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

10.2196/16959 ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. e16959
Author(s):  
Roberto Silingardi ◽  
Pasqualino Sirignano ◽  
Francesco Andreoli ◽  
Wassim Mansour ◽  
Mattia Migliari ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Clinical Success ◽  
Aortic Aneurysms ◽  
Endovascular Aortic Repair ◽  
Intraoperative Radiation ◽  
Nonrandomized Study ◽  
Aortic Repair ◽  
Number Of Patients

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

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

2019 ◽  
Author(s):  
Roberto Silingardi ◽  
Pasqualino Sirignano ◽  
Francesco Andreoli ◽  
Wassim Mansour ◽  
Mattia Migliari ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Clinical Success ◽  
Aortic Aneurysms ◽  
Endovascular Aortic Repair ◽  
Intraoperative Radiation ◽  
Nonrandomized Study ◽  
Aortic Repair ◽  
Number Of Patients

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

Outcomes of open and endovascular repair of inflammatory abdominal aortic aneurysms

Vascular ◽  
2017 ◽  
Vol 26 (2) ◽  
pp. 203-208 ◽  
Author(s):  
África Duque Santos ◽  
Andrés Reyes Valdivia ◽  
María Asunción Romero Lozano ◽  
Enrique Aracil Sanus ◽  
Julia Ocaña Guaita ◽  
...  
Keyword(s):  
Open Surgery ◽  
Aortic Aneurysms ◽  
Endovascular Aortic Repair ◽  
Abdominal Aneurysm ◽  
Aortic Abdominal Aneurysm ◽  
Aortic Repair ◽  
Number Of Patients ◽  
Repair Group

Objective Reports on inflammatory aortic abdominal aneurysm treatment are scarce. Traditionally, open surgery has been validated as the gold standard of treatment; however, high technical skills are required. Endovascular aortic repair has been suggested as a less invasive treatment by some authors offering good results. The purpose of our study was to report our experience and outcomes in the treatment of inflammatory aortic abdominal aneurysm using both approaches. Material and methods A retrospective review and data collection of all patients treated for inflammatory aortic abdominal aneurysm between 2000 and 2015 was done in one academic center. Diagnosis of inflammatory aortic abdominal aneurysm was based on preoperative CT-scan imaging. Type of treatment, postoperative and long-term morbidity and mortality are described. Abdominal compressive symptoms (hydronephrosis) severity and relief after treatment are described. Results Thirty-four patients with intact inflammatory aortic abdominal aneurysm were included. Twenty-nine (85.3%) patients were treated by open means and the remaining five (14.7%) with endovascular aortic repair. Nearly 90% were considered high-risk patients. Median follow-up was 46 months (range 24–112). The two groups were comparable, except for the age and preoperative hydronephrosis. There was no statistical significance in blood transfusion requirements, intensive care hospitalization, 30-day and long-term mortality between the two groups. Preoperative hydronephrosis was diagnosed in four (13.8%) patients in the open surgery group and three (60%) patients in the endovascular aortic repair group. Improvement of hydronephrosis was recognized in three out of the four patients in the open repair group and two out of the three in the endovascular aortic repair group. Renal function remained stable in both groups during follow-up. Conclusions Open surgery remains a safe and valid option for the treatment of inflammatory aortic abdominal aneurysm. Although our study included a small number of patients with endovascular aortic repair treatment, results are promising. Further randomized controlled studies may be necessary to assess long-term effectiveness of endovascular aortic repair treatment in this disease.

scholarly journals Tocilizumab in treatment-naïve patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labeled trial

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Arsene Mekinian ◽  
◽  
David Saadoun ◽  
Eric Vicaut ◽  
Sara Thietart ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Disease Activity ◽  
Primary Endpoint ◽  
Takayasu Arteritis ◽  
Number Of Patients ◽  
Treatment Naïve ◽  
Secondary Endpoints ◽  
Steroid Sparing

Abstract Objectives To assess long-term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK). Methods Prospective open-labeled trial in naïve patients with TAK who received steroids at the dose of 0.7 mg/kg/day and 7 infusions of 8 mg/kg/month of tocilizumab. The primary endpoint was the number of patients who discontinued steroids after 7 infusions of tocilizumab. Secondary endpoints included disease activity and the number of relapses during 18-month follow-up. Results Thirteen patients with TAK were included, with a median age of 32 years [19–45] and 12 (92%) females. Six (54%) patients met the primary end-point. A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3, 4] at baseline, versus 1 [0–2] after 6 months; p < 0.001), ITAS-2010 score (5 [2–7] versus 3 [0–8]; p = 0.002), and ITAS-A score (7 [4–10] versus 4 [1–15]; p = 0.0001)]. During the 12-month follow-up after tocilizumab discontinuation, a relapse occurred among 5 patients (45%) out of 11 in which achieved remission after 6 months of tocilizumab. Conclusion Tocilizumab seems an effective steroid sparing therapy in TAK, but maintenance therapy is necessary. Trial registration ClinicalTrials.gov NCT02101333. Registered on 02 April 2014.

scholarly journals Improved outcomes from endovascular aortic repair in younger patients: Towards improved risk stratification

Vascular ◽  
2019 ◽  
Vol 27 (6) ◽  
pp. 573-581 ◽  
Author(s):  
Wan Chin Hsieh ◽  
Chung Dann Kan ◽  
Chong Chao Hsieh ◽  
Mohamed Omara ◽  
Brandon Michael Henry ◽  
...  
Keyword(s):  
Open Repair ◽  
Abdominal Aortic Aneurysms ◽  
Aortic Aneurysms ◽  
Endovascular Aortic Repair ◽  
Younger Patients ◽  
Aortic Repair ◽  
Abdominal Aortic ◽  
Short And Long Term ◽  
Long Term Mortality

Objectives Abdominal aortic aneurysms are conventionally treated by open repair surgery. While endovascular aortic repair improves survival in high-risk patients, younger patients (40–65 years) potentially at lower risk with asymptomatic abdominal aortic aneurysms undergoing endovascular aortic repair usually have poorer post-operative outcomes and require longer term follow-up. In this study, clinical data on younger patients were analyzed to investigate whether endovascular aortic repair leads to poorer short- and long-term outcomes. Methods This was a systematic review and meta-analysis of articles comparing clinical outcomes in patients aged 40–65 years undergoing open repair or endovascular aortic repair and published between 2000 and 2017. In-hospital mortality, long-term mortality, and post-operative complication data were retrieved from eligible studies and clinical outcomes were compared. Twenty-one retrospective cohort analyses were included, accounting for 250,837 patients (149,051 endovascular aortic repair; 101,786 open repair). Risk ratios were pooled using the DerSimonian and Laird random effects model. All statistical analyses were performed in Review Manager 5.3. Results Younger patients with asymptomatic abdominal aortic aneurysms undergoing endovascular aortic repair had a significantly reduced 30-day mortality (odds ratio (OR) = 0.40, 95% confidence intervals (CI) 0.28–0.57; p < 0.00001), long-term mortality (OR = 0.37, 95% CI 0.17–0.82; p = 0.01), incidence of reintervention (OR = 0.47, 95% CI 0.34–0.66; p < 0.0001), and incidence of renal failure (OR = 1.58, 95% CI 1.37–1.82; p < 0.00001). Conclusions Endovascular aortic repair may improve short- and long-term survival and reduce post-operative complications in younger patients with asymptomatic abdominal aortic aneurysms.

Preoperative proteinuria and clinical outcomes in type B aortic dissection after thoracic endovascular aortic repair

2019 ◽  
Vol 57 (5) ◽  
pp. 752-758
Author(s):  
Hongwei Yang ◽  
Jianwei Zhou ◽  
Keli Huang ◽  
Tao Yu ◽  
Zuhui Wang ◽  
...  
Keyword(s):  
Aortic Dissection ◽  
Clinical Outcomes ◽  
Multivariate Logistic Regression Analysis ◽  
Thoracic Endovascular Aortic Repair ◽  
Endovascular Aortic Repair ◽  
Type B ◽  
Urine Dipstick ◽  
Aortic Repair

Abstract Background Proteinuria is a marker of poor outcomes in several diseases; however, few studies have been conducted to explore the prognostic value of proteinuria, assessed by urine dipstick test, for clinical outcomes in patients with type B acute aortic dissection (TBAD) undergoing thoracic endovascular aortic repair (TEVAR). Methods Consecutive patients with TBAD undergoing TEVAR were enrolled from January 2010 to July 2015. Proteinuria was defined as trace or higher, according to the results of urine dipstick testing. Associations among proteinuria and adverse events were evaluated. Results In total, 671 patients with a mean age of 44±15 years were included in the analysis. Proteinuria was detected in 281 patients (41.9%) before TEVAR. Multivariate logistic regression analysis showed that C-reactive protein and impaired renal function were independent predictors for proteinuria. During hospitalization, 21 patients died. In-hospital mortality was higher in patients with proteinuria (1.5% vs. 5.3%, p=0.005). After a median 3.4 years follow up, the post-TEVAR death rate was 10.4% (85 patients were lost to follow-up). The long-term cumulative mortality was significantly higher in patients with proteinuria (17.2% vs. 8.2%, log-rank=11.36, p=0.001). Multivariate Cox survival modeling indicated that proteinuria was significantly associated with long-term death, after adjustment for potential confounding risk factors (HR=1.92, p=0.012). Conclusions Pre-TEVAR proteinuria was identified as a prognostic marker in patients with TBAD and has potential for application as a convenient and simple risk assessment method before TEVAR.

scholarly journals Importance of Follow-up Imaging in the Detection of Delayed Type 2 Endoleaks Despite Complete Aneurysmal Sac Shrinkage

2019 ◽  
Vol 2 (1) ◽  
pp. 53-55
Author(s):  
Gergana T Taneva ◽  
Omid Shafe ◽  
Giovanni B Torsello ◽  
Arne Schwindt ◽  
Jamal Moosavi ◽  
...  
Keyword(s):  
Endovascular Aortic Repair ◽  
The Other ◽  
Small Subset ◽  
Delayed Onset ◽  
Aortic Repair ◽  
Type 2 Endoleak ◽  
New Onset

Type 2 endoleaks usually constitute a benign and self-limited phenomenon, which rarely leads to aneurysmal sac expansion. However, in a small subset of patients, a persistent type 2 endoleak might pressurise the aneurysmal sac causing expansion. The authors present two cases with delayed new-onset type 2 endoleak. One occurred after standard endovascular aortic repair and the other after chimney endovascular aortic repair, causing expansion of the aneurysmal sac after a period of complete aneurysmal sac shrinkage. Accordingly, there is a risk of sac re-expansion due to delayed onset endoleaks, independent of the technique, justifying the need for a continuous follow-up despite long-term aneurysmal sac shrinkage.

scholarly journals In-hospital and mid-term outcome after complex endovascular aortic repair with fenestrated and branched stent-grafts

2021 ◽  
Vol 108 (Supplement_4) ◽  
Author(s):  
V Makaloski ◽  
D Broger ◽  
S Weiss ◽  
S Jungi ◽  
D Becker ◽  
...  
Keyword(s):  
Stent Graft ◽  
Renal Arteries ◽  
Aortic Aneurysms ◽  
Endovascular Aortic Repair ◽  
Mesenteric Arteries ◽  
Hospital Death ◽  
Stent Grafts ◽  
Term Outcome ◽  
Aortic Repair

Abstract Objective The aim of the study is to evaluate in-hospital and mid-term outcome after complex endovascular aortic repair with fenestrated and branched stent-grafts (fEVAR / bEVAR). Methods This is a single-center retrospective analysis from a prospectively collected database of all patients treated electively with fEVAR or bEVAR for para/suprarenal (PAA) and thoraco-abdominal aortic aneurysm (TAAA) between September 2010 and June 2019. In-hospital and mid-term mortality, major adverse events and re-interventions were assessed. Results Fifty-one patient (84% male) with a mean age of 74±7 years were analysed. Eighteen patients (35%) had TAAA, four patients (8%) suprarenal, and 29 patients (57%) pararenal aortic aneurysms. Mean aneurysm diameter was 64±8 mm. Thirty-eight patients (75%) underwent fEVAR and 13 patients (25%) bEVAR. A total of 157 target vessels were incorporated: 22 celiac trunks (CT), 40 superior mesenteric arteries (SMA), 92 renal arteries (RA), two separate hepatic arteries and one splenic artery. No in-hospital death or stroke was recorded. One patient suffered from early postoperative paraplegia and did not recover and one had paraparesis after 38 days and recovered completely. Six patients (12%) with patent renal arteries experienced acute postoperative kidney injury; one required temporary dialysis. Five in-hospital re-interventions were stent-graft related (four bridging stents angioplasty and one iliac leg extension) and seven re-interventions were not stent-graft related. Mean follow-up was 19±17 months. Eleven patients (22%) died during follow-up: nine were not aortic-related and two were unknown. The Kaplan-Meier estimated survival rates at 1 and 2 years were 81% and 77%, respectively. Five renal stents (5%, 5/92) occluded during follow-up: three were successfully recanalized and two remained occluded. Ten stents (three CT, five SMA, and two RA stents required relining after 13±16 months postoperatively, resulting with estimated primary assisted patency at 2 years of 100%, 100%, 93%, and 95% for the CT, SMA, right RA and left RA, respectively. Conclusion Complex endovascular aortic repair with fEVAR / bEVAR for PAA and TAAA is safe with very low early mortality and morbidity. In-stent stenosis/occlusions occurred within the first two years. However, primary assisted patency was high. A surveillance program to detect potential stent-graft related complications is mandatory.

Contrast-Enhanced Ultrasound in the Follow-Up of Endoleaks after Endovascular Aortic Repair (EVAR)

2017 ◽  
Vol 38 (03) ◽  
pp. 244-264 ◽  
Author(s):  
Johannes Rübenthaler ◽  
Hanna Zimmermann ◽  
Marco Armbruster ◽  
Katharina Müller-Peltzer ◽  
Florian Bogner ◽  
...  
Keyword(s):  
Ionizing Radiation ◽  
Imaging Modality ◽  
Cost Effective ◽  
Aortic Aneurysms ◽  
Endovascular Aortic Repair ◽  
Contrast Enhanced Ultrasound ◽  
Perioperative Morbidity ◽  
Aortic Repair ◽  
Contrast Enhanced

AbstractEndovascular aortic repair (EVAR) has become established in the treatment of abdominal aortic aneurysms and shows potential benefits such as a low perioperative morbidity and a short hospitalization duration. The follow-up after EVAR primarily consists of lifelong postinterventional imaging of the aneurysm size in order to detect complications such as endoleaks or stent dislocation. Computed tomography angiography, an imaging modality that uses ionizing radiation and that relies on a contrast medium which is dependent on thyroid and renal function, is widely used for follow-up. Meanwhile, contrast-enhanced ultrasound (CEUS) has been established as a viable, fast and cost-effective imaging alternative for the follow-up and the detection of endoleaks after EVAR with the additional benefit of being a real-time non-ionizing radiation examination and having comparable or even superior diagnostic performance. This review describes the use of CEUS for follow-up after EVAR and describes the most common pathologies.

Endovascular treatment of proximal para-anastomotic aneurysms after previous surgical repair of infrarenal aortic aneurysms by the chimney technique

Vascular ◽  
2018 ◽  
Vol 27 (1) ◽  
pp. 3-7
Author(s):  
Georgios I Karaolanis ◽  
Marco Damiano Pipitone ◽  
Giovanni Torsello ◽  
Martin Austermann ◽  
Konstantinos P Donas
Keyword(s):  
Endovascular Repair ◽  
Open Repair ◽  
Abdominal Aortic Aneurysms ◽  
Aortic Aneurysms ◽  
Endovascular Aortic Repair ◽  
Short Neck ◽  
Aortic Repair ◽  
Aortic Neck ◽  
Abdominal Aortic

Objectives To evaluate the use of chimney grafts in the treatment of para-anastomotic aneurysms after previous abdominal aortic aneurysms open repair with short neck. Methods A retrospective analysis of prospectively collected data of consecutive patients who underwent endovascular repair for proximal aortic para-anastomotic aneurysms following previous open repair for infrarenal abdominal aortic aneurysms was performed. All included patients had a short infrarenal aortic neck (<10 mm) excluding standard endovascular aortic repair. Five patients were symptomatic at the admission needed urgent treatment. Results Twelve patients with para-anastomotic aneurysms underwent placement of chimney grafts. The median time between the original operations to redo endovascular procedure was 11 years (interquartile range, 9.5 years). The mean infrarenal length was 4.3 mm (1–9 mm). A total of 28 chimneys grafts were deployed for the 12 patients. The technical success rate was 91.7%. At a median radiologic follow-up of 16 months (2.0–29.4, 95% confidence interval), one patient died, while two late endoleaks and two reinterventions at one and three years for type Ia endoleak were performed by proximal extension and triple chimney graft placement. Conclusion The results of the present study show that ch-endovascular aortic repair is a safe technique for patients who suffered from proximal para-anastomotic aneurysms and having short neck unsuitable for standard endovascular repair. Longer follow up warranted to evaluate the durability of ch-endovascular aortic repair for this specific indication.

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