ObjectiveType A aortic dissection (TAAD) is associated with high morbidity and mortality, and open surgery is the best treatment option. Development of endovascular repair devices for TAAD will benefit patients deemed unfit for open surgery. In this study, we performed a thorough investigation of anatomical features in Asian patients with TAAD to learn about the patient eligibility of a novel ascending aortic endograft technique.MethodsComputed tomography angiography (CTA) images of TAAD cases in our institution from January 2015 to November 2021 were reviewed, and three-dimensional reconstructions were performed with the Endosize software (Therenva, Rennes, France). Anatomic structures including length measured along centerline and greater/lesser curvature, ascending aorta/aortic root dimensions, as well as location of entry tear and extent of dissection were analyzed.ResultsA total of 158 patients were included [median age 58 years, interquartile range (IQR), 30–76 years; 115 males, 72.8%]. In 99 (62.7%) of the cases, entry tear was distal to the sinotubular junction (STJ). In 106 (67.1%) of the cases, the pathology proximally extended into the aortic root, which was intramural hematoma in 37 (23.4%) of the cases, and the aortic root was free from the pathology in 52 (32.9%) of the cases. The median distance from the STJ to the proximal edge of the ostium of the innominate artery (IA) measured along the centerline was 65 mm (IQR 58–74 mm). The median distance from the distal edge of the higher coronary ostium to the STJ was 7.95 mm (IQR 5.625–10.9 mm). The bare metal stent part was set between the edge of the higher coronary ostium and the STJ. In our series, 63 (39.9%) of the cases had this distance >10 mm. The relative difference was <20% between the STJ and the proximal edge of the ostium of the IA in 92 (58.2%) of the cases. Ascending aorta radius of curvature was 52.2 mm (IQR 43.7–63.7 mm).ConclusionsOur study demonstrates that 56.3% of the TAAD cases would be amenable to endovascular repair by the novel ascending aortic endograft, with sufficient landing zone free of the dissected aorta.

Background: To assess the feasibility and first-in-human experience of a novel endovascular robotic system for treatment of lower extremity peripheral arterial disease (PAD). Methods: Between November 2021 and January 2022, consecutive patients with obstructive lower extremity PAD and claudication (Rutherford 2–5) with >50% stenosis demonstrated on angiography were enrolled in this study. Lower extremity peripheral arterial intervention was performed using the endovascular robotic system, which consisted of a bedside unit and an interventional console. The primary endpoints were technical success, defined as the successful manipulation of the lower extremity peripheral arterial devices using the robotic system, and safety. The secondary endpoints were clinical success, defined as 50% residual stenosis at the completion of the robot-assisted procedure without major adverse cardiac events and radiation exposure. Results: In total, 5 patients with PAD were enrolled in this study (69.2±6.0 years; 80% men). The novel endovascular robotic system successfully completed the entire procedure of endovascular treatment of lower extremity PAD. Conversion to manual operation, including advancement, retracement, rotation of the guidewires, catheters, sheaths, deployment, and release of the balloons and stent grafts, was not necessary. We achieved the criteria for clinical procedural and technical success in all patients. No deaths, myocardial infarctions, or ruptures occurred in the period up to 30 days after the procedure, and no device-related complications were observed. The robotic system operator had 97.6% less radiation exposure than that at the procedure table, with a mean of 1.40±0.49 μGy. Conclusions: This study demonstrated the safety and feasibility of the robotic system. The procedure reached technical and clinical performance metrics and resulted in significantly lower radiation exposure to the operators at the console compared with that at the procedure table. Clinical Impact There were some reports about several robotic systems used in the peripheral arterial disease, but no robotic system was able to perform entire procedure of endovascular treatment of lower extremity peripheral arterial disease (PAD). To solve this problem, we designed a remote-control novel endovascular robotic system. It was the first robotic system that can perform entire procedure of endovascular treatment of PAD worldwide. A novelty retrieval report about this is provided in the supplementary materials. The robotic system is compatible with all commercial endovascular surgical devices currently available in the market, including guidewires, catheters and stent delivery systems. It can perform all types of motion, such as forward, backward, and rotation to meet the requirements of all types of endovascular procedures. During the operation, the robotic system can perform these operations in a fine-tuned manner, so it is easy to cross the lesions, which is the key factor influencing the success rate of the operation. In addition, the robotic system can effectively reduce the exposure time to radiation, thereby reducing the risk of occupational injury.

Objectives To assess the practicability and safety of a novel endovascular robotic system for performing endovascular aortic repair in human. Methods A prospective observational study was conducted in 2021 with 6 months post-operative follow-up. Patients with aortic aneurysms and clinical indications for elective endovascular aortic repair were enrolled in the study. The novel developed robotic system is applicable for the majority of commercial devices and various types of endovascular surgeries. The primary endpoint was technical success without in-hospital major adverse events. Technical success was defined as the ability of the robotic system to complete all procedural steps based on procedural segments. Results The first-in-human evaluation of robot-assisted endovascular aortic repair was performed in five patients. The primary endpoint was achieved in all patients (100%). There were no device- or procedure-related complications or no in-hospital major adverse events. The operation time and total blood loss in these cases were equal to those in the manual procedures. The radiation exposure of the surgeon was 96.5% lower than that in the traditional position while the radiation exposure of the patients was not significantly increased. Conclusions Early clinical evaluation of the novel endovascular aortic repair in endovascular aortic repair demonstrated practicability, safety, and procedural effectiveness comparable to manual operation. In addition, the total radiation exposure of the operator was significantly lower than that of traditional procedures. Clinical relevance statement This study applies a novel approach to perform the endovascular aortic repair in a more accurate and minimal-invasive way and lays the foundation for the perspective automation of the endovascular robotic system, which reflects a new paradigm for endovascular surgery. Key Points • This study is a first-in-human evaluation of a novel endovascular robotic system for endovascular aortic repair (EVAR). • Our system might reduce the occupational risks associated with manual EVAR and contribute to achieving a higher degree of precision and control. • Early evaluation of the endovascular robotic system demonstrated practicability, safety, and procedural effectiveness comparable to that of manual operation.

Objectives: This study evaluated the feasibility and safety of zone 1 thoracic endovascular aortic repair (TEVAR) with fenestrated surgeon-modified stent-graft (SMSG) for aortic arch pathologies. Methods: Between March 2016 and November 2020, 34 consecutive patients underwent zone 1 TEVAR with fenestrated SMSG for aortic arch pathologies. Outcomes included technical success, perioperative, and follow-up morbidity and mortality. Results: During the study period, 34 patients were treated with zone 1 TEVAR with fenestrated SMSG. Twenty-four (70.6%) patients presented with type B aortic dissections, 9 (26.5%) patients presented with aneurysms (7 located on the lesser curvature side of aortic arch), 1 (2.9%) patient presented with type Ia endoleak after previous TEVAR owing to traumatic aortic dissection. The proximal landing zone for all patients were in zone 1, and all supra-aortic trunks were reconstructed, except for one left subclavian artery. Technical success was achieved in all cases. The 30-day estimated survival (±SE) was 90.9% ± 5.0% [95% confidence interval (CI): 77.0%–97.0%]. The 30-day estimated freedom from reintervention (±SE) was 87.9% ± 5.7% (95% CI: 73.4%–95.3%). At a median follow-up of 48 months (range, 12–68 months), 2 patients died, including 1 aortic-related death and 1 non-aortic-related death. One patient had reintervention 13 months after the operation owing to type Ia endoleak. All supra-aortic trunks were patent. The estimated survival (±SE) during follow-up was 85.1% ± 6.2% (95% CI: 69.9%–93.6%). One (2.7%) patient had stroke. The estimated freedom from reintervention (±SE) during follow-up was 84.2% ± 6.5% (95% CI: 69.9%–93.5%). Conclusions: Zone 1 TEVAR with fenestrated SMSG is an alternate option for treatment of aortic arch pathologies in experienced centers.