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

OBJECTIVE: The clinical significance of family history (FH) of aortic disease on the outcomes of fenestrated/branched endovascular aneurysm repair (FB-EVAR) has not been well described. This study aimed to assess how FH of aortic disease affects outcomes following FB-EVAR for complex aortic aneurysms (CAAs). METHODS: This study retrospectively reviewed the clinical data of consecutive patients enrolled in 10 ongoing, prospective, non-randomised, physician sponsored, investigational device exemption studies to evaluate FB-EVAR (2005 - 2022) in the United States Aortic Research Consortium database. Patients were stratified by presence or absence of FH of any aortic disease in any relative. Patients with confirmed genetically triggered aortic diseases were excluded. Primary outcomes were 30 day major adverse events (MAEs) and late survival. Secondary outcomes included late secondary interventions and aneurysm sac enlargement. RESULTS: During the study period, 2 901 patients underwent FB-EVAR. A total of 2 355 patients (81.2%) were included in the final analysis: 427 (18.1%) with and 1 928 (81.9%) without FH of aortic disease. Patient demographics, clinical characteristics, and aneurysm extent were similar between the groups. Patients with FH of aortic disease more frequently had prior open abdominal aortic repair, but less frequently had prior endovascular aneurysm repair (p < .050). There were no statistically significant differences in 30 day mortality (4% vs. 2%; p = .12) and MAEs for patients with or without FH of aortic disease (12% vs. 12%; p = .89). Three year survival estimates were 71% (95% confidence interval [CI] 0.67 - 0.78%) and 71% (95% CI 0.68 - 0.74%), respectively (p = .74). Freedom from secondary intervention and aneurysm sac enlargement were also not statistically significantly different between groups. CONCLUSION: A family history of aortic disease had no impact on 30 day and midterm outcomes of FB-EVAR of CAAs. In the absence of an identified genetically triggered aortic disease, treatment selection for CAAs should be based on clinical risk and patient anatomy rather than FH of aortic disease.

Risk factors and effect of dyspnea inappropriate treatment in adults' emergency department: a retrospective cohort study.

Dyspnea is a frequent symptom in adults' emergency departments (EDs). Misdiagnosis at initial clinical examination is common, leading to early inappropriate treatment and increased in-hospital mortality. Risk factors of inappropriate treatment assessable at early examination remain undescribed herein. The objective of this study was to identify clinical risk factors of dyspnea and inappropriate treatment in patients admitted to ED. This is an observational retrospective cohort study. Patients over the age of 15 who were admitted to adult EDs of the University Hospital of Toulouse (France) with dyspnea were included from 1 July to 31 December 2019. The primary end-point was dyspnea and inappropriate treatment was initiated at ED. Inappropriate treatment was defined by looking at the final diagnosis of dyspnea at hospital discharge and early treatment provided. Afterward, this early treatment at ED was compared to the recommended treatment defined by the International Guidelines for Acute Heart Failure, bacterial pneumonia, chronic obstructive pulmonary disease, asthma or pulmonary embolism. A total of 2123 patients were analyzed. Of these, 809 (38%) had inappropriate treatment in ED. Independent risk factors of inappropriate treatment were: age over 75 years (OR, 1.46; 95% CI, 1.18-1.81), history of heart disease (OR, 1.32; 95% CI, 1.07-1.62) and lung disease (OR, 1.47; 95% CI, 1.21-1.78), SpO2 <90% (OR, 1.64; 95% CI, 1.37-2.02), bilateral rale (OR, 1.25; 95% CI, 1.01-1.66), focal cracklings (OR, 1.32; 95% CI, 1.05-1.66) and wheezing (OR, 1.62; 95% CI, 1.31-2.03). In multivariate analysis, under-treatment significantly increased in-hospital mortality (OR, 2.13; 95% CI, 1.29-3.52) compared to appropriate treatment. Over-treatment nonsignificantly increased in-hospital mortality (OR, 1.43; 95% CI, 0.99-2.06). Inappropriate treatment is frequent in patients admitted to ED for dyspnea. Patients older than 75 years, with comorbidities (heart or lung disease), hypoxemia (SpO2 <90%) or abnormal pulmonary auscultation (especially wheezing) are at risk of inappropriate treatment.

Transcatheter electrosurgical septotomy technique for chronic postdissection aortic aneurysms.

Aortic dissection often results in chronic aneurysmal degeneration due to progressive false lumen expansion. Thoracic endovascular aortic repair and other techniques of vessel incorporation such as fenestrated-branched or parallel grafts have been increasingly used to treat chronic postdissection aneurysms. True lumen compression or a vessel origin from the false lumen can present considerable technical challenges. In these cases, the limited true lumen space can result in inadequate stent graft expansion or restrict the ability to reposition the device or manipulate catheters. Reentrance techniques can be used selectively to assist with target vessel catheterization. Transcatheter electrosurgical septotomy is a novel technique that has evolved from the cardiology experience with transseptal or transcatheter aortic valve procedures. This technique has been applied in select patients with chronic dissection to create a proximal or distal landing zone, disrupt the septum in patients with an excessively compressed true lumen, or connect the true and false lumen in patients with vessels that have separate origins. In the present report, we summarize the indications and technical pitfalls of transcatheter electrosurgical septotomy in patients treated by endovascular repair for chronic postdissection aortic aneurysms.

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

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

How We Would Treat Our Own Thoracoabdominal Aortic Aneurysm.

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

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

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

Technical pitfalls and proposed modifications of instructions for use for endovascular aortic aneurysm repair using the Gore Excluder conformable device in angulated and short landing zones.

We describe a case of an abdominal aortic aneurysm (AAA) and angulated proximal neck treated with a Gore Excluder conformable endoprosthesis and show relevant technical pitfalls in the deployment of the graft main body. An 82-year-old man presented with a 71-mm asymptomatic AAA with an angulated infrarenal proximal neck (75°) and was referred to our unit. The patient was treated with a 26-mm Gore Excluder conformable device, which was deployed slightly above the renal arteries after precatheterization of the lowest renal artery. The graft was then repositioned with support of the introducer sheath and a stiff guide wire. The proximal sealing zone was ballooned before the endograft delivery system was retrieved to avoid distal migration. Technical success was achieved. The patient was discharged with no complications. No type Ia endoleak was present on the 6-month computed tomography scan. Endovascular treatment of an AAA with a severe angulated proximal neck can be effective with a conformable stent graft if technical measures are used during deployment of the main body to optimize the seal.

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

OBJECTIVE: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). BACKGROUND: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. METHODS: Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006-2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. RESULTS: A total of 2603 patients (69% males; mean age 72±10 year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P <0.001) and rates of MAEs (34% vs 20%, P <0.001). Median follow-up was 15 months (interquartile range, 7-37 months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P <0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50-2.44; P <0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63-3.62; P <0.001). CONCLUSIONS: Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.

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

OBJECTIVE: Stenting of renal and mesenteric vessels may result in changes in velocity measurements due to arterial compliance, potentially giving rise to confusion about the presence of stenosis during follow-up. The aim of our study was to compare preoperative and postoperative changes in peak systolic velocity (PSV, cm/s) after placement of the celiac axis (CA), superior mesenteric artery (SMA) and renal artery (RAs) bridging stent grafts during fenestrated-branched endovascular aortic repair (FB-EVAR) for treatment of complex abdominal aortic aneurysms (AAA) and thoracoabdominal aortic aneurysms. METHODS: Patients were enrolled in a prospective, nonrandomized single-center study to evaluate FB-EVAR for treatment of complex AAA and thoracoabdominal aortic aneurysms between 2013 and 2020. Duplex ultrasound examination of renal-mesenteric vessels were obtained prospectively preoperatively and at 6 to 8 weeks after the procedure. Duplex ultrasound examination was performed by a single vascular laboratory team using a predefined protocol including PSV measurements obtained with <60° angles. All renal-mesenteric vessels incorporated by bridging stent grafts using fenestrations or directional branches were analyzed. Target vessels with significant stenosis in the preoperative exam were excluded from the analysis. The end point was variations in PSV poststent placement at the origin, proximal, and mid segments of the target vessels for fenestrations and branches. RESULTS: There were 419 patients (292 male; mean age, 74 ± 8 years) treated by FB-EVAR with 1411 renal-mesenteric targeted vessels, including 260 CAs, 409 SMAs, and 742 RAs. No significant variances in the mean PSVs of all segments of the CA, SMA, and RAs at 6 to 8 weeks after surgery were found as compared with the preoperative values (CA, 135 cm/s vs 141 cm/s [P = .06]; SMA, 128 cm/s vs 125 cm/s [P = .62]; RAs, 90 cm/s vs 83 cm/s [P = .65]). Compared with baseline preoperative values, the PSV of the targeted vessels showed no significant differences in the origin and proximal segment of all vessels. However, the PSV increased significantly in the mid segment of all target vessels after stent placement. CONCLUSIONS: Stent placement in nonstenotic renal and mesenteric vessels during FB-EVAR is not associated with a significant increase in PSVs at the origin and proximal segments of the target vessels. Although there is a modest but significant increase in velocity measurements in the mid segment of the stented vessel, this difference is not clinically significant. Furthermore, PSVs in stented renal and mesenteric arteries were well below the threshold for significant stenosis in native vessels. These values provide a baseline or benchmark for expected PSVs after renal-mesenteric stenting during FB-EVAR.

Intraoperative complications during standard and complex endovascular aortic repair.

This study aimed to provide a comprehensive overview of the most common intraoperative adverse events that occur during standard endovascular repair and fenestrated-branched endovascular repair to treat abdominal aortic aneurysms, thoracoabdominal aortic aneurysms, and aortic arch aneurysms. Despite advancements in endovascular techniques, sophisticated imaging and improved graft designs, intraoperative difficulties still occur, even in highly standardized procedures and high-volume centers. This study emphasized that with the increased adoption and complexity of endovascular aortic procedures, strategies to minimize intraoperative adverse events should be protocolized and standardized. There is a need for robust evidence on this topic, which could potentially optimize treatment outcomes and durability of the available techniques.

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

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

Does surgical companionship modify the learning curve for fenestrated and branched endovascular aortic repair?

OBJECTIVES: The goal of this study was to describe the learning curve of an operator trained in an aortic centre during the first years of performing fenestrated/branched endovascular aortic repairs independently. METHODS: Patients electively treated with fenestrated/branched stent grafts from January 2013 to March 2020 were included retrospectively. Groups were defined according to the treating operator: experienced operator (group 1), early-career operator (group 2) or both during a 14-month surgical companionship period (group 3). The early-career operator's learning curve was assessed using a cumulative sum analysis. A composite criterion including technical failure, death and/or any major adverse event was evaluated in a logistic regression model. RESULTS: Overall, 437 patients (93% male; median 69 (63, 77) years old) were included (group 1: n = 240; group 2: n = 173; group 3: n = 24). There were significantly more extended thoraco-abdominal aneurysms (extent I, II, III and V) in group 1 compared to group 2 [n = 68 (28%) vs 19 (11%), P<0.001]. The technical success rate was 94% (P=0.874). The 30-day mortality and/or major adverse event rates in juxta-/pararenal aneurysms or extent IV thoraco-abdominal aneurysms were 8.1% in group 1 and 9.7% in group 2 (P = 0.612), whereas they were 10% (group 1) and 0 (group 2) for extended thoraco-abdominal aneurysms (P=0.339). The adjusted cumulative sum analysis highlighted satisfactory results from the beginning of the experience. The operator's experience was not predictive of the composite criterion [adjusted OR 0.77; 95% (0.42, 1.40); P=0.40]. CONCLUSIONS: This study demonstrated favourable outcomes in patients treated with a fenestrated/branched aortic stent graft performed by an early-career operator trained in a high-volume centre from the beginning of independent practice.

Benefits of Prehabilitation before Complex Aortic Surgery.

The purpose of this narrative review was to detail and discuss the underlying principles and benefits of preoperative interventions addressing risk factors for perioperative adverse events in open aortic surgery (OAS). The term "complex aortic disease" encompasses juxta/pararenal aortic and thoraco-abdominal aneurysms, chronic aortic dissection and occlusive aorto-iliac pathology. Although endovascular surgery has been increasingly favored, OAS remains a durable option, but by necessity involves extensive surgical approaches and aortic cross-clamping and requires a trained multidisciplinary team. The physiological stress of OAS in a fragile and comorbid patient group mandates thoughtful preoperative risk assessment and the implementation of measures dedicated to improving outcomes. Cardiac and pulmonary complications are one of the most frequent adverse events following major OAS and their incidences are correlated to the patient's functional status and previous comorbidities. Prehabilitation should be considered in patients with risk factors for pulmonary complications including advanced age, previous chronic obstructive pulmonary disease, and congestive heart failure with the aid of pulmonary function tests. It should also be combined with other measures to improve postoperative course and be included in the more general concept of enhanced recovery after surgery (ERAS). Although the current level of evidence regarding the effectiveness of ERAS in the setting of OAS remains low, an increasing body of literature has promoted its implementation in other specialties. Consequently, vascular teams should commit to improving the current evidence through studies to make ERAS the standard of care for OAS.

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

OBJECTIVE: The aim of this study was to compare outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs) in patients with or without prior history of abdominal open surgical (OSR) or endovascular aortic repair (EVAR). METHODS: The clinical data of consecutive patients enrolled in a prospective, non-randomized study to evaluate FB-EVAR for treatment of CAAAs and TAAAs was reviewed. Clinical outcomes were analyzed in patients with no previous aortic repair (Controls), prior EVAR (Group 1), and prior abdominal OSR (Group 2), including 30-day mortality and major adverse events (MAEs), patient survival and freedom from aortic-related mortality (ARM), secondary interventions, any type II endoleak, sac enlargement (≥5 mm), and new-onset permanent dialysis. RESULTS: There were 506 patients (69% male; mean age, 72 ± 9 years) treated by FB-EVAR, including 380 controls, 54 patients in Group 1 (EVAR), and 72 patients in Group 2 (abdominal OSR). FB-EVAR was performed on average 7 ± 4 and 12 ± 6 years after the index EVAR and abdominal OSR, respectively (P < .001). All three groups had similar clinical characteristics, except for less coronary artery disease in controls and more TAAAs and branch stent graft designs in Group 2 (P < .05). Aneurysm extent was CAAA in 144 patients (28%) and TAAA in 362 patients (72%). Overall technical success, mortality, and MAE rate were 96%, 1%, and 14%, respectively, with no difference between groups. Mean follow up was 30 ± 21 months. Patient survival was significantly lower in Group 2 (P = .03), but there was no difference in freedom from ARM and secondary interventions at 5 years between groups. Group 1 patients had lower freedom from any type II endoleak (P = .02) and sac enlargement (P < .001), whereas Group 2 patients had lower freedom from new-onset permanent dialysis (P = .03). CONCLUSIONS: FB-EVAR was performed with high technical success, low mortality, and similar risk of MAEs, regardless of prior history of abdominal aortic repair. Patient survival was significantly lower in patients who had previous abdominal OSR, but freedom from ARM and secondary interventions were similar among groups. Patients with prior EVAR had lower freedom from type II endoleak and sac enlargement. Patients with prior OSR had lower freedom from new-onset dialysis.

Evaluation of a Medical Grade Thermoplastic Polyurethane for the Manufacture of an Implantable Medical Device: The Impact of FDM 3D-Printing and Gamma Sterilization.

Three-dimensional printing (3DP) of thermoplastic polyurethane (TPU) is gaining interest in the medical industry thanks to the combination of tunable properties that TPU exhibits and the possibilities that 3DP processes offer concerning precision, time, and cost of fabrication. We investigated the implementation of a medical grade TPU by fused deposition modelling (FDM) for the manufacturing of an implantable medical device from the raw pellets to the gamma (γ) sterilized 3DP constructs. To the authors' knowledge, there is no such guide/study implicating TPU, FDM 3D-printing and gamma sterilization. Thermal properties analyzed by differential scanning calorimetry (DSC) and molecular weights measured by size exclusion chromatography (SEC) were used as monitoring indicators through the fabrication process. After gamma sterilization, surface chemistry was assessed by water contact angle (WCA) measurement and infrared spectroscopy (ATR-FTIR). Mechanical properties were investigated by tensile testing. Biocompatibility was assessed by means of cytotoxicity (ISO 10993-5) and hemocompatibility assays (ISO 10993-4). Results showed that TPU underwent degradation through the fabrication process as both the number-averaged (Mn) and weight-averaged (Mw) molecular weights decreased (7% Mn loss, 30% Mw loss, p < 0.05). After gamma sterilization, Mw increased by 8% (p < 0.05) indicating that crosslinking may have occurred. However, tensile properties were not impacted by irradiation. Cytotoxicity (ISO 10993-5) and hemocompatibility (ISO 10993-4) assessments after sterilization showed vitality of cells (132% ± 3%, p < 0.05) and no red blood cell lysis. We concluded that gamma sterilization does not highly impact TPU regarding our application. Our study demonstrates the processability of TPU by FDM followed by gamma sterilization and can be used as a guide for the preliminary evaluation of a polymeric raw material in the manufacturing of a blood contacting implantable medical device.

Patient selection and anatomical considerations for zone 0 endovascular aneurysm arch repair.

Endovascular aortic arch repair has been widely used in select patients who are considered high risk for open surgical repair and have suitable anatomy. The anatomical challenges of placement of stent-grafts in the ascending aorta are many, including the curved configuration, short landing zone, proximity to the aortic valve and coronary arteries and need to incorporate the supra-aortic trunks. Stent-graft designs with fenestrations and/or directional branches are applicable to patients who have suitable landing zones in the aorta and supra-aortic trunks, adequate access and absence of significant atheromatous debris. These devices include single and multibranch concepts, which are used in combination or not with cervical debranching procedures. This article summarizes the most commonly used anatomical criterion with currently utilized arch branch stent-grafts.

Iliac Branch Devices in the Repair of Ruptured Aorto-iliac Aneurysms: A Multicenter Study.

PURPOSE: To evaluate the outcomes of preserving the internal iliac artery (IIA) with iliac branched devices (IBDs) during acute endovascular repair of ruptured aortoiliac aneurysms. MATERIAL AND METHODS: This is a multicenter retrospective review of all consecutive patients undergoing acute endovascular repair of ruptured aortoiliac aneurysm with an IBD at 8 aortic centers between December 2012 and June 2020. A control group was used where the IIA was intentionally occluded from the same study period. The main outcome measures were 30-day mortality, major adverse events, technical success, and clinical success. Secondary outcomes were buttock claudication, primary patency, primary-assisted and secondary patency of the IBD, occurrence of endoleak types I/III, and reintervention. Values are presented as numbers and percentages or interquartile range in parenthesis. RESULTS: Forty-eight patients were included in the study: 24 with IBD and 24 with IIA occlusion. There was no difference in demographics, cardiovascular risk factors, and aneurysm extent. Twenty (83%) of them were hemodynamically stable during the procedure as opposed to 14 (58%, p=.23) with the IIA occlusion. Technical success was achieved in all cases with a procedure time of 180 (133-254) minutes, 45 (23-65) of which were from IBD. There were 2 (8%) deaths during the first 30 days and 2 (8%) major complications unrelated to the IBD, whereas in the IIA occlusion, the figures were 10 (42%) and 7 (29%), respectively. No patient in the IBD group developed buttock claudication compared to 8 (57%, p<.0001) in the IIA occlusion group; 1 (4%) patient developed bowel ischemia on both groups, with 1 in the IIA occlusion group needing resection. The median follow-up duration was 17 months (interquartile range 2-39) for the IBD group, with a primary patency of 60±14% at 3 years that went up to 92±8% with reinterventions (8 reinterventions in 6 patients). When the first 90 days were disregarded, there were no differences in survival between the groups. CONCLUSION: IBD is a valid alternative for maintaining the pelvic circulation for endovascular aortic aneurysm repair of ruptured aortoiliac aneurysms. The technical success and midterm outcomes are very satisfactory but require patient selection particularly regarding hemodynamic stability. The reintervention rate is considerable, mandating continuous follow-up. CLINICAL IMPACT: This multicenter study demonstrates that ruptured aortoiliac aneurysms do not necessarily require mandatory occlusion of hypogastric arteries. Iliac branch devices are shown to be a valid alternative in highly selected cases, with good midterm results, even if reinterventions are required in a significant proportion of patients.

Technical tips and clinical experience with the Cook Triple inner arch branch stent-graft.

Open surgical repair remains the gold standard for treatment for aortic arch diseases, but these operations can be associated with wide heterogeneity in outcomes and significant morbidity and mortality, particularly in elderly patients with severe comorbidities or those who had prior arch procedures via median sternotomy. Endovascular repair has been introduced as a less invasive alternative to reduce morbidity and mortality associated with open surgical repair. The technique evolved with new device designs using up to three inner branches for incorporation of the supra-aortic trunks. This manuscript summarizes technical tips and clinical experience with the triple inner arch branch stent graft for total endovascular repair of aortic arch pathologies.

Technical tips and clinical experience with the Gore Thoracic Branch Endoprosthesis®.

Thoracic endovascular aortic repair (TEVAR) has been widely accepted as a treatment option in patients with thoracic aortic aneurysms and dissections who have suitable anatomy. It is estimated that up to 60% of patients treated by TEVAR require extension of the repair into the distal aortic arch across Ishimaru zone 2. In these patients, coverage of the left subclavian artery (LSA) without revascularization has been associated with increased risk of arm ischemia, stroke, and spinal cord injury. The Gore Thoracic Branch Endoprosthesis (TBE, WL Gore, Flagstaff, AZ, USA) is the first off-the-shelf thoracic branch stent-graft approved by the Federal Drug Administration for treatment of distal aortic arch lesions requiring extension of the proximal seal into zone 2. This article summarizes the technical pitfalls and clinical outcomes of the TBE® device in zone 2.

Evaluation of Arterial and Venous Allografts in Subinguinal Bypasses.

BACKGROUND: Autologous saphenous vein is the preferred conduit for below-the-knee bypasses in patients with critical limb-threatening ischemia. Alternative graft must be considered for patients without (autologous saphenous vein). The aim of this article is to evaluate the mid-term performance of arterial allograft (AA) and venous allograft (VA) used as alternative conduits. METHODS: This retrospective study included patients with critical limb-threatening ischemia, with or without a history of homolateral femoropopliteal bypass, and no autologous veins were available who underwent infrainguinal arterial reconstructions using VA or AA from 2008 to 2018. Patients undergoing revision operations for infected bypasses were excluded. Primary patency (PP), primary assisted patency, secondary patency, major amputation, and death from any cause were the endpoints. For each event, a set of analyses were performed. RESULTS: Overall, 111 patients (63 VAs and 48 AAs) were included, with 108 having below-the-knee bypass. The median follow-up time was 27.8 months (15.6-37.4). The difference in PP between the 2 allograft types was significant (P = 0.049), with 65.9% (43.7-81.0), 44.1% (24.2-62.3), and 44.1% (24.2-62.3) in the AA group, respectively, at 6, 12, and 18 months, whereas 55.6% (40.0-68.6), 46.0% (30.6-60.2), and 33.2% (18.2-49.0) in the VA group. The choice of an AA over a VA was an independent factor associated with patency (for PP: hazard ratio [HR] = 0.43 [0.24-0.75], P = 0.003); primary assisted patency: HR = 0.52 (0.30-0.89], P = 0.018; and secondary patency: HR = 0.49 (0.27-0.88), P = 0.016. The allograft type did not affect either the incidence of major amputation or death from any cause (respectively, HR = 1.20 [0.49-2.93], and 0.88 [0.37-2.14]). CONCLUSIONS: The nature of the allograft appears to influence the patency of infrainguinal reconstruction, but not the course of the disease. Performant alternative grafts answering infectious issues are needed.