A Greek Multicentre Study Assessing the Outcome of Late Rupture After Endovascular Abdominal Aortic Aneurysm Repair.

OBJECTIVE: Late rupture after endovascular aortic aneurysm repair (EVAR) for an abdominal aortic aneurysm (AAA) is an increasing complication associated with a high mortality rate. This study aimed to analyse the causes and outcomes in patients with AAA rupture after EVAR. METHODS: A multi-institutional Greek study of late ruptures after EVAR between 2008 - 2022 was performed. Primary outcomes were intra-operative and in hospital death. RESULTS: A total of 70 patients presented with late rupture after EVAR (proportion of ruptured EVARs among all EVARs, 0.6%; 69 males; mean age 77.2 ± 6.7 years). The mean time interval between EVAR and late rupture was 72.3 months (range 6 - 180 months). In all cases the cause of rupture was the presence of an endoleak (type I, 73%) with sac enlargement. Moreover, 34% of subjects with rupture after EVAR had been lost to follow up and 32% underwent a secondary intervention. Additionally, 57 patients (81%) were treated by conversion to open surgical repair (COSR) and the remainder by endovascular correction of endoleak (ECE). Eleven intra-operative deaths (16%) were recorded. The overall in hospital mortality rate was 41% (23% ECE vs. 46% COSR; p = .21). Of the patients who presented as initially haemodynamically stable, 23% died during hospitalisation, while the respective mortality rate for patients who presented as unstable was 78% (odds ratio [OR] 11.8, 95% confidence interval [CI] 3.6 - 39.1; p < .001). Multivariable logistic regression analysis revealed that severity of haemodynamic shock was the most significant risk factor for intra-operative (OR 7.15, 95% CI 1.58 - 32.40; p = .010) and in hospital death (OR 9.53, 95% CI 2.79 - 32.58; p < .001). CONCLUSION: These data underline the devastating prognosis of late rupture after EVAR. Haemodynamic status at presentation was an important predictive factor for death both in the ECE and COSR groups. Rigorous follow up and prompt evaluation of an unstable patient in case of rupture after EVAR is recommended.

Prospective Multicentre Cohort Study of Fenestrated and Branched Endografts After Failed Endovascular Infrarenal Aortic Aneurysm Repair with Type Ia Endoleak.

OBJECTIVE: Failed endovascular infrarenal aortic aneurysm repair (EVAR) due to development of late type Ia endoleak exposes patients to the risk of rupture and should be treated. The purpose of this study was to evaluate the results of fenestrated/branched EVAR (F/BEVAR) for treatment of failed EVAR with type Ia endoleak. METHODS: From January 2010 to December 2019, a prospective multicentre study was conducted (ClinicalTrials.gov identifier: NCT04532450) that included 85 consecutive patients who had undergone F/BEVAR to treat a type Ia endoleak following EVAR. The primary outcome was overall freedom from any re-intervention or death related to the F/BEVAR procedure. RESULTS: In 30 cases (35%) EVAR was associated with a short < 10 mm or angulated (> 60°) infrarenal aortic neck, poor placement of the initial stent graft (n = 3, 4%), sizing error (n = 2, 2%), and/or stent graft migration (n = 7, 8%). Type Ia endoleak was observed after a period of 59 ± 25 months following EVAR. The authors performed 82 FEVAR (96%) and three BEVAR (4%) procedures with revascularisation of 305 target arteries. Overall technical success was 94%, with three failures including one persistent Type Ia endoleak and two unsuccessful stent graft implantations. Intra-operative target artery revascularisation was successful in 303 of 305 attempts. The in hospital mortality rate was 5%. Cardiac, renal and pulmonary complications occurred in 6%, 14%, and 7% of patients, respectively. Post-operative spinal cord ischaemia occurred in four patients (4.7%). At three years, the survival rate was 64% with overall freedom from any re-intervention or aneurysm related death of 40%, and freedom from specific F/BEVAR re-intervention of 73%. At three years, the secondary patency rate of the target visceral arteries was 96%. During follow up, 27 patients (33%) required a revision procedure of the fenestrated (n = 11) or index EVAR stent graft (n = 16), including six open conversions. CONCLUSION: While manufactured F/BEVAR was effective in treating type Ia endoleak in patients with failed EVAR, it was at the cost of a number of secondary endovascular and open surgical procedures.

Systematic review of embolization of type I endoleaks using liquid embolic agents.

OBJECTIVE: The long-term success of endovascular aneurysm repair (EVAR) is limited by complications, most importantly endoleaks. In case of (persistent) type I endoleak (T1EL), secondary intervention is indicated to prevent secondary aneurysm rupture. Different treatment options are suggested for T1ELs, such as endo anchors, (fenestrated) cuffs, embolization, or open conversion. Currently, the treatment of T1EL with liquid embolic agents is available; however, results are not yet addressed. This review presents the safety and efficacy of embolization with liquid embolic agents for treatment of T1ELs after EVAR. METHODS: A systematic literature search was performed for all studies reporting the use of liquid embolic agents as monotherapy for treatment of T1ELs after EVAR. Patient numbers, technical success (successful delivery of liquid embolics in the T1EL) and clinical success (absence of aneurysm related death, endoleak recurrence or additional interventions during follow-up) were examined. RESULTS: Of 1604 articles, 10 studies met the selection criteria, including 194 patients treated with liquid embolics; 73.2% of the patients were male with a median age of 71 years. The overall technical success was 97.9%. Clinical success was 87.6%. Because the median follow-up was only 13.0 months (range, 1-89 months), data on long-term success are almost absent. Four cases (2.1%) of secondary aneurysm rupture after embolization owing to endoleak recurrence were reported. All ruptures occurred in aneurysms exceeding initial treatment diameter of 70 mm. CONCLUSIONS: Initial technical success after liquid embolization for T1EL is high, although long-term clinical success rates are lacking. Within this review, the risk of secondary rupture is comparable with untreated T1EL at 2% with a median follow-up of 13 months, regardless of the initial success of embolization. In general, no decrease in secondary aneurysm rupture after embolization of T1EL after EVAR is demonstrated, although the results of late embolization are debated.

Aortic endograft sizing and endoleak, reintervention, and mortality following endovascular aneurysm repair.

OBJECTIVE: Endograft sizing for endovascular abdominal aortic aneurysm repair (EVAR) is not consistent despite published instructions for use (IFU). We sought to identify factors associated with over/undersizing, determine sex influence on sizing, and examine sizing effects on endoleak, reintervention, and mortality by analyzing data obtained from the W.L. Gore & Associates Global Registry for Endovascular Aortic Treatment (GREAT). METHODS: All patients enrolled in GREAT undergoing EVAR were included for analysis. Proximal/distal aortic landing zones were compared with device implanted to assess sizing as related to IFU. χ2/Fisher exact tests were used to evaluate associations between IFU sizing and demographics. Logistic regression modeling was used to identify predictors of outside IFU sizing. Cox proportional hazards regression analyzed the relationship between sizing and endoleak, device-related reinterventions, and all-cause/aortic mortality. RESULTS: There were 3607 EVAR subjects enrolled in GREAT as of March 2020. Of them, 1896 (53%) were within IFU for sizing, 791 (22%) were oversized, 540 (15%) were undersized, and 380 (10%) had both over- and undersized components. Factors predictive of use outside of IFU included female sex (P = .001), non-white race (P = .0003), decreased proximal neck length (P < .061), or larger iliac diameters (P < .0001). Women were more likely than men to have proximal neck undersizing and iliac limb oversizing, and men were more likely to have iliac limb undersizing. On multivariate analysis, undersizing of the proximal graft was associated with endoleak (hazard ratio [HR], 1.8) and aortic (HR, 60.5) and all-cause (HR, 18.0) mortality. Undersizing of iliac limbs was associated with endoleak (HR, 1.5) and device-related reintervention (HR, 1.4). Iliac limb outside IFU sizing was associated with aortic (HR, 2.6) and all-cause (HR, 1.3) mortality. Proximal and distal oversizing was not associated with adverse outcomes. Female sex was associated with mortality on univariate but not multivariate analysis. CONCLUSIONS: Women undergoing EVAR with GORE EXCLUDER abdominal aortic aneurysm Endoprosthesis (W.L. Gore & Associates Inc, Flagstaff, Ariz) are more likely to have proximal stent-graft undersizing and iliac limb oversizing, whereas men are more likely to have undersized iliac limbs. Proximal aortic graft undersizing is associated with endoleak and all-cause/aortic mortality, whereas undersizing of iliac limbs is associated with endoleak and device-related reintervention. Oversizing was not associated with adverse outcomes.

Impact of Instructions for Use and Endoleaks On Long-Term Mortality After Treatment for Abdominal Aortic Aneurysm.

OBJECTIVES: We reported the clinical outcomes after open repair and endovascular aortic repair for abdominal aortic aneurysm and analyzed the risk factors for all-cause mortality and endoleak after endovascular aortic repair. METHODS: Patients who underwent elective treatment for abdominal aortic aneurysm from January 2009 to March 2020 were included in this study. The treatment was according to a procedure selection algorithm based on the Society for Vascular Surgery comorbidity scores and instructions for use. All patients were divided into open repair and endovascular aortic repair groups, and the clinical results were compared between the groups. RESULTS: Of the 278 patients, 116 patients (41.9%) underwent open repair, and 161 patients (58.1%) underwent endovascular aortic repair. The cumulative survival rate with endovascular aortic repair was 78.6%. In the Cox proportional hazard analysis, hemodialysis (hazard ratio = 4.56; 95% confidence interval = 1.5-14.0) and the presence of type I or III endoleak (hazard ratio = 5.7; 95% confidence interval = 1.50-14.5) were independent risk factors for all-cause mortality. The Society for Vascular Surgery comorbidity score was not an independent risk factor (hazard ratio = 1.11; 95% confidence interval = 1.0-1.2). In the multivariate logistic regression analysis to identify the risk factors for type I or III endoleak after endovascular aortic repair, anticoagulation drug therapy (odds ratio = 3.99; 95% confidence interval = 1.8-8.9), untreated thoracic aortic aneurysm (odds ratio = 4.8; 95% confidence interval = 1.8-17.3), and outside instruction for use for the proximal neck (odds ratio = 5.8; 95% confidence interval = 2.3-9.8) were independent risk factors. CONCLUSIONS: We analyzed the risk factors for all-cause mortality after treatment and endoleak after endovascular aortic repair. The results indicated that the instructions for use should be respected to reduce the frequency of endoleaks and that open repair should be chosen more often to improve late survival.

Management of Nellix migration and type Ia endoleak from proximal endovascular aneurysm sealing relining to late open conversion.

BACKGROUND: Despite promising early results, midterm failures of the Nellix endovascular aneurysm sealing (EVAS) system (Endologix Inc, Irvine, Calif) have been reported at higher than expected rates. The management of proximal endoleaks and migration differs from those after conventional endovascular aortic aneurysm repair (EVAR) owing to the peculiar design of the Nellix device. In the present study, we report a monocentric experience in the management of EVAS complications using various techniques. We also performed a comprehensive review of the relevant literature on both open surgical and endovascular management of proximal failure of EVAS from the MEDLINE database. METHODS: We retrospectively analyzed the reinterventions for type Ia endoleak and migration after elective infrarenal EVAS at our institution. We collected preoperative, intraoperative, and follow-up data. Open and endovascular techniques are described. Overall survival, aortic-related mortality, and the technical success rate (rate of exclusion of endoleaks) with endovascular techniques were the primary outcomes. RESULTS: We performed 101 infrarenal elective EVAS procedures from 2013 to 2018. Of the 101 patients, 20 (19.8%) had required reintervention for proximal sealing failure. The indications were type Ia (Is2, Is3) endoleak, migration >5 mm, sac expansion >5 mm, and secondary rupture. Of the 20 patients, 6 (30%) were treated with endovascular techniques-2 with a chimney Nellix-in-Nellix application and 4 with proximal relining with a covered stent. The remaining 14 patients (70%) were treated with late open conversion (OC). The average time from EVAS to reintervention was 36.1 months (range, 3-65 months). Six patients (30%) had undergone OC in an emergent setting because of secondary rupture. The technical success rate for the patients treated with endovascular reinterventions was 100%. The 30-day mortality was 20% (4 of 20), all emergent cases (four of six emergent repairs; 67%). The overall survival for the 20 patients was 75% (n = 15) at a mean follow-up of 15.1 months (range, 2-47 months). One patient had died after 7 months of non-aortic-related causes. CONCLUSIONS: The high reintervention rate of the Nellix graft mandates careful evaluation for its further use with the revised instructions for use, and it should not be used off-label. OC remains the strategy of choice when managing Nellix proximal sealing failures in fit patients. Chimney Nellix-in-Nellix application and transcatheter embolization are feasible alternative techniques. Proximal relining also appears to be an effective alternative to more complex interventions, although it requires further studies for validation.

The Effect of Abdominal Aortic Aneurysm Size on Endoleak, Secondary Intervention and Overall Survival Following Endovascular Aortic Aneurysm Repair.

OBJECTIVE: The purpose of this study was to identify the effect of abdominal aortic aneurysm (AAA) size on endoleak development and secondary intervention after endovascular repair (EVAR), as well as to examine the effect on overall survival and cause of mortality. METHODS: Retrospective analysis was performed on all non-ruptured AAA treated by elective EVAR using FDA-approved endografts in our facility from July 2004 to December 2017. Patients were grouped into 3 cohorts based on preoperative aneurysm size: Group I (<5.5 cm), Group II (5.5-6.4 cm), and Group III (≥ 6.5 cm). Occurrences of endoleak, secondary intervention and overall survival underwent univariate and multivariate analysis. Cause of death data on deceased patients was similarly examined. RESULTS: A total of 517 patients were analyzed. There was no difference between size groups in the rate of endoleak (Group I 48/277, 17.3%; Group II 33/160, 20.6%; Group III 18/80, 22.5%; p = 0.46) or time until endoleak development. Univariate analysis showed no difference in the rate of secondary intervention (Group I 36/277, 13.0%; Group II 24/160, 15.0%; Group III 18/80, 22.5%; p = 0.11), time until intervention or number of interventions performed. Multivariate analysis showed an association with shorter time to secondary intervention for both Group III aneurysms (HR 2.03, 95% CI 1.11-3.73; p = 0.02) and female patients (HR 1.79, 95% CI 1.02-3.13; p = 0.04). There was no difference in overall survival, aneurysm-related mortality or overall cause of mortality. CONCLUSION: AAA diameter prior to EVAR was not associated with any differences in rates of endoleak or secondary intervention, and was not associated with poorer overall survival or greater aneurysm-related mortality. Patients with suitable anatomy for EVAR can be considered for this intervention without concern for increased complications or poorer outcomes related to large aneurysm diameter alone.

Midterm single-center results after endovascular aneurysm sealing reveal a high rate of stent graft migration, secondary aneurysm ruptures, and device-related reinterventions.

OBJECTIVE: To report procedural results and mid-term follow-up outcomes of patients treated with endovascular aneurysm sealing (EVAS) for abdominal aortic disease. METHODS: In this retrospective observational study, all patients treated with EVAS between March 2013 and January 2018 for abdominal aortic aneurysm (AAA) or abdominal penetrating aortic ulcer were included. The datasets included demographics, aneurysm morphology, and procedural and clinical surveillance outcomes. Furthermore, patients treated within the original instructions for use (IFU-group) were compared with patients treated outside the IFU (non-IFU-group) with regard to survival, reintervention-free survival, freedom from type I endoleak, and freedom from stent graft migration. RESULTS: Seventy patients were included (67 male; median age, 72.5 years). Sixty-five patients were treated for AAA and 5 patients for abdominal penetrating aortic ulcer. Sixty-nine cases were treated electively (98.6%). Technical success was achieved in 68 cases (97.1%). The median clinical follow-up was 50.5 months (interquartile range, 29.3-62.7 months) with a median computed tomography angiographic follow-up of 38.5 months (interquartile range, 17.1-60.2 months). There were five deaths during the study period (7.1%), four of which were aneurysm related (5.7%). Five secondary AAA ruptures were detected (7.1%). Overall, 25 of 70 patients (35.7%) underwent 35 reinterventions, mostly owing to thrombotic complications (18.6%), stent graft migration (17.1%), and type I endoleak (12.9%). Fifteen patients were treated outside of the IFU (non-IFU-group) (21.4%). The estimated reintervention-free survival for the entire cohort at 30 days and 1, 3, and 5 years was 94.3%, 88.5%, 72%, and 56.9%, respectively. Freedom from stent graft migration at 1, 3, and 5 years was 98.6%, 82.0%, and 47.3%, respectively. The estimated freedom from type I endoleak at 30 days and 1, 3, and 5 years in the IFU-group was 100%, 100%, 94.9% and, 91.1% and significantly different when compared with the non-IFU-group with 79.5%, 72.2%, 72.2%, and 72.2% (P = .012). CONCLUSIONS: Although the technical and initial results were satisfying, the mid-term results were disappointing. The enforcement of a close follow-up protocol for all patients treated with EVAS, especially vigilant for stent graft migration to prevent secondary type I endoleak and rupture, is strongly recommended.

Evaluation of Aortic Zone 2 Proximal Landing Accuracy During Thoracic Endovascular Aortic Repair Following Carotid-Subclavian Revascularization.

BACKGROUND: Adequate seal for thoracic endovascular aortic repair (TEVAR) commonly requires landing in zone 2, but can prove to be challenging due to the tortuous and angulated anatomy of the region. OBJECTIVES: Our objective was to determine the proximal landing accuracy of zone 2-targeted TEVARs following carotid-subclavian revascularization (CSR) and its impact on clinical outcomes. METHODS: Retrospective review of patients that underwent CSR for zone 2 endograft delivery at a tertiary institute between January 2008 and March 2018 was conducted. Technical outcomes were assessed by examining the incidence of intraoperative corrective maneuvers, 1a endoleaks and reinterventions. Distance to target and incidence of LSA stump filling were examined as radiographic markers of landing accuracy. RESULTS: Zone 2-targeted TEVAR with CSR was performed in 53 patients for treatment of dissections (49%), aneurysms (30%) or trauma (21%). Nine (17%) cases required intraoperative corrective procedures: 5 (9%) proximal cuffs due to type 1a endoleak and 4 (8%) left common carotid artery (LCCA) stenting due to inadvertent coverage. Cases performed using higher resolution hybrid fluoroscopy machine compared to mobile C-arm were associated with increased proximal cuff use (OR 8.8; 95% CI 1.2-62.4). Average distance between the proximal edge of the covered graft to LCCA was 8 ± 1 mm and larger distances were not associated with higher rates of 1a endoleak. Twenty-eight (53%) cases of antegrade LSA stump filling were noted on follow-up imaging, but were not associated with higher rates of reinterventions (OR 0.8, 95% CI [0.2-4.6]). Three (6%) patients had a stroke within 30 days and 4 (8%) patients expired within 1 month. Intraoperative corrective maneuvers, post-operative 1a endoleak and reinterventions were not associated with higher rates of stroke or mortality. CONCLUSION: Using current endografts and imaging modalities, zone 2-targeted TEVARs have suboptimal technical accuracy.

A Canadian multicenter experience describing outcomes after endovascular abdominal aortic aneurysm repair stent graft explantation.

BACKGROUND: Most studies describing the outcomes after endovascular abdominal aortic aneurysm repair (EVAR) explantation have been from single, high-volume, centers. We performed a multicenter cross-Canadian study of outcomes after EVAR stent graft explantation. Our objectives were to describe the outcomes after late open conversion and EVAR graft explantation at various Canadian centers and the techniques and outcomes stratified by the indication for explant. METHODS: The Canadian Vascular Surgery Research Group performed a retrospective multicenter study of all cases of EVAR graft explantation at participating centers from 2003 to 2018. Data were collected using a standardized, secure, online platform (RedCap [Research Electronic Data Capture]). Univariate statistical analysis was used to compare the techniques and outcomes stratified the indication for graft explantation. RESULTS: Patient data from 111 EVAR explants collected from 13 participating centers were analyzed. The mean age at explantation was 74 years, the average aneurysm size was 7.5 cm, and 28% had had at least one instructions for use violation at EVAR. The average time between EVAR and explantation was 42.5 months. The most common indication for explantation was endoleak (n = 66; type Ia, 46; type Ib, 2; type II, 9; type III, 2; type V, 7), followed by infection in 20 patients; rupture in 18 patients (due to type Ia endoleak in 10 patients, type Ib in 1, type II in 1, type III in 2, and type V in 1), and graft thrombosis in 7 patients. The overall 30-day mortality was 11%, and 45% of the patients had experienced at least one major perioperative complication. Mortality was significantly greater for patients with rupture (33.3%) and those with infection (15%) compared with patients undergoing elective explantation for endoleak (4.5%; P = .003). The average center volume during the previous 15 years was 8 cases with a wide range (2-19 cases). A trend was seen toward greater mortality for patients treated at centers with fewer than eight cases compared with those with eight or more cases (19% vs 9%). However, the difference did not reach statistical significance (P = .23). Overall, 41% of patients had undergone at least one attempt at endovascular salvage before explantation, with the highest proportion among patients who had undergone EVAR explantation for endoleak (51%). Only 22% of patients with rupture had undergone an attempt at endovascular salvage before explantation. CONCLUSIONS: The performance of EVAR graft explantation has increasing in Canada. Patients who had undergone elective explantation for endoleak had lower mortality than those treated for either infection or rupture. Thus, patients with an indication for explanation should be offered surgery before symptoms or rupture has occurred. A trend was seen toward greater mortality for patients treated at centers with lower volumes.

Management of Type IA Endoleak After EVAR by Explantation or Custom Made Fenestrated Endovascular Aortic Aneurysm Repair.

OBJECTIVE: Proximal type 1 endoleak after endovascular abdominal aortic aneurysmal repair (EVAR) remains challenging to solve with no existing consensus. This work aims to compare two different surgical strategies to remedy type IA endoleak: endograft explantation (EXP) and aortic reconstruction or relining by custom made fenestrated EVAR (F-EVAR). METHODS: A retrospective single centre analysis between 2009 and 2018 was conducted including patients treated for type IA endoleak after EVAR with either EXP or F-EVAR. The choice of surgical technique was based on morphological factors (F-EVAR eligibility), sac growth rate, emergency presentation and/or patient symptoms. Technical success, morbidity, secondary interventions, 30 day mortality, and long term survival according to Kaplan-Meier were determined for each group and compared. RESULTS: Fifty-nine patients (91% male, mean age 79 years) underwent either EXP (n = 26) or F-EVAR (n = 33) during the study period. The two groups were equivalent in terms of comorbidity and age at the time of procedure. The median time from initial EVAR was 60.4 months (34-85 months), with no difference between groups. The maximum aneurysm diameter was greater in the EXP group compared with the F-EVAR group, 86 mm (65-100) and 70 mm (60-80), respectively (p = .008). Thirty day secondary intervention (EXP: 11.5% vs. F-EVAR: 9.1%) and mortality (EXP: 3.8% vs. F-EVAR: 3.3%) rates did not differ between groups, while major adverse events at 30 days, defined by the current SVS guidelines, were lower in the F-EVAR group (2.4% vs. 13.6%; p = .016). One year survival rates were similar between the groups (EXP: 84.0% vs. F-EVAR: 86.6%). CONCLUSION: Open explantation and endovascular management with a fenestrated device for type IA endoleak after EVAR can be achieved in high volume centres with satisfactory results. F-EVAR is associated with decreased early morbidity. Open explantation is a relevant option because of acceptable outcomes and the limited applicability of F-EVAR.

Midterm outcomes for 605 patients receiving Endologix AFX or AFX2 Endovascular AAA Systems in an integrated healthcare system.

BACKGROUND: Endologix issued important safety updates for the AFX Endovascular AAA System in 2016 and 2018 owing to the risk of type III endoleaks. Outcomes with these devices are limited to small case series with short-term follow-up. We describe the midterm outcomes for a large cohort of patients who received an Endologix AFX or AFX2 device. STUDY DESIGN: Data from an integrated healthcare system's implant registry, which prospectively monitors all patients after endovascular aortic repair, was used for this descriptive study. Patients undergoing endovascular aortic repair with three AFX System variations (Strata [AFX-S], Duraply [AFX-D], and AFX2 with Duraply [AFX2]) were identified (2011-2017). Crude cumulative event probabilities for endoleak (types I and III), major reintervention, conversion to open, rupture, and mortality (aneurysm related and all cause) were estimated. RESULTS: Among 605 patients, 375 received AFX-S, 197 received AFX-D, and 33 received AFX2. Median follow-up for the cohort was 3.9 (interquartile range, 2.5-5.1) years. The crude 2-year incidence of overall endoleak, any subsequent reintervention or conversion, and mortality was 8.8% (95% confidence interval [CI], 6.3-12.3), 12.0% (95% CI, 9.1-15.9), and 8.8% (95% CI, 6.3-12.2) for AFX-S. Respective estimates for AFX-D were 7.9% (95% CI, 4.8-13.0), 10.6% (95% CI, 6.9-16.1), and 9.7% (95% CI, 6.3-14.7); for AFX2, they were 14.1% (95% CI, 4.7-38.2), 16.2% (95% CI, 6.4-37.7), and 21.2% (95% CI, 10.7-39.4). CONCLUSIONS: The midterm outcomes of a large U.S. patient cohort with an Endologix AFX or AFX2 System demonstrate a concerning rate of adverse postoperative events. Patients with these devices should receive close clinical surveillance to prevent device-related adverse events.

Secondary Interventions and Long-term Follow-up after Endovascular Abdominal Aortic Aneurysm Repair.

BACKGROUND: Early morbidity and mortality are low after endovascular abdominal aneurysm repair (EVAR), but secondary interventions and late complications are common. The aim of the present multicenter cohort study is to detail the frequency and indication for interventions after EVAR and the impact on long-term survival. METHODS: A retrospective multicenter cohort study of secondary interventions after elective EVAR for an infrarenal abdominal aortic aneurysm was conducted. Consecutive patients (n = 349) undergoing EVAR between January 2007 and January 2012 were analyzed, with long-term follow-up until December 2018. Those requiring intervention were classified in accordance with the indications and specific nature of the intervention and treatment. The primary study end point was overall survival classified for patients with and without intervention. Kaplan-Meier analysis was used to estimate overall survival for those who did and who did not undergo secondary interventions. Univariable and multivariable Cox regression were performed to identify independent variables associated with mortality. RESULTS: Some 56 patients (16%) underwent 72 secondary interventions after EVAR during a median (interquartile range) follow-up period of 53.2 months (60.1). Some 45 patients (80.4%) underwent one intervention. Indications for intervention included mainly endograft kinking/outflow obstruction and type II endoleak. An endovascular technique was used in 40.3% of interventions. Median time to secondary intervention was 24.1 months. In 93 patients with abnormalities on imaging, no intervention was performed mainly because the abnormality had disappeared on follow-up imaging (43%). Kaplan-Meier curves showed no difference in survival for patients with and without secondary interventions (P = 0.153). Age (hazard ratio [HR]: 1.089, 95% confidence interval [CI]: 1.063-1.116), ASA classification (ASA III, IV HR: 1.517, 95% CI: 1.056-2.178) were significantly related to mortality. CONCLUSIONS: Secondary intervention rates are still considerable after EVAR. Endograft kinking/outflow obstruction and endoleak type II are the most common indications for a secondary intervention. Secondary interventions did not adversely affect long-term overall survival after EVAR.

Prevention of Retrograde Ascending Aortic Dissection by Cardiac Pacing During Hybrid Surgery for Zone 0 Aortic Arch Repair.

BACKGROUND: Retrograde type A dissection (RTAD) after zone 0 hybrid aortic arch repair is highly lethal and not infrequent complication. The aim of this study was to assess the safety and effectiveness of rapid cardiac pacing as an adjunctive tool to prevent RTAD during or after hybrid procedures for zone 0 disease. METHODS: We performed a retrospective review of 42 consecutive patients with zone 0 hybrid aortic arch repair between November 2004 and January 2018. Right ventricular pacing was carried out through unipolar electrodes attached to the epicardium of the right ventricle through the sternotomy (the indifferent electrode was in the subcutaneous tissue). Pacing was utilised during the clamping of the ascending aorta, release of the aortic clamp, and stent-graft deployment. RESULTS: Operative indications were aortic arch aneurysm 45% (n = 19), aortic arch dissection 45% (n = 19), traumatic rupture of isthmus 7% (n = 3), and type IA endoleak 2% (n = 1). Urgent procedures 48% (n = 20). The mean proximal aortic diameter was 34.14 ± 2.9 mm. Mean stent-graft oversizing was 12.97 ± 3.4%. The 30-day mortality rate was 14% (n = 6). RTAD was observed in 7% (n = 3). The actuarial survival rate was 74% over a mean follow-up of 50 ± 30.2 months. Since January 2013, rapid right ventricular pacing (overdrive pacing at a rate of 200 beats/min) was systematically used (n = 24). No RTAD was observed in this group of patients. Rapid right ventricular pacing reduced significatively the risk of RTAD (P = 0.038). CONCLUSIONS: Rapid right ventricular pacing is an effective method of inducing hypotension and appears to decrease the risk of retrograde type A dissection after zone 0 hybrid aortic arch repair.

Protocolized Based Management of Cerebrospinal Fluid Drains in Thoracic Endovascular Aortic Aneurysm Repair Procedures.

BACKGROUND: Spinal cord ischemia (SCI) resulting in paraplegia is a devastating complication associated with thoracic endovascular aortic aneurysm repair (TEVAR) whose incidence has significantly declined over time. In this review, we present our experience with a multidisciplinary clinical protocol for cerebrospinal fluid (CSF) drain management in patients undergoing TEVAR. Furthermore, we aimed to characterize complications of CSF drain placement in a large, single center experience of patients who underwent TEVAR. METHODS: This retrospective review is of patients undergoing TEVAR with and without CSF drain placement between January 2014 and December 2019 at a single institution. Patient demographics, hospital course, and drain-related complications were analyzed to assess the incidence of CSF drain-related complications. RESULTS: A total of 235 patients were included in this study, of which 85 received CSF drains. Eighty patients (94.1%) were placed by anesthesiologists, while 5 (5.9%) were placed under fluoroscopic guidance by interventional neurosurgery. The most common level of placement was L3-L4 in 38 (44.7%) cases followed by L4-L5 in 36 (42.4%) cases. The mean duration of CSF drain was 1.9 ± 1.4 days. Complications due to CSF drainage occurred in 5 (5.9%) patients and included partial retainment of catheter, subdural edema, epidural hematoma, headache, and bleeding near the drain site. The overall 30-day mortality rate was 5.5% and did not differ between those who received a CSF drain and those who did not (P = 0.856). The overall incidence of SCI resulting in paraplegia was 1.7% in the studied patients. CONCLUSIONS: A protocol-based CSF drainage program for spinal cord protection involves a multifaceted approach in identification and selection of patients meeting criteria for prophylactic drain placement, direct closed loop communication, and perioperative management by an experienced team. Despite the inherent advantages of CSF drain placement, it is not without complications, thus risk and benefit need to be weighed in context of the procedure and the patient with close communication and team approach.

Prediction, pattern recognition and modelling of complications post-endovascular infra renal aneurysm repair by artificial intelligence.

OBJECTIVES: The study evaluates the plausibility and applicability of prediction, pattern recognition and modelling of complications post-endovascular aneurysm repair (EVAR) by artificial intelligence for more accurate surveillance in practice. METHODS: A single-centre prospective data collection on (n = 250) EVAR cases with n = 26 preoperative attributes (factors) on endpoint of endoleak (types I-VI), occlusion, migration and mortality over a 13-year period was conducted. In addition to the traditional statistical analysis, data was subjected to machine learning algorithm through artificial neural network. The predictive accuracy (specificity and -1 sensitivity) on each endpoint is presented with percentage and receiver operative curve. The pattern recognition and model classification were conducted using discriminate analysis, decision tree, logistic regression, naive Bayes and support vector machines, and the best fit model was deployed for pattern recognition and modelling. RESULTS: The accuracy of the training, validation and predictive ability of artificial neural network in detection of endoleak type I was 95, 96 and 94%, type II (94, 83, 90 and 82%) and type III was 96, 94 and 96%, respectively. Endpoints are associated with increase in weights through predictive modeling that were not detected through statistical analytics. The overall accuracy of the model was >86%. CONCLUSION: The study highlights the applicability, accuracy and reliability of artificial intelligence in the detection of adverse outcomes post-EVAR for an accurate surveillance stratification.

Type II endoleak and aortic aneurysm sac shrinkage after preemptive embolization of aneurysm sac side branches.

OBJECTIVE: Type II endoleak (T2EL) is the most common endoleak after endovascular aneurysm repair (EVAR). Its optimal management has been controversially discussed. Thus, preliminary selective embolization of aneurysm sac side branches (ASSBs) has been adopted to prevent T2EL. Our goal was to determine the rate of T2EL and the diameter decrease of abdominal aortic aneurysms (AAAs) after EVAR performed after preemptive embolization of ASSBs. METHODS: From September 2014 to September 2019, 139 patients with AAAs underwent percutaneous ASSB embolization before EVAR. Follow-up imaging studies were performed at 1 and 6 months and annually thereafter. The end points included freedom from T2EL, AAA sac shrinkage, T2EL-related reinterventions, and all-cause mortality. RESULTS: The mean follow-up was 23 ± 16 months (range, 1-61 months). The patients had had a median of five (range, one to eight) patent ASSBs found on preoperative imaging studies. After completion of embolization, 76.4% of the initially patent ASSBs were occluded, with no major procedure-related complications. Follow-up imaging studies showed T2ELs in seven patients (5%), with an aneurysm sac increase seen in six of these patients. The number of ASSBs remaining patent after embolization was the only discriminative factor in patients with and without T2EL. Six T2EL-related reinterventions were performed during follow-up. Most patients (n = 91; 86.7%) had experienced aneurysm sac shrinkage, and the mean diameter reduction was 9.2 ± 7.7 mm (P < .001) in all patients with follow-up data available. One aneurysm-related death occurred within 30 days after EVAR. CONCLUSIONS: Preemptive embolization of ASSBs for patients with AAAs is safe and effective in preventing T2ELs after EVAR. Aneurysm sac shrinkage was observed in a high proportion of patients.

Long-term failure after endovascular aneurysm sealing in a real-life, single-center experience with the Nellix endograft.

BACKGROUND: Endovascular aneurysm sealing (EVAS) is an innovative alternative to conventional endovascular aneurysm repair (EVAR). EVAS relies on sac anchoring without proximal fixation to achieve sealing and should have allowed for the treatment of a broader range of anatomic features compared with standard EVAR. Despite the encouraging early reports, the mid- and long-term follow-up data have shown increased rates of failure. To address the issue, the manufacturer introduced revised instructions for use (IFU) in 2016. The present study reports the outcomes of this system after a median follow-up of 45 months. METHODS: Data for all patients electively treated with EVAS at our institution were retrospectively collected. The patients were retrospectively reclassified according to the 2016 revised IFU of the device. All patients in the present series had undergone EVAS for the treatment of infrarenal abdominal aortic aneurysms (AAAs). The primary end point was therapeutic failure: graft migration >5 mm, sac expansion >5 mm, type IA endoleak (Is2 and Is3 using the Van den Ham classification), type Ib endoleak, and secondary rupture. The overall mortality, aortic-related mortality, and reintervention rates were also analyzed. RESULTS: A total of 101 patients had undergone elective treatment by EVAS from 2013 to 2018 for infrarenal AAAs. The median follow-up was 3.75 years. Therapeutic failure was observed in 31 of the 101 patients (30.7%), with no significant difference between the in-IFU and off-IFU 2016 subgroups. Failure occurred at a median interval of 34 months from the index procedure. Of the 101 patients, 6.9% had presented with secondary rupture. Freedom from aneurysm-related mortality was 96.9% at 1 and 2 years and 89.9% at 5 years. Freedom from reintervention decreased over time: 94.7% at 1 year, 77% at 4 years, and 52.1% at 6 years. Of the 101 patients, 14 (13.9%) had undergone emergent or elective graft explantation. CONCLUSIONS: EVAS performed worse than conventional endografts for several critical end points, regardless of any preoperative anatomic parameters. The incidence of therapeutic failures tended to increase over time, especially 4 years after the index procedure.

Late Open Conversion Following Failure of EVAR and TEVAR: "State of the Art".

Abdominal endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR) have changed the aortic surgery, due to several advantages in terms of reduced morbidity and mortality. However, increasing rate of late complications requiring secondary procedures has been observed over time. Even if the majority of them may be treated by means of endovascular techniques, late open surgical conversion (LOSC) is required in specific situations. This paper aims to provide our single-center experience with LOSCs and an updated review of the literature. From 1995 to 2020, indications and outcomes of patients treated with LOSC for failed EVAR and TEVAR, at our institutions, were analyzed. LOSC was required to treat a broad range of complications that were classified into two main groups: "disease related" and "stent-graft (SG) related." Among the 121 patients treated with LOSC after EVAR, endoleak (75.2%) represented the most common indication. The overall 30-day mortality rate was 3.3%. A higher mortality rate was associated with infection after EVAR (p. 006). Among the 81 patients treated with LOSC after TEVAR, endoleak (32.1%) was the most common indication. The overall 30-day mortality rate was 13.6% with a higher incidence in the SG-related group (p. 02). LOSC is associated with an increased surgical complexity, in both the abdominal and thoracic area, that results in higher morbidity and mortality rates compared with standard open repair. Depending on the indication to LOSC, specific surgical maneuvers are required to improve clinical outcomes.