Complex Endovascular Procedures Research Articles

Bridging Stent-Graft Implantation in the Renal Artery During Complex Endovascular Aortic Procedures does not alter the Renal Sonographic Resistance Index

Abstract Background Ultrasound examination of the resistance index (RI) of both kidneys can provide evidence of renal artery stenosis. The extent to which the RI is changed after bridging stent-graft implantation due to altered flow characteristics is not known. Aims The aim of the study was to investigate the influence of renal bridging stent-grafts on the RI of the kidneys after fenestrated endovascular aortic repair (FEVAR). Methods Ultrasound examinations of the kidneys were conducted using a GE LOGIQ S7 XDclear ultrasound system (GE Medical Systems AG, Glattburg, Switzerland). The evaluation was performed according to SGUM 2D standard criteria. The RI was determined in all consecutive patients on the day before and after renal bridging stent-graft implantation. For this purpose, the kidneys were divided into 3 areas according to the standard protocol and 2 RI values were recorded per area by evaluating intrarenal arterial Doppler signals. Mean values were calculated and compared for each kidney. Results For 64 kidneys in 32 consecutive patients (73.9±7.8 years, 4 female, 28 male) treated with FEVAR and renal bridging stent–graft implantation pre- and postinterventional examinations were carried out. Sono-morphologically, the kidneys examined were inconspicuous (pre: size at least 107.1x52.4 mm, parenchymal margin 18.3 mm versus post: size at least 107.9x52.9 mm, parenchymal margin 18.6 mm, p>0.4). The arborization of the renal perfusion was preserved pre and post implantation. The RI did not differ before and after implantation (0.66±0.06 versus 0.67±0.07; p=0.10). None of the patients experienced severe impairment of renal function. Conclusion After successful implantation of a bridging stent-graft in a non-stenosed renal artery, there is no relevant change in the RI of the kidney. The RI seems therefore to be suitable for assessing renal perfusion after complex endovascular aortic therapy.

Intraoperative Staff Radiation Exposure During Aortic Endovascular Procedures

The risk of radiation exposure in the surgical operating room (OR) and/or catheterization laboratory is now well established. Complex endovascular procedures often require multiple approaches and different positioning of the staff members around the patient, potentially increasing the levels of radiations exposure. Our goal was to evaluate the levels of radiation exposure of the members of the staff during endovascular aortic procedures in order to propose radioprotection optimization. We included 41 aortic endovascular procedures out of 114 procedures performed between January 12, 2014, and August 31, 2015, including 24 standard endovascular aortic aneurysm repair (EVAR), 7 EVAR with iliac branch (EVARib), 8 complex fenestrated/branched EVAR (F/B EVAR), and 2 thoracic EVAR (TEVAR). Procedures were performed in an OR equipped with a carbon fiber table and a mobile fluoroscopy C-arm. We collected the usual dosimetry data given by the C-arm as well as the patient's peak skin dose (PSD). In all staff members, radiation exposure was measured with thermoluminescent chip dosimeters placed on both temples, on posterior sides of both hands, and on both lower legs. PSD levels were low for EVAR because 24 patients had values below the reading threshold. PSD significantly increased with more complex procedures. Main operator (MO) received the higher level of irradiation on whole body, hands, and ankles. Eye lenses irradiation was higher on both assistant operators (AOs). Other members received low levels of irradiation. We found a high ranges of radiation exposure with a high risk of exposure for the AO, mainly for F/B EVAR and EVARib. Even if all personal protections are used, staff positioning is a major point that must be considered. If MO is supposed to be the most exposed to X-rays, specific conditions of positioning of the AO may be at risk of exposure.

Plug-Based Embolization Techniques of Aortic Side Branches during Standard and Complex Endovascular Aortic Repair.

Vascular plugs are an evolving family of vessel occluders providing a single-device embolization system for large, high-flow arteries. Nitinol mesh plugs and polytetrafluoroethylene membrane plugs are available in different configurations and sizes to occlude arteries from 3 to 20 mm in diameter. Possible applications during complex endovascular aortic procedures are aortic branch embolization to prevent endoleak or to gain an adequate landing zone, directional branch occlusion, and false lumen embolization in aortic dissection. Plugs are delivered through catheters or introducers, and their technical and clinical results are comparable to those of coil embolization. Plugs are more accurate than coils as repositionable devices, less prone to migration, and have fewer blooming artifacts on postoperative computed tomography imaging. Their main drawback is the need for larger delivery systems. This narrative review describes up-to-date techniques and technology for plug embolization in complex aortic repair.

Outcome of Endovascular and Open Treated Penetrating Aortic Ulcers.

Penetrating aortic ulcer (PAU) is a rare etiology of acute aortic syndrome. Few studies exist regarding the perioperative outcome. The aim was to analyze clinical outcome and risk factors of mortality in this treatment population. Retrospective, monocentric study from 2010 to 2021. Clinical data of endovascular or open treated PAU were analyzed. In-hospital mortality was selected as the primary study endpoint. Angio-morphologies were analyzed and risk factors for mortality were identified by using univariate analysis. Overall, 133 patients were identified. 29% (n=38) of patients presented symptomatically. In 64% (n=85), the PAU was localized in the thoracic aorta. On average, PAUs had a depth of 15.4±10.1 mm and a width of 17.9±9.6 mm. The patients had a median of 2 (95% confidence interval [CI]=2-3) high-risk features (HRF) as PAU depth >10 mm, PAU width >20 mm, aortic diameter >40 mm, symptomatic, intramural hematoma (IMH), pleural effusion. Significantly more HRF were observed in symptomatic patients (p=0.01). 53% (n=71) of patients were treated with thoracic endovascular aortic repair (TEVAR), 41% (n=54) by endovascular aortic repair (EVAR), and 6% (n=8) by open surgery. A hybrid procedure with cervical debranching was performed in 16% (n=21) and complex endovascular repair with fenestrated or branched endografts in 15% (n=20). Overall, complications greater than grade II according to the Clavien-Dindo classification occurred in 19% (n=25) and of the patients. In-hospital mortality manifested in 6% (n=8). Factors associated with increased mortality were the diameter of the aorta >40 mm (88% vs 39%, p=0.03), as well as symptomatic patients (63% vs 26%, p=0.04), coincident IMHs (38% vs 10%, p=0.05), and complex endovascular procedures (50% vs 50% p<0.01). Penetrating aortic ulcer width >20 mm tended to show higher mortality (75% vs 40%, p=0.06). Routine follow-up was available for 89% (n=117) for a median of 39 months (95% CI=25-42). One-year and 5-year survival were 83% and 60%, respectively, with 1 aortic pathology-related death. Treatment of PAU is associated with an acceptable perioperative morbidity and mortality. Risk factors associated with increased mortality are an elevated aortic diameter, the presence of IMHs, clinical symptomatology at presentation, and complex endovascular procedures.

Safety and learning curve of percutaneous axillary artery access for complex endovascular aortic procedures: Presented at the plenary session of the 2022 Vascular Annual Meeting of the Society for Vascular Surgery, Boston, Massachusetts, June 15-18, 2022.

Safety and learning curve of percutaneous axillary artery access for complex endovascular aortic procedures: Presented at the plenary session of the 2022 Vascular Annual Meeting of the Society for Vascular Surgery, Boston, Massachusetts, June 15-18, 2022.

The changing face of surgical education: transfer of surgical and endovascular knowledge to young surgeons.

The goal of vascular surgery education is to provide the best possible training to vascular residents and fellows and to assure the highest standards of care for patients with vascular disease. In the USA, the currently used Vascular Surgery Milestones Program includes milestones as set targets at five levels, from novice to expertise, to assess the trainees' performance in knowledge, skills, attitudes, and other attributes of competencies. Competencies are broad and foundational domains of ability, the most important being the care of the patient. The soon to be introduced Entrustable Professional Activities (EPA) Project, a competency-based assessment, appears to be the best way to evaluate that trainees are ready to practice independently. Transferring surgical and endovascular skills to trainees has been, however, a challenge, because of the decreased number of open surgical procedures, the increasing number of the endovascular interventions, the decreased work hours for residents and that learning on patients in the operating room is no longer acceptable. Simulation laboratories, using 3D reconstructions of real patient's aneurysms has been most helpful to teach even complex endovascular procedures. In open or endovascular simulation laboratories, deliberate practice with focused attention and specific goals of improving performance should be combined with expert feedback. Greatness is not coded into our DNA but comes from deliberate practice, dedication and perseverance.

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

BackgroundPercutaneous 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. MethodsOne-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. ResultsOne-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. ConclusionsLarge-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.

The Flux One Magnetic Navigation System: A Preliminary Assessment for Stent Implantation

Minimally-invasive surgery (MIS) for stent implantation is a complex procedure requiring specialized instruments. It often leads to prolonged patient recovery, and interrupted operations due to incorrect instrument selection and complex anatomy. This study presents a novel magnetic navigation system that addresses these challenges by using magnetic fields and computed tomography imaging to precisely navigate minimally-invasive surgical guidewires. The system is designed based on consultations with surgeons, and analysis of technical and clinical requirements of stent implantation procedures. Results from a human-in-the-loop case study with eleven operators indicate a 47% reduction in guidewire navigation times, while successfully reaching all predetermined luminal targets. The clinical relevance, usability, and operator satisfaction are also measured using a user experience questionnaire, and interviews and showed positive results. Compared to conventional, manual guidewire navigation, the magnetic navigation system has the potential to significantly impact the efficiency of the clinical workflow and improve complex endovascular aortic repair procedures.

Novel Technique for Intentional Occlusion of Directional Branches During Complex Endovascular Aortic Repair Using Microvascular Plugs.

To demonstrate the feasibility and outcomes of using the microvascular plug (MVP) for intentional occlusion of directional branches (DB) during complex endovascular aortic procedures. Two patients were treated with the off-the-shelf four-branched Zenith t-Branch thoracoabdominal stent-graft (Cook Medical, Bloomington, Ind). In both cases, the renal arteries (on one side in patient #1 and on both sides in patient #2, respectively) were occluded at time of index intervention. Preoperative planning included the intentional occlusion of each DB with one 7Q-MVP. Technical success was achieved in all cases and maintained at mid-term follow-up (12months and 36months, respectively). Use of the MVP appears to be feasible and effective for intentional occlusion of DB during complex endovascular aortic repair. This novel and simple technique may present some unique technical advantages, allowing precise placement of the device while avoiding extension using a bridging stent and DB cannulation with larger sheaths.

Carbon Dioxide Guided Endovascular Aortic Aneurysm Repair in Impaired Renal Function: Propensity Score Matched Study

Carbon dioxide (CO2) is the preferred contrast agent in patients with impaired renal function and or contrast allergy and, particularly, in patients who require large volumes of contrast for complex endovascular procedures. In this study, the aim was to clarify the possible protective effects of CO2 guided endovascular aneurysm repair (EVAR) for patients with impaired renal function by propensity score matching. A retrospective analysis of the database was performed for 324 patients having EVAR between January 2019 and January 2022. A total of 34 patients treated with CO2 guided EVAR were evaluated. This cohort was matched for age, sex, pre-operative serum creatinine levels and glomerular filtration rate (GFR) levels and specific comorbidities to obtain homogeneous groups that included only patients with impaired renal function (eGFR < 60 mL/min/1.73m2). The primary endpoint was to compare the decrease in eGFR from baseline and development of contrast induced nephropathy (CIN) using propensity score matching. Secondary endpoints were the need for renal replacement therapy, other peri-procedural morbidity and mortality. Thirty-one patients (9.6%) of the total population developed CIN. There was no difference in the rate of CIN development between the standard EVAR group and the CO2 guided EVAR group in the unmatched population (10% vs. 3%, p= .15). After matching, the decrease in eGFR values after the procedure was more pronounced for the standard EVAR group (from 44 to 40 mL/min/1.73m2, interaction p= .034). Meanwhile, CIN development was more frequent for the standard EVAR group (24% vs. 3%, p= .027). In matched patients, early death did not differ between the groups (5.9% vs. 0, p= .15) CONCLUSION: Patients with impaired renal function are at higher risk of CIN after an endovascular procedure. CO2 guided EVAR is a safe, effective, and feasible treatment option, especially for patients with impaired renal function. CO2 guided EVAR may be a protective measure for contrast induced nephropathy.

Balloon-Assisted Retrieval of a Retained Vascular Sheath during Complex Inferior Vena Cava Filter Removal.

A potential complication of complex endovascular procedures is retained foreign bodies such as fragmented catheters, wires, stents, or sheaths in the intravascular space. Different techniques are available for retrieval of intravascular foreign bodies including snares, forceps, baskets, tip-deflecting wires, and balloon catheters. The aim of this article is to describe our experience in which a lost large intravascular sheath was retrieved using balloon assistance. We also provide a review of different techniques used for intravascular large sheath retrieval and methods to avoid this complication during endovascular procedures such as complex inferior vena cava filter removal.

Remote training and evaluation of asimulator-based training course for complex endovascular procedures.

Intimate knowledge of the materials used in endovascular aortic interventions is essential for trainees and supporting staff taking part in an endovascular intervention. Training courses can help to familiarize trainees with the equipment. However, the pandemic has changed the landscape of hands-on training courses significantly. Therefore, we developed atraining course including an educational recording of the procedure to transfer knowledge about the materials used during endovascular interventions and radiation exposure reduction. We produced avideo depicting cannulation of the left renal artery in asilicon cast of an aorta and its major side branches under C‑arm fluoroscopy. Apresentation using the video was given to the trainees. The trainees were randomized into acontrol and an intervention group. Their performance was filmed and rated on astandardized five-point scale in the style of the OSATS global rating scale. The intervention group was remeasured after additional training time. In total, 23trainees participated in the training and agreed to have their performance recorded. The control and intervention groups showed no difference in the assessed performance metrics during their initial attempt. However, after receiving additional training, the intervention group significantly improved in all evaluated metrics. Our data add to the growing evidence that simulator-based training can help to increase trainees' understanding and performance of relevant skills. Astandardized and evidence-based validation process for simulators could improve their acceptance in the medical field.

Biomarkers of Spinal Cord Injury in Patients Undergoing Complex Endovascular Aortic Repair Procedures-A Narrative Review of Current Literature.

Complex endovascular aortic repair (coEVAR) of thoracoabdominal aortic aneurysms (TAAA) has greatly evolved in the past decades. Despite substantial improvements of postoperative care, spinal cord injury (SCI) remains the most devastating complication of coEVAR being associated with impaired patient outcome and having an impact on long-term survival. The rising number of challenges of coEVAR, essentially associated with an extensive coverage of critical blood vessels supplying the spinal cord, resulted in the implementation of dedicated SCI prevention protocols. In addition to maintenance of adequate spinal cord perfusion pressure (SCPP), early detection of SCI plays an integral role in intra- and postoperative patient care. However, this is challenging due to difficulties with clinical neurological examinations during patient sedation in the postoperative setting. There is a rising amount of evidence, suggesting that subclinical forms of SCI might be accompanied by an elevation of biochemical markers, specific to neuronal tissue damage. Addressing this hypothesis, several studies have attempted to assess the potential of selected biomarkers with regard to early SCI diagnosis. In this review, we discuss biomarkers measured in patients undergoing coEVAR. Once validated in future prospective clinical studies, biomarkers of neuronal tissue damage may potentially add to the armamentarium of modalities for early SCI diagnosis and risk stratification.

Total Iodine Contrast-free Strategy for the Endovascular Management of Abdominal Aortic Aneurysms in Chronic Kidney Disease Patients: A Pilot Study

To retrospectively evaluate the feasibility and effectiveness of the endovascular treatment of patients with abdominal aortic aneurysm and chronic kidney disease (CKD) without the need for using iodinated contrast media throughout the diagnostic, therapeutic, and follow-up pathway. A retrospective review of prospectively collected data concerning 251 consecutive patients presenting an abdominal aortic or aorto-iliac aneurysm who underwent endovascular aneurysm repair (EVAR) from January 2019 to November 2022 at our academic institution was performed in order to identify patients with feasible anatomy with respect to manufacturer's instructions for use and with CKD. Patients whose preoperative workout included duplex ultrasound and plain computed tomography for preprocedural planning were extracted from a dedicated EVAR database. EVAR was performed with the use of carbon dioxide (CO2) as the contrast media of choice, whereas follow-up examinations consisted of either duplex ultrasound, plain computed tomography, or contrast-enhanced ultrasound. Primary endpoints were technical success, perioperative mortality, and early renal function variations. Secondary endpoints were all-type endoleaks and reinterventions, midterm aneurysm-related and kidney-related mortality. Forty-five patients had CKD and were treated electively (45/251, 17.9%). Of them, 17 patients were managed with a total iodinated contrast media-free strategy and constituted the object of the present study (17/45, 37.8%; 17/251, 6.8%). In 7 cases, an adjunctive planned procedure was performed (7/17, 41.2%). No intraoperative bail-out procedures were needed. This extracted cohort of patients presented similar mean preoperative and postoperative (at discharge) glomerular filtration rate values, 28.14 (SD 13.09; median 28.06, interquartile range (IQR) 20.25) ml/min/1.73m2 and 29.33 (SD 14.61; median 27.35, IQR 22) ml/min/1.73m2, respectively (P=0.210). Mean follow-up was 16.4months (SD 11.89; median 18, IQR 23). During follow-up, no graft-related complications occurred in terms of either thrombosis, type I or III endoleaks, aneurysm rupture, or conversion. The mean glomerular filtration rate at follow-up was 30.39ml/min/1.73m2 (SD 14.45; median 30.75, IQR 21.93), with no significant worsening in comparison with preoperative and postoperative values (P=0.327 and P=0.856 respectively). No aneurysm- or kidney-related deaths occurred during follow-up. Our initial experience shows that total iodine contrast-free abdominal aortic aneurysm endovascular management in patients with CKD may be feasible and safe. Such an approach seems to guarantee the preservation of residual kidney function without increasing the risks of aneurysm-related complications in the early and midterm postoperative periods, and it could be considered even in the case of complex endovascular procedures.

Feasibility and Safety of Percutaneous Axillary Artery Access in a Prospective Series of 100 Complex Aortic and Aortoiliac Interventions

We aimed to review the feasibility and safe use of the percutaneous axillary artery (AxA, 100 patients) approach for endovascular repair (ER) of thoraco-abdominal aortic aneurysms (TAAA, 90 patients) using fenestrated, branched, and chimney stent grafts and other complex endovascular procedures (10 patients) necessitating AxA access. Percutaneous puncture of the AxA in its third segment was performed using sheaths sized between 6 to 14F. For closing puncture sites greater than 8F, two Perclose ProGlide percutaneous vascular closure devices (PVCDs) (Abbott Vascular, Santa Clara, CA, USA) were deployed in the pre-close technique. The median maximum diameter of the AxA in the third segment was 7.27 mm (range 4.50-10.80). Device success, defined as successful hemostasis by PVCD, was reported in 92 patients (92.0%). As recently reported results in the first 40 patients suggested that adverse events, including vessel stenosis or occlusion, occurred only in cases with a diameter of the AxA < 5 mm, in all subsequent 60 cases AxA access was restricted to a vessel diameter ≥ 5 mm. In this late group, no hemodynamic impairment of the AxA occurred except in six early cases below this diameter threshold, all of which could be repaired by endovascular measures. Overall mortality at 30 days was 8%. In conclusion, percutaneous approach of the AxA in its third segment is feasible and represents a safe alternative access to open access for complex endovascular aorto-iliac procedures. Complications are rare, especially if the maximum diameter of the access vessel (AxA) is ≥5 mm.

Snare-Dragging Technique to Target the Hypogastric Artery in an Iliac Bifurcation Dissection.

To describe snare-assisted vessel targeting to selectively overcome a dissection in the iliac bifurcation and gain antegrade access to the hypogastric artery (HA). The technique is demonstrated in a 64-year-old woman with an asymptomatic Crawford type III thoracoabdominal aneurysm. A 2-stage endovascular repair, consisting of a thoracic endovascular aortic repair (TEVAR) and a branched endovascular aortic repair was planned. In the control angiography after TEVAR, a disrupted plaque with consequent dissection in the right iliac bifurcation was detected. The perfusion of the common iliac artery and external iliac artery resulted impaired. The targeting of the right HA through a contralateral antegrade approach failed, whereas an ipsilateral retrograde approach was possible but unsuitable for therapeutic purposes. Using the catheter of the retrograde ipsilateral access, a snare from a contralateral crossover was cached and dragged into the HA, allowing the targeting of the vessels and further endovascular therapy with angioplasty and stenting. Follow-up 8 months postoperatively demonstrated the patency of the stents and well-preserved perfusion in the right iliac bifurcation. The snare-dragging technique can be used to gain access to vessels presenting challenging conformations or dissections. This application may be a valuable support for complex endovascular treatment in a variety of patients. The snare-dragging technique can be used to gain access to vessels presenting challenging conformations or dissections. It allows the catheterization to be establish from the easiest and safest approach and then "transferred" from one access to the other. It avoids the risk of repeated loss of catheterization due to unstable and unfavorable working angles, and it saves time and radiation. It permits different material combinations, adapting to the available resources and materials. We believe that the current technique may increase the strategy spectrum available for endovascular therapy and complex endovascular procedures.

Safety and Learning Curve of Percutaneous Axillary Artery Access for Complex Endovascular Aortic Procedures

Percutaneous axillary artery access is increasingly used for large-bore access during vascular and interventional cardiology procedures. The aim of this study is to evaluate the safety and learning curve of percutaneous axillary artery access in patients undergoing complex endovascular aortic repair (FBEVAR) requiring large-bore upper extremity access and to discuss best practices for technique and complication management.

Updates in Endovascular Procedural Navigation.

There have been significant advancements in endovascular technology over the past decade. Increasingly complex disease processes are being addressed in a less invasive fashion, while still relying on standard 2-dimensional greyscale fluoroscopy imaging to guide the procedures. With the advent of flat-panel detectors as standard on fluoroscopy units and the use of fluoroscopy cone-beam computed tomography, the development of improved imaging tools has occurred that will help improve the imaging modalities used to perform these endovascular procedures. Fusion imaging, the overlay of preoperative 3-dimensional computed tomographic images, helps interventionalists perform endovascular procedures. Building on this technology, improvements in its function and use have occurred with the additional application of artificial intelligence and machine learning, allowing the images to independently accommodate to changes in the visualised anatomy. Corresponding development of navigation systems, allowing for the tracking of endovascular tools within these images by means of either fibre optics or electromagnetic field generators, are looking to improve the accuracy of the procedures while reducing the need for radiation and contrast agents. These tools are making a dramatic change in our ability to perform complex endovascular procedures, and are the future gold standard. Ultimately, these will allow procedures to occur more quickly and more safely.

Safety and Efficacy of Cangrelor in Acute Stroke Treated with Mechanical Thrombectomy: Endovascular Treatment of Ischemic Stroke Registry and Meta-analysis.

Rescue therapies are increasingly used in the setting of endovascular therapy for large-vessel occlusion strokes. Among these, cangrelor, a new P2Y12 inhibitor, offers promising pharmacologic properties to join the reperfusion strategies in acute stroke. We assessed the safety and efficacy profiles of cangrelor combined with endovascular therapy in patients with large-vessel-occlusion stroke. We performed a retrospective patient data analysis in the ongoing prospective multicenter observational Endovascular Treatment in Ischemic Stroke Registry in France from July 2018 to December 2020 and conducted a systematic review and meta-analysis using several data bases. Indications for cangrelor administration were rescue strategy in case of refractory intracranial occlusion with or without intracranial rescue stent placement, and cervical carotid artery stent placement in case of cervical occlusion (tandem occlusion or isolated cervical carotid occlusion). In the clinical registry, 44 patients were included (median initial NIHSS score, 12; prior intravenous thrombolysis, 29.5%). Intracranial stent placement was performed in 54.5% (n = 24/44), and cervical stent placement, in 27.3% (n = 12/44). Adjunctive aspirin and heparin were administered in 75% (n = 33/44) and 40.9% (n = 18/44), respectively. Rates of symptomatic intracerebral hemorrhage, parenchymal hematoma, and 90-day mortality were 9.5% (n = 4/42), 9.5% (n = 4/42), and 24.4% (n = 10/41). Favorable outcome (90-day mRS, 0-2) was reached in 51.2% (n = 21/41), and successful reperfusion, in 90.9% (n = 40/44). The literature search identified 6 studies involving a total of 171 subjects. In the meta-analysis, including our series data, symptomatic intracerebral hemorrhage occurred in 8.6% of patients (95% CI, 5.0%-14.3%) and favorable outcome was reached in 47.6% of patients (95% CI, 27.4%-68.7%). The 90-day mortality rate was 22.6% (95% CI, 13.6%-35.2%). Day 1 artery patency was observed in 89.7% (95% CI, 81.4%-94.6%). Cangrelor offers promising safety and efficacy profiles, especially considering the complex endovascular reperfusion procedures in which it is usually applied. Further large prospective data are required to confirm these findings.

First-in-Human Clinical Application of the Medyria TrackCath System in Endovascular Repair of Complex Aortic Aneurysms (ACCESS Trial): A Prospective Multicenter Single-Arm Clinical Trial

Purpose: The Medyria TrackCath Catheter (MedTCC) is an innovative, thermal convection–based blood flow velocity (BFV) tracking catheter that may be used during complex aortic endovascular procedures for identification and catheterization of target orifices. The ACCESS Trial analyzes the safety and performance of the MedTCC for targeted vessel catheterization to generally evaluate the feasibility of thermal convection–based BFV. Materials and Methods: We performed a first-in-human, proof-of-concept, prospective single-arm multicenter clinical trial between March 2018 and February 2019 in patients who underwent endovascular aortic procedures at 4 high-volume centers. During these procedures, the MedTCC was advanced over a guidewire through the femoral access. The D-shape was enfolded in the reno-visceral part of the aorta and target orifices were identified and catheterized with a guidewire via the side port of the MedTCC through BFV tracking. BFV measurements were performed at baseline (Baseline-BFV), alignment to the orifice (Orifice-BFV), and following catheterization (Confirmation-BFV) to prove correct identification and catheterization of target orifices. The procedural success rate, the catheterization success rate, procedure-related parameters, and (serious) adverse events ((S)AE) during the follow-up were analyzed. Results: A total of 38 patients were included in the safety group (SG) and 26 in the performance group (PG). The procedural success rate was 89% (PG), the MedTCC catheterization success rate was 98% (PG). The MedTCC reliably measured BFV changes indicated by significant differences in BFV between Baseline-BFV and Orifice-BFV (p<0.05). Median (interquartile range; IQR) fluoroscopy time per orifice was 5.0 (1.5–8.5) minutes [total surgery 49 (26–74) minutes], median (IQR) contrast agent used per orifice was 1.0 (0–5.0) mL [total surgery 80 (40–100) mL], and median (IQR) MedTCC-based procedural time was 3.0 (2.0–6.0) minutes. There was no device-related SAE. Conclusions: The ACCESS Trial suggests that BFV measurement allows for reliable target orifice identification and catheterization. The use of MedTCC is safe and generates short fluoroscopy time and low contrast agent use, which in turn might facilitate complex endovascular procedures.