Pini R, Bianchini Massoni C, Faggioli G, Caputo S, Sufali G, Ancetti S, Vacirca A, Gallitto E, Perini P, Freyrie A, and Gargiulo M
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- Aged, Aged, 80 and over, Female, Humans, Male, Blood Vessel Prosthesis, Iliac Artery surgery, Iliac Artery diagnostic imaging, Retrospective Studies, Risk Factors, Stents adverse effects, Time Factors, Treatment Outcome, Vascular Patency, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Abdominal diagnostic imaging, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures adverse effects, Endovascular Procedures instrumentation, Graft Occlusion, Vascular prevention & control, Graft Occlusion, Vascular etiology, Graft Occlusion, Vascular epidemiology, Prosthesis Design
- Abstract
Objective: Numerous articles have reported an increased incidence of limb graft occlusion (LGO) with the Cook Zenith Alpha endograft compared with other endografts in endovascular aortic aneurysm repair (EVAR). The present study aimed to assess the rate of LGO after EVAR in particular with the Cook Zenith Alpha device when adhering to a standardised protocol designed to prevent limb related complications., Methods: This was a non-sponsored retrospective study performed in two university vascular surgery centres employing the same protocol for limb complication prevention during EVAR from 2016 to 2019. The protocol encompassed: (1) angioplasty of any common or external iliac artery with > 50% stenosis before endograft navigation; (2) proximal sealing zone of limbs at the same level of the flow divider with minimum overlap, which is more restrictive than the Cook Zenith Alpha instructions for use; (3) semi-compliant kissing ballooning of limbs; (4) limb stenting for any residual tortuosity, kinking, or stenosis; and (5) adjunctive common and external iliac stenting for residual stenosis or dissection after EVAR. Patients enrolled in this study were treated with standard aortobi-iliac EVAR. Follow up was performed by clinical visit and duplex ultrasonography at discharge, six months, and yearly thereafter. The primary endpoint was to evaluate the LGO rate with different EVAR devices (Cook Zenith Alpha, Gore C3, and Medtronic Endurant) and to determine potential risk factors for LGO associated with the Zenith Alpha., Results: In the study period, 547 EVARs were considered: 233 (42.6%) Cook Zenith Alpha, 196 (35.8%) Gore Excluder, and 118 (21.6%) Medtronic Endurant. The mean follow up was 44 ± 23 months, and the five year freedom from LGO was 97 ± 3%, without differences between groups (97 ± 2%, 95 ± 3%, and 100% with Cook Zenith Alpha, Medtronic Endurant, and Gore Excluder, respectively; p = .080). In the Zenith Alpha group, intra-operative adjunctive iliac artery angioplasty, iliac artery stenting, or iliac limb stenting was performed in 8%, 3.4%, and 9.7% of cases, respectively. Analysis of potential risk factors for LGO identified external iliac artery distal landing and large main bodies (ZIMB 32 - 36) to be independently associated with LGO during follow up (hazard ratio [HR] 18, 95% confidence interval [CI] 3 - 130, p = .004; and HR 12, 95% CI 1.2 - 130, p = .030, respectively)., Conclusion: The present experience with a protocol for limb complication prevention allows achievement of a low rate of LGO at five years with Zenith Alpha endografts similar to other endografts. Specific risk factors for the Cook Zenith Alpha endograft are external iliac artery distal landing and the use of a large main body (ZIMB 32 - 36)., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)
- Published
- 2024
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9. Medical and interventional outcome of dissection of the cervical arteries: Systematic review and meta-analysis.
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Pini R, Faggioli G, Lodato M, Campana F, Vacirca A, Gallitto E, and Gargiulo M
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- Humans, Risk Assessment, Risk Factors, Treatment Outcome, Vertebral Artery Dissection therapy, Vertebral Artery Dissection mortality, Vertebral Artery Dissection diagnostic imaging, Anticoagulants therapeutic use, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Endovascular Procedures instrumentation, Platelet Aggregation Inhibitors therapeutic use, Stents, Stroke etiology
- Abstract
Objective: The management of cervical artery dissections (CADs) is poorly standardized given the scarce number of prospective studies comparing medical and interventional approach to CAD. The aim of the present study is to perform a systematic review and meta-analysis of studies on the treatments of CAD., Methods: Systematic review and meta-analysis (pre-registered on PROSPERO [CRD42022297512] are performed according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses [PRISMA] guidelines searching in three different databases [PubMed, Embase and Cochrane Database]) of studies on medical or interventional approach to CAD. Only prospective studies were selected to reduce the risk of bias for the primary meta-analysis. Secondarily, retrospective studies were also included. The aim was to assess the rate of stroke and of stroke/death/bleeding (major or intracranial) by Der Simonian-Laird weights of random effects model., Results: After screening 456 articles, 6 prospective and 22 retrospective studies were identified. Two randomized controlled trials and five retrospective studies comparing antiplatelet (APT) vs oral anticoagulant therapy (OAC) for CAD were identified, as well as four prospective and 17 retrospective single-arm studies evaluating stenting for CAD. In the meta-analysis of randomized controlled trials comparing APT vs OAC, 444 patients were considered, and a borderline significant association was identified in terms of stroke/death in the APT vs OAC groups (odds ratio [OR], 5.6; 95% confidence interval [CI], 0.94-33.38; P = .06; I
2 = 0%). No differences were found for the stroke/death/bleeding outcome (OR, 1.25; 95% CI, 0.19-8.18; P = .81; I2 = 0%) between the two treatments. In the meta-analysis including also retrospective studies, overall risk of bias was considered "serious," and 4104 patients were included with no differences in APT vs OAC for stroke (OR, 1.06; 95% CI, 0.53-2.11; P = .29; I2 = 18%); no other comparisons were possible. The pooled meta-analysis of prospective studies on stenting for CAD included four series, for a total of 68 patients, in whom stenting was adopted primarily after failed medical therapy or after traumatic dissection. The pooled rate of stroke/death was 7% (95% CI, 3%-17%; I2 = 0%). The analysis of moderators identified a significant inverse association between the percentage of traumatic dissection and a reduction in postoperative stroke (Y = -1.60-2.02X; P = .03). The pooled rate of the composite endpoint of stroke/death/ or major bleeding was 8% (95% CI, 3%-18%; I2 = 0%). Secondarily, the meta-analysis also included 17 retrospective studies with overall 457 patients and showed a 2.1% pooled rate of stroke/death (95% CI, 1.0%-3.3%; I2 = 0%) and 3.2% stroke/death/bleeding (95% CI, 1.8%-4.7%; I2 = 0%)., Conclusions: Few prospective studies on CAD treatment are present in literature. APT and OAC seem to have similar efficacy in reducing the recurrence of stroke after CAD. No definitive conclusion can be drawn for stenting, due to the low number of studies available. More prospective studies are necessary to evaluate its potential additional value over medical therapy alone in the early phase after CAD., Competing Interests: Disclosures None., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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10. Type II endoleaks after fenestrated/branched endografting for juxtarenal and pararenal aortic aneurysms.
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Gallitto E, Faggioli GL, Campana F, Feroldi FM, Cappiello A, Caputo S, Pini R, and Gargiulo M
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- Humans, Male, Retrospective Studies, Female, Risk Factors, Aged, Time Factors, Aged, 80 and over, Incidence, Risk Assessment, Treatment Outcome, Prosthesis Design, Stents, Endovascular Procedures adverse effects, Endovascular Procedures instrumentation, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal mortality, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation instrumentation, Endoleak etiology, Endoleak therapy, Endoleak diagnostic imaging, Blood Vessel Prosthesis
- Abstract
Objective: Persistent type II endoleaks (pEL2s) are not uncommon after endovascular aneurysm repair and their impact on long-term outcomes is well-documented. However, their occurrence and natural history after fenestrated/branched endografting (F/B-EVAR) for juxtarenal and pararenal aneurysms (J/P-AAAs) have been scarcely investigated. Aim of this study was to report incidence, risk factors, and natural history of pEL2 after F/B-EVAR in J/P-AAAs., Methods: Between 2016 and 2022, all J/P-AAAs undergoing F/B-EVAR were prospectively collected and retrospectively analyzed. EL2 were assessed at the completion angiography, at 30 days and after 6 months as primary outcomes. Preoperative risk factors for pEL2, follow-up survival, freedom from reinterventions (FFR) and aneurysm shrinkage (≥5 mm) were considered as secondary outcomes., Results: Of 132 patients, there were 88 (67%) JAAAs and 44 (33%) PAAAs. Seventeen EL2 (13%) were detected at the completion angiography and 36 (27%) at 30-day computed tomography angiography. The mean follow-up was 28 ± 23 months. Eleven (31%) EL2 sealed spontaneously within 6 months and three new cases were detected, for an overall of 28 pEL2/107 patients (26%) with available radiological follow-up of ≥6 months. Preoperative antiplatelet therapy (odds ratio, 4.7; 95% confidence interval [CI[, 1-22.1; P = .05), aneurysm thrombus volume of ≤40% and six or more patent aneurysm afferent vessels (odds ratio, 7.2; 95% CI, 1.8-29.1; P = .005) were independent risk factors for pEL2. The estimated 3-year survival was 80%, with no difference between cases with and without pEL2 (78% vs 85%; P = .08). The estimated 3-year FFR was 86%, with no difference between cases with and without pEL2 (81% vs 87%; P = .41). Four cases (3%) of EL2-related reinterventions were performed. In 65 cases (49%), aneurysm shrinkage was detected. pEL2 was an independent risk factor for absence of aneurysm shrinkage during follow-up (hazard ratio, 3.2; 95% CI, 1.2-8.3; P = .014). Patients without shrinkage had lower follow-up survival (64% vs 86% at 3-year; P = .009) and FFR (74% vs 90% at 3 years; P = .014) than patients with shrinkage., Conclusions: PEL2 is not infrequent (26%) after F/B-EVAR for J/P-AAAs and is correlated with preoperative antiplatelet therapy, aneurysm thrombus volume of ≤40%, and six or more patent sac afferent vessels. Patients with pEL2 have a diminished aneurysm shrinkage, which is correlated with lower follow-up survival and FFR compared with patients with aneurysm shrinkage., Competing Interests: Disclosures E.G., G.L.F., and M.G. are clinical proctors for Cook Medical fenestrated and branched endografting., (Copyright © 2024. Published by Elsevier Inc.)
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- 2024
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11. An international, multispecialty, expert-based Delphi Consensus document on controversial issues in the management of patients with asymptomatic and symptomatic carotid stenosis.
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Paraskevas KI, Mikhailidis DP, Ringleb PA, Brown MM, Dardik A, Poredos P, Gray WA, Nicolaides AN, Lal BK, Mansilha A, Antignani PL, de Borst GJ, Cambria RP, Loftus IM, Lavie CJ, Blinc A, Lyden SP, Matsumura JS, Jezovnik MK, Bacharach JM, Meschia JF, Clair DG, Zeebregts CJ, Lanza G, Capoccia L, Spinelli F, Liapis CD, Jawien A, Parikh SA, Svetlikov A, Menyhei G, Davies AH, Musialek P, Roubin G, Stilo F, Sultan S, Proczka RM, Faggioli G, Geroulakos G, Fernandes E Fernandes J, Ricco JB, Saba L, Secemsky EA, Pini R, Myrcha P, Rundek T, Martinelli O, Kakkos SK, Sachar R, Goudot G, Schlachetzki F, Lavenson GS Jr, Ricci S, Topakian R, Millon A, Di Lazzaro V, Silvestrini M, Chaturvedi S, Eckstein HH, Gloviczki P, and White CJ
- Subjects
- Humans, Consensus, Delphi Technique, Constriction, Pathologic, Carotid Stenosis diagnosis, Carotid Stenosis diagnostic imaging, Stroke diagnosis, Stroke etiology
- Abstract
Objective: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear., Methods: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response., Results: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence., Conclusions: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research., Competing Interests: Disclosures D.P.M. has given talks, acted as a consultant or attended conferences sponsored by Amgen and Novo Nordisk. J.F.M. receives funding from the United States National Institute of Neurologic Disorders and Stroke for work related to running the CREST-2 clinical trial (U01NS080168) and the CREST-2 Long-term Observational Extension study (U01NS119169). E.A.S. has received research grants from the United States Food and Drug Administration, BD, Boston Scientific, Cook, CSI, Laminate Medical, Medtronic and Philips; has received consulting/speaking fees from Abbott, Bayer, BD, Boston Scientific, Cook, Cordis, CSI, Inari, Infraredx, Medtronic, Philips, Shockwave and VentureMed. H.-H.E. is a local Principal Investigator for the ROADSTER 2 trial and a scientific committee member of SPACE-1, SPACE-2 and ACST-2. T.R. is funded by grants from the National Institutes of Health (R01 MD012467, R01 NS029993, R01NS040807, 1U24NS107267), and the National Center for Advancing Translational Sciences (UL1 TR002736, KL2 TR002737). J.S.M. has received institutional research grants from Abbott, Cook, Endologix, Gore and Medtronic., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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12. Outcomes of Fenestrated and Branched Endografts for Partial and Total Endovascular Repair of the Aortic Arch - A Systematic Review and Meta-Analysis.
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Spath P, Campana F, Tsilimparis N, Gallitto E, Pini R, Faggioli G, Caputo S, and Gargiulo M
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- Humans, Blood Vessel Prosthesis, Treatment Outcome, Risk Factors, Postoperative Complications surgery, Prosthesis Design, Retrospective Studies, Aortic Aneurysm, Thoracic, Blood Vessel Prosthesis Implantation, Endovascular Procedures
- Abstract
Objective: Fenestrated and branched thoracic endovascular aortic repair (F/B-TEVAR) of the aortic arch is a viable approach in patients unsuitable for open repair. The aim was to summarise the published results of manufactured F/B-TEVAR devices for partial and total repair of the aortic arch, and to compare fenestrated with branched configurations., Data Sources: PubMed, Scopus and The Cochrane Library were searched for articles (2018 - 2021) about patients with elective, urgent, or emergency aortic requiring a proximal landing zone in the aortic arch (zone 0 - 1 - 2) and treated by F/B-TEVAR., Review Methods: The systematic review and meta-analysis were performed according to the PRISMA guidelines. Open repair, supra-aortic trunk (SAT) debranching + standard TEVAR, and in situ physician modified and parallel grafts were excluded. Primary outcomes were technical success and 30 day mortality rate. Secondary outcomes were 30 day major adverse events, and overall survival and procedure related endpoints during follow up., Results: Of 458 articles screened, 18 articles involving 571 patients were selected. Indications for intervention were chronic dissections (50.1%), degenerative aneurysms (39.6%), penetrating aortic ulcers (7.4%), and pseudoaneurysms (2%). F-TEVAR, B-TEVAR, and F+B-TEVAR were used in 38.4%, 54.1%, and 7.5% of patients, respectively. Overall, technical success was 95.9% (95% confidence interval [CI] 0.93 - 0.97; I
2 = 0%; p for heterogeneity (Het) = .77) and the 30 day mortality rate was 6.7% (95% CI 0.05 - 0.09; I2 = 0%; p Het = .66). No statistical differences were found comparing fenestrated with branched endografts, except for a higher rate of type I - III endoleaks in F-TEVAR (9.8% vs. 2.6%; p = .034). The overall survival rate and freedom from aortic related death at the one year follow up ranged between 82 - 96.4% and 94 - 94.7%, respectively. Thirteen and five studies were considered at moderate and high risk of bias, respectively., Conclusion: F/B-TEVAR for the treatment of the aortic arch, according to experience in dedicated centres, now enjoys a satisfactory level of technical success together with a progressively reduced early mortality rate. There are several limitations, and further studies are needed to reach clearer conclusions., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)- Published
- 2024
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13. Revascularisation of Chronic Limb Threatening Ischaemia in Patients with no Pedal Arteries Leads to Lower Midterm Limb Salvage.
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Vacirca A, Faggioli G, Pini A, Pini R, Abualhin M, Sonetto A, Spath P, and Gargiulo M
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- Humans, Male, Middle Aged, Aged, Aged, 80 and over, Female, Limb Salvage methods, Chronic Limb-Threatening Ischemia, Treatment Outcome, Ischemia diagnostic imaging, Ischemia etiology, Ischemia surgery, Popliteal Artery surgery, Risk Factors, Retrospective Studies, Vascular Patency, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease surgery, Peripheral Arterial Disease etiology, Endovascular Procedures adverse effects, Endovascular Procedures methods
- Abstract
Objective: Chronic limb threatening ischaemia (CLTI) involving the infragenicular arteries is treated by distal angioplasty or pedal bypass; however, this is not always possible, due to chronically occluded pedal arteries (no patent pedal artery, N-PPA). This pattern represents a hurdle to successful revascularisation, which must be limited to the proximal arteries. The aim of the study was to analyse the outcome of patients with CLTI and N-PPA after a proximal revascularisation., Methods: All patients with CLTI submitted to revascularisation in a single centre (2019 - 2020) were analysed. All angiograms were reviewed to identify N-PPA, defined as total obstruction of all pedal arteries. Revascularisation was performed with proximal surgical, endovascular, and hybrid procedures. Early and midterm survival, wound healing, limb salvage, and patency rates were compared between N-PPA and patients with one or more patent pedal artery (PPA)., Results: Two hundred and eighteen procedures were performed. One hundred and forty of 218 (64.2%) patients were male, mean age 73.2 ± 10.6 years. The procedure was surgical in 64/218 (29.4%) cases, endovascular in 138/218 (63.3%), and hybrid in 16/218 (7.3%). N-PPA was present in 60/218 (27.5%) cases. Eleven of 60 (18.3%) cases were treated surgically, 43/60 (71.7%) by endovascular and 6/60 (10%) by hybrid procedures. Technical success was similar in the two groups (N-PPA 85% vs. PPA 82.3%, p = .42). At a mean follow up of 24.5 ± 10.2 months, survival (N-PPA 93.7 ± 3.5% vs. PPA 95.3 ± 2.1%, p = .22) and primary patency (N-PPA 53.1 ± 8.1% vs. PPA 55.2 ± 5%, p = .56) were similar. Limb salvage was significantly lower in N-PPA patients (N-PPA 71.4 ± 6.6% vs. PPA 81.5 ± 3.4%, p = .042); N-PPA was an independent predictor of major amputation (hazard ratio [HR] 2.02, 1.07 - 3.82, p = .038) together with age > 73 years (HR 2.32, 1.17 - 4.57, p = .012) and haemodialysis (2.84, 1.48 - 5.43, p = .002)., Conclusion: N-PPA is not uncommon in patients with CLTI. This condition does not hamper technical success, primary patency, and midterm survival; however, midterm limb salvage is significantly lower than in patients with PPA. This should be considered in the decision making process., (Copyright © 2023 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)
- Published
- 2023
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14. Clarifying the rationale supporting selective screening for asymptomatic carotid artery stenosis.
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Paraskevas KI, Nicolaides AN, Spence JD, Mikhailidis DP, Lanza G, Liapis CD, Goudot G, Faggioli G, Pini R, Musiałek P, Suri JS, Silvestrini M, Fernandes E Fernandes J, Eckstein HH, Jawien A, Spinelli F, Stilo F, Myrcha P, Rundek T, Kakkos SK, Di Lazzaro V, Svetlikov A, Antignani PL, Poredos P, Saba L, Jezovnik MK, Blinc A, Sultan S, Knoflach M, Jezovnik MK, Capoccia L, Proczka RM, Fraedrich G, Zeebregts CJ, Davies AH, Geroulakos G, Ricco JB, Mansilha A, Dardik A, and Gloviczki P
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- Humans, Stents, Treatment Outcome, Risk Factors, Asymptomatic Diseases, Carotid Stenosis, Endarterectomy, Carotid, Stroke prevention & control
- Abstract
Competing Interests: Declaration of Competing Interest None.
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- 2023
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15. Screening for asymptomatic carotid stenosis in patients with non-valvular atrial fibrillation.
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Paraskevas KI, Eckstein HH, Mansilha A, Ricco JB, Geroulakos G, Di Lazzaro V, Rundek T, Lanza G, Fraedrich G, Svetlikov AS, Suri JS, Zeebregts CJ, Davies AH, Capoccia L, Proczka RM, Myrcha P, Antignani PL, Fernandes E Fernandes J, Spence JD, Dardik A, Jezovnik MK, Knoflach M, Lavenson GS Jr, Kakkos SK, Jawien A, Silvestrini M, Blinc A, Spinelli F, Stilo F, Musiałek P, Sultan S, Goudot G, Liapis CD, Saba L, Faggioli G, Pini R, Poredos P, Mikhailidis DP, Gloviczki P, and Nicolaides AN
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- Humans, Atrial Fibrillation diagnosis, Atrial Fibrillation epidemiology, Carotid Stenosis diagnosis, Carotid Stenosis diagnostic imaging, Stroke diagnostic imaging, Stroke epidemiology, Ischemic Attack, Transient
- Abstract
Competing Interests: Declaration of Competing Interest None.
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- 2023
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16. Why do guidelines recommend screening for abdominal aortic aneurysms, but not for asymptomatic carotid stenosis? A plea for a randomized controlled trial.
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Paraskevas KI, Spence JD, Mikhailidis DP, Antignani PL, Gloviczki P, Eckstein HH, Spinelli F, Stilo F, Saba L, Poredos P, Dardik A, Liapis CD, Mansilha A, Faggioli G, Pini R, Jezovnik MK, Sultan S, Musiałek P, Goudot G, Lavenson GS Jr, Jawien A, Blinc A, Myrcha P, Fernandes E Fernandes J, Geroulakos G, Kakkos SK, Knoflach M, Proczka RM, Capoccia L, Rundek T, Svetlikov AS, Silvestrini M, Ricco JB, Davies AH, Di Lazzaro V, Suri JS, Lanza G, Fraedrich G, Zeebregts CJ, and Nicolaides AN
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- Humans, Risk Factors, Mass Screening, Asymptomatic Diseases, Randomized Controlled Trials as Topic, Carotid Stenosis diagnostic imaging, Carotid Stenosis epidemiology, Stroke prevention & control, Aortic Aneurysm, Abdominal diagnosis, Aortic Aneurysm, Abdominal epidemiology, Aortic Aneurysm, Abdominal complications, Endarterectomy, Carotid
- Abstract
Background: Current guidelines do not recommend screening for asymptomatic carotid artery stenosis (AsxCS). The rationale behind this recommendation is that detection of AsxCS may lead to an unnecessary carotid intervention. In contrast, screening for abdominal aortic aneurysms is strongly recommended., Methods: A critical analysis of the literature was performed to evaluate the implications of detecting AsxCS., Results: Patients with AsxCS are at high risk for future stroke, myocardial infarction and vascular death. Population-wide screening for AsxCS should not be recommended. Additionally, screening of high-risk individuals for AsxCS with the purpose of identifying candidates for a carotid intervention is inappropriate. Instead, selective screening for AsxCS should be considered and should be viewed as an opportunity to identify individuals at high risk for atherosclerotic cardiovascular disease and future cardiovascular events for the timely initiation of intensive medical therapy and risk factor modification., Conclusions: Although mass screening should not be recommended, there are several arguments suggesting that selective screening for AsxCS should be considered. The rationale supporting such selective screening is to optimize risk factor control and to initiate intensive medical therapy for prevention of future cardiovascular events, rather than to identify candidates for an intervention., Competing Interests: Declaration of Competing Interest All authors are members of the Faculty Advocating Collaborative and Thoughtful Carotid Artery Treatments (FACTCATS; available at www.FACTCATS.org) with the shared goal of optimizing stroke prevention. The views of particular FACTCATS do not necessarily reflect the views of other FACTCATS., (Copyright © 2022 Elsevier B.V. All rights reserved.)
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- 2023
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17. Midterm results of complicated penetrating abdominal aortic ulcer treated by aortobi-iliac endograft and embolization.
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Gallitto E, Faggioli G, Spath P, Ancetti S, Pini R, Logiacco A, Palermo S, and Gargiulo M
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- Humans, Endoleak diagnostic imaging, Endoleak etiology, Endoleak therapy, Ulcer diagnostic imaging, Ulcer surgery, Treatment Outcome, Risk Factors, Blood Vessel Prosthesis adverse effects, Retrospective Studies, Blood Vessel Prosthesis Implantation, Aortic Aneurysm, Abdominal surgery, Endovascular Procedures
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Background: Penetrating aortic ulcer (PAU) is determined by atherosclerotic degeneration of the tunica media with disruption of the intima. Usually it is detected in the thoracic aorta, with few series describing an abdominal location. The aim of the study was to report early and late outcomes of the endovascular repair of complicated infrarenal abdominal PAU (a-PAU) by aortobi-iliac endograft and embolization., Methods: Data from all complicated a-PAU submitted to endovascular repair by aortobi-iliac endograft (Cook-Zenith Alpha) between 2016 and 2021 (February) were analyzed. The a-PAU coil embolization was performed to decrease the risk of persistent type II endoleak whenever possible. Complicated a-PAU were defined according with the presence of symptoms, aortic rupture, or saccular or pseudo-aneurysm. Technical success, 30-day morbidity and mortality, and reinterventions were assessed as early outcomes. Survival, endoleaks, and freedom from reinterventions were evaluated during follow-up., Results: Of 1153 endovascular aortic procedures, 45 cases (4%) of complicated a-PAU were identified. Fourteen cases (31%) were managed in urgent setting (symptoms, n = 10 [22%]; shock, n = 4 [9%]). The median diameter of a-PAU was 49 mm (interquartile range, 14 mm). Thirteen patients (29%) had severe femoral or iliac access (angle >90°, circumferential calcification [>50%], hemodynamic iliac stenosis or obstruction, an external iliac artery diameter of less than 7 mm, or a previous femoral surgical graft). The a-PAU embolization was performed in 30 cases (67%). Technical success was achieved in all patients. Postoperative cardiac, pulmonary and renal morbidity occurred in one (2%), two (4%), and eight (18%) patients, respectively. Two patients (4%) required reintervention within 30 days for access related complications. The 30-day mortality was 2%. At a median follow-up of 24 months (interquartile range, 18 months), no type I or III endoleaks, iliac leg occlusion, or graft infection occurred and no patient required late reinterventions; the 36-month survival rate was 72%. No a-PAU enlarged or ruptured during follow-up., Conclusions: Endovascular repair of complicated a-PAU by a low-profile aortobi-iliac endograft and embolization is safe and effective. Excellent technical results are reported even in challenging anatomic features. Midterm clinical results are satisfactory in terms of aortic-related complications or mortality, freedom from reintervention, and survival., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2023
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18. Assessment and Management of Transplant Renal Artery Stenosis. A Literature Review.
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Pini A, Faggioli G, Pini R, Mauro R, Gallitto E, Mascoli C, Grandinetti V, Donati G, Odaldi F, Ravaioli M, La Manna G, and Gargiulo M
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- Aged, Angioplasty adverse effects, Female, Humans, Male, Retrospective Studies, Stents adverse effects, Treatment Outcome, Angioplasty, Balloon adverse effects, Renal Artery Obstruction diagnostic imaging, Renal Artery Obstruction etiology, Renal Artery Obstruction therapy
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Background: Transplant renal artery stenosis (TRAS) following kidney transplantation is a possible cause of graft failure. This review aimed to summarize the evidence about physiopathology, diagnosis and early and late effectiveness of the endovascular treatment (EVT), including angioplasty and stenting procedures., Methods: A literature research was performed using Pubmed, Scopus and the Cochrane Library databases (January 2000-September 2020) according to PRISMA guidelines. Studies were included if they describe EVT, percutaneous transluminal angioplasty or stent placement of TRAS, published in English and with a minimum of ten patients., Results: Fifty-six studies were included. TRAS incidence ranges from 1% up to 12% in transplanted kidneys. The TRAS risk factors were: elderly donor and recipient, cytomegalovirus match status, Class II Donor Specific Antibodies (DSA), expanded donor criteria, delayed graft functioning and other anatomical and technical factors. The highest frequency of TRAS presentation is after 3-6 months after kidney transplantation. The most frequent localization of stenosis was para-anastomotic (ranging from 25% to 78%). In 9 studies, all patients were treated by percutaneous transluminal angioplasty (PTA), in 16 studies all patients received percutaneous transluminal stenting (PTS) and in 21 series patients received either PTA or PTS. The twelve months patency rates after EVT ranged from 72% to 94%. The overall complication rate was 9%, with pseudoaneurysms and hematomas as most frequent complications., Conclusions: TRAS can be successfully and safely treated through an endovascular approach. Stent delivery seems to guarantee a higher patency rate compared to simple angioplasty, however further studies are needed to confirm these results., (Copyright © 2022 Elsevier Inc. All rights reserved.)
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- 2022
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19. A systematic review and meta-analysis of the occurrence of spinal cord ischemia after endovascular repair of thoracoabdominal aortic aneurysms.
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Pini R, Faggioli G, Paraskevas KI, Alaidroos M, Palermo S, Gallitto E, and Gargiulo M
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- Cerebrospinal Fluid Leak complications, Humans, Retrospective Studies, Risk Factors, Time Factors, Treatment Outcome, Aortic Aneurysm, Thoracic complications, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures, Spinal Cord Ischemia diagnosis, Spinal Cord Ischemia epidemiology, Spinal Cord Ischemia etiology
- Abstract
Objective: The rate of endovascular repair of thoracoabdominal aortic aneurysms (TAAA-ER) has increased considerably in recent years. Although the mortality and morbidity rates have improved, the incidence of spinal cord ischemia (SCI) has not declined significantly. The aim of the present systematic review and meta-analysis was to examine the SCI rates with respect to the efficacy of the different approaches., Methods: Cohort studies and case series (>20 patients) reporting SCI rates after TAAA-ER were eligible for inclusion. The primary outcome measure was the evaluation of SCI. The moderators considered were primarily the staged vs nonstaged approach, the use of cerebrospinal fluid drainage (CSFD), and TAAA extension. The permanent SCI and mortality rates were extracted., Results: A total of 27 studies with 2333 patients were included in the meta-analysis. The pooled estimate for SCI was 11% (95% confidence interval [CI], 8%-15%; I
2 , 79%). For extent I, II, III, and V TAAA, the pooled SCI rate was 13% (95% CI, 10%-17%; I2 , 69%). For extent IV TAAA, the pooled SCI rate was 6% (95% CI, 3%-10%; I2 , 62%). A staged TAAA-ER approach was used in 20 studies and a nonstaged approach in 8 (1 study had included both). A lower pooled SCI rate was identified after staged than after nonstaged TAAA-ER (9% vs 18%, respectively; P = .02). Staging was accomplished in >1 month in nine studies and ≤1 month in two studies, leading to similar SCI rates (7% vs 11%, respectively; P = .26). The method of staging (thoracic endoprosthesis or temporary aortic sac perfusion) did not affect the SCI rates. Symptomatic CSFD was associated with a similar pooled rate of SCI compared with prophylactic CSFD (10% vs 10%, respectively; P = .99). The pooled permanent SCI rate was 6% (6% for extent I, II, III, and V TAAA; and 3% for extent IV TAAA). The pooled rate of 30-day mortality was 7%, with a similar incidence for the staged and nonstaged approaches (6% vs 9%, respectively). Interstage mortality was reported in 9 studies, with a pooled estimate rate of 1.6%., Conclusions: SCI had occurred in 11% of TAAA-ER, and one half of these cases were permanent. A staged approach can reduce SCI rates independently of the timing and method adopted. The overall mortality rate for staged TAAA-ER was 7%, with one fifth of the deaths (1.6%) occurring between stages., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)- Published
- 2022
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20. CO 2 Automated Angiography in Endovascular Aortic Repair Preserves Renal Function to a Greater Extent Compared with Iodinated Contrast Medium. Analysis of Technical and Anatomical Details.
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Vacirca A, Faggioli G, Mascoli C, Gallitto E, Pini R, Spath P, Logiacco A, Palermo S, and Gargiulo M
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- Angiography, Carbon Dioxide adverse effects, Contrast Media adverse effects, Humans, Kidney, Retrospective Studies, Risk Factors, Treatment Outcome, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal etiology, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects
- Abstract
Background: Contrast induced nephropathy occurs in up to 7.5% of cases in endovascular aortic repair (EVAR). Carbon dioxide (CO
2 ) has been proposed as an alternative agent to iodinated contrast medium (ICM); however, specific protocols are not universally adopted, and the visualization of the renal arteries may be suboptimal in some cases. The aim of this study was to analyze our CO2 -EVAR experience with automatic injections, in order to identify the anatomical characteristics associated with the best visualization of all the aortic vessels, with particular attention to the lowest renal artery (LoRA)., Methods: From 2016 to 2019, all EVAR performed with either CO2 or ICM were analyzed and compared. CO2 -EVAR was performed using an automated injector (600 mm Hg pressure; 100 cc volume); a small amount of ICM was injected in case of difficulty in LoRA visualization or doubts at the completion angiogram. Clinical and CT-Scan preoperative characteristics were considered. The study endpoints were technical success, amount of ICM and radiation dose, postoperative renal function and possible CO2 -related adverse events. Statistical analysis was by Fisher's exact, t-Student, Mann-Whitney tests and ROC curve., Results: In the considered period, 321 EVAR procedures, 72 (22.4%) with CO2 and 249 (77.6%) with ICM, were performed. The 2 groups were similar for clinical characteristics and preoperative renal function. ICM was injected in a significantly lower amount in the CO2 -EVAR group (52.8 ± 6.1 vs. 88.1 ±9.2 cc, P < 0.001), which received a significantly higher mean radiation dose (Total DAP: 500,550.8 ± 377,394.6 mGy/cm2 CO2 -EVAR vs. 332,301.8 ±230,139.3 mGy/cm2 ICM-EVAR, P = 0.001). Postoperative eGFR decreased significantly less in the CO2 -EVAR (2.3 ± 1.1 mL/min) compared with the ICM-EVAR group (10.6 ±5.3 mL/min), P < 0.001. LoRA was correctly visualized in 50/72 (69.4%) cases of CO2 -EVAR, which had a significantly longer proximal neck (Median [IQR]: 30 [14] vs. 18 [15] mm, P = 0.001). At ROC curve, a proximal neck length >24.5 mm was predictive of LoRA visualization (72.1% sensitivity, 73.8% specificity). Three CO2 -EVAR cases had intraoperative transient hypotension with no consequences. Sixteen/72 (22.2%) CO2 -EVAR procedures were performed using 0 cc of ICM., Conclusions: CO2 -EVAR by automated injections is safe and requires a lower amount of ICM if compared with ICM-EVAR, with a consequent significant benefit on postoperative renal function. If specific anatomical situations are present, ICM may be completely unnecessary. The radiation dose is however significantly higher, therefore procedural protocols need further refinements., (Copyright © 2021. Published by Elsevier Inc.)- Published
- 2022
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21. Multi-Staged Endovascular Repair of Thoracoabdominal Aneurysms by Fenestrated and Branched Endografts.
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Gallitto E, Faggioli G, Fenelli C, Mascoli C, Pini R, Logiacco A, Spath P, and Gargiulo M
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- Blood Vessel Prosthesis, Cohort Studies, Humans, Prosthesis Design, Retrospective Studies, Risk Factors, Time Factors, Treatment Outcome, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic surgery, Aortic Rupture surgery, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects
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Background: To report outcomes of a multi-staged approach for endovascular repair of thoracoabdominal aortic aneurysms (TAAAs) by fenestrated/branched endografting (F/B-EVAR)., Methods: Between 2010 and 2020 (June), patients undergoing F/B-EVAR for TAAAs were collected. Data of cases managed by a multi-staged approach, to reduce the incidence of spinal cord ischemia (SCI), were retrospectively analyzed and reported in a cohort study. Thirty-day mortality and SCI were assessed as study's outcomes., Results: One hundred and thirty-seven patients underwent TAAAs repair by F/B-EVAR. A multi-staged approach was applied in 73(53%) cases, more frequently for Crawford's extent I-III (60/78) compared with IV (13/59) (P < 0.0001). A complete TAAAs exclusion was achieved in 2, 3 or 4 steps in 64(88%), 8(11%) and 1(1%) cases, respectively, within the same hospitalization in 68(93%) cases. The mean time between first and last step was 16 ± 8days, with a mean hospital stay of 21 ± 12days. In 3(4%) cases the complete TAAA repair was not achieved due to inter-steps mortality (2) or permanent paraplegia (1). There were no cases of aortic rupture or target visceral vessels occlusions between the different steps. Seven (10%) patients suffered postoperative SCI with 2(4%) cases of permanent paraplegia. In 5/7 cases SCI occurred after the first stage; in 3/5 cases TAAAs exclusion was successfully completed with total SCI recovery. The 30-day mortality was 4% (3/73)., Conclusions: A multi-staged endovascular repair with F/B-EVAR can be safely performed for TAAAs repair. The majority of cases can be treated within a single, long hospitalization. The cost/effectiveness of the prolonged in-hospital time should be evaluated., (Copyright © 2021. Published by Elsevier Inc.)
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- 2022
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22. Parallel Graft to Preserve a Reimplanted Inferior Mesenteric Artery During Thoracoabdominal Multibranched Endografting.
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Fenelli C, Faggioli G, Gallitto E, Ancetti S, Indelicato G, Pini R, Sonetto A, and Gargiulo M
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- Aged, Angiography, Celiac Artery surgery, Humans, Male, Replantation, Spinal Cord Ischemia prevention & control, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Thoracic surgery, Constriction, Pathologic surgery, Endovascular Procedures methods, Mesenteric Artery, Inferior surgery, Stents
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Introduction: Preserving pelvic circulation is crucial to minimize the risk of spinal cord and colonic ischemia, especially during the endovascular treatment of extended thoraco-abdominal aneurysm (TAAA) after previous open repair (OR)., Case Report: A 78-years-old patient, previously treated for AAA with OR and reimplantation of inferior mesenteric artery (IMA), has presented with 9 cm type-III TAAA and underwent to a multi-stage endovascular procedure. Two thoracic endografts, t-Branch and a straight endograft by Cook Zenith platform were deployed. Renal and superior mesenteric arteries were cannulated and revascularized. Through the left axillary access, a 5F-vertebral catheter was delivered over a 0.035 inch guidewire to selectively catheterize IMA. A post-anastomotic stenosis was stented to advance the sheath and the parallel-graft (Viabahn 7 × 150 mm, Gore) into the artery. Thus, a bifurcated endograft was deployed inside the previous OR. According to the Sandwich-Technique, the stentgraft was deployed parallel and outside the bifurcated device, inside the straight one and 2 cm into the IMA and then reinforced by a bare-metal-stent (Protégé EverFlex™ 7 × 120 mm, Medtronic). Finally, a kissing ballooning of iliac endografts and parallel-graft was performed. The procedure was completed five days later, by stenting the celiac trunk. Post-operative course was uneventful. The 36-months CTA showed the patency of the IMA with no complications., Conclusion: The combination of t-Branch and Sandwich-Technique for IMA could be employed to treat extended TAAA with previous OR and reimplanted IMA thus minimizing the risk of colonic and spinal cord ischemia., (Copyright © 2021. Published by Elsevier Inc.)
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- 2022
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23. Platelet Depletion after Thoraco-Abdominal Aortic Aneurysm Endovascular Repair is Associated with Clinically Relevant Hemorrhagic Complications.
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Pini R, Faggioli G, Gallitto E, Mascoli C, Fenelli C, Angherà C, Logiacco A, Ancetti S, and Gargiulo M
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- Aged, Aged, 80 and over, Aortic Aneurysm, Thoracic blood, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic mortality, Aortic Rupture blood, Aortic Rupture diagnostic imaging, Aortic Rupture mortality, Blood Vessel Prosthesis Implantation mortality, Databases, Factual, Endovascular Procedures mortality, Female, Humans, Male, Middle Aged, Platelet Count, Postoperative Hemorrhage blood, Postoperative Hemorrhage diagnosis, Postoperative Hemorrhage mortality, Retrospective Studies, Risk Assessment, Risk Factors, Thrombocytopenia blood, Thrombocytopenia diagnosis, Thrombocytopenia mortality, Time Factors, Treatment Outcome, Aortic Aneurysm, Thoracic surgery, Aortic Rupture surgery, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects, Postoperative Hemorrhage etiology, Thrombocytopenia etiology
- Abstract
Background: Thoraco-abdominal endovascular aortic repair (TA-EVAR) can be associated with platelet depletion (PD); the present study aims to evaluate PD incidence after TA-EVAR and to investigate its possible predictors and its influence on hemorrhagic complications and mortality., Methods: A retrospective analysis of all TA-EVAR from 2010 to 2021 was performed to identify patients with PD, (reduction > 60%). Spontaneous hemorrhages considered were: intracranial or any hemorrhages requiring surgery. Risk factors for PD, correlation with hemorrhagic complications and 30-day mortality were investigated by uni/multivariate analysis., Results: A total of 158 TA-EVAR were considered, 35(22%) female, 86(54%) extended thoraco-abdominal aortic aneurysm (TAAA) (Crawford type I, II, III), 79(50%) staged procedure, 31(20%) urgent treatment (symptomatic/ruptured). PD was identified in 42 (27%) patients and correlated to female sex, thrombus-free aortic lumen > 50mm, urgent treatment, extensive TAAA, blood transfusion >3 units and staged procedure at the univariate analysis. The multivariate analysis confirmed a significant correlation between PD and thrombus-free aortic lumen > 50mm, urgent treatment, blood transfusion > 3 units and staged procedure (odds ratio [OR]: 2.5 (95% confidence interval [CI] 1.03-7.0), P = 0.04, OR 3.2 (95% CI 1.01-8.6), P= 0.03, OR 3.16 (95% CI 1.23-7.7), P = 0.03 and OR 2.71 (95% CI 1.2-6.2), P= 0.04, respectively). Overall, 13 hemorrhagic complications occurred (8 intracranial and 5 peripheral); PD was associated with higher risk of hemorrhagic complications (9/42 - 21% vs. 4/116 - 3%, OR: 7.6 [95% CI: 2.2-26.3], P= 0.001) and a higher risk of 30-day mortality in elective cases 4/25 - 16% vs. 3/101 - 3%, OR: 6.2 (95% CI: 1.3-29.8), P= 0.03., Conclusions: PD is a relatively common event after TA-EVAR and is associated with thrombus-free aortic lumen > 50mm, urgent treatment, blood transfusion > 3 units and staged procedure. Hemorrhagic complications and mortality are increased under these circumstances., (Copyright © 2021 Elsevier Inc. All rights reserved.)
- Published
- 2022
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24. Reinterventions after fenestrated and branched endografting for degenerative aortic aneurysms.
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Gallitto E, Faggioli G, Pini R, Logiacco A, Mascoli C, Fenelli C, Abualhin M, and Gargiulo M
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- Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal mortality, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation mortality, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Female, Humans, Male, Postoperative Complications diagnostic imaging, Postoperative Complications mortality, Progression-Free Survival, Prosthesis Design, Registries, Retreatment, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Postoperative Complications therapy
- Abstract
Objective: Fenestrated/branched endovascular abdominal aortic aneurysm repair (F/B-EVAR) is widely accepted technique to treat juxta/pararenal abdominal aortic aneurysms (J/P-AAAs) and thoracoabdominal aortic aneurysms (TAAAs) for patients at high-surgical risk. However, the follow-up results should be carefully evaluated, especially in terms of the reintervention rate. The aim of the present study was, therefore, to evaluate the early and mid-term reinterventions after FB-EVAR for J/P-AAAs and TAAAs and their effects on follow-up survival., Methods: From 2006 to 2019, all consecutive patients who had undergone F/B-EVAR for J/P-AAAs or TAAAs were prospectively enrolled. Cases requiring reinterventions were retrospectively analyzed. Patients with aortic dissection were excluded from the present analysis. Reinterventions were classified as follows: access related, aortoiliac related, or target visceral vessel (TVV) related. Freedom from reintervention and survival were assessed using the Kaplan-Meier method, and univariate and multivariate analyses were used to determine the risk factors., Results: Overall, 221 F/B-EVAR procedures were performed for 111 J/P-AAAs (50.3%) and 110 TAAAs (49.7%) in an elective (182; 82%) or urgent (39; 18%) setting. The median follow-up was 27 months (interquartile range, 13 months). Overall, 41 patients had undergone 52 reinterventions (single, 30 [14%]; multiple, 11 [5%]; access related, 17 [33%]; aortoiliac related, 6 [12%]; TVV related, 29 [55%]). Of the 52 reinterventions, 32 (62%) and 20 (38%) had occurred within and after 30 days, respectively. Eight reinterventions (15%) had been were performed in an urgent setting. Endovascular and open reinterventions were performed in 32 (62%) and 20 (38%) cases, respectively. Open reinterventions were frequently access related (access, 16; no access, 4; P ≤ .001). Technical success was 95% (39 patients); failures consisted of one splenic artery rupture and one renal artery loss. Patients undergoing reintervention had more frequently undergone a primary urgent F/B-EVAR (urgent, 12 of 39 [31%]; elective, 29 of 182 [16%]; P < .001) and had had TAAAs (TAAAs, 34 of 41 [83%]; J/P-AAAs, 7 of 41 [17%]; P < .001). The patients with TAAAs had had a greater incidence of TVV-related reintervention (TAAAs, 26 of 28 [93%]; J/P-AAAs, 2 of 28 [7%]; P < .001) and multiple reinterventions (TAAAs, 9 of 11 [82%]; J/P-AAAs, 2 of 11 [18%]; P = .03) compared with those with J/P-AAAs. Survival at 3 years was 75%. Freedom from reintervention was 81% at 3 years. Patients who had undergone reinterventions had lower 3-year survival (reintervention, 61%; no reintervention, 77%; P = .02). Preoperative chronic renal failure (hazard ratio [HR], 2.0; 95% confidence interval [CI], 1.1-3.6; P = .02), TAAAs (HR, 2.3; 95% CI, 1.1-4.8; P = .03), and urgent primary F/B-EVAR procedures (HR, 2.5; 95% CI, 1.2-4.9; P = .01) were independent predictors of late mortality., Conclusions: Reinterventions after F/B-EVAR are not uncommon and were related to TVVs in only one half of cases. Most of them can be performed in an elective setting using endovascular techniques. The technical success rate was excellent. Reinterventions were more frequent after TAAAs and urgent F/B-EVAR procedures and had a significant effect on overall survival in these situations., (Copyright © 2021. Published by Elsevier Inc.)
- Published
- 2021
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25. Tailored Sac Embolization During EVAR for Preventing Persistent Type II Endoleak.
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Mascoli C, Faggioli G, Gallitto E, Pini R, Fenelli C, Cercenelli L, Marcelli E, and Gargiulo M
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- Aged, Aged, 80 and over, Aortic Aneurysm, Abdominal diagnostic imaging, Blood Vessel Prosthesis, Databases, Factual, Endoleak diagnostic imaging, Endoleak etiology, Female, Humans, Male, Middle Aged, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Aortic Aneurysm, Abdominal therapy, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation instrumentation, Embolization, Therapeutic adverse effects, Endoleak prevention & control, Endovascular Procedures adverse effects, Endovascular Procedures instrumentation
- Abstract
Background: Persistent type II endoleaks (ELIIp) occur in 8-23% of patients submitted to endovascular aneurysm repair (EVAR) and may lead to aneurysm progression and rupture. Intraoperative embolization of the abdominal aortic aneurysm (AAA) sac is effective to prevent their occurrence, however a method to achieve complete sac thrombosis has not been standardized yet. Aim of our study was to identify factors associated with prevention of ELIIp after intraoperative embolization, in order to optimize technical details., Methods: Patients at high risk for ELIIp, who underwent EVAR with AAA - sac coil embolization were prospectively collected into a dedicated database from January 2012 to March 2015. The endoluminal residual sac volume (ERV), not occupied by the endograft [ERV= AAA total volume (TV) - (AAA-thrombus volume (THV) + endograft volume (EgV)] was calculated on preoperative computed tomography and the concentration of coils implanted (CCoil= n coils implanted/ERV) for each patient was evaluated. AAA volumetric evaluation was conducted by dedicated vessels analysis software (3Mensio). ELIIp presence was evaluated by contrast-enhanced ultrasound at 6 and 12-month. Patients with ELIIp at 12 months (Group 1) were clustered and compared to patients without ELIIp (Group 2), in order to evaluate the incidence of ELIIp in patients undergone to preventive AAA-sac embolization, and identify the predictors of ELIIp prevention. Morphological potential risk factors for ELIIp such as TV, THV, VR% and EgV were also considered in all patients. Statistical correlation was assessed by Fisher Exact Test., Results: Among 326 patients undergone to standard EVAR, 61 (19% - M: 96.7%, median age: 72 [IQR: 8] years, median AAA diameter: 57 [IQR: 7] mm) were considered at high risk for ELIIp and were submitted to coil embolization. The median AAA total volume (TV) and median ERV were 156 (IQR: 59) cc and 46 (IQR: 26) cc, respectively. The median number and concentration of coils (IMWCE-38-16-45 Cook M-Ray) positioned in AAA-sac were 5 (IQR: 1) coils and 0.17 coil/cm
3 (range 0.02-1.20). Among this high-risk population, the incidence of ELIIp was 29.5% and 23% at 6 and 12-month, respectively. Fourteen patients (23%) were clustered in Group1 and 47 (77%) in Group 2. Both groups were homogeneous for clinical characteristics and preoperative morphological risk factors. There were no differences in the preoperative median TV, AAA-thrombus volume (THV), %VR, EgV and number of implanted coils between Group1 and Group2. Patients in Group1 had a significantly higher ERV (59 [IQR: 13] cm3 vs. 42 [IQR: 27] cm3 , P = 0.002) and lower CCoil (0.09 [IQR: 0.03] vs. 0.18 [IQR: 0.21], P = 0.006) than patients of Group2. ELIIp was significantly related to the presence of ERV > 49 cm3 (86 % vs. 42 %, Group1 and Group2 respectively, P = 0.006) and CCoil < 0.17coil/ cm3 (100% vs. 68%, Group1 e Group2 respectively, P = 0.014)., Conclusion: According with our results, Coil concentration and endoluminal residual volume can affect the efficacy of the AAA - sac embolization in the prevention of ELIIp, moreover CCoil ≥0.17coil/ cm3 maight be considered to determine the tailored number of coils., (Copyright © 2021 Elsevier Inc. All rights reserved.)- Published
- 2021
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26. New Routes for Continuous Endovascular Advancement.
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Faggioli G and Pini R
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- Humans, Endovascular Procedures adverse effects
- Published
- 2021
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27. Recapture of the Sapien-3 Delivery System After Transversal Balloon Rupture Using a Whole Percutaneous Femoral Approach.
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Bruno AG, Taglieri N, Saia F, Pini R, Gallitto E, Ghetti G, Orzalkiewicz M, Marrozzini C, Faggioli G, Gargiulo M, Leone A, Savini C, Pacini D, Galié N, and Palmerini T
- Subjects
- Aortic Valve surgery, Humans, Prosthesis Design, Treatment Outcome, Aortic Valve Stenosis surgery, Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement
- Abstract
Competing Interests: Funding Support and Author Disclosures Dr Saia has received consulting fees from Abbott Vascular, Eli Lilly, AstraZeneca, and St. Jude Medical; and speakers fees from Abbott Vascular, Eli Lilly, AstraZeneca, St. Jude Medical, Terumo, Biosensors, Edwards, and Boston Scientific outside the submitted work. Dr Palmerini has received personal fees from Abbott and Edwards outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Published
- 2021
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28. Proximal Aortic Coverage and Clinical Results of the Endovascular Repair of Juxta-/Para-renal and Type IV Thoracoabdominal Aneurysm with Custom-made Fenestrated Endografts.
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Gallitto E, Faggioli G, Pini R, Logiacco A, Mascoli C, Fenelli C, Abualhin M, and Gargiulo M
- Subjects
- Aged, 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, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Female, Humans, Male, Postoperative Complications etiology, Prosthesis Design, Retrospective Studies, Risk Factors, Time Factors, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Stents
- Abstract
Background: Juxta-renal (JAAA)/para-renal (PAAA) and type IV-thoracoabdominal (TAAA) aneurysms can be repaired by custom-made fenestrated endografts (CM-FEVAR). Differently from open repair, a relatively long segment of healthy proximal aorta needs to be covered to achieve a durable sealing, and this may be considered a disadvantage of the endovascular approach. We aimed to quantify the additional proximal aortic coverage in JAAAs, PAAAs, and type-IV TAAAs treated with CM-FEVAR and to evaluate its impact on early/follow-up clinical outcomes., Methods: Between 2006 and 2018, preoperative, intraoperative, and postoperative data of JAAAs, PAAAs, and type-IV TAAAs submitted to CM-FEVAR were collected. The length of proximal healthy aortic coverage was evaluated on the preoperative endograft planning as the distance between the top of the CM-FEVAR endograft and the hypothetical level of aortic cross-clamping in case of open repair (type-IV TAAA-above the celiac trunk; PAAA-above the superior mesenteric artery; JAAA-above the lowest renal artery). Spinal cord ischemia (SCI), bowel ischemia (BI), renal function worsening (RFW) (estimated glomerular filtration rate reduction > 25% of the baseline level - RFW), and mortality were assessed at 30-day. Survival, target visceral vessel (TVV) patency, and freedom from reinterventions (FFRs) were assessed during follow-up by Kaplan-Meier analysis R2., Results: One hundred forty-seven cases were submitted to CM-FEVAR, for 72 (49%) JAAAs, 46 (31%) PAAAs, and 29 (20%) type IV-TAAAs, with 1(4-3%), 2 (28-19%), 3 (48-33%), and 4 (67-45%) fenestrations. JAAAs required a fenestration + bridging stent graft for the superior mesenteric artery and celiac trunk, in 46(64%) and 24(33%) cases, respectively. Nineteen (41%) PAAAs required a fenestration + bridging stent graft for the celiac trunk. The mean proximal additional aortic coverage was 48 ± 2 mm with no differences among JAAAs (52 ± 1 mm), PAAAs (42 ± 2 mm), and type IV-TAAAs (50 ± 2 mm) (P.09). Technical success, defined as correct endograft deployment, with TVV patency, absence of type I-III endoleaks, iliac leg stenosis/occlusions, open surgical conversion, and 24-hour mortality, was achieved in 98% of cases. Failures occurred for 1 type-III endoleak (type-IV TAAA) and 2 renal artery losses (PAAA and type IV-TAAA). The only case of SCI (0.7%) occurred in a type-IV TAAA where the proximal healthy aortic coverage was 80 mm. One BI was caused by acute thrombosis of the bridging stent graft for the superior mesenteric artery at 24 hours in 1 type IV-TAAA (0.7%). Thirty-five patients (24%) suffered postoperative RFW and required hemodialysis in 1 (0.7%) JAAA with severe preoperative chronic renal failure. There was no difference of proximal additional aortic coverage between patients with (49 ± 29 mm) and without (48 ± 23 mm) RFW (P.2). The 30-day mortality was 1.4%. The mean follow-up was 37 ± 2 months with no cases of aneurysm-related late mortality. Survival was 94%, 89%, and 75% at 1, 2, and 5 years, respectively. TVV patency was 97%, 97%, and 93% at 1, 2, and 5 years, respectively. FFR was 98%, 95%, and 87% at 1, 2, and 5 years, respectively., Conclusions: Custom-made FEVAR requires a mean proximal additional aortic coverage of 48 ± 2 mm above the level of hypothetical aortic cross-clamping in case of open repair. This aspect should be considered for CM-FEVAR indication in JAAAs, PAAAs, and type-IV TAAAs; nevertheless, it does not appear to be associated with negative early and follow-up clinical sequelae., (Copyright © 2020. Published by Elsevier Inc.)
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- 2021
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29. Kissing Stent Technique for TASC C-D Lesions of Common Iliac Arteries: Clinical and Anatomical Predictors of Outcome.
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Sonetto A, Faggioli G, Pini R, Abualhin M, Goretti M, Fronterrè S, Pini A, and Gargiulo M
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- Aged, Constriction, Pathologic, Dual Anti-Platelet Therapy, Endovascular Procedures adverse effects, Female, Humans, Male, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease physiopathology, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Vascular Patency, Endovascular Procedures instrumentation, Iliac Artery diagnostic imaging, Iliac Artery physiopathology, Peripheral Arterial Disease therapy, Stents
- Abstract
Background: The endovascular treatment of peripheral artery obstructive disease in Trans-Atlantic Inter-Society (TASC) C and D lesions involving the aortic bifurcation is a matter of debate. The aim of this study is to evaluate the technical and clinical success of kissing stenting in this context and to analyze predictors of outcome., Methods: All patients treated for aortoiliac TASC C and D lesions with kissing stenting (from 2012 to 2017) in a 6-year period were retrospectively analyzed. Preoperative anatomical features were evaluated by reviewing computed tomography angiography images to identify severe iliac calcifications (SICs) versus not SIC (NSICs). Primary end points were as follows: technical success (TS), procedural success, primary patency (PP), and clinical success (CS). Secondary end points were as follows: secondary patency, assisted patency, survival, mid-term procedure-related complications, and risk factors that affected TS and mid-term results., Results: In a 6-year period, 51 patients fulfilled the inclusion criteria. TS was achieved in 49 (96.1%) cases. Thirty-one patients (60.8%) received a dual antiplatelet therapy (DAPT) for at least 1 month after the procedure. 30-day CS was 94.1%. Median follow-up was 45.7 months (IQR: 24.5, 8-86 range). The CS was 92.6% at 3 years, with a PP of 86.8% and a secondary patency of 93.2% at 3 years. Six (13.2%) iliac axis occluded during the first follow-up year. NSIC was statistically and independently associated with a lower PP (73% vs. 96%, P = 0.03); DAPT was statistically and independently associated with higher PP than single antiplatelet therapy (96% vs. 75%, P = 0.03); these results were confirmed by Cox regression analysis (HR: 0.14, 95%, IC: 0.01-0.89, P = 0.05 for DAPT analysis; HR: 6.8, 95%, IC: 1.21-59, P = 0.05 for NSIC analysis)., Conclusions: Endovascular treatment for TASC C-D is an effective technique. Postoperative stent occlusion is higher in patients with no DAPT and it usually occurs during the first postoperative year. Preoperative NSIC lesions are associated with reduced PP at 3 years of follow-up., (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Published
- 2021
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30. The benefit of deferred carotid revascularization in patients with moderate-severe disabling cerebral ischemic stroke.
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Pini R, Faggioli G, Vacirca A, Dieng M, Goretti M, Gallitto E, Mascoli C, Ricco JB, and Gargiulo M
- Subjects
- Aged, Aged, 80 and over, Brain Ischemia diagnosis, Brain Ischemia etiology, Carotid Stenosis complications, Carotid Stenosis diagnosis, Computed Tomography Angiography, Female, Humans, Male, Risk Factors, Severity of Illness Index, Treatment Outcome, Brain Ischemia prevention & control, Carotid Stenosis surgery, Endarterectomy, Carotid methods
- Abstract
Objective: Symptomatic carotid artery stenosis needs revascularization within 2 weeks by carotid endarterectomy (CEA) to reduce the risk of symptom recurrence; however, the optimal timing of intervention is yet to be defined in patients with large-volume cerebral ischemic lesion (LVCIL) and modified Rankin scale (mRS) score ≥3. The aim of this study was to determine the most appropriate timing for CEA in patients with a recent stroke and LVCIL., Methods: Data from patients with symptomatic carotid stenosis with LVCIL and mRS score of 3 or 4 from 2007 to 2017 were considered. Patients were submitted to CEA if they had a stable clinical condition and life expectancy >1 year. LVCIL was defined as a cerebral ischemic lesion of volume >4000 mm
3 . Perioperative stroke and death were evaluated by stratifying for timing of CEA by χ2 test and multiple logistic regression. Patients with similar characteristics (LVCIL and mRS score of 3 or 4) unfit for CEA served as the control group for recurrence of stroke at 1-year follow-up., Results: In an 11-year period, of a total 4020 CEAs, 126 (2.9%) were performed in patients with a moderate stroke and LVCIL occurring in the same admission. The patients' median age was 69 years (interquartile range [IQR], 10 years); 72% (91) were male, with mRS score of 3 (IQR, 1) and LVCIL volume of 20,000 mm3 (IQR, 47,000 mm3 ). The median time elapsed from symptoms to CEA was 7 weeks (IQR, 8 weeks). Overall perioperative stroke/death was 7.3% (eight strokes and one death). By selective timing evaluation of the postoperative events, CEA performed within 4 weeks was associated with a significantly higher rate of stroke/death compared with patients operated on after 4 weeks: 11.9% (8/67) vs 1.7% (1/59; P = .03). By logistic regression, CEA within 4 weeks was an independent (from sex, cerebral ischemic lesion volume, dyslipidemia, and carotid stenosis) predictor of postoperative stroke/death (odds ratio, 8.2; 95% confidence interval, 1.01-73). In the same period, 101 patients were considered unfit for CEA for dementia (n = 22), severe comorbidities (n = 55), or short (<1-year) life expectancy (n = 24), and 43 (43%) survived at 1 year. At 1 year, the perioperative/recurrent stroke after CEA vs patients unfit for CEA was similar (6.2% vs 13.9%; P = .11), but CEA performed after 4 weeks led to significantly lower perioperative/recurrent stroke (1.7% vs 13.9%; P = .02)., Conclusions: The surgical risk of CEA in patients with a recent moderate-severe ischemic stroke and LVCIL is high. However, if the intervention is delayed >4 weeks, its benefit seems significant., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)- Published
- 2021
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31. Fenestrated and Branched Thoraco-abdominal Endografting after Previous Open Abdominal Aortic Repair.
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Gallitto E, Sobocinski J, Mascoli C, Pini R, Fenelli C, Faggioli G, Haulon S, and Gargiulo M
- Subjects
- Aged, Anastomosis, Surgical adverse effects, Aortic Aneurysm, Abdominal etiology, Blood Vessel Prosthesis, Endovascular Procedures adverse effects, Female, Heart Diseases etiology, Hospital Mortality, Humans, Intestines blood supply, Ischemia etiology, Kidney Diseases etiology, Male, Postoperative Complications etiology, Postoperative Complications surgery, Reoperation, Retrospective Studies, Spinal Cord Ischemia etiology, Survival Rate, Treatment Outcome, Vascular Grafting adverse effects, Vascular Patency, Aorta, Abdominal surgery, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Thoracic surgery, Endovascular Procedures methods, Vascular Grafting methods
- Abstract
Objective: Proximal para-anastomotic aneurysms, or aneurysmal degeneration of the native aorta above a previous open abdominal aortic repair (Pr-AAAs), are challenging scenarios. The aim of this study was to report the early and mid term outcomes of endovascular repair of Pr-AAAs by fenestrated and branched endovascular aneurysm repair (FB-EVAR)., Methods: From 2006 to 2017, pre-operative, intra-operative, and post-operative data from patients undergoing FB-EVAR for Pr-AAAs at two European vascular surgery units were prospectively collected and retrospectively analysed. Early results were considered in terms of technical success (target visceral vessel cannulation and stenting, absence of type I - III endoleak, iliac limb occlusion and 24 h mortality); spinal cord ischaemia (SCI) and 30 day and in hospital mortality. Survival, target visceral vessel (TVV) patency, and freedom from re-interventions were also considered at the mid term follow up., Results: Five hundred and forty-four patients underwent FB-EVAR to treat juxta/pararenal or thoraco-abdominal aneurysms. Of these patients, 108 (19.8%) cases were Pr-AAAs (94% male; mean ± standard deviation [SD] age 71 ± 4 years; American Society of Anesthesiologists' grade 3-4 in 74% and 26%, respectively). The previous open aortic repair (OR) was performed 10 ± 2 years before FB-EVAR. It was a tubular aorto-aortic repair in 63 (58.3%) cases, a bifurcated aortobi-iliac repair in 37 (34.2%) cases, and an aortobifemoral bypass repair in eight (7.4%) cases. A previous thoracic endovascular aneurysm repair (TEVAR) had been performed in seven patients (6.5%). The aortic lesion at the time of FB-EVAR was, according to the Crawford classification, a type I - III in 69 (63.9%) or a type IV 39 (36.1%) thoraco-abdominal aneurysm. The mean ± SD aneurysm diameter was 64 ± 6 mm. Overall, 390 TVVs (3.6 ± 1 TVV/case) were revascularised by an endograft with fenestrations (n = 63 [58.3%]), with branches (n = 26 [24.1%]), or with both fenestrations and branches (n = 19 [17.6%]). Tubular, trimodular, or aorto-uni-iliac implants were planned in 68 (63.0%), 38 (35.2%), and two (1.8%) patients, respectively. Proximal TEVAR, carotid-subclavian bypass, and iliac branch devices were planned as adjunctive procedures in 41 (38.0%), five (4.6%), and three (2.8%) cases, respectively. Overall technical success was 93%, with technical failures including five TVV losses (coeliac trunk, n = 1; renal arteries, n = 4) and three deaths within 24 h. Post-operative SCI occurred in seven patients (6.5%), four of which (3.7%) were permanent. SCI was more frequent in category I - III TAAAs (p = .042) and in endografts incorporating both fenestrations and branches (p = .023). Cardiac, pulmonary, and renal complications (reduction in glomerular filtration rate of ≥30% compared with baseline) occurred in 9%, 10%, and 20%, respectively. Bowel ischaemia was seen in three (2.8%) patients. Thirty day mortality was 4% and was associated with pre-operative chronic renal failure (p = .034), post-operative cardiac morbidity (p = .041), and bowel ischaemia (p = .003). Overall in hospital mortality was 5.5% (n = 6). Mean ± SD follow up was 38 ± 18 months. Survival was 82%, 64%, and 54% at one, three, and five years, respectively, and target visceral vessel patency was 93%, 91%, and 91%, respectively. Permanent haemodialysis was needed in four patients (3.7%). There was no late aneurysm related mortality. Survival during follow up was statistically significantly affected by pre-operative chronic renal failure (p = .022), post-operative cardiac morbidity (p = .042), SCI (p = .044), and bowel ischaemia (p = .003). Freedom from re-intervention at one, three, and five years was 89%, 77%, and 74%, respectively., Conclusion: Endovascular treatment of aneurysmal aortic degeneration above a previous open abdominal repair with FB-EVAR is safe and effective. If those promising results are confirmed at later follow up, FB-EVAR should be considered a prominent therapeutic option, especially in high risk patients., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)
- Published
- 2020
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32. The benefit of combined carbon dioxide automated angiography and fusion imaging in preserving perioperative renal function in fenestrated endografting.
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Gallitto E, Faggioli G, Vacirca A, Pini R, Mascoli C, Fenelli C, Logiacco A, Abualhin M, and Gargiulo M
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- Aged, Aged, 80 and over, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Thoracic diagnostic imaging, Female, Glomerular Filtration Rate drug effects, Humans, Kidney drug effects, Kidney physiopathology, Kidney Diseases chemically induced, Kidney Diseases physiopathology, Length of Stay, Male, Operative Time, Predictive Value of Tests, Prospective Studies, Radiation Dosage, Radiation Exposure, Radiographic Image Interpretation, Computer-Assisted, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Thoracic surgery, Aortography adverse effects, Blood Vessel Prosthesis Implantation adverse effects, Carbon Dioxide adverse effects, Computed Tomography Angiography adverse effects, Contrast Media adverse effects, Endovascular Procedures adverse effects, Kidney Diseases prevention & control
- Abstract
Background: Contrast-induced nephropathy is a possible adverse event in fenestrated endovascular aneurysm repair (FEVAR). Automated carbon dioxide (CO
2 ) angiography has been proposed as an alternative to iodinated contrast medium (ICM) for standard endovascular aneurysm repair; however, its use in FEVAR has not yet been investigated. The aim of this study was to analyze the possibility of reducing the amount of procedural ICM during FEVAR by combining CO2 with intraprocedural three-dimensional preoperative computed tomography angiography images overlaid on two-dimensional live fluoroscopy images (fusion imaging [FI])., Methods: Between January and April 2018, juxtarenal and pararenal abdominal aortic aneurysms and type IV thoracoabdominal aortic aneurysms undergoing FEVAR with a CO2 + FI protocol were prospectively collected and compared with FEVAR cases treated with standard procedural imaging (ICM + FI) between June and December 2017. Preoperative, intraoperative, and postoperative data were analyzed. Amount of ICM, procedure and fluoroscopy time, total radiation dose (dose-area product), endoleaks, and technical success (defined as absence of type I or type III endoleak and target visceral vessel patency at completion angiography) were assessed. The 30-day renal function worsening (estimated glomerular filtration rate reduction >25% of the preoperative value) and 6-month reinterventions were also considered. Analysis was done by Fisher exact and Mann-Whitney tests., Results: Forty-five patients were enrolled, 15 (33%) managed by CO2 + FI and 30 (67%) by ICM + FI. The two groups were homogeneous in their clinical, anatomic, and endograft features. Median ICM administration was significantly lower in CO2 + FI compared with ICM + FI (41 mL [interquartile range (IQR), 26 mL] vs 138.5 mL [IQR, 88 mL]; P = .001). There was no difference in median procedure time, fluoroscopy time, and dose-area product between CO2 + FI and ICM + FI. Intraoperative type I or type III endoleak detection was similar (P = 1) in CO2 + FI (7%) and ICM + FI (7%), with immediate repair and technical success achieved in all cases. Early type II endoleak did not differ in the two groups (CO2 + FI, 27%; ICM + FI, 20%; P = .7). Postoperative renal function deteriorated in two patients (13%) in the CO2 + FI group vs eight patients (27%) in the ICM + FI group (P = .04). The median increase of postoperative creatinine concentration was smaller in the CO2 + FI group than in the ICM + FI group (0.09 mg/dL [IQR, 0.03 mg/dL] vs 0.3 mg/dL [IQR, 0.4 mg/dL]; P = .04). The median hospitalization time was shorter in the CO2 + FI group (5 days [IQR, 1 day] vs 8 days [IQR, 4 days]; P = .002). No reintervention was necessary at 30-day and 6-month follow-up in either group., Conclusions: CO2 + FI is safe and effective in FEVAR and allows the amount of ICM to be significantly reduced, leading to shorter hospitalization time and better renal function preservation at 30 days. Technical success, procedure and fluoroscopy time, radiation dose, and 6-month reinterventions are comparable with those of the standard ICM imaging protocol for FEVAR. Based on this preliminary experience, CO2 + FI may be proposed as an effective tool to reduce the overall amount of procedural ICM, with consequent benefits on perioperative renal function., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)- Published
- 2020
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33. The Efficacy of a Protocol of Iliac Artery and Limb Treatment During EVAR in Minimising Early and Late Iliac Occlusion.
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Vacirca A, Faggioli G, Pini R, Spath P, Gallitto E, Mascoli C, Abualhin M, and Gargiulo M
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- Aged, Aged, 80 and over, Aortic Aneurysm, Abdominal mortality, Clinical Protocols, Computed Tomography Angiography, Female, Follow-Up Studies, Graft Occlusion, Vascular epidemiology, Graft Occlusion, Vascular etiology, Graft Occlusion, Vascular surgery, Hospital Mortality, Humans, Iliac Artery diagnostic imaging, Iliac Artery pathology, Intraoperative Care methods, Kaplan-Meier Estimate, Male, Reoperation statistics & numerical data, Retrospective Studies, Risk Assessment, Risk Factors, Stents adverse effects, Treatment Outcome, Vascular Patency, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects, Graft Occlusion, Vascular prevention & control, Iliac Artery surgery, Intraoperative Care standards
- Abstract
Objective: Iliac limb occlusion (ILO) is a complication of endovascular aortic repair (EVAR) and requires re-intervention in most cases. Attention to any intra-operative defect of iliac limbs and arteries may prevent ILO. The study aimed to analyse the long term effect of an intra-operative protocol of iliac limb treatment during EVAR on ILO., Methods: Patients treated from 2012 to 2017 for abdominal aortic aneurysm (AAA) with standard EVAR were collected prospectively. Pre-operative computed tomography angiography anatomical characteristics were evaluated. The protocol for intra-operative iliac limb management was: a. pre-EVAR angioplasty of common/external iliac artery stenosis; b. precise contralateral iliac limb deployment at the same level of the flow divider; c. iliac limb kissing ballooning with high pressure non-compliant balloons; d. iliac limb stenting for residual tortuosity/kink and adjunctive external iliac stenting for residual stenosis/dissection after EVAR. ILO was evaluated at 30 days and at follow up, which was performed by duplex ultrasonography before discharge, at three, six, and 12 months and yearly thereafter. Kaplan-Meier and Cox linear regression were used., Results: Four hundred and forty-two patients and 884 iliac limbs were included in the study. Severe iliac tortuosity and calcification were present in 15% (132/884) and 8% (70/884), respectively. External iliac angioplasty and stenting of iliac limb were performed in 2% (18/884) and 9.5% (84/884) of limbs. The thirty day mortality was 1.6%, with no ILO. At a mean follow up of 33 ± 12 months, ILO occurred in 7/884 (0.8%) limbs of six patients. Five ILO were treated by endovascular relining, two surgically: one by femorofemoral bypass and one by surgical explant. On univariable analysis, sac shrinkage was significantly associated with ILO (HR 1, 95% CI 0.8-2.5, p = .043)., Conclusion: A protocol of aggressive iliac limb treatment in EVAR leads to a very low rate of late ILO. The role of sac shrinkage in ILO should be investigated further., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)
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- 2020
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34. Endovascular Repair of a Common Carotid Artery Perforation during Pacemaker Insertion.
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Palermo S, Faggioli G, Ancetti S, Gallitto E, Logiacco A, Pini R, and Gargiulo M
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- Aged, 80 and over, Blood Vessel Prosthesis, Carotid Artery Injuries diagnostic imaging, Carotid Artery Injuries etiology, Carotid Artery, Common diagnostic imaging, Female, Humans, Stents, Angioplasty, Balloon adverse effects, Angioplasty, Balloon instrumentation, Blood Vessel Prosthesis Implantation instrumentation, Cardiac Pacing, Artificial, Carotid Artery Injuries surgery, Carotid Artery, Common surgery, Catheterization adverse effects, Iatrogenic Disease, Pacemaker, Artificial
- Abstract
Background: We report the percutaneous endovascular management of an iatrogenic perforation of the left common carotid artery (LCCA) during an attempted trans-subclavian pacemaker (PM) placement., Methods: An 87-year-old woman was urgently transferred after an attempted left subclavian vein PM implantation. Computed tomography angiography scan showed the accidental cannulation of LCCA in its most proximal segment. Owing to the significant surgical risks, the mortality rate, and the distal position of the vessel from the skin, we opted for an endovascular strategy with a balloon-expandable stent graft. The Advanta 8 × 38 mm V12 was inserted via a 7 French Flexor Introducer sheath through the right common femoral artery., Results: The patient was discharged on postoperative day 2 without complications. A 6-month follow-up computed tomography angiography demonstrated stent graft and LCCA patency and the patient was in a good stable condition., Conclusions: This case highlights the effectiveness of a minimal invasive endovascular approach to treat this uncommon but potentially lethal injury., (Copyright © 2020 Elsevier Inc. All rights reserved.)
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- 2020
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35. The Combined Use of a Distal Self-Expandable and Proximal Balloon-Expandable Stent Graft in Bridging Hostile Renal Arteries in Thoracoabdominal Branched Endografting.
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Gallitto E, Faggioli G, Fenelli C, Mascoli C, Pini R, Ancetti S, Logiacco A, Sonetto A, and Gargiulo M
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- Angioplasty, Balloon adverse effects, Aortic Aneurysm, Thoracic diagnostic imaging, Blood Vessel Prosthesis Implantation adverse effects, Humans, Postoperative Complications therapy, Prosthesis Design, Renal Artery diagnostic imaging, Retrospective Studies, Risk Factors, Time Factors, Treatment Outcome, Angioplasty, Balloon instrumentation, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Renal Artery surgery, Stents
- Abstract
Background: To evaluate early/midterm outcomes of a specific configuration of a bridging stent graft-that is a distal self-expandable (SE) stent graft combined with proximal balloon-expandable (BE) one-in hostile renal artery (RA) anatomy in branched thoracoabdominal aneurysm (TAAA) repair., Methods: Between 2010 and 2019, all TAAAs undergoing fenestrated and branched endografting (FB-EVAR) were prospectively collected. Preoperative, procedural, and postoperative data of RAs accommodated by branch design and patent at the completion angiography were retrospectively analyzed. Hostile RA anatomy included upward (type B) and downward + upward (type D) orientations. Type B and D RAs treated by the combination of an SE + BE stent graft as a bridging stent (BE + SE group) were compared with RAs treated by a BE stent graft only (BE group). RA occlusion, reinterventions, and branch instability were assessed., Results: Over a total of 112 TAAAs undergoing FB-EVAR, 189 RAs were treated by fenestrations (113-60%) and branches (76-40%). Among the 66 (86%) RAs accommodated by branch and patent at completion angiography, 55 had a type B/D orientation. BE stent grafts were used in 15/55 (27%) RAs and SE + BE in 40/55 (73%). At a median follow-up of 12 (8) months, 5/55 (9%) RAs occluded: 4/15 (27%) in the BE group and 1/40(2.5%) in the SE + BE group (P: 0.017). RA patency was 83 ± 5% at 24 months. The SE + BE group had higher patency than the BE group (90 ± 5% vs. 68 ± 5% at 12 months; P: 0.039). Overall freedom from RA-related reinterventions was 87 ± 5% at 24 months. Six (9%) RAs required reinterventions: 4/15 (27%) in the BE group and 2/40 (5%) in the BE + SE group (P: 0.041). RAs managed by an SE + BE stent graft had lower reinterventions than RAs treated by a BE stent graft only (93 ± 5% vs. 76 ± 5% at 12 months; P: 0.01). Freedom from branch instability was 78 ± 5% at 24 months, with 8 overall cases (12%) occurring-5/15 (33.3%) in the BE group versus 3/40 (7.5%) in the SE + BE group (P: 0.02). RAs managed by an SE + BE stent graft had lower branch instability than RAs treated only by a BE stent graft (BE: 68 ± 5% vs. SE + BE: 80 ± 5% at 12 months; P: 0.02)., Conclusions: In hostile renal anatomy, the combination of a distal SE and proximal BE stent graft as a bridging stent in branched endografting is safe and effective with lower rates of occlusion, reinterventions, and branch instability at midterm follow-up compared with a BE stent graft alone., (Copyright © 2020. Published by Elsevier Inc.)
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- 2020
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36. Long-term Efficacy of EVAR in Patients Aged Less Than 65 Years with an Infrarenal Abdominal Aortic Aneurysm and Favorable Anatomy.
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Gallitto E, Faggioli G, Mascoli C, Spath P, Pini R, Ricco JB, Logiacco A, Sonetto A, and Gargiulo M
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- Age Factors, Aged, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal mortality, Blood Vessel Prosthesis, Clinical Decision-Making, Databases, Factual, Female, Humans, Length of Stay, Male, Middle Aged, Postoperative Complications mortality, Postoperative Complications therapy, Prosthesis Design, Retrospective Studies, Risk Factors, Stents, Time Factors, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation instrumentation, Blood Vessel Prosthesis Implantation mortality, Endovascular Procedures adverse effects, Endovascular Procedures instrumentation, Endovascular Procedures mortality
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Background: The aim of this study was to compare early and long-term outcomes of endovascular aneurysm repair (EVAR) versus open surgical repair (OSR) in patients aged ≤ 65 years., Methods: Data of patients aged ≤65 years undergoing infrarenal abdominal aortic aneurysm repair, between 2005 and 2013, were retrospectively reviewed. All EVAR procedures were performed according to the instruction for use, and only OSR procedures with an infrarenal aortic cross-clamping were included in the study., Results: In this group of 115 patients (EVAR: 58 patients, 51% and OSR: 57 patients, 49%), EVAR and OSR patients had similar comorbidities, except for obesity (EVAR: 38% vs. OSR: 19%; P = 0.03). A stay in the intensive care unit (ICU) was necessary in 19% of patients with EVAR versus 79% with OSR (P = 0.001), and the amount of blood transfusion was 236 ± 31 mL for EVAR versus 744 ± 98 mL for OSR (P = 0.001). The hospital stay was 4 ± 2 days for EVAR versus 9 ± 6 days for OSR (P = 0.03). The overall 30-day mortality was 1% (EVAR: 0% vs. OSR: 2%; P = 0.30). Five patients (4%) required reinterventions within 30 days (EVAR: 0% vs. OSR: 8%, P = 0.001). The mean follow-up was 86 ± 38 months. Freedom from reintervention at 10 years after EVAR was 81% versus OSR 74%; (P = 0.77). Late reinterventions were reported in 13 patients (23%) with OSR and in 10 patients (17%) with EVAR. Postoperative retrograde ejaculation occurred more often in patients with OSR (31%) versus EVAR (2%) (P = 0.001). During the follow-up, cancer was found in 19 (17%) patients with no difference between EVAR and OSR (P = 0.83). The global survival at 10 years was 72% (EVAR: 79% vs. OSR: 70%; P = 0.94)., Conclusions: In this study, EVAR was associated with a shorter hospital stay, less need for the ICU, and less early reinterventions than OSR. Survival and reinterventions during the follow-up were not significantly different between EVAR and OSR. According to these results, EVAR may be considered for patients aged ≤65 years with a favorable anatomy., (Copyright © 2020. Published by Elsevier Inc.)
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- 2020
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37. Different Drugs Effect on Mesenchymal Stem Cells Isolated From Abdominal Aortic Aneurysm.
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Pini R, Ciavarella C, Faggioli G, Gallitto E, Indelicato G, Fenelli C, Mascoli C, Vacirca A, Gargiulo M, and Pasquinelli G
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- Aorta, Abdominal metabolism, Aorta, Abdominal pathology, Aortic Aneurysm, Abdominal metabolism, Aortic Aneurysm, Abdominal pathology, Cell Separation, Cell Survival drug effects, Cells, Cultured, Female, Humans, Male, Matrix Metalloproteinase 9 genetics, Matrix Metalloproteinase 9 metabolism, Mesenchymal Stem Cells metabolism, Mesenchymal Stem Cells pathology, Middle Aged, PPAR gamma genetics, PPAR gamma metabolism, Signal Transduction, Aorta, Abdominal drug effects, Aortic Aneurysm, Abdominal drug therapy, Doxycycline pharmacology, Mesenchymal Stem Cells drug effects, Pioglitazone pharmacology, Simvastatin pharmacology
- Abstract
Background: Abdominal aortic aneurysm (AAA) is a progressive dilation of the aortic wall, determined by the unbalanced activity of matrix metalloproteinase (MMPs). In vitro and in vivo studies support the pivotal role of MMP-9 to AAA pathogenesis. In our experience, we elucidated the expression of MMP-9 in an ex vivo model of human mesenchymal stem cells isolated from AAA specimen (AAA-MSCs). Thus, MMP-9 inhibition could be an attractive therapeutic strategy for inhibiting AAA degeneration and rupture. Our study was aimed at testing the effect of 3 different drugs (pioglitazone, doxycycline, simvastatin) on MMP-9 and peroxisome proliferator-activated receptor (PPAR)-γ expression in AAA-MSCs., Methods: Aneurysmal aortic wall segments were taken from AAA patients after the open surgical treatment. MSCs were isolated from AAA (n = 20) tissues through enzymatic digestion. AAA-MSCs were exposed to different doses of pioglitazone (5-10-25 μM), doxycycline (10-25 μM), and simvastatin (10 μM) for 24 h. The effect of each drug was evaluated in terms of cell survival, by crystal violet stain. MMP-9 and PPAR-γ mRNA were analyzed using real-time PCR., Results: AAA-MSCs were not affected by the exposure to the selected drugs, as shown by the analysis of cell viability. Interestingly, MMP-9 mRNA resulted significantly decreased after each treatment, recording a downregulation of 50% in presence of pioglitazone, 90% with doxycycline, and 40% with exposed to simvastatin, in comparison to untreated cells. We further analyzed the expression of PPAR-γ, target of pioglitazone, observing an upregulation in exposed AAA-MSCs to controls., Conclusions: Our data support the potential therapeutic effect of pioglitazone, doxycycline, and simvastatin on AAA by reducing the MMP-9 expression in a patient-specific model (AAA-MSCs). In addition, pioglitazone drives the increase of PPAR-G, another promising target for AAA therapy. Further studies are necessary to elucidate the mechanism driving this inhibitory pathway, which can reduces the mortality risk associated with AAA rupture., (Copyright © 2020 Elsevier Inc. All rights reserved.)
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- 2020
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38. The Italian Multicentre Registry of Fenestrated Anaconda™ Endografts for Complex Abdominal Aortic Aneurysms Repair.
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Pini R, Giordano J, Ferri M, Palmieri B, Solcia M, Michelagnoli S, Chisci E, Fadda Gian F, Cappiello P, Talarico F, Licata S, Frigatti P, Ronchey S, Mangialardi N, Pratesi C, Salvini M, Milite D, Pilon F, Perkmann R, Stringari C, Pulli R, Faggioli G, and Gargiulo M
- Subjects
- 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, Italy, Male, Prospective Studies, Prosthesis Design, Registries, Risk Factors, Time Factors, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation
- Abstract
Objective: The aim was to describe the outcomes of the Anaconda™ Fenestrated endograft Italian Registry for complex aortic aneurysms (AAAs), unsuitable for standard endovascular aneurysm repair (EVAR)., Methods: Between 2012 and 2018 patients with a proximal neck unsuitable for standard EVAR, treated with the fenestrated Anaconda™ endograft, were prospectively enrolled in a dedicated database. Endpoints were peri-operative technical success (TS) and evaluation of type Ia/b or 3 endoleaks (T1/3 EL), target visceral vessel (TVV) occlusion, re-interventions, and AAA related mortality at 30 days, six months, and later follow up., Results: One hundred twenty seven patients (74 ± 7 years, American Society Anesthesiology (ASA) II/III/IV: 12/85/30) were included in the study in 49 Italian Vascular Surgery Units (83 juxta/para-renal AAA, 13 type IV thoraco-abdominal AAA, 16 T1aEL post EVAR, and 15 short neck AAA). Configurations with one, two, three, and four fenestrations were used in 5, 56, 39, and 27 cases, respectively, for a total of 342 visceral vessels. One hundred and eight (85%) bifurcated and 19 (15%) tube endografts were implanted. In 35% (44/127) of cases the endograft was repositioned during the procedure, and 37% (128/342) of TVV were cannulated from brachial access. TS was 87% (111/127): five T1EL, six T3EL (between fenestration and vessel stent), and six loss of visceral vessels (one patient with a Type Ia EL had also a TVV loss) occurred. Thirty day mortality was 4% (5/127). Two of the five T1EL resolved spontaneously at 30 days. The overall median follow up was 21 ± 16 months; one T1EL (5%) occurred at six months and one T3EL (4%) at the three year follow up. Another two (3%) TVV occlusions occurred at six months and five (3%) at three years. The re-intervention rate at the 30 days, six months, and three year follow up was 5%, 7%, and 18 ± 5%, respectively., Conclusion: The fenestrated Anaconda™ endograft is effective in the treatment of complex AAA. Some structure properties, such as the re-positionability and the possibility of cannulation from above, are specific characteristics helpful for the treatment of some complex anatomies., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)
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- 2020
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39. Predictors of Survival in Patients Over 80 Years Old Treated with Fenestrated and Branched Endograft.
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Pini R, Faggioli G, Gallitto E, Mascoli C, Fenelli C, Vacirca A, and Gargiulo M
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- Age Factors, 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, Databases, Factual, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Female, Humans, Male, Prosthesis Design, Risk Factors, Time Factors, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation
- Abstract
Background: Fenestrated and branched endovascular aneurysm repair endograft (f/bEVAR) allows the endovascular repair of thoracoabdominal and juxtarenal and pararenal abdominal aortic aneurysms (T-J-P-AAAs); however, given their high cost and complexity, their use should be limited to patients with life expectancy >2 years. Nevertheless, the number of patients older than 80 years treated by f/bEVAR is growing, with no hard evidence of the real efficacy in this context. The aim of the present study is to analyze the survival of ≥80-year-old patients treated with f/bEVAR, and to identify possible predictors of late mortality., Methods: An analysis of clinical, anatomical, and technical characteristics of patients treated with f/bEVAR for J-, P-, and T-AAA from 2010 to 2019 in a single academic center was performed. Follow-up data were collected prospectively with clinical visit and computed tomography angiography at discharge, after 6 months, and yearly thereafter. Survival after 2 years was evaluated by Kaplan-Meier analysis. Possible predictors of mortality were evaluated by univariable/multivariable analysis., Results: In the study period, a total of 243 f/bEVARs were considered: 83 for TAAA (34%) and 160 for J/PAAA (66%). Mean age was 73 ± 6 years, with 35 (14%) patients ≥80 years old; 209 patients (86%) were male and 78 (39%) had an American Society of Anesthesiology score IV. The 30-day and 2-year survival were 96% and 80 ± 3%, respectively. At a mean follow-up of 36 ± 25 months, independent predictors of late mortality by Cox regression analysis were chronic obstructive pulmonary disease (COPD), chronic renal failure (CRF), and ≥80 years old (hazard ratio [HR] 1.8, 95% confidence interval [CI] 1.02-3.2, P = 0.05; HR 1.7, 95% CI 1.01-3.4, P = 0.04; HR 3.1, 95% CI 1.5-6.3, P = 0.002, respectively). Preoperative clinical characteristics were similar in ≥80 years old versus younger patients, except for the prevalence of TAAA (14% vs. 38%, P = 0.04). The technical success and 30-day mortality were similar in ≥80 vs. <80-year-old patients (93% vs. 96%, P = 0.31; 7% vs. 3.5%, P = 0.60, respectively). The 2-year survival estimation was significantly lower in ≥80 years old compared with younger patients (62 ± 10% vs. 82 ± 3%, P = 0.003). The association of COPD and CRF significantly affects the 2-year survival in ≥80-year-old patients (no patients survived at 2 years) and was significantly different compared with the survival in ≥80-year-old patients without these risk factors (70 ± 11%, P = 0.001)., Conclusions: The early mortality rate and the 2-year survival after f/bEVAR justify this type of treatment in patients ≥80 years old; however, the presence of comorbidities such as COPD and CRF significantly reduces mid-term survival in this group and should be taken into consideration in the indication to f/bEVAR., (Copyright © 2020 Elsevier Inc. All rights reserved.)
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- 2020
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40. Early and Mid-term Efficacy of Fenestrated Endograft in the Treatment of Juxta-Renal Aortic Aneurysms.
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Gallitto E, Faggioli G, Giordano J, Pini R, Mascoli C, Fenelli C, Abualhin M, Ancetti S, Logiacco A, and Gargiulo M
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- Aged, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal mortality, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation mortality, Databases, Factual, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Female, Humans, Male, Postoperative Complications mortality, Postoperative Complications surgery, Prosthesis Design, Pulmonary Disease, Chronic Obstructive mortality, Reoperation, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation
- Abstract
Background: The aim of this study was to report early and mid-term outcomes of fenestrated endografting (FEVAR) for juxtarenal aneurysm (J-AAAs)., Methods: Between 2008 and 2017, all consecutive J-AAAs treated by FEVAR were prospectively collected. Early endpoints were technical success, renal function worsening, and 30-day mortality. Follow-up endpoints were survival, freedom from reinterventions (FFRs), target visceral vessels (TVVs) patency, J-AAAs shrinkage, and renal function worsening., Results: Among 181 cases who underwent FB-EVAR, 66 (36%) were J-AAAs. Endograft with 1, 2, 3, and 4 fenestrations were planned in 2 (3%), 22 (33%), 27 (41%) and 15 (23%) cases, respectively. Overall, 236 TVVs were treated by fenestrations and scallops. Technical success was achieved in 65 (99%) cases. The only failure occurred for a type III endoleak requiring renal artery relining. No TVVs were lost. Renal function worsening occurred in 7 (10%) cases: 4 returned to baseline within 30-day, 1 required hemodialysis and died within 30 days (1.5%). This was the only case of 30-day mortality. The mean follow-up was 46 ± 32 months. Aneurysm sac shrinkage or stability was observed in 42 (64%) and 22 (33%) cases, respectively. Two patients (3%) with persistent type II endoleak had sac enlargement and required reinterventions. Freedom from reinterventions at 5 years was 88%. An asymptomatic celiac trunk occlusion (accommodated by a scallop) occurred at 24 months in a case with a severe preoperative stenosis. No late renal arteries occlusions or type I-III endoleaks occurred. Overall, renal function worsening was reported in 5 (8%) patients during follow-up. Survival at 5 years was 67%, with no j-AAA-related mortality. COPD was the only independent predictor for mortality at the multivariate analysis (P: 0.021; OR: 5.3; 95% CI, 1.3-21.9)., Conclusions: FEVAR for J-AAAs is safe and effective at early and mid-term follow-up. According to these results, it could be proposed as the first-line treatment in high-risk patients if anatomically fit. Long-term survival is reduced in the presence of preoperative COPD., (Copyright © 2019 Elsevier Inc. All rights reserved.)
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- 2020
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41. Is it Possible to Safely Maintain a Regular Vascular Practice During the COVID-19 Pandemic?
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Pini R, Faggioli G, Vacirca A, Gallitto E, Mascoli C, Attard L, Viale P, and Gargiulo M
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- Adult, Betacoronavirus isolation & purification, COVID-19, Clinical Protocols, Comorbidity, Critical Pathways trends, Female, Humans, Italy epidemiology, Male, Middle Aged, Program Evaluation, SARS-CoV-2, Coronavirus Infections diagnosis, Coronavirus Infections epidemiology, Coronavirus Infections prevention & control, Elective Surgical Procedures methods, Elective Surgical Procedures statistics & numerical data, Emergency Service, Hospital organization & administration, Emergency Service, Hospital statistics & numerical data, Infection Control methods, Infection Control organization & administration, Pandemics prevention & control, Pneumonia, Viral diagnosis, Pneumonia, Viral epidemiology, Pneumonia, Viral prevention & control, Vascular Diseases epidemiology, Vascular Diseases surgery, Vascular Surgical Procedures methods, Vascular Surgical Procedures statistics & numerical data
- Abstract
Objective: This study aimed to evaluate the protocol adopted during the emergency phase of the COVID-19 pandemic to maintain elective activity in a vascular surgery unit while minimising the risk of contamination to both patients and physicians, and the impact of this activity on the intensive care (IC) resources., Methods: The activity of a vascular surgery unit was analysed from 8 March to 8 April 2020. Surgical activity was maintained only for acute or elective procedures obeying priority criteria. The preventive screening protocol consisted of nasopharyngeal swabs (NPS) for all patients and physicians with symptoms and for unprotected contact infected cases, and serological physician evaluations every 15 days. Patients treated in the acute setting were considered theoretically infected and the necessary protective devices were used. The number of patients and the possible infection of physicians were evaluated. The number and type of interventions and the need for post-operative IC during this period were compared with those in the same periods in 2018 and 2019., Results: One hundred and fifty-one interventions were performed, of which 34 (23%) were acute/emergency. The total number of interventions was similar to those performed in the same periods in 2019 and 2018: 150 (33, of which 22% acute/emergency) and 117 (29, 25% acute/emergency), respectively. IC was necessary after 6% (17% in 2019 and 20% in 2018) of elective operations and 33% (11) of acute/emergency interventions. None of the patients treated electively were diagnosed with COVID-19 infection during hospitalisation. Of the 34 patients treated in acute/emergency interventions, five (15%) were diagnosed with COVID-19 infection. It was necessary to screen 14 (47%) vascular surgeons with NPS after contact with infected colleagues, but none for unprotected contact with patients; all were found to be negative on NPS and serological evaluation., Conclusion: A dedicated protocol allowed maintenance of regular elective vascular surgery activity during the emergency phase of the COVID-19 pandemic, with no contamination of patients or physicians and minimal need for IC resources., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)
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- 2020
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42. The risk of aneurysm rupture and target visceral vessel occlusion during the lead period of custom-made fenestrated/branched endograft.
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Gallitto E, Faggioli G, Spath P, Pini R, Mascoli C, Ancetti S, Stella A, Abualhin M, and Gargiulo M
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- Aged, Aortic Aneurysm, Abdominal complications, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal physiopathology, Aortic Aneurysm, Thoracic complications, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic physiopathology, Aortic Rupture diagnostic imaging, Arterial Occlusive Diseases diagnostic imaging, Arterial Occlusive Diseases physiopathology, Blood Vessel Prosthesis Implantation adverse effects, Clinical Decision-Making, Databases, Factual, Endovascular Procedures adverse effects, Female, Humans, Male, Prosthesis Design, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Vascular Patency, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Thoracic surgery, Aortic Rupture etiology, Arterial Occlusive Diseases etiology, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Time-to-Treatment
- Abstract
Objective: The objective of this study was to evaluate adverse events occurring during the lead period of custom-made fenestrated/branched endograft for juxtarenal/pararenal abdominal aortic aneurysm (j/p-AAA) and thoracoabdominal aortic aneurysm (TAAA)., Methods: Between 2008 and 2017, patients enrolled for custom-made fenestrated/branched endograft repair were prospectively collected. Anatomic, procedural, and postoperative data were retrospectively analyzed. Lead period was defined as the time between the endograft order to the manufacturer and implantation. Aneurysm diameter, target visceral vessel (TVV) severe stenosis (>75% of ostial lumen), and number of planned TVVs were evaluated at preoperative computed tomography angiography. Patency of TVVs was evaluated intraoperatively. Aneurysm rupture and TVV occlusion during the lead period were assessed., Results: There were 141 custom-made fenestrated/branched endograft repairs planned. Of these, 133 patients (male, 87%; age, 73 ± 6 years) with complete available data were considered for the study. There were 75 (56%) j/p-AAAs and 58 (44%) TAAAs. The mean aneurysm diameter was 58 ± 6 mm (j/p-AAA, 56 ± 6 mm; TAAA, 67 ± 8 mm); 15 cases (11%) had >70-mm diameter. Planned TVVs were 431 (mean, 3 ± 1 TVVs/patient). The mean lead period was 89 ± 25 days, with five (3.8%) aneurysm ruptures (j/p-AAA, one; TAAA, four) occurring, two (1.5%) during manufacture and three (2.3%) with endograft available in the hospital (all three procedures were postponed because of cardiac or pulmonary comorbidities). In one TAAA rupture, the endograft was successfully implanted and the patient survived. Four of five ruptures had >70-mm diameter. On univariate analysis, chronic obstructive pulmonary disease (P = .01; odds ratio [OR], 2.6; 95% confidence interval [CI], 2.1-3.2) and aneurysm diameter >70 mm (P = .001; OR, 42; 95% CI, 4-411) were risk factors for aneurysm rupture during the lead period, with aneurysm diameter >70 mm being confirmed as an independent risk factor on multivariate analysis (P = .005; OR, 29.3; 95% CI, 2.8-308). Overall, eight endografts (6%) were not implanted (refusal, two; aneurysm rupture, four; death not related to aneurysm, two). In the remaining 125 patients (94%), 405 TVVs were planned. Of them, 46 (11%) had severe stenosis at preoperative computed tomography angiography. Twelve (3%) TVVs occluded in the lead period (renal arteries, five; celiac trunks, seven); six were recanalized and six were abandoned. Severe preoperative stenosis was a risk factor for TVV occlusion during the lead period (P = .000; OR, 1.3; 95% CI, 1.1-1.6)., Conclusions: In our series, custom-made design required a mean lead period of 89 days, which was determined by both manufacturing time and clinical reasons. During this delay, there is a high risk of both rupture in aneurysms >70 mm and TVV occlusion in severely stenosed vessels. These factors should be considered in the indication for custom-made fenestrated/branched endograft repair., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2020
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43. Endovascular Treatment of a Ruptured Superficial Femoral Artery Aneurysm in Behcet's Disease: Case Report and Literature Review.
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Sallustro M, Faggioli G, Ancetti S, Gallitto E, Vento V, Pini R, and Gargiulo M
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- Adult, Aneurysm, Ruptured diagnostic imaging, Aneurysm, Ruptured etiology, Aneurysm, Ruptured physiopathology, Behcet Syndrome diagnosis, Behcet Syndrome drug therapy, Blood Vessel Prosthesis, Femoral Artery diagnostic imaging, Femoral Artery physiopathology, Humans, Immunosuppressive Agents therapeutic use, Male, Stents, Treatment Outcome, Vascular Patency, Aneurysm, Ruptured surgery, Behcet Syndrome complications, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Femoral Artery surgery
- Abstract
Purpose: The aim of the study was to report the endovascular repair of a ruptured superficial femoral artery (SFA) aneurysm in a young patient with Behcet's disease and review the literature., Case Report: A 43-year-old man with a known history of vasculo-Behcet's disease (v-BD) under daily immunosuppressive therapy presented with a ruptured aneurysm of the left SFA. The patient underwent urgent endovascular exclusion of the aneurysm using a self-expanding covered stent. Surgical cut-down followed by direct puncture of the SFA was preferred to percutaneous approach to reduce the risk of postoperative pseudoaneurysm formation. The procedure and postoperative recovery were successful. Doppler ultrasound performed at 3 months and computed tomography angiography performed at 6 months after the procedure confirmed aneurysm exclusion, the endograft patency, and the absence of aneurysm degeneration both at the level of surgical access and endograft landing zone., Conclusions: The endovascular treatment of ruptured lower limb aneurysms has been scarcely reported in the literature despite representing the less invasive option. A rare case of ruptured aneurysm SFA in a patient with v-BD was successfully treated with endovascular therapy (ET) and led to satisfactory midterm outcomes. ET offers encouraging results in terms of reduced vessel trauma and reduced postoperative complication rates., (Copyright © 2019 Elsevier Inc. All rights reserved.)
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- 2020
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44. Predictors of survival in malignant aortic tumors.
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Vacirca A, Faggioli G, Pini R, Freyrie A, Indelicato G, Fenelli C, Bacchi Reggiani ML, Vasuri F, Pasquinelli G, Stella A, and Gargiulo M
- Subjects
- Humans, Predictive Value of Tests, Survival Analysis, Aortic Diseases mortality, Aortic Diseases surgery, Vascular Neoplasms mortality, Vascular Neoplasms surgery
- Abstract
Objective: Malignant aortic tumors (MATs) are exceedingly rare, and a comprehensive review of clinical and therapeutic aspects is lacking in the literature. The aim of this study was to analyze all known cases of MATs and to identify predictors of patients' survival., Methods: All patients diagnosed with an aortic tumor treated in a single center along with all case reports and reviews available in the literature through a specific PubMed search using keywords such as "malignant" and "aorta" or "aortic," "tumor," or "sarcoma" or "angiosarcoma" were analyzed. The tumor's primary location, clinical presentation, histologic subtype, and treatment choice were examined. Survival at 1 year, 3 years, and 5 years and the possible preoperative and operative outcome predictors were evaluated using Kaplan-Meier analysis with a log-rank test and by Cox regression for multivariate analysis., Results: In addition to the 5 cases treated in our center, 218 other cases of MAT were reported in the literature from 1873 to 2017. The mean age of the patients was 60.1 ± 11.9 years, and the male to female ratio was 1.59:1. The median overall survival from diagnosis was 8 (7-9) months; 1-, 3-, and 5-year survival rates were 26%, 7.6%, and 3.5%, respectively. Chronic hypertension (P = .03), fever (P = .03), back pain (P = .01), asthenia (P = .04), and signs of peripheral embolization (P = .007) were significant predictors of a poor result. Histologic subtypes had a different impact on survival, with no statistical significance. Compared with other treatment strategies, combined surgical-medical therapy had the best impact on the median survival rate (surgical-medical, 12 [8-24] months; medical, 8 [5-10] months; surgical 7 [2-16] months; no treatment, 2 [0.5-15] months; P = .001). Analyzing exclusively medical approaches, chemotherapy and radiotherapy had the best impact on median survival rate compared with untreated patients (chemotherapy-radiotherapy, 18 [10-26] months; radiotherapy, 16 [8-20] months; chemotherapy, 10 [7-24] months; no medical treatment, 6 [2-16] months; P = .005); these data were not sustained by multivariate analysis., Conclusions: Aortic tumors are a malignant pathologic condition with a short survival rate after initial diagnosis. Survival is further diminished in the presence of clinical factors such as hypertension, fever, back pain, asthenia, and signs of peripheral embolization. Combined surgical and medical treatment, particularly with chemotherapy and radiotherapy, has shown the highest survival rate., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2020
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45. The different effect of branches and fenestrations on early and long-term visceral vessel patency in complex aortic endovascular repair.
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Pini R, Faggioli G, Gallitto E, Mascoli C, Fenelli C, Ancetti S, Vacirca A, and Gargiulo M
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- Aged, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Thoracic diagnostic imaging, Computed Tomography Angiography, Contrast Media, Female, Fluoroscopy, Humans, Male, Middle Aged, Postoperative Complications, Retrospective Studies, Vascular Patency, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis, Endovascular Procedures instrumentation, Stents
- Abstract
Background: Aortic endovascular treatment with fenestrated or branched devices (f/bEVAR) requires a connection between the aortic graft and the visceral vessel (VV). However, data on the perioperative and long-term fate of the VVs remain scarce. The aim of our study was to evaluate the VV loss (VVL) according to the type of revascularization performed (fenestrations vs branched) and the necessity for adjunctive visceral procedures (AVPs)., Methods: From 2012 to 2017, all f/bEVAR procedures for juxtarenal abdominal aortic aneurysms (JAAAs), pararenal abdominal aortic aneurysms (PAAAs), and thoracoabdominal aortic aneurysms (TAAAs) were considered. The perioperative VVL, AVPs, and graft configuration were considered and evaluated during the follow-up period., Results: In 158 patients, 523 VVs were considered, 140 (26%) in JAAAs, 165 (32%) in PAAAs, and 218 (42%) in TAAAs. Branches were used for 114 vessels (52%) in TAAAs, 8 (5%) in PAAAs, and 0 (0%) in JAAAs. The overall perioperative VVL was 20 (3.8%) and was significantly greater in TAAAs than in PAAAs or JAAAs (6.4% vs 2.4% vs 1.4%; P = .03). The branches resulted in greater perioperative VVL compared with fenestration (9% [11 of 122] vs 2% [9 of 401]; P = .0001). A significant VVL difference between the branches and fenestrations was identified selectively only for the renal arteries: 11 of 52 (21%) vs 6 of 224 (2.5%; P = .001). The results of the multivariate analysis confirmed the independent greater risk of VVL for branches and renal arteries (odds ratio, 4.7; 95% confidence interval, 12.5-1.7; P = .04; odds ratio, 7.1; 95% confidence interval, 52.6-1.05; P = .05, respectively). AVPs were performed in 43 VVs (8.2%) because of dissection (n = 2; 0.4%), stenosis (m = 3; 0.6%), bleeding (n = 3; 0.6%), or kinking between the bridging stent graft and the VV (n = 35; 7%). A significant difference between the branches and fenestrations was seen only for kinking between the bridging stent graft and VV (12% [15 of 112] vs 5% [20 of 401]; P = .005). At 5 years, the incidence of VVL was 2% ± 1%. The fenestrations had significantly greater freedom from VVL compared with the branches (100% vs 87% ± 6%; P = .04), which was confirmed selectively for TAAAs (100% vs 87% ± 6%; P = .04). The use of AVPs did not affect long-term visceral patency., Conclusions: Early and late VVL was infrequent in complex aortic procedures but seemed to occur more frequently in branches than in fenestration, especially for renal arteries. AVPs were often required to correct artery kinking but this did not affect the long-term patency., (Copyright © 2019. Published by Elsevier Inc.)
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- 2020
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46. First/Preliminary Experience of Gore Viabahn Balloon-Expandable Endoprosthesis as Bridging Stent in Fenestrated and Branched Endovascular Aortic Repair.
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Gallitto E, Faggioli G, Pini R, Mascoli C, Sonetto A, Abualhin M, Logiacco A, Ricco JB, and Gargiulo M
- Subjects
- Aged, Angioplasty, Balloon adverse effects, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal physiopathology, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic physiopathology, Blood Vessel Prosthesis Implantation adverse effects, Endoleak diagnostic imaging, Endoleak etiology, Endoleak physiopathology, Female, Humans, Male, Preliminary Data, Prospective Studies, Prosthesis Design, Self Expandable Metallic Stents, Time Factors, Treatment Outcome, Angioplasty, Balloon instrumentation, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endoleak surgery, Stents
- Abstract
Background: The aim of this study is to evaluate the preliminary outcomes of the Gore® Viabahn® balloon-expandable endoprosthesis (VBX) as bridging stent for fenestrated/branched aortic endograft., Methods: Between April and June 2018, patients undergoing fenestrated and branched-endovascular aortic repair were prospectively collected. Anatomical, procedural, and postoperative data of patients treated with VBX as bridging stents to connect fenestrations/branches to target visceral vessels (TVVs) were analyzed. Technical success and any TVV-related adverse event were assessed before discharge, at 30 days, and after 6 months of follow-up., Results: Fifteen patients undergoing fenestrated and branched-endovascular aortic repair for juxta/pararenal aneurysms (11), proximal type I endoleak after endovascular aortic repair (1), and thoracoabdominal aneurysms (3) were included in the study. Overall, 60 TVVs-celiac trunk (n = 14), superior mesenteric artery (n = 13), renal arteries (n = 30), hypogastric artery (n = 3)-were accommodated by fenestrations (n = 51), branches (n = 7), and scallops (n = 2). The bridging stent graft was a VBX in 40 (67%) TVVs. A renal artery dissection was successfully managed by a self-expandable bare metal stent. Overall, relining of a bridging stent graft was required in 2 TVVs revascularized by fenestrations (superior mesenteric artery: n = 1, renal artery: n = 1). One intraoperative type III endoleak from renal fenestration was detected and successfully sealed by an adjunctive flaring maneuver. Technical success was achieved in all cases. At 5-day, 1 VBX (1/40: 2.5%) lost its sealing in a renal artery revascularized by a branch (type II thoracoabdominal aortic aneurysm) and required reintervention and relining with a self-expandable stent graft. No TVV occlusion or reintervention occurred <30 days or after 6 months of follow-up., Conclusions: According to these preliminary results, the Gore Viabahn VBX balloon-expandable endoprosthesis can be safely used as bridging stent graft for fenestrated or branched endografts. A longer follow-up with a larger case load is necessary in order to validate this preliminary experience., (Copyright © 2019 Elsevier Inc. All rights reserved.)
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- 2019
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47. Planning and Endograft Related Variables Predisposing to Late Distal Type I Endoleaks.
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Mascoli C, Faggioli G, Gallitto E, Longhi M, Abualhin M, Pini R, Massoni CB, Freyrie A, Stella A, and Gargiulo M
- Subjects
- Aged, Aortic Aneurysm, Abdominal diagnosis, Aortography, Computed Tomography Angiography, Endoleak diagnosis, Endoleak epidemiology, Female, Follow-Up Studies, Humans, Iliac Artery diagnostic imaging, Incidence, Italy epidemiology, Male, Prognosis, Prosthesis Failure, Retrospective Studies, Time Factors, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis adverse effects, Endoleak etiology, Endovascular Procedures adverse effects
- Abstract
Objective: Late distal type I endoleak (ELIB) hampers the outcome of endovascular repair (EVAR) for abdominal aortic aneurysm (AAA); however, only few dedicated experiences have been reported in the literature. The aim of the study was to evaluate the incidence, presentation and treatment of late ELIB and to identify possible anatomical and technical predictors., Methods: All patients undergoing elective EVAR between 2008 and 2013 were collected prospectively. Follow up was by post-operative computed tomography angiography (CTA) performed within 30 days and CTA and/or duplex ultrasound (DUS) at six or 12 months and yearly thereafter. Patients with late ELIB, defined as distal type I endoleak detected more than six months after the primary intervention without endoleak on the intra-operative completion angiogram and on the post-operative CTA, were retrospectively selected (G1) and compared with a control group with no ELIB (G2) homogeneous for clinical conditions, endograft implanted, and timing of follow up. The minimum follow up required for inclusion in the study was 24 months. Pre-operative morphological aorto-iliac features and EVAR implant details were evaluated, and measurements performed after centre lumen line reconstructions using dedicated software. The differences between G1 and G2 were analysed using the chi-square test, the Student t test, and logistic regression., Results: Six hundred and sixteen patients were submitted to EVAR. ELIB was detected in 14 cases (2.3%) (G1) at a median follow up of 32.8 (IQR 48) months. In three of the 14 cases ELIB was symptomatic (AAA rupture, 2; pain, 1); in the remaining 11 cases it was asymptomatic and found incidentally at routine follow up. Treatment was by open repair in one case and by endovascular iliac leg extension in 13 cases. Hypogastric exclusion was necessary in two of 14 cases. Thirty patients were included in G2, with a median follow up of 41.2 (25) months. Common iliac artery length <4 cm (OR 5.3, 95% CI 1.1-29.5, p = .05), diameter > 15 mm (OR 3.5, 95% CI 1.2-10.9, p = .03), and severe thrombotic apposition (>50% of circumference) (OR 5, 95% CI 1.2-19.2, p = .02), at the iliac sealing zone were significant predictors of ELIB, on univariable analysis; oversizing of the iliac leg diameter < 10% and distal sealing > 1 cm above the hypogastric origin were independently associated with ELIB (OR 5.4, 95% CI 1.3-21.5, p = .01 and OR 6.6, 95% CI 1.1-39.3, p = .03, respectively), on multivariable analysis., Conclusion: The present data underline that ELIB is a non-negligible occurrence during long term EVAR follow up and requires further interventions, most often by endovascular solutions. According to the ELIB risk factors identified in this study, an iliac leg diameter oversize >10% and extensive common iliac artery coverage (<1 cm above the hypogastric origin) would be suggested to prevent this complication., (Copyright © 2019 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)
- Published
- 2019
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48. The Clinical Impact of Splanchnic Ischemia on Patients Affected by Thoracoabdominal Aortic Aneurysms Treated with Fenestrated and Branched Endografts.
- Author
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Gallitto E, Faggioli G, Ancetti S, Pini R, Mascoli C, Sonetto A, Calculli L, Pezzilli R, and Gargiulo M
- Subjects
- Aged, Aged, 80 and over, Aortic Aneurysm, Thoracic mortality, Aortic Aneurysm, Thoracic physiopathology, Blood Vessel Prosthesis Implantation mortality, Computed Tomography Angiography, Databases, Factual, Embolism diagnostic imaging, Embolism mortality, Embolism physiopathology, Endovascular Procedures mortality, Female, Humans, Male, Mesenteric Artery, Superior diagnostic imaging, Mesenteric Ischemia diagnostic imaging, Mesenteric Ischemia mortality, Mesenteric Ischemia physiopathology, Mesenteric Vascular Occlusion diagnostic imaging, Mesenteric Vascular Occlusion mortality, Mesenteric Vascular Occlusion physiopathology, Prospective Studies, Prosthesis Design, Risk Factors, Thrombosis etiology, Thrombosis physiopathology, Time Factors, Treatment Outcome, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation instrumentation, Embolism etiology, Endovascular Procedures adverse effects, Endovascular Procedures instrumentation, Mesenteric Artery, Superior physiopathology, Mesenteric Ischemia etiology, Mesenteric Vascular Occlusion etiology, Splanchnic Circulation
- Abstract
Background: Fenestrated/branched endografts for aortic repair (FB-EVAR) are valid options to treat thoracoabdominal aortic aneurysms (TAAAs). Successful repair requires manipulation of target visceral vessels (TVVs) with possible splanchnic ischemia. The aim of the study was to evaluate the clinical impact of splanchnic ischemia occurring in FB-EVAR for TAAA., Methods: Between 2010 and 2015, patients with TAAAs undergoing FB-EVAR were prospectively enrolled. Clinical, morphological, procedural, and 30-day data were evaluated. Splanchnic ischemia was defined as the presence of splanchnic ischemic lesions (SILs) visible at perioperative computed tomography angiography. Preoperative, postoperative, and 30-day hepatic/pancreatic/renal laboratory functions were analyzed. End points were incidence of SILs, laboratory splanchnic functions worsening (≥25% of baseline), and presence of related clinical/morphological and procedural risk factors., Results: Thirty-six patients (male: 78%; age: 73 ± 7 years) with 27 (75%) type I-III and 9 (25%) type IV TAAA who underwent FB-EVAR for a total of 127 TVV (branches: 47-60%; fenestrations: 53-67%). Fourteen SILs occurred in 12 (33%) patients: 4 (29%) in pancreas, 3 (21%) in spleen, 2 (14%) in bowel, 5 (36%) in kidney. The cause was embolic in 79% and thrombotic in 21%. No preoperative clinical/morphological data or procedural data were correlated with SIL. Pancreatic, hepatic, or renal function worsening occurred at 24 hr in 16 (44%), 16 (44%), and 9 (25%) cases, respectively. Overall, SILs were associated with increased values of C-reactive protein (CRP) (17.9 ± 0.4 vs. 9.9 ± 9.0 mg/dL; P = 0.03) and bilirubin (1.2 ± 2.3 vs. 1.0 ± 0.5 mg/dL; P = 0.02) at 24 hr. Specifically, SIL of the celiac trunk and superior mesenteric and renal arteries' parenchyma were associated with the significant laboratory function changes 24 hr. SIL of the superior mesenteric artery was associated with increased 30-day mortality (50% vs. 7 %; P = 0.002). Pancreatic, hepatic, or renal function worsening occurred at 30 days in 2 (6%), 0 (0%), and 4 (12%) cases, with similar laboratory tests in patients with and without SIL., Conclusions: SIL can be frequently detected after FB-EVAR for TAAA and appears mainly of embolic origin. No clinical, morphological, or procedural predictors could be identified in our series. Postoperative laboratory changes of CRP, bilirubin, activated partial thromboplastin time, and amylases are associated with SIL but disappear without clinical consequences within 30 days. However, SIL occurring in the superior mesenteric artery are associated with an increased 30-day mortality., (Copyright © 2019 Elsevier Inc. All rights reserved.)
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- 2019
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49. Total Endovascular Repair of Contained Ruptured Thoracoabdominal Aortic Aneurysms.
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Gallitto E, Faggioli G, Pini R, Mascoli C, Freyrie A, Vento V, Ancetti S, Stella A, and Gargiulo M
- Subjects
- Aged, Aged, 80 and over, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic mortality, Aortic Aneurysm, Thoracic physiopathology, Aortic Rupture diagnostic imaging, Aortic Rupture mortality, Aortic Rupture physiopathology, Aortography methods, Blood Vessel Prosthesis, Computed Tomography Angiography, Female, Hemodynamics, Hospital Mortality, Humans, Male, Operative Time, Postoperative Complications mortality, Postoperative Complications therapy, Prospective Studies, Prosthesis Design, Risk Factors, Stents, Time Factors, Treatment Outcome, Aortic Aneurysm, Thoracic surgery, Aortic Rupture surgery, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation instrumentation, Blood Vessel Prosthesis Implantation mortality, Endovascular Procedures adverse effects, Endovascular Procedures instrumentation, Endovascular Procedures mortality
- Abstract
Background: To report perioperative and 1-year results of total endovascular repair of contained ruptured thoracoabdominal aortic aneurysms (TAAAs)., Methods: Between 2015 and 2017, preoperative, procedural, and postoperative data of patients with radiographic evidence of contained ruptured TAAAs treated by endovascular repair were prospectively collected. Only patients with stable hemodynamic parameters were enclosed. Primary endpoints were 30-day/in-hospital mortality, spinal cord ischemia (SCI), postoperative cardiopulmonary complications, and new onset of hemodialysis. Secondary endpoints were endoleaks, reinterventions, and overall follow-up survival., Results: Twelve patients underwent endovascular repair for contained ruptured TAAAs. According with the Crawford/Safi's classification, 6 type II (50%), 3 type III (25%), 1 type IV (8%), and 2 type V (17%) TAAAs were treated. All patients were symptomatic. Overall, 34 target visceral vessels were planned to be revascularized. The mean time from admission to treatment was 48 hours (range 4-96), with 4 patients operated within 24 hours. Five patients (42%) were treated by T-branch, 3 (25%) by custom-made fenestrated/branched endografts, 3 (25%) by parallel graft technique, and 1 (8%) by standard thoracic endovascular aortic repair covering a stenotic celiac trunk. The 30-day and in-hospital mortality was 17% and 25%, respectively. Two patients (17%) developed SCI. Cardiac and pulmonary complications were reported in 1 (8%) and 3 (25%) cases, respectively. One patient (8%) needed permanent hemodialysis. Two endoleaks (17%) were detected at the postoperative computed tomography angiography (1 low-flow gutter endoleak and 1 type III endoleak). Four patients (33%) required re-interventions within 30 postoperative days. The mean follow-up was 12 months (range 1-22). No late target visceral vessels occlusion, endoleak, or reintervention occurred in this series. Overall, 7/12 (59%) patients were alive, and no cases of TAAA-related mortality occurred during follow-up., Conclusions: According to our results, endovascular repair of contained ruptured TAAAs is feasible by a flexible approach in selected patients with anatomical suitability and stable hemodynamic conditions. Although early mortality and morbidity are significant, with frequent reintervention necessity, subsequent follow-up is free from reinterventions and TAAA-related mortality., (Copyright © 2019 Elsevier Inc. All rights reserved.)
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- 2019
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50. Predictors of perioperative and late survival in octogenarians undergoing elective endovascular abdominal aortic repair.
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Pini R, Gallitto E, Faggioli G, Mascoli C, Vacirca A, Fenelli C, Gargiulo M, and Stella A
- Subjects
- Age Factors, Aged, 80 and over, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal mortality, Databases, Factual, Elective Surgical Procedures, Female, Health Status, Humans, Male, Postoperative Complications mortality, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation mortality, Endovascular Procedures adverse effects, Endovascular Procedures mortality
- Abstract
Objective: The appropriateness of endovascular aneurysm repair (EVAR) of uncomplicated abdominal aortic aneurysm depends on the risk-benefit ratio, particularly in elderly patients with short life expectancy. The aim of this study was to assess the efficacy of EVAR in >80-year-old patients by evaluating their postoperative survival and analyzing the possible predictors of late mortality., Methods: All consecutive patients aged >80 years undergoing elective EVAR from 2006 to 2015 were prospectively evaluated. The 30-day mortality and long-term survival were assessed, and independent risk factors for mortality were determined by multivariate logistic and Cox analysis., Results: Of a total of 1135 EVARs performed in a 10-year period, 201 (18%) occurred in patients older than 80 years. The median age was 84 years (interquartile range, 3 years), and 85% were male. Thirty-four patients (17%) had a score of 4 according to the American Society of Anesthesiologists (ASA) classification. Overall 30-day mortality was 2% (n = 4); it was significantly higher in those with ASA score of 4 compared with ASA score <4 (9.4% vs 0.6%; P = .04) and was also confirmed by multivariate analysis (odds ratio, 12.7; 95% confidence interval [CI], 1.1-141.8; P = .04). The mean follow-up was 36 ± 18 months, and the overall survival at 1 year, 3 years, and 5 years was 85% ± 2%, 77% ± 3%, and 52% ± 4%, respectively. Using multivariate Cox regression, ASA score of 4 and peripheral artery obstructive disease (PAOD) were the only independent predictors for midterm mortality (hazard ratio of 2.0 [95% CI, 1.2-2.9; P = .04] and 3.07 [95% CI, 1.06-5.2; P = .04], respectively). The 2-year survival was significantly influenced by the presence of both (ASA score of 4 and PAOD; survival, 33% ± 2%) or one (ASA score of 4 or PAOD; survival, 67% ± 8%) of the two independent predictors. If neither ASA score of 4 nor PAOD was present, survival was significantly improved (92% ± 3%; P = .02)., Conclusions: The performance of EVAR in >80-year-old patients is associated with an overall early mortality rate as low as 2%. In patients with no or only one risk factor, the survival rate warrants the treatment of abdominal aortic aneurysm; in contrast, patients with ASA score of 4 and PAOD have a significantly higher mortality rate and reduction of life expectancy., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2019
- Full Text
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