The semi-compliant balloon bounce technique for total femoral approach during fenestrated-branched endovascular aortic aneurysm repair.

A total femoral approach for fenestrated-branched endovascular aortic aneurysm repair has been increasingly favored to minimize risks of aortic arch manipulation. We describe a novel technique to support the advancement of endovascular devices into a target vessel. Following catheterization of the intended target artery and deployment of the diameter-reducing ties, a Coda semi-compliant balloon (Cook Medical) is advanced and inflated immediately above the target artery. It is used as a support as the wire, catheter, or sheath "bounces" on the balloon, stabilizing the support wire to advance stent grafts, balloons, or sheaths into the downward renal or mesenteric vessels.

Effectiveness of Intra-operative Contrast-Enhanced Ultrasound Assessment to Optimize Type II Endoleak Embolization.

PURPOSE: To analyze the effectiveness of type II endoleaks (T2E) embolization using intra-operative contrast-enhanced ultrasound (CEUS). METHODS: Consecutive patients treated for T2E underwent a standardized protocol with trans-arterial or trans-lumbar access, large volume embolization, onlay fusion, and intra-operative CEUS. Technical success was defined by exclusion of endoleak by CEUS. RESULTS: Twenty-six patients (mean age 81 ± 11 years old; 89% male) were treated. The mean aneurysm sac enlargement was 11 ± 8 mm from T2E diagnosis. Embolization was performed using Onyx® 18 in all patients with adjunctive coils in 13 patients (50%). After the first embolization, CEUS documented residual T2E in 13 patients (50%). Ten patients (38%) had additional embolization, which successfully eradicated the T2E in seven of them. Technical success was 50% after the first embolization attempt and 77% after additional attempts guided by CEUS (P = 0.080). There was no mortality. Median imaging follow-up was 22 months. Among the 20 patients with no residual T2E on completion CEUS, 16 (80%) had sac stabilization and none required additional interventions for T2E. Of the six patients with residual T2Es on CEUS, three had sac stabilization (50%) and one required additional reintervention for T2E. There was one late aortic rupture at 56 months. CONCLUSION: One in two patients treated by T2E embolization had residual endoleak on intra-operative CEUS after a first embolization attempt, decreasing to one in four patients after multiple attempts. A negative completion CEUS following embolization was associated with higher rates of sac stabilization and no need for additional T2E embolization.

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

OBJECTIVE: 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). METHODS: 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. RESULTS: 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. CONCLUSION: 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. CLINICAL IMPACT: 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.

Comparison of single- and multistage strategies during fenestrated-branched endovascular aortic repair of thoracoabdominal aortic aneurysms.

OBJECTIVE: The aim of this study was to compare outcomes of single or multistage approach during fenestrated-branched endovascular aortic repair (FB-EVAR) of extensive thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of consecutive patients treated by FB-EVAR for extent I to III TAAAs in 24 centers (2006-2021). All patients received a single brand manufactured patient-specific or off-the-shelf fenestrated-branched stent grafts. Staging strategies included proximal thoracic aortic repair, minimally invasive segmental artery coil embolization, temporary aneurysm sac perfusion and combinations of these techniques. Endpoints were analyzed for elective repair in patients who had a single- or multistage approach before and after propensity score adjustment for baseline differences, including the composite 30-day/in-hospital mortality and/or permanent paraplegia, major adverse event, patient survival, and freedom from aortic-related mortality. RESULTS: A total of 1947 patients (65% male; mean age, 71 ± 8 years) underwent FB-EVAR of 155 extent I (10%), 729 extent II (46%), and 713 extent III TAAAs (44%). A single-stage approach was used in 939 patients (48%) and a multistage approach in 1008 patients (52%). A multistage approach was more frequently used in patients undergoing elective compared with non-elective repair (55% vs 35%; P < .001). Staging strategies were proximal thoracic aortic repair in 743 patients (74%), temporary aneurysm sac perfusion in 128 (13%), minimally invasive segmental artery coil embolization in 10 (1%), and combinations in 127 (12%). Among patients undergoing elective repair (n = 1597), the composite endpoint of 30-day/in-hospital mortality and/or permanent paraplegia rate occurred in 14% of single-stage and 6% of multistage approach patients (P < .001). After adjustment with a propensity score, multistage approach was associated with lower rates of 30-day/in-hospital mortality and/or permanent paraplegia (odds ratio, 0.466; 95% confidence interval, 0.271-0.801; P = .006) and higher patient survival at 1 year (86.9±1.3% vs 79.6±1.7%) and 3 years (72.7±2.1% vs 64.2±2.3%; adjusted hazard ratio, 0.714; 95% confidence interval, 0.528-0.966; P = .029), compared with a single stage approach. CONCLUSIONS: Staging elective FB-EVAR of extent I to III TAAAs was associated with decreased risk of mortality and/or permanent paraplegia at 30 days or within hospital stay, and with higher patient survival at 1 and 3 years.

Characterization of Secondary Interventions After Fenestrated-branched Endovascular Repair of Complex Aortic Aneurysms and Its Effect on Quality of Life and Patient Survival.

OBJECTIVE: To assess the impact of secondary intervention (SI) on health-related quality of life (HR-QOL) after fenestrated-branched endovascular aortic repair (FB-EVAR) for complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. BACKGROUND: The effect of SI after FB-EVAR on physical and mental HR-QOL has not been described. METHODS: A cohort of 430 consecutive patients enrolled in a prospective, nonrandomized study to evaluate FB-EVAR (2013-2020) was assessed with 1325 short-form 36 HR-QOL questionnaires preoperatively and during follow-up visits. SIs were classified as major or minor procedures. Endpoints included patient survival, freedom from aortic-related mortality (ARM), freedom from SIs, and changes in HR-QOL physical component score (PCS) and mental component score. RESULTS: There were 302 male with mean age 74±8 years treated by FB-EVAR for 133 complex abdominal aortic aneurysms and 297 thoracoabdominal aortic aneurysms. After a mean follow up of 26±20 months, 97 patients (23%) required 137 SIs. At 5 years, freedom from any SI was 64%±4%, including freedom from minor SIs of 77%±4% and major SIs of 87%±3%. There was no difference in patient survival and freedom from ARM at same interval. On adjusted analysis, minor SIs correlated with improved survival. SIs had a negative correlation with PCS ( r =-0.8). There were no significant changes in mental component score with SIs. Predictors for SIs were fluoroscopy time, graft design, and aneurysm sac change. CONCLUSION: SIs were needed in nearly 1 out of 4 patients treated by FB-EVAR with no effect on patient survival or ARM. SI resulted in decline in PCS.

Safety of Percutaneous Femoral Access for Endovascular Aortic Aneurysm Repair Through Previously Surgically Exposed or Repaired Femoral Arteries.

OBJECTIVE: Percutaneous femoral artery access is being increasingly used in endovascular aortic repair (EVAR). The technique can be challenging in patients with previously surgically exposed or repaired femoral arteries because of excessive scar tissue. However, a successful percutaneous approach may cause less morbidity than a "re-do" open femoral approach. The aim of this study was to assess the impact of prior open surgical femoral exposure on technical success and clinical outcomes of percutaneous approach. METHODS: This study retrospectively reviewed the clinical data of patients who underwent percutaneous EVAR between 2010 and 2020 at 2 major aortic centers. Patients were divided into 2 groups (with or without prior open surgical femoral access) for analysis of clinical outcomes. Only punctures with sheaths ≥12Fr were included for analysis. The access and (pre)closure techniques were similar in both institutions. Primary end points were intraoperative technical success, access-related revision, and access complications. A multivariate analysis was performed to identify determinants of conversion to open approach and femoral access complications in intact and re-do groins. RESULTS: A total of 632 patients underwent percutaneous (complex) EVAR: 98 had prior open surgical femoral access and 534 patients underwent de novo femoral percutaneous access. A total of 1099 femoral artery punctures were performed: 149 in re-do and 950 in intact groins. The extent of endovascular repair included 159 infrarenal, 82 thoracic, 368 fenestrated/branched, and 23 iliac branch devices. No significant differences were seen in technical success (re-do 93.3% vs intact 95.3%, p=0.311), access-related surgical revision (0.7% vs 0.6%, p=0.950), and access complications (2.7% vs 4.0%, p=0.443). For the whole group, significant predictors for access complications in multivariate analyses were main access site (odds ratio [OR] 2.39; 95% confidence interval [CI] 1.07%-5.35%; p=0.033) and increase of the procedure time per hour (OR 1.65; 95% CI 1.34%-2.04%; p<0.001), while increase in sheath-vessel ratio had a protective effect (OR 0.33; 95% CI 0.127%-0.85%; p=0.021). Surgical conversion was predicted by main access site (OR 2.32; 95% CI 1.28%-4.19%; p=0.007) and calcification of 50% to 75% of the circumference of the access vessel (OR 3.29; 95% CI 1.38%-7.86%; p=0.005). CONCLUSION: Within our population prior open surgical femoral artery exposure or repair had no negative impact on the technical success and clinical outcomes of percutaneous (complex) endovascular aortic aneurysm repair.

Outcomes of iliofemoral conduits during fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: To describe the technical pitfalls and outcomes of iliofemoral conduits during fenestrated-branched endovascular repair (FB-EVAR) of complex abdominal aortic aneurysms (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs). METHODS: We retrospectively reviewed the clinical data of 466 consecutive patients enrolled in a previous prospective nonrandomized study to investigate FB-EVAR for CAAAs/TAAAs (2013-2021). Iliofemoral conduits were performed through open surgical technique (temporary or permanent) in patients with patent internal iliac arteries or endovascular technique among those with occluded internal iliac arteries. End points were assessed in patients who had any iliac conduit or no conduits, and in patients who had conduits performed prior or during the index FB-EVAR, including procedural metrics, technical success, and major adverse events (MAE). RESULTS: There were 138 CAAAs, 141 extent IV, and 187 extent I-III TAAAs treated by FB-EVAR with an average of 3.89 ± 0.52 vessels incorporated per patient. Any iliac conduit was required in 35 patients (7.5%), including 24 patients (10.4%) treated between 2013 and 2017 and 11 (4.7%) who had procedures between 2018 and 2021 (P = .019). Nineteen patients had permanent conduits using iliofemoral bypass, 11 had temporary iliac conduits, and 5 had endoconduits. Iliofemoral conduits were necessary in 12% of patients with extent I to III TAAA, in 6% with extent IV TAAA, and in 3% with CAAA (P = .009). The use of iliofemoral conduit was more frequent among women (74% vs 27%; P < .001) and in patients with chronic obstructive pulmonary disease (49% vs 28%; P = .013), peripheral artery disease (31% vs 15%; P = .009), and American Society of Anesthesiologists classification of III or higher (74% vs 51%; P = .009). There were no inadvertent iliac artery disruptions in the entire study. The 30-day mortality and MAE were 1% and 19%, respectively, for all patients. An iliofemoral conduit using retroperitoneal exposure during the index FB-EVAR was associated with longer operative time (322 ± 97 minutes vs 323 ± 110 minutes vs 215 ± 90 minutes; P < .001), higher estimated blood loss (425 ± 620 mL vs 580 ± 1050 mL vs 250 ± 400 mL; P < .001), and rate of red blood transfusion (92% vs 78% vs 32%; P < .001) and lower technical success (83% vs 87% vs 98%; P < .001), but no difference in intraoperative access complications and MAEs, compared with iliofemoral conduits without retroperitoneal exposure during the index FB-EVAR and control patients who had FB-EVAR without iliofemoral conduits, respectively. There were no differences in mortality or in other specific MAE among the three groups. CONCLUSIONS: FB-EVAR with selective use of iliofemoral conduits was safe with low mortality and no occurrence of inadvertent iliac artery disruption or conversion. A staged approach is associated with shorter operating time, less blood loss, and lower transfusion requirements in the index procedure.

Multicenter Study to Evaluate Endovascular Repair of Extent I-III Thoracoabdominal Aneurysms Without Prophylactic Cerebrospinal Fluid Drainage.

OBJECTIVE: To assess outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) of Extent I-III thoracoabdominal aortic aneurysms (TAAAs) without prophylactic cerebrospinal fluid drainage (CSFD). BACKGROUND: Prophylactic CSFD has been routinely used during endovascular TAAA repair, but concerns about major drain-related complications have led to revising this paradigm. METHODS: We reviewed a multicenter cohort of 541 patients treated for Extent I-III TAAAs by FB-EVAR without prophylactic CSFD. Spinal cord injury (SCI) was graded as ambulatory (paraparesis) or nonambulatory (paraplegia). Endpoints were any SCI, permanent paraplegia, response to rescue treatment, major drain-related complications, mortality, and patient survival. RESULTS: There were 22 Extent I, 240 Extent II and 279 Extent III TAAAs. Thirty-day mortality was 3%. SCI occurred in 45 patients (8%), paraparesis occurring in 23 (4%) and paraplegia in 22 patients (4%). SCI was more common in patients with Extent I-II compared with Extent III TAAAs (12% vs. 5%, P =0.01). Rescue treatment included permissive hypertension in all patients, with CSFD in 22 (4%). Symptom improvement was noted in 73%. Twelve patients (2%) had permanent paraplegia. Two patients (0.4%) had major drain-related complications. Independent predictors for SCI by multivariate logistic regression were sustained perioperative hypotension [odds ratio (OR): 4.4, 95% confidence interval (95% CI): 1.7-11.1], patent collateral network (OR: 0.3, 95% CI: 0.1-0.6), and total length of aortic coverage (OR: 1.05, 95% CI: 1.01-1.10). Patient survival at 3 years was 72%±3%. CONCLUSION: FB-EVAR of Extent I-III TAAAs without CSFD has low mortality and low rates of permanent paraplegia (2%). SCI occurred in 8% of patients, and rescue treatment improved symptoms in 73% of them.

Total Transfemoral Percutaneous Endovascular Aortic Arch Repair Using 3-Vessel Inner Branch Stent-Graft.

Endovascular repair has been introduced to decrease the morbidity and mortality associated with open surgical repair of aortic arch pathology. We illustrate total percutaneous transfemoral approach with a 3-vessel inner branch stent-graft to treat aortic arch aneurysm. (Level of Difficulty: Advanced.).

Single-Center Experience with the Femoral-to-Brachial Preloaded Delivery System for Fenestrated-Branched Endovascular Repair of Complex Aortic Aneurysms.

PURPOSE: To assess technical aspects and outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) using a femoral-to-brachial (FTB) preloaded delivery system (PDS) with two separate configurations. METHODS: Clinical data of all consecutive patients enrolled in a prospective study to evaluate FB-EVAR for complex abdominal and thoracoabdominal aortic aneurysms (CAAAs & TAAA) between 2013 and 2020 were reviewed. Patients treated with FTB-PDS were included. The two configurations included 4 trans-brachial preloaded wires (4BR) or 2 trans-brachial and 2 transfemoral preloaded wires (2BR-2FE). Outcome measures included technical success, procedural metrics, 30-day or in-hospital mortality, major adverse events (MAEs), and target-vessel outcomes. RESULTS: There were 115 patients with a mean age of 73.8 ± 8 years, treated with FTB-PDS. Of these, 62 patients (54%) had 4BR and 53 patients (46%) had 2BR-2FE FTB-PDS. There were 106 TAAA (92%) and 9 CAAAs (8%). Technical success, defined as successful implantation of the stent-graft and all intended target-vessel stents without type I or III endoleak, was 97%, with no differences in total operating time, endovascular time, and radiation dose between groups. There were 3 deaths (3%) at 30 days. MAEs were noticed in 21 patients (18%) with no difference between groups, including new-onset dialysis (2% vs. 4%, P = 0.59), and paraplegia (7% vs. 11%, P = 0.51), for 4BR and 2BR-2FE, respectively. Patient survival and freedom from aortic-related mortality at 2-years were 79 ± 5% and 97 ± 1.7%, respectively, with no difference between groups. CONCLUSION: The use of FTB-PDS for FB-EVAR is safe with high technical success and a reasonable rate of MAEs. Each configuration provides specific benefits based on patient anatomy, while having similar procedural metrics and clinical outcomes.

Outcomes of "Anterior Versus Posterior Divisional Branches of the Hypogastric Artery as Distal Landing Zone for Iliac Branch Devices": The International Multicentric R3OYAL Registry.

OBJECTIVE: The aim of this multicentric registry was to assess the outcomes of "anteRior versus posteRior divisional bRanches Of the hYpogastric artery as distAl landing zone for iLiac branch devices (R3OYAL)." METHODS: The main exposure of interest for the purpose of this study was the internal iliac artery (IIA) divisional branch (anterior vs posterior) that was used as distal landing zone. Early endpoints included technical success and adverse events. Late endpoints included survival, primary/secondary IIA patency, and IIA branch instability. RESULTS: A total of 171 patients were included in the study, of which 50 received bilateral implantation of iliac branch devices (IBDs). This resulted in a total of 221 incorporated IIAs included in the final analysis, of which 40 were anterior divisional branches and 181 were posterior divisional branches. Technical success was high in both groups (anterior division: 98% vs posterior division: 100%, P = .18). Occurrence of any adverse event was noted in 14% of patients in both groups (P = 1.0). The overall rate of freedom from the composite IBD branch instability did not show significant differences between patients receiving distal landing in the anterior or posterior division of the IIA at 3 years (79% vs 87%, log-rank test = .215). The 3-year estimates of IBD patency were significantly lower in patients who received distal landing in the anterior divisional branch than those who received distal landing in the posterior divisional branch (primary patency: 81% vs 96%, log-rank test = .009; secondary patency: 81% vs 97%, log-rank test < .001). CONCLUSIONS: The use of the anterior or posterior divisional branches of the IIA as distal landing zone for IBD implantation shows comparable profiles in terms of immediate technical success, perioperative safety, and side-branch instability up to 3 years. However, IBD patency at 3 years was higher when the distal landing zone was achieved within the posterior divisional branch of the IIA. CLINICAL IMPACT: The results from this large multicentric registry confirm that use of the anterior or posterior divisional branches of the internal iliac artery (IIA) as distal landing zone for implantation of iliac branch devices (IBD) shows comparable profiles of safety and feasibility, thereby allowing to extend the indications for endovascular repair of aorto-iliac aneurysms to cases with unsuitable anatomy within the IIA main trunk. Although mid-term rates of device durability and branch instability seem to be similar, the rates of primary and secondary IBD patency at three years was favored when the distal landing zone was achieved in the posterior divisional branch of the IIA.

Endovascular Repair of Complex Aortic Aneurysms.

Fenestrated-branched endovascular aortic repair (FB-EVAR) has gained widespread acceptance in patients with complex aortic aneurysms. It has evolved from an alternative to treat elderly and higher risk patients to the first line of treatment in most patients with suitable anatomy, independent of the clinical risk. Currently, these devices are available off-the-shelf (ready to use) and tailored to the patient anatomy with the options of fenestrated, branched and mixed fenestrated, and branched designs. Reports from single and multicenter experiences and systematic reviews have shown lower mortality and morbidity for FB-EVAR compared with historical results of open surgical repair. The main advantages are noted on mortality, respiratory complications, acute kidney injury, and length of hospital stay. The purpose of this article is to review the advances in the endovascular repair of complex aortic aneurysms exploring the indications for treatment, preoperative evaluation, patient selection, device design, and implantation technique.

Outcomes of low- and standard-profile fenestrated and branched stent grafts for treatment of complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: We compared the outcomes of fenestrated-branched (FB) endovascular abdominal aortic aneurysm repair (EVAR) using low-profile (LP) and standard-profile (SP) stent grafts for the treatment of complex abdominal aortic aneurysms (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of 466 consecutive patients (70% male; mean age, 74 ± 8 years) enrolled in a prospective nonrandomized study to investigate FB-EVAR for the treatment of CAAAs and TAAAs (2013-2021). The endpoints compared between the patients treated with LP (18F-20F) and SP (20F-22F) devices included procedural metrics, access-related complications, major adverse events (MAE), patient survival, freedom from secondary intervention, thromboembolic events, stent graft integrity issues, aneurysm sac enlargement, and the rate of sac shrinkage. RESULTS: Of the 466 aneurysms treated by FB-EVAR, 138 were CAAAs and 141 were extent IV and 187 extent I to III TAAAs, with a mean number of 3.9 ± 0.5 vessels stented per patient. LP devices had been used in 239 patients (51%) and SP devices in 227 patients (49%). LP devices had been used more frequently for chronic dissections (12% vs 7%; P = .041) and with preloaded systems (77% vs 65%; P = .005) and bilateral percutaneous femoral access (83% vs 74%; P = .020) and less frequently with upper extremity access (67% vs 88%; P < .001) and iliac conduits (2% vs 6%; P = .020). The patients treated using LP devices had experienced similar technical success (96% vs 97%; P = .527), with a shorter total operating time (225 ± 81 minutes vs 243 ± 78 minutes; P = .018), lower radiation exposure (median, 0.93 Gy; interquartile range [IQR], 0.94; vs median, 1.01 Gy; IQR, 0.91 Gy; P < .001), and less use of contrast (median, 135 mL; IQR, 68 mL; vs median, 144 mL; IQR, 80 mL; P = .008). No differences were found in the rates of iliofemoral access complications between the LP and SP device groups (1.3% vs 3.5%; P = .107). At 30 days, 5 patients had died (1%) and MAEs had occurred in 89 patients (19%), with no differences between the two groups. The mean follow-up was 28 months (95% confidence interval, 25-30 months). At 4 years, the patients treated with LP devices had had similar freedom from all-cause mortality (69% ± 6% vs 68% ± 4%; P = .199), freedom from aortic-related mortality (97% ± 1% vs 98% ± 1%; P = .488), freedom from any secondary intervention (65% ± 6% vs 70% ± 4%; P = .433), freedom from thromboembolic events (98% ± 1% vs 99% ± 1%; P = .364) and aneurysm sac enlargement (93% ± 3% vs 91% ± 3%; P = .293). However, the LP group had had less freedom from any integrity-related issues (92% ± 5% vs 100%; P < .001). The cumulative risk of sac shrinkage was greater for patients treated with LP devices (adjusted hazard ratio, 2.040; 95% confidence interval, 1.516-2.744; P < .001). CONCLUSIONS: FB-EVAR was performed with low rates of mortality and MAEs, irrespective of the device profile. However, the procedures performed with LP devices had had less need for iliac conduits and had had better procedural metrics. The use of LP devices resulted in higher rates of sac shrinkage. However, the results on stent graft integrity require future investigation.

Impact of gap distance between fenestration and aortic wall on target artery instability following fenestrated-branched endovascular aortic repair.

OBJECTIVE: Target artery (TA) instability has been the most frequent indication for secondary intervention after fenestrated and branched endovascular aortic repair (FB-EVAR) of pararenal and thoracoabdominal aortic aneurysms (TAAAs). The aim of the present study was to evaluate the effect of the gap distance between the endograft reinforced fenestration and TA origin at the aortic wall (fenestration gap [FG]) on target-related outcomes after FB-EVAR. METHODS: The clinical data and imaging studies of 430 patients enrolled in a prospective, nonrandomized study to evaluate FB-EVAR using manufactured stent grafts were reviewed. Of the 430 patients, 340 (79%) had had more than one vessel incorporated by fenestration. The FG was retrospectively measured on postoperative imaging studies and classified into three groups: no gap (FG, 0 mm), FG 1 to 4 mm, and FG ≥5 mm. The primary outcome was freedom from TA instability. The secondary end points included TA-related endoleak, TA secondary intervention, and TA patency. RESULTS: A total of 1558 renal-mesenteric TAs were incorporated by 1104 reinforced fenestrations and 454 directional branches (DBs), with a mean of 3.9 ± 0.5 vessels per patient. The mean FG was 2.8 ± 4.5 mm, with an FG of 0 mm for 646 TAs, 1 to 4 mm for 209 TAs, and ≥5 mm for 249 TAs. An FG of ≥5 mm was associated with significantly lower (P < .001) freedom from TA instability, type Ic or IIIc endoleak, and secondary interventions at 5 years. Compared with DBs, fenestrations with an FG of ≥5 mm had similar primary patency and freedom from TA instability but significantly lower freedom from type Ic or IIIc endoleak (91% ± 2% vs 95% ± 1%; log rank, P = .02) and secondary interventions (87% ± 3% vs 93% ± 2%; log-rank, P = .02) at 5 years. The independent predictors of TA instability included postdissection TAAAs (hazard ratio, 2.5; 95% confidence interval, 1.2-5.4) and FG ≥5 mm (hazard ratio, 1.6; 95% confidence interval, 1.2-1.8). TAs incorporated by reinforced fenestrations had higher primary (99% ± 0.8% vs 97% ± 1.0%; P = .039) and secondary (100% vs 98% ± 1.0%; P = .012) patency rates at 5 years compared with DBs, with the lowest primary patency observed for renal DBs (80% ± 6% vs 92% ± 2%; P = .008). CONCLUSIONS: An FG of ≥5 mm was independently associated with an increased risk of TA instability, type Ic or IIIc endoleaks, and secondary interventions for patients treated by FB-EVAR using fenestrated designs. TAs incorporated by DBs had lower 5-year primary and secondary patency compared with those with reinforced fenestrations, with the lowest 5-year patency of 80% for renal branches. Compared with DBs, fenestrations with an FG of ≥5 mm carried a greater risk of type Ic or IIIc endoleak and secondary interventions. Independent predictors of TA instability included postdissection TAAAs and a greater FG. In contrast, dual antiplatelet therapy and larger TA diameters were protective.

Outcomes of balloon-expandable versus self-expandable stent graft for endovascular repair of iliac aneurysms using iliac branch endoprosthesis.

PURPOSE: The purpose of this study was to compare outcomes of internal iliac artery (IIA) stenting using balloon-expandable (BESG) or self-expandable stent grafts (SESG) during endovascular repair of aortoiliac aneurysms with iliac branch endoprosthesis (IBE; W. L. Gore, Flagstaff, Ariz). METHODS: We retrospectively reviewed all consecutive patients treated for aortoiliac aneurysms using IBE between 2014 and 2020. IIA stenting was performed using either the IIA side branch SESG or a Gore VBX BESG (W. L. Gore). Indications for use of BESGs were "up-and-over" IBE technique for type IB endoleak after prior endovascular aortic aneurysm repair (EVAR), short IIA length, and need for IIA extension into divisional branches (outside instructions for use). End points included technical success, freedom from buttock claudication, primary IIA patency, and freedom from IIA branch instability (eg, branch-related death or rupture, occlusion, disconnection, or reintervention for stenosis, kink, or endoleak), freedom from type IC/IIIC endoleak, and freedom from secondary interventions. RESULTS: There were 90 patients (86 males and 4 females) with a mean age of 74 ± 7 years treated by EVAR with 108 IBEs. Choice of stent was BESG in 43 and SESG in 65 targeted IIAs. BESGs were used more frequently in patients with prior EVAR (22% vs 2%; P = .003,), isolated IBEs (31% vs 2%; P < .001), and in patients with IIA aneurysms requiring stenting into divisional branches (36% vs 5%; P < .001). Technical success was similar for BESGs and SESGs (97% vs 100%; P = .40), respectively. The mean follow-up was 25 ± 16 months (range, 11-34 months). At 2 years, freedom from buttock claudication was 100% for BESG and 95 ± 3% for SESG (Log-rank 0.26), with no difference in primary patency (BESG, 100% vs SESG, 94 ± 4%; Log-rank 0.94). There were four (9%) IIA-related endoleaks in the BESG group and one (2%) in the SESG group (P = .08). Freedom from IIA branch instability was 87 ± 6% for BESG and 96 ± 3% for SESG at 2 years (Log-rank 0.043). Freedom from type IC/IIIC endoleak was 87 ± 7% for BESG and 98 ± 2% for SESG at the same interval (Log-rank 0.06). There was no difference in freedom from reinterventions for BESG and SESG (92 ± 6% vs 98 ± 2%; Log-rank 0.34), respectively. CONCLUSIONS: BESGs were used more frequently during IBE procedures indicated for failed EVAR, isolated common iliac aneurysms, and IIA aneurysms requiring extension into divisional branches. Despite these differences and BESG being used outside instructions for use, both stent types had similar primary patency, freedom from buttock claudication, and freedom from reinterventions. However, BESGs were associated with higher rates of IIA-related branch instability.

Outcomes of off-the-shelf multibranched stent grafts with intentional occlusion of directional branches using endovascular plugs during endovascular repair of complex aortic aneurysms.

OBJECTIVE: To evaluate the technique and outcomes of intentional occlusion of directional branches (DBs) using endovascular plugs during branched endovascular aortic repair using off-the-shelf Zenith t-Branch thoracoabdominal (TAAA) stent grafts. METHODS: We reviewed the clinical data and outcomes of all consecutive patients treated by branched endovascular aortic repair using off-the-shelf Zenith t-Branch TAAA stent-graft (Cook Medical, Bloomington, Ind) in seven academic centers from 2013 to 2019. All patients had at least one DB intentionally occluded using extension of the branch with balloon or self-expandable covered stent, followed by placement of endovascular plugs. Intentional occlusion was indicated in patients with variations in the normal four-vessel renal-mesenteric anatomy, pre-existing dialysis, or in those who failed catheterization of a target vessel. End points were 30-day/in-hospital mortality, major adverse events, secondary interventions, target artery (TA) patency, TA instability, and patient survival. RESULTS: There were 100 patients, 65 male and 35 female, with median age of 71 years (interquartile range [IQR], 66-75 years). Of these, 31 patients (31%) had urgent/emergent operations for symptomatic/contained ruptured aneurysms. The median aneurysm diameter was 72 mm (IQR, 61-85 mm). A total of 290 renal-mesenteric arteries were incorporated with a median of three (IQR, 3-3) vessels/patient. Indications for DB occlusion were less than four suitable renal-mesenteric targets in 84 patients or pre-existing dialysis and inability to catheterize a target vessel in eight patients each. There were 110 DBs occluded by vascular plugs, including 48 celiac axis, one superior mesenteric artery, and 61 renal DBs. Thirty-day/in-hospital mortality was 10%, including 9% for elective and 13% for urgent/emergent procedures. Major adverse events occurred in 44 patients (44%), including acute kidney injury in 19 patients (19%), estimated blood loss >1 L in 12 patients (12%), respiratory failure and new onset dialysis in six patients (6%) each, bowel ischemia in five patients (5%), and myocardial infarction and paraplegia in two patients (2%) each. The median follow-up was 5 months (range, 1-13 months). Eighteen patients (18%) required secondary interventions, none for problems related to the occluded DB. There were no endoleaks related to the occluded DB. At 2 years, primary and secondary patency and freedom from TA instability were 93% ± 3%, 97% ± 2%, and 91% ± 4%, respectively. Freedom from secondary interventions and patient survival were 75% ± 6% and 63% ± 7%, respectively. CONCLUSIONS: Intentional occlusion of DBs using endovascular plugs allows versatile use of a four-vessel off-the-shelf multi-branched TAAA stent graft in patients with variations in the normal renal and mesenteric anatomy or when technical difficulties prevent successful target vessel stenting. There were no endoleaks or secondary interventions associated with the occluded DB.