The Society for Vascular Surgery® pursued development of clinical practice guidelines for the management of traumatic thoracic aortic injuries with thoracic endovascular aortic repair. In formulating ...clinical practice guidelines, the Society selected a panel of experts and conducted a systematic review and meta-analysis of the literature. They used the Grading of Recommendations Assessment, Development and Evaluation methods (GRADE) to develop and present their recommendations. The systematic review included 7768 patients from 139 studies. The mortality rate was significantly lower in patients who underwent endovascular repair, followed by open repair, and nonoperative management (9%, 19%, and 46%, respectively, P < .01). Based on the overall very low quality of evidence, the committee suggests that endovascular repair of thoracic aortic transection is associated with better survival and decreased risk of spinal cord ischemia, renal injury, graft, and systemic infections compared with open repair or nonoperative management (Grade 2, Level C). The committee was also surveyed on a variety of issues that were not specifically addressed by the meta-analysis. On these select matters, the majority opinions of the committee suggest urgent repair following stabilization of other injuries, observation of minimal aortic defects, selective (vs routine) revascularization in cases of left subclavian artery coverage, and that spinal drainage is not routinely required in these cases.
This study reports the technical aspects and 30-day outcomes of the prospective, multicenter early feasibility study designed to evaluate the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis ...(TAMBE; W. L. Gore & Associates, Flagstaff, Ariz).
Thirteen patients with pararenal or extent IV thoracoabdominal aortic aneurysms were prospectively enrolled at five U.S sites and one non-U.S. site from 2014 to 2016. The TAMBE included four portals with either retrograde or antegrade renal portal configuration and used GORE VIABAHN Balloon-Expandable Endoprosthesis (W. L. Gore & Associates) for stenting of the renal and mesenteric arteries. The primary end point was procedural safety at 30 days, defined by absence of major adverse events, including any-cause mortality, myocardial infarction, stroke, paraplegia, bowel ischemia, respiratory failure, severe acute kidney injury (>50% decline in estimated glomerular filtration rate), dialysis, and procedural blood loss >1000 mL.
There were 11 male and two female patients with a mean age of 69 ± 8 years. Mean aneurysm diameter was 61 ± 13 mm. A total of 52 renal and mesenteric arteries were incorporated (4 vessels/patient). Technical success was achieved in 12 patients (92%). One patient had inadvertent occlusion of a right renal artery due to dissection. There was no mortality, aneurysm rupture, conversion to open repair, dialysis, or spinal cord injury. Mean length of hospital stay was 5 ± 3 days. At 30 days, four patients (31%) had major adverse events, all due to procedural blood loss >1000 mL. One patient had a type I endoleak at the distal renal branch, which was successfully treated by placement of an additional renal stent before dismissal. Computed tomography angiography at 30 days showed patent target vessels and no type I or type III endoleak.
This study confirms the early feasibility of the TAMBE for treatment of pararenal and extent IV thoracoabdominal aortic aneurysms. The high technical success, no mortality, and low morbidity rate support continuation of clinical investigation in a larger population of patients.
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Failure of infrarenal endovascular aneurysm repair (EVAR) due to loss of proximal seal is increasingly common. Open surgical conversion can be challenging and has been associated with significant ...morbidity and mortality. The aim of this study was to evaluate the use of fenestrated-branched EVAR (F/BEVAR) for the treatment of patients with prior EVAR failure.
Consecutive patients enrolled as part of the Aortic Research Consortium in six prospective, nonrandomized, physician-sponsored investigational device exemption studies evaluating F/BEVAR between 2012 and 2018 were included in this study. The cohort was stratified according to whether the F/BEVAR procedure was performed after EVAR failure. Demographics, operative details, perioperative complications, and length of stay were compared between groups. Postprocedural survival, type I or type III endoleak, target artery patency, target artery instability, and reintervention rates were calculated using Kaplan-Meier method and compared between groups.
A total of 893 patients underwent F/BEVAR; 161 (18%) were treated after failed EVAR and 732 (82%) were treated without prior EVAR. Patients with failed EVAR were more often men (84% vs 66%; P < .01) with larger aneurysms (6.9 cm vs 6.4 cm; P < .01). There were no differences in aneurysm extent (P = .20) between groups; for the entire cohort, there were 19% juxtarenal, 9.2% suprarenal, and 72% thoracoabdominal aneurysms. The average number of targeted arteries per patient was 3.6 in both groups. The procedural technical success (99% vs 97%; P = .15) did not differ between groups, but radiation dose (4750 vs 2920 mGy; P = .02), dose-area product (154,572 vs 82,842 mGy·cm2; P < .01), and operative time (5.2 vs 4.6 hours; P < .01) were significantly higher in the failed EVAR group. Median intensive care unit length of stay (2.9 days) and total length of stay (6.3 days) did not differ between groups. The 30-day mortality rate (failed EVAR, 2.5%; no EVAR, 1.1%; P = .25) and 30-day major adverse event rates did not differ between groups. Kaplan-Meier estimates of freedom from type I or type III endoleak (91.9% vs 92.5%; P = .65), target artery patency (97.3% vs 97.0%; P = .91), freedom from target artery instability (86.3% vs 88.8%; P = .53), and freedom from reintervention at 1 year (84.7% vs 88.7%; P = .10) did not differ between the failed EVAR and no EVAR groups, respectively. One-year survival was decreased in the failed EVAR group (86.3% vs 91.9%; P = .02), but this effect did not persist on multivariable analysis (hazard ratio, 1.52; 95% confidence interval, 0.88-2.62; P = .14).
In this multicenter study, F/BEVAR was safe and effective in patients with prior failed EVAR, with nearly identical outcomes to those of patients without prior EVAR. However, differences in procedural metrics indicate higher level of technical challenge in performing F/BEVAR in patients with prior failed EVAR.
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We evaluated the outcomes of total endovascular aortic arch repair using three-vessel inner branch stent-grafts for aneurysms and chronic dissections.
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.
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.
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.
Abdominal aortic aneurysms (AAAs) are focal dilations of the aorta that develop from degenerative changes in the media and adventitia of the vessel. Ruptured AAAs have a mortality of up to 85%, thus ...it is important to identify patients with AAA at increased risk for rupture who would benefit from increased surveillance and/or surgical repair. Although the exact genetic and epigenetic mechanisms regulating AAA formation are not completely understood, Mendelian cases of AAA, which result from pathologic variants in a single gene, have helped provide a basic understanding of AAA pathophysiology. More recently, genome wide associated studies (GWAS) have identified additional variants, termed single nucleotide polymorphisms, in humans that may be associated with AAAs. While some variants may be associated with AAAs and play causal roles in aneurysm pathogenesis, it should be emphasized that the majority of SNPs do not actually cause disease. In addition to GWAS, other studies have uncovered epigenetic causes of disease that regulate expression of genes known to be important in AAA pathogenesis. This review describes many of these genetic and epigenetic contributors of AAAs, which altogether provide a deeper insight into AAA pathogenesis.
To report the outcomes of patients enrolled in a physician-sponsored investigational device exemption trial for endovascular treatment of complex thoracoabdominal aortic aneurysms with fenestrated ...and/or branched devices.
This study represents a retrospective analysis of a prospectively maintained database of patients enrolled in a physician-sponsored investigational device exemption trial for endovascular treatment of complex thoracoabdominal aneurysms between July 2012 and July 2017. Subjects included high-risk patients for open repair and patients with unsuitable anatomy for either standard endovascular aneurysm repair or Zenith (Cook Medical, Bloomington, Ind) fenestrated device. Aneurysm classification was based upon Crawford classification. We included the pararenal and paravisceral aneurysms in the type IV aneurysm group, because the repair of these aneurysms usually involved treatment of all four visceral branches. The endografts implanted were custom manufactured devices or off-the-shelf devices based on the Cook Zenith platform. Variables analyzed included preoperative demographics and comorbidities, anatomic aneurysmal characteristics, procedural details, and perioperative complications.
One -hundred fifty patients with a mean age of 71 ± 7.9 years were treated; 69% were male. Tobacco use (93%) and hypertension (91%) were the most common risk factors. Fifty-seven patients (38%) had a history of previous aortic repair. The mean aneurysm diameter was 62 ± 12 mm and 14 (9%) aneurysms were associated with chronic dissection. A total of 573 visceral vessels were incorporated (celiac artery/superior mesenteric artery 287 vessels, renal arteries 275 vessels, and 11 additional vessels) and 539 were stented. The celiac artery/superior mesenteric artery received a fenestrated design in 76.1% of cases. Branch designs were used in the renal artery in 13.2%, with the remainder treated with fenestrations. Spinal cord drainage was used in 51% of patients (76/150). The mean operative time, fluoroscopy time, and estimated blood loss were 283 ± 89 minutes, 83 ± 38 minutes, and 417 ± 404 mL, respectively. There were five patients (3.3%) with intraoperative complications, resulting in one intraoperative death. The early mortality was 2.7% (4/150). Major complications included respiratory failure in 7% (10/150), stroke and myocardial infarction in 0.7% each (1/150), and paraplegia in 2.7% (4/150). Acute kidney injury occurred in 4.7% of patients (7/150), two of whom required temporary dialysis. Thirty-nine percent of patients experienced at least one complication. Early branch vessel patency was 99.8% (525/526). Survival, primary, and primary-assisted branch patency at 2 years of follow-up were 79%, 97%, and 99%, respectively.
Endovascular repair of complex aneurysms is safe and effective when performed in a high-volume center experienced in aortic disease management. Branch vessels patency and the low incidence of paraplegia and mortality support expanded use to treat most complex thoracoabdominal aortic aneurysms.
To report 5-year results of the prospective, multicenter study designed to evaluate the Zenith Fenestrated AAA Endovascular Graft (William A. Cook Australia, Brisbane, Australia) for juxtarenal ...abdominal aortic aneurysms (AAAs).
Sixty-seven patients (54 male, mean age 74 ± 8 years) were prospectively enrolled at 14 U.S. centers from 2005 to 2012. Fenestrated stent grafts were used in patients with infrarenal aortic neck lengths of 4 to 14 mm to target 178 renal-mesenteric arteries with a mean of 2.7 vessels per patient. At 5 years, 42 of the 67 patients completed the final study follow-up, with clinical examination obtained in 41 and computed tomography imaging in 39. Outcomes adjudicated by a clinical events committee included all-cause and aneurysm-related mortality, major adverse events, renal stent occlusion/stenosis, renal function changes and renal infarcts, aneurysm sac enlargement (>5 mm), device migration (≥10 mm), type I/III endoleak, and secondary interventions.
Median follow-up was 59.8 months (range, 0.1-67.5 months). There were seven deaths, including one (1.5%) within 30 days (procedure-related) and six beyond 30 days (not procedure-related in five, indeterminate in one). At 5 years, freedom from all-cause mortality was 88.8 ± 4.2% and freedom from aneurysm-related mortality was 96.8 ± 2.3%. There were no aneurysm ruptures or conversions to open surgery. Of the 129 renal arteries targeted by fenestrations, five (4%) occluded and 14 (11%) developed in-stent stenosis. Treatment included redo stenting/angioplasty in 13 vessels, renal artery bypass in 2 vessels, and failed thrombectomy in 1 vessel. Primary and secondary renal target patency was 82.7 ± 4.1% and 95.7 ± 2.1% at 5 years, respectively. Dialysis was required in one patient who had pre-existing chronic kidney disease. During the 5 years, there was 1 type IA endoleak (1.5%), 1 type IB endoleak (1.5%), 2 device migrations (3%), and 4 aneurysm sac enlargements (6%). Overall, 81% of patients had sac shrinkage at 5 years. Of 20 patients who underwent secondary interventions, 12 were for renal in-stent stenosis or occlusion, 7 were for endoleak, and 1 was for both indications. Freedom from secondary intervention was 63.5 ± 7.2% at 5 years.
These 5-year results confirm the safety and effectiveness of the Zenith Fenestrated AAA stent graft with no late graft- or aneurysm-related deaths. In-stent stenosis of bare metal renal stents was the most frequent indication for secondary intervention. The low rate of type IA endoleak, sac enlargement, and device migration support its use in patients with juxtarenal AAAs.
The Society for Vascular Surgery pursued development of clinical practice guidelines for the management of the left subclavian artery with thoracic endovascular aortic repair (TEVAR). In formulating ...clinical practice guidelines, the society selected a panel of experts and conducted a systematic review and meta-analysis of the literature. They used the grading of recommendations assessment, development, and evaluation (GRADE) method to develop and present their recommendations. The overall quality of evidence was very low. The committee issued three recommendations. Recommendation 1: In patients who need elective TEVAR where achievement of a proximal seal necessitates coverage of the left subclavian artery, we suggest routine preoperative revascularization, despite the very low-quality evidence (GRADE 2, level C). Recommendation 2: In selected patients who have an anatomy that compromises perfusion to critical organs, routine preoperative LSA revascularization is strongly recommended, despite the very low-quality evidence (GRADE 1, level C). Recommendation 3: In patients who need urgent TEVAR for life-threatening acute aortic syndromes where achievement of a proximal seal necessitates coverage of the left subclavian artery, we suggest that revascularization should be individualized and addressed expectantly on the basis of anatomy, urgency, and availability of surgical expertise (GRADE 2, level C).
The objective of this study was to analyze outcomes of fenestrated-branched endovascular aneurysm repair (F/BEVAR) for treatment of postdissection and degenerative thoracoabdominal aortic aneurysms ...(TAAAs).
We reviewed the clinical data of 240 patients with extent I to extent III TAAAs enrolled in seven prospective physician-sponsored investigational device exemption studies from 2014 to 2017. All patients had manufactured off-the-shelf or patient-specific fenestrated-branched stent grafts used to target 888 renal-mesenteric arteries with a mean of 3.7 vessels per patient. End points included mortality, major adverse events (any-cause mortality, stroke, paralysis, dialysis, myocardial infarction, respiratory failure, bowel ischemia, and estimated blood loss >1 L), technical success, target artery patency, target artery instability, occlusion or stenosis, endoleak, rupture or death, reintervention, and renal function deterioration.
There were 50 patients (21%) treated for postdissection TAAAs and 190 (79%) who had degenerative TAAAs. Postdissection TAAA patients were significantly younger (67 ± 9 years vs 74 ± 8 years; P < .001), were more often male (76% vs 52%; P = .002), and had more prior aortic repairs (84% vs 67%; P = .02) and larger renal (6.4 ± 1.2 mm vs 5.8 ± 0.9 mm; P < .001) and mesenteric (8.9 ± 1.7 mm vs 7.8 ± 1.4 mm; P < .001) target artery diameters. There was no difference in aneurysm diameter (66 ± 13 mm vs 67 ± 11 mm; P = .50), extent I or extent II TAAA classification (64% vs 56%; P = .33), and length of supraceliac coverage (22 ± 9.5 cm vs 20 ± 10 cm; P = .38) between postdissection and degenerative patients, respectively. Preloaded guidewire systems (66% vs 43%; P = .003) and fenestrations as opposed to directional branches (58% vs 24%; P < .001) were used more frequently to treat postdissection patients. Technical success was 100% for postdissection TAAAs and 99% for degenerative TAAAs (P = .14). At 30 days, there was no difference in mortality (2% postdissection, 3% degenerative), major adverse events (24% postdissection, 26% degenerative; P = .73), spinal cord injury (6% postdissection, 12% degenerative; P = .25), paraplegia (2% postdissection, 7% degenerative; P = .19), and dialysis (0% postdissection, 5% degenerative; P = .24). Mean follow-up was 14 ± 12 months. Endoleaks were significantly more frequent in patients with postdissection TAAAs (76%) compared with degenerative TAAAs (43%; P < .001). At 2 years, there was no difference in patient survival (84% ± 7% vs 72% ± 4%; P = .13), freedom from aorta-related death (98% ± 2% vs 94% ± 2%; P = .45), primary (95% ± 2% vs 97% ± 1%; P = .93) and secondary target artery patency (99% ± 1% vs 98% ± 1%; P = .48), target artery instability (89% ± 3% vs 91% ± 1%; P = .17), and freedom from reintervention (58% ± 10% vs 67% ± 5%; P = .23) for postdissection and degenerative TAAAs, respectively.
Despite minor differences in demographics, anatomic factors, and stent graft design, F/BEVAR was safe and effective with nearly identical outcomes in patients with postdissection and degenerative TAAAs. Larger clinical experience and longer follow-up are needed to better evaluate differences in mortality, spinal cord injury, target artery instability, and reintervention.
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).
...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.
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.
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.
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