Anatomic feasibility of the investigational GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE), off-the-shelf multibranched endograft for the treatment of pararenal and thoracoabdominal aortic aneurysms.

OBJECTIVE: The objective of this study was to evaluate the proportion of pararenal aortic aneurysms and thoracoabdominal aortic aneurysms (TAAAs) that could theoretically be treated with the investigational GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE; W. L. Gore & Associates, Flagstaff, Ariz) off-the-shelf multibranched endograft. METHODS: The preoperative computed tomography scans of patients with pararenal aortic aneurysms and TAAAs treated at a single institution between 2007 and 2017 were reviewed. This cohort included both open and endovascular repairs performed in either elective or urgent/emergent settings. These studies were included in a retrospective feasibility study to verify anatomic feasibility of the TAMBE graft (with four antegrade portals) employed within the manufacturer's investigational instructions for use during the U.S. pivotal trial. The patient cohort was divided into two groups: extended thoracoabdominal aneurysm (E-TAA)-extent I, II, and III TAAA; and limited pararenal and thoracoabdominal aneurysm (L-TAA)-pararenal aortic aneurysm and extent IV TAAA. The anatomic factors determining the overall theoretical feasibility were further divided into three groups: vascular access feasibility, aortic feasibility, and visceral vessel feasibility. RESULTS: Computed tomography scans of 227 patients with degenerative aneurysms were analyzed, 166 with E-TAA and 61 with L-TAA. In the L-TAA group, 49% of the cases could have been treated with the TAMBE endograft alone; access feasibility was 85%, aortic feasibility 74%, and visceral vessel feasibility 72%. In the E-TAA group, only 23% of the cases could have been treated with a TAMBE combined with a GORE CTAG proximal thoracic stent graft; access feasibility was 79%, aortic feasibility 48%, and visceral vessel feasibility 63%. The different feasibility rate was related to a difference in aortic feasibility between L-TAA and E-TAA (74% vs 48%; P = .0008) because of the lack of a dedicated tapered thoracic component. CONCLUSIONS: The TAMBE multibranched endograft can theoretically be employed in half of an all-comers cohort of patients with degenerative L-TAA. Development of a dedicated tapered thoracic component is warranted to increase the feasibility for E-TAA, and comparative studies are required to investigate differences with other available off-the-shelf stent grafts.

Comparison of anatomic feasibility of three different multibranched off-the-shelf stent-grafts designed for thoracoabdominal aortic aneurysms.

OBJECTIVE: We compared the theoretical anatomic feasibility of endovascular treatment of thoracoabdominal aortic aneurysms (TAAAs) with three off-the-shelf multibranched stent-grafts: t-Branch (Zenith t-Branch; Cook Medical, Bloomington, Ind), Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE; W. L. Gore & Associates, Flagstaff, Ariz), and E-nside (E-nside multibranch stent graft system; Jotec GmbH, Hechingen, Germany). METHODS: Computed tomography scans of patients with degenerative TAAAs treated from 2007 to 2019 were reviewed, and the anatomic feasibility of the multibranched stent-grafts was assessed according to the manufacturer's instructions for use. The anatomic factors determining the overall feasibility were divided into access feasibility, aortic feasibility, and visceral vessel feasibility. RESULTS: Degenerative TAAAs in 268 patients were analyzed. The overall feasibility did not differ significantly (TAMBE, 33%; t-Branch, 39%; E-nside, 43%; P = .271). Access, aortic, and visceral vessel feasibility alone excluded 18% to 22%, 35% to 49% and 21% to 26% of the patients respectively. The only significant difference between the devices was in aortic feasibility (P = .005), which was more frequently limited by the proximal aortic neck diameter in the TAMBE cohort and the inner visceral aortic diameter in the t-Branch cohort. The overall treatment feasibility using any of the three devices would have been 58%. CONCLUSIONS: The new investigational off-the-shelf multibranched stent-grafts did not significantly improve the theoretical applicability in an extensive cohort of patients with TAAAs. Improvements are warranted to increase their overall feasibility.

Sex-Related Anatomical Feasibility Differences in Endovascular Repair of Thoracoabdominal Aortic Aneurysms With a Multibranched Stent-Graft.

PURPOSE: To evaluate the potential anatomical feasibility of using the off-the-shelf multibranched Zenith t-Branch for the treatment of thoracoabdominal aortic aneurysms (TAAAs) in female patients. MATERIALS AND METHODS: A total of 268 patients (median age 68 years; 69 women) with degenerative TAAA treated at a single institution by means of open or endovascular repair between 2007 and 2019 were retrospectively analyzed to determine the feasibility of using the Zenith t-Branch based on the manufacturer's instructions for use. The factors determining overall anatomical feasibility were divided into vascular access, aortic anatomy, and visceral vessels. The results were stratified by sex and compared. A logistic regression model was constructed to determine any association between feasibility and clinical factors or potential confounding variables; results are expressed as the odds ratio (OR) with 95% confidence interval (CI). RESULTS: The overall anatomical feasibility was 39% (22% women vs 45% men, p=0.001). The feasibility was negatively influenced by female sex (p<0.001) in multivariable analysis (OR 2.9, 95% CI 1.5 to 5.4, p=0.001). Vascular access feasibility was 82% (61% women vs 89% men, p<0.001). Aorta feasibility was 65% (52% women vs 69% men, p<0.001), and visceral vessel feasibility was 74% (78% women vs 73% men, p=0.260). An access diameter ≤8.5 mm excluded 17% of the patients (39% women vs 9% men, p<0.001). The aortic feasibility was limited by the infrarenal aortic diameter in 16% of patients (45% women vs 6% men, p<0.001) and the aortic lumen at the visceral vessels in 17% patients (19% women vs 17% men, p=0.741). The visceral vessel feasibility was mainly limited by inadequate numbers or diameters of target vessels. Location and orientation of the target vessels were adequate in 96% of patients. CONCLUSION: A little more than a third of an all-comers cohort of patients with degenerative TAAA could have been treated with on-label use of the Zenith t-Branch. However, only 22% of women could have been treated because of sex-related anatomical limitations. New generations of multibranched devices should address these differences.

Carotid to subclavian bypass and Amplatzer vascular plug subclavian endovascular occlusion before thoracic open or endovascular repair.

OBJECTIVE: The aim of this study was to evaluate the safety and effectiveness of endovascular occlusion of the prevertebral subclavian artery (SA) using an Amplatzer vascular plug after prophylactic revascularization with carotid-subclavian bypass (CSB) in the setting of endovascular thoracic stent grafting or open arch repair with frozen elephant trunk. METHODS: All patients who underwent SA plug embolization (SAPE) and CSB from September 2009 to December 2018 were enrolled in a registered study (SAPE study: clinicaltrials.govNCT03620006). The primary end point was technical success, defined as complete occlusion of the origin of the SA, and how it was influenced by SA anatomy. The secondary end points were access vessel complications, cerebrovascular events, and CSB patency. RESULTS: The 101 SAPE procedures were performed using a type I (35 patients) or a type II (66 patients) Amplatzer vascular plug. A percutaneous ipsilateral upper extremity access was used in 66% of patients and a radial artery access was used in 50% of procedures. The 30-day primary technical success rate was 95% (five patients received an additional plug during the index); five type IC endoleaks were observed and successfully treated either with surgical ligation (in open arch repair procedures) or secondary embolization procedure (thoracic endovascular aneurysm repair group). Three access vessel complications (3%) were recorded with percutaneous brachial approach. At a median follow-up time of 11 months (range, 2-19 months), no new-onset type IC endoleak was observed, and the CSB patency rate was 97%. CONCLUSIONS: SAPE after CSB is feasible and safe, and has low incidence of type IC endoleaks. Further device developments are needed to better adapt to the subclavian anatomy.

Percutaneous axillary artery access for fenestrated and branched thoracoabdominal endovascular repair.

OBJECTIVE: The aim of this study was to assess the safety and effectiveness of upper extremity access (UEA) with percutaneous closure of the axillary artery (AxA) during endovascular treatment of thoracoabdominal aortic aneurysms with fenestrated and branched endografts. METHODS: Between January 2014 and 2017, 34 out of 37 patients (92%) required UEA during a staged branched and fenestrated endovascular approach. A percutaneous AxA (pAxA) approach was used in 14 consecutive patients (41%) with the off-label use of two Perclose ProGlide (Abbott Vascular, Santa Clara, Calif) devices. The results of patients who had received a pAxA access were analyzed; technical success was defined as successful arterial closure with no evidence of persistent bleeding or arterial occlusion requiring secondary interventions. Early (30 days) and short-term (6 months) success rates were recorded. The anatomic characteristics of the AxA of the entire cohort (34 cases) were studied. RESULTS: Primary technical success of pAxA was 100%; in one case, an adjunctive Perclose ProGlide device was used to achieve complete closure. No secondary open or endovascular procedures were required. At predischarge computed tomography, no intimal defects, pseudoaneurysms, or signs of bleeding were observed, and all patients were discharged without neurologic deficits related to the AxA puncture site. All 14 patients are alive at follow-up, and 9 of 14 patients completed a 6-month clinical follow-up with computed tomography examination; no late complications were observed at the site of UEA percutaneous repair. With regard to the anatomic characteristics of the AxA, the vessel diameters in the first and third segments were statistically different (P < .001) with a median difference of 1.5 mm (1.0-2.0 mm), with no differences between the right and left sides. The distance between the end of the first segment of the AxA and the origin from the aortic arch was statistically different between the right and left sides, with a median difference of 36 mm (17-50 mm). A positive linear correlation was found between the diameter of the AxA and the height of the patients. CONCLUSIONS: AxA is adequate in terms of both caliber and lack of calcifications as an access vessel for large-sheath catheterizations, and it might be considered an alternative UEA for complex aortic endovascular procedures thanks to its proximity to visceral target vessels. In this preliminary experience, percutaneous closure of AxA access with the Perclose ProGlide device is clinically safe and technically feasible with high rates of success.

Comparison of sacrificed healthy aorta during thoracoabdominal aortic aneurysm repair using off-the-shelf endovascular branched devices and open surgery.

BACKGROUND: Off-the-shelf devices for branched endovascular aortic repair of thoracoabdominal aortic aneurysm (TAAA) have been developed to overcome the manufacturing- and logistics-related delays characteristic of device customization. Nonetheless, the structural requirements of branched endovascular aortic repair, together with the need for additional thoracic components to suit different anatomies, might lead to a large sacrifice of healthy aorta. METHODS: We enrolled 18 consecutive TAAA patients treated between 2010 and 2016 in two centers employing the off-the-shelf t-Branch (Cook Medical, Bloomington, Ind) device (TB group). We matched these 18 patients one-to-one with another 18 patients of the 464 consecutive TAAAs treated in the same period by means of open repair (O group) in one of the two centers. The patients were matched on the basis of t-Branch feasibility, distance from the left subclavian artery to the beginning of the aneurysm, and diameter of proximal landing zone evaluated at preoperative computed tomography angiography. We compared the overall length of sacrificed healthy native aorta (the sealing zone in the TB group) in the two groups according to postoperative computed tomography angiography, and we investigated the number of intercostal arteries lost from that healthy aortic segment. We calculated also the real unnecessary sacrificed aorta by subtracting the compulsory minimum neck coverage requested to obtain the proximal sealing (25 mm). RESULTS: We matched one-to-one six extent II, seven extent III, and five extent IV TAAAs. Overall, the length of sacrificed healthy aorta was longer (P < .001) in the TB group (median length: TB group, 49 mm [interquartile range (IQR), 31-60 mm]; O group, 14 mm [IQR, 10-20 mm]), and consequently the number of intercostal arteries lost (median number of pairs lost: TB group, four [IQR, three-four]; O group, two [IQR, one-three]) was higher (P = .004). Stratifying the results according to TAAA extent and after having subtracted from the TB group the length of aorta required for proximal sealing (25 mm), the length of sacrificed healthy aorta was longer (P = .008) only in the extent IV TAAA, 125 mm (IQR, 56-155 mm). The number of intercostal artery pairs sacrificed was longer only in extent III TAAA (P = .043) and extent IV TAAA (P = .024). No significant 30-day clinical outcomes difference was observed between the matched groups. CONCLUSIONS: The use of the t-Branch device compared with open repair is associated with a greater sacrifice of healthy aorta in extent IV TAAA and with an increased loss of intercostal arteries arising from healthy aortic proximal neck. The theoretical possible increased risk of spinal cord ischemia secondary to the routine use of this off-the-shelf device should thus be analyzed further.

Management of visceral aortic patch aneurysms after thoracoabdominal repair with open, hybrid, or endovascular approach.

OBJECTIVE: The objective of this study was to investigate the outcomes of patients with visceral aortic patch (VAP) aneurysms after open repair of thoracoabdominal aortic aneurysm (TAAA) treated with three different approaches: open, hybrid, and endovascular repair. METHODS: Between 1993 and 2016, there were 29 cases treated for VAP aneurysm after initial TAAA open repair (median time interval, 6.2 years; interquartile range, 4-8 years). Three different treatment modalities were employed: redo open repair (O group) in 14 cases (48.3%), hybrid repair (H group) in 10 cases (34.5%), and endovascular custom-made fenestrated endograft repair (E group) in 5 cases (17.2%). Early (30-day) and midterm results were recorded. The primary end point was a composite major adverse event score: any 30-day death plus any grade ≥2 postoperative complications plus any surgical revision classified according to the Society for Vascular Surgery/American Association for Vascular Surgery reporting standards. Patients were evaluated with computed tomography scans in the outpatient clinic at 3, 6, and 12 months and annually thereafter. RESULTS: The composite major adverse event score significantly differed among groups (O group, 79%; H group, 60%; E group, 0%; P = .009). Two cases (6.9%) of temporary delayed spinal cord ischemia (grade 1) were observed in both the E and H groups. The treatment modality employed was differently associated with blood loss ≥1000 mL (O group, 79%; H group, 40%; E group, 0%; P = .007), number of packed red blood cells transfused ≥3 units (O group, 100%; H group, 90%; E group, 40%; P = .003), intensive care unit stay >1 day (O group, 71%; H group, 70%; E group, 0%; P = .014), and length of hospital stay ≥7 days (O group, 79%; H group, 80%, E group, 20%; P = .034). At short term (6 months), we observed one endovascular reintervention in the E group and one fatal visceral graft thrombosis in the H group. At a median follow-up of 30 months (interquartile range, 15-75 months), we observed another aneurysm-related death in the H group due to graft infection and four unrelated deaths (one case in the H group and two cases in the O group). CONCLUSIONS: This retrospective study confirms that repair of VAP aneurysms that develop after open repair of TAAAs can be performed with open, hybrid, and endovascular techniques. Current practice favors endovascular repair if possible, but a conclusion that it is superior to any other technique requires validation in a larger sample or a randomized trial.

Reentry Devices for Lamella Neofenestration During Endovascular Aortic Repair of Chronic Type B Aortic Dissection.

PURPOSE: To present a technique that creates a neofenestration in the dissecting lamella of chronic aortic dissections using standard or intravenous ultrasound (IVUS)-guided reentry devices. TECHNIQUE: To create a neofenestration, a standard or IVUS-guided reentry device is deployed in either the true or false aortic lumen while a balloon is simultaneously inflated in the opposite lumen to stabilize the lamella, provide needle counterforce, and prevent displacement of the lamella away from the reentry needle. Once the lamella is perforated and a guidewire passed across the 2 lumens, progressive dilation of the neofenestration is performed to establish persistent communication. CONCLUSION: The balloon-supported lamella neofenestration technique involving off-label application of two currently available reentry devices can be applied to endovascular treatment chronic aortic dissections. While the technique will definitely not become a standard of practice, it provides a safe, effective, and readily available option for endovascular management of those patients with complex chronic aortic dissections requiring bailout maneuvers or elective treatment.

Preliminary Outcomes of the LifeStream Balloon-Expandable Covered Stent in Fenestrated and Branched Thoracoabdominal Endovascular Repairs.

PURPOSE: To evaluate the 1-year outcomes of thoracoabdominal aortic aneurysm (TAAA) repair using fenestrated and branched stent-grafts and a novel balloon-expandable covered stent. METHODS: Between March 2015 and January 2017, 18 patients (median age 74.7 years; 14 men) received 43 LifeStream balloon-expandable covered stents in conjunction with Zenith fenestrated/branched stent-grafts to bridge 11 celiac trunks, 8 superior mesenteric arteries, and 24 renal arteries (total 32 fenestrations and 11 branches). RESULTS: Stent delivery and deployment was successful in all cases. At 30 days, 5 patients presented with perifenestration endoleaks (type IIIc) secondary to inadequate sealing of the LifeStream covered stent in 7 (22%) of 32 fenestrations. No type IIIc endoleaks were reported in the branched cases. Four patients had a secondary endovascular reintervention with proximal relining by means of a bare balloon-expandable stent at the perifenestration transition area, with complete resolution of the endoleak at 1-year follow-up. One patient refused reintervention. The last 4 fenestrated stent-grafts of this series had prophylactic perifenestration bare stent relining with no evidence of type IIIc endoleaks at imaging. At a median follow-up of 14.1 months (interquartile range 11, 22), the 12-month LifeStream patency rate was 100%. CONCLUSION: This single-center preliminary experience with the LifeStream balloon-expandable covered stent in fenestrated/branched stent-grafts for TAAA repairs demonstrated good patency; however, an unexpectedly high rate of type IIIc endoleaks was observed. These endoleaks were resolved with reintervention or during the index procedure by proximal relining with a bare balloon-expandable stent, achieving adequate perifenestration sealing.

Fenestrated and Branched Endovascular Treatment of Recurrent Visceral Aortic Patch Aneurysm after Open Thoracoabdominal Repair.

The most common visceral revascularization technique during open repair of thoracoabdominal aortic aneurysms (TAAA) is the "inclusion technique," but its main long-term drawback is that the retained portion of the diseased aorta might be prone to further dilatation, thus giving rise to a recurrent visceral aortic patch aneurysm. This brief report presents 4 consecutive cases of visceral aortic patch aneurysms treated by means of fenestrated and branched endovascular approach with custom-made endografts. The procedures were technically successful in all 4 patients and no major complications were recorded at 11.9 months of follow-up.

Fracture of a Supera Interwoven Nitinol Stent After Treatment of Popliteal Artery Stenosis.

PURPOSE: To present a Supera stent fracture following treatment of popliteal artery stenosis. CASE REPORT: A 60-year-old man previously treated with angioplasty/stenting of a popliteal artery lesion with a Supera stent presented at 8 months with in-stent occlusion that proved to be secondary to stent fracture. CONCLUSION: Supera interwoven nitinol stents, despite having higher radial force and conformability than classic tube stents, are not free from fracture. Moreover, due to their peculiar structure, a break in these stents results in complete loss of integrity and consequent device collapse, thus jeopardizing endovascular recanalization and relining.

Endotension after Abdominal Aortic Aneurysm Endovascular Repair in Cirrhotic Patients.

BACKGROUND: Endotension can present a real challenge for the long-term success of endovascular aortic repair (EVAR). Sometimes, it can be associated with liver dysfunction and consequent plasmatic alterations as in the 2 cases reported here. METHODS: Significant and progressive abdominal aortic aneurysms (AAA) sac enlargement, without radiologic signs of endoleak, was observed in 2 patients during a 3-year follow-up after EVAR. The first was a 70-year-old man affected by viral liver cirrhosis and the second was a 71-year-old man with cirrhosis due to alcoholic liver disease. RESULTS: Both patients underwent successful conversion to open AAA repair; intraoperative findings confirmed the diagnosis of endotension. CONCLUSIONS: Cirrhosis-induced plasmatic alterations may affect long-term efficacy of EVAR and should be considered when weighing endovascular treatment against open AAA repair in these high-risk patients. Surgical conversion is feasible despite the high procedural risk associated with liver disease.

Endovascular Stent-Grafting of the Ascending Aorta for Symptomatic Parietal Thrombus.

PURPOSE: To present stent-graft treatment of parietal thrombus in the ascending aorta. CASE REPORT: A 64-year-old man with no history of vascular disease developed a right cerebral hemisphere transient ischemic attack and was diagnosed with mural thrombosis of the ascending aorta involving the greater curvature just proximal to the origin of the innominate artery. He was treated for 2 months with anticoagulants, but new imaging studies showed significant increase in the size of the thrombus and an irregular aspect. The thrombus was excluded from the aortic blood flow by deployment of a custom-made stent-graft in the ascending aorta, with embolic protection of the right internal carotid artery. At 6 months, the patient was well, and the thrombus in the ascending aorta appears to be completely excluded by the stent-graft. CONCLUSION: In highly selected cases, custom-made thoracic stent-grafts may be used for stabilization and exclusion of symptomatic ascending aorta parietal thrombosis to prevent progression and recurrent embolization.

Effect of Perioperative Stroke on Survival After Carotid Intervention.

OBJECTIVES: Perioperative stroke is the most dreaded complication of carotid artery interventions and can severely affect patients' quality of life. This study evaluated the impact of this event on mortality for patients undergoing interventional treatment of carotid artery stenosis with three different modalities. METHODS: Patients undergoing carotid revascularization at participating Memorial Hermann Health System facilities were captured from 2003-2022. These patients were treated with either carotid endarterectomy (CEA), transfemoral carotid stenting (TF-CAS), or transcarotid artery revascularization (TCAR). Perioperative outcomes, including stroke and mortality, as well as follow-up survival data at 6-month intervals, were analyzed and stratified per treatment modality. RESULTS: Of the 1681 carotid revascularization patients identified, 992 underwent CEA (59.0%), 524 underwent TCAR (31.2%), and 165 underwent TF-CAS (9.8%). The incidence of stroke was 2.1% (CEA 2.1%, TCAR 1.7%, and TF-CAS 3.6%; P = .326). The perioperative (30-day) death rate was 2.1% (n = 36). The perioperative death rate was higher in patients who suffered from an intraoperative stroke than in those who did not (8.3% vs 1.9%, P = .007). Perioperative death was also different between CEA, TCAR, and TF-CAS for patients who had an intraoperative stroke (.0% vs 33.3% vs .0%, P = .05). TCAR patients were likely to be older (P < .001), have a higher body mass index (P < .001), and have diabetes mellitus (P < .001). Patients who suffered from an intraoperative stroke were more likely to have a symptomatic carotid lesion (58.3% vs 28.8%, P < .001). The TCAR group had a significantly lower survival at 6 months and 12 months when compared to the other two groups (64.9% vs 100% P = .007). CONCLUSION: Perioperative stroke during carotid interventions significantly impacts early patient survival with otherwise no apparent change in mid-term outcomes at 5 years. This difference appears to be even more significant in patients undergoing TCAR, possibly due to their baseline higher-risk profile and lower functional reserve.

Transcarotid stenting of extracranial carotid artery aneurysm with covered stents and flow reversal.

Introduction: An extracranial carotid artery aneurysm (ECAA) is a rare pathology comprising <1% of all arterial aneurysms. The etiology includes trauma, previous surgery, radiation, and infection. Treatment of ECAAs has evolved from open repair to endovascular repair with stenting. Reports of endovascular repair describe the transfemoral approach; however, little more than case reports are available describing the transcarotid approach for ECAAs. In this study, we describe a cohort of patients who safely underwent transcarotid repair of ECAAs. Methods: We performed a retrospective medical record review of all cases of transcarotid stenting using covered stents for a carotid aneurysm within 11 different hospitals within the Memorial Hermann Health System from December 2019 through December 2022. Technical success is defined as coverage of the aneurysm with no endoleak. We report the patient demographics, clinical presentation, intraoperative metrics, and outcomes. Results: Seven patients underwent transcarotid covered stent placement using flow reversal for neurologic protection. Their average age was 65 years, and four of the seven patients were men. Three patients presented with pain, two with transient ischemic attack, one with stroke, and one with a pulsatile mass. Technical success was 100%. All the patients were treated with transcarotid stenting, and the average aneurysm size was 13 mm. The average operative time was 69 minutes, and the flow reversal time was 9 minutes. No postoperative stroke, myocardial infarction, or death occurred. The average length of hospital stay was 2.7 days. Conclusions: A transcarotid approach for endovascular treatment of ECAAs was safe for this cohort of patients, with no postoperative death, stroke, or myocardial infarction. Also, the technical success was 100%.

An Analysis of Sex-Based Outcomes Following Transcarotid Artery Revascularization.

OBJECTIVE: Several studies suggest that females have higher perioperative adverse events and decreased benefit from carotid artery revascularization with transfemoral carotid artery stenting and carotid endarterectomy (CEA) compared to males. However, there are limited data of sex-based outcomes for transcarotid artery revascularization (TCAR). METHODS: A retrospective review of prospectively maintained system-wide TCAR databases was performed between December 2015-January 2022. Patients who underwent TCAR were stratified based on sex. Relevant demographics, medical conditions, anatomical characteristics, intra- and postoperative courses, and adverse events were captured. RESULTS: 729 patients underwent TCAR, 486 (66.6%) male and 243 (33.3%) female. Males were more likely to be diagnosed with coronary artery disease (56.9% vs 47.7%, P<.01) and were active smokers (30.4% vs 21.4%, P < .01). Age, symptomatic status, BMI, hypertension, hyperlipidemia, diabetes mellitus, arrhythmia, chronic obstructive pulmonary disease, history of myocardial infarction, heart failure with reduced ejection fraction <30%, end-stage renal disease and Charlson Comorbidity Index were similar. In the perioperative period, there was no significant difference in reintervention rates (1.6% vs 1.2%, P = .75), cranial nerve palsy (.6% vs .4%, P > .99), ipsilateral stroke (1.9% vs 3.3%, P = .29), stent thrombosis (.4% vs .8%, P > .99), myocardial infarction (0% vs 0%, P > .99) and death (1.2% vs 1.2%, P > .99). In follow-up, no significant difference was found in reintervention, ipsilateral stroke, contralateral stroke, myocardial infarction, in-stent restenosis >50%, stent thrombosis, and death. CONCLUSIONS: Males and females did not have a statistically significant difference in outcomes when comparing ipsilateral stroke, in-stent thrombosis, conversion to CEA, and death after TCAR. However, our cohort comprised predominantly male patients and may conceal statistical significance as the females in our cohort did have a higher tendency toward developing complications. Future studies with a larger female cohort should be conducted to determine whether there is a true disparity of outcomes between the males and females undergoing TCAR.

Initial experience and early outcomes of the management of acute pulmonary embolism using the FlowTriever mechanical thrombectomy device.

BACKGROUND: Submassive and massive pulmonary embolism is associated with a high risk of complications. We aimed to evaluate our initial experience with a mechanical thrombectomy device in the management of these patients. METHODS: A single-center, retrospective study was performed in patients with acute submassive and massive pulmonary embolism treated with the FlowTriever device (Inari Medical, Irvine, CA, USA) between June 2019 and November 2020. Clinical and technical parameters were analyzed during the hospitalization and at 30- and 180-days after the procedure. RESULTS: Fourteen patients were evaluated with a median (IQR) age of 60 (50-69) years and 64% were male. All had right heart strain as the main indication for thrombectomy. The procedure duration and fluoroscopic time was 52 (37-89) and 13 (9-24) minutes, respectively. There was 100% technical success, and the pulmonary arterial pressure went from 60 (48-65) mmHg to 40 (34-47) mmHg. Thrombolysis was used in two patients and nine patients required intensive care. 100% experienced improvement in symptoms at the time of discharge. There were no device-related complications, major bleeding events, myocardial infarctions, or deaths. Preprocedural hemoglobin was 13 (12-15) g/dL, and predischarge was 12 (10-13) g/dL. Overall postprocedural length of stay was three (2-6) days. All the patients were discharged with oral anticoagulation. There were no device-related complications or recurrence of embolism at 30 and 180 days. CONCLUSIONS: The mechanical thrombectomy device for submassive and massive pulmonary embolism is promising and appears a safe and effective procedure with 100% technical success, no complications, short intensive care requirement/stay, and good early clinical outcomes.

Anatomical feasibility of a new off-the-shelf inner branch stent graft (E-nside) for endovascular treatment of thoraco-abdominal aneurysms.

OBJECTIVES: The aim of this study was to evaluate the proportion of thoraco-abdominal aortic aneurysms (TAAAs) that could theoretically be treated with the JOTEC® E-nside® Thoracoabdominal Branch Endoprosthesis off-the-shelf multibranched endograft. METHODS: Preoperative computed tomography scans of patients with atherosclerotic TAAA treated between 2007 and 2019 were reviewed, and the anatomical feasibility of the E-nside graft was verified by a retrospective study (clinicaltrials.gov: NCT03959670) based on the investigational manufacturer instructions for use. The anatomical factors determining overall feasibility were divided into vascular access (AC) feasibility, aortic (AO) feasibility and visceral vessels (VV) feasibility. RESULTS: Two hundred sixty-eight patients with thoraco-abdominal aneurysms were analysed: the overall treatment feasibility was 43%. AC feasibility was 78%, AO feasibility 60% and VV feasibility 79%. An iliac diameter <8.5 mm excluded 21% of the patients. Aortic feasibility was limited by infrarenal aortic diameter (16%) and size of aortic lumen at the level of visceral vessels (14%). Visceral vessels feasibility was mainly limited by inadequate number (8%) or diameter (12%) of target vessels. Height and orientation of target vessels were adequate in 97% of the cases. Overall feasibility was negatively influenced by female gender (Odds ratio: 3.89; 95% confidence interval 2.03-7.44; P < 0.001): the limiting factors in this subgroup being iliac diameter, infrarenal aortic diameter and visceral vessels diameter. CONCLUSIONS: The E-nside off-the-shelf stent graft can be theoretically employed in almost half of the cases from an all-comers cohort of patients with TAAA. Improvement of device profile and creation of a dedicated infrarenal component are warranted to increase overall feasibility. Female gender significantly affects the overall feasibility. CLINICALTRIALS.GOV: NCT03959670.

Preliminary Results of Debranch-First Technique in Frozen Elephant Trunk Procedures.

BACKGROUND: To evaluate the outcomes of frozen elephant trunk (FET) procedures performed with a customized graft that allows debranch-first technique with continuous antegrade cerebral perfusion and early distal aortic and myocardial reperfusion. METHODS: Between 2016 and 2018 34 patients (30 men; median age, 59.7 years) were enrolled in an ambispective single-center study called FET Optimization (clinicaltrials.gov: NCT03600077). The patients underwent FET procedure using a novel modified E-Vita graft (JOTEC GmbH, Hechingen, Germany) plus graft with 2 dedicated reperfusion branches with debranch-first technique. Mortality and morbidity were primary endpoints. Secondary endpoints were overall duration of cardiopulmonary bypass, debranching, limb ischemia, cardiac ischemia, cerebral perfusion, and amount of aortic coverage. RESULTS: No deaths at 30 days were recorded, and the major adverse event (grade ≥ 2) rate was 33% (11 patients) including 1 (3%) nondisabling stroke and 1 (2.9%) permanent spinal cord ischemic event. Proximal FET collar anastomosis were in zone 0 (68%) or zone 1 (32%). Median cardiopulmonary bypass duration was 165 minutes (range, 144-185), distal aortic ischemic time 38 minutes (range, 32-45), and cardiac ischemic time 74 minutes (range, 62-94). The time of distal aortic ischemia was shorter in nonobese patients (27 vs 49 minutes, P = .043) and in zone 0 (23 cases) vs zone 1 (11 cases) anastomosis (34 vs 42 minutes, P = .043). CONCLUSIONS: The FET procedure with debranch-first technique is safe and feasible and resulted in low mortality and morbidity rates. Further investigation is needed to compare it with standard techniques.