Tenorio, Emanuel R

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.

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.

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.

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.

Objective: The aim of this study was to investigate the midterm outcomes of fenestrated and branched endovascular aortic repair (FB-EVAR) of pararenal (PRA) and thoracoabdominal aortic aneurysms (TAAAs). Summary Background Data: FB-EVAR has been associated with decreased morbidity compared to open repair, but there is limited midterm data. Methods: A total of 430 patients (302 males, mean age 74 ± 8 years) treated by FB-EVAR were enrolled in a prospective, nonrandomized investigational device exemption study. Endpoints included 30-day mortality and major adverse events (MAEs), freedom from all cause and aortic-related mortality, target vessel patency, and freedom from secondary intervention and target vessel instability. Results: There were 133 PRAs and 297 TAAAs with 1673 renal-mesenteric arteries incorporated by fenestrations or directional branches (3.9 ± 0.5 vessels/patient). At 30 days or within the hospital stay if longer than 30 days, there were 4 (0.9%) deaths. MAEs included new-onset dialysis in 8 patients (2%), permanent paraplegia or stroke in 10 patients each (2%), and respiratory failure requiring tracheostomy in 2 patients (0.5%). After a mean follow-up of 26 ± 20 months, there were 3 (0.7%) aortic-related deaths from SMA stent occlusion, gastrointestinal hemorrhage, or complications of open arch repair. At 5 years, freedom from all-cause and aortic-related mortality were 57% ± 5% and 98% ± 1%, respectively. Freedom from secondary intervention was 64% ± 4%, primary target vessel patency was 94% ± 1%, and freedom from target vessel instability was 89% ± 2% at same interval. One patient (0.2%) had nonfatal aneurysm treated using endovascular repair. Conclusion: FB-EVAR is safe and effective for treatment of PRA and TAAAs with low rate of aortic-related mortality and aneurysm rupture on midterm follow-up.

Purpose: Common celiomesenteric trunk (CMT) is a rare anatomical variation that occurs in 0.5% to 3.4% of the general population. Its presence may complicate planning and implantation of fenestrated and branched stent-grafts because the wide diameter and short length of the CMT to its bifurcation does not allow sufficient sealing for placement of bridging stents. Case Report: We report a patient with thoracoabdominal aortic aneurysm (TAAA) and CMT treated by fenestrated-branched endovascular aortic repair (FB-EVAR) using double kissing directional branches to incorporate the celiac axis and superior mesenteric artery. Pitfalls of stent design and implantation are outlined. Conclusion: Double kissing directional branches should be considered as an alternative to incorporate vessels with early bifurcation such as a CMT.

Objective: The aim of this study was to analyze the outcomes of a standardized protocol using routine CSFD, neuromonitoring, LL reperfusion, and selective TASP to prevent SCI during F-BEVAR. Background: SCI is to be the most devastating complication for the patient, family, and surgeon, with impact on patient’s quality of life and long-term prognosis. An optimal standardized protocol may be used to improve outcomes. Methods: Patients enrolled in a prospective, nonrandomized single-center study between 2013 and 2018. A SCI prevention protocol was used for TAAAS or complex abdominal aneurysms with ≥5-cm supraceliac coverage including CSFD, neuromonitoring, LL reperfusion, and selective TASP. Endpoints included mortality and rates of SCI. Results: SCI prevention protocol was used in 170 of 232 patients (73%) treated by F-BEVAR. Ninety-one patients (55%) had changes in neuromonitoring, which improved with maneuvers in all except for 9 patients (10%) who had TASP. There was one 30-day or in-hospital mortality (0.4%). Ten patients (4%) developed SCIs including in 1% (1/79) of patients with normal neuromonitoring and 10% (9/91) of those who had decline in neuromonitoring (P = 0.02). Permanent paraplegia occurred in 2 patients (1%). Factors associated with SCI included total operating time (odds ratio 1.5, 95% confidence interval 1.1–2.2, P = 0.02) and persistent changes in neuromonitoring requiring TASP (odds ratio 15.7, 95% confidence interval 2.9–86.2, P = 0.001). Conclusion: This prospective nonrandomized study using a standardized strategy to prevent SCI was associated with low incidence of the SCI during F-BEVAR. Permanent paraplegia occurred in 1%.

Purpose: To evaluate the incidence and outcomes of cerebral embolic events when using right (RUE) vs left upper extremity (LUE) access for fenestrated/branched endovascular aneurysm repair (f/bEVAR). Materials and Methods: A retrospective review was conducted of 290 consecutive patients enrolled in a physician-sponsored Investigational Device Exemption study to evaluate f/bEVAR between 2013 and 2018. Of these, 270 patients (93%) had an upper extremity access with 12-F sheaths, including 205 patients (mean age 75±8 years; 147 men) with LUE and 65 patients (mean age 73±8 years; 42 men) with RUE access. Outcome measures were technical success, procedural metrics, major adverse events (MAEs), any stroke or transient ischemic attack (TIA), and mortality. Results: Technical success was higher (p=0.04) for LUE (99.6%) vs RUE access (98.4%). Patients treated via RUE access more often had extent I-III thoracoabdominal aortic aneurysms (57% vs 39%, p=0.03). Procedural metrics were similar for LUE vs RUE sides, including endovascular time (255±80 vs 246±83 minutes, respectively; p=0.23), fluoroscopy time (84±32 vs 90±35 minutes, respectively; p=0.80), and contrast volume (156±57 vs 153±56 mL, respectively; p=0.82). Total radiation exposure was significantly higher for LUE vs RUE access (2463±1912 vs 1757±1494 mGy, respectively; p=0.02). There were 2 deaths (1%) at 30 days or during hospital admission, both unrelated to access site complications. MAEs occurred in 32% of patients who had LUE and 26% of those who had RUE access (p=0.44). Five patients (2%) had embolic stroke and none had TIA. Embolic strokes were ipsilateral to the access side in 4 patients and affected the posterior circulation in 3. Two patients (1%) had hemorrhagic strokes. The incidence of stroke was 3% for LUE and 2% for RUE access (p>0.99). Conclusion: Fenestrated/branched stent-graft repair was associated with low rates of cerebral embolic events and no significant difference between the right vs left upper extremity approach.

Purpose: To evaluate the outcomes of the Gore Excluder Iliac Branch Endoprosthesis (IBE) using division branches of the internal iliac artery (IIA) as distal landing zones. Materials and Methods: Between January 1, 2014, and December 31, 2018, 74 patients (mean age 74±7 years; 72 men) treated for aortoiliac or common iliac artery aneurysms had an IBE deployed with distal landing of the side branch within the main trunk (n=60) of the internal iliac artery (IIA) vs within a division branch (n=25). Thirteen (17%) patients received bilateral IBE implantations for a total of 85 vessels evaluated. Early endpoints were technical success, 30-day mortality, 30-day major adverse events (MAEs), and 30-day major access complications. Late endpoints were survival, primary and secondary IIA patency, freedom from IIA branch instability, freedom from new-onset buttock claudication, and aneurysm sac diameter changes. Time-dependent outcomes were reported as Kaplan-Meier curves with differences assessed using the log-rank test. Estimates are presented with the 95% confidence interval (CI). Results: The overall technical success rate was 97%, with 1 technical failure per group (p=0.43). Two patients, one from each group, died within 30 days (p=0.43). No significant differences were seen in the rates of 30-day MAEs (7% vs 17%, p=0.35) or major access complications (9% vs 11%, p>0.99) for patients receiving distal landing in the main trunk vs a division branch, respectively. The mean follow-up for the entire cohort was 19±12 months. The overall 1-year survival rate was 94% (95% CI 74% to 99%). The primary and secondary patency rates at 1 year were 98% (95% CI 88% to 99%) vs 95% (95% CI 72% to 99%, p=0.72) and 98% (95% CI 88% to 99%) vs 100% (p=0.41) for the main trunk vs division branch groups, respectively. Freedom from IIA branch instability estimates were also similar at 1-year follow-up [93% (95% CI 82% to 97%) vs 90% (95% CI 66% to 97%), p=0.29], as were the freedom from new-onset buttock claudication estimates [98% (95% CI 86% to 99%) and 94% (95% CI 67% to 99%), respectively; p=0.62]. Mean sac diameter change was 5.4±5.3 mm, not significantly different between the groups (p=0.85). Conclusion: Use of the posterior or anterior division of the IIA as a distal landing zone for the Gore Excluder IBE was safe and efficacious in the midterm. This technique may permit extending indications for endovascular repair of aortoiliac aneurysms to cases with unsuitable anatomy within the IIA main trunk. Long-term assessment is needed to affirm the efficacy of this technique.