Multicenter Study on Physician-Modified Endografts for Thoracoabdominal and Complex Abdominal Aortic Aneurysm Repair.

BACKGROUND: Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal aortic aneurysm, however, previous data are limited to small single center studies and robust data on safety and effectiveness of PMEGs are lacking. We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. METHODS: An international multicenter single-arm cohort study was performed analyzing the outcomes of PMEGs in the treatment of elective, symptomatic, and ruptured complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. Variables and outcomes were defined according to the Society for Vascular Surgery reporting standards. Device modification and procedure details were collected and analyzed. Efficacy outcomes included technical success and safety outcomes included major adverse events and 30-day mortality. Follow-up outcomes included reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. Multivariable analysis was performed aiming at identifying predictors of technical success, 30-day mortality, and major adverse events. RESULTS: Overall, 1274 patients were included in the study from 19 centers. Median age was 74 (IQR, 68-79), and 75.7% were men; 45.7% were complex abdominal aortic aneurysms, and 54.3% were thoracoabdominal aortic aneurysms; 65.5% patients presented electively, 24.6% were symptomatic, and 9.9% were ruptured. Most patients (83.1%) were submitted to a fenestrated repair, 3.6% to branched repair, and 13.4% to a combined fenestrated and branched repair. Most patients (85.8%) had ≥3 target vessels included. The overall technical success was 94% (94% in elective, 93.4% in symptomatic, and 95.1% in ruptured cases). Thirty-day mortality was 5.8% (4.1% in elective, 7.6% in symptomatic, and 12.7% in ruptured aneurysms). Major adverse events occurred in 25.2% of cases (23.1% in elective, 27.8% in symptomatic, and 30.3% in ruptured aneurysms). Median follow-up was 21 months (5.6-50.6). Freedom from reintervention was 73.8%, 61.8%, and 51.4% at 1, 3, and 5 years; primary target vessel patency was 96.9%, 93.6%, and 90.3%. Overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6%, and 55.0%/89.1% at 1, 3, and 5 years. CONCLUSIONS: PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data and future prospective studies are needed for more robust and detailed analysis.

Distal Repair After Total Aortic Arch Replacement With Frozen Elephant Trunk in Patients With Chronic Multilevel Thoracic Aortic Disease.

OBJECTIVE: To examine the management of distal aortic disease after total arch replacement with the frozen elephant trunk (TAR + FET) in patients with chronic thoracic aortic disease. METHODS: Two centre retrospective study of consecutive patients treated between January 2010 and December 2019. The primary endpoint was 30 day or in hospital death. The secondary endpoint was midterm survival. Data are presented as median (interquartile range [IQR]). The χ2 or Fisher's exact test was used as appropriate. Estimated survival (standard error) was assessed by calculating the Kaplan-Meier product limit estimator with right censoring of survival data. A p value of < .050 was considered statistically significant. STROBE guidelines were followed. RESULTS: A total of 158 patients (72 men; median age 70 years, IQR 64, 75; median distal aortic diameter 58 mm, IQR 46, 68; 127 aneurysmal disease, 31 chronic dissection) underwent TAR + FET. The peri-operative mortality rate was 10.1% (9/107 elective, 7/51 non-elective). Of 74 (46.8%) patients with a primary distal seal, seven (9.5%) died peri-operatively, the distal seal was maintained during follow up in 51, nine underwent late distal repair (two planned, seven unplanned; one open, eight endovascular; one peri-operative death) with a median interval to unplanned repair of 777 days (IQR 462, 1480), and seven with loss of seal had no intervention. Distal seal failed in 2/28 (7%) patients with a distal seal length > 30 mm and device oversizing > 10%, compared with 12/39 (31%) patients who did not meet these criteria (p = .031). In 84 patients without a primary distal seal, nine (10.7%) died peri-operatively, the distal aorta remained below the size threshold for repair during follow up in 12 patients, 44 had distal repair (median aortic diameter 64 mm, IQR 60, 75; eight open, one hybrid, 35 endovascular repairs; no deaths) at a median of 256 days (IQR 135, 740), and 19 did not have distal repair at the end of the follow up period: six died before planned repair at a median interval of 115 days (IQR 85, 120); eight were considered unfit; one was assessed as fit but declined; and four patients were awaiting assessment. Median follow up was 46 months (IQR 26, 75): no patients were lost to follow up. Estimated ± standard error five year survival was 61.5 ± 4.1%: elective 70.6 ± 4.7%, non-elective 43.2 ± 7.2%. CONCLUSION: TAR + FET achieved primary distal seal in 47% of patients, but late failure occurred in 21%. Distal repair was ultimately indicated in 84% of survivors without a primary distal seal and of these 70% underwent repair, almost 10% died before planned repair, and 13% were considered unfit. Earlier distal endovascular repair and better assessment of patient fitness may improve midterm outcomes.

The Complementary Roles of Open and Endovascular Repair of Extent I - III Thoraco-abdominal Aortic Aneurysms in a United Kingdom Aortic Centre.

OBJECTIVE: A multidisciplinary approach offering both open surgical repair (OSR) and complex endovascular aortic repair (cEVAR) is essential if patients with thoraco-abdominal aortic aneurysms (TAAAs) are to receive optimal care. This study reports early and midterm outcomes of elective and non-elective OSR and cEVAR for extent I - III TAAA in a UK aortic centre. METHODS: Retrospective study of consecutive patients treated between January 2009 and December 2021. Primary endpoint was 30 day/in hospital mortality. Secondary endpoint was Kaplan-Meier estimates of midterm survival. Data are presented as median (interquartile range [IQR]). RESULTS: In total, 296 patients (176 men; median age 71 years [IQR 65, 76]; median aneurysm diameter 66 mm [IQR 61, 75]) underwent repair (222 elective, 74 non-elective). OSR patients (n = 66) were significantly younger with a higher incidence of heritable disease and chronic dissection, while cEVAR patients (n = 230) had a significantly higher prevalence of coronary, pulmonary, and renal disease. Overall, in hospital mortality after elective and non-elective repair was 3.2% (n = 7) and 23.0% (n = 17), respectively, with no significant difference between treatment modalities (elective OSR 6.5% vs. cEVAR 2.3%, p = .14; non-elective OSR 25.0% vs. cEVAR 20.3%, p = .80). Major non-fatal complications occurred in 15.3% (33/215) after elective repair (OSR 39.5%, 17/43, vs. cEVAR 9.3%, 16/172; p < .001) and 14% (8/57) after non-elective repair (OSR 26.7%, 4/15, vs. cEVAR 9.5%, 4/42; p = .19). Median follow up was 52 months (IQR 23, 78). Estimated survival ± standard error at 1, 3, and 5 years for the entire cohort was 89.6 ± 2.0%, 76.6 ± 2.9%, and 69.0% ± 3.2% after elective repair, and 67.6 ± 5.4%, 52.1 ± 6.0%, and 41.0 ± 6.2% after non-elective repair. There was no difference in 5 year survival comparing modalities after elective repair for patients younger than 70 years and those with post-dissection aneurysms. CONCLUSION: A multidisciplinary approach offering OSR and cEVAR can deliver comprehensive care for extent I - III TAAA with low early mortality and good midterm survival. Further studies are required to determine the optimal complementary roles of each treatment modality.

Multicentre International Registry of Open Surgical Versus Percutaneous Upper Extremity Access During Endovascular Aortic Procedures.

OBJECTIVE: To investigate access failure (AF) and stroke rates of aortic procedures performed with upper extremity access (UEA), and compare results of open surgical vs. percutaneous UEA techniques with closure devices. METHODS: A physician initiated, multicentre, ambispective, observational registry (SUPERAXA - NCT04589962) was carried out of patients undergoing aortic procedures requiring UEA, including transcatheter aortic valve replacement, aortic arch, and thoraco-abdominal aortic endovascular repair, pararenal parallel grafts, renovisceral and iliac vessel repair. Only vascular procedures performed with an open surgical or percutaneous (with a suture mediated vessel closure device) UEA were analysed. Risk factors and endpoints were classified according to the Society for Vascular Surgery and VARC-3 (Valve Academic Research Consortium) reporting standards. A logistic regression model was used to identify AF and stroke risk predictors, and propensity matching was employed to compare the UEA closure techniques. RESULTS: Sixteen centres registered 1 098 patients (806 men [73.4%]; median age 74 years, interquartile range 69 - 79 years) undergoing vascular procedures using open surgical (76%) or percutaneous (24%) UEA. Overall AF and stroke rates were 6.8% and 3.0%, respectively. Independent predictors of AF by multivariable analysis included pacemaker ipsilateral to the access (odds ratio [OR] 3.8, 95% confidence interval [CI] 1.2 - 12.1; p = .026), branched and fenestrated procedure (OR 3.4, 95% CI 1.2 - 9.6; p = .019) and introducer internal diameter ≥ 14 F (OR 6.6, 95% CI 2.1 - 20.7; p = .001). Stroke was associated with female sex (OR 3.4, 95% CI 1.3 - 9.0; p = .013), vessel diameter > 7 mm (OR 3.9, 95% CI 1.1 - 13.8; p = .037), and aortic arch procedure (OR 7.3, 95% CI 1.7 - 31.1; p = .007). After 1:1 propensity matching, there was no difference between open surgical and percutaneous cohorts. However, a statistically significantly higher number of adjunctive endovascular procedures was recorded in the percutaneous cohort (p < .001). CONCLUSION: AF and stroke rates during complex aortic procedures employing UEA are non-negligible. Therefore, selective use of UEA is warranted. Percutaneous access with vessel closure devices is associated with similar complication rates, but more adjunctive endovascular procedures are required to avoid surgical exposure.

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.

Complex Endovascular Repair of Paravisceral Infective Native Aortic Aneurysms.

OBJECTIVE: To report the early and mid-term outcome of complex endovascular repair (EVAR) for paravisceral infective native aortic aneurysms (INAA). METHODS: Interrogation of a prospectively maintained database identified consecutive patients who underwent non-elective complex EVAR for paravisceral INAAs in a single institution between December 2013 and June 2020. All patients were considered to have definite INAAs based on diagnostic criteria. Patients who had prior aortic repair were excluded. RESULTS: A total of 26 patients (19 men; mean age 67 years [SD = 11.4]; median diameter 60 mm [IQR: 55-73]) with acute symptomatic (n = 24) or contained ruptured (n = 2) aneurysms underwent surgeon-modified fenestrated EVAR (SM-FEVAR; n = 24) or chimney-periscope EVAR (CHIMPS; n = 2). Median observed follow-up was 36.2 months (18.3-53.5). Nine patients had positive venous blood cultures and a further seven had recent or concomitant infection. All patients received pre- and post-operative antibiotic therapy and rifampicin-soaked endografts. A total of 95 vessels were targeted for preservation and 86 were stent-grafted. One vessel occluded intra-operatively and a further 3 occluded within 30 days. The 30-day/in-hospital mortality was 11.5% (n = 3), and the estimated 1- and 3-year survival (±SD) was 85% ± 7%. Infection-related complications (IRCs) occurred in two patients: both developed new INAA within 30 days of index repair and were treated by EVAR with no mortality. Estimated 3-year freedom from late re-intervention was 100%. One patient required infrarenal EVAR for a non-infective aneurysm at 43 months. CONCLUSION: Complex EVAR for paravisceral INAAs is associated with acceptable early and mid-term outcomes and is an acceptable alternative to open surgery. We propose that these patients are managed with long-term antimicrobials, impregnation of graft material with rifampicin, and rigorous post-operative surveillance. CLINICAL IMPACT: A multi-disciplinary approach is required to deliver the best possible outcome for patients with this challenging aortic pathology.

Fenestrated-branched endovascular repair for distal thoracoabdominal aortic pathology after total aortic arch replacement with frozen elephant trunk.

OBJECTIVE: To report the outcomes of fenestrated-branched endovascular repair (FBEVAR) for thoracoabdominal aortic pathology after total aortic arch replacement with frozen elephant trunk (TAR+FET). METHODS: Interrogation of prospectively maintained databases from four high-volume aortic centers identified consecutive patients treated with distal FBEVAR after prior TAR+FET between August 2013 and September 2020. The primary end point was 30-day/in-hospital mortality. Secondary end points were technical success, early clinical success, midterm survival, and freedom from reintervention. Data are presented as median (interquartile range). RESULTS: A total of 39 patients (21 men; median age, 73 years [67-75 years]) with degenerative (n = 22) and postdissection thoracoabdominal aortic aneurysms (n = 17) (median diameter, 71 mm [61-78 mm]) were identified. Distal FBEVAR was intended in 27 patients (median interval, 9.8 months [6.2-16.6 months]), anticipated in 7, and unexpected in 5. A total of 31 patients had a two- (n = 24) or three-stage (n = 7) distal FBEVAR. Renovisceral target vessel preservation was 99.3% (145 of 146). Early primary and secondary technical success was 92% and 97%, respectively. Thirty-day mortality was 2.6% (n = 1; respiratory failure and spinal cord ischemia [SCI]). Six survivors also developed SCI, which was associated with complete (n = 4) or partial recovery (n = 2) at hospital discharge. No patients required renal replacement therapy or suffered a stroke. Early clinical success was 95%. Median follow-up was 30.5 months (23.7-49.7 months). Eleven patients required 16 late reinterventions. Estimated 3-year survival and freedom from reintervention were 84% ± 6% and 63% ± 10%, respectively. CONCLUSIONS: Distal FBEVAR after prior TAR+FET is associated with high technical success and low early mortality. The risk of SCI is significant although the majority of patients demonstrate full or partial recovery before hospital discharge. Midterm patient survival is favorable, but there remains a high requirement for late reintervention. FBEVAR represents an acceptable alternative to distal open thoracoabdominal aortic aneurysm repair.

Fenestrated-Branch Endovascular Repair After Prior Abdominal Aortic Aneurysm Repair.

OBJECTIVE: To report the outcome of fenestrated and branch endovascular aortic repair (FEVAR-BEVAR) for asymptomatic and acute symptomatic proximal aortic pathology in patients with prior open (OSR) or endovascular (EVAR) abdominal aortic aneurysm (AAA) repair. METHODS: This was a single centre retrospective study of consecutive patients with non-ruptured (asymptomatic and acute symptomatic) proximal aortic pathology after prior OSR or EVAR treated between December 2007 and February 2020. The primary endpoint was 30 day/in hospital mortality. Secondary endpoints were technical success, primary clinical success, and Kaplan-Meier estimates of medium term survival and freedom from re-intervention. Data are presented as median (interquartile range [IQR]). The effect of covariates on medium term survival was estimated using multivariable (Cox proportional hazards model) analysis. A p value < .05 was considered to be statistically significant. RESULTS: Ninety-two patients (83 men; median age 75 years [IQR 71 - 80 years]; median diameter 73 mm [IQR 64 - 89 mm]; 82 elective, 10 acute) underwent FEVAR-BEVAR after prior OSR (n = 47) or EVAR (n = 45). Indications for intervention were aneurysmal degeneration with or without type 1a endoleak (n = 57; four juxtarenal [JR] AAA, 21 extent II/III, 32 extent IV thoraco-abdominal aortic aneurysms); type 1a endoleak alone (n = 27) and to create a more durable repair after acute infrarenal EVAR (n = 8; JRAAA). In total, 348 renovisceral vessels were targeted for preservation and 324 were stent grafted. Twenty-four unstented vessels comprised one bypass, 11 scallops and six fenestrations intentionally not stent grafted, two vessels occluded before graft implantation, and four vessels occluded intra-operatively. Primary technical success was 95.6%. The thirty day mortality rate was 1.1% and one patient each (1.1%) required permanent dialysis or developed temporary spinal cord ischaemia. Early primary clinical success was 94.6%. Median follow up was 36 months (IQR 23 - 64 months). Estimated overall survival (± standard error) at one, two, and three years was 86% ± 4%, 85% ± 4%, and 70% ± 5%, respectively. Multivariable analysis did not demonstrate any independent predictors of survival. Four target vessels occluded during follow up. Nineteen patients underwent 28 late re-interventions, with almost half performed for issues arising distal to the FEVAR-BEVAR. Patients treated with a cuff were statistically significantly more likely to require distal re-intervention compared with those treated by relining (9/49 vs. 1/43, p = .018 [odds ratio 9.3, 95% confidence interval 1.2 - 423]). In patients with prior EVAR alone, this did not reach statistical significance (cuff 7/25 vs. relining 1/20, p = .059 [odds ratio 7.1, 95% confidence interval 0.8 - 350]). Estimated freedom from re-intervention at one, two, and three years was 88% ± 3%, 81% ± 4%, and 81% ± 4%, respectively. CONCLUSION: FEVAR-BEVAR after prior OSR or EVAR is associated with low peri-operative morbidity and mortality, and acceptable medium term survival and freedom from re-intervention. Treatment with a FEVAR-BEVAR cuff is associated with a higher requirement for distal re-intervention than relining of the original repair.

Elective Fenestrated and Branched Endovascular Thoraco-abdominal Aortic Repair with Supracoeliac Sealing Zones and without Prophylactic Cerebrospinal Fluid Drainage: Early and Medium-term Outcomes.

OBJECTIVE: To report the outcome of elective fenestrated and branch (FEVAR-BEVAR) endovascular aortic repair with supracoeliac (SC) sealing zones and the impact of staged repair without prophylactic cerebrospinal fluid (CSF) drainage on the incidence of spinal cord ischaemia (SCI). METHODS: Two hundred and seventy consecutive patients (217 men; mean [SD] age, 72.8 ± 6.3 years; median (IQR) diameter 65 mm [62-75 mm]) with juxtarenal (JRAAA) (n = 69) or thoraco-abdominal aortic aneurysms (TAAAs) (n = 201) underwent elective FEVAR (n = 192) or BEVAR (n = 78) with renovisceral stent grafting, proximal SC (Zones 1-5; <40 mm [n = 83]; ≥40 mm [n = 187]) and distal infrarenal aorto-iliac sealing zone (Zones 9-11) between December 2008 and September 2017. A spinal cord protection protocol (SCPP) including staging without prophylactic CSF drainage was introduced in September 2012. RESULTS: A total of 1026 renovisceral vessels (mean 3.8 ± 0.5 per patient) were targeted for preservation. One patient (0.4%) died in the institution within 30 days and 31 (11.4%) developed 36 major non-fatal complications including unplanned permanent dialysis (n = 1, 0.4%) and non-ambulatory SCI (n = 6, 2.2%). In patients with <40 mm SC coverage, none were staged or had prophylactic CSF drains and none developed SCI. In patients with ≥40 mm SC coverage, SCI occurred in 3.3% (pre-SCPP: 4/20 [20%; none staged, 13 prophylactic CSF drains] vs. post-SCPP: 2/167 [1.2%; 89 staged, no prophylactic CSF drains]; p = .001 [OR = 19.9]). Estimated survival (±SE) at one, two and three years was 92.6% ± 1.6%, 86.5% ± 2.4%, and 73.8% ± 3.5%, respectively, with no significant difference comparing extent of aneurysm or SC coverage. Forty-three (15.9%) patients required late re-intervention. Estimated freedom from re-intervention at one, two and three years was 91.9% ± 1.8%, 85.1% ± 2.5%, and 79.5% ± 3.2%, respectively. CONCLUSION: Elective endovascular thoraco-abdominal aortic repair with SC sealing zones can be performed with low peri-operative risk and good medium-term outcomes. Selective staging without prophylactic CSF drainage contributed to a significant reduction in the incidence of SCI.

Endovascular Repair of Acute Thoraco-abdominal Aortic Aneurysms.

OBJECTIVES: The outcome of endovascular repair (EVAR) for acute thoraco-abdominal aortic aneurysm (TAAA) is reported and the applicability of the t-Branch off the shelf (OTS) device is determined. METHODS: Interrogation of a prospectively maintained database identified all patients who underwent EVAR for acute TAAA between September 2012 (when the first non-elective t-Branch case was performed) and November 2015. Early and medium-term outcomes were analysed. Survival and re-intervention-free survival were calculated by Kaplan-Meier analysis. RESULTS: A total of 39 patients (27 men; mean ± SD age, 72 ± 8 years) were treated for acute symptomatic (n = 29) or ruptured (n = 10) TAAA (20 anatomical extent I-III, 19 extent IV). Fourteen patients had mycotic aneurysms. The mean aneurysm diameter was 80 ± 20 mm. The mean ± SD follow-up was 21.4 ± 15.4 months. Surgeon modified fenestrated EVAR was used in 24 patients, chimney/periscope EVAR in two, and t-Branch in 13 (33%) patients. Aortic coverage was greater than 40 mm above the coeliac axis in all patients. A total of 127 target vessels (TVs) were preserved (mean 3.3 per patient) and two occluded within 30 days. The 30 day mortality was 26%. Four (10%) patients developed spinal cord ischaemia (SCI): two with paraplegia died within 30 days, and two with paraparesis recovered completely with blood pressure manipulation and cerebrospinal fluid drainage. Estimated overall survival (±SD) at 12 and 24 months was 71.8 ± 7.2% and 63.2 ± 7.9%, respectively. Estimated freedom from re-intervention at 12 and 24 months was 93 ± 4.8% and 85.3 ± 6.8%, respectively. CONCLUSIONS: EVAR for acute TAAA is associated with acceptable early and mid-term results in patients who have no other treatment options. Only one third of these patients were suitable for the t-Branch device, indicating that further advances in device design are required to treat the majority of acute TAAA patients with commercially available OTS technology.

Open aortic arch replacement in high-risk patients: the gold standard.

OBJECTIVES: Open total aortic arch replacement (TAR) in high-risk patients is considered by some to be associated with a prohibitively perioperative risk. Recent reports describe hybrid techniques to treat this group. We reviewed our outcomes of open surgery in a 'high-risk' group of patients. METHODS: All patients who underwent open TAR between 2000 and 2013 were identified from our prospectively maintained database. Patients comparable with the ones who underwent hybrid repair in previous studies (logistic EuroSCORE between 20 and 60 without intervention on the aortic root or on the mitral/tricuspid valve) were selected for analysis. RESULTS: Fifty-eight patients were identified. Median logistic EuroSCORE was 27.4 (range 20-57) and median age was 76 years (34.5% male). There were 11 resternotomies (18.9%) and 20 procedures were urgent/emergency (34.5%). Preoperative comorbidities included chronic obstructive pulmonary disease (31%), coronary artery disease (22.4%), peripheral vascular disease (48.3%), previous stroke (5.2%), previous myocardial infarction (3.4%) and left ventricular dysfunction (12%). Concomitant procedures included aortic valve replacement/resuspension (58.7%), coronary artery bypass grafting (22.4%), open descending aorta replacement (10.3%) and frozen elephant trunk (19%). Overall in-hospital mortality, permanent stroke and spinal cord injury rate were 6.9, 1.7 and 0%, respectively. There were no deaths or stroke in the elective group. One-year, 5-year and 10-year estimates of survival were 82.7, 70.0 and 37.8%, respectively. CONCLUSIONS: Open TAR can be performed with low mortality and morbidity and excellent long-term results even in high-risk patients. Total endovascular repair may represent an option for patients not suitable for open surgery.

Current results of endovascular repair of thoraco-abdominal aneurysms†.

OBJECTIVES: Fenestrated and branch endografts represent a totally endovascular solution for high-risk patients with atherosclerotic thoraco-abdominal aortic aneurysms (TAAAs). This study reports the early outcome of endovascular TAAA repair. METHODS: Interrogation of a prospective database of consecutive patients who underwent endovascular repair (EVAR) for TAAA between June 2007 and October 2012. RESULTS: Sixty-two high-risk patients (55 men; median age 72, range 54-84 years) underwent fenestrated (n = 39) or branch (n = 23) EVAR for non-ruptured TAAA [extent I-III (n = 26) and IV (n = 36)]. Twenty patients had undergone 22 previous aortic procedures. A total of 221 target vessels (coeliac 50, superior mesenteric 61, renal 106, left subclavian 1 and hypogastric 3) were preserved with scallops (n = 17), fenestrations (n = 140) or branches (n = 62) and 201 of these vessels were stent-grafted (coeliac 34, superior mesenteric 58, renal 105, left subclavian 1 and hypogastric 3). The 30-day mortality was 1.6% (n = 1) and one further patient died on postoperative day 62 from respiratory complications. Spinal cord injury (SCI) developed in 5 (8%) patients (3 women and 2 men). Two patients required temporary renal replacement therapy and a further two commenced planned postoperative dialysis. CONCLUSIONS: In high-risk patients with TAAA, fenestrated and branch EVAR is associated with low early mortality and requirement for renal support, but the risk of SCI is not insignificant despite the use of cerebrospinal fluid drainage and blood pressure manipulation. Our current practice is to stage the repair of extent I-III aneurysms and this has significantly reduced the incidence of SCI.

Endovascular aortic aneurysm repair with chimney and snorkel grafts: indications, techniques and results.

The chimney technique in endovascular aortic aneurysm repair (Ch-EVAR) involves placement of a stent or stent-graft parallel to the main aortic stent-graft to extend the proximal or distal sealing zone while maintaining side branch patency. Ch-EVAR can facilitate endovascular repair of juxtarenal and aortic arch pathology using available standard aortic stent-grafts, therefore, eliminating the manufacturing delays required for customised fenestrated and branched stent-grafts. Several case series have demonstrated the feasibility of Ch-EVAR both in acute and elective cases with good early results. This review discusses indications, technique, and the current available clinical data on Ch-EVAR.

Assessment of renal function by means of cystatin C following standard and fenestrated endovascular aneurysm repair.

BACKGROUND: Cystatin C (Cyst C) is more sensitive marker for early renal injury. However, serum creatinine (sCr) and estimated glomerular filtration rate (eGFR) are still used as the standard renal markers after endovascular aortic aneurysm repair (EVAR). The goal of this study was to compare the efficacy of Cyst C, sCr, and eGFR as markers of renal function after EVAR. PATIENTS AND METHODS: This study examined 29 patients (27 men) with a mean age of 76.9 years (range, 55-89 years) undergoing standard (n = 19) and fenestrated (n = 10) EVAR for abdominal aortic aneurysm (AAA) of mean diameter 6.9 cm (range, 5.5-10 cm). Cyst C and sCr were measured and eGFR calculated before and 1 day and 1, 6, and 12 months after EVAR. RESULTS: At 24 hours after procedure, a significant increase in Cyst C (P < 0.005) and sCr (P = 0.028) and significant decrease in eGFR (P = 0.04) were seen. Cyst C continued to increase and was significantly higher at 1 (P < 0.002), 6 (P < 0.005), and 12 (P < 0.005) months compared with baseline. By contrast, sCr and eGFR did not show any significant change at 1, 6, and 12 months from the baseline level. Cyst C increased significantly postoperatively regardless of the baseline renal function. None of the patients required renal replacement therapy. CONCLUSIONS: EVAR is associated with a significant increase in Cyst C starting 24 hours after the procedure and is maintained for 12 months. sCr and eGFR only show significant change at 24 hours and therefore may underestimate long-term renal damage after EVAR.

Effect of endovascular and open abdominal aortic aneurysm repair on thrombin generation and fibrinolysis.

BACKGROUND: Abdominal aortic aneurysm (AAA) is associated with a prothrombotic diathesis that may increase the risk of cardiovascular events. This diathesis is exacerbated in the short term by open aneurysm repair (OAR) and endovascular aneurysm repair (EVAR). However, the effect of EVAR and OAR on coagulation and fibrinolysis in the medium and long term is poorly understood. The purpose of this study was to investigate the medium-term effects of EVAR and OAR on thrombin generation, neutralization, and fibrinolysis. METHODS: Prothrombin fragment (PF)1+2, thrombin antithrombin (TAT) complex, plasminogen activator inhibitor (PAI) activity, and tissue-plasminogen activator (t-PA) antigen were measured in eight age-matched controls (AMCs), 29 patients with AAA immediately before (preoperatively) and 12 months after EVAR (post-EVAR), and in 11 patients at a mean of 16 months after OAR (post-OAR). RESULTS: Preoperatively, PF1+2 levels were significantly higher in patients with AAAs than in AMC. PF1+2 levels post-EVAR and post-OAR were significantly lower than preoperative values and similar to AMC. There was no significant difference in TAT, PAI, or t-PA between AMC, AAA preoperatively, and post-EVAR. Post-OAR, PAI activity was significantly higher than in preoperative patients. CONCLUSIONS: AAA is associated with increased thrombin generation without upregulation of fibrinolysis. The prothrombotic, hypofibrinolytic diathesis observed in patients with AAA returns toward normal in the medium term after EVAR and OAR, although there is a trend toward decreased fibrinolysis post-OAR.

The relationship between aortic aneurysm sac thrombus volume on coagulation, fibrinolysis and platelet activity.

AIM: Abdominal aortic aneurysm (AAA) is associated with chronic mural inflammation and a pro-thrombotic diathesis. It has been suggested that both may be related to biologically active intra-sac thrombus. The aim of this study was to examine the relationship between thrombin generation, fibrinolysis, platelet activity and AAA sac thrombus volume. METHODS: 30 patients (29 men) of median (IQR) age 75 (71-82) years with an infra-renal AAA >5.5 cm in antero-posterior diameter were prospectively studied. AAA, lumen and thrombus volumes were calculated using a CT workstation (Vitrea). Plasma thrombin-antithrombin (TAT), plasminogen activator inhibitor (PAI)-1, and soluble (s) P-selectin were measured as biomarkers of coagulation, fibrinolysis and platelet activity, respectively RESULTS: Median (IQR) AAA total, lumen and thrombus volumes were 188 (147-247) cm(3), 80 (54.3-107) cm(3) and 97.6 (63-127) cm(3) respectively. TAT levels were significantly higher (median, QR, 7.15 [4.7-31.3] µg/L, p=<0.001) and sP-selectin levels significantly lower (median, IQR, 80.5 [68-128] ng/ml, p=<0.0001) than the normal range. PAI-1 levels (median, IQR, 20.9 [8.4-50.7] ng/ml) were normal. There was no correlation between AAA thrombus volume and PAI-1 (r=-0.25, p=0.47), sP-Selectin (r=0.26, p=0.43) or TAT plasma levels (r=-0.21, p=0.54). CONCLUSION: The present study confirms that patients with AAA demonstrate haemostatic derangement, but the extent of the haemostatic derangement does not correlate with AAA sac thrombus volume.

Changes in thrombin generation, fibrinolysis, platelet and endothelial cell activity, and inflammation following endovascular abdominal aortic aneurysm repair.

BACKGROUND: Abdominal aortic aneurysm (AAA) is a chronic inflammatory condition associated with a prothrombotic, hypofibrinolytic diathesis that may increase the risk of cardiovascular events. The effect of endovascular aneurysm repair (EVAR) on this prothrombotic diathesis is not fully understood, especially over the medium and long term. A better understanding of these postintervention changes may improve the risk of cardiovascular complications in the long term. The purpose of this study was to examine thrombin generation, fibrinolysis, platelet and endothelial activation, and the inflammatory response during the 12 months following EVAR. METHODS: Twenty-nine patients (mean age, 76.9 years) undergoing EVAR for AAA (mean diameter 6.9 cm) had prothrombin fragment (PF) 1 + 2, thrombin-antithrombin complex (TAT), plasminogen activator inhibitor (PAI) activity, tissue plasminogen activator (t-PA) activity and antigen, soluble P- and E-selectin, and highly sensitive C-reactive protein (hsCRP) measured before and at 24 hours, and 1, 6, and 12 months after surgery. RESULTS: PF1 + 2 were markedly elevated prior to EVAR and remained so at 24 hours and 1 month, but had decreased significantly at 6 and 12 months. TAT was also elevated prior to EVAR and increased still further by 24 hours, but fell to below baseline levels thereafter. PAI activity and t-PA antigen were normal prior to EVAR, increased significantly at 24 hours, and then fell to baseline levels. t-PA activity was only detectable at 1 and 6 months; there was a significant rise in soluble P- and E-selectin after EVAR, which was sustained for 12 months. hsCRP increased transiently in response to EVAR but returned to preoperative levels by 1 month. CONCLUSIONS: The prothrombotic, hypofibrinolytic diathesis associated with AAA is normalized 12 months after EVAR. This beneficial systemic effect of EVAR for AAA disease may help protect patients against future thromboembolic cardiovascular events.

Coagulation, fibrinolysis, and platelet activation in patients undergoing open and endovascular repair of abdominal aortic aneurysm.

BACKGROUND: Endovascular aneurysm repair (EVAR) is associated with an improved perioperative mortality compared to open surgical repair. This benefit may reflect reduced incidence of microvascular and macrovascular thrombotic complications after EVAR. PURPOSE: The purpose of this study was to review and compare the effects of abdominal aortic aneurysm (AAA), open surgical repair, and EVAR on coagulation, fibrinolysis, and platelet activation. METHODS: A MEDLINE (1966-2010) and Cochrane library search for articles relating to the effects of AAA, open surgical repair, and EVAR on hemostasis was performed utilizing and cross-linking terms such as clotting, fibrinolysis, AAA, EVAR, and open surgical repair. Studies with a small cohort of patients (less than 7) or in which values of assessed biomarkers were not included were rejected. RESULTS: AAA is associated with increased thrombin generation, activity, and fibrin turnover as evidenced by increased plasma levels of thrombin-antithrombin III-complex (TAT), activated protein C-protein C inhibitor (APC-PCI), fibrin-monomer-fibrinogen (FM-F), F1+2, fibrinogen, and D-dimer. The extent of hemostatic derangement correlates with the volume of intraluminal thrombus. This procoagulant state is exaggerated in the immediate perioperative period after both open surgical repair and EVAR, but is attenuated at medium-term follow-up although not normalized. CONCLUSION: The resultant prothrombotic diathesis after open surgical repair and EVAR may account for the high level of perioperative thrombotic complications.