Fenestrated Aortic Aneurysm Repair in Patients Treated Inside Versus Outside of Instructions for Use

2022 ◽  
pp. 152660282110687
Author(s):  
Jordan R. Stern ◽  
Céline Deslarzes-Dubuis ◽  
Kenneth Tran ◽  
Jason T. Lee
Keyword(s):  
Univariate Analysis ◽  
Aortic Aneurysms ◽  
Neck Length ◽  
Cox Proportional Hazard ◽  
Potential Association ◽  
Contrast Volume ◽  
Instructions For Use ◽  
Aneurysm Repair ◽  
Neck Diameter

Objectives: The aim of this study was to compare outcomes of patients treated with the Cook Zenith Fenestrated (ZFEN) device for juxtarenal aortic aneurysms inside versus outside the IFU. Methods: We retrospectively reviewed our institutional ZFEN database for cases performed between 2012 and 2018, with analysis performed in 2020 in order to report midterm outcomes. The cohort was stratified based on treatment inside (IFU group) and outside (non-IFU group) the IFU for criteria involving the proximal neck: neck length 4 to 14 mm, neck diameter 19 to 31 mm, and neck angulation ≤45°. Patients with thoracoabdominal aneurysms or concurrent chimney grafting were excluded. The primary outcomes in question were mortality, type 1a endoleak, and reintervention. Univariate and multivariate analyses were performed to determine associations between adherence to IFU criteria and outcomes. Results: We identified 100 consecutive patients (19% female, mean age 73.6 years) for inclusion in this analysis. Mean follow-up was 21.6 months. Fifty-four patients (54%) were treated outside the IFU because of inadequate neck length (n=48), enlarged neck diameter (n=10), and/or excessive angulation (n=16). Eighteen patients were outside IFU for two criteria, and one patient was outside IFU for all three. Non-IFU patients were exposed to higher radiation doses (3652 vs 5445 mGy, p=0.008) and contrast volume (76 vs 95 mL, p=0.004). No difference was noted between IFU and non-IFU groups for 30-day mortality (0% vs 3.7%, p=0.18), or type 1a endoleak (0% vs 1.9%, p=0.41). Reintervention was also similar between cohorts (13% vs 27.8%, p=0.13). Being outside IFU for neck diameter or length was each borderline significant for higher reintervention on univariate analysis (p=0.05), but this was not significant on multivariate Cox proportional hazard modeling (HR 1.82 [0.53–6.25]; 2.03 [0.68–7.89]), respectively. No individual IFU deviations were associated with the primary outcomes on multivariate analysis, nor being outside IFU for multiple criteria. Conclusions: Patients with juxtarenal aortic aneurysms may be treated with the ZFEN device with moderate deviations from the IFU. While no differences were seen in mortality or proximal endoleak, larger studies are needed to examine the potential association between IFU nonadherence and reinterventions and close follow-up is warranted for all patients undergoing such repair.

scholarly journals Midterm Results of Proximal Aneurysm Sealing With the Ovation Stent-Graft According to On- vs Off-Label Use

2017 ◽  
Vol 24 (2) ◽  
pp. 191-197 ◽  
Author(s):  
Gianmarco de Donato ◽  
Francesco Setacci ◽  
Luciano Bresadola ◽  
Patrizio Castelli ◽  
Roberto Chiesa ◽  
...  
Keyword(s):  
Stent Graft ◽  
Morphological Changes ◽  
Endovascular Aneurysm Repair ◽  
Neck Length ◽  
Off Label ◽  
Aortic Neck ◽  
Type Ia ◽  
Instructions For Use ◽  
Aneurysm Repair

Purpose: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks <7 mm long. Methods: A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76.4±2.4 years; 84 men) with a mean follow-up of 32 months (range 24–50). Standard CT scans (preoperative, 1-month postoperative, and latest follow-up) were reviewed by an independent core laboratory for morphological changes. For analysis, patients were stratified into 2 groups based on proximal neck length ≥7 mm (IFU group, n=57) or <7 mm (OL group, n=32). Outcome measures included freedom from type Ia endoleak, any device-related reintervention, migration, and neck enlargement (>2 mm). Results: At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was −0.05±0.8 mm in the IFU group and −0.1±0.5 mm in the OL group. Conclusion: Use of the Ovation stent-graft in patients with neck length <7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration–approved changes to the IFU.

scholarly journals Outcomes of Advanta V12 Covered Stents After Fenestrated Endovascular Aneurysm Repair

2021 ◽  
pp. 152660282110164
Author(s):  
Claire van der Riet ◽  
Richte C. L. Schuurmann ◽  
Eric L. G. Verhoeven ◽  
Clark J. Zeebregts ◽  
Ignace F. J. Tielliu ◽  
...  
Keyword(s):  
Endovascular Aneurysm Repair ◽  
Aortic Aneurysms ◽  
Stent Fracture ◽  
Covered Stents ◽  
Significant Stenosis ◽  
Primary Endpoints ◽  
Visceral Arteries ◽  
Aneurysm Repair ◽  
Type 3

Purpose: Fenestrated endovascular aneurysm repair (FEVAR) is a well-established endovascular treatment option for pararenal abdominal aortic aneurysms in which balloon-expandable covered stents (BECS) are used to bridge the fenestration to the target vessels. This study presents midterm clinical outcomes and patency rates of the Advanta V12 BECS used as a bridging stent. Methods: All patients treated with FEVAR with at least 1 Advanta V12 BECS were included from 2 large-volume vascular centers between January 2012 and December 2015. Primary endpoints were freedom from all-cause reintervention, and freedom from BECS-associated complications and reintervention. BECS-associated complications included significant stenosis, occlusion, type 3 endoleak, or stent fracture. Secondary endpoints included all-cause mortality in-hospital and during follow-up. Results: This retrospective study included 194 FEVAR patients with a mean age of 72.2±8.0 years. A total of 457 visceral arteries were stented with an Advanta V12 BECS. Median (interquartile range) follow-up time was 24.6 (1.6, 49.9) months. The FEVAR procedure was technically successful in 93% of the patients. Five patients (3%) died in-hospital. Patient survival was 77% (95% CI 69% to 84%) at 3 years. Freedom from all-cause reintervention was 70% (95% CI 61% to 78%) at 3 years, and 33% of all-cause reinterventions were BECS associated. Complications were seen in 24 of 457 Advanta V12 BECSs: type 3 endoleak in 8 BECSs, significant stenosis in 4 BECSs, occlusion in 6 BECSs, and stent fractures in 3 BECSs. A combination of complications occurred in 3 BECSs: type 3 endoleak and stenosis, stent fracture and stenosis, and stent fracture and occlusion. The freedom from BECS-associated complications for Advanta V12 BECSs was 98% (95% CI 96% to 99%) at 1 year and 92% (95% CI 88% to 95%) at 3 years. The freedom from BECS-associated reinterventions was 98% (95% CI 95% to 100%) at 1 year and 94% (95% CI 91% to 97%) at 3 years. Conclusion: The Advanta V12 BECS used as bridging stent in FEVAR showed low complication and reintervention rates at 3 years. A substantial number of FEVAR patients required a reintervention, but most were not BECS related.

Early Clinical Outcomes of the Active Seal Technology of the AFX Endovascular Aortic Aneurysm System With the VELA Cuff for Patients With a Conical Proximal Neck

2022 ◽  
pp. 152660282110709
Author(s):  
Naoki Fujimura ◽  
Hideaki Obara ◽  
Takaaki Nagano ◽  
Yukihisa Ogawa ◽  
Taira Kobayashi ◽  
...  
Keyword(s):  
Aortic Aneurysm ◽  
Endovascular Aneurysm Repair ◽  
Aortic Aneurysms ◽  
Proximal Neck ◽  
Landing Zone ◽  
The Core ◽  
The Mean ◽  
Instructions For Use ◽  
Lost To Follow Up

Purpose: To evaluate the efficacy of the Active Seal technology employed in the AFX endovascular aortic aneurysm system (AFX), during endovascular aneurysm repair (EVAR) in patients with abdominal aortic aneurysms (AAAs) having a conical proximal neck. Materials and Methods: A retrospective analysis of the EVAR for AAA with a conical proximal neck using the AFX was performed at 17 Japanese hospitals between January 2016 and August 2020. The conical proximal neck was defined as a cone-shaped proximal neck, with more than 10% diameter increase within a 15 mm length at the proximal landing zone. All anatomical analyses were performed in the core laboratory, and cases with parallel walls within the proximal neck adequate for the landing zone were excluded from the study. Results: This study included 53 patients, but only 39 patients (mean age, 76.6 ± 6.7 years; 87.0% males; mean aneurysm diameter, 52.0 ± 8.0 mm) were analyzed after being characterized as having a pure conical neck by the core laboratory. The mean proximal neck diameters at the lower renal artery and proximal edge of the aneurysm were 20.0 ± 2.9 mm and 27.5 ± 4.9 mm, respectively. The mean proximal neck length was 21.5 ± 6.0 mm. Instructions for use violations other than the conical neck were observed in 15 patients (38.5%). The VELA cuff was used in all cases; however, additional proximal cuff was required in 9 more cases (23.1%). The Active Seal technology was able to significantly extend the proximal sealing zone from 21.5 ± 6.0 to 26.0 ± 12.2 mm ( p = .047). Thirty-six patients completed the 12-month follow-up (one patient was lost to follow-up, and 2 patients died from causes unrelated to the aneurysm), and there were no type-1a and 3 endoleaks with only one reintervention (2.6%) related to type 1b endoleak in the 12-month period. Furthermore, there was no significant enlargement of the proximal neck diameter at 12 months (at 1 month: 20.6 ± 3.4 mm and at 12 months: 21.3 ± 3.8 mm; p = .420). Conclusion: The Active Seal technology of the AFX significantly extended the proximal seal zone and no type-1a endoleak and proximal neck dilation was observed in patients with conical proximal neck at 12 months.

Comparing polymer-filled versus self-expanding endografts in Chinese patients

2018 ◽  
Vol 26 (9) ◽  
pp. 667-676
Author(s):  
Yuk Law ◽  
Yiu Che Chan ◽  
Stephen Wing-Keung Cheng
Keyword(s):  
Endovascular Aneurysm Repair ◽  
Aortic Aneurysms ◽  
The Self ◽  
Chinese Patients ◽  
Type Ii ◽  
Mortality And Morbidity ◽  
Type Ia ◽  
One Year ◽  
Aneurysm Repair

Introduction We performed a single-center nonrandomized study on patients who underwent endovascular aneurysm repair using polymer-filled or other self-expanding endografts. Methods Consecutive patients with asymptomatic infrarenal abdominal aortic aneurysms who underwent endovascular repair were retrospectively reviewed. They were divided into a polymer-filled ( n = 20) or self-expanding group ( n = 42). Baseline characteristics, operative mortality and morbidity, and follow-up data were compared. Results Aneurysm diameter, neck and iliac morphologies did not differ between the two groups. Technical success was 100%. The 30-day mortality was 0% and 2.4% in the polymer-filled and self-expanding group, respectively. At a mean follow-up of 17 months, the changes in sac size were −2.1 mm and −5.1 mm ( p = 0.144) at one year, and −3.5 mm and −7.7 mm ( p = 0.287) at 2 years in the polymer-filled and self-expanding group, respectively. The polymer-filled group had 7 (35%) type II endoleaks, and the self-expanding group had 1 (2.4%) type Ia and 13 (31%) type II endoleaks. Neck diameter remained stable in the polymer-filled stent-grafts whereas there was progressive neck degeneration in the self-expanding group. The rates of reintervention and overall survival were similar in both groups. The presence of an endoleak was the only predictor of non-regression of the aneurysm (odds ratio = 17.00, 95% confidence interval: 4.46–64.88, p < 0.001). Conclusion Polymer-filled endografts had similar safety, effectiveness, and durability to other self-expanding endografts. The major advantage is the small iliofemoral access. They also have the potential long-term benefit of a more stable neck.

Anatomical Predictors of Endoleaks or Migration After Endovascular Aneurysm Sealing

2018 ◽  
Vol 25 (6) ◽  
pp. 719-725 ◽  
Author(s):  
Kim van Noort ◽  
Johannes T. Boersen ◽  
Aleksandra C. Zoethout ◽  
Richte C. L. Schuurmann ◽  
Jan M. M. Heyligers ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Large Scale ◽  
High Volume ◽  
Control Group ◽  
Neck Length ◽  
Aortic Neck ◽  
Distal Migration ◽  
Aneurysm Growth ◽  
Instructions For Use ◽  
Neck Diameter

Purpose: To identify preoperative anatomical aortic characteristics that predict seal failures after endovascular aneurysm sealing (EVAS) and compare the incidence of events experienced by patients treated within vs outside the instructions for use (IFU). Methods: Of 355 patients treated with the Nellix EndoVascular Aneurysm Sealing System (generation 3SQ+) at 3 high-volume centers from March 2013 to December 2015, 94 patients were excluded, leaving 261 patients (mean age 76±8 years; 229 men) for regression analysis. Of these, 83 (31.8%) suffered one or more of the following events: distal migration ⩾5 mm of one or both stent frames, any endoleak, and/or aneurysm growth >5 mm. Anatomical characteristics were determined on preoperative computed tomography (CT) scans. Patients were divided into 3 groups: treated within the original IFU (n=166), outside the original IFU (n=95), and within the 2016 revised IFU (n=46). Categorical data are presented as the median (interquartile range Q1, Q3). Results: Neck diameter was significantly larger in the any-event cohort vs the control cohort [23.7 mm (21.7, 26.3) vs 23.0 mm (20.9, 25.2) mm, p=0.022]. Neck length was significantly shorter in the any-event cohort [15.0 mm (10.0, 22.5) vs 19.0 mm (10.0, 21.8), p=0.006]. Maximum abdominal aortic aneurysm (AAA) diameter and the ratio between the maximum AAA diameter and lumen diameter in the any-event group were significantly larger than the control group (p=0.041 and p=0.002, respectively). Regression analysis showed aortic neck diameter (p=0.006), neck length (p=0.001), and the diameter ratio (p=0.011) as significant predictors of any event. In the comparison of events to IFU status, 52 (31.3%) of 166 patients in the inside the original IFU group suffered an event compared to 13 (28.3%) of 46 patients inside the 2016 IFU group (p=0.690). Conclusion: Large neck diameter, short aortic neck length, and the ratio between the maximum AAA and lumen diameters are preoperative anatomical predictors of the occurrence of migration (⩾5 mm), any endoleak, and/or aneurysm growth (>5 mm) after EVAS. Even under the refined 2016 IFU, more than a quarter of patients suffered from an event. Improvements in the device seem to be necessary before this technique can be implemented on a large scale in endovascular AAA repair.

Endovascular Aneurysm Sealing (EVAS) and Chimney EVAS in the Treatment of Failed Endovascular Aneurysm Repairs

2016 ◽  
Vol 24 (1) ◽  
pp. 115-120 ◽  
Author(s):  
Marwan Youssef ◽  
Sebastian Zerwes ◽  
Rudolf Jakob ◽  
Oroa Salem ◽  
Fritz Dünschede ◽  
...  
Keyword(s):  
Endovascular Aneurysm Repair ◽  
Multiple Organ ◽  
Aortic Aneurysms ◽  
Technical Success ◽  
Graft Thrombosis ◽  
Type Ia ◽  
Aneurysm Repair ◽  
Chimney Graft ◽  
Bifurcated Graft

Purpose: To assess the technical success and clinical outcome of reinterventions using the Nellix Endovascular Aneurysm Sealing (EVAS) System to treat complications after endovascular aneurysm repair (EVAR). Methods: Fifteen consecutive patients (mean age 79 years; 14 men) with prior EVAR were treated with EVAS between March 2014 and December 2015 at 2 institutions. The failed prior EVARs included 13 bifurcated endografts, 1 bifurcated graft plus fenestrated cuff, and 1 tube endograft. Endoleaks were the predominant indications: type Ia in 10 and type III in 5 (3 type IIIa and 2 type IIIb). All patients presented with progressive aortic aneurysms (median 7.85-cm diameter; range 6.5–11). Eight patients were treated on an urgent or emergency basis (6 symptomatic aneurysms and 2 contained ruptures). All patients underwent Nellix relining of the failed stent-graft; 10 had chimney (Ch) procedures in combination with EVAS (chEVAS) because the proximal landing zones were inadequate. Results: Technical success was 100%. All endoleaks were successfully sealed, and no additional intervention was required. No further endoleak after EVAS or chEVAS was recorded. Endobag protrusion occurred in 1 case without sequelae. One elderly patient with ruptured aneurysm died from multiple organ failure 2 months postoperatively. One renal artery guidewire injury led to nephrectomy because of active bleeding. No reinterventions, aneurysm-related mortalities, graft thrombosis, endoleaks, or chimney graft occlusions were observed during a median follow-up of 8 months (range 3–24). Conclusion: The present preliminary experience demonstrates that the use of EVAS/chEVAS is feasible for treatment of failed EVAR. This technique may be used as bailout or an alternative treatment when other established methods are infeasible or not available.

scholarly journals Maximum Diameter Measurements of Aortic Aneurysms on Axial CT Images After Endovascular Aneurysm Repair: Sufficient for Follow-up?

2010 ◽  
Vol 34 (6) ◽  
pp. 1182-1189 ◽  
Author(s):  
Stephan Baumueller ◽  
Thi Dan Linh Nguyen ◽  
Robert Paul Goetti ◽  
Mario Lachat ◽  
Burkhardt Seifert ◽  
...  
Keyword(s):  
Endovascular Aneurysm Repair ◽  
Ct Images ◽  
Aortic Aneurysms ◽  
Maximum Diameter ◽  
Axial Ct ◽  
Aneurysm Repair

scholarly journals Endovascular repair of thoraco-abdominal aortic aneurysms by fenestrated and branched endografts†

2019 ◽  
Vol 56 (5) ◽  
pp. 993-1000 ◽  
Author(s):  
Enrico Gallitto ◽  
Gianluca Faggioli ◽  
Rodolfo Pini ◽  
Chiara Mascoli ◽  
Stefano Ancetti ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Hospital Mortality ◽  
Endovascular Repair ◽  
Endovascular Aneurysm Repair ◽  
Abdominal Aortic Aneurysms ◽  
Aortic Aneurysms ◽  
Abdominal Aortic ◽  
The Mean ◽  
Aneurysm Repair

Abstract OBJECTIVES Our objective was to report the outcomes of fenestrated/branched endovascular aneurysm repair of thoraco-abdominal aortic aneurysms (TAAAs) with endografts. METHODS Between January 2010 and April 2018, patients with TAAAs, considered at high surgical risk for open surgery and treated by Cook-Zenith fenestrated/branched endovascular aneurysm repair, were prospectively enrolled and retrospectively analysed. The early end points were 30-day/hospital mortality rate, spinal cord ischaemia and 30-day cardiopulmonary and nephrological morbidity. Follow-up end points were survival, patency of target visceral vessels and freedom from reinterventions. RESULTS Eighty-eight patients (male: 77%; mean age: 73 ± 7 years; American Society of Anesthesiologists 3/4: 58/42%) were enrolled. Using Crawford’s classification, 43 (49%) were types I–III and 45 (51%) were type IV TAAAs. The mean aneurysm diameter was 65 ± 15 mm. Custom-made and off-the-shelf endografts were used in 60 (68%) and 28 (32%) cases, respectively. Five (6%) patients had a contained ruptured TAAA. The procedure was performed in multiple steps in 42 (48%) cases. There was 1 (1%) intraoperative death. Five (6%) patients suffered spinal cord ischaemia with permanent paraplegia in 3 (3%) cases. Postoperative cardiac and pulmonary complications occurred in 7 (8%) and 12 (14%) patients, respectively. Worsening of renal function (≥30% of baseline level) was detected in 11 (13%) cases, and 2 (2%) patients required haemodialysis. The 30-day and hospital mortality rates were 5% and 8%, respectively. The mean follow-up was 36 ± 22 months. Survival at 12, 24 and 36 months was 89%, 75% and 70%, respectively. The patency of target visceral vessels at 12, 24 and 36 months was 92%, 92% and 92%, respectively. Freedom from reinterventions at 12, 24 and 36 months was 85%, 85% and 83%, respectively. CONCLUSIONS The endovascular repair of TAAAs with fenestrated/branched endovascular aneurysm repair is feasible and effective with acceptable technical/clinical outcomes at early/midterm follow-up.

Endovascular abdominal aortic aneurysm repair in patients with Marfan syndrome

Vascular ◽  
2019 ◽  
Vol 28 (1) ◽  
pp. 48-52
Author(s):  
Allan Marc Conway ◽  
Khalil Qato ◽  
Gautam Anand ◽  
Laurie Mondry ◽  
Gary Giangola ◽  
...  
Keyword(s):  
Marfan Syndrome ◽  
Open Repair ◽  
Aortic Surgery ◽  
Endovascular Aneurysm Repair ◽  
Aortic Aneurysms ◽  
Type I ◽  
Femoral Access ◽  
Abdominal Aortic ◽  
Aneurysm Repair

Objectives Marfan syndrome patients are at risk for aortic degeneration. Repair is traditionally performed with open surgery as this is deemed more durable. Endovascular aneurysm repair remains controversial. We report on the outcomes of Marfan syndrome patients with abdominal aortic aneurysms undergoing endovascular aneurysm repair. Methods The Vascular Quality Initiative registry identified 35,889 patients, including 29 with Marfan syndrome, treated with endovascular aneurysm repair from January 2003 to December 2017. Outcomes were analyzed per the Society for Vascular Surgery reporting standards. Results Median age was 70.0 years (IQR, 57.0–75.0), and 22 (75.9%) were male. Median aneurysm diameter was 5.3 cm (IQR, 4.9–6.3 cm), with an aortic neck length and diameter of 2.0 cm (IQR, 1.6–2.8 cm) and 2.5 cm (IQR, 2.2–2.8 cm), respectively. Twenty-one (72.4%) patients were asymptomatic, seven (24.1%) symptomatic, and one (3.4%) presented with rupture. Ten (34.5%) patients had prior aortic surgery. Six (20.7%) were unfit for open surgical repair. Length of stay was 2.0 days (IQR, 1.0–3.0 days). Percutaneous femoral access was performed in 15 (51.7%) patients with no complications. A type IA endoleak was present in one (3.4%), type IB in one (3.4%), and type II endoleak in two (6.9%) patients. There were no postoperative pulmonary, cardiac, or neurological complications. In-hospital mortality occurred in one (3.4%) patient who presented with a rupture and had been deemed unfit for open repair. A conversion to open repair was required. The patient expired on post-operative day 0. Early clinical success was achieved in 26 (89.7%) patients. Follow-up was available for 15 (51.7%) patients at a median time of 766 days (IQR, 653–937). There were no reinterventions or mortalities. Change in sac diameter was −0.6 cm (IQR, −1.1 to −0.2 cm), with no type I or III endoleaks. Discussion Endovascular aneurysm repair for patients with Marfan syndrome is feasible, and can be performed safely. Mid-term outcomes suggest this technique is durable. More robust long-term follow-up is needed.

Outcomes of endosutured aneurysm repair with the Heli-FX EndoAnchor implants

Vascular ◽  
2020 ◽  
Vol 28 (5) ◽  
pp. 568-576
Author(s):  
Georgios Karaolanis ◽  
Constantine N Antonopoulos ◽  
Stylianos Koutsias ◽  
George A Antoniou ◽  
Efthymios Beropoulis ◽  
...  
Keyword(s):  
Therapeutic Option ◽  
Meta Analysis ◽  
Endovascular Aneurysm Repair ◽  
Pooled Analysis ◽  
Aortic Aneurysms ◽  
Technical Success ◽  
Hostile Neck ◽  
Type Ia ◽  
Aneurysm Repair

Objective Endovascular aneurysm repair has gained field over open surgery for the treatment of abdominal aortic aneurysm. However, type Ia endoleak represents a common complication especially in hostile neck anatomy that is recently faced using endoanchors. We conducted a systematic review and meta-analysis to collect and analyse all the available comparative evidence on the outcomes of the endosuture aneurysm repair in patients with or without hostile neck in standard endovascular aneurysm repair. Methods The current meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All the prospective and retrospective studies reporting primary use of the Heli-FX EndoAnchor implants were considered eligible for inclusion in this study. The main study outcomes (technical success of endoanchor implantation, incidence of type Ia endoleak, aortic stent graft migration and the percentage of patients who presented regression or expansion of aneurysm sac throughout the follow-up) were subsequently expressed as proportions and 95% confidence intervals. Results Eight studies with a total of 968 patients were included in a pooled analysis. The technical success of the primary endoanchor fixation was 97.12% (95%CI: 92.98–99.67). During a mean six months follow-up period, a pooled rate of 6.23% (95%CI: 0.83–15.25) of the patients developed a persistent type Ia endoleak despite the primary implantation. Migration of the main graft was reported in five studies, in which a 0.26% (95%CI = 0.00–1.54) of the patients required an additional proximal aortic cuff. Regression of the aneurysm sac was observed at 68.82% (95%CI: 51.02–84.21). An expansion of the aneurysm sac was found in 1.93% (95%CI: 0.91–3.24) of the participants. The overall survival rate was 93.43% (95%CI: 89.97–96.29) at a mean six months follow-up period. Conclusions Endosuture aneurysm repair with the Heli-FX EndoAnchor implants seems to be technically feasible and safe either for prevention or for repair of intraoperative type Ia endoleak. Despite the primary implants of endoanchors, few cases of persistent type Ia endoleak and migration are still conspicuous. Long-term follow up is needed to determinate the role of this therapeutic option in the treatment of aortic aneurysms.

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