Safety and learning curve of percutaneous axillary artery access for complex endovascular aortic procedures.

BACKGROUND: Percutaneous axillary artery access is increasingly used for large-bore access during interventional vascular and cardiac procedures. The aim of this study was to evaluate the safety and learning curve of percutaneous axillary artery access in patients undergoing complex endovascular aortic repair (fenestrated and branched endovascular aneurysm repair [FBEVAR]) requiring large-bore upper extremity access and to discuss best practices for technique and complication management. METHODS: One-hundred forty-six patients undergoing large-bore percutaneous axillary artery access during FBEVAR in a prospective, nonrandomized, Investigational Device Exemption study between September 2017 and January 2023 were analyzed. Ultrasound guidance and micropuncture were used to access the second portion of the axillary artery and 2 Perclose Proglide or Prostyle devices (Abbott Vascular) were predeployed before the insertion of the large-bore sheath. Completion angiography was performed in all patients to verify hemostatic closure. Axillary artery patency was also assessed on follow-up computed tomography angiography. Patient-related, procedural, and postoperative variables were collected and analyzed. RESULTS: One-hundred forty-five patients underwent successful percutaneous axillary artery access; 1 patient failed axillary access and alternative access was established. The left axillary artery was accessed in 115 patients (79%), and the right axillary artery was accessed in 30 patients (21%). The largest profile sheath was 14 F in 4 patients (2.8%), 12F in 133 patients (91.7%), and 8F in 8 patients (5.5%). Ten patients (6.9%) required covered stent placement (Viabahn, W. L. Gore & Associates) for failure to achieve hemostasis; there were no conversions to open surgical repair. Additional adverse events included transient upper extremity weakness in two patients (1.3%) and transient upper extremity paresthesias in two patients (1.3%). Three patients (2%) suffered postoperative strokes, including one unrelated hemorrhagic stroke and two possibly access-related embolic strokes. On follow-up, axillary artery patency was 100%. There was a trend toward decreased closure failure over time, with seven patients (10%) in the early cohort and three (4%) in the late cohort. There was a significant negative correlation between the cumulative complication rate and the cumulative experience. CONCLUSIONS: Large-bore percutaneous axillary artery access provides safe upper extremity large-bore access during FBEVAR, achieving successful closure in >90% of patients with a low incidence of access-related complications. There was a trend toward better closure rates with increasing experience, suggesting a learning curve effect. Application of best practices including ultrasound guidance and angiography may ensure safe application of the technique of percutaneous large-bore axillary artery access.

Elective open repair with the debranch, perfuse, reconstruct technique to treat suprarenal or type IV thoracoabdominal aortic aneurysms.

BACKGROUND: Open surgical repair of suprarenal abdominal aortic aneurysm (SRAAA) and type IV thoracoabdominal aortic aneurysm (TAAA) remains a surgical challenge because of the inducted intraoperative visceral and renal ischemia. We report a novel three-step technique named debranch, perfuse, reconstruct (DPR), using debranching and passive arterial shunt to decrease these ischemic complications. The main aim of this study was to evaluate the 30-day and 1-year mortality rates associated with these DPR technique. The secondary aim was to evaluate the impact on renal function and the primary patency of the repaired arteries. METHODS: This retrospective study included all consecutive patients who underwent elective surgery for SRAAA or type IV TAAA using the DPR technique between January 2011 and June 2022. In debranching, using partial side clamping, a multibranch graft was implanted side-to-end into the descending thoracic aorta. The left renal artery was anastomosed end-to-end to the graft. As needed, the superior mesenteric artery (SMA), the celiac trunk, and the right renal artery could also be anastomosed to the graft. In the perfusion step, cannulas were connected to the last branch of the multibranch graft to perfuse other arteries during aortic cross-clamping. For repair, a tube or bifurcated graft was used for the aortic repair. The branch used as a passive temporary arterial shunt was ligated at the end of the intervention. Clinical, radiological, and biological preoperative and postoperative factors were reviewed using a standardized database. Procedural complications and reinterventions were analyzed, as well as artery patency. RESULTS: There were 40 patients who underwent DPR technique. The mean patient age was 67 ± 13 years and two were women. Twenty-three patients presented with a SRAAA and 17 with a type IV TAAA. The 30-day and 1-year mortality rates were 2.5% (one patient). Two respiratory complications (5%) and three mesenteric ischemic complications (7%) have been recorded. No patient developed signs of cardiac or spinal cord dysfunction. We did not observe a significant change in postoperative renal function. The celiac trunk, superior mesenteric artery, left renal artery, and right renal artery bypass patency rates at 1 year were 95%, 100%, 90%, and 100%, respectively. CONCLUSIONS: The SRAAA and type IV TAAA repair with DPR technique provides short visceral and renal ischemia times with a low mortality rate. This technique could be an option to consider for visceral and renal protection during open surgical repair.

Midterm outcomes of the Viabahn VBX balloon-expandable covered stent for fenestrations during complex endovascular aortic aneurysm repair.

OBJECTIVES: The optimal bridging stent for fenestrations during complex endovascular aortic aneurysm repair (EVAR) has not been defined. At our institution, the Viabahn VBX is frequently used given its availability and mechanical and heparin-bonding characteristics. This study aimed to assess the performance of the Viabahn VBX vs the iCast balloon-expandable covered stents as bridging stents for fenestrations during complex EVAR. METHODS: A retrospective study of consecutive patients undergoing complex EVAR between 2015 and 2021 was performed. Celiac arteries (CAs), superior mesenteric arteries (SMAs), left renal arteries, and right renal arteries stented with fenestrations were grouped according to the type of bridging stent, VBX vs iCast. Target vessels (TV) stented with a branch or scallop were excluded. The primary end points included primary patency and freedom from TV instability. RESULTS: A total of 292 patients undergoing complex EVAR were treated using VBX or iCast with a mean follow-up of 190 days (interquartile range, 36-384 days) for the VBX cohort and 804 days (interquartile range, 384-1507 days) for the iCast cohort. A total of 677 TVs were stented, including 134 CAs (20%), 175 SMAs (26%), 182 left RAs (27%), 186 right RAs (27%), and 12 additional vessels (2%). Proximal reinforcement was more frequent with VBX than with iCast stent (23% vs 2.4%; P < .0001). There was no difference in primary patency rates at 2 years between VBX and iCast stent for CA (100% vs 96.4%; P = .32), SMA (97.8% vs 100%; P = .14), and the RAs (96.7% vs 99.4%; P = .11). There was no difference between VBX and iCast in the cumulative incidence of type Ic and type IIIc endoleaks (3.2% vs 5.6%; P = .69) or freedom from TV instability at 2 years. CONCLUSIONS: Viabahn VBX stents are a safe and effective option as bridging stents in fenestrations during complex EVAR with comparable midterm outcomes to iCast stents. However, proximal stent reinforcement may be required with VBX stent to ensure adequate sealing at the fenestrations. Longer follow-ups and larger series are required to assess long-term outcomes and durability.

Multilayer Flow Modulator Stent for Aortic Pathology: A Meta-Analysis and Additional Data from a Single-Centre Retrospective Cohort.

Background: Thoracoabdominal aneurysms and aortic dissections are a challenge for vascular surgeons. Open surgery, fenestrated or branched endograft, and the chimney technique are not possible in some patients, because of comorbidities or anatomical restrictions. However, the multilayer flow modulator (MFM) can be implanted in some of these patients. In this systematic review, we will describe the experience with the multilayer stent. To augment the limited number of studies available, we will include a cohort of patients from our hospital. Methods: We retrieved data on all consecutive patients treated using the MFM between May 2013 and August 2020. This included patients with type B dissections and thoracoabdominal or thoracic aneurysms who were unfit for open surgery. The systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We included all the studies that used the MFM in the aortic segment. Single-arm meta-analyses were performed using OpenMeta (Brown University, Providence, RI, USA). Results: A total of 37 patients were treated in our hospital during the study period. The technical success was 97.3% and the 30-day mortality was 5.4%. In 40.5% of the included patients, the instructions for use were not followed. Off-label implantation was associated with a higher aneurysm-related mortality. A total of 12 studies were included in the meta-analysis and the technical success was 97.8%. In 68.5%, the aneurysm sack or false lumen remained perfused, 97% of all the covered side branches remained patent. After a follow-up period of 1 year, five patients in the meta-analysis presented with a ruptured aneurysm. Conclusions: The overall quality of evidence is poor because long-term results are lacking, patients are frequently lost during follow-up and all the studies were non-comparative. Our retrospective study suggests a relatively low incidence of perioperative complications, although there was a high incidence of persistent perfusion in the aneurysm sac (102 of 149 patients). The risk of rupture at the 1-year follow-up was 2.1%.

Endovascular Conversion of a Failed Nellix AAA-Repair by a Custom-Made Branched Device.

PURPOSE: This technical note presents a case of a patient with a failed Nellix device (Endologix, Irvine, Calif) who was not deemed fit for open conversion. Our planned approach for repair involved an endovascular procedure utilizing a custom-made branched device. TECHNIQUE: An endovascular repair was performed via a custom-made four outer branched device in conjunction with a custom-made bifurcated graft featuring inverted limbs (Cook Inc., Bloomington, Ind). All branches were connected to the target vessel with Gore Viabahn VBX balloon-expandable covered stents (Gore & Associates Inc.). CONCLUSION: Endovascular conversion with branched endovascular repair in a patient not deemed fit for open surgery was successfully performed, thereby reducing the risk of a high morbid and mortal procedure. CLINICAL IMPACT: Novel useful treatment solution of failed EVAR with Nellix device.

Pre-emptive False Lumen Embolization to Prevent Persistent Type II Endoleak in Fenestrated-Branched Endovascular Repair of Post-Dissection Thoracoabdominal Aortic Aneurysms.

PURPOSE: The purpose was to describe a technique to promote false lumen (FL) thrombosis in post-dissection thoracoabdominal aortic aneurysms (PD-TAAAs) managed by fenestrated/branched endografting (F/B-EVAR). TECHNIQUE: A 5/6Fr-90 cm length sheath is advanced from the true lumen (TL) to FL through the most distal entry tear of the infrarenal aorta or iliac arteries. It is parked in the most cranial portion of the FL in the thoracic aorta. Aortic endografts are deployed in the TL excluding all the para-visceral/distal entry tears and target visceral vessels bridging stenting is performed. A selective FL angiography is performed through the 5/6Fr sheath to detect the origin of all segmentary arteries. Embolization of FL is performed from above to below by M-reye pushable coils, obtaining the packaging of FL. After completion angiography, the 5/6Fr sheath is retrieved in external iliac artery and molding ballooning of the distal segment of the aortic/iliac endograft is performed. Between 2019 and 2023, this technique was applied in 11cases with a median number of 73 (interquartile range [IQR=12) coils. Out of 8 (72%) patients with available radiological follow-up at 1 year, 7 exhibited complete FL thrombosis. CONCLUSIONS: The FL coiling in PD-TAAAs managed by F/B-EVAR is feasible, safe, and effective to promote the complete FL thrombosis. CLINICAL IMPACT: Preemptive false lumen embolization is a feasible, safe, and effective technique for preventing persistent type II endoleaks after fenestrated-branched endovascular repair of post-dissection thoracoabdominal aortic aneurysms. This technique may be routinely recommended to promote FL thrombosis and aortic remodeling after FB-EVAR in PD-TAAAs, thereby reducing the incidence of reinterventions during follow-up.

Intravascular Ultrasound in the Detection of Bridging Stent Graft Instability During Fenestrated and Branched Endovascular Aneurysm Repair Procedures: A Multicentre Study on 274 Target Vessels.

OBJECTIVE: The use of intravascular ultrasound (IVUS) reduces contrast medium use and radiation exposure during conventional endovascular aneurysm repair (EVAR). The aim of this study was to evaluate the safety and efficacy of IVUS in detecting bridging stent graft (bSG) instability during fenestrated and branched EVAR (F/B-EVAR). METHODS: This was a prospective observational multicentre study. The following outcomes were evaluated: (1) technical success of the IVUS in each bSG, (2) IVUS findings compared with intra-operative angiography, (3) incidence of post-operative computed tomography angiography (CTA) findings not detected with IVUS, and (4) absence of IVUS related adverse events. Target visceral vessel (TVV) instability was defined as any branch or fenestration issues requiring an additional manoeuvre or re-intervention. Any IVUS assessment that detected stenosis, kinking, or any geometric TVV issue was considered to be branch instability. All procedures were performed in ad hoc hybrid rooms. RESULTS: Eighty patients (69% males; median age 72 years; interquartile range 59, 77 years) from four aortic centres treated with F/B-EVAR between January 2019 and September 2021 were included: 70 BEVAR (21 off the shelf; 49 custom made), eight FEVAR (custom made), and two F/B-EVAR (custom made), for a total of 300 potential TVVs. Two TVVs (0.7%) were left unstented and excluded from the analysis. The TVVs could not be accessed with the IVUS catheter in seven cases (2.3%). Furthermore, 17 (5.7%) TVVs could not be examined due to a malfunction of the IVUS catheter. The technical success of the IVUS assessment was 91.9% (274/298), with no IVUS related adverse events. Seven TVVs (2.5%) showed signs of bSG instability by means of IVUS, leading to immediate revisions. The first post-operative CTA at least 30 days after the index procedure was available in 268 of the 274 TVVs originally assessed by IVUS. In seven of the 268 TVVs (2.6%) a re-intervention became necessary due to bSG instability. CONCLUSION: This study suggests that IVUS is a safe and potentially valuable adjunctive imaging technology for intra-operative detection of TVV instability. Further long term investigations on larger cohorts are required to validate these promising results and to compare IVUS with alternative technologies in terms of efficiency, radiation exposure, procedure time, and costs.

Inner branched complex aortic repair outcomes from a national multicenter registry using the E-xtra design platform.

BACKGROUND: Complex aortic pathology still represents an open issue in contemporary endovascular management, with continuous technological advancement being introduced in practice over time aiming to improve outcomes. Thus far, the dualism between the fenestrated and branched configuration for visceral artery revascularization is yet unsolved, with each approach having its own pros and cons. The inner branched technology for endovascular aneurysm repair (iBEVAR) aims to take the best out of both strategies, offering wide applicability and stable bridging stent sealing. The objective of this study was to evaluate the early outcomes obtained with a single manufacturer custom-made inner-branched endograft in a multicenter Italian experience. METHODS: All patients consecutively treated with E-xtra design devices in three Italian facilities were enrolled. Anatomic characteristics and perioperative data were analyzed. The main objective was to asses technical and clinical success after iBEVAR. Secondary end points were overall survival, aortic-related mortality, target visceral vessel (TVV) patency, and freedom from target vessel instability during follow-up. RESULTS: From 2016 to 2021, 45 patients were treated with an E-xtra design device revascularizing at least one visceral vessel through an inner branch. The mean age at the time of the procedure was 71.1 ± 9.3 years and 77.8% were males. The total number of target visceral arteries to be bridged with an inner branch was 159. The extent of aortic repair was thoracoabdominal in 91.1% of the cases. Technical success was achieved in 93.3% of the procedures (42/45) with all failures owing to a type I endoleak at final angiography. Each TVV was successfully connected to the graft's main body as planned without complications. Following their intervention, five patients developed spinal cord ischemia and in three of these cases symptoms persisted after discharge (6.7%). At 30 days clinical success was 93.3% (42/45). No death as well as no TVV thrombosis occurred within 30 days from the primary procedures. The mean follow-up was 22.8 ± 14.2 months. The Kaplan-Meier estimate of overall survival and TVV patency at 36 months were 83.9% and 95.9%, respectively. CONCLUSIONS: Inner branches seem to be a promising technology in the complex aortic repair landscape, with an applicability ranging from type II thoracoabdominal aneurysm to type I endoleak repair after infrarenal endografting. Whether iBEVAR could offer results comparable with those provided by fenestrated/branched endovascular aneurysm repair in terms of target vessel patency and stent stability is yet to be established and further studies are, therefore, needed.

Comparison of upper extremity and transfemoral access for fenestrated-branched endovascular aortic repair.

OBJECTIVE: The use of upper extremity (UE) access is an accepted and often implemented approach for fenestrated/branched endovascular aortic aneurysm repair (F-BEVAR). The advent of steerable sheaths has enabled the performance of F-BEVAR using a total transfemoral (TF) approach without UE access, potentially decreasing the risks of cerebral embolic events. The purpose of the present study was to assess the outcomes of F-BEVAR using UE vs TF access. METHODS: Prospectively collected data from nine physician-sponsored investigational device exemption studies at U.S. centers were analyzed using a standardized database. All patients were treated for complex abdominal aortic aneurysms (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs) using industry-manufactured fenestrated and branched stent grafts between 2005 and 2020. The outcomes were compared between patients who had undergone UE vs total TF access. The primary composite outcome was stroke or transient ischemia attack (TIA) and 30-day or in-patient mortality during the perioperative period. The secondary outcomes included technical success, local access-related complications, and perioperative mortality. RESULTS: Among 1681 patients (71% men; mean age, 73.43 ± 7.8 years) who had undergone F-BEVAR, 502 had had CAAAs (30%), 535 had had extent IV TAAAs (32%), and 644 had had extent I to III TAAAs (38%). UE access was used for 1103 patients (67%). The right side was used for 395 patients (24%) and the left side for 705 patients (42%). UE access was preferentially used for TAAAs (74% vs 47%; P < .001). In contrast, TF access was used more frequently for CAAAs (53% vs 26%; P < .01). A total of 38 perioperative cerebrovascular events (2.5%), including 32 strokes (1.9%) and 6 TIAs (0.4%), had occurred. Perioperative cerebrovascular events had occurred more frequently with UE access than with TF access (2.8% vs 1.2%; P = .036). An individual component analysis of the primary composite outcome revealed a trend for more frequent strokes (2.3% vs 1.2%; P = .13) and TIAs (0.54% vs 0%; P = .10) in the UE access group. On multivariable analysis, total TF access was associated with a 60% reduction in the frequency of perioperative cerebrovascular events (odds ratio, 0.39; P = .029). No significant differences were observed between UE and TF access in the technical success rate (96.5% vs 96.8%; P = .72), perioperative mortality (2.9% vs 2.6%; P = .72), or local access-related complications (6.5% vs 5.5%; P = .43). CONCLUSIONS: In the present large, multicenter, retrospective analysis of prospectively collected data, a total TF approach for F-BEVAR was associated with a lower rate of perioperative cerebrovascular events compared with UE access. Although the cerebrovascular event rate was low with UE access, the TF approach offered a lower risk of stroke and TIA. UE access will continue to play a role for appropriately selected patients requiring more complex repairs with anatomy not amenable to the TF approach.

Characterization and management of type II and complex endoleaks after fenestrated/branched endovascular aneurysm repair.

INTRODUCTION: Endoleaks are more common after fenestrated/branched endovascular aneurysm repair (F/B-EVAR) than infrarenal EVAR secondary to the length of aortic coverage and number of component junctions. Although reports have focused on type I and III endoleaks, less is known regarding type II endoleaks after F/B-EVAR. We hypothesized that type II endoleaks would be common and often complex (associated with additional endoleak types), given the potential for multiple inflow and outflow sources. We sought to describe the incidence and complexity of type II endoleaks after F/B-EVAR. METHODS: F/B-EVAR data prospectively collected at a single institution in an investigational device exemption clinical trial (G130210) were retrospectively analyzed (2014-2021). Endoleaks were characterized by type, time to detection, and management. Primary endoleaks were defined as those present on completion imaging or at first postoperative imaging, and secondary were those on subsequent imaging. Recurrent endoleaks were those that developed after a successfully resolved endoleak. Reinterventions were considered for type I or III endoleaks or any endoleak associated with sac growth >5 mm. Technical success defined as the absence of flow in the aneurysm sac at procedure conclusion and methods of intervention were captured. RESULTS: Among 335 consecutive F/B-EVARs (mean ± standard deviation follow-up: 2.5 ± 1.5 years), 125 patients (37%) experienced 166 endoleaks (81 primary, 72 secondary, and 13 recurrent). Of these 125 patients, 50 (40% of patients) underwent 71 interventions for 60 endoleaks. Type II endoleaks were the most frequent (n = 100, 60%), with 20 identified during the index procedure, 12 (60%) of which resolved before 30-day follow-up. Of the 100 type II endoleaks, 20 (20%; 12 primary, 5 secondary, and 3 recurrent) were associated with sac growth; 15 (75%) of those with associated sac growth underwent intervention. At intervention, 6 (40%) were reclassified as complex, with a concomitant type I or type III endoleak. Initial technical success for endoleak treatment was 96% (68 of 71). There were 13 recurrences, all of which were associated with complex endoleaks. CONCLUSIONS: Nearly half of the patients who underwent F/B-EVAR experienced an endoleak. The majority were classified as type II, with nearly a fifth associated with sac expansion. Interventions for a type II endoleak frequently led to reclassification as complex, with a concomitant type I or III endoleak not appreciated on computed tomography angiography and/or duplex. Further study is needed to determine if the primary treatment goal for complex aneurysm repair is sac stability or sac regression, as this would inform both the importance of properly classifying endoleaks noninvasively and the intervention threshold for managing type II endoleaks.

Aneurysm extent-based mortality differences in complex endovascular repair of thoracoabdominal aneurysms in the Vascular Quality Initiative and the United States Aortic Research Consortium.

BACKGROUND: Endovascular management of thoracoabdominal aneurysms (TAAA) is becoming more common. Technological advances including custom devices under the Physician-Sponsored Investigational Device Exemption (PS-IDE), physician-modified endografts (PMEG), and parallel stenting techniques have expanded the extent of disease that is amenable to endovascular treatment. Patients within the PS-IDE studies are a highly selected group of patients, whereas patients treated with PMEG as captured within the Society for Vascular Surgery Vascular Quality Initiative (SVS VQI) represent a real-world experience. Research within both the SVS VQI on PMEG and the US Aortic Research Consortium (US-ARC) has demonstrated a relationship between extent of aneurysmal disease and mortality after complex endovascular TAAA repair, but no direct comparison of these cohorts has been conducted. In this study, we sought to compare outcomes of custom PS-IDE devices with off-label uses of commercially available devices for the endovascular management of TAAAs. METHODS: A retrospective review of patients presenting for elective endovascular TAAA repair for asymptomatic disease between 2011 and 2019 was conducted within both the SVS VQI registry and the US-ARC. Patients within the SVS VQI registry were treated with either PMEG or with parallel stenting techniques. Patients within the US-ARC were treated with PS-IDE custom devices. The extent of aneurysm disease was defined by the deployment zones documented for the devices entered in the registry using Crawford extents I to V. Primary outcomes were 30-day and 1-year mortality rates. RESULTS: A total of 3212 patients were included in the study: 1571 PMEG/parallel stenting within the VQI registry and 1641 with PS-IDE within the US-ARC database. The majority of patients presented with extent IV aneurysms (n = 1827 [57%]), with extent IV aneurysms being slightly more prevalent within the US-ARC cohort. Maximal aneurysm diameter within each extent did not vary between the US-ARC and VQI cohorts. Across all patients, the 30-day mortality was 4.4% and the 1-year mortality was 12.2%. Unadjusted mortality at 30-days was 6.7% within the VQI, and 2.2% in the US-ARC (P < .001). The unadjusted 1-year mortality was 14.3% within the VQI and 10.2% within the US-ARC (P < .001). When adjusted for aneurysm extent, similar differences in 30-day and 1-year survivals were identified. CONCLUSIONS: Patients treated in PS-IDE studies had better 30-day and 1-year survival rates compared with those treated with a similar extent of disease using off-label approaches in a real-world registry. These differences are complex and likely associated with a number of factors, including arterial anatomy, patient comorbidities, device construct, and volume outcomes, as well as complex and unmeasurable surgeon- and patient-specific factors.

Redo Fenestrated-Branched Endovascular Aortic Repair (F-BEVAR) for Failed F-BEVAR.

Failed fenestrated-branched endovascular aortic repair (F-BEVAR) requiring a redo F-BEVAR is a rare event. In this study, we report 2 cases of a failed F-BEVAR secondary to a type IIIb endoleak from tears on the fabric graft successfully treated with redo F-BEVAR. This is a technically challenging procedure that requires meticulous planning, advanced imaging technologies and experienced operators. Redo F-BEVAR appears to be a feasible and safe treatment option. However, larger series and long-term follow-up are needed to confirm effectiveness and durability.

The Association of Sarcopenia and ASA Score to Spinal Cord Ischemia in Patients Treated With the t-Branch Device.

PURPOSE: Sarcopenia has been identified as an independent predictor of mortality in patients with infrarenal abdominal aortic aneurysm and may also affect outcomes in patients with complex aortic pathologies. The aim of this study was to assess sarcopenia, combined with the American Society of Anesthesiologists (ASA) score, as predictors for spinal cord ischemia (SCI) in patients treated with the t-Branch off-the-shelf device. MATERIALS AND METHODS: A single-center retrospective observational study was conducted including elective and urgent patients managed with the t-Branch device (Cook Medical, Bjaeverskov, Denmark) between January 1, 2018, and September 30, 2020. Data were collected according to the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement. The psoas muscle area (cm2) and attenuation (Hounsfield units, HU) were measured in the arterial phase of the pre-operative computed tomography angiography for each patient. The lean psoas muscle area (LPMA) was used to stratify patients into 3 groups, and further stratification was performed with a combination of the ASA score and LPMA. RESULTS: Eighty patients were included (mean age at 71±9 years; 62.5% males). Thoracoabdominal aneurysms were managed in 72.5% of cases (42.5% for type I-III). Thirty-seven (46%) were treated urgently. Eleven patients died within 30 days (14%). Twelve patients (15%) presented SCI of any severity. Among the LPMA groups, the only statistically significant difference was recorded in age; group 3 was older compared with groups 1 and 2 (67.1 years vs 72.1 years vs 73.5 years, p=0.004). After ASA combined LPMA categorization, 28 patients were considered as low risk, 16 as moderate risk, and 36 as high risk. A statistically significant difference was recorded in terms of SCI (3.5% [1/28] in low risk vs 12.5% [2/16] in moderate risk vs 25% [9/36] in high risk, p=0.049). Multivariate analysis showed that moderate-risk patients were at risk to evolve to SCI (p=0.04). CONCLUSIONS: Low-risk patients, with ASA score I-II or LPMA>350cm2HU, are at lower risk for developing SCI after BEVAR using the t-Branch device. Patients' stratification according to the combination of ASA score and psoas muscle area and attenuation may identify a group at higher risk of SCI after branched endovascular aneurysm repair. CLINICAL IMPACT: Sarcopenia has been identified as a factor of increased mortality in patients managed for aortic aneurysm repair. However, significant heterogeneity has been recorded in the tools assessing its presence. In this analysis, an already used method, combining the ASA score and psoas muscle area and attenuation, has been used to assess the impact of sarcopenia in patients managed with the t-branch device. This analysis showed that patients at low risk, with an ASA score I-II or LPMA>350cm2HU were at lower risk to evolve spinal cord ischemia. Along this line, sarcopenia may be a valuable marker for the prediction of perioperative adverse events , other than mortality, in patients managed using complex endovascular repair.

Monocentric Evaluation of Physician-Modified Fenestrations or Parallel Endografts for Complex Aortic Diseases.

PURPOSE: This study aimed to investigate the demographic and anatomic characteristics, as well as perioperative and follow-up results of fenestration and parallel techniques for the endovascular repair of complex aortic diseases. MATERIALS AND METHODS: A retrospective study was conducted on 67 consecutive patients underwent endovascular treatment for complex aortic diseases including abdominal aortic aneurysm (AAA), thoracoabdominal aneurysm (TAAA), aortic dissection, or prior endovascular repair with either fenestrated and parallel endovascular aortic repair (f-EVAR or ch-EVAR) at a single institute from 2013 to 2021. Choices of intervention were made by the disease' emergency, patients' general condition, the anatomic characteristics, as well as following the recommendation from the devices' guidelines. Patients' clinical demographics, aortic disease characteristics, perioperative details, and disease courses were discussed. Short- and mid-term follow-up results were obtained and analyzed. Endpoints were aneurysm-related and unrelated mortality, branch instability, and renal function deterioration. RESULTS: Totally, 34 and 27 patients received f-EVAR and ch-EVAR, while 6 patients received a combination of both. Fenestrated endovascular aortic repair was conducted mainly in AAA affecting visceral branches and TAAA, whereas ch-EVAR was normally utilized for infrarenal AAA. Regarding the average number of reconstructed arteries per patient, there was a significant difference among f-EVAR, ch-EVAR, and the combination group (mean = 2.3 ± 0.9, 1.4 ± 0.6, 3.5 ± 0.5, p<0.001). Primary technical success was achieved in 28 (82.4%), 22 (81.5%), and 3 (50.0%) patients for each group. Besides operational time (5.77 ± 2.58, 4.47 ± 1.44, p=0.033), no significant difference was observed for blood transfusion, intensive care unit (ICU) or hospital stay, blood creatinine level, 30-day complications, or follow-up complications between patients undergoing f-EVAR or ch-EVAR. Patients receiving combination of both techniques had a higher rate of blood transfusion (p=0.044), longer operational time (p=0.008) or hospital stay (p=0.017), as well as more stent occlusion (p=0.001), endoleak (p=0.004) at short-term and a higher rate of endoleak (p=0.023) at mid-term follow-up. CONCLUSION: In conclusion, this study demonstrated that f-EVAR and ch-EVAR techniques had acceptable perioperative and follow-up results and should be considered viable alternatives when encountering complex aortic diseases. CLINICAL IMPACT: This study sought to investigate the baseline and pathological characteristics, as well as perioperative and follow-up results of f-EVAR and ch-EVAR at a single Chinese institution. F-EVAR (mostly physician-modified f-EVAR) was applied in patients with a wide range of etiologies and disease types, while ch-EVAR was preferred for AAA in older patients with an average higher ASA grade. Our experience suggested acceptable safety and efficacy both for techniques, and no significant difference was observed between the two groups regarding any short or mid-term adverse events.

Technical Pitfalls for Fenestrated-Branched Endovascular Aortic Repair Following PETTICOAT.

PURPOSE: The Provisional Extension to Induce Complete Attachment Technique (PETTICOAT) uses a bare-metal stent to scaffold the true lumen in patients with acute or subacute aortic dissections. While it is designed to facilitate remodeling, some patients with chronic post-dissection thoracoabdominal aortic aneurysms (TAAAs) require repair. This study describes the technical pitfalls of fenestrated-branched endovascular aortic repair (FB-EVAR) in patients who underwent prior PETTICOAT repair. TECHNIQUE: We report 3 patients with extent II TAAAs who had prior bare-metal dissection stents treated by FB-EVAR. Two patients required maneuvers to reroute the aortic guidewire, which was initially placed in-between stent struts. This was recognized before the deployment of the fenestrated-branched device. A third patient had difficult advancement of the celiac bridging stent due to a conflict of the tip of the stent delivery system into one of the stent struts, requiring to redo catheterization and pre-stenting with a balloon-expandable stent. There were no mortalities and target-related events after a follow-up of 12 to 27 months. CONCLUSION: FB-EVAR following the PETTICOAT is infrequent, but technical difficulties should be recognized to prevent complications from the inadvertent deployment of the fenestrated-branched stent-graft component in-between stent struts. CLINICAL IMPACT: The present study highlights a few maneuvers to prevent or overcome possible complications during endovascular repair of chronic post-dissection thoracoabdominal aortic aneurysm following PETTICOAT. The main problem to be recognized is the placement of the aortic wire beyond one of the struts of the existing bare-metal stent. Moreover, encroachment of catheters or the bridging stent delivery system into the stent struts may potentially cause difficulties.

Urgent Juxtarenal Aortic Aneurysm Repair With Modified Off-the-shelf Endograft to Preserve Intercostal Arteries and Branch Incorporation by Transfemoral Access.

PURPOSE: To demonstrate the feasibility of the modification to preserve intercostal arteries of the t-Branch Endograft (Cook Medical, Bloomington, IN) in an urgent setting, associated with a less invasive approach for branch incorporation from percutaneous femoral access with steerable sheaths. TECHNIQUE: A 73-year-old female patient presented at our institution with intense abdominal pain. Angiotomography showed a 50-mm juxtarenal aortic aneurysm, with no signs of rupture. Urgent endovascular repair was indicated due to abdominal symptom with an off-the-shelf multi-branched endograft. To limit descending thoracic aortic coverage, we performed t-Branch modification to preserve intercostal arteries and minimize the risk of spinal cord injury, associated with a percutaneous transfemoral approach and branch incorporation with steerable sheaths to avoid the risks associated with a superior axillary or brachial access. Control angiotomography showed adequate aneurysm sac exclusion with patency of all four visceral vessels. CONCLUSION: t-Branch-modified endograft to limit aortic coverage is an alternative option in urgent cases to diminish the risk of spinal cord injury, and association of steerable sheaths with branch incorporation is leading complex aortic repairs to an even less invasive procedure. CLINICAL IMPACT: This paper highlights the possibility of performing complex endovascular aortic repair in an urgent setting with modification of an off-the-shelf multi branched endograft limiting intercostal arteries coverage, thereby diminishing the risk of spinal cord ischemia. This technical innovation provides an alternative for clinicians when treating large, rapidly expanding, or symptomatic juxtarenal, pararenal, paravisceral or type 4 thoracoabdominal aortic aneurysms that could not wait for a custom-made device and do not need extensive thoracic aortic coverage that an off-the-shelf device provides. In summary, expand the possibilities of an endovascular repair of complex aortic aneurysms.

Outcomes of Secondary Endovascular Aortic Repair After Frozen Elephant Trunk.

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

Initial Outcomes of Physician-Modified Inner Branched Endovascular Repair in High-Surgical-Risk Patients.

PURPOSE: To report the initial outcomes of physician-modified inner branched endovascular repair (PMiBEVAR) for pararenal aneurysms (PRAs), thoracoabdominal aortic aneurysms (TAAAs), and aortic arch aneurysms in high-surgical-risk patients. MATERIALS AND METHODS: A total of 10 patients (6 men; median age, 83.0 years) treated using PMiBEVAR were enrolled in this retrospective, single-center study. All patients were at high surgical risk because of severe comorbidities (American Society of Anesthesiologists physical status score≥3 or emergency repair). End points were defined as technical success per patient and per vessel (successful deployment), clinical success (no endoleaks postoperatively), in-hospital death, and major adverse events. RESULTS: There were 3 PRAs, 4 TAAAs, and 3 aortic arch aneurysms with 12 renal-mesenteric arteries and 3 left subclavian arteries incorporated by inner branches. The technical success rate was 90.0% (9/10) per patient and 93.3% (14/15) per vessel. The clinical success rate was 90% (9/10). There were 2 in-hospital deaths, unrelated to aneurysms. Paraplegia and shower emboli occurred separately in 2 patients. Three patients experienced prolonged ventilation for 3 days after surgery. Aneurysm sac shrinkage occurred in 4 patients, and aneurysm size stabilized in 1 patient during follow-up, more than 6 months later. None of the patients required intervention. CONCLUSION: PMiBEVAR is a feasible approach for treating complex aneurysms in high-surgical-risk patients. This technology may complement the existing technology in terms of improved anatomical adaptability, no time delay and practicability in many countries. However, long-term durability remains undetermined. Further large-scale and long-term studies are needed. CLINICAL IMPACT: This is the first clinical study to investigate outcomes of physician-modified inner branched endovascular repair (PMiBEVAR). PMiBEVAR for treating pararenal aneurysm, thoracoabdominal aortic aneurysm, or aortic arch aneurysm is a feasible procedure. This technology is likely to complement existing technology in terms of improved anatomical adaptability (compared to off-the-shelf devices), no time delay (compared to custom-made devices), and the potential to be performed in many countries. On the other hand, surgery time varied greatly depending on the case, suggesting a learning curve and the need for technological innovation to perform more consistent surgeries.

Kidney autotransplantation as a key solution for a BEVAR type IIIb endoleak.

OBJECTIVES: Target vessel endoleaks are one of the most common causes of revision procedures after a fenestrated or branched endovascular aneurysm repair. Usually, a redo stenting is an effective therapy, however, not always feasible. We present a case of a hybrid treatment for a type IIIb endoleak using the renal autotransplantation technique. METHODS: A 60-year-old man with a thoracoabdominal aortic aneurysm has been treated with a custom-made branched endoprosthesis. Occlusion of the bridging stent to the right renal artery with total infarction of the right kidney was identified one week later and conservatively managed. After four years, a type IIIb endoleak was identified. Endovascular treatment was attempted unsuccessfully. So, the endoleak was corrected using a hybrid strategy with the kidney autotransplantation technique. RESULTS: A left kidney autotransplantation followed by an aortic stent-graft relining with a tubular graft has been done uneventfully, in a phased manner. Postoperative computed tomography angiography confirmed the patency of vascular reconstructions with no endoleaks. No adverse events occurred during one year of follow-up. CONCLUSION: Our case highlights kidney autotransplantation as a viable solution for a hybrid treatment of target vessel endoleaks and shows that this technique can assist complex endovascular aortic reconstructions.

Perioperative neurologic outcomes of right versus left upper extremity access for fenestrated-branched endovascular aortic aneurysm repair.

OBJECTIVE: Upper extremity (UE) access is frequently used for fenestrated-branched endovascular aortic aneurysm repair (F-BEVAR), particularly for complex repairs. Traditionally, left-side UE access has been used to avoid crossing the arch and the origin of the supra-aortic vessels, which could potentially result in cerebral embolization and an increased risk of perioperative cerebrovascular events. More recently, right UE has been more frequently used as it is more convenient and ergonomic. The purpose of this study was to assess the outcomes and cerebrovascular events after F-BEVAR with the use of right- vs left-side UE access. METHODS: During an 8-year period, 453 patients (71% male) underwent F-BEVAR at a single institution. UE access was used in more complex repairs. Left UE access was favored in the past, whereas right UE access is currently the preferred UE access side. Brachial artery cutdown was used in all patients for the placement of a 12F sheath. Outcomes were compared between patients undergoing right vs left UE access. End points included cerebrovascular events, perioperative mortality, technical success, and local access-related complications. RESULTS: UE access was used in 361 (80%) patients. The right side was used in 232 (64%) and the left side in 129 (36%) patients for the treatment of 88 (25%) juxtarenal, 135 (38%) suprarenal, and 137 (38%) thoracoabdominal aortic aneurysms. Most procedures were elective (94%). Technical success was achieved in 354 patients (98%). In-patient or 30-day mortality was 3.3%. Five (1%) perioperative strokes occurred in patients undergoing right UE access, of which three were ischemic and two were hemorrhagic. No transient ischemic attacks occurred perioperatively. Two hemorrhagic strokes were associated with permissive hypertension to prevent spinal cord ischemia. No perioperative strokes occurred in patients undergoing left UE access (P = .16). Overall, perioperative strokes occurred with similar frequency in patients undergoing UE (5, 1%) and femoral access only (1, 1%) (P = .99). Arm access-related complications occurred in 15 (5%) patients, 11 (4.8%) on the right side and 4 (6%) on the left side (P = .74). CONCLUSIONS: Right UE access can be used for F-BEVAR with low morbidity and minimal risk of perioperative ischemic stroke or transient ischemic attacks. In general, UE access is not associated with an increased risk of perioperative stroke compared with femoral access only. Tight blood pressure control is, however, critical to avoid intracranial bleeding related to uncontrolled hypertension.