Fenestrated-branched Endovascular Aortic Repair Research Articles

Fate of primary determinate and indeterminate target vessel endoleaks after fenestrated-branched endovascular aortic repair

ObjectiveThe aim of this study was to investigate the outcomes of primary determinate and indeterminate target vessel endoleaks (TVELs) after fenestrated-branched endovascular aortic repair (F-BEVAR). MethodsWe conducted a single-center retrospective study (2014-2023) on F-BEVAR for thoracoabdominal (TAAAs) or pararenal aortic aneurysms (PRAAs). TVELs were classified as “primary” if present at the first postoperative computed tomography angiogram. Endoleaks were defined “determinate” (dELs) if the cause (type Ic or IIIc) and implicated target vessel were identifiable and “indeterminate” (iELs) if contrast enhancement was detectable at the level of fenestrations/branches without any evident source. Endoleaks involving multiple inflows (type II and target vessels) were defined as “complex” (cELs). Endpoints were endoleak spontaneous resolution, 1-year aneurysm sac failure to regress (>5 mm diameter decrease), and 4-year endoleak-related secondary interventions. Kaplan-Meier estimates and Cox regression were used for the analysis. ResultsThere were 142 patients with JRAAs/PRAAs (n = 85; 60%) or TAAAs (n = 57; 40%), with 513 target arteries incorporated through a fenestration (n = 294; 57%) or directional branch (n = 219; 43%). Fifty-nine primary TVELs (12%) were identified in 35 patients (25%), a dEL in 20 patients (14%) and iEL in 15 (11%); 22 (15%) had a determinate or indeterminate cEL. Overall spontaneous resolution rate was 75% (95% confidence interval [CI], 51%-87%) at 4 years. cELs (odds ratio [OR], 5.00; 95% CI, 1.10-49.4; P < .001) and iELs after BEVAR (OR, 9.43; 95% CI, 3.41-56.4; P = .002) were more likely to persist >6 months, and persistent forms were associated with sac failure to regress at 1 year (OR, 1.72; 95% CI, 1.03-12.59; P = .040). Overall freedom from endoleak-related reinterventions was 85% (95% CI, 79%-92%) at 4 years, 92% (95% CI, 87%-97%) for those without primary TVELs and 62% (95% CI, 46%-84%) for those with any primary TVEL (P < .001). In particular, cELs (hazard ratio, 1.94; 95% CI, 1.4-18.81; P = .020) were associated with an increased need for reintervention. In case a secondary intervention was needed, iEL or cEL had an increased risk for multiple secondary procedures (hazard ratio, 2.67; 95% CI, 1.22-10.34; P = .034). ConclusionsPrimary TVELs are frequent after F-BEVAR, and a clear characterization of the endoleak source by computed tomography angiogram is not possible in 40% of patients. Most primary TVELs spontaneously resolve, but during follow-up, patients with any primary TVEL experience a worsened freedom from endoleak-related reinterventions that is mostly driven by persistence of cELs and post-BEVAR iELs. Multiple secondary procedures may be required in case of iELs or cELs.

Multicenter trans-Atlantic experience with fenestrated-branched endovascular aortic repair of chronic post-dissection thoracoabdominal aortic aneurysms: Presented at the 2022 Vascular Annual Meeting of the Society for Vascular Surgery, Boston, Massachusetts, June 15-18, 2022.

Multicenter trans-Atlantic experience with fenestrated-branched endovascular aortic repair of chronic post-dissection thoracoabdominal aortic aneurysms: Presented at the 2022 Vascular Annual Meeting of the Society for Vascular Surgery, Boston, Massachusetts, June 15-18, 2022.

Outcomes of Renal Branch Instability in Patients Undergoing Fenestrated-Branched Endovascular Aortic Repair

Outcomes of Renal Branch Instability in Patients Undergoing Fenestrated-Branched Endovascular Aortic Repair

Changes in renal-mesenteric duplex ultrasound velocities after fenestrated and branched endovascular aortic aneurysm repair

ObjectiveStenting of renal and mesenteric vessels may result in changes in velocity measurements due to arterial compliance, potentially giving rise to confusion about the presence of stenosis during follow-up. The aim of our study was to compare preoperative and postoperative changes in peak systolic velocity (PSV, cm/s) after placement of the celiac axis (CA), superior mesenteric artery (SMA) and renal artery (RAs) bridging stent grafts during fenestrated-branched endovascular aortic repair (FB-EVAR) for treatment of complex abdominal aortic aneurysms (AAA) and thoracoabdominal aortic aneurysms. MethodsPatients were enrolled in a prospective, nonrandomized single-center study to evaluate FB-EVAR for treatment of complex AAA and thoracoabdominal aortic aneurysms between 2013 and 2020. Duplex ultrasound examination of renal-mesenteric vessels were obtained prospectively preoperatively and at 6 to 8 weeks after the procedure. Duplex ultrasound examination was performed by a single vascular laboratory team using a predefined protocol including PSV measurements obtained with <60° angles. All renal-mesenteric vessels incorporated by bridging stent grafts using fenestrations or directional branches were analyzed. Target vessels with significant stenosis in the preoperative exam were excluded from the analysis. The end point was variations in PSV poststent placement at the origin, proximal, and mid segments of the target vessels for fenestrations and branches. ResultsThere were 419 patients (292 male; mean age, 74 ± 8 years) treated by FB-EVAR with 1411 renal-mesenteric targeted vessels, including 260 CAs, 409 SMAs, and 742 RAs. No significant variances in the mean PSVs of all segments of the CA, SMA, and RAs at 6 to 8 weeks after surgery were found as compared with the preoperative values (CA, 135 cm/s vs 141 cm/s [P = .06]; SMA, 128 cm/s vs 125 cm/s [P = .62]; RAs, 90 cm/s vs 83 cm/s [P = .65]). Compared with baseline preoperative values, the PSV of the targeted vessels showed no significant differences in the origin and proximal segment of all vessels. However, the PSV increased significantly in the mid segment of all target vessels after stent placement. ConclusionsStent placement in nonstenotic renal and mesenteric vessels during FB-EVAR is not associated with a significant increase in PSVs at the origin and proximal segments of the target vessels. Although there is a modest but significant increase in velocity measurements in the mid segment of the stented vessel, this difference is not clinically significant. Furthermore, PSVs in stented renal and mesenteric arteries were well below the threshold for significant stenosis in native vessels. These values provide a baseline or benchmark for expected PSVs after renal-mesenteric stenting during FB-EVAR.

Outcomes of Elective and Non-elective Fenestrated-branched Endovascular Aortic Repair for Treatment of Thoracoabdominal Aortic Aneurysms.

To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006-2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. A total of 2603 patients (69% males; mean age 72±10year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P <0.001) and rates of MAEs (34% vs 20%, P <0.001). Median follow-up was 15 months (interquartile range, 7-37months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P <0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50-2.44; P <0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63-3.62; P <0.001). Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.

Mid-Term Outcomes of "Complete Aortic Repair": Surgical or Endovascular Total Arch Replacement With Thoracoabdominal Fenestrated-Branched Endovascular Aortic Repair.

To describe a single-center experience of "complete aortic repair" consisting of surgical or endovascular total arch replacement/repair (TAR) followed by thoracoabdominal fenestrated-branched endovascular aortic repair (FB-EVAR). We reviewed 480 consecutive patients who underwent FB-EVAR with physician-modified endografts (PMEGs) or manufactured stent-grafts between 2013 and 2022. From those, we selected only patients treated with open or endovascular arch repair and distal FB-EVAR for aneurysms involving the ascending, arch and thoracoabdominal aortic segments (zones 0-9). Manufactured devices were used under an investigational device exemption protocol. Endpoints included early/in-hospital mortality, mid-term survival, freedom from secondary intervention, and target artery instability. There were 22 patients, 14 men and 8 women with a median age of 72±7 years. Thirteen postdissection and 9 degenerative aortic aneurysms were repaired with a mean maximum diameter of 67±11 mm. Time from index aortic procedure to aneurysm exclusion was 169 and 270 days in those undergoing 2- and 3-stage repair strategies, respectively. The ascending aorta and aortic arch were treated with 19 surgical and 3 endovascular TAR procedures. Three (16%) surgical arch procedures were performed elsewhere, and perioperative details were unavailable. Mean bypass, cross-clamp, and circulatory arrest times were 295±57, 216±63, and 46±11 minutes, respectively. There were 4 major adverse events (MAEs) in 2 patients: both required postoperative hemodialysis, 1 had postbypass cardiogenic shock necessitating extracorporeal membrane oxygenation, and the other required evacuation of an acute-on-chronic subdural hematoma. Thoracoabdominal aortic aneurysm repair was performed with 17 manufactured endografts and 5 PMEGs. There was no early mortality. Six (27%) patients experienced MAEs. There were 4 (18%) cases of spinal cord injury with 3 (75%) experiencing complete symptom resolution before discharge. Mean follow-up was 30±17 months in which there were 5 patient deaths-0 aortic related. Eight patients required ≥1 secondary intervention, and 6 target arteries demonstrated instability (3 IC, 1 IIIC endoleaks; 2 TA stenoses). Kaplan-Meier 3-year estimates of patient survival, freedom from secondary intervention, and target artery instability were 78±8%, 56±11%, and 68±11%, respectively. Complete aortic repair with staged surgical or endovascular TAR and distal FB-EVAR is safe and effective with satisfactory morbidity, mid-term survival, and target artery outcomes. The presented study demonstrates that repair of the entirety of the aorta - via total endovascular or hybrid means- is safe and effective with low rates of spinal cord ischemia. Cardiovascular specialists within comprehensive aortic teams at should feel confident that staged repair of the most complex degenerative and post-dissection thoracoabdominal aortic aneurysms can be safely performed in their patients with complication profile similar to that of less extensive repairs. Meticulous and intentional case planning is imperative for immediate and long-term success.

Multicenter trans-Atlantic experience with fenestrated-branched endovascular aortic repair of chronic post-dissection thoracoabdominal aortic aneurysms

ObjectiveThis multicenter international study aimed to describe outcomes of fenestrated-branched endovascular aortic repairs (FB-EVAR) in a cohort of patients treated for chronic post-dissection thoracoabdominal aortic aneurysms (PD-TAAAs). MethodsWe reviewed the clinical data of all consecutive patients treated by FB-EVAR for repair of extent I to III PD-TAAAs in 16 centers from the United States and Europe (2008-2021). Data were extracted from institutional prospectively maintained databases and electronic patient records. All patients received off-the-shelf or patient-specific manufactured fenestrated-branched stent grafts. Endpoints were any cause mortality and major adverse events at 30 days, technical success, target artery (TA) patency, freedom from TA instability, minor (endovascular with <12 Fr sheath) and major (open or ≥12 Fr sheath) secondary interventions, patient survival, and freedom from aortic-related mortality (ARM). ResultsA total of 246 patients (76% male; median age, 67 years [interquartile range, 61-73 years]) were treated for extent I (7%), extent II (55%), and extent III (35%) PD-TAAAs by FB-EVAR. The median aneurysm diameter was 65 mm (interquartile range, 59-73 mm). Eighteen patients (7%) were octogenarians, 212 (86%) were American Society of Anesthesiologists class ≥3, and 21 (9%) presented with contained ruptured or symptomatic aneurysms. There were 917 renal-mesenteric vessels targeted by 581 fenestrations (63%) and 336 directional branches (37%), with a mean of 3.7 vessels per patient. Technical success was 96%. Mortality and rate of major adverse events at 30 days was 3% and 28%, including disabling complications such as new onset dialysis in 1%, major stroke in 1%, and permanent paraplegia in 2%. Mean follow-up was 24 months. Kaplan-Meier (KM) estimated patient survival at 3 and 5 years was 79% ± 6% and 65% ± 10%. KM estimated freedom from ARM was 95% ± 3% and 93% ± 5% at the same intervals. Unplanned secondary interventions were needed in 94 patients (38%), including minor procedures in 64 (25%) and major procedures in 30 (12%). There was one conversion to open surgical repair (<1%). KM estimated freedom from any secondary intervention was 44% ± 9% at 5 years. KM estimated primary and secondary TA patency were 93% ± 2% and 96% ± 1% at 5 years, respectively. ConclusionsFB-EVAR for chronic PD-TAAAs was associated with high technical success and a low rate of mortality (3%) and disabling complications at 30 days. Although the procedure is effective in the prevention of ARM, patient survival was low at 5 years (65%), likely due to the significant comorbidities in this cohort of patients. Freedom from secondary interventions at 5 years was 44%, although most procedures were minor. The significant rate of reinterventions highlights the need for continued patient surveillance.

Incidence and risk factors for interval aortic events during staged fenestrated-branched endovascular aortic repair

ObjectiveStaged endovascular repair of complex aortic aneurysms with first-stage thoracic endovascular aortic repair may decrease the risk of spinal cord ischemia (SCI) associated with fenestrated-branched endovascular aortic repair (FB-EVAR) of thoracoabdominal aortic aneurysms or optimize the proximal landing zone in the cases requiring total aortic arch repair. However, a limitation of multistaged procedures is the risk of interval aortic events (IAEs) including mortality from a ruptured aneurysm. We aim to identify the incidence of and risk factors associated with IAEs during staged FB-EVAR. MethodsThis was a single-center, retrospective review of patients who underwent planned staged FB-EVAR from 2013 to 2021. Clinical and procedural details were reviewed. End points were the incidence of and risk factors associated with IAEs (defined as rupture, symptoms, and unexplained death) and outcomes in patients with or without IAEs. ResultsOf 591 planned FB-EVAR patients, 142 underwent first-stage repairs. Twenty-two did not have a planned second stage because of frailty, preference, severe comorbidities, or complications after the first stage and were excluded. The remaining 120 patients (mean age: 73 ± 6 years, 51% female) were planned for second-stage completion FB-EVAR and comprised our cohort. The incidence of IAEs was 13% (16 of 120). This included confirmed rupture in 6 patients, possible rupture in 4, symptomatic presentation in 4, and early unexplained interval death with possible rupture in 2. The median time to IAEs was 17 days (range: 2-101 days), and the median time to uncomplicated completion repairs was 82 days (interquartile range: 30-147 days). Age, sex, and comorbidities were similar between the groups. There were no differences in familial aortic disease, genetically triggered aneurysms, aneurysm extent, or presence of chronic dissection. Patients with IAEs had significantly larger aneurysm diameters than those without IAEs (76.6 vs 66.5 mm, P ≤ .001). This difference persisted with indexing for body surface area (aortic size index: 3.9 vs 3.5 cm/m2, P = .04) and height (aortic height index: 4.5 vs 3.9 cm/m, P ≤ .001). IAE mortality was 69% (11 of 16) compared with no perioperative deaths for those with uncomplicated completion repairs. ConclusionsThe incidence of IAEs was 13% in patients planned for staged FB-EVAR. This represented a notable morbidity, including rupture, which must be balanced with SCI and landing zone optimization when planning repair. Larger aneurysms, especially when adjusted for body surface area, are associated with IAEs. Minimizing time between stages vs single-stage repairs for larger (>7 cm) complex aortic aneurysms in patients with reasonable SCI risk should be considered when planning repair.

Fiber Optic RealShape imaging using upper extremity and transfemoral access for fenestrated-branched endovascular aortic aneurysm repair.

We report our initial experience using Fiber Optic RealShape (FORS), an innovative real-time three-dimensional visualization technology that uses light instead of radiation, to achieve upper extremity (UE) access during fenestrated/branched endovascular aortic aneurysm repair (FBEVAR). An 89-year-old male patient with a type III thoracoabdominal aortic aneurysm, unfit for open aortic repair, underwent FBEVAR. Dual fluoroscopy, intravascular ultrasound, and three-dimensional fusion overlay were used, in addition to FORS. All target artery catheterizations were successfully accomplished using FORS, from UE access, without radiation. Our experience demonstrates that FBEVAR with FORS using UE access can be used for target artery catheterization without radiation.

Total Transfemoral Approach Is Associated With Lower Rates of Cerebrovascular Events and Improved Outcomes Compared With Upper Extremity Approach During Fenestrated-Branch Endovascular Aortic Repair

Upper extremity (UE) access has been widely used during fenestrated-branched endovascular aortic repair (FB-EVAR) but potentially increases the risk of cerebrovascular events. Steerable sheaths have allowed more liberal use of a total transfemoral (TF) approach (Fig), but this technique may increase technical difficulty, operative time, and lower extremity ischemia. The aim of this study was to compare procedural metrics and early outcomes of FB-EVAR for complex abdominal and thoracoabdominal aortic aneurysms using either the UE or TF approach for vessel incorporation. Patients enrolled in a prospective, nonrandomized study to investigate FB-EVAR were analyzed (2013-2022). End points included procedural metrics, technical success, 30-day mortality, major adverse events (MAEs), and rates of cerebrovascular events in patients who had a UE or TF approach for renal-mesenteric vessel incorporation. A total of 541 patients (70% male; mean age 74 ± 8 years) were treated by FB-EVAR using the UE approach in 366 (68%) patients and TF access in 177 (33%) patients. A total of 2107 renal-mesenteric arteries were incorporated with a mean of 3.9 ± 0.5 vessels per patient. The TF approach was used in 8% of patients between 2013 and 2018 and progressively increased to 31% between 2018 and 2020 and 96% between 2020 and 2022 (P < .05). Both groups had similar characteristics, except for significantly (P < .05) less ASA >3 (51% vs 75%), less complex abdominal aortic aneurysms (24% vs 37%), and more thoracoabdominal aortic aneurysms (76% vs 63%) among patients who had a UE approach as compared to a TF approach, respectively. The use of the TF approach was associated with lower fluoroscopy time (P = .001), lower operative time (P < .001), similar cumulative air kerma (P = .20), and similar technical success (P = .96) as compared with the UE approach (Table). Mortality was 1% for all patients, with no difference between the groups (P = .67). Patients treated by the UE approach had significantly higher rates of MAEs (18% vs 8%, P = .006) and more cerebrovascular events (3% vs 0%, P = .035). Access complications occurred in 2% of patients, mostly related to femoral access sites, with no difference between the groups (P > .99). The total TF approach has been increasingly used during FB-EVAR and was associated with lower rates of MAEs and cerebrovascular events. There was no difference in technical success between the two approaches, but the TF approach was associated with a shorter operative time.TableDifferences in procedural metrics and outcomes between patients treated by fenestrated-branched endovascular repair using an upper extremity (UE) or total femoral (TF) approachUE (n = 366)TF (n = 175)P valueFluoroscopy time, minutes83 ± 3272 ± 39<.001Total operating time, minutes249 ± 78194 ± 71<.001Total endovascular time, minutes166 ± 63147 ± 58<.001Cumulative air kerma, mGy2 039.4 ± 1 7591 635.2 ± 1 304.2030-day mortality5 (1.4)1 (0.6).6730-day MAE67 (18)16 (9).006Acute kidney injury35 (9.6)13 (7.6).45Any cerebrovascular event10 (2.7)0 (0).035Any access complication8 (2.2)3 (1.7)>.99Any femoral access complication7 (1.9)3 (1.7)>.99Any UE access complication1 (0.3)0 (0)>.99MAE, Major adverse event.Continuous variables are presented as mean ± standard deviation, and categorical variables as number (%).Boldface P values represent significance P < .05. Open table in a new tab

Effect of Narrow Paravisceral Aorta on Target Vessel Instability After Fenestrated-Branched Endovascular Aortic Repair

The aim of this study was to investigate the effect of narrow paravisceral aorta (NPA) on target vessels instability (TVI) after fenestrated-branched endovascular aortic repair (F-BEVAR). We conducted a single-center retrospective study (2014-2022) on patients treated by F-BEVAR for thoracoabdominal (TAAAs) or pararenal aortic aneurysms (PRAAs). Paravisceral aorta was defined as the aortic segment limited by the diaphragmatic hiatus proximally and the emergence of lower renal artery distally and was considered “narrow” in case of minimum inner diameter <25 mm. Minimum aortic diameter, location, longitudinal extension, angulation, calcification, and thrombus thickness of NPA were evaluated at the preoperative computed tomography angiogram. Endpoints were technical success and freedom TVI (target vessel-related death, occlusion, rupture or reintervention for stenosis, endoleak, or disconnection). Kaplan-Meier estimates and Cox proportional hazards were used for analysis. Three hundred ninety-five incorporated target arteries were analyzed (110 patients; 50 TAAAs and 60 PRAAs), 214 fenestrations (54%), 102 outer branches (26%), and 79 inner branches (20%). NPA was present in 59 patients (54%), accounting for 202 target vessels (136 fenestrations, 44 inner branches, and 22 outer branches); the non-NPA group had 193 target vessels (78 fenestrations, 35 inner branches, and 80 outer branches). Overall technical success was 99% (NPA: 99%, Non-NPA: 99%; P = .879). Overall freedom from TVI at 4 years was 91% ± 5% (NPA: 90% ± 6%, non-NPA: 93% ± 6%; P = .752). After stratification by endograft design, NPA was not associated with TVI (fenestrations: hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.04-3.47; P = .442; inner branches: HR, 2.25; 95% CI, 0.47-16.25; P = .343; outer branches: HR, 1.09; 95% CI, 0.27-4.17; P = .891). The association of use of outer branches in NPA plus location at the level of the aortic zone 6 (from the origin of the celiac artery to the superior mesenteric artery), longitudinal extension >25 mm, or aortic wall moderate/severe calcifications, was cause of worsened freedom from TVI (P = .043; P = .031; and P = .045; respectively). Thrombus thickness (HR, 1.03; 95% CI, 0.93-1.13; P = .536) and angulation (HR, 1.02; 95% CI, 0.94-1.18; P = .602) of NPA were not significantly associated. NPA <20 mm was a negative predictor for bridging stents patency (HR, 1.12; 95% CI, 1.09-6.99; P = .028) with the use of fenestrations. FEVAR and BEVAR are both feasible in cases of NPA, and overall provide satisfactory target vessels durability. The use of outer branches should be avoided in cases with inner aortic diameter <25 mm at the level of the aortic zone 6, with longitudinal extension >25 mm, or moderate/severe NPA calcifications. In FEVAR, bridging stent patency may be negatively influenced by NPA<20 mm.

Prospective Assessment of Direct Measurements of Absorbed Radiation Exposure in Operators and Patients Undergoing Fenestrated and Branched Endovascular Aortic Repair

To analyze the direct dose of absorbed radiation exposure of the primary operator and the patient during fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs). Patients treated by FB-EVAR for CAAAs and TAAAs were prospectively enrolled between March and December 2022. Measurements of direct dose of absorbed radiation exposure were obtained using nanodots sensors (Landauer Inc., Glenwood, IL) positioned in standard location within unprotected skin area of the primary operator and patient face and periorbital area. The primary operator was positioned in the right femoral access site. Measurements of direct dose of absorbed radiation exposure (mGy) were compared with recorded metrics of the imaging unit including total radiation dose (mGy), dose area product (DAP) (mGy·cm2) and fluoroscopy time (minutes). There were 48 patients (75% male; mean age, 73 ± 9 years) enrolled in the study and treated by FB-EVAR for TAAAs in 38 patients (79%), CAAAs in 8 (17%), and arch aneurysms in 2 (4%). As shown in the Figure, measurements of DDRAE was three-fold higher for the patient compared to the primary operator (0.34 ± 0.27 vs 0.09 ± 0.06 mGy; P < .001). The left side of the primary operator face and periorbital artery was exposed to five-fold higher DDRAE compared to the right side (0.16 ± 0.12 vs 0.03 ± 0.004 mGy; P < .001). For the patient, the left side was exposed to significantly higher DDRAE as compared to the right side (0.42 ± 0.34 vs 0.32 ± 0.33 mGy; P < .001). All three recorded metrics (total radiation dose, DAP, and fluoroscopy time) had significant linear correlation with DDRAE measurements for the primary operator (P < .001). However, for the patient a linear correlation with DDRAE measurements was observed only for fluoroscopy time (P = .002) and not for total radiation dose (P = .28) or DAP (P = .49). Patients treated by FB-EVAR have on average five-fold higher dose of absorbed radiation in the unprotected face and periorbital areas as compared to their primary operators, with significantly higher doses in their left side as compared to the right side. For the primary operator, the left side of the face and periorbital area are exposed to three-fold more absorbed radiation that the right side. When compared to metrics provided by the imaging unit, measurements of DDRAE had linear correlation with fluoroscopy time, total radiation exposure and DAP for the primary operator, but only fluoroscopy time for the patient.

Target Vessel Catheterization With Fiber Optic Realshape Using Upper Extremity vs Transfemoral Access for Fenestrated-Branched Endovascular Aortic Aneurysm Repair

The Fiber Optic RealShape (FORS) technology uses pulses of light delivered through specially designed guidewire and catheters that allow the operator to navigate through the vasculature without radiation. Traditionally, and because of length constraints, FORS has been used primarily for transfemoral (TF) access. The purpose of this study is to report the feasibility and benefits of using FORS during fenestrated-branched endovascular aortic aneurysm repair (FBEVAR), including cannulation times of target vessels (TV) and radiation measures comparing upper extremity (UE) (Figure) vs TF access. A single-center retrospective study with prospectively collected data was performed. Patients undergoing FBEVAR with FORS guidance for TV catheterization were included. Custom-made devices, off-the-shelf (TAMBE, tBranch), Zfen, and physician-modified endografts were used. Navigation data was reported per task, including duration, dose area product (DAP), reference air kerma (RAK), and fluoroscopy time (FT) required to accomplish each catheterization. The primary end point included technical success, defined as the navigation accomplishment with no need to switch from FORS to conventional fluoroscopy, and overall radiation exposure. During an 11-month period, 74 patients (70.3% male) underwent FBEVAR with FORS, including 50 custom-made devices, 15 physician-modified endografts, 7 tBranch, 1 TAMBE, and 1 Zfen. Among 370 navigation tasks reported, 350 (94.6%) were performed with FORS, including catheterizations for 225 (64.3%) fenestrations, 61 (17.4%) branches, 50 (14.3%) contralateral gates, and 14 (4%) vessels for preemptive embolization or prestenting. Technical success was 90.3%. Mean time required to deem the catheterization as failure was 8.4 ± 5 minutes. FORS guidewires were used for all procedures. UE access, steerable sheath, and FORS catheters were used in 54.3%, 17.7%, and 13.7%, respectively. The median task duration, RAK, DAP, and FT required for TV cannulation were 5 minutes (interquartile range [IQR], 3-7 minutes), 9.4 mGy (IQR, 4.3-23.7 mGy), 1.0 GyCm2 (IQR, 0.4-2.5 GyCm2), and 1.5 minutes (IQR, 0.8-3.2 minutes), respectively. Among 186 UE TV cannulations and 168 TF TV cannulations, the mean RAK was significantly higher for UE access (25.6 mGy vs 12.5 mGy; P < .00). There were no significant differences in DAP, FT, and TV technical success between UE vs TF access. Overall radiation levels are included in the Table. FBEVAR with FORS technology is feasible using both UE and TF access and facilitates target artery catheterization with acceptable technical success and potentially reduced radiation. Further experience is required to optimize the use of FORS during FBEVARTableFiber-Optic RealShape (FORS) procedural data during fenestrated-branched endovascular aortic aneurysm repair (FBEVAR)VariablesProcedures with FORS technology (n = 74)Cannulation technical success316 (90.3)Procedure duration, minutes313 [246.8-380.8]Total DAP, Gycm2179.5 [116.3-232.5]Total RAK, mGy1327.5 [840.4-1872.3]Fluoroscopy time, minutes71.3 [57.5-92.1]Operator radiation, μSv93 [43-178]Fellow radiation, μSv36.5 [17.3-64.8]Circulator nurse radiation, μSv2 [0-4]Scrub tech radiation, μSv4 [1-9]Anesthesia radiation, μSv5 [2-18]Cannulation time, minutes5 [3-7]Cannulations UE183 (57)Cannulations TF168 (47)Cannulations measuresUETFP valueTotal DAP, Gycm21.0 (0.4-2.10)1.5 (0.5-1.5)NSTotal RAK, mGy8.8 (4.7-20.9)10.5 (4-33.5)<.001Fluoroscopy time, minutes1.6 (0.9-3.2)1.5(0.7-1.5)NSCannulation time, minutes5 (3-7)4 (3-8)NSDAP, Dose area product; N, not significant; RAK, reference air kerma; TF, transfemoral; UE, upper extremity.Values are median [interquartile range] or number (%). Open table in a new tab

Outcomes of Primary Determinate and Indeterminate Target Vessel Endoleaks After Fenestrated-branched Endovascular Aortic Repair

Outcomes of Primary Determinate and Indeterminate Target Vessel Endoleaks After Fenestrated-branched Endovascular Aortic Repair

Family History of Aortic Disease Has No Effect on Outcomes of Fenestrated-branched Endovascular Aortic Repair in Patients with Complex Aortic Aneurysms

Prior reports have indicated an increased risk of aneurysm-related complications after endovascular repair in patients with familial aortic aneurysms. The aim of this study was to evaluate outcomes of fenestrated-branched endovascular aortic repair (F-BEVAR) for the treatment of complex abdominal (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs) in patients with familial history of aortic aneurysms or dissections (FAA). The clinical data of 506 consecutive patients (69% male; 74 ± 8 years old) enrolled in a prospective non-randomized study to investigate outcomes of F-BEVAR for the treatment of CAAAs and TAAAs between 2013 and 2022 was reviewed. Outcomes were analyzed in patients with FAA affecting a first or second-degree relative and compared with patients with sporadic aortic aneurysms (SAAs). Endpoints included differences in the distribution of aortic disease, procedural metrics, 30-day mortality, and major adverse events (MAEs), patient survival, and mid-term stent-graft-related outcomes. There were 68 patients (13%) with FAAs and 438 (87%) with SAAs. Both groups had similar cardiovascular risk factors, history of aortic dissection, and aneurysm extent. FAA patients had significantly (P < .05) longer fluoroscopy time (82 vs 71 minutes) and higher radiation dose (1782 vs 1210 mGy). Technical success was achieved in 94.1% of the FAA group and in 96.6% of SAA group (P = .51). Median follow-up was 19 months. There was no difference in 30-day mortality and MAEs, and long-term patient survival, freedom from aortic-related mortality, and freedom from secondary interventions. Patients with FAA had higher sac shrinkage >5mm as compared with patients with SAAs (P = .006). FB-EVAR was performed with high technical success, low mortality, and low incidence of MAEs regardless of the presence of FAAs. There was no difference in the distribution of aortic disease nor in stent graft-related outcomes.TableVariablesFAA (n = 68)SAA (n = 438)P valueAneurysm type (Crawford class)0.862 Extent I4 (8.0)23 (7.4) Extent II22 (44.0)103 (33.1) Extent III8 (16.0)47 (15.1) Infrarenal short neck0 (0.0)1 (0.2) Pararenal18 (26.5)125 (28.6)30-day mortality1 (1.5)4 (0.9)1.00030-day MAESpinal cord injury0.588 No62 (91.2)411 (94.3) Motor (able to ambulate)2 (2.9)7 (1.6) Non-ambulatory4 (5.9)18 (4.1)Myocardial infarction2 (2.9)10 (2.3)1.000Major stroke0 (0.0)3 (0.7)1.000Respiratory failure5 (7.4)12 (2.8)0.111Acute kidney injury0.016 No61 (89.7)396 (90.8) Creatinine >2 but no dialysis3 (4.4)34 (7.8) Temporary dialysis3 (4.4)2 (0.5) Permanent dialysis1 (1.5)4 (0.9)Long-term secondary intervention17 (25.4)96 (22.5)0.721Aneurysm sac behavior Stable17 (25.4)199 (47.2)0.001 Enlarged >5 mm3 (4.5)33 (7.8)0.471 Shrunk >5 mm47 (70.1)189 (44.8)<0.001Final sac diameter53.8 (14.9)59.3 (15.1)0.006FAA, Familial history of aortic aneurysms or dissections; MAE, major adverse event; SAA, sporadic aortic aneurysms.Data are presented as number (%) or mean (standard deviation).Boldface P values indicate statistical significance. Open table in a new tab

Comparative outcomes of physician-modified fenestrated-branched endovascular repair of post-dissection and degenerative complex abdominal or thoracoabdominal aortic aneurysms

ObjectiveFenestrated-branched endovascular repair has become a favorable treatment strategy for patients with complex abdominal aortic aneurysms (cAAAs) and thoracoabdominal aortic aneurysms (TAAAs) who are high risk for open repair. Compared with degenerative aneurysms, post-dissection aneurysms can pose additional challenges for endovascular repair. Literature on physician-modified fenestrated-branched endovascular aortic repair (PM-FBEVAR) for post-dissection aortic aneurysms is sparse. Therefore, the aim of this study is to compare the clinical outcomes of patients who underwent PM-FBEVAR for degenerative and post-dissection cAAAs or TAAAs. MethodsA single-center institutional database was retrospectively reviewed for patients that underwent PM-FBEVAR between 2015 and 2021. Infected aneurysms and pseudoaneurysms were excluded. Patient characteristics, intraoperative details, and clinical outcomes were compared between degenerative and post-dissection cAAAs or TAAAs. The primary outcome was 30-day mortality. The secondary outcomes included technical success, major complications, endoleak, target vessel instability, and reintervention. ResultsOf the 183 patients who underwent PM-FBEVAR in the study, 32 had aortic dissections, and 151 had degenerative aneurysms. There was one 30-day death (3.1%) in the post-dissection group and eight 30-day deaths (5.3%) in the degenerative aneurysm group (P = .99). Technical success, fluoroscopy time, and contrast usage were similar between the post-dissection and degenerative groups. Reintervention during follow-up (28% vs 35%; P = .54) and major complications were not statistically significantly different between the two groups. Endoleak was the most common reason for reintervention, with the post-dissection group having a higher rate of type IC, II, and IIIA endoleaks (31% vs 3%; P < .0001; 59% vs 26%; P = .0002; and 16% vs 4%; P = .03). During the mean follow-up of 14 months, all-cause mortality was similar between the groups (12.5% vs 21.9%; P = .23). ConclusionsPM-FBEVAR is a safe treatment for post-dissection cAAAs and TAAAs with high technical success. However, endoleaks requiring reintervention were more frequent in post-dissection patients. The impact of these reinterventions on long-term durability will be assessed with continued follow-up.

Outcomes of Secondary Endovascular Aortic Repair After Frozen Elephant Trunk.

The aim of this study was to evaluate the midterm outcomes of secondary extension of frozen elephant trunk (FET) by means of thoracic endovascular aortic repair (TEVAR). This single-center prospective study was conducted in a tertiary aortic center on consecutive patients having undergone TEVAR with an endograft covering most of the 10 cm FET module with 2 to 4 mm oversizing. All patients were monitored by computerized tomography angiography (CTA) at sixth month and yearly thereafter. From January 2015 to July 2022, among 159 patients who received FET, 30 patients (18.8%) underwent a TEVAR procedure (13 for a thoracoabdominal aneurysm, 11 for a chronic aortic dissection and 6 for an emergency procedure). All connections were successfully achieved with 2 postoperative deaths (6.6%) and 1 paraplegia (3.3%). At a median follow-up of 21 months (interquartile range [IQR], 4.2-34.7), 5 patients (25%) required a fenestrated-branched endovascular aortic repair (F-BEVAR) extension followed by 4 patients with 5 reinterventions, 3 for a Type 3 endoleak due to disconnection between FET and TEVAR endograft, and 2 unrelated to the FET for a secondary Type 1C endoleak. All reinterventions were successful, without mortality or morbidity. In this series, FET connection with a TEVAR endograft was effective with low postoperative morbidity but with a risk of aortic reintervention related to disconnection between the FET and TEVAR endograft. These results suggest the need for annual CTA monitoring with no time limit in patients following connection of the FET with a TEVAR endograft. In this series of 30 patients, midterm outcomes of secondary extension of frozen elephant trunk (FET) by thoracic endovascular repair (TEVAR) showed 3 disconnections (10%) with a Type 3 endoleak between FET and TEVAR. These findings suggest the need for annual CTA monitoring with no time limit. But so far, only a few studies provide some information after one year while the risk of disconnection increases over time and becomes a concern after 3 years. This is the new message brought by our study.

Outcomes of fenestrated-branched endovascular aortic repair in patients with or without prior history of abdominal endovascular or open surgical repair

ObjectiveThe aim of this study was to compare outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs) in patients with or without prior history of abdominal open surgical (OSR) or endovascular aortic repair (EVAR). MethodsThe clinical data of consecutive patients enrolled in a prospective, non-randomized study to evaluate FB-EVAR for treatment of CAAAs and TAAAs was reviewed. Clinical outcomes were analyzed in patients with no previous aortic repair (Controls), prior EVAR (Group 1), and prior abdominal OSR (Group 2), including 30-day mortality and major adverse events (MAEs), patient survival and freedom from aortic-related mortality (ARM), secondary interventions, any type II endoleak, sac enlargement (≥5 mm), and new-onset permanent dialysis. ResultsThere were 506 patients (69% male; mean age, 72 ± 9 years) treated by FB-EVAR, including 380 controls, 54 patients in Group 1 (EVAR), and 72 patients in Group 2 (abdominal OSR). FB-EVAR was performed on average 7 ± 4 and 12 ± 6 years after the index EVAR and abdominal OSR, respectively (P < .001). All three groups had similar clinical characteristics, except for less coronary artery disease in controls and more TAAAs and branch stent graft designs in Group 2 (P < .05). Aneurysm extent was CAAA in 144 patients (28%) and TAAA in 362 patients (72%). Overall technical success, mortality, and MAE rate were 96%, 1%, and 14%, respectively, with no difference between groups. Mean follow up was 30 ± 21 months. Patient survival was significantly lower in Group 2 (P = .03), but there was no difference in freedom from ARM and secondary interventions at 5 years between groups. Group 1 patients had lower freedom from any type II endoleak (P = .02) and sac enlargement (P < .001), whereas Group 2 patients had lower freedom from new-onset permanent dialysis (P = .03). ConclusionsFB-EVAR was performed with high technical success, low mortality, and similar risk of MAEs, regardless of prior history of abdominal aortic repair. Patient survival was significantly lower in patients who had previous abdominal OSR, but freedom from ARM and secondary interventions were similar among groups. Patients with prior EVAR had lower freedom from type II endoleak and sac enlargement. Patients with prior OSR had lower freedom from new-onset dialysis.

Obesity is Not Associated with Adverse Perioperative or Poorer Clinical Outcomes following Thoracic and Fenestrated-Branched Endovascular Aortic Repair

Obesity is a risk factor for higher morbidity and mortality following open aortic repair but currently there is limited literature on its impact on clinical and procedural outcomes following thoracic endovascular aortic repair (TEVAR) and branched-fenestrated endovascular aortic repair (B-FEVAR). We conducted a retrospective case-control analysis of a prospectively collected nonrandomized database to evaluate the effects of obesity on procedural and clinical outcomes after B-FEVAR/TEVAR in treatment of pararenal/thoracoabdominal aortic aneurysm and dissection at the University hospital of Nantes (France) between January 2016 and December 2021. Patients were divided in 2 groups according to their body mass index (BMI) and the rate of technical success, complications (renal, pulmonary, cardiac, and neurological events), 30-day and long-term survival, freedom from target vessel instability and reintervention were compared. 195 patients were included (mean age 69.6 DS±11.2; n=135, 69.2% men; mean BMI: 26.6kg/m2 range 19-41) totalling n=72 (36.8%) TEVAR, n=107 (55.4%) FEVAR and n=14 (7.3%) BEVAR. Patients were divided in 2 groups [obese: BMI≥30kg/m2n=52 (26.7%); and nonobese, BMI<30kg/m2, n=143 (73.3%) that statistically differed only in terms of coronary artery disease (obese 42.3% vs. 26.6% nonobese, P=0.035) and diabetes (obese 25% vs. 12.6% nonobese, P=0.03). No statistical differences were noted in primary technical (94.2% vs. 94.4%, P=1.00) and clinical (92.3% vs. 95.1%, P=0.49) success. Overall morbidity (30.8% vs. 21.1%, P=0.16), visceral vessels instability (1.9% vs. 1.4% P=1.00), reintervention rate within 30days (9.6% vs. 5.6% P=0.33), 90days (7.7% vs. 9.8%, P=0.78) and during follow-up (9.8% vs. 20%, P=0.14) were comparable. No statistical difference were noted in 30-day mortality (3.8% vs. 4.9%, P=1.00) and the 2-year follow-up survival (86.8% vs. 78.4%, P=0.180) between the 2 groups. In this series, obesity was not associated to worst clinical outcomes or higher mortality rate following TEVAR/B-FEVAR. However, considering our small patient sample, a conclusive analysis on obesity as risk factors for adverse events after endovascular treatment is not possible. A larger sample from the collaboration of multiple centers will be required to obtain definitive conclusions.

Mid-term Renal and Mesenteric Artery Outcomes During Fenestrated and Branched Endovascular Aortic Repair for Complex Abdominal and Thoracoabdominal Aortic Aneurysms in The United States Aortic Research Consortium.

To report mid-term outcomes of renal-mesenteric target arteries (TA) after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal (CAAAs) and thoracoabdominal aortic aneurysm (TAAAs). TA instability (TAI) is the most frequent indication for reintervention after FB-EVAR. Data from consecutive patients enrolled in nine prospective non-randomized physician-sponsored investigational device exemption (PS-IDE) studies between 2005 and 2020 were reviewed. TA outcomes through 5 years of follow-up were analyzed for vessels incorporated by fenestrations or directional branches (DBs), including TA patency, endoleak, integrity failure, reintervention, and instability. A total of 1,681 patients had 6349 renal-mesenteric arteries were targeted using 3720 fenestrations (59%), 2435 DBs (38%) and 194 scallops (3%). Mean follow was 23±21 months. At 5-years, TAs incorporated by fenestrations had higher primary (95±1% vs. 91±1%, P<0.001 ) and secondary patency (98±1% vs. 94±1%, P<0.001) , and higher freedom from TAI (87±2% vs. 84±2%, P=0.002) compared to TAs incorporated by DBs, with no differences in other TA events. DBs targeted by balloon-expandable stent-grafts (BESGs) had significantly lower freedom from TAI (78±4% vs. 88±1%, P=0.006 ), TA endoleak (87±3% vs. 97±1%, P<0.001 ), and TA reintervention (83±4% vs. 95±1%, P<0.00 1 ) compared to those targeted by self-expandable stent-grafts (SESGs). Incorporation of renal and mesenteric TA during FB-EVAR is safe and durable with high 5-year patency rates and low freedom from TAI. DBs have lower patency rates and lower freedom from TAI than fenestrations, with better performance for SESGs as compared to BESGs.