Fenestrated-branched Endovascular Aortic Repair Research Articles

Outcomes of target vessel endoleaks after fenestrated-branched endovascular aortic repair

ObjectiveThe objective of this study was to determine the incidence rate, outcomes, and risk factors of target vessel-related endoleaks after fenestrated-branched endovascular aortic repair (F-BEVAR) for pararenal aneurysms or thoracoabdominal aortic aneurysms (TAAAs). MethodsWe reviewed consecutive patients treated by F-BEVAR between 2007 and 2017. Target vessel endoleaks were identified by computed tomography angiography (CTA). Follow-up included CTA and duplex ultrasound before discharge, at 2 months, at 6 months, and annually thereafter. Primary endoleaks were detected by predismissal CTA; secondary endoleaks were absent on the first CTA and were identified during follow-up. End points were spontaneous resolution of primary endoleaks, secondary interventions, and aneurysm rupture. Multivariable analyses were performed for risk factors of target vessel endoleaks and predictors of spontaneous resolution. ResultsA total of 382 patients (mean age, 75 ± 8 years; 75% male) underwent F-BEVAR for 195 pararenal aneurysms and 187 TAAAs with 1204 renal-mesenteric arteries targeted by 981 fenestrations and 223 directional branches. Fifty-two target vessel endoleaks were identified in 41 patients; 41 were type IIIC (interattachment), 10 were type IC (distal bridging stent sealing zone), and 1 was type IIIB (bridging stent fabric tear). Thirty-three patients (9%) had primary target vessel endoleaks in 41 target vessels (3%). Eight patients (2%) developed 11 secondary target vessel endoleaks. Directional branches were more prone to primary endoleaks (13/223 [6%]) in comparison to fenestrations (28/981 [3%]; P = .03). However, branch endoleaks resolved more often spontaneously (11/14 [79%]) compared with fenestration endoleaks (14/38 [37%]; P = .008). Other risk factors for target vessel endoleaks included inner aortic diameter ≥30 mm at the target vessel origin, four or more targeted vessels, TAAA (for primary endoleaks), and physician-modified endograft (for secondary endoleaks). Four patients with primary endoleaks underwent successful reintervention before discharge, and 29 were observed with a mean follow-up of 24 ± 21 months. Of the 41 primary endoleaks, 25 resolved spontaneously in 20 patients (61%) at first follow-up with no recurrences. Of the observed endoleaks, 11 persisted in 9 patients, and 8 of those endoleaks were treated in 7 patients. All secondary target vessel endoleaks required reintervention. There was one possible aneurysm rupture attributed to persistent secondary target vessel endoleak. ConclusionsTarget vessel endoleak on CTA at discharge occurs in 1 of 10 patients treated by F-BEVAR. Of these, two-thirds resolve spontaneously, especially those affecting directional branches. Among patients with a persistent endoleak, endovascular reintervention is usually successful and aneurysm rupture is rare.

Safety and Efficacy of Totally Percutaneous Femoral Access for Fenestrated-Branched Endovascular Aortic Repair of Pararenal-Thoracoabdominal Aortic Aneurysms.

We sought to evaluate the safety and efficacy of totally percutaneous femoral access (TPFA) for fenestrated-branched endovascular aortic repair (F/B-EVAR) of pararenal-thoracoabdominal aortic aneurysms (PRAs/TAAAs). We reviewed all consecutive patients enrolled in single-center prospective non-randomized single-arm study to investigate F/B-EVAR for PRAs/TAAAs (2013-2017). Percutaneous approach was selected in all patients when anatomically feasible; otherwise, surgical femoral access (SFA), with or without construction of temporary prosthetic conduit, was selected. Primary outcomes were technical success, mortality, major adverse events (MAEs) and major vascular access complications. A total of 231 patients were included in the study: TPFA was possible in 163 (70%) with technical success rate of 93%, while 68 (30%) required SFA. Patients with TPFA and SFA had similar mortality rate of 1%. The rate of MAEs for TPFA was 20% versus 38% for SFA (p = .07). The trend was mainly driven by reduced rates of estimated blood loss (EBL) ≥ 1L (6% vs 21%, p = .001) and acute myocardial infarction (2% vs 9%, p = .03). Similarly, TPFA carried a significantly lower rate of major vascular access complications as compared with SFA (6% vs 21%, p < .001; adjusted OR 3.4, 95% CI 1.3-8.9, p = .01). A percutaneous-first approach for elective F/B-EVAR of PRAs/TAAAs is safe, feasible and effective when proper patient selection is provided. When the presence of hostile iliofemoral anatomy requires open-vessel exposure, higher rates of perioperative major bleeding, cardiac events and access complications may be expected. Level 3 (single-center prospective non-randomized single-arm study).

Dual Fluoroscopy With Live-Image Zooming Significantly Reduces Patient and Operating Staff Radiation During Fenestrated-Branched Endovascular Aortic Aneurysm Repair

Fenestrated-branched endovascular aneurysm repair (F/BEVAR) is a complex procedure that generates high radiation dose. Use of magnification views aids in the success of vessel cannulation but increases the overall radiation dose. The aim of the study was to compare the radiation doses to patients and operating room staff from two fluoroscopy techniques, standard magnification vs dual fluoroscopy with live-image digital zooming during F/BEVAR.

Effects of Preoperative Visceral Artery Stenosis on Target Artery Outcomes After Fenestrated-Branched Endovascular Aortic Aneurysm Repair (F/BEVAR)

Visceral artery stenosis is among the exclusion criteria for fenestrated-branched endovascular aneurysm repair (F/BEVAR) trials. Whether branch stability is affected by preoperative stenosis is unknown. The aim of this study was to assess the effects of preoperative stenosis of the celiac artery and superior mesenteric artery (SMA) on target artery outcomes after F/BEVAR.

Performance of Viabahn Balloon-Expandable Stent Compared With Self-expanding Covered Stents for Fenestrated-Branched Endovascular Aortic Repair

The objective of this study was to compare the performance between Viabahn (W. L. Gore & Associates, Flagstaff, Ariz) balloon-expandable stent (VBX) and self-expanding covered stents (SESs; Viabahn and Fluency [Bard Peripheral Vascular, Tempe, Ariz]) used as bridging stents for directional branches during fenestrated-branched endovascular aneurysm repair of complex aortic aneurysms. Patients with thoracoabdominal aortic aneurysms (type I-IV) or pararenal aortic aneurysms unsuitable for either open repair or endovascular repair with commercially available devices were prospectively enrolled into a physician-sponsored investigational device exemption trial. Descriptive statistics of the cohort included demographics, risk factors, and anatomic and device characteristics. Individual branches were grouped as either VBX or SES and were analyzed for primary patency, branch-related type I or type III endoleaks, branch instability, branch-related secondary intervention, and branch-related aortic rupture or death. Categorical variables were expressed as total and percentage and continuous variables as median (interquartile range). Kaplan-Meier curves were used to estimate long-term result. Groups were compared with the log-rank test. P value < .05 was considered statistically significant. During the period from July 2012 through April 2019, there were 263 patients treated for complex aortic aneurysm with fenestrated-branched endovascular aneurysm repair. The devices used were either a custom-manufactured device or off-the-shelf p-Branch or t-Branch devices (Cook Medical, Bloomington, Ind). The median age was 71 years (interquartile range, 66-79 years), 70% male, and 81% white. The most common cardiac risk factors were smoking (92%), hypertension (91%), hyperlipidemia (78%), and chronic obstructive pulmonary disease (52%). The total number of vessels incorporated to repair was 977, with branches representing 18.4% (179 branches). Among the 179 branches were 54 (30%) celiac artery, 56 (31%) superior mesenteric artery, 38 (21%) right renal artery, and 31 (18%) left renal artery. VBX and SES groups represented, respectively, 53% (n = 95) and 47% (n = 84) of the total (Fig).The overall cohort survival rate at 24 months was 78.5% ± 3%. There was no branch-related rupture or death. Primary patency at 24 months (VBX, 98.1%; SES, 98.6%; log-rank, P = .98), freedom from endoleak (VBX, 97.3%; SES, 98.6%; log-rank, P = .63), freedom from secondary intervention (VBX, 91.5%; SES, 95%; log-rank, P = .69), and freedom from branch instability (VBX, 95.5%; SES, 97.3%; log-rank, P = .72) were similar between groups (Fig 2). The initial experience with VBX stents demonstrated excellent primary patency and similarly low rates of branch-related complications and endoleaks, with no branch-related aortic rupture or death. Our results demonstrate that in high volume and experienced aortic center, the VBX stent is a safe and effective bridging stent option during branched endovascular aortic repair. Multicenter studies with longer follow-up are necessary to validate our initial results.Fig 2Freedom from branch instability (BI). CI, Confidence interval; SES, self-expanding covered stent; VBX, Viabahn balloon-expandable stent.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Prospective Comparison of Cone Beam Computed Tomography with Routine or Selective Predismissal Computed Tomography Angiography to Detect Technical Problems During Fenestrated-Branched Endovascular Aortic Repair

Introduction: To compare two imaging strategies using cone beam computed tomography (CBCT) with rotational angiography and routine or selective predismissal computed tomography angiography (CTA) for technical assessment of fenestrated-branched endovascular aortic aneurysm repair (F-BEVAR). Methods: One hundred and seventy consecutive patients (119 male, mean age 74±8 years old) treated by F-BEVAR were enrolled in a prospective non-randomized study (2016-2018). Technical assessment in the first 85 patients (Group 1) consisted of intraoperative CBCT with rotational angiography and routine predismissal CTA. The subsequent 85 patients (Group 2) had CBCT with rotational angiography and selective predismissal CTA, which was obtained only if clinically indicated. Imaging surveillance in both groups included CTA at 30-days, 6-months and annually thereafter. End-points analyzed as intention-to-treat included effective dose (ED, mSv) and contrast volume for CBCT and predismissal CTA, presence of findings warranting immediate revision (stent kink/compression, type I/III endoleak, dissection/thrombus), and mortality, major adverse events (MAEs) and reinterventions at 30-days. Results: Patients in both groups had similar clinical and anatomical characteristics, stent design and procedural variables. Patients in Groups 1 and 2 had similar technical success (97% vs. 95%, P=.66), endoleak detection (53% vs. 59%, P=.53) and rate of positive findings by CBCT with rotational angiography (21% vs. 27%, P=.37). Immediate revisions (Table) were indicated for stent kink/compression in 20 patients (12%), type I/III endoleak in 19 patients (11%) and vessel dissection/thrombosis in two patients (1%). Predismissal CTA was obtained in 83 patients (97%) assigned to Group 1 and in 24 patients (28%) assigned to Group 2 (P< .0001), and identified new findings in three (4%) and two (2%) patients, respectively (P>.99). Patients in Group 1 had higher ED (+20mSv, P=.0007) and contrast volume (+102ml, P< .0001) compared to patients in Group 2 (Figure). At 30-days, CTA revealed new findings in none of Group 1 and in two (2%) patients in Group 2 (P=.49). There were no differences in mortality (1% vs. 1%, P=.97), MAEs (32% vs. 23%, P=.21) and reinterventions (9% vs. 4%, P=.13) at 30-days between patients in Group 1 and 2, respectively. Conclusion: CBCT with rotational angiography is sufficient to detect technical problems requiring immediate revisions. Mortality, morbidity and rate of early reinterventions were similar in patients who had CBCT with routine or selective predismissal CTA, indicating that routine predismissal CTAs can be safely eliminated from F-BEVAR protocols without deleterious effect on early outcomes.TablePositive findings by CBCT, predismissal and 30-day CTAFigureEffective Dose and Contrast Volume.View Large Image Figure ViewerDownload Hi-res image Download (PPT) Disclosure: GSO has received consulting fees and grants from Cook Medical, W. L. Gore, and GE Healthcare (all paid to Mayo Clinic with no personal income). PO is employed by GE Healthcare

Fenestrated-branched Endovascular Aortic Repair (F-BEVAR) is a Safe and Effective Option for Octogenarians in Treating Complex Aortic Aneurysm (CAA) Compared to Non-octogenarians

OBJECTIVE Open repair of complex aortic aneurysms is frequently not an option for octogenarians because of prohibitive surgical risks. This study aimed to analyze the outcomes of fenestrated-branched endovascular aortic repair (F-BEVAR) in octogenarians (≥80 years old) compared with nonoctogenarians (<80 years old). METHODS We reviewed 893 patients with pararenal or extent I to V thoracoabdominal aneurysms, enrolled in six prospective physician-sponsored investigational device exemption studies from 2012 to 2018. All patients were treated with either company-manufactured off-the-shelf or patient-specific F-BEVAR stent grafts. Data analyzed included demographics, cardiovascular risk factors, history of active cancer, American Society of Anesthesiologists classification, aortic anatomy characteristics, and procedural data. End points included mortality, major adverse events (all-cause mortality, stroke, paralysis, acute kidney injury [RIFLE criteria], dialysis, myocardial infarction, respiratory failure, and bowel ischemia), technical success, hospital length of stay, target artery instability (occlusion/stenosis, endoleak, rupture or death), and secondary interventions. RESULTS During the study period, 195 octogenarian patients (22%) and 698 (78%) nonoctogenarian patients were treated with F-BEVAR. Octogenarians presented more frequently with a history of cancer (17% vs 11%; P = .01), whereas nonoctogenarians more frequently had hyperlipidemia (76% vs 65%; P = .003), chronic obstructive pulmonary disease (42% vs 33%; P = .04) and American Society of Anesthesiologists class III to V (78% vs 70%; P = .02). Male sex was similar between groups (68% [octogenarians] vs 70% [nonoctogenarians]; P = .62). Octogenarians had a larger mean aneurysm diameter (67 ± 1 mm vs 65 ± 1 mm; P = .002). The thoracoabdominal classification and the use of upper extremity access were similar between groups. Estimated blood loss was also similar (484 ± 454 mL [octogenarian] vs 416 ± 457 mL [nonoctogenarian]; P = .07). Octogenarians had an increased mean number of vessels incorporated into the repair (3.1 ± 1.4 vs 2.7 ± 1.7; P < .001). The technical success rate was 99% for octogenarians and 97% for nonoctogenarians (P = .19). The 30-day mortality rate was 0.5% for octogenarians and 1.3% for the nonoctogenarians (P = .70). Major adverse events (9.2% vs 9.7%), types I/III endoleak (4.6% vs 2.4%) access complication (3.1% vs 3.3%), and length of stay (8.2 ± 27 days vs 5.7 ± 6.3 days) were all similar between the groups. Freedom from target artery instability and freedom from secondary interventions at 3 years were similar between the groups. Octogenarian survival was lower at 3 years compared with nonoctogenarians on univariate analysis (log-rank P < .01) and on multivariable analysis after adjusting for history of active cancer, hyperlipidemia, and chronic obstructive pulmonary disease. CONCLUSIONS Despite small differences in demographics, anatomic factors, and procedural data, F-BEVAR was safe and effective with nearly identical early outcomes in octogenarians in these experienced aortic centers. More extensive clinical experience and longer follow-up are needed to better delineate factors impacting longer term mortality.

Preoperative Psoas Muscle Size and Radiodensity Predict Mid-term Survival and Quality of Life After Fenestrated-branched Endovascular Aortic Repair

Introduction: Age alone is a relatively poor predictor of survival due to the discrepancy between biological and chronological age. We need better predictors of clinical outcomes and life expectancy in elderly patients considered for endovascular repair of complex aortic aneurysms. Sarcopenia may be a key determinant of survival in elderly people. Psoas muscle area (PMA) measured at L3-level has been shown to be a reproducible and reliable surrogate for sarcopenia. However, the association of PMA with survival has been inconsistent in previous studies involving patients treated for infrarenal abdominal aortic aneurysms (1-7). PMA alone does not take the muscle quality over quantity into account. Decreased radiodensity, on the other hand, could indicate fatty infiltration of skeletal muscle (myesteatosis) that is associated with frailty and sarcopenia. The aim of this study was to investigate the association of PMA and psoas muscle density (PMD) with survival and quality of life (QOL) after fenestrated-branched endovascular aortic repair (F-BEVAR) of pararenal and thoracoabdominal aortic aneurysms. Methods: The study included 244 consecutive patients enrolled in a prospective study to investigate outcomes of F-BEVAR. Preoperative computed tomography angiography was used to measure PMA (cm2) and PMD (Hounsfield unit, HU) from a single axial slice at L3-level. Lean psoas muscle area (LPMA) was calculated (LPMA = PMA×PMD). Patients were divided into two groups using LPMA cut-point based on Cox hazard model (Figure 1). Group A was defined as LPMA ≥ 350 (n=79) and group B as LPMA < 350 cm2×HU (n=165). QOL was assessed at baseline and 12 months using SF-36 survey. Results: Patients in Group A were younger (mean age, 72±8 vs 76±7 years, P< .001), more often males (95% vs 59%, P< .001) and had higher body mass index (30±6 vs 27±5 kg/m2, P=.001). There were no major differences in comorbidities, aneurysm extent and procedural measures between the groups. Thirty-day mortality (0% vs 0.6%, P=1.00) and major adverse event rates (15% vs 24%, P=.18) were similar in Group A and B. At 3 years, patient survival was 94±3% in Group A and 75±4% in Group B (hazard ratio [HR] 0.20, 95% confidence interval [CI] 0.07-0.56, P=.002, Figure 2). The 3-year survival difference was even more prominent in patients aged ≥75 years: 100% for Group A and 72±5% for Group B (HR 0.12, 95% CI 0.02-0.86, P=.035). Group A patients had significantly higher QOL scores at baseline and 12 months. Out of all preoperative variables, LPMA was the strongest independent predictor of survival during the follow-up in multivariable analysis (adjusted HR 0.59 per one standard deviation, 95% CI 0.40-0.87, P=.008), whereas PMA alone was not a significant predictor. Conclusion: A high LPMA was independently and strongly associated with better mid-term survival and quality of life after F-BEVAR. LPMA can be used to identify suitable candidates for F-BEVAR among elderly patients. The measurement of psoas muscle radiodensity should be included in future studies assessing CT parameters as predictors of survival in patients undergoing vascular surgical procedures.Figure 2Kaplan-Meier survival estimates, dotted line adjusted for age, gender and BMI.View Large Image Figure ViewerDownload Hi-res image Download (PPT) Disclosure: The last author has received consulting fees and grants from Cook Medical, W. L. Gore, and GE Healthcare (all paid to the affiliated institution with no personal income).

Learning Curve of Fenestrated and Branched Endovascular Aortic Repair for Pararenal and Thoracoabdominal Aortic Aneurysms

Introduction - To review the learning curve of fenestrated-branched endovascular aortic repair (F-BEVAR) of pararenal (PRA) and thoracoabdominal aortic aneurysms (TAAAs). Methods - We reviewed the clinical data of 334 consecutive patients (255 male, mean age 75±8 years old) who underwent F-BEVAR between 2007-2016. Manufactured devices were performed under a prospective physician-sponsored investigational device exemption protocol (PS-IDE) since 2013. Outcomes were analyzed in four quartiles of experience (Q1-Q4) each consisting of 81-85 patients. Clinical outcomes included trends in patient characteristics, device design, procedural variables, 30-day mortality and major adverse events (MAEs), defined by estimated blood loss >1 Liter, myocardial infarction, respiratory failure, increase in serum creatinine >2 mg/dl, dialysis, paraplegia, stroke and bowel ischemia. Results - There were 178 patients (53%) treated for PRAs and 156 (47%) for TAAAs. During the study period, there was a statistically significant increase in the proportion of TAAAs and in the number of vessels incorporated. Despite this, there was a steady decrease in 30-day mortality (6% in Q1 to 0% in Q4; P<0.0001) and in the rate of MAEs (58% in Q1 to 21% in Q4;P<0.0001). By linear regression analysis, there was significant (P<0.01) decline in EBL, total operating time, total fluoroscopy time, contrast volume and radiation dose. Conclusion - This study demonstrate significant improvement in perioperative mortality, major adverse events and procedural variables in patients treated by F-BEVAR, despite the increase in complexity of aneurysm pathology and device design during the study period.

Outcomes of Small Renal Artery (&lt;4mm) Targets in Patients Treated by Fenestrated-branched Endovascular Aortic Repair

Outcomes of Small Renal Artery (&lt;4mm) Targets in Patients Treated by Fenestrated-branched Endovascular Aortic Repair

Prospective Assessment of a Protocol using Neuromonitoring, Early Limb Reperfusion and Selective Temporary Aneurysm Sac Perfusion to Prevent Spinal Cord Injury During Fenestrated-branched Endovascular Aortic Repair

Introduction - Spinal cord injury (SCI) is a devastating complication of thoracoabdominal aortic aneurysm (TAAA) repair. The aim of this study was to analyze the outcomes of a standardized protocol using continuous neuromonitoring, lower limb (LL) reperfusion and selective temporary aneurysm sac perfusion (TASP) to prevent SCI in patients undergoing fenestrated-branched endovascular repair (F-BEVAR). Methods - Patients enrolled in a prospective, non-randomized single-center study between 2014 and 2017 underwent a SCI prevention protocol for TAAAs or >5-cm supraceliac coverage, including staged thoracic endovascular aortic repair (TEVAR) for Extent I-II TAAAs, cerebrospinal fluid (CSF) drainage, permissive hypertension (mean arterial pressure [MAP] >80 mmHg), LL reperfusion and neuromonitoring. A >75% decrease in motor evoked (MEP) and somatosensory evoked potential (SSEP) amplitude triggered standardized maneuvers. Selective TASP was indicated in patients with persistent decline or delayed recovery (>10 min) in MEP/SSEPs despite maneuvers. End-points adjudicated by independent clinical event committee and included mortality and rates of immediate and delayed (>6 hours) SCI. Results - SCI prevention protocol was indicated in 166 of 232 patients (72%) treated by F-BEVAR for pararenal aneurysms in 22 patients, Extent IV TAAAs in 59 and Extent I-III TAAAs in 85 (Figure). CSF drainage was successful in 162 patients (98%) and stable neuromonitoring was achieved in all patients. Eighty-eight patients (53%) had changes in neuromonitoring starting 50±37 minutes after introduction of the aortic device. Changes in neuromonitoring improved with maneuvers in all except for 10 patients (11%) who had persistent decline in MEP/SSEPs after LL reperfusion. All 10 patients had TASP by leaving a renal-mesenteric branch or contralateral iliac gate incomplete. There was one 30-day or in-hospital mortality (0.4%) due to a subarachnoid hemorrhage from CSF drainage. Ten patients (4%) developed SCIs, including 6 paraplegia and 4 paraparesis. SCIs were immediate in 4 and delayed in 6 with an incidence of 1% for pararenal, 0% for Extent IV, 13% for Extent III and 10% for Extent I-II TAAAs. The probable cause of SCI was hemodynamic compromise in 6 patients, embolic in 2 and epidural hematoma in 2. SCIs occurred in 1/78 patients (1%) with normal neuromonitoring and in 9/88 patients (10%) who had decline in MEP/SSEPs (P=0.02). Among the 10 patients with TASP, neurologic exam was normal in 8 and showed SCI in 2. TASP closure was completed in all patients at 22±16 days, with one SCI 2 days after completion. All 3 patients with post-TASP SCI had complete recovery to ambulatory status. Overall, 2 patients (1%) had permanent paraplegia, which was immediate and probably embolic in both. Factors associated with SCI included extent I-III TAAAs, change in neuromonitoring and need for TASP. Conclusion - This prospective non-randomized study showed that a standardized protocol was associated with low rate of permanent paraplegia (1%). The predominance of SCIs among patients with Extent I-III TAAAs confirms that this protocol may be avoided in lower risk patients (e.g. pararenal and Extent IV TAAAs) due to potential risk of spinal and cerebral hemorrhagic complications from CSF drainage. Although TASP does not completely prevent SCI, it may optimize recovery to ambulatory status. Further investigation is needed to evaluate the benefits of TASP to prevent permanent paraplegia.

Female Sex is not A Factor In Early and Midterm Outcomes Following Fenestrated-branched Endovascular Aortic Repair (F-BEVAR) of Complex Aortic Aneurysms (CAA)

Introduction: Female sex has been associated with worse outcomes, as compared to males, after open and infra-renal endovascular aortic repair (EVAR). This study aimed to evaluate and compare outcomes between males and females following F-BEVAR for CAA. Methods: A prospective nonrandomized trial for treating CAA was conducted at our institution between 2012 and 2018. In the retrospective analysis, patients were grouped by sex status (male vs. female). Data captured included demographics, comorbidities, aneurysm anatomical characteristics, procedural data, early and late outcomes. Aneurysms were grouped as Crawford types I-III or juxta/para-renal/Crawford type IV, based on the extent of the repair. Early outcomes included death and major adverse events (MAE: a composite of any death, estimated blood loss [EBL] >1L, myocardial infarction, respiratory failure, stroke/transient ischemic attack, spinal cord injury [SCI] or acute kidney injury). Chi-square and Student t-test were used to compare categorical and continuous variables, respectively, between groups. Kaplan-Meier curves were used to estimate survival, freedom from any-reintervention and branch instability. The log-rank test was used to compare groups. Cox proportional hazards regression models were used to adjust for variables found to be statistically significant in bivariate analyses with a p-value < .05 considered significant. Results: During our study period, we found 213 patients (62 [29%] females, 151 males [71%]) who underwent F-BEVAR for TAAA. The mean age was 71.1 years and not different between groups (p=.59). Males presented more frequently with CAD (53% vs. 37%,p=.03) and CHF (20% vs. 6.5%,p=.01) compared to females. Females had more frequent CKD stage 3-5 (47% vs. 30%, p=.02). Mean aneurysm diameter was larger in males (66 mm vs. 62 mm, p=.02). Females had more frequent aneurysm types I-III (45% vs. 15%[males], p< .0001). Regarding procedural data, females needed more frequent use of iliac conduits (32% vs. 7.3%,p< .0001) and upper extremity access (85% vs. 65%, p=.003. There was no difference in terms of operative time (p=.07), technical success (98% both groups, p=.85), the volume of contrast used (p=.87) or EBL (p=.41). The overall 30-day mortality and MAE were 1.9% (n=4) and 14% (n=31), with no difference between groups. Females presented with more frequent vascular access complications (18% vs. 8%, p=.03) and longer hospital stay (mean 6.4 vs. 4.5 days, p=.01). The mean follow-up was 17.8 months. The 3-year survival was 72.8% and 75.4% respectively for females and males (p=.66; figure 1). The unadjusted analysis showed lower rates of freedom from re-intervention (56.6% vs. 68.4%, p=.02) and branch-instability (70.3% vs. 82.1%) for females at 2-years. When adjusted for CAD, CHF, CKD and Crawford classification, female sex was not associated with an increased risk of re-intervention (HR: 0.81, 95%CI:0.46, 1.42; p=.46), branch-instability (HR:0.64, 95%CI:0.32, 1.28; p=.21) or death (HR: 1.48, 95%CI: 0.70, 3.13; p=.30). Conclusion: Although females presented with more extensive aneurysms necessitating increased procedural complexity, the 30-day mortality, MAE, and midterm outcomes were similar between males and females in adjusted analyses. Therefore, sex does not appear to be a determining factor in the decision-making process for complex endovascular aortic repair. Disclosure: M.F: Consultant, research support and clinical trials from Cook Medical; Consultant and clinical trials from W.L Gore, Medtronic, and Endologix. M.K: Consultant and proctor from Cook Medical; Consultant from Philips Volcano, and Penumbra.

Pre-operative Psoas Muscle Size Combined With Radiodensity Predicts Mid-Term Survival and Quality of Life After Fenestrated-Branched Endovascular Aortic Repair

To investigate the association between psoas muscle area (PMA) and density (PMD) with survival and quality of life (QoL) after fenestrated-branched endovascular aortic repair (F-BEVAR). The study included 244 consecutive patients enrolled in a prospective study to investigate outcomes of F-BEVAR. Pre-operative computed tomography angiography was used to measure PMA (cm2) and PMD (Hounsfield unit [HU]) at the L3 level. Lean PMA (LPMA) was calculated (PMA×PMD). Patients were divided into two groups using the LPMA cut off point based on a Cox hazard model. Group A was defined as LPMA ≥350 (n=79) and group B as LPMA<350cm2×HU (n=165). QoL was assessed at baseline and at 12 months using the Short Form-36. Patients in group A were younger (mean age 72±8 vs. 76±7 years; p<.001), more often male (95% vs. 59%; p<.001), and had higher body mass index (30±6 vs. 27±5kg/m2; p=.001). There were no major differences in comorbidities, aneurysm extent, or procedural measures between the groups. Thirty day mortality (0% vs. 0.6%; p=1.0) and major adverse event rates (15% vs. 24%; p=.18) were similar in groups A and B. At three years, patient survival was 94%±3% in group A and 75%±4% in group B (hazard ratio [HR] 0.20, 95% confidence interval [CI] 0.07-0.56; p=.002). The three-year survival difference was even more prominent in patients aged ≥75 years: 100% for group A and 72%±5% for group B (HR 0.12, 95% CI 0.02-0.86; p=.035). Patients in group A had significantly higher QoL scores at baseline and at 12 months. LPMA was the strongest independent predictor of survival during follow up in multivariable analysis (adjusted HR 0.59 per 1 standard deviation, 95% CI 0.40-0.87; p=.008). A high LPMA was independently and strongly associated with better mid term survival and QoL after F-BEVAR. LPMA may help to identify the best candidates for F-BEVAR among elderly patients.

Cerebrospinal fluid drainage complications during first stage and completion fenestrated-branched endovascular aortic repair

ObjectiveTo determine the rates and risk factors of complications related to cerebrospinal fluid drainage (CSFD) during first stage and completion fenestrated-branched endovascular aortic repair (F-BEVAR) of pararenal and thoracoabdominal aortic aneurysms. MethodsWe reviewed the outcomes of 293 consecutive patients enrolled in a prospective, nonrandomized study to investigate outcomes of F-BEVAR between 2013 and 2018. Patients who received CSFD during first-stage thoracic endovascular aortic repair, index F-BEVAR, or completion of temporary aneurysm sac perfusion procedures were included in the analysis. CSFD complications were graded as severe or moderate if they were life threatening, escalated the level of care, or prolonged the hospital stay. Presence of substantial degenerative lumbar disease (DLD) was identified based on review of preoperative computed tomography. End points included technical difficulties during CSFD placement and CSFD-related complications. ResultsA total of 187 patients (mean age, 73 ± 8 years; 70% male) treated for 20 pararenal and 167 thoracoabdominal aortic aneurysms received CSFD in 240 procedures, including 51 first-stage thoracic endovascular aortic repairs, 184 index F-BEVARs, and 5 completion temporary aneurysm sac perfusion procedures. Nineteen patients (10%) had 22 CSFD-related complications after 21 aortic procedures (9%). Complications were graded as severe to moderate in 17 patients (9%). There were 12 patients (6%) with intracranial hypotension, including three (2%) who had intracranial hemorrhage and nine (5%) with post dural puncture headache requiring blood patches in six. Another six patients (3%) developed spinal hematomas resulting in paraplegia in two (1%) and transient paraparesis in two (1%). One patient had CSF leakage from the puncture site (no intervention required). Four patients had bleeding during attempted drain placement, which required postponement of F-BEVAR. Technical difficulties were experienced in 57 drain insertions (24%), more often in patients with DLD than in those without DLD (35/113 [31%] vs 22/121 [18%]; P = .03). Fluoroscopic guidance was used in 44 drain placements (18%) with a lower rate of technical difficulties compared with the blind approach (9% vs 28%; P = .01). There was a statistically nonsignificant trend toward more complications in patients with technical challenges (14% vs 7%; P = .10). Of 13 study patients who developed spinal cord injuries during aortic procedures, 4 (31%) were attributed to CSFD. ConclusionsAlthough CSFD is widely used to prevent ischemic spinal cord injury during complex aortic repair, the risk of major CSFD-related complications is not negligible and should be carefully weighed against its potential benefits. One-third of spinal cord injuries were caused by CSF drain placement. The use of fluoroscopic guidance may decrease the risk of CSFD-related complications.

Renal volumes and estimated glomerular filtration rate changes after fenestrated-branched endovascular aortic repair

ObjectiveTo describe changes in renal volumes (RV) and renal function after fenestrated-branched endovascular repair (F-BEVAR) for complex aortic aneurysms. MethodsThe data from patients enrolled in a physician-sponsored investigational device exemption clinical trial for endovascular treatment of complex aortic aneurysms from July 2012 to April 2017 were retrospectively analyzed. Descriptive statistics were calculated using the mean ± standard deviation. The mean estimated glomerular filtration rate (eGFR) and RV were calculated at baseline and 6, 12, and 18 months after F-BEVAR. Variable distributions were evaluated for skewness, and all models required log-transformation. Linear models using generalized estimating equations were used to assess the association between the RV and eGFR over time after adjustment for relevant covariates. We used Kaplan-Meier life-table analysis to calculate survival and branch patency. ResultsA total of 139 patients were followed up for 18 months or until death. The mean age was 71 ± 8 years (70% male). The most common risk factor was hypertension (92%). Chronic kidney disease (CKD; eGFR <60 mL/min) was present in 56 patients (40%). Thirty-one patients (22%) had ≥1 accessory renal artery. Of these 31 accessory arteries, 27 (87%) were embolized or covered. On average, the eGFR had decreased over time compared with baseline, with a median change of −4.4 mL/min (interquartile range [IQR], −11.4 to 4.9 mL/min), −2.6 mL/min (IQR, −11.9 to 6.5 mL/min), and −3.4 mL/min (IQR, −11.9 to 5.5 mL/min) at 6, 12, and 18 months postoperatively, respectively. Similarly, the RV had decreased from baseline by 8% ± 17%, 10% ± 17%, and 11% ± 22% at 6, 12, and 18 months, respectively. An increase in the baseline patient age of 5 years was estimated to be associated with a 3% (95% confidence interval [CI], 0.2%-6.0%) decrease in the mean eGFR during the follow-up period, collapsing over time. This change is similar to the natural history of renal deterioration with age. We estimated that an increase in the log-RV of 1 U would be associated with an estimated 26% (95% CI, 3%-52%) increase in the mean eGFR. Preexisting CKD did not affect the average change in RV. Of the 56 patients with previous CKD, 9 (16.1%) showed improvement in the eGFR to >60 mL/min. The median follow-up period was 17.9 months (IQR, 6.3-24.8). The Kaplan-Meier survival rate at 1 and 2 years was 84.7% (95% CI, 78.3%-91.1%) and 78.8% (95% CI, 71.0%- 86.6%), respectively. ConclusionsThe RV and eGFR decreased in patients undergoing repair at the rates expected for patients with complex aortic disease. The eGFR correlated with the RV. Most of the decline in renal function occurred within the first 6 months postoperatively, after which, the renal function had stabilized.

Preloaded Catheters and Guide-Wire Systems to Facilitate Catheterization During Fenestrated and Branched Endovascular Aortic Repair.

The aim of this study was to review the clinical outcomes for patients treated for pararenal (PRA) and thoracoabdominal aortic aneurysms (TAAAs) by fenestrated-branched endovascular aortic repair (F-BEVAR) using preloaded systems (PLS). We reviewed clinical data of 83 patients (64 male, mean age 75 ± 7years) enrolled in a prospective study to investigate F-BEVAR. All patients had PLS, which included two catheters or two through-and-through guide wires with 12-Fr trans-brachial sheaths positioned in the descending thoracic aorta. Outcome measurements were technical success defined as successful deployment of the main fenestrated stent graft and cannulation of all target vessels, total endovascular time, total lower extremity ischemia time and complications, 30-day mortality, and major adverse events (MAEs). Aneurysm extent was PRA in 27 patients and TAAA in 56 (35 extent IV and 21 extent I-III). A total of 333 target vessels were incorporated with an average of 4 ± 0.4 vessels per patient. Technical success was 99.7%. Total endovascular time was 160 ± 51min. Sixty-five (78%) patients had motor and somatosensory evoked potentials monitoring, and lower extremity ischemia time was 115 ± 42min. There were no 30-day mortalities. Fifteen patients (18%) had MAEs, including three (3.6%) minor ischemic strokes. There were no upper extremity complications. All ischemic strokes occurred in female patients (3.6% vs. 0%, P = .001). One (1.2%) patient had paraplegia. This study shows high technical success and early lower limb reperfusion using PLS with trans-brachial access. The risk of stroke, especially in female patients, should be carefully assessed by review of preoperative arch imaging.

Secondary Endovascular Repair of Recurring Lesions and Perioperative Complications after Open Aortic Repair: The Complementary Role of Different Technical Solutions

The aim of our article was to describe the complementary role of different technical solutions for secondary endovascular repair of recurring lesions and perioperative complications after open aortic repair (OAR). We describe our clinical experience of secondary endovascular repair after OAR. We included in the analysis all consecutive patients who presented recurring lesions and perioperative complications after OAR and underwent secondary endovascular repair between January 1, 2015 and June 31, 2018. Both elective and nonelective cases were captured. Early end points were technical success, 30-day mortality, 30-day major adverse events, and 30-day vascular access complications. Late end points were survival and freedom from secondary interventions. Three different techniques were used in 6 patients: 2 cases of fenestrated-branched endovascular aortic repair (F-BEVAR), 2 cases of parallel-graft EVAR (pg-EVAR), and 2 cases of off-label use of standard devices. Technical success was 100%. One patient died within 30days from acute pulmonary embolism. One patient developed acute kidney injury not requiring renal replacement therapy, whereas the remaining 4 patients were free from 30-day major adverse events. The cumulative rate of 30-day vascular access complications was 0%. All the 5 patients who survived the index hospitalization had ≥12months of clinical and imaging follow-up. At the longest individual follow-up, they all were alive and free from secondary interventions. Computed tomography angiography showed in all cases sustained clinical success. Secondary endovascular repair of recurring lesions and perioperative complications after OAR is safe and feasible and offers a minimally invasive effective treatment option when a redo surgical operation would be associated with a considerable risk to the patient. Different solutions are available (including F-BEVAR, pg-EVAR, and off-label use of standard devices) and are complementary rather than competitive. Careful preoperative assessment and familiarity with advanced techniques are essential to achieve satisfactory outcomes.

IPC07. Outcomes of Standard Versus Low-Profile Fenestrated-Branched Endovascular Aortic Repair for Pararenal and Thoracoabdominal Aneurysms

The aim of this study was to compare outcomes of standard-profile (SP) and low-profile (LP) fenestrated and branched stent grafts for treatment of pararenal and thoracoabdominal aortic aneurysms. We reviewed the clinical data of all consecutive patients enrolled in a prospective, nonrandomized study to investigate fenestrated-branched endovascular aortic repair (F-BEVAR) for PRAs and TAAAs between 2013 and 2018. Outcomes were analyzed in patients treated with SP (22F) or LP (18-20F) off-the-shelf or patient-specific devices with up to five fenestrations or branches. End points were access-related complications (iliofemoral rupture, dissection, thrombosis), need for iliac conduit, procedural metrics, major adverse events, and mortality. There were 298 patients treated by F-BEVAR (71% male; mean age, 74 ± 8 years old), including 118 patients (40%) with extent I to III TAAAs, 78 patients (26%) with extent IV TAAAs, and 102 patients (34%) with PRAs. SP stent grafts were used in 186 patients (62%) and LP devices in 112 patients (38%). LP devices were more frequently used for chronic dissections (13% vs 4%; P = .009) and for extent I to III TAAAs (57% vs 30%; P < .0001) compared with SP devices. Preloaded catheters were used in 126 patients (68%) treated with SP devices, whereas preloaded guidewire systems were used in 68 patients (61%) who had LP stent grafts. A total of 1144 target vessels were incorporated with a mean of 3.9 ± 0.6 vessels per patient in both groups (P = .17). There were no differences in procedural metrics (Table I), including total operating time, estimated blood loss, contrast use, and radiation exposure between SP and LP devices, respectively. Technical success was similar in patients who had SP and LP stent grafts (98% vs 95%; P = .07), respectively. There were six access-related complications (four ruptures, one dissection and one thrombosis), all in patients treated by SP devices (P = .05). Autotransfusion was used more often in patients treated with SP compared with LP devices (32% vs 19%; P = .02). Iliac conduits were required in 11 patients (6%) treated with SP and in 2 (2%) who had LP devices (P = .09). Overall, two patients (1%) died at 30 days and 83 (28%) had major adverse events, without significant differences in between groups (Table II). F-BEVAR was performed with similar procedural metrics and early outcomes using either SP or LP devices. LP devices were associated with less access-related complications, less autotransfusion requirement, and a nonsignificant trend toward less need for iliac conduits.Table IProcedures metrics and technical successOverall (n = 298)Standard-profile (n = 186)Low-profile (n = 112)P valueContrast volume, mL154 ± 56156 ± 58151 ± 54.47Fluoroscopy time, min83 ± 3282 ± 3184 ± 33.51Total endovascular time, min165 ± 63166 ± 59164 ± 69.87Total operation time, min245 ± 80248 ± 78240 ± 82.41Estimated blood loss, mL441 ± 505454 ± 493419 ± 525.57Technical success per patients289/298 (96.9)183/186 (98.3)106/112 (94.6).07Values are number (%) or mean ± standard deviation. Open table in a new tab Table IIEarly outcomesOverall (n = 298)Standard-profile (n = 186)Low-profile (n = 112)P valueAny MAE83 (28)49 (26)34 (30).45Death2 (1)1 (1)1 (1).71EBL >1 L25 (8)16 (9)9 (8).86AKI by RIFLE criteria43 (14)26 (14)17 (15).77New-onset dialysis6 (2)4 (2)2 (2).83Myocardial infarction10 (3)6 (3)4 (4).87Respiratory failure6 (2)3 (2)3 (3).52Paraplegia8 (3)5 (3)3 (3).99Permanent paraplegia4 (1)2 (1)2 (2).61Major stroke2 (1)1 (1)1 (1).71Bowel ischemia5 (2)3 (2)2 (2).91AKI, Acute kidney injury; EBL, estimated blood loss; MAE, major adverse event; RIFLE, Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease.Values are number (%). Open table in a new tab

SS08. Cerebrospinal Fluid Drainage Complications During First Stage and Completion Fenestrated-Branched Endovascular Aortic Repair

To determine the rates and risk factors of complications related to cerebrospinal fluid drainage (CSFD) during fenestrated-branched endovascular aortic repair (F-BEVAR) of pararenal and thoracoabdominal aortic aneurysms. We reviewed outcomes of 293 consecutive patients enrolled in a prospective, nonrandomized study to investigate outcomes of F-BEVAR between 2013 and 2018. Patients who received CSFD during first-stage thoracic endovascular aortic repair, index F-BEVAR or completion temporary aneurysm sac perfusion procedures were included in the analysis. CSFD complications were graded as severe or moderate if these were life threatening, escalated the level of care or prolonged hospital stay. Presence of degenerative lumbar disease (DLD) was identified based on review of computed tomography scans. End points included technical difficulties during CSFD placement and CSFD-related complications. A total of 187 patients (mean age, 73 ± 8 years; 70% male) treated for 20 pararenal and 167 thoracoabdominal aortic aneurysms received CSFD in 240 procedures, including 51 first-stage thoracic endovascular aortic repairs, 184 index F-BEVARs and 5 completion temporary aneurysm sac perfusion procedures. Nineteen patients (10%) had 22 severe to moderate CSFD-related complications after 21 aortic procedures (9%). There were 12 patients (6%) with intracranial hypotension, including 3 (2%) who had intracranial hemorrhage (Fig 1) and 9 (5%) with severe headache requiring blood patches in 6. Another six patients (3%) developed spinal hematomas (Fig 2) resulting in paraplegia in two (1%) or transient paraparesis in two (1%). Other complications were cerebrospinal fluid leakage in one patient (no intervention) and bleeding during attempted CSFD placement requiring postponement of index F-BEVAR in three. In addition, 20 patients (11%) had blood-tinged drainage or bleeding at the puncture site without any clinical sequela. Technical difficulties were experienced in 57 drain insertions (24%), more often in patients with DLD compared with those without DLD (35/113 [31%] vs 22/121 [18%]; P = .03). Fluoroscopic guidance was used in 44 CSFD placements (18%) with lower rate of technical difficulties compared with blind approach (9% vs 28%; P = .01). There was a statistically nonsignificant trend toward more complications in patients with technical challenges (14% vs 7%; P = .10). Of the 13 patients who developed spinal cord injuries during aortic procedures, 4 (31%) were attributed to CSFD placement. Although CSFD is widely used to prevent ischemic spinal cord injury during complex aortic repair, the risk of major CSFD-related complications is not negligible and should be carefully weighed against its potential benefits. Use of fluoroscopic guidance may reduce the risk of CSFD complications.Fig 2Spinal hematoma.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Should endovascular approach be considered as the first option for thoraco-abdominal aortic aneurysms?

Open surgical repair has been the gold standard for treatment of thoracoabdominal aortic aneurysms (TAAAs). The technique of open TAAA repair has evolved from the use of "island" patch incorporation to separate branch vessel bypass, from "clamp and go" to routine use of distal perfusion, and towards more extensive repair in patients with connective tissue disorders. Open TAAA repair can be done with excellent results in highly specialized centers. However, these operations continue to carry excessive risk when performed outside large aortic centers, with 30-day mortality estimated on 20% according to statewide and national databases. In octogenarians, the mortality of elective open TAAA repair can be up to 40%. Endovascular repair was introduced as an alternative to open surgical repair in the elderly or higher risk patients using hybrid reconstruction, parallel grafts or fenestrated and branched endografts. Several large aortic centers have developed dedicated clinical programs to advance techniques of fenestrated-branched endovascular repair using patient-specific and off-the-shelf devices, offering a minimally invasive alternative to open repair allowing treatment of increasingly older and sicker TAAA patients. During the last decade, improvements in device design, patient selection, spinal cord injury protocols, and perioperative management have contributed to a continued decline in morbidity and mortality of fenestrated-branched endovascular aortic repair, challenging open surgical repair as the new "gold standard" for treatment of TAAAs. Despite the improved results, endovascular repair is a highly technical procedure that requires vast experience, involves a significant risk of complications, and also, has an impact on patients' physical quality of life. In this article, we review the current technical aspects of endovascular TAAA repair with the main focus on the evidence of open versus endovascular outcomes of TAAA repair.