scholarly journals Correction: Unibody Endograft Using AFX 2 for Less Invasive and Faster Endovascular Aortic Repair: Protocol for a Multicenter Nonrandomized Study

10.2196/20698 ◽  
2020 ◽  
Vol 9 (6) ◽  
pp. e20698
Author(s):  
Roberto Silingardi ◽  
Pasqualino Sirignano ◽  
Francesco Andreoli ◽  
Wassim Mansour ◽  
Mattia Migliari ◽  
...  

2020 ◽  
Author(s):  
Roberto Silingardi ◽  
Pasqualino Sirignano ◽  
Francesco Andreoli ◽  
Wassim Mansour ◽  
Mattia Migliari ◽  
...  

INTERNATIONAL REGISTERED REPORT PRR1-10.2196/20698


10.2196/16959 ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. e16959
Author(s):  
Roberto Silingardi ◽  
Pasqualino Sirignano ◽  
Francesco Andreoli ◽  
Wassim Mansour ◽  
Mattia Migliari ◽  
...  

Background Since the introduction of endovascular aortic repair (EVAR) for treatment of abdominal aortic aneurysms (AAAs), progressive improvements in results have been achieved. However, conventional bifurcated stent grafts have been proven to have a nonnegligible risk of failure and secondary intervention, principally due to the lack of adequate proximal sealing. The unique AFX 2 Endovascular AAA System (Endologix, Irvine, CA) unibody device, which provides different sealing and fixation features compared with conventional devices, seems to overcome these limitations. Objective The aim of this study is to evaluate intraoperative, perioperative, and postoperative results in patients treated with the AFX 2 Endovascular AAA System endografts for elective AAA repair in a large cohort of consecutive patients. Methods All eligible EVAR patients will be included in this observational, multicenter, prospective, nonrandomized study. The number of patients to be enrolled is 500. Results The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with unibody endografts in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will also be addressed: operative time, intraoperative radiation exposure, contrast medium usage, AAA sac shrinkage at 12-month and 5-year follow-up, and any potential role of patients’ baseline characteristics and device configuration on primary endpoint. The actual start date of the investigation was November 2019. The final patient is expected to be treated by the end of December 2020, and the estimated study completion date is December 2025. Conclusions This study will provide verified real-world data on AAAs treated by AFX 2 endografts and followed for a long-term interval. International Registered Report Identifier (IRRID) PRR1-10.2196/16959


Author(s):  
Rajesh Vijayvergiya ◽  
Ganesh Kasinadhuni ◽  
Pruthvi C Revaiah ◽  
Anupam Lal ◽  
Ashish Sharma ◽  
...  

Abstract Background Aortobronchial fistula (ABF) formation following the rupture of thoracic pseudoaneurysm is a rare clinical entity. Its aetiology includes atherosclerosis, infections, trauma, post-surgery, and post-endovascular aortic repair. The clinical presentation of ABF includes intermittent or massive haemoptysis, acute respiratory distress, hypotension, and even death. These patients require an emergency aortic intervention to stop active haemorrhage. Thoracic endovascular aortic repair (TEVAR) is a less invasive, safe, and effective treatment compared to conventional open surgical repair Case summary We hereby report three cases of ruptured descending thoracic aortic pseudoaneurysms resulting in a fistula formation. The first two cases had tuberculosis as their underlying aetiology, while the third case was the result of previous open post-aortic surgery. All patients presented with massive haemoptysis and were successfully treated by emergency TEVAR and had favourable outcomes. Discussion Thoracic endovascular aortic repair is a rapid, less invasive, and effective treatment for emergency management of ABF. It has more than 85% technical success rates in the reported literature. We had procedural success in all three cases. The short and midterm outcome of ABF following TEVAR is favourable and encouraging.


2019 ◽  
Author(s):  
Roberto Silingardi ◽  
Pasqualino Sirignano ◽  
Francesco Andreoli ◽  
Wassim Mansour ◽  
Mattia Migliari ◽  
...  

BACKGROUND Since the introduction of endovascular aortic repair (EVAR) for treatment of abdominal aortic aneurysms (AAAs), progressive improvements in results have been achieved. However, conventional bifurcated stent grafts have been proven to have a nonnegligible risk of failure and secondary intervention, principally due to the lack of adequate proximal sealing. The unique AFX 2 Endovascular AAA System (Endologix, Irvine, CA) unibody device, which provides different sealing and fixation features compared with conventional devices, seems to overcome these limitations. OBJECTIVE The aim of this study is to evaluate intraoperative, perioperative, and postoperative results in patients treated with the AFX 2 Endovascular AAA System endografts for elective AAA repair in a large cohort of consecutive patients. METHODS All eligible EVAR patients will be included in this observational, multicenter, prospective, nonrandomized study. The number of patients to be enrolled is 500. RESULTS The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with unibody endografts in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will also be addressed: operative time, intraoperative radiation exposure, contrast medium usage, AAA sac shrinkage at 12-month and 5-year follow-up, and any potential role of patients’ baseline characteristics and device configuration on primary endpoint. The actual start date of the investigation was November 2019. The final patient is expected to be treated by the end of December 2020, and the estimated study completion date is December 2025. CONCLUSIONS This study will provide verified real-world data on AAAs treated by AFX 2 endografts and followed for a long-term interval. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/16959


2020 ◽  
Vol 71 (6) ◽  
pp. 1982-1993.e5 ◽  
Author(s):  
Emanuel R. Tenorio ◽  
Gustavo S. Oderich ◽  
Giuliano A. Sandri ◽  
Pinar Ozbek ◽  
Jussi M. Kärkkäinen ◽  
...  

2015 ◽  
Vol 31 (10) ◽  
pp. S333 ◽  
Author(s):  
K. McLean ◽  
K. Murfitt ◽  
K. McPhail ◽  
M. Boodhwani

2015 ◽  
Vol 63 (S 01) ◽  
Author(s):  
K. Tsagakis ◽  
R. Jánosi ◽  
D. Dohle ◽  
J. Benedik ◽  
P. Kahlert ◽  
...  

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