Early experience with patient-specific unibody bifurcated fenestrated-branched devices for complex endovascular aortic aneurysm repair.

OBJECTIVE: Short distances between the lowest visceral/renal artery and the aortic bifurcation are technically challenging during complex endovascular aortic aneurysm repair (EVAR), particularly after previous infrarenal repair. Traditionally, inverted limb bifurcated devices have been used in addition to fenestrated-branched (FB) endografts, but short overlap, difficult cannulation, and potential crushing of bridging stents are limitations for their use. This study reviews the early experience of patient-specific company manufactured devices (PS-CMDs) with a unibody bifurcated FB design for complex EVAR. METHODS: Consecutive complex EVAR procedures over a 34-month period with unibody bifurcated FB-devices as part of physician-sponsored investigational device exemption studies at two institutions were reviewed. Unibody bifurcated FB designs included FB bifurcated or fenestrated inverted limb devices. End points included technical success, survival, frequency of type I or III endoleaks, limb occlusion, and secondary interventions. RESULTS: Among 168 patients undergoing complex EVAR, 33 patients (19.6%; 78.7% male; mean age, 77 years) received unibody bifurcated FB PS-CMDs. FB bifurcated and fenestrated inverted limb devices were used in 31 (93.9%) and 2 (6.06%) patients, respectively. The median maximum aneurysm diameter was 61 mm (interquartile range [IQR], 55-69 mm). Prior EVAR was reported by 29 patients (87.9%), of whom 2 (6.06%) had suprarenal stents. A short distance between the lowest renal artery and aortic bifurcation was demonstrated in 30 patients (90.9%), with median distance of 47 mm (IQR, 38-54 mm). Preloaded devices were used in 23 patients (69.7%). A total of 128 fenestrations were planned; 22 (17.2%) were preloaded with guidewires and 5 (3.9%) with catheters. The median operative time was 238 minutes (226-300 minutes), with a median fluoroscopy time of 65.5 minutes (IQR, 56.0-77.7 minutes) and a median dose area product of 147 mGy∗cm2 (IQR, 105-194 mGy∗cm2). Exclusive femoral access was used in 14 procedures (42.4%). Technical success was 100%. Target vessel primary patency was 100% at a median follow-up time of 11.7 months (IQR, 3.5-18.6 months). Two patients (6.06%) required reintervention for iliac occlusion; one patient required stenting and the other a femoral-femoral bypass. No aortic-related deaths occurred after the procedure. During follow-up, 11 type II endoleaks (33.3%) and 1 type Ib endoleak (3.03%) were detected; the latter was treated with leg extension. No type Ia or III endoleaks occurred. CONCLUSIONS: Complex EVAR using unibody bifurcated FB-PS-CMDs is a simple, safe, and cost-effective alternative for the treatment of patients with short distances between the renal arteries and the aortic bifurcation. Further studies are required to assess benefits and durability of unibody bifurcated FB devices.

Prospective evaluation of upper extremity access and total transfemoral approach during fenestrated and branched endovascular repair.

OBJECTIVE: Total transfemoral (TF) access has been increasingly used during fenestrated-branched endovascular aortic repair (FB-EVAR). However, it is unclear whether the potential decrease in the risk of cerebrovascular events is offset by increased procedural difficulties and other complications. The aim of this study was to compare outcomes of FB-EVAR using a TF vs upper extremity (UE) approach for target artery incorporation. METHODS: We analyzed the clinical data of consecutive patients enrolled in a prospective, nonrandomized clinical trial in two centers to investigate the use of FB-EVAR for treatment of complex abdominal aortic aneurysms (CAAA) and thoracoabdominal aortic aneurysms (TAAA) between 2013 and 2022. Patients were classified into TF or UE access group with a subset analysis of patients treated using designs with directional branches. End points were technical success, procedural metrics, 30-day cerebrovascular events defined as stroke or transient ischemic attack, and any major adverse events (MAEs). RESULTS: There were 541 patients (70% males; mean age, 74 ± 8 years) treated by FB-EVAR with 2107 renal-mesenteric TAs incorporated. TF was used in175 patients (32%) and UE in 366 patients (68%) including 146 (83%) TF and 314 (86%) UE access patients who had four or more TAs incorporated. The use of a TF approach increased from 8% between 2013 and 2017 to 31% between 2018 and 2020 and 96% between 2021 and 2022. Compared with UE access patients, TF access patients were more likely to have CAAAs (37% vs 24%; P = .002) as opposed to TAAAs. Technical success rate was 96% in both groups (P = .96). The use of the TF approach was associated with reduced fluoroscopy time and procedural time (each P < .05). The 30-day mortality rate was 0.6% for TF and 1.4% for UE (P = .67). There was no early cerebrovascular event in the TF group, but the incidence was 2.7% for UE patients (P = .035). The incidence of MAEs was also lower in the TF group (9% vs 18%; P = .006). Among 237 patients treated using devices with directional branches, there were no significant differences in outcomes except for a reduced procedural time for TF compared with UE access patients (P < .001). CONCLUSIONS: TF access was associated with a decreased incidence of early cerebrovascular events and MAEs compared with UE access for target artery incorporation. Procedural time was decreased in TF access patients irrespective of the type of stent graft design.

Aneurysm sac shrinkage at 1 year after fenestrated-branched endovascular aortic repair of complex aortic aneurysms offers mid-term survival advantage.

OBJECTIVES: To investigate the impact of 1-year changes in aneurysm sac diameter on patient survival after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms or thoracoabdominal aortic aneurysms. METHODS: We reviewed the clinical data of patients enrolled in a prospective nonrandomized study investigating FB-EVAR (2013-2022). Patients with sequential follow up computed tomography scans at baseline and 6 to 18 months after FB-EVAR were included in the analysis. Aneurysm sac diameter change was defined as the difference in maximum aortic diameter from baseline measurements obtained in centerline of flow. Patients were classified as those with sac shrinkage (≥5 mm) or failure to regress (<5 mm or expansion) according to sac diameter change. The primary end point was all-cause mortality. Secondary end points were aortic-related mortality (ARM), aortic aneurysm rupture (AAR), and aorta-related secondary intervention. RESULTS: There were 549 patients treated by FB-EVAR. Of these, 463 patients (71% male, mean age, 74 ± 8 years) with sequential computed tomography imaging were investigated. Aneurysm extent was thoracoabdominal aortic aneurysms in 328 patients (71%) and abdominal aortic aneurysms in 135 (29%). Sac shrinkage occurred in 270 patients (58%) and failure to regress in 193 patients (42%), including 19 patients (4%) with sac expansion at 1 year. Patients from both groups had similar cardiovascular risk factors, except for younger age among patients with sac shrinkage (73 ± 8 years vs 75 ± 8 years; P < .001). The median follow-up was 38 months (interquartile range, 18-51 months). The 5-year survival estimate was 69% ± 4.1% for the sac shrinkage group and 46% ± 6.2% for the failure to regress group. Survival estimates adjusted for confounders (age, chronic pulmonary obstructive disease, chronic kidney disease, congestive heart failure, and aneurysm extent) revealed a higher hazard of late mortality in patients with failure to regress (adjusted hazard ratio, 1.72; 95% confidence interval, 1.18-2.52; P = .005). The 5-year cumulative incidences of ARM (1.1% vs 3.1%; P = .30), AAR (0.6% vs 2.6%; P = .20), and aorta-related secondary intervention (17.0% ± 2.8% vs 19.0% ± 3.8%) were both comparable between the groups. CONCLUSIONS: Aneurysm sac shrinkage at 1 year is common after FB-EVAR and is associated with improved patient survival, whereas sac enlargement affects only a minority of patients. The low incidences of ARM and AAR indicate that failure to regress may serve as a surrogate marker for nonaortic-related death.

Effect of Family History of Aortic Disease on Outcomes of Fenestrated and Branched Endovascular Aneurysm Repair of Complex Aortic Aneurysms.

OBJECTIVE: The clinical significance of family history (FH) of aortic disease on the outcomes of fenestrated and branched endovascular aneurysm repair (FB-EVAR) has not been well described. This study aimed to assess how FH of aortic disease affects outcomes following FB-EVAR for complex aortic aneurysms (CAAs). METHODS: This study retrospectively reviewed the clinical data of consecutive patients enrolled in 10 ongoing, prospective, non-randomised, physician sponsored, investigational device exemption studies to evaluate FB-EVAR (2005 - 2022) in the United States Aortic Research Consortium database. Patients were stratified by presence or absence of FH of any aortic disease in any relative. Patients with confirmed genetically triggered aortic diseases were excluded. Primary outcomes were 30 day major adverse events (MAEs) and late survival. Secondary outcomes included late secondary interventions and aneurysm sac enlargement. RESULTS: During the study period, 2 901 patients underwent FB-EVAR. A total of 2 355 patients (81.2%) were included in the final analysis: 427 (18.1%) with and 1 928 (81.9%) without a FH of aortic disease. Patient demographics, clinical characteristics, and aneurysm extent were similar between the groups. Patients with a FH of aortic disease more frequently had prior open abdominal aortic repair, but less frequently had prior endovascular aneurysm repair (p < .050). There were no statistically significant differences in 30 day mortality (4% vs. 2%; p = .12) and MAEs (12% vs. 12%; p = .89) for patients with or without a FH of aortic disease. Three year survival estimates were 71% (95% confidence interval [CI] 67 - 78%) and 71% (95% CI 68 - 74%), respectively (p = .74). Freedom from secondary intervention and aneurysm sac enlargement were also not statistically significantly different between groups. CONCLUSION: A FH of aortic disease had no impact on 30 day or midterm outcomes of FB-EVAR of CAAs. In the absence of an identified genetically triggered aortic disease, treatment selection for CAAs should be based on clinical risk and patient anatomy rather than FH of aortic disease.

Midterm Outcomes and Aneurysm Sac Dynamics Following Fenestrated Endovascular Aneurysm Repair after Previous Endovascular Aneurysm Repair.

OBJECTIVE: Fenestrated endovascular aneurysm repair (FEVAR) is a feasible option for aortic repair after endovascular aneurysm repair (EVAR), due to improved peri-operative outcomes compared with open conversion. However, little is known regarding the durability of FEVAR as a treatment for failed EVAR. Since aneurysm sac evolution is an important marker for success after aneurysm repair, the aim of the study was to examine midterm outcomes and aneurysm sac dynamics of FEVAR after prior EVAR. METHODS: Patients undergoing FEVAR for complex abdominal aortic aneurysms from 2008 to 2021 at two hospitals in The Netherlands were included. Patients were categorised into primary FEVAR and FEVAR after EVAR. Outcomes included five year mortality rate, one year aneurysm sac dynamics (regression, stable, expansion), sac dynamics over time, and five year aortic related procedures. Analyses were done using Kaplan-Meier methods, multivariable Cox regression analysis, chi square tests, and linear mixed effect models. RESULTS: One hundred and ninety-six patients with FEVAR were identified, of whom 27% (n = 53) had had a prior EVAR. Patients with prior EVAR were significantly older (78 ± 6.7 years vs. 73 ± 5.9 years, p < .001). There were no significant differences in mortality rate. FEVAR after EVAR was associated with a higher risk of aortic related procedures within five years (hazard ratio [HR] 2.6; 95% confidence interval [CI] 1.1 - 6.5, p = .037). Sac dynamics were assessed in 154 patients with available imaging. Patients with a prior EVAR showed lower rates of sac regression and higher rates of sac expansion at one year compared with primary FEVAR (sac expansion 48%, n = 21/44, vs. 8%, n = 9/110, p < .001). Sac dynamics over time showed similar results, sac growth for FEVAR after EVAR, and sac shrinkage for primary FEVAR (p < .001). CONCLUSION: There were high rates of sac expansion and a need for more secondary procedures in FEVAR after EVAR than primary FEVAR patients, although this did not affect midterm survival. Future studies will have to assess whether FEVAR after EVAR is a valid intervention, and the underlying process that drives aneurysm sac growth following successful FEVAR after EVAR.

How We Would Treat Our Own Thoracoabdominal Aortic Aneurysm.

This manuscript is intended to provide a comprehensive review of the current state of knowledge on endovascular repair of thoracoabdominal aortic aneurysms (TAAAs). The management of these complex aneurysms requires an interdisciplinary and patient-specific approach in high-volume centers. An index case is used to discuss the diagnosis and treatment of a patient undergoing fenestrated-branched endovascular aneurysm repair for a TAAA.

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

OBJECTIVE: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). BACKGROUND: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. METHODS: 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. RESULTS: A total of 2603 patients (69% males; mean age 72±10 year 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, 7-37 months). 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). CONCLUSIONS: 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.

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

OBJECTIVE: The 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). METHODS: The 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. RESULTS: There 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). CONCLUSIONS: FB-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.

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

OBJECTIVE: Stenting 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. METHODS: Patients 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. RESULTS: There 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. CONCLUSIONS: Stent 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.

Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair.

OBJECTIVE: Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters. METHODS: A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter. RESULTS: Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively. CONCLUSIONS: The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results.