Urgent and emergent repair of complex aortic aneurysms using an off-the-shelf branched device.

Introduction: Endovascular repair using off-the-shelf endografts is a viable solution in patients with ruptured or symptomatic complex aortic aneurysms. This analysis aimed to present the peri-operative and follow-up outcomes in urgent and emergent cases managed with the t-Branch multibranched thoracoabdominal endograft. Methods: Prospectively collected data from all consecutive urgent and emergent cases managed in two aortic centers between January 1st, 2014, to November 30th, 2022, using the t-Branch device (Cook Medical Inc., Bjaeverskov, Denmark) were analyzed. Patients presenting with ruptured aortic complex aneurysms were characterized as emergent and patients with aneurysms >90 mm of diameter, or symptomatic aneurysms were characterized as urgent. Technical success, 30-day mortality, major adverse events (MAE) and spinal cord ischemia (SCI) rates were assessed. Results: 225 patients (36.5% females, 72.5 ± 2.8 years) were included; 73.0% were urgent. The mean aneurysm diameter was 109 ± 3.9 mm and 44.4% were type I-III TAAAs. Females (p = .03), para-renal aneurysms (p = .02) and ASA score IV (p < .001) were more common in emergent cases. Technical success was 97.8%. Thirty-day mortality and MAE rates were 17.8% and 30.6%, respectively. SCI rate was 14.7%, (4.8% paraplegia rate) with 22.2% of patients receiving prophylactic cerebrospinal drainage. Thirty-day mortality (13.3% vs. 26.7%, p = .04) and MAE (26.0% vs. 43.0%, p = .02) were more common among emergent cases while technical success (97.6% vs. 98.3%, p = .9), and SCI (13.3% vs. 18.3%, p = .4) were similar. Survival at 12-months was 83.5% (SE 5.9%) for the urgent and 77.1% (SE 8.2%) for the emergent group (log rank, p = 0.96). Conclusion: T-Branch represents an effective and safe solution for the management of urgent and emergent cases with complex aortic aneurysms, with high technical success, promising early mortality and SCI rates.

Evaluation of selected parameters of inflammation, coagulation system, and formation of extracellular neutrophil traps (NETs) in the perioperative period in patients undergoing endovascular treatment of thoracoabdominal aneurysm with a branched device (t-Branch).

Extracellular Neutrophils Traps (NETs) and their formation, known as NETosis, have become pivotal in the pathogenesis of aortic aneurysm development. This study investigates the NETosis markers with the assessment of selected parameters of inflammation and coagulation system in patients with thoracoabdominal aortic aneurysms in the pre-and postop period undergoing t-Branch stent-graft implantation. The study included 20 patients with thoracoabdominal aortic aneurysms. Three markers double-stranded DNA (dsDNA), single-stranded DNA (ssDNA), and citrullinated H3 histones (Cit-H3) were tested at three-time points from patients' blood. The parameters of NETosis, inflammation, and coagulation system were examined in the preoperative period (within 24 h before surgery) and in the postoperative period (on the 3rd and 5th postoperative day). Free-circulating DNA (cfDNA) was isolated from the blood using the MagMAXTM Cell-Free DNA Extraction Kit. Double-stranded DNA (dsDNA) and single-stranded DNA (ssDNA) were then quantified using the Qubit dsDNA HS Assay Kit and the Qubit ssDNA Assay Kit. Cit-H3 concentration was determined by enzyme immunoassay ELISA (Cayman). The results revealed the significance of NETs secretion in response to the complex processes after stent-graft implantation. All NET markers increased shortly after surgery, with histones being the first to return to preoperative levels. The lack of normalization of dsDNA and ssDNA levels to preoperative levels by the last postoperative blood collection demonstrates NETs reorganization. The increase in the number of neutrophils was not related to the expansion of postoperative NETosis. The study reveals a new marker of NETosis, ssDNA, that has not been studied so far. The implantation of a stent graft in a patient with TAAA triggers an inflammatory response manifested by an increase in inflammatory parameters. One of the hallmarks of inflammation is the activation of neutrophil extracellular traps.

Sex-Comparative Outcomes of the T-Branch Device for the Treatment of Complex Aortic Aneurysms.

INTRODUCTION: Females are at increased risk of mortality compared to males after complex endovascular aortic repair. This study aims to examine sex-related peri-operative and follow-up outcomes in patients managed with the t-Branch device. METHODS: A two-center retrospective analysis of patients managed with the off-the-shelf t-Branch device (Cook Medical Inc., Bjaeverskov, Denmark) between 1 January 2014 and 30 September 2020 was performed. Primary outcomes were sex-comparative 30-day mortality, major adverse events (MAEs) and spinal cord ischemia (SCI). RESULTS: A total of 542 patients were included; 28.0% were females. Urgent repair and type I-III thoracoabdominal aneurysms were more common among females (52.6% vs. 34%, p = 0.01, and 57.1% vs. 35.8%, p = 0.004). Technical success was similar (97.4% vs. 96.9%, p = 0.755), as well as early mortality (16.2% in females vs. 10.8% in males; p = 0.084). SCI rates were similar between groups (13.6% vs. 9.2% p = 0.183). MAEs were more common in females; 33.7% vs. 21.4% (p = 0.022). Multivariate analysis did not identify sex as an independent predictor of adverse events. The 12-month survival rate was 75.7% (SE 0.045) for females and 84.1% (SE 0.026) for males (log rank, p = 0.10). CONCLUSIONS: Sex was not detected as an independent factor of mortality, MAEs and SCI within patients managed with the t-Branch device. Feasibility was high in both groups. No significant difference was shown in survival during the 12-month follow-up.

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

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

Early and Mid-Term Outcomes of Females Treated with t-Branch off the Shelf Device.

BACKGROUND: Female sex has been characterized as a risk factor of increased mortality in patients managed for complex aortic aneurysm using endovascular means. This study aimed to present the perioperative and follow-up outcomes of females managed electively or urgently with the t-Branch device and investigate factors affecting the early outcomes. METHODS: A 2-center retrospective observational study was conducted including elective and urgent female patients managed with the t-Branch device (Cook Medical, Bjaeverskov, Denmark) for thoracoabdominal and pararenal aneurysms between January 1, 2018 and September 30, 2020. Primary early outcomes included technical success and 30-day mortality and morbidity [spinal cord ischemia (SCI) and acute kidney injury]. Follow-up survival and freedom from reintervention rates were assessed using Kaplan-Meier estimates. RESULTS: In total, 153 females were included; 81 (52.9%) treated urgently. Urgent patients were older (73.2 ± 8.6 vs. 68.5 ± 6.8 years; P < 0.001) and presented higher previous coronary angioplasty/stenting (16.0% vs. 5.6%, P = 0.005) and lower double antiplatelet therapy (DAPT, 46.3% vs. 53.7%, P = 0.04) rates. Technical success was 97.4%. Early mortality was 16.3% (22% in urgent; 12% in elective; P = 0.2) and SCI and acute kidney injury were diagnosed in 13.7% (11% in urgent; 16% in elective; P = 0.2) and 18.3% (22.2% in urgent; 13.9% in elective; P = 0.18), respectively. Multivariate regression analyses showed that DAPT and b-blockers were related to lower 30-day mortality. DAPT was also preventive for SCI. Survival rates were 68.4% [standard error (SE) 0.07] at 12 months for the urgent and 75.6% (SE 0.09) at 24 months for the elective group (P = 0.14). Freedom from reintervention rates were 81.4% (SE 0.06) at 6 months and 64.7% (SE 0.09) at 18 months for the urgent and 81.7% (SE 0.06) at 6 months and 75.4% (SE 0.081) at 18 months for the elective group (P = 0.94). CONCLUSIONS: Female patients managed with the t-Branch device for thoracoabdominal and pararenal aneurysms in elective and urgent setting presented similar 30-day mortality and SCI rates.

Comparison of single- and multistage strategies during fenestrated-branched endovascular aortic repair of thoracoabdominal aortic aneurysms.

OBJECTIVE: The aim of this study was to compare outcomes of single or multistage approach during fenestrated-branched endovascular aortic repair (FB-EVAR) of extensive thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of consecutive patients treated by FB-EVAR for extent I to III TAAAs in 24 centers (2006-2021). All patients received a single brand manufactured patient-specific or off-the-shelf fenestrated-branched stent grafts. Staging strategies included proximal thoracic aortic repair, minimally invasive segmental artery coil embolization, temporary aneurysm sac perfusion and combinations of these techniques. Endpoints were analyzed for elective repair in patients who had a single- or multistage approach before and after propensity score adjustment for baseline differences, including the composite 30-day/in-hospital mortality and/or permanent paraplegia, major adverse event, patient survival, and freedom from aortic-related mortality. RESULTS: A total of 1947 patients (65% male; mean age, 71 ± 8 years) underwent FB-EVAR of 155 extent I (10%), 729 extent II (46%), and 713 extent III TAAAs (44%). A single-stage approach was used in 939 patients (48%) and a multistage approach in 1008 patients (52%). A multistage approach was more frequently used in patients undergoing elective compared with non-elective repair (55% vs 35%; P < .001). Staging strategies were proximal thoracic aortic repair in 743 patients (74%), temporary aneurysm sac perfusion in 128 (13%), minimally invasive segmental artery coil embolization in 10 (1%), and combinations in 127 (12%). Among patients undergoing elective repair (n = 1597), the composite endpoint of 30-day/in-hospital mortality and/or permanent paraplegia rate occurred in 14% of single-stage and 6% of multistage approach patients (P < .001). After adjustment with a propensity score, multistage approach was associated with lower rates of 30-day/in-hospital mortality and/or permanent paraplegia (odds ratio, 0.466; 95% confidence interval, 0.271-0.801; P = .006) and higher patient survival at 1 year (86.9±1.3% vs 79.6±1.7%) and 3 years (72.7±2.1% vs 64.2±2.3%; adjusted hazard ratio, 0.714; 95% confidence interval, 0.528-0.966; P = .029), compared with a single stage approach. CONCLUSIONS: Staging elective FB-EVAR of extent I to III TAAAs was associated with decreased risk of mortality and/or permanent paraplegia at 30 days or within hospital stay, and with higher patient survival at 1 and 3 years.

Multicenter Study to Evaluate Endovascular Repair of Extent I-III Thoracoabdominal Aneurysms Without Prophylactic Cerebrospinal Fluid Drainage.

OBJECTIVE: To assess outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) of Extent I-III thoracoabdominal aortic aneurysms (TAAAs) without prophylactic cerebrospinal fluid drainage (CSFD). BACKGROUND: Prophylactic CSFD has been routinely used during endovascular TAAA repair, but concerns about major drain-related complications have led to revising this paradigm. METHODS: We reviewed a multicenter cohort of 541 patients treated for Extent I-III TAAAs by FB-EVAR without prophylactic CSFD. Spinal cord injury (SCI) was graded as ambulatory (paraparesis) or nonambulatory (paraplegia). Endpoints were any SCI, permanent paraplegia, response to rescue treatment, major drain-related complications, mortality, and patient survival. RESULTS: There were 22 Extent I, 240 Extent II and 279 Extent III TAAAs. Thirty-day mortality was 3%. SCI occurred in 45 patients (8%), paraparesis occurring in 23 (4%) and paraplegia in 22 patients (4%). SCI was more common in patients with Extent I-II compared with Extent III TAAAs (12% vs. 5%, P =0.01). Rescue treatment included permissive hypertension in all patients, with CSFD in 22 (4%). Symptom improvement was noted in 73%. Twelve patients (2%) had permanent paraplegia. Two patients (0.4%) had major drain-related complications. Independent predictors for SCI by multivariate logistic regression were sustained perioperative hypotension [odds ratio (OR): 4.4, 95% confidence interval (95% CI): 1.7-11.1], patent collateral network (OR: 0.3, 95% CI: 0.1-0.6), and total length of aortic coverage (OR: 1.05, 95% CI: 1.01-1.10). Patient survival at 3 years was 72%±3%. CONCLUSION: FB-EVAR of Extent I-III TAAAs without CSFD has low mortality and low rates of permanent paraplegia (2%). SCI occurred in 8% of patients, and rescue treatment improved symptoms in 73% of them.

Outcomes of Directional Branches of the T-Branch Off-the-Shelf Multi-Branched Stent-Graft.

BACKGROUND: A controversy on bridging covered stent (BCS) choice, between self-expanding (SECS) and balloon-expandable (BECS) stents, still exists in branched endovascular repair. This study aimed to determine the primary target vessel (TV) patency in patients treated with the t-Branch device and identify factors impairing the outcomes. METHODS: A retrospective study was undertaken, including patients treated with the t-Branch (Cook Medical, Bloomington, IN, USA) between 2014 and 2019 (early 2014-2016; late 2017-2019). The endpoint was the primary patency (CT: celiac trunk, SMA, superior mesenteric artery, RRA: right renal artery, LRA: left renal artery) during the follow-up. Any branch instability event was assessed. The factors affecting the patency were determined using multivariable regression models and Kaplan-Meier analyses. RESULTS: In total, 2018 TVs were analyzed; 1542 SECSs and 476 BECSs. The CT patency was 99.8% (SE 0.2%) at the 1st month, with no other event. The SMA patency was 97.8% (SE 1) at the 12th month. The RRA patency was 96.7% (SE 2) at the 24th month. The LRA patency was 99% (SE 0.4) at the 6th month. Relining was the only factor independently associated with the SMA patency (OR 8.27; 95% CI 1.4-4.9; p = 0.02). The freedom from instability was 62% (SE 4.3%) and 45% (SE 5.4%) at the 24th month and 36th month. No significant difference was identified between the BECSs and SECSs in the early or late experience. CONCLUSION: BCS for the t-Branch branches performed with a good primary patency during the short-term follow-up. The type of BCS did not influence the patency. Relining might be protective for SMA patency.

Platelet function changes in patients undergoing endovascular aortic aneurysm repair: Review of the literature.

Patients with abdominal aortic aneurysm (AAA) have a higher risk of cardiovascular (CV) events, which seems to be associated with disturbed platelet (PLT) function. Endovascular aneurysm repair (EVAR) is an emerging, less-invasive treatment alternative to surgical AAA repair. Both platelet function abnormalities in patients with AAA and the effect of EVAR on platelet function are poorly understood. In this review, we aim to fill the gap regarding the effect of EVAR on PLT function in AAA patients by discussing PLT function disturbances in patients with AAA, PLT function changes after EVAR, evidence from clinical studies regarding PLT function before and after EVAR, and antiplatelet or and antithrombotic treatment in patients undergoing EVAR. The goal of our review is to summarize the contemporary knowledge and initiate further studies to better understand PLT function changes in patients undergoing EVAR, optimize the pharmacotherapy before and after EVAR and further improve outcomes in this group of patients.

Five Year Outcomes in Patients with End Stage Renal Disease Who Received a Bioengineered Human Acellular Vessel for Dialysis Access.

OBJECTIVE: Patients with end stage renal failure who require haemodialysis suffer morbidity and mortality due to vascular access. Bioengineered human acellular vessels (HAVs) may provide a haemodialysis access option with fewer complications than other grafts. In a prospective phase II trial from 2012 to 2014 (NCT01744418), HAVs were implanted into 40 haemodialysis patients at three sites in Poland. The trial protocol for this "first in man" use of the HAV contemplated only two years of follow up, and the trial results were initially reported in 2016. In light of the retained HAV function seen in many of the patients at the two year time point, follow up for patients who were still alive was extended to a total of 10 years. This interim follow up report, at the long term time point of five years, assessed patient and conduit status in those who continued routine dialysis with the HAV. METHODS: HAVs are bioengineered by culturing human vascular smooth muscle cells on a biodegradable polymer matrix. In this study, patients with patent HAV implants at 24 months were followed every three months, starting at month 27 through to month 60, or at least five years post-implantation. This report contains the follow up functional and histological data on 29 of the original 40 patients who demonstrated HAV function at the 24 month time point. RESULTS: Eleven patients completed at month 60. One patient maintained primary patency, and 10 maintained secondary patency. Secondary patency was estimated at 58.2% (95% confidence interval 39.2-73.1) at five years, after censoring for deaths (n = 8) and withdrawals (n = 1). No HAV conduit infections were reported during the follow up period. CONCLUSION: This phase II long term follow up shows that the human acellular vessel (HAV) may provide durable and functional haemodialysis access for patients with end stage renal disease.

Pre-operative platelet reactivity is a strong, independent predictor of bleeding complications after branched endovascular thoracoabdominal aortic aneurysm repair.

Endovascular aortic repair (EVAR) an alternative to open surgical repair of thoracoabdominal aortic aneurysm (TAAA). The effect of EVAR on platelet reactivity is unknown. We prospectively determined the effect of branched EVAR (bEVAR) on platelet reactivity in patients with TAAA, and evaluated the predictive value of preoperative platelet reactivity for post-operative bleeding in 50 consecutive patients undergoing elective bEVAR (mean age 70.9 ± 5.7 years, 66% male). Blood samples were collected within 24 hours before bEVAR, after bEVAR and at hospital discharge. Platelet reactivity was assessed with impedance aggregometry using ASPI, ADP and TRAP tests. Platelet reactivity decreased within 24 hours after bEVAR compared to the measurement before bEVAR in all tests (p ≤ 0.04), with a further decrease in hospital discharge in the ADP test (p = .004). Twenty-three patients experienced post-operative bleeding complications (transfusion ≥2 red blood cell [RBC] units). Preoperative platelet reactivity below the cutoff value of 30 AUC units predicted post-operative bleeding with 78% sensitivity and 59% specificity (p = .045). In the multivariable analysis, platelet reactivity was the only independent predictor of postoperative bleeding (OR 6.507, 95% CI 1.227-34.506, p = .028). We conclude that platelet reactivity decreases following bEVAR of TAAA and is a strong and independent predictor for postoperative bleeding complications.

Outcomes of off-the-shelf multibranched stent grafts with intentional occlusion of directional branches using endovascular plugs during endovascular repair of complex aortic aneurysms.

OBJECTIVE: To evaluate the technique and outcomes of intentional occlusion of directional branches (DBs) using endovascular plugs during branched endovascular aortic repair using off-the-shelf Zenith t-Branch thoracoabdominal (TAAA) stent grafts. METHODS: We reviewed the clinical data and outcomes of all consecutive patients treated by branched endovascular aortic repair using off-the-shelf Zenith t-Branch TAAA stent-graft (Cook Medical, Bloomington, Ind) in seven academic centers from 2013 to 2019. All patients had at least one DB intentionally occluded using extension of the branch with balloon or self-expandable covered stent, followed by placement of endovascular plugs. Intentional occlusion was indicated in patients with variations in the normal four-vessel renal-mesenteric anatomy, pre-existing dialysis, or in those who failed catheterization of a target vessel. End points were 30-day/in-hospital mortality, major adverse events, secondary interventions, target artery (TA) patency, TA instability, and patient survival. RESULTS: There were 100 patients, 65 male and 35 female, with median age of 71 years (interquartile range [IQR], 66-75 years). Of these, 31 patients (31%) had urgent/emergent operations for symptomatic/contained ruptured aneurysms. The median aneurysm diameter was 72 mm (IQR, 61-85 mm). A total of 290 renal-mesenteric arteries were incorporated with a median of three (IQR, 3-3) vessels/patient. Indications for DB occlusion were less than four suitable renal-mesenteric targets in 84 patients or pre-existing dialysis and inability to catheterize a target vessel in eight patients each. There were 110 DBs occluded by vascular plugs, including 48 celiac axis, one superior mesenteric artery, and 61 renal DBs. Thirty-day/in-hospital mortality was 10%, including 9% for elective and 13% for urgent/emergent procedures. Major adverse events occurred in 44 patients (44%), including acute kidney injury in 19 patients (19%), estimated blood loss >1 L in 12 patients (12%), respiratory failure and new onset dialysis in six patients (6%) each, bowel ischemia in five patients (5%), and myocardial infarction and paraplegia in two patients (2%) each. The median follow-up was 5 months (range, 1-13 months). Eighteen patients (18%) required secondary interventions, none for problems related to the occluded DB. There were no endoleaks related to the occluded DB. At 2 years, primary and secondary patency and freedom from TA instability were 93% ± 3%, 97% ± 2%, and 91% ± 4%, respectively. Freedom from secondary interventions and patient survival were 75% ± 6% and 63% ± 7%, respectively. CONCLUSIONS: Intentional occlusion of DBs using endovascular plugs allows versatile use of a four-vessel off-the-shelf multi-branched TAAA stent graft in patients with variations in the normal renal and mesenteric anatomy or when technical difficulties prevent successful target vessel stenting. There were no endoleaks or secondary interventions associated with the occluded DB.

A Review of the Impact of Neutrophils and Neutrophil Extracellular Traps (NETs) on the Development of Aortic Aneurysms in Animal and Human Studies.

The pathogenesis of the aortic aneurysm (AA) includes several mechanisms, such as chronic sterile inflammation and homeostasis imbalance, with arteriosclerosis, hemodynamic forces, and genetic factors. In addition to the roles of these processes in the development of AA, neutrophilic activity may play a pivotal role (mostly in inflammation and thrombus formation). Neutrophils, which play a crucial role in innate immunity, can release neutrophil extracellular traps (NETs), one of the mechanisms against fighting pathogens, beside phagocytosis and degranulation. NETs are structures composed of nuclear elements (eg, chromatin and modified histones) and granular and cytoplasmic components, which can lead to inflammation and coagulation changes. In addition, the exacerbation of NETosis (the process of NET formation) can be noticed in vascular diseases, including in the development of AA and myocardial infarction and in diabetes, hypertension, and COPD, which are the risk factors of the presence of AA. The discharge of NETs, which are extracellular materials formed by citrullinated histones (Cit-H), cell-free DNA fibers (cf-DNA), and granular and cytoplasmic molecules, is a newly identified method of neutrophil activation that can be activated by endogenous inflammatory stimuli, which contribute to AA development. Cit-H and cf-DNA can be used as biomarkers of AA growth. By understanding the neutrophilic influence of NET release, a new pathway of screening AA growth (by measurement of biomarkers of NETosis) and pharmacological assessment (by repression of NET formation) can be developed. This review summarizes the current knowledge about the influence of NETs on AA growth in human and animal studies.

Early outcomes of the t-Branch off-the-shelf multi-branched stent graft in 542 patients for elective and urgent aortic pathologies: A retrospective observational study.

OBJECTIVE: The t-Branch, a standardized off-the-shelf multi-branched stent graft has been used for the treatment of elective and urgent cases in aortic disease. The aim of this study was to assess the early outcomes in terms of technical success, mortality, and morbidity in >500 patients being treated with the t-Branch device. METHODS: A two-center retrospective observational study was undertaken including patients treated using the t-Branch (Cook Medical, Bloomington, IN) in elective or urgent settings for complex abdominal aortic aneurysm and thoraco-abdominal aortic aneurysm between 2014 and 2019 (early experience 2014-2016; late experience 2017-2019). Primary endpoints were technical success and early (30-day) mortality, and secondary endpoints were early morbidity, endoleak, and target vessel patency rates. Multivariable regression models were used to determine the independent association of risk factors with (1) mortality and (2) spinal cord ischemia. RESULTS: A total of 542 patients (mean age, 70.5 ± 8.5 years; 388 men [72%]; mean aneurysm diameter, 7.5 ± 2.5 cm) were included (63% elective; 90% thoraco-abdominal aortic aneurysm). The technical success rate was 97% (526/542) (elective, 96.7% [328/339] vs urgent, 97.6% [208/213]). The total 30-day mortality rate was 12.3% (8.5% in elective, 15% in symptomatic, and 30% in contained rupture). After multivariate regression analysis, the mortality rate was associated with older age (odds ratio [OR], 1.07; 95% confidence interval [CI], 1.03-1.11; P < .001) and with lower baseline glomerular filtration rate (OR, 0.98; 95% CI, 0.98-0.99; P < .001). In elective cases, the mortality rate was associated with a history of coronary artery disease (OR, 0.26; 95% CI, 0.09-0.73; P < .011) and higher body mass index (OR, 0.87; 95% CI, 0.77-0.98; P < .027). In urgent cases, the mortality rate was associated with older age, (OR, 1.07; 95% CI, 1.02-1.13; P < .010) and lower baseline glomerular filtration rate (OR, 0.97; 95% CI, 0.95-0.99; P < .001). The spinal cord ischemia rate was 10.5% (6.5% temporary, 4% permanent) and was associated with the early study period (OR, 2.01; 95% CI, 1.03-3.89; P < .038). The renal impairment rate was 13%, the stroke rate was 2.5%, and the myocardial infarction rate was 1.8%, whereas the access complications rate was 7.7%. On early computed tomography angiography, the primary patency rate for the right renal artery was 99.6%, for the left renal artery was 100%, for the superior mesenteric artery was 99.4%, and for the coeliac trunk was 99.8%. The endoleak I and III rates were 2.7% (15/542) and 2.7% (15/542), respectively. CONCLUSIONS: Elective and urgent use of the t-Branch multi-branched off-the shelf stent graft showed high technical success and early target vessel patency rates. Early mortality and morbidity rates were acceptable.

Multicenter global early feasibility study to evaluate total endovascular arch repair using three-vessel inner branch stent-grafts for aneurysms and dissections.

OBJECTIVE: We evaluated the outcomes of total endovascular aortic arch repair using three-vessel inner branch stent-grafts for aneurysms and chronic dissections. METHODS: We reviewed the clinical data and outcomes of consecutive patients treated by total endovascular aortic arch repair at eight academic centers using three-vessel inner branch stent-grafts (William Cook Europe, Bjaeverskov, Denmark) from 2016 to 2019. All patients received three-vessel designs with two antegrade and one retrograde inner branch, which was used to incorporate the innominate, left common carotid, and left subclavian arteries. The antegrade inner branches were accessed via a carotid or an upper extremity approach. A preloaded catheter was used for access to the retrograde left subclavian artery branch via a transfemoral approach. The endpoints were technical success, mortality, major adverse events, any stroke (minor or major) or transient ischemia attack, secondary interventions, target vessel patency, target vessel instability, aneurysm-related mortality, and patient survival. RESULTS: A total of 39 patients (31 men [79%]; mean age, 70 ± 7 years) had undergone treatment of 14 degenerative (36%) and 25 chronic (64%) postdissection arch aneurysms. The clinical characteristics included American Society of Anesthesiologists class ≥III in 28 patients (95%) and previous median sternotomy for ascending aortic repair in 28 patients (72%). The technical success rate was 100%. Two patients had died in-hospital or within 30 days (5%), and two patients had experienced a stroke (one minor). The combined mortality and any stroke rate was 8% (n = 3). Major adverse events occurred in 10 patients (26%), including respiratory failure in 4 (10%) and estimated blood loss >1 L, myocardial infarction, and acute kidney injury in 2 patients each (5%). The median follow-up was 3.2 months (interquartile range, 1-14 months). Of the 39 patients, 12 (31%) required secondary interventions to treat vascular access complications in 5, endoleak in 6 (three type II, one type Ic, one type Ia/Ib, one type IIIa), and target vessel stenosis in 1 patient. At 1 year, the primary and secondary patency rates and freedom from target vessel instability were 95% ± 5%, 100%, and 91% ± 5%, respectively. Freedom from aortic-related mortality and patient survival was 94% ± 4% and 90% ± 6%, respectively. CONCLUSIONS: The findings from the present multicenter global experience have demonstrated the technical feasibility and safety of total endovascular aortic arch repair for aneurysms and chronic dissections using three-vessel inner branch stent-grafts. The mortality and stroke rates compare favorably with those after open surgical repair in a higher risk group of patients. However, the rate of secondary interventions was high (31%), emphasizing need for greater experience and longer follow-up.

Bioengineered human acellular vessels for dialysis access in patients with end-stage renal disease: two phase 2 single-arm trials.

BACKGROUND: For patients with end-stage renal disease who are not candidates for fistula, dialysis access grafts are the best option for chronic haemodialysis. However, polytetrafluoroethylene arteriovenous grafts are prone to thrombosis, infection, and intimal hyperplasia at the venous anastomosis. We developed and tested a bioengineered human acellular vessel as a potential solution to these limitations in dialysis access. METHODS: We did two single-arm phase 2 trials at six centres in the USA and Poland. We enrolled adults with end-stage renal disease. A novel bioengineered human acellular vessel was implanted into the arms of patients for haemodialysis access. Primary endpoints were safety (freedom from immune response or infection, aneurysm, or mechanical failure, and incidence of adverse events), and efficacy as assessed by primary, primary assisted, and secondary patencies at 6 months. All patients were followed up for at least 1 year, or had a censoring event. These trials are registered with ClinicalTrials.gov, NCT01744418 and NCT01840956. FINDINGS: Human acellular vessels were implanted into 60 patients. Mean follow-up was 16 months (SD 7·6). One vessel became infected during 82 patient-years of follow-up. The vessels had no dilatation and rarely had post-cannulation bleeding. At 6 months, 63% (95% CI 47-72) of patients had primary patency, 73% (57-81) had primary assisted patency, and 97% (85-98) had secondary patency, with most loss of primary patency because of thrombosis. At 12 months, 28% (17-40) had primary patency, 38% (26-51) had primary assisted patency, and 89% (74-93) had secondary patency. INTERPRETATION: Bioengineered human acellular vessels seem to provide safe and functional haemodialysis access, and warrant further study in randomised controlled trials. FUNDING: Humacyte and US National Institutes of Health.

Hand-assisted laparoscopic donor nephrectomy: a single centre experience.

INTRODUCTION: The advantages of a minimally invasive nephrectomy are a faster recovery and better quality of life for the donors. Until recently, the majority of donor nephrectomies in Poland were done by open surgery. AIM: To present a single centre experience in hand-assisted laparoscopic donor nephrectomy (HALDN). MATERIAL AND METHODS: The first videoscopic left donor nephrectomy in Poland was performed in our department in 2003 using a hand-assisted retroperitoneal approach. From 2011, we changed the method to a transperitoneal approach and started to harvest also right kidneys. Since then, it has become the method of choice for donor nephrectomy and has been performed in 59 cases. Preoperatively, kidneys were assessed by scintigraphy and by angio-computed tomography. We harvested 32 left and 27 right kidneys. There were double renal arteries in 2 cases and triple renal arteries in 1 case. The warm ischaemia time (WIT) was 80-420 s (average 176.13 s); operative time was 85-210 min (average 140 min). RESULTS: All procedures were uncomplicated, and all donors were discharged after 2-8 days with normal creatinine levels. The average follow-up period lasted 23 months (1-51 months). Out of all of the cases, 1 case had two minor complications, while all others were uneventful. None of the donors were lost to follow-up. All of the kidneys were transplanted. There were 2 cases of delayed graft function (DGF) and 2 cases of ureter necrosis. One of those kidneys was lost in the third postoperative week. CONCLUSIONS: Our limited experience shows that HALDN is a safe method and should be used routinely instead of open surgery.