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.

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.

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.

External validation of Villalta score in high-middle income country patients with deep vein thrombosis.

ABSTRACT: Post-thrombotic syndrome (PTS) is a late complication that does not have a cure yet, with a prevalence estimated between 20 to 75%, associated with previous deep vein thrombosis event. Although the Villalta score (VS) is the gold-standard clinical tool for diagnostic and prognostic evaluation of PTS, there are currently no VS intra-rater agreement established and no validation studies for VS' application into Brazilian Portuguese. We sought to translate and validate VS reliability systematically; and, secondarily, to compare the ultrasound findings with the severity of PTS.We systematically translated the original VS into Brazilian Portuguese (BP). Fifty participants who underwent two outpatient visits were evaluated using the translated VS. We assessed its intra-rater and inter-rater agreement and compared BP VS versus CEAP clinical component (CEAP C), and the clinical PTS severity versus the duplex ultrasound (DUS) findings. The study and its report followed the Guidelines for Reporting Reliability and Agreement Studies.The intra-rater evaluation of VS grades had a simple Kappa coefficient of 0.73, and the simple Kappa coefficient inter-rater for VS grades was 0.67. When VS was compared to CEAP C, it established a remarkably high correlation over 0.9. There was difference among VS values compared to DUS initial deep vein thrombosis territory, with femoropopliteal showing higher values than distal veins. Higher VS values were correlated to DUS venous recanalization and reflux.There was a substantial inter-rater and intra-rater agreement when the BP VS was applied; and when compared to CEAP C, VS showed a high correlation. When VS grading was compared to DUS characteristics, there were significant statistical and clinical correlation, with presence of reflux and recanalization showing higher VS values. This external VS validation also changes the clinical practice allowing the VS use in a different population and establishes the VS intra-rater agreement.

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.

Incidence, predictive factors, and outcomes of intraprocedure adverse events during fenestrated-branched endovascular aortic repair of complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: To evaluate the incidence of intraoperative adverse events (IAEs) and their impact on outcomes after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysm (TAAAs). METHODS: We reviewed the clinical and imaging data of 600 consecutive patients (445 males; mean age, 75 ± 8 years) who underwent FB-EVAR between 2007 and 2019 in a single institution. IAE was defined as any intraoperative complication or technical problem requiring additional and unplanned procedures, and was classified as access-related, target artery (TA)-related, or graft-related. End points included rates of IAEs, 30-day or in-hospital mortality, major adverse events, patient survival, freedom from secondary intervention, and TA instability. RESULTS: A total of 122 IAEs were identified in 105 patients (18%). IAEs were TA-related in 55 patients (9%), access-related in 46 patients (8%), and graft-related in seven patients (1%). Female sex was more frequent among patients with IAEs (44% vs 22%; P < .001). Patients with IAEs had smaller renal artery diameter (-0.4 mm, 5.4 ± 0.8 mm vs 5.8 ± 0.9 mm; P < .001), and were treated more often for TAAAs (72% vs 54%; P < .03). Technical success was achieved in 96.5% of patients and was lower for patients with IAEs (82% vs 99%; P < .001). Major adverse events were significantly more frequent among patients who had IAEs (odds ratio [OR], 1.98; 95% confidence interval [CI], 1.21-3.25), most due to acute kidney injury (27% vs 11%; P < .001) including new-onset dialysis (5% vs 1%; P = .01). On multivariate logistic regression model, female sex (OR, 2.5; 95% CI, 1.5-4.0), TA stenosis >50% (OR, 2.0; 95% CI, 1.3-3.3), and Crawford Extent II TAAA (OR, 1.9; 95% CI, 1.1-3.3) were predictive of IAEs, whereas preloaded design (OR, 0.6; 95% CI, 0.4-0.9) and TA diameter (+1 mm; OR, 0.6; 95% CI, 0.4-0.9) were protective of IAEs. IAEs negatively affected secondary intervention (hazard ratio [HR], 1.6; 95% CI, 1.1-2.3) and TA instability (HR, 2.5; 95% CI, 1.2-5.4); however, IAEs did not affect patient survival (HR, 1.0; 95% CI, 0.7-1.4). CONCLUSIONS: IAEs are common, occurring in nearly one of five patients treated with FB-EVAR for complex aortic aneurysms, and have a negative impact on clinical outcomes. IAEs were associated with female sex, TA diameter, and more extensive aortic disease.

Evaluation of Safety of Overhead Upper Extremity Positioning During Fenestrated-Branched Endovascular Repair of Thoracoabdominal Aortic Aneurysms.

PURPOSE: Peripheral nerve and brachial plexus injury can occur from compression or stretching during positioning for operative procedures. The aim of this study was to evaluate the safety of overhead upper extremity positioning to optimize imaging during fenestrated-branched endovascular aortic repair (FB-EVAR) of pararenal (PRA) and thoracoabdominal aortic aneurysms (TAAAs). METHODS: Forty-four consecutive patients enrolled in a prospective non-randomized study underwent FB-EVAR with overhead upper extremity positioning. Patients underwent intra-operative neuromonitoring of upper and lower extremities and neurological examination prior to discharge and at 2 months following the procedure. End points were peripheral or brachial plexus nerve injury, quality of lateral projection and cone beam computed tomography (CBCT) and major adverse event (MAEs). RESULTS: There were 28 (64%) male patients with mean age of 74 ± 8 years treated for 10 PRAs (23%) and 34 (78%) TAAAs. Mean body mass index was 29 ± 7 kg/m2, with 17 obese patients (39%). Open surgical upper extremity access was used in 19 patients (43%). Three patients (16%) had access-related complications, all focal brachial artery dissections treated by patch angioplasty. Two patients (5%) developed upper extremity changes in neuromonitoring, which immediately resolved with repositioning of the upper extremity. Technical success was 95%. Lateral projection and rotational CBCT were feasible in all patients with satisfactory imaging quality for catheterization and stenting of the celiac axis and superior mesenteric artery. There was one mortality (2%) at 30 days, and six patients (14%) had MAEs. There were no upper extremity neurological injuries. CONCLUSION: Overhead upper extremity position allows optimal imaging on lateral projections and rotational CBCT during FB-EVAR. There were no upper extremity neurological injuries in this study.

Midterm Outcomes of a Prospective, Nonrandomized Study to Evaluate Endovascular Repair of Complex Aortic Aneurysms Using Fenestrated-Branched Endografts.

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 ±â€Š8 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 ±â€Š0.5 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 ±â€Š20 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% ±â€Š5% and 98% ±â€Š1%, respectively. Freedom from secondary intervention was 64% ±â€Š4%, primary target vessel patency was 94% ±â€Š1%, and freedom from target vessel instability was 89% ±â€Š2% 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.

Differences in procedural metrics and clinical outcomes among patients treated by fenestrated-branched endovascular repair of thoracoabdominal aortic aneurysms using infrarenal aortic versus iliac sealing zones.

OBJECTIVE: The purpose of the present study was to assess the outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) using infrarenal aortic vs iliac sealing zones. METHODS: We reviewed the clinical data of 430 consecutive patients enrolled in a prospective nonrandomized study to evaluate FB-EVAR from 2013 to 2020. The outcomes were analyzed for patients with extent I to IV thoracoabdominal aortic aneurysms who had undergone FB-EVAR with distal implantation in the native infrarenal aorta. The minimum anatomic criteria for the use of infrarenal aortic seal was a >3-cm length of parallel aorta with a diameter of 18 to 32 mm without excessive thrombus or calcification. A control group matched for the extent of aortic disease with an iliac artery seal was used to compare the following endpoints: 30-day mortality, major adverse events, freedom from type Ib endoleak (TIbE), freedom from secondary interventions, and changes in the infrarenal aortic diameter. RESULTS: A total of 110 patients (55 men; mean age, 73 ± 8 years) were included in the present study, 55 with an infrarenal aortic distal seal and 55 with the iliac arteries as the sealing zone. Both groups had similar clinical characteristics and aneurysm extent and diameter, except for a greater number of men and higher serum creatinine in the iliac seal group. Technical success was obtained in 106 patients (96%) and was greater for the iliac sealing zone group (100% vs 93%; P = .04). The use of the infrarenal aortic sealing zone was associated with shorter endovascular (148 ± 56 minutes vs 191 ± 61 minutes; P < .001) and fluoroscopy (76 ± 28 minutes vs 96 ± 32 minutes; P < .001) times and lower radiation exposure (cumulative air kerma, 1.4 ± 1.4 Gy vs 2.1 ± 2.0 Gy; P = .02; dose area product, 147 ± 75 Gy ∙ cm2 vs 208 ± 102 Gy ∙ cm2; P = .006). One patient had died (1%) within 30 days. No differences were found in the major adverse events among the patients treated with infrarenal aortic vs iliac sealing zones (22% vs 18%; P = .63), including any spinal cord injury (13% vs 9%; P = .54) and grade 3 spinal cord injury (7% vs 7%; P = 1.0). The mean clinical follow-up was 24 ± 18 months. TIbE occurred in one patient in each group (P = 1.0). The 3-year freedom from TIbE and freedom from secondary intervention rate was 98% ± 2% and 67% ± 8% for the infrarenal aortic seal group and 97% ± 3% and 67% ± 8% for the iliac seal group, respectively (P = NS). Among the patients treated with infrarenal aortic sealing zones, the mean enlargement of the infrarenal aortic diameter was 5 ± 3.2 mm at 3 years. No late TIbE due to disease progression had developed in the infrarenal aorta. CONCLUSIONS: Infrarenal aortic and iliac artery seal zones are safe and effective during FB-EVAR, provided the patients have suitable segments. The use of the infrarenal aortic sealing zone had modest procedural advantages such as shorter endovascular and fluoroscopy times and lower radiation exposure. No differences were found in the clinical outcomes or development of TIbEs.

Incorporation of Celiomesenteric Trunk With Double Kissing Directional Branches During Fenestrated-Branched Endovascular Aortic Repair.

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.

Comparison of Cerebral Embolic Events Between Right and Left Upper Extremity Access During Fenestrated/Branched Endovascular Aortic Repair.

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.

Impact of Number of Vessels Targeted on Outcomes of Fenestrated-Branched Endovascular Repair for Complex Abdominal Aortic Aneurysms.

BACKGROUND: The aim of this study was to investigate the impact of number of vessels targeted by fenestrations or branches on early outcomes of fenestrated-branched endovascular aortic repair (F-BEVAR) for complex abdominal aortic aneurysms (cAAAs). METHODS: The clinical data of 260 patients (209 men; mean, 74 ± 7 years) treated for cAAAs in four academic centers using fenestrated-branched stent grafts with one to five fenestrations or branches were entered into prospectively maintained databases (2010-2015). Data were analyzed in patients treated with ≤2-vessel (group 1, n = 124), 3-vessel (group 2, n = 80), or ≥4 fenestrations or directional branches (group 3, n = 56). For group definition, only vessels incorporated by fenestrations or directional branches were accounted. End points were technical success, procedural variables, 30-day mortality, and major adverse events (MAEs). RESULTS: A total of 830 vessels (mean, 3.19 ± 0.8 vessels/patient) were targeted by fenestrations (n = 672), scallops (n = 136), or branches (n = 22). Two-vessel designs were used more often in the early experience (64%), whereas ≥3-vessel design (groups 2 and 3) was preferred in the late experience (68%, P < 0.05). Patients with ≥4-vessel designs had longer operating and fluoroscopy time (+78 min, P < 0.0001 and + 27 min, P < 0.001), higher volume of contrast use (+31 mL, P = 0.03), and longer hospital stay (+3 days, P = 0.007) of those who had ≤2-vessel designs. Technical success, estimated blood loss, mortality, MAEs, and rate of spinal cord injury were similar in all three groups (P > 0.05). CONCLUSIONS: F-BEVAR for complex abdominal aortic aneurysms was associated with high technical success and low 30-day mortality and morbidity. Increasing complexity was associated with longer operating and fluoroscopy time, more contrast use, and longer hospital stay but did not affect technical success and MAEs of the procedure.

Impact of intentional accessory renal artery coverage on renal outcomes after fenestrated-branched endovascular aortic repair.

OBJECTIVE: The objective of this study was to evaluate the impact of intentional coverage of accessory renal arteries (ARAs) on renal outcomes after fenestrated-branched endovascular aortic repair (FB-EVAR) for pararenal aortic aneurysms or thoracoabdominal aortic aneurysms. METHODS: We analyzed the clinical data of 296 patients enrolled in a prospective nonrandomized study to evaluate outcomes of FB-EVAR between 2013 and 2018. Patients with solitary kidneys, intraoperative loss of main renal arteries, or pre-existing stage V chronic kidney disease were excluded. Two groups were analyzed: patients with intentional ARA coverage; and controls, who had complete preservation. End points included 30-day mortality; major adverse events; acute kidney injury (AKI), defined by RIFLE criteria (Risk, Injury, Failure, Loss of kidney function, and End-stage renal disease); renal function deterioration (RFD), defined by >30% decline in baseline estimated glomerular filtration rate; and presence of renal infarcts. RESULTS: There were 254 patients (184 male; mean age, 75 ± 8 years) included in the study, 56 (22%) with intentional ARA coverage and 198 controls, of whom 16 had ARA preservation. ARA diameter was smaller in patients who had intentional coverage vs preservation (2.7 ± 0.9 mm vs 3.4 ± 0.2 mm; P < .001). There was no difference in demographics, cardiovascular risk factors, and aneurysm extent. All ARAs intended to be incorporated were successfully stented. Patients with ARA coverage had a higher frequency of kidney infarction (75% vs 25%; P < .001). There were two (1%) deaths within 30 days, both among controls. Patients with ARA coverage had more major adverse events (32% vs 19%; P = .04) because of higher incidence of AKI (21% vs 9%; P = .02). None of the 16 patients who had ARA preservation developed AKI. At 3 years, freedom from RFD was lower for patients who had ARA coverage compared with controls (55% ± 9% vs 76% ± 5%; log-rank, P = .02). By multivariate analysis, predictors of AKI were ARA coverage (odds ratio, 2.8; 95% confidence interval [CI], 1.2-6.2; P = .01) and estimated blood loss >1 L (odds ratio, 3.8; 95% CI, 1.2-12.3; P = .03). Postoperative AKI (hazard ratio [HR], 4.4; 95% CI, 2.4-8.1; P < .001), renal reintervention for stenosis (HR, 3.2; 95% CI, 1.6-6.7; P = .002), aneurysm diameter (HR, 1.04; 95% CI, 1.02-1.06; P < .001), and ARA coverage (HR, 2.0; 95% CI, 2.4-8.1; P = .02) were predictors of RFD. CONCLUSIONS: Intentional ARA coverage during FB-EVAR was associated with a threefold increase in AKI and with lower freedom from RFD. Factors associated with RFD included postoperative AKI, renal reinterventions for stenosis, and ARA coverage. Incorporation of ARAs during FB-EVAR, when it is technically feasible, helps decrease risk of AKI and RFD.

Staged total arch replacement, followed by fenestrated-branched endovascular aortic repair, for patients with mega aortic syndrome.

OBJECTIVE: The aim of the present study was to review the clinical outcomes of a staged approach using total arch replacement (TAR) with an elephant trunk or a frozen elephant trunk, followed by fenestrated-branched endovascular aortic repair (F-BEVAR) for patients with mega aortic syndrome. METHODS: We reviewed the clinical data and outcomes of 11 consecutive patients (8 men; mean age, 71 ± 7 years) treated by staged TAR and F-BEVAR from January 2014 to December 2018. The F-BEVAR procedures were performed under a prospective, nonrandomized, physician-sponsored investigational device exemption protocol. All patients had had mega aortic syndrome, defined by an ascending aorta, arch, and extent I-II thoracoabdominal aortic aneurysm. The endpoints were 30-day mortality, major adverse events (MAE), patient survival, freedom from reintervention, and freedom from target vessel instability. RESULTS: Of the 11 patients, 6 had developed chronic postdissection aneurysms after previous Stanford A (three A11, two A10, one A9) dissection repair and 5 had had degenerative aneurysms with no suitable landing zone in the aortic arch. The thoracoabdominal aortic aneurysms were classified as extent I in four patients and extent II in seven. One patient had died within 30 days after TAR (9.0%). However, none of the remaining 10 patients who had undergone F-BEVAR had died. First-stage TAR resulted in MAE in three patients (27%), including one spinal cord injury. The mean length of stay was 12 ± 6 days. The mean interval between TAR and F-BEVAR was 245 ± 138 days with no aneurysm rupture during the interval. Second-stage F-BEVAR was associated with MAE in two patients (20%), including spinal cord injury in one patient from spinal hematoma due to placement of a cerebrospinal fluid drain. The mean follow-up period was 14 ± 10 months. At 2 years postoperatively, patient survival, primary patency, secondary patency, and freedom from renal-mesenteric target vessel instability was 80% ± 9%, 94% ± 6%, 100%, and 86% ± 8%, respectively. No aortic-related deaths occurred during the follow-up period. Four patients had required reintervention, all performed using an endovascular approach. CONCLUSIONS: A staged approach to treatment of mega aortic syndrome using TAR and F-BEVAR is a feasible alternative for selected high-risk patients. Larger clinical experience and longer follow-up are needed.

Sizing and planning fenestrated and branched stent-grafts in patients with chronic post-dissection thoracoabdominal aortic aneurysms.

Fenestrated-branched endovascular repair (FB-EVAR) has been widely applied to treat chronic post-dissection thoracoabdominal aortic aneurysms (TAAAs) with favorable outcomes. A recent multicenter experience indicates that outcomes of FB-EVAR for chronic post-dissection are comparable to degenerative TAAAs. Anatomical and technical pitfalls are different than degenerative aneurysms because of true lumen compression, separate target vessel origin from true or false lumen and possible extension of dissection flaps into the renal and mesenteric vessels. This article focuses on planning and sizing FB-EVAR in patients with chronic post-dissection TAAAs.