Proximal sealing in the aortic arch for inner curve disease using the custom Relay scalloped and fenestrated stent graft.

OBJECTIVE: This study aimed to analyze early and midterm results of custom-made proximal scallop and fenestrated stent grafts for thoracic endovascular aortic repair (TEVAR) with a proximal landing zone (PLZ) in the aortic arch. METHODS: All consecutive patients treated with the custom made proximal scalloped and fenestrated Relay stent grafts (Terumo Aortic Bolton Medical Inc.) in 10 Italian centers between January 2014 and December 2022 were included. The primary end points were technical success, incidence of intraoperative major adverse events, deployment accuracy, and rate of early neurological complications, endoleaks (ELs) and retrograde aortic dissection. RESULTS: During the study period, 49 patients received TEVAR with Relay custom-made endograft in Italy were enrolled. The median patient age was 70.1 years (interquartile range, 23-86 years) and 65.3% were male. The indication for treatment was atherosclerotic aneurysms in 59.2% of cases and penetrating aortic ulcer in 22.4%. The endograft configuration was proximal fenestration in 55.1% and scallop in 44.9%. The proximal landing zone was zone 0 in 25 cases (51%), zone 1 in 14 cases (28.6%), and zone 2 in 10 cases (20.4%). The supra-aortic debranching procedures were 38 (77.5%). Technical success was 97.9% (48/49) owing to one case (2.0%) of inaccurate deployment. Intraoperatively, one (2.0%) type Ia and one (2.0%) type III EL were detected. There were no cases of in-hospital mortality, major adverse events, or retrograde dissection. Three minor strokes (6.1%) (National Institutes of Health Stroke Scale score of ≤4) were observed. At a mean follow-up time of 36.3 ± 21.3 months the rate of types I to III ELs and reintervention was 4.1%, respectively. Four patients (8.2%) died during the follow-up period, one (2.1%) from abdominal aortic rupture and three (6.1%) from nonaortic causes. CONCLUSIONS: Our early and midterm outcomes suggest that scalloped and fenestrated TEVAR may provide an acceptable alternative treatment option for aortic arch pathologies. Large-scale studies are needed to assess the long-term durability of this technique.

Unintended Exchange of Target Vessels for Celiac Trunk and Superior Mesenteric Artery Branches in Complex Endovascular Aortic Repair.

PURPOSE: The treatment of thoracoabdominal aortic aneurysms (TAAAs) using branched endovascular aortic repair (BEVAR) is safe and effective. During deployment, the superior mesenteric artery (SMA) branch can unintentionally open into the celiac trunk (CT) ostium and switched catheterization of the SMA from the CT branch and the CT from the SMA branch can be used as an alternative technique in these cases. This study aimed to investigate the outcome of exchanging the intended target vessels (TVs) for the CT and SMA branches during BEVAR. MATERIALS AND METHODS: A single-center retrospective analysis of patients with TAAAs who underwent BEVAR, using off-the-shelf or custom-made devices (CMDs), with an unintended exchange of TVs for the CT and SMA branches was performed. RESULTS: Between 2014 and 2023, 397 patients were treated with BEVAR for TAAA. Eighteen (4.5%) of those patients were treated with an exchange of TVs for the CT and SMA branches. T-branch was used in 9 cases (50%) and the remaining patients were treated with CMDs. Twelve patients were treated electively, 3 were symptomatic and 3 presented with rupture. Of 36 mesenteric TVs in those 18 patients, 34 (94%) were catheterized successfully, including all 18 SMAs and 16 of the 18 CTs. No branch stenosis or occlusion of the switched mesenteric TVs was detected during follow-up. During 30-day follow-up, 3 patients died and during a median follow-up of 3 (interquartile range [IQR]: 1-15) months 3 more patients died. None of the deaths or the 2 unintended reinterventions was induced by the mesenteric TV exchange. The median hospital stay was 14 (IQR: 9-22) days with a median of 4 (IQR: 2-11) days at the intensive care unit. CONCLUSION: The exchange of the mesenteric TVs for the CT and SMA branches during BEVAR with off-the-shelf and CMD endografts is feasible with good TV patency and freedom from TV-related reinterventions. This alternative technique should be considered in selected cases when direct catheterization via the intended branch is deemed more time-consuming or not feasible. CLINICAL IMPACT: This is the first description of using an exchange of target vessels for the celiac trunk and the superior mesenteric artery branches in patients with thoracoabdominal aortic aneurysms undergoing BEVAR, using off-the-shelf or custom-made devices. The high success rate as well as the good clinical results without any branch stenosis or occlusion during follow-up highlight the feasibility of this alternative technique. It could help in challenging cases when catheterization of the intended target vessels is not possible or too time consuming, resulting in higher success rates of BEVAR and better clinical results.

Editor's Choice - Sex Related Anatomical Differences in Patients With Aortic Arch Pathology and Their Impact on the Feasibility of Double and Triple Branched Endografts.

OBJECTIVE: To evaluate sex based differences in ascending aorta and arch anatomy in patients with underlying proximal aortic disease and to evaluate their impact on feasibility for total endovascular repair with custom made, branched arch devices. METHODS: This was a retrospective cross sectional review of all patients undergoing open and or total endovascular arch repair due to distal ascending aorta and or aortic arch pathologies in a single high volume aortic centre between 2012 and 2022. Anatomical ascending aorta and aortic arch parameters were analysed on a flow centreline on a dedicated 3D workstation. Sex related differences of the ascending aorta, aortic arch, and supra-aortic vessels were evaluated. Subsequently, four endovascular devices were assessed for feasibility: double and triple branched devices both for the Zenith (Cook Medical) and Relay (Terumo Aortic) platforms, first in accordance with the instructions for use and then considering the possibility of adjunctive cervical debranching. The primary endpoints were sex specific differences in aortic anatomy, while secondary endpoints included sex based feasibility of branched endograft devices. RESULTS: During the study period, 395 patients underwent total aortic arch repair, of whom 152 (51 female, 33.5%) had high quality computed tomography angiograms available and were included in the study. Female patients had a shorter proximal landing zone than males (22 mm vs. 47 mm; p < .001). Left subclavian artery dissection was more frequent in men (24.8% vs. 3.9%; p < .001). Other anatomical parameters showed a similar distribution between sexes. Female patients presented a lower feasibility for double branched devices (35.3% vs. 58.4%; p = .015) as well as a tendency for lower feasibility rates for triple branched devices (31.4% vs. 47.5%; p = .081). CONCLUSION: Although most ascending aortic and arch parameters showed similar trends in both sexes, the availability of a suitable proximal landing zone was lower in female patients. Consequently, female patients had lower feasibility rates for double arch branched endografts and, to lesser extent, for triple arch branched endografts.

Evaluation of Different Subperiosteal Implant Thicknesses on Mechanical Strength and Stress on Bone by Finite Element Analysis.

Implants have always been within the interest of both clinicians and material scientists due to their places in reconstructive and prosthetics surgery. Excessive bone loss or resorption in some patients makes it difficult to design and manufacture the implants that bear the necessary loads to carry the final prosthetics. With this study; we tried to determine the minimum material thickness of the subperiosteal implants that can withstand the physiological forces. We have created a digital average bone structure based on actual patient data and designed different subperiosteal implants with 1, 1.5, and 2mm material thicknesses (M1, M2, M3) for this digital model. The designed implant models are subjected to 250 Newtons (N) of force, and the implant and bone are tested for the stress they are exposed to, the pressure they transmit to, and their mechanical strength with Finite Element Analysis with the physical parameters boot for the implant material and human bone. Results show us that under specific design parameters and thicknesses, the 1mm thickness design failed due to exceeding the yield stress limit of 415MPa with a 495,44MPa value. The thinnest implant showed plastic deformation and transmitted excessive forces, which may cause bone resorption due to residual stress. We determined that thinner subperiosteal implants down to 1.5mm that have the necessary material parameters for function and tissue support can be designed and manufactured with current technologies.

Surgical treatment outcomes of acetabular posterior wall and posterior column fractures using 3D printing technology and individualized custom-made metal plates: a retrospective study.

BACKGROUND: Fractures involving the posterior acetabulum with its rich vascular and neural supply present challenges in trauma orthopedics. This study evaluates the effectiveness of 3D printing technology with the use of custom-made metal plates in the treatment of posterior wall and column acetabular fractures. METHODS: A retrospective analysis included 31 patients undergoing surgical fixation for posterior wall and column fractures of the acetabulum (16 in the 3D printing group, utilizing 3D printing for a 1:1 pelvic model and custom-made plates based on preoperative simulation; 15 in the traditional group, using conventional methods). Surgical and instrument operation times, intraoperative fluoroscopy frequency, intraoperative blood loss, fracture reduction quality, fracture healing time, preoperative and 12-month postoperative pain scores (Numeric Rating Scale, NRS), hip joint function at 6 and 12 months (Harris scores), and complications were compared. RESULTS: The surgical and instrument operation times were significantly shorter in the 3D printing group (p < 0.001). The 3D printing group exhibited significantly lower intraoperative fluoroscopy frequency and blood loss (p = 0.001 and p < 0.001, respectively). No significant differences were observed between the two groups in terms of fracture reduction quality, fracture healing time, preoperative pain scores (NRS scores), and 6-month hip joint function (Harris scores) (p > 0.05). However, at 12 months, hip joint function and pain scores were significantly better in the 3D printing group (p < 0.05). Although the incidence of complications was lower in the 3D printing group (18.8% vs. 33.3%), the difference did not reach statistical significance (p = 0.433). CONCLUSION: Combining 3D printing with individualized custom-made metal plates for acetabular posterior wall and column fractures reduces surgery and instrument time, minimizes intraoperative procedures and blood loss, enhancing long-term hip joint function recovery. CLINICAL TRIAL REGISTRATION: 12/04/2023;Trial Registration No. ChiCTR2300070438; http://www.chictr.org.cn .

In-Shoe Pressure Measurements in Diabetic Footwear Practice: Success Rate and Facilitators of and Barriers to Implementation.

We aimed to assess the success rate and facilitators of and the barriers to the implementation of in-shoe plantar pressure measurements in footwear practice for people with diabetes at high risk of foot ulceration. Eleven Dutch footwear practices were partly supported in purchasing a pressure measurement system. Over a 2.5-year period, trained shoe technicians evaluated 1030 people with diabetes (range: 13 to 156 across practices). The implementation success and associated facilitators and barriers were evaluated quantitatively using completed measurement forms and pressure measurement data obtained during four monitoring sessions and qualitatively through semi-structured interviews with technicians. Across the 11 practices, the primary target group (people with diabetes and a healed plantar foot ulcer) represented 25-90% of all the patients measured. The results showed that three practices were successful, five moderately successful, and three not successful. The facilitators included support by the company management board, collaboration with a prescribing physician, measurement sessions separate from the outpatient clinic, and a (dedicated) shoe technician experiencing a learning effect. The barriers included investment costs, usability aspects, and limited awareness among shoe technicians. In-shoe plantar pressure measurements can be implemented to a moderate to large degree in diabetic footwear practice. The barriers to and facilitators of implementation are organizational, logistical, financial, or technical, and the barriers are modifiable, supporting future implementation.

Comfort and wearability properties of custom-made and boil-and-bite mouthguards among basketball players: A randomized parallel arm clinical trial.

BACKGROUND/AIM: Thermoplastic mouthguards have been a reliable means of protection against impacts and shocks for a century. Although orofacial injuries are prevalent among basketball players, many athletes still avoid using mouthguards due to concerns regarding impaired breathing, speech interference, and nausea. This study aims to compare basketball players' subjective assessments of two different thicknesses of custom-made mouthguards (MGs) with boil-and-bite MGs (B&B MG). MATERIAL AND METHODS: A total of 60 systematically healthy male professional basketball players, without active orthodontic treatment, were enrolled and randomly assigned to three groups: Group 1 (received B&B MGs; n = 20), Group 2 (received custom-made MGs with a 3 mm thickness [ethyl vinyl asetat]; n = 20), and Group 3 (received custom-made MGs with a 5 mm thickness; n = 20). To evaluate MG comfort and usability, 12 key factors, including comfort, fit, stability, tiredness, thirsting, oral dryness, nausea, speaking, breathing, drinking, ease of wear and removal, and inclination to chew, were assessed. The athletes were made to rate these factors using a 10 cm-long Visual Analog Scale, measured at three-time intervals, and the values for both inter-group and intra-group were compared. RESULTS: Data from 48 basketball players were retrieved, and data analysis revealed that B&B MGs had the least favorable parameter values. Among the B&B MG group, stability was reported to be poorer during the initial measurement (p < .05). In the second measurement, B&B MGs showed significantly lower values for comfort, stability, tiredness, speaking, and inclination to chew (p < .05). During the third measurement, the B&B MG group exhibited significantly reduced values for comfort, breathing, drinking, and speaking (p < .05). In contrast, no statistically significant difference was observed between 3 and 5 mm thickness MGs in these measurements. CONCLUSIONS: Custom-made MGs with different thicknesses consistently outperformed B&B MGs in all measurements, indicating the potential to tailor MG thickness based on sport, age, professional level of athlete, and presence of other protective equipment. While custom-made mouthguards are considered the gold standard, dentists who provide B&B MGs can lead to cost savings while maintaining protection and encouraging athletes to use higher-quality custom-made mouthguards.

Investigation of the effectiveness of preoperative intubation simulation using a custom-made simulator for pediatric patients with difficult airway: a pilot study.

The purpose of this study is to investigate whether preoperative intubation simulation using custom-made simulator is useful during anesthesia induction for the children who have difficult airway. We included the children under 15 years of age who have difficult airway which had been already known. Prior to the scheduled surgery, CT imaging was performed and a 3D reconstruction of the face from the chest was performed. Then custom-made airway simulator was made. We tried to intubate custom-made simulator of patients preoperatively. We planned how to intubate the patient for anesthesia induction from the result of intubation simulation. The findings of direct laryngoscopy were compared with the findings during intubation. Three patients were included in this study. It took up to 3 weeks to create a simulator, which was difficult due to time constraints to accommodate emergency surgeries. Simulation findings correlated well with findings during anesthesia induction. There were no cases of severe hypotension or hypoxia during induction of anesthesia with the planned intubation method. In conclusion, preoperative intubation simulation using custom-made simulator may be useful for the patients who have difficult airway.

Exploring consistent ratios in morphometry of the proximal tibia: insights for knee arthroplasty.

INTRODUCTION: The current study, which delves into proximal tibia morphometric parameters in a Greek sample, not only analyzes whether specific linear distance ratios are consistent but also paves the way for a potential novel metric system for knee arthroplasty imaging studies using constant ratios. These findings could have significant implications for future enlarged research and clinical practice. METHODS: A total of 38 dried tibiae were evaluated by two independent investigators. The following distances were measured with a digital Vernier sliding caliper: (1) the mediolateral distance of the proximal surface (A), (2) the anteroposterior distance of the proximal surface (B), (3) The longitudinal length of the bone (C), (4) the line connecting the anterior margin of the proximal surface with the highest peak of the tibia tuberosity (D), (5) the depth of the proximal margin of the medial articular facet (AF) (medial plateau) (E) and (6) the depth of the proximal margin of the lateral AF (lateral plateau) (F). RESULTS: The A, B, C, D, E, and F mean distances were 71.3 mm, 47.4 mm, 340.2 mm, 37.1 mm, 42 mm, and 35.9 mm. Reliability analysis for each observer on all measurements revealed an interclass correlation (ICC) score of 0.975 (observer 1) and 0.971 (observer 2). The ratio A/B was 1.5, A/C was a constant 0.2, and D/C was 0.1. The ratio E/F was 1.2. The six measurements (A-F) showed excellent inter-observer reliability (all ICC values > 0.990). CONCLUSIONS: The study established constant ratios of the studied linear distances around the proximal tibia. Considering these ratios, asymmetrical tibial components in knee arthroplasty seem to replicate the native anatomy more closely. Furthermore, the distance from the anterior margin of the proximal surface to the tibial tuberosity peak, constituting one-tenth of the longitudinal length of the tibia, shows promise as a metric system for imaging studies, especially in assessing lesions around tibial components.

Unlocking Self-antioxidant Capability and Processability of Additive-free MXene Ink towards High-performance Customizable Supercapacitors.

The solution processing of MXene ink is the feasible strategy to realize its state-of-the-art applications. Nevertheless, achieving high stability and processability of additive-free MXene ink is particularly challenging. Herein, we propose an oxyanion-terminated Ti3C2Tx MXene ink that exhibits excellent self-antioxidant capability and processability. The vertex-connected polyhedrons of oxyanions capping on the Ti3C2 host serve as an in-situ antioxidative shield, effectively preventing the attack of free H2O molecules while increasing the robustness of the Ti-C bond and reducing the susceptibility of surface Ti atoms to oxidation. Consequently, the shelf life of MXene ink can be extended up to 5 months at room temperature. Moreover, the high electron accumulation of oxyanions enhances the interlayer interactions among MXene sheets through electrostatic binding, which enables the formation of stable and uniform MXene inks with controlled rheological properties and processability. Inspired by Chinese calligraphy, we utilize the oxyanion-terminated MXene ink to fabricate high-performance and customizable paper supercapacitors, which exhibit exceptional flexibility and stability, allowing them to be tailored to desired capacity, stretchability, and shapes. This in-situ surface chemistry strategy of oxyanion can activate the self-antioxidant capability and solution processability of MXene, paving the way for its widespread applications in flexible and wearable electronics.

Custom-made total ankle arthroplasty with patient-specific instrumentation for severe bone loss conditions: a case series.

PURPOSE: Management of bone loss around the ankle is a challenging condition. This retrospective study describes the design process, the surgical technique, and the preliminary results of custom-made total ankle arthroplasties (TAA) with patient-specific instrumentation (PSI) for different severe bone loss conditions. METHODS: Consecutive patients that underwent custom-made TAA for severe bone loss conditions were included. The primary outcome was to describe the implant design in relation to the bone defect. Moreover, pre-operative and final follow-up clinical scores were compared. RESULTS: Seven patients were included. Post-operative radiographs showed good correspondence between the pre-operative planning and the prosthesis alignment in all patients. Improvement in clinical scores was observed in all patients at the final follow-up. One patient developed a deep infection. CONCLUSION: Short-term results reported herein are encouraging suggesting that custom-made TAA implants with PSI may represent an effective solution for ankle bone loss conditions.

Preliminary results from an Italian National Registry on the outcomes of the Najuta fenestrated aortic arch endograft.

BACKGROUND: Arch pathology represents one of the last frontiers in aortic aneurysm endovascular management. Several companies recently developed dedicated branched and fenestrated endografts specifically designed for the aortic arch, aiming to overcome some of the issues associated with standard thoracic endograft and supra-aortic vessels extra-anatomic debranching. This study aimed to evaluate early outcomes obtained with a custom-made fenestrated endograft approved for thoracic aortic aneurysms exclusion. METHODS: All consecutive patients treated with the Najuta endograft (Kawasumi Laboratories, Inc, Tokyo, Japan) in Italy were enrolled prospectively and included in the study population. Anatomic characteristics and perioperative data were analyzed retrospectively. Study end points were technical success, 30-day clinical success, overall survival, supra-aortic vessel patency, endoleak, and need for reintervention or surgical conversion. RESULTS: Between 2018 and 2022, 76 patients received a Najuta endograft in Italy and were enrolled in the study. The median patient age was 72 years (interquartile range, 69-76 years) and 80.3% were male. Most of the patients received treatment for atherosclerotic aneurysms (80.3%); others were treated for postdissection aneurysms (7.9%), penetrating aortic ulcer (9.2%), or type I endoleak correction after previous thoracic endovascular repair (2.6%). Overall, 161 supra-aortic vessels were preserved through a dedicated fenestration. Technical success was achieved in 74 of 76 procedure (97.4%); both failures were associated with endoleak detection at final angiography (one type I and one type III endoleak). Two distal migrations occurred during the implanting procedure. Clinical success at 30 days was 94.7%. Two early reinterventions were needed within 30 days after index procedure: in one case, an aortic false lumen coils embolization was performed, because distal re-entry caused enlargement of the postdissection thoracic aneurysm. The other procedure consisted of a femoral pseudoaneurysm repair. The median follow-up was 7 months (interquartile range, 3-15 months); no supra-aortic vessel occlusions occurred and no patients needed surgical conversion. CONCLUSIONS: Early results suggest that, in selected patients with aortic arch pathology needing a proximal landing, an endovascular approach with the Najuta system is safe and effective, especially for those at high surgical risk. A strict follow-up with high-quality computed tomography angiography images and eventual evaluation for long-term complications is needed to confirm these initial experience findings.

Physician Modification of a Custom-Made Fenestrated Endograft By Closure of a Fenestration With Bovine Patch.

PURPOSE: Ruptured mycotic pararenal aortic aneurysms are rare and serious condition that requires prompt treatment. Open surgery with aortic resection and in-situ or extra-anatomic reconstruction is the standard treatment. The aim of this technical note is to report urgent endovascular treatment using a readily available custom-made device (created for another patient), with a back-table modification using pericardium patch and a new fenestration. TECHNIQUE: In preoperative measurements on centerline-based workstation, aortic diameter in proximal and distal landing zone and target vessel position matched the measurements of graft plan of custom-made device (CMD) besides left renal artery. To address current patient`s anatomy, closure of the nonsuitable fenestration with pericardial patch and creation of new fenestration (1 cm above and 1:15 hours posterior to original fenestration) for the respective target vessel have been performed. Postoperative computed tomography angiography (CTA) scan showed complete exclusion of aneurysm, perfused target vessels, and no endoleak. Under resistance-based antibiotic therapy, the patient was asymptomatic and showed normal infection parameters in blood samples postoperatively. CONCLUSION: In the hands of an experienced endovascular aortic surgeon modification of a custom-made device is a quick and feasible technique in this emergency situation. Long-term follow-up must confirm the durability and reliability of this new technique. CLINICAL IMPACT: The described technique of modification of a custom-made endograft can provide an alternative endovascular treatment option for urgent complex abdominal aortic pathologies. Compared to the current available treatment modalities, like physician modified endografts, off-the-shelf branched devices, parallel grafts and in-situ fenestration, it can save considerable time and provides reasonable sealing in ruptured cases. The technique offers a valuable add-on to the armamentarium of experienced endovascular physicians.

Fractured Sealing Rings in a Fenestrated Anaconda Stent-Graft.

An 81 year-old man presented with an asymptomatic juxtrarenal abdominal aortic aneurysm and was subsequently treated with a fenestrated endovascular Anaconda stent-graft. Surveillance imaging within the first postoperative year demonstrated a lower proximal sealing ring fracture. In the second postoperative surveillance year, the upper proximal sealing ring was also fractured with extension of the wire into the right paravertebral space. Despite these sealing ring fractures, there were no endoleak nor visceral stent complications and the patient continued on standard surveillance protocols. There are an increasing number of reports of fractured proximal sealing rings with the fenestrated Anaconda platform. Those analysing the surveillance scans of patients treated with this device should stay vigilant for the development of this complication.

New Preloaded System for Renal and Visceral Arteries in Fenestrated Endografting.

AIM/BACKGROUND: The New Preloaded System (NPS) for renal/visceral arteries (TVVs) is an emerging technology in fenestrated endografting (FEVAR) that allows TVVs cannulation and stenting through the same access of the endograft main body. However, only few preliminary experiences are currently available in the literature. The aim of this study is to report the outcomes of NPS-FEVAR in juxta/para-renal (J/P-AAAs) and thoracoabdominal (TAAAs) aneurysms repair. METHODS: This is a prospective (NCT05224219), single-center/observational study of patients submitted to NPS-FEVAR for J/PAAAs and TAAAs between 2019 and 2022 (July). Definitions and outcomes were evaluated according to the current SVS-reporting standard. Technical success (TS) and TS preloaded related, spinal cord ischemia (SCI), and 30-day mortality were assessed as early endpoints. Survival, freedom from reinterventions (FFRs), and freedom from TTVs-instability (FFTVVs-instability) were analyzed during follow-up. RESULTS: Among 157 F/B-EVAR cases, 74 (47%) NPS-FEVAR were planned and enrolled in the study [48 (65%) J/P-AAAs; 26 (35%) TAAAs]. The main indication for NPS-FEVAR was the presence of a hostile iliac axis (54%-73%) or the necessity of expeditious pelvic/lower-limb reperfusion for SCI prevention in TAAAs (20%-27%). Overall, 292 TVVs were accommodated by 289 fenestrations and 3 branches; 188 of 289 (65%) fenestrations were preloaded. NPS-FEVAR configuration was from "below" and "from below to above" in 28 (38%) and 46 (62%) cases, respectively. TS and TS preloaded system-related was 96% (71/74) and 99% (73/74), respectively. Target visceral vessels patency at the completion angiography was 99% (290/292). Failures were 2 renal arteries loss and 1 massive bleeding from a percutaneous closure system breakage. The latter patient developed postoperative multiorgans failure and died on the fifth postoperative day, causing only 30-day/in-hospital mortality (1.3%). One (1.3%) patient with a JAAA and preoperative bilateral occlusion of the hypogastric arteries suffered SCI. The median follow-up was 14 (IQR: 8) months. The estimated 3-year survival was 91% with no aneurysm-related mortality during follow-up. The estimated 3-year FFR and FFTVVs-instability were 85 and 92%, respectively. CONCLUSION: New preloaded system FEVAR is a safe and effective option in the treatment of J/PAAAs and TAAAs in the presence of hostile iliac access or to guarantee an expeditious pelvic/lower limb reperfusion, leading to satisfactory results in terms of TS, early and mid-term clinical outcomes. CLINICAL IMPACT: New preloaded system for fenestrated and branched endografting allows to increase the feasibility of the advanced endovascular aortic repair in challenging iliac access, thoracoabdominal aneurysm repair and reduce difficulties in target visceral vessels cannulation.

Off-the-Shelf Single-Fenestrated Endograft for Emergent Juxtarenal and Pararenal Abdominal Aortic Aneurysm.

INTRODUCTION: Endovascular solutions to emergent juxtarenal and pararenal abdominal aortic aneurysms (AAAs) are complicated. Endovascular aortic repair (EVAR) with in situ laser fenestration (ISLF) is promising but requires a period of visceral ischemia. With an off-the-shelf, single superior mesenteric artery (SMA)-fenestrated device mesenteric ischemia is avoided and renal ischemia decreased. The aim was to develop an optimized design of such an endograft suitable for >90% of juxtarenal and pararenal AAAs. METHODS: Single-center analysis on 44 consecutive preoperative CTs for previously elective fenestrated EVARs for juxtarenal and pararenal aneurysms. Anatomical characteristics were analyzed to define: (1) shortest aortic coverage above SMA fenestration to achieve ≥4 cm seal; (2) feasibility of a scallop for the celiac artery; (3) shortest distance between the SMA and lowest renal, to facilitate renal ISLF in a straight endograft; (4) distance from the lowest renal to the aortic bifurcation, to allow an overlapping zone >40 mm with a bifurcated stent graft; (5) aortic diameter in the sealing zone, for optimal proximal stent graft diameter with 10% to 30% oversizing; (6) the final design was then tested on individual level. RESULTS: (1) The stent graft needs to start 40 mm above the SMA fenestration to achieve a 4 cm sealing zone in >90% of cases. (2) A proximal sealing zone of 40 mm without a scallop covers 77% of celiac arteries. With an addition of a 20 mm deep, 20 mm wide scallop at 12:30, the stent graft still covers 27% of celiacs. This suggests that a scallop would not be practically feasible. (3) In >90% of cases, the lowest renal was <31 mm from the SMA, suggesting that the tapering should start 30 mm below the SMA. (4) The distance from the lowest renal to the aortic bifurcation ranged from 82 to 166 mm. This allows for a 20 mm tapering and 50 mm straight part in all cases. (5) The 5th and 95th percentile of the aortic diameter in the sealing zone was 22 and 31 mm, respectively. Thus, 2 different stent graft diameters (28 and 34 mm) would fit >90% of cases. (6) The final design was suitable in 91% cases. CONCLUSIONS: Two sizes of a single-fenestrated aortic stent graft without scallop cover >90% of juxtarenal and pararenal anatomies. CLINICAL IMPACT: Emergent juxta- and pararenal aortic aneurysms is a difficult clinical scenario that continuously challenges physicians. An endovascular option is in situ laser fenestrated endografts. One risk with these is the complete visceral ischemia occurring before the fenestrations are completed. An off-the-shelf single-fenestrated stent graft facilitates the treatment by removing the ischemia time for the SMA and reducing the ischemia time for the celiac and renal arteries thus decreasing the risk of visceral ischemia complications.

Additional Aortic Coverage With an Off The Shelf, Multibranched Endograft Compared With Custom Made Devices For Endovascular Repair of Pararenal Abdominal Aortic Aneurysms.

OBJECTIVE: Pararenal abdominal aortic aneurysms (p-AAA) require complex endovascular aortic repair or open surgical repair with suprarenal clamping. Custom made devices (CMD), including fenestrated and branched endovascular aortic repair (F/B-EVAR) or off the shelf (OTS) multibranched devices, are available treatment options. The aim of this study was to determine the additional healthy aortic coverage using an OTS multibranched endograft vs. a CMD for the treatment of p-AAAs. METHODS: This was a retrospective single centre analysis of prospectively collected data. Consecutive patients with p-AAAs requiring a proximal landing zone above the coeliac artery (CA), planned and treated with CMDs (Zenith Fenestrated) between January 2017 and December 2021 were included in this study. Treatment with supracoeliac coverage using available OTS multibranched devices was simulated using available pre-operative images: T-Branch; E-nside; and TAMBE. Study endpoints included the need for additional proximal aortic coverage, and the number of the segmental arteries additionally covered proximally from the CA for OTS devices compared with CMDs. RESULTS: Eighty three patients with p-AAAs were treated with CMDs (all FEVAR), including juxtarenal AAAs (n = 46; 56%), suprarenal AAAs (n = 20; 24%), and short neck AAAs (n = 17; 20%). In this study, treatment with 249 (3 × 83) OTS endografts was simulated. When compared with CMDs, OTS devices required a mean of 74 ± 19 mm of additional proximal healthy aortic coverage from the CA (CMD: 33 ± 19 mm vs. OTS: 108 ± 6 mm; p ≤ .001), as well as an average sacrifice of 2.5 additional segmental arteries (CMD: 1.3 ± 0.8 vs. OTS: 3.8 ± 0.9; p ≤ .001). In 94% of patients, at least one of the available multibranched endografts could have been implanted in accordance with instructions for use. CONCLUSION: Despite not requiring customisation time, OTS endografts for the treatment of p-AAA lead to more extensive healthy aortic coverage, as well as an average sacrifice of 2.5 additional segmental arteries, compared with CMDs. When compared with OTS devices, CMDs appear to limit the extent of unnecessary aortic coverage and the theoretical subsequent risk of spinal cord ischaemia.

Custom-made Subperiosteal Implants: A Finite Element Analysis on Monoblock and Dual Implant Systems in Atrophic Maxilla.

This study aims to investigate and compare the stress distribution, displacement, and bone loading of monoblock and dual custom-made subperiosteal implant systems in atrophic maxilla using finite element analysis (FEA). A total of 11 patients with insufficient bone tissue for conventional implant treatment were included in the study. Customized subperiosteal implant designs were generated using the 3D average models obtained from patients' computed tomography (CT) scans. Two different models were produced: a monoblock that covered the entire maxillary bone and a dual implant system where two mirror-imaged implants covered the left and right halves of the maxillary bone separately. We have calculated residual stress values formed on the implant models and jaw bone models separately. In addition, the highest displacement values formed on the implants and the highest stress values formed on abutment parts have also been observed in this study. Results showed that the stresses formed on implants that are under the mastication forces were significantly lower than the yield strength of the selected material, indicating that plastic deformation would not occur under static load. The dual implant geometry demonstrated a substantial reduction in stress compared to the monoblock structure. The highest von Mises stress values for the monoblock implants ranged from 131 MPa to 206 MPa, while those for the dual structure ranged from 124 MPa to 178 MPa. The highest residual stress values on the upper jawbone were observed in the M6 implant model, and the lowest was seen in the M1 and M3 models at 12 MPa. Displacement values under static load showed that loads on the implant would be below 0.21 mm. In conclusion, custom subperiosteal implants are a viable treatment option for patients with insufficient bone tissue for conventional implants. Dual implant systems were found to have lower stress and displacement values compared to monoblock structures, indicating a potential advantage in clinical use. However, mono implants may have benefits in cases of immediate teeth loading due to their ability to absorb and distribute occlusal forces better.

Predictors of postoperative epidural hematomas after custom-made porous hydroxyapatite cranioplasty: a single-center experience of 194 consecutive cases.

Cranioplasty is important for improving cosmesis and functional recovery after decompressive craniectomy. We assessed the incidence and predictors of post-cranioplasty epidural hematomas requiring surgical evacuation. A single-institution, retrospective study enrolled 194 consecutive patients who underwent a cranioplasty using custom-made hydroxyapatite between February 2008 and April 2022. Variables associated with postoperative epidural hematoma requiring surgical evacuation at the p < 0.1 level in unadjusted analysis were entered into multivariable analyses. Nine patients (4.6%) experienced postoperative epidural hematomas requiring evacuation, with time interval between craniectomy and cranioplasty <6 months (adjusted odds ratio (aOR), 20.75, p = 0.047), cranioplasty-to-bone shift > half of the bone thickness (aOR, 17.53, p = 0.008), >10 mm difference between pre-cranioplasty and post-cranioplasty midline brain shift contralateral to the cranioplasty (aOR, 17.26, p < 0.001), and non-resorbable duraplasty (aOR, 17.43, p = 0.011) identified as independent predictors. Seventeen patients (8.8%) experienced post-cranioplasty hydrocephalus requiring shunt placement. Twenty-six patients (13.4%) experienced postoperative infection. Sixteen patients (8.2%) had postoperative epileptic seizures. The identification of independent predictors of post-cranioplasty epidural hematomas requiring surgical evacuation will help identify at-risk patients, guide prophylactic care, and reduce morbidity of this common and important procedure.

Treatment of a type Ia endoleak following EVAR using a custom-made inner branch device.

OBJECTIVES: We represent two cases of late proximal type I endoleak following EVAR with aneurysm expansion that were treated with a custom-made graft with inner branches. METHODS: Two patients of 87 and 82 years old were operated by EVAR 6 and 8 years ago for abdominal aortic aneurysm. Both had proximal type I endoleak with aneurysm sac expansion. Open surgery had a high risk, and a proximal aortic extension with a simple aortic cuff was not possible neither because previous EVAR grafts were already at the level of the renal arteries. A custom-made endograft with inner branches was planned as a fenestrated graft was not technically possible. RESULTS: We successfully treated both patients using a custom-made graft with four inner branches from Jotec (Cryolife, Kennesaw, GA). Three months' follow-up CT scan did not show any endoleaks. All target vessels were patent with good conformability of the bridging stents. CONCLUSION: The treatment of proximal type I endoleak using inner branches' endografts is feasible. This novel technology might broaden the indications for complex aortic repair in a group of patients where fenestrated endografts are not possible.