Midterm Results of Physician-Modified Stent Grafts for Thoracoabdominal and Complex Abdominal Aortic Aneurysms Repair.

BACKGROUND: To assess midterm results of physician-modified stent grafts (PMSG) for the treatment of emergent complex abdominal and thoracoabdominal aortic aneurysms (TAAA) in high-risk patients. METHODS: All consecutive patients with emergent complex abdominal or TAAA undergoing PMSG technique between January 2012 and July 2019 were retrospectively included. Indications for PMSG were symptomatic aneurysms and rapidly growing aneurysms >70 mm. Ruptured aneurysms were excluded. RESULTS: Thirty-three patients (mean age: 74 +/- 11 years) were included. The mean aneurysm diameter was 76 +- 20 mm. Patients presented with TAAA (n = 20, 61%), complex abdominal aortic aneurysms (CAAA, n = 9, 27%), type I endoleak after previous endovascular aneurysm repair (n = 3, 9%) and intramural aortic hematoma (n = 1, 3%). Chimney technique was performed in addition to PMSG in seven cases (21%). Intraoperative adverse events were recorded in seven cases (35%) in the TAAA group and one case (11%) in the CAAA group. In-hospital mortality rate was 15% (n = 3) in the TAAA group and 11% (n = 1) in the CAAA group. Moderate to severe complications were recorded in 45% of cases (n = 15). Spinal cord ischemia occurred in two cases (6%, one case without residual deficit and one with minor motor deficit). One (3%) patient required transient hemodialysis. One patient presented with early aortic rupture and required an open conversion. The mean follow-up duration was 31 months (1-79). Overall survival estimates were 81.4% (95% confidence interval [CI]: 63.1.-91.2) at 1 year and 71.6% (95% CI: 52.6-84.1) at 2 years. Freedom from reintervention rates at 1 and 2 years were 61.2% (95% CI: 41.7-75.9) and 57.4% (95% CI: 37.9-72.8). Target vessel primary patency rates at 1 and 2 years were 99.2% (95% CI: 94.2-99.9) and 97.7% (95% CI: 90.7-99.4). CONCLUSIONS: PMSG for high-risk patients with complex aneurysms provided acceptable technical success and excellent target vessel patency rates but were associated with a 12% in-hospital mortality rate. Reinterventions were frequent. This technique should be limited to selected high-risk patients for whom the risk of rupture in the short-term is deemed too high to wait for graft manufacturing of custom-made device.

Time-to-event data meta-analysis of late outcomes of endovascular versus open repair for ruptured abdominal aortic aneurysms.

OBJECTIVE: We investigated whether the well-documented perioperative survival advantage of emergency endovascular aneurysm repair (EVAR) compared with open repair would be sustained during follow-up. METHODS: A systematic review conforming to the PRISMA (preferred reporting items for systematic reviews and meta-analyses) statement standards was conducted to identify studies that had reported the follow-up outcomes of endovascular vs open repair for ruptured abdominal aortic aneurysms. Electronic bibliographic sources (MEDLINE [medical literature analysis and retrieval system online], Embase [Excerpta Medica database], CINAHL [cumulative index to nursing and allied health literature], and CENTRAL [Cochrane central register of controlled trials]) were interrogated using the Healthcare Databases Advanced Search interface (National Institute for Health and Care Excellence, London, United Kingdom). A time-to-event data meta-analysis was performed using the inverse variance method, and the results were reported as summary hazard ratios (HRs) and associated 95% confidence intervals (CIs). Mixed effects regression was applied to investigate the outcome changes over time. The quality of the body of evidence was appraised using the GRADE (grades of recommendation, assessment, development, and evaluation) system. RESULTS: Three randomized controlled trials and 22 observational studies reporting a total of 31,383 patients were included in the quantitative synthesis. The mean follow-up duration across the studies ranged from 232 days to 4.9 years. The overall all-cause mortality was significantly lower after EVAR than after open repair (HR, 0.79; 95% CI, 0.73-0.86). However, the postdischarge all-cause mortality was not significantly different (HR, 1.10; 95% CI, 0.85-1.43). The aneurysm-related mortality, which was reported by one randomized controlled trial, was not significantly different between EVAR and open repair (HR, 0.89; 95% CI, 0.69-1.15). Meta-regression showed the mortality difference in favor of EVAR was more pronounced in more recent studies (P = .069) and recently treated patients (P = .062). The certainty for the body of evidence for overall and postdischarge all-cause mortality was judged to be low and that for aneurysm-related mortality to be high. CONCLUSIONS: EVAR showed a sustained mortality benefit during follow-up compared with open repair. A wider adoption of an endovascular-first strategy is justified.

Endurant stent graft demonstrates promising outcomes in challenging abdominal aortic aneurysm anatomy.

OBJECTIVE: We aimed to assess the 5-year safety and effectiveness outcomes of patients enrolled in the Endurant Stent Graft Natural Selection Global Post Market Registry (ENGAGE) who were treated outside the approved indications for use (IFU) of the Endurant stent graft. METHODS: Our primary outcome measure was 12-month treatment success, defined as successful endograft delivery and deployment and the absence of type I or III endoleak, stent migration or limb occlusion, late conversion, and abdominal aortic aneurysm diameter increase or rupture. Secondary outcome measures included 30-day all-cause mortality, major adverse events, secondary procedures, technical observations, aneurysm-related mortality, and all-cause mortality within 12 months. RESULTS: Demographic characteristics of ENGAGE patients treated outside (225 [17.8%]) and within (1038 [82.2%]) the IFUs were similar, except that female patients comprised a much higher percentage of the outside IFU group (19.1% vs 8.7%; P < .001). The outside IFU group presented with lower rates of coronary artery disease and cardiac revascularization and a greater number of symptomatic patients compared with the within IFU group (21.3% vs 15.0%; P = .020). Technical success was achieved in more than 99% of all patients. The outside and within IFU groups showed a comparable and low occurrence of uncorrected type I (0.9% vs 1.2%; P = 1.00) and type III endoleak (0.4% vs 0.3%; P = .54) immediately after device implantation. The 5-year freedom from type IA endoleaks was 89.4% vs 96.7% (P < .0001) for those patients outside and within the IFUs, respectively, although both groups had similar type III endoleaks through 5 years (P = .61). Stent graft limb occlusion estimated overall survival, and freedom from aneurysm-related mortality and endovascular interventions were comparable in both patient groups through the 5-year follow-up. The Kaplan-Meier estimates at 5 years showed a trend for low but increased need for type I or III endoleak correction procedures in the outside IFU group compared with the within IFU group (7.2% vs 5.2%; P = .099). CONCLUSIONS: Differences were not observed in all-cause mortality, aneurysm-related mortality, and secondary procedures between within and outside IFU patients through a 5-year follow-up in the ENGAGE registry. Proximal necks with angulation or diameters outside the IFUs were the most common reasons for patients identified as being outside IFU, and the cohort had increased incidence of type IA endoleaks. Despite the challenges presented from the broad range of aortic and abdominal aortic aneurysm morphologies, the Endurant stent graft showed promising 5-year outcomes.

Five Year Patient Outcomes of Endovascular Abdominal Aortic Aneurysm Repair in the ENDURANT France Registry.

OBJECTIVE: Endovascular repair is the preferred method of treatment for infrarenal abdominal aortic aneurysms with numerous publications from multiple geographic regions showing excellent patient outcomes. Since the original ACE (Anevrysme de l'aorte abdominale: Chirurgie versus Endoprothese) randomised control trial, studies of French specific population have also contributed significantly to the body of evidence in support of endovascular abdominal aortic repair. METHODS: In the ENDURANT France registry, 180 patients were consecutively enrolled from 20 French centres starting in 2012. Investigational sites included public and private practice and differing centre volumes to be as representative of real world French experience as possible. The aim of this study was to present the five year outcomes from this registry. RESULTS: Instructions for use (IFU) were respected in 97.8% (176/180) of patients. At five years, the Kaplan-Meier overall survival was 69.9% ± 3.5% and the freedom from aneurysm related death was 97.6% ± 1.2%. The freedom from Type IA endoleaks was 94.5% ± 1.7%, freedom from endoleaks of any type was 70.1 ± 3.4%, and freedom from secondary endovascular procedure 90.4% ± 2.6%. In addition, 61.6% (45/73) of patients exhibited sac shrinkage at five years. CONCLUSION: In this five year report of the Endurant France registry, survival, re-intervention, and freedom from endoleak rates were comparable to recent EVAR registries and there was a high sac shrinkage rate. Secondary procedure and aneurysm rupture were lower than those of ACE, the French RCT which included older generation devices. This prospective registry demonstrates favourable five year outcomes of the Endurant stent graft used within IFU.

Prospective, Randomised Two Centre Trial of Endovascular Repair of Abdominal Aortic Aneurysm With or Without Sac Embolisation.

OBJECTIVE: The benefit of aneurysm sac coil embolisation (ASCE) during endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) remains unclear. This prospective randomised two centre study (SCOPE 1: Sac COil embolisation for Prevention of Endoleak) compared the outcomes of standard EVAR in patients with AAA at high risk of type II endoleak (EL with EVAR with ASCE during the period 2014-2019. METHODS: Patients at high risk of type II EL were randomised to standard EVAR (group A) or EVAR with coil ASCE (group B). The primary endpoint was the rate of all types of EL during follow up. Secondary endpoints included freedom from type II EL related re-interventions, and aneurysm sac diameter and volume variation at two year follow up. Adverse events included type II EL and re-interventions. CTA and Duplex ultrasound scans were scheduled at 30 days, six months, one year, and two years after surgery. RESULTS: Ninety-four patients were enrolled, 47 in each group. There were no intra-operative complications. At M1, 16/47 early type II EL occurred (34%) in group A vs. 2/47 (4.3%) in group B (p < .001). At M6, 15/36 type II EL (41.7%) occurred in group A vs. 2/39 (4.26%) in group B (p < .001). At M12, 15/37 type II El (40.5%) occurred in group A vs. 5/35 (14.3%) in group B (p = .018). At 24 months, 8/32 type 2 El (25%) occurred in group A vs. 3/29 (6.5%) in group B (p = .19). Kaplan-Meier curves of survival free from EL and re-interventions were significantly in favour of group B (p < .001). Aneurysm sac volume decreased significantly in group B compared with group A at M6 (p = .081), at M12 (p = .004), and M24 (p = .001). CONCLUSION: For selected patients at risk of EL, ASCE seems effective in preventing EL at one, six, and at 12 months. However, the difference was not statistically significant at 24 months. ASCE decreases the re-intervention rate two years after EVAR. A significantly faster aneurysm volume shrinkage was observed at one and two years following surgery. (SCOPE 1 trial: NCT01878240).

Editor's Choice - Risk of Stroke before Revascularisation in Patients with Symptomatic Carotid Stenosis: A Pooled Analysis of Randomised Controlled Trials.

OBJECTIVE: Current guidelines recommending rapid revascularisation of symptomatic carotid stenosis are largely based on data from clinical trials performed at a time when best medical therapy was potentially less effective than today. The risk of stroke and its predictors among patients with symptomatic carotid stenosis awaiting revascularisation in recent randomised controlled trials (RCTs) and in medical arms of earlier RCTs was assessed. METHODS: The pooled data of individual patients with symptomatic carotid stenosis randomised to stenting (CAS) or endarterectomy (CEA) in four recent RCTs, and of patients randomised to medical therapy in three earlier RCTs comparing CEA vs. medical therapy, were compared. The primary outcome event was any stroke occurring between randomisation and treatment by CAS or CEA, or within 120 days after randomisation. RESULTS: A total of 4 754 patients from recent trials and 1 227 from earlier trials were included. In recent trials, patients were randomised a median of 18 (IQR 7, 50) days after the qualifying event (QE). Twenty-three suffered a stroke while waiting for revascularisation (cumulative 120 day risk 1.97%, 95% confidence interval [CI] 0.75 - 3.17). Shorter time from QE until randomisation increased stroke risk after randomisation (χ2 = 6.58, p = .011). Sixty-one patients had a stroke within 120 days of randomisation in the medical arms of earlier trials (cumulative risk 5%, 95% CI 3.8 - 6.2). Stroke risk was lower in recent than earlier trials when adjusted for time between QE and randomisation, age, severity of QE, and degree of carotid stenosis (HR 0.47, 95% CI 0.25 - 0.88, p = .019). CONCLUSION: Patients with symptomatic carotid stenosis enrolled in recent large RCTs had a lower risk of stroke after randomisation than historical controls. The added benefit of carotid revascularisation to modern medical care needs to be revisited in future studies. Until then, adhering to current recommendations for early revascularisation of patients with symptomatic carotid stenosis considered to require invasive treatment is advisable.

Intraoperative adverse events and early outcomes of custom-made fenestrated stent grafts and physician-modified stent grafts for complex aortic aneurysms.

OBJECTIVE: Physician-modified fenestrated stent grafts (PMSGs) are a useful option for urgent or semiurgent treatment of complex abdominal aortic aneurysms (CAAAs). The aim of this study was to describe in-hospital outcomes of custom-made fenestrated stent grafts (CMSGs) and PMSGs for the treatment of CAAAs and thoracoabdominal aortic aneurysms (TAAAs). METHODS: In this single-center, retrospective study, all consecutives patients with CAAAs or TAAAs undergoing endovascular repair using Zenith CMSGs (Cook Medical, Bloomington, Ind) or PMSGs between January 2012 and November 2017 were included. End points were intraoperative adverse events, in-hospital mortality, postoperative complications, reinterventions, target vessel patency, and endoleaks. RESULTS: Ninety-seven patients were included (CMSGs, n = 69; PMSGs, n = 28). The PMSG group included more patients assigned to American Society of Anesthesiologists class 4 (n = 14 [50%] vs n = 16 [23%]; P = .006) and more TAAAs (n = 17 [61%] vs n = 10 [15%]; P < .0001). Intraoperative adverse events were recorded in eight (11%) patients in the CMSG group vs six (21%) patients in the PMSG group. No intraoperative death or open conversion occurred. In-hospital mortality rates were of 4% (n = 3) in the CMSG group and 14% in the PMSG group (n = 4). Chronic renal failure was an independent preoperative risk factor of postoperative death or complications (odds ratio, 4.88; 95% confidence interval, 1.65-14.43; P = .004). Rates of postoperative complications were 22% (n = 15) and 25% (n = 7) in the CMSG and PMSG groups. Spinal cord ischemia rates were 4% (n = 3) and 7% (n = 2) in the CMSG and PMSG groups. Reintervention rates were 16% (n = 11) in the CMSG group and 32% (n = 9) in the PMSG group. At discharge, target vessel patency rate in CMSGs was 98% (n = 207/210). All target vessels (n = 98) were patent in the PMSG group. Endoleaks at discharge were observed in 24% of the CMSG group (n = 16) vs 8% of the PMSG group (n = 2). CONCLUSIONS: Our study showed clinically relevant differences of several important in-hospital outcomes in the CMSG and PMSG groups. Larger cohorts and longer follow-up are needed to allow direct comparison. PMSGs may offer acceptable in-hospital results in patients requiring urgent interventions when CMSGs are not available or possible.

Incidence, natural course, and outcome of type II endoleaks in infrarenal endovascular aneurysm repair based on the ENGAGE registry data.

OBJECTIVE: The purpose of this study was to report the incidence, natural history, and outcome of type II endoleaks in the largest prospective real-world cohort to date. METHODS: Patients were extracted from the prospective Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE). Two groups were analyzed: first, patients with an isolated type II endoleak; and second, patients with a type II endoleak who later presented with a type I endoleak. A health status analysis between patients with an early type II endoleak and patients with no endoleak was performed. Second, an attempt was made to identify risk factors in patients with a type II endoleak who later presented with a type I endoleak. RESULTS: Through 5 years of follow-up, a total of 197 (15.6%) patients with isolated type II endoleaks were identified. Most were detected within the first 30 days (n = 73 [37.1%]) and through the first year (n = 73 [37.1%]), with the remainder being detected after 1 year of follow-up (n = 51 [25.8%]). Patients with a type II endoleak had a higher incidence of aneurysm growth and more secondary endovascular procedures (15.4% vs 7.5% at 5 years; P < .001). Overall survival was higher in the isolated type II endoleak group compared with patients with no endoleak (77.2% vs 67.0% at 5 years; P = .010). Twenty-two patients (10%) with a type II endoleak were diagnosed with a late type I endoleak (type IA, n = 10; type IB, n = 12), with a secondary intervention rate of 67.5% through 5 years. There was no difference in health status scores between patients with an early type II endoleak and patients without any type of endoleak at 1-year follow-up. CONCLUSIONS: In the ENGAGE registry, isolated type II endoleaks are present in 15.6% of patients during follow-up. The majority do not require secondary intervention, and an early isolated type II endoleak does not have an impact on health status through 1 year. However, a small group of patients with a type II endoleak will present with a type I endoleak, resulting in a high secondary intervention rate and significant risk of aneurysm-related complications.

Analysis of Midterm Outcomes of Endovascular Aneurysm Repair in Octogenarians From the ENGAGE Registry.

PURPOSE: To assess periprocedural results and secondary endovascular procedure outcomes over 5 years in patients aged ≥80 vs <80 years undergoing endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: Data from the Endurant Stent Graft Natural Selection Global post-market registry (ENGAGE) were used for the analyses. A total of 1263 consecutive patients were enrolled in the prospective, observational, single-arm registry and divided into 2 groups according to age: ≥80 years (290, 22.9%) and <80 years (973, 77.1%). Baseline patient characteristics, risk scores according to the Society for Vascular Surgery (SVS) reporting standards, American Society of Anesthesiologists (ASA) classification, quality of life assessments [EuroQol 5 (EQ5D) index], and treatment outcomes, including all-cause mortality, aneurysm-related mortality, major adverse events, secondary endovascular procedures, and endoleaks were compared between groups. RESULTS: Octogenarians were classified into the highest category of the SVS risk stratification system; however, this did not result in a significant difference in the 30-day mortality [1.4% (4/290) vs 1.2% (12/973) for controls; p=0.85] or major adverse event rates [5.2% (15/290) vs 3.6% (35/973), p=0.23]. Multivariable analysis confirmed that age ≥80 years, pulmonary disease, large aneurysm diameter, and renal insufficiency were significantly associated with all-cause mortality, whereas diameter was the only parameter associated with increased aneurysm-related mortality. The differences in freedom from secondary endovascular procedures over 5 years between octogenarians and controls did not reach statistical significance (88.5% vs 83.2%, p=0.07). CONCLUSION: EVAR can be performed in individuals aged ≥80 years with no statistically significant difference in midterm aneurysm-related deaths compared with younger patients. The findings in this elderly patient cohort show that EVAR can be safely performed with acceptable morbidity rates in octogenarians.

A Hybrid Technique to Treat Iliofemoral Lesions Using a Covered Stent Associated with Open Femoral Repair.

BACKGROUND: To describe a hybrid approach for complex iliofemoral lesions and report short-term and mid-term results. METHODS: In this single-center retrospective study, all consecutive patients (n = 32, 36 limbs) who underwent hybrid repair of complex iliofemoral lesions between 2012 and 2017 using a conformable self-expandable covered stent for external iliac artery lesions and open repair of the common femoral artery were included. Lesions were responsible for claudication in 13 (36%) limbs, rest pain in 13 (36%) limbs and tissue loss in 10 (28%) limbs. Over a wire crossing the iliac lesion, the covered stent was deployed, externalized through the femoral arteriotomy, and cut at the iliofemoral junction in such a way that no untreated transition zone remained between the stent and the open reconstruction of the femoral artery. RESULTS: Two elderly patients with critical limb ischemia died during the postoperative course, giving in-hospital mortality of 6.2%. Four (12.5%) presented with moderate to severe complications, including one transtibial amputation in a patient who presented with tissue loss at admission. The median follow-up period was 24.1 months (range: 0.8-64 months). One-year and two-year Kaplan-Meier estimates of overall survival were 91% (95% CI: 97-74) and 76% (95% CI: 89-53). One-year and two-year estimates of freedom from major amputation were 96% (95% CI: 99-76) and 91% (95% CI: 97-66). Estimates of primary patency, assisted primary patency, and secondary patency were: 93.7 (95% CI: 77.1-98.4) at 1 year, and 93.7 (95% CI: 77.1-98.4) at 2 years; 96.7% (95% CI: 78.6-99.6) at 1 year, and 96.7% (95% CI: 78.6-99.6) at 2 years; 96.7% (95% CI: 78.6-99.6) at 1 year and 96.7% (95% CI: 78.6-99.6) at 2 years, respectively. CONCLUSIONS: Our hybrid approach for iliofemoral lesions provided acceptable mortality and good mid-term patency rates. Further studies with long-term followup are needed to evaluate the safety and durability of this technique.

Associations of Perioperative Variables With the 30-Day Risk of Stroke or Death in Carotid Endarterectomy for Symptomatic Carotid Stenosis.

Background and Purpose- This analysis was performed to assess the association between perioperative and clinical variables and the 30-day risk of stroke or death after carotid endarterectomy for symptomatic carotid stenosis. Methods- Individual patient-level data from the 5 largest randomized controlled carotid trials were pooled in the Carotid Stenosis Trialists' Collaboration database. A total of 4181 patients who received carotid endarterectomy for symptomatic stenosis per protocol were included. Determinants of outcome included carotid endarterectomy technique, type of anesthesia, intraoperative neurophysiological monitoring, shunting, antiplatelet medication, and clinical variables. Stroke or death within 30 days after carotid endarterectomy was the primary outcome. Adjusted risk ratios (aRRs) were estimated in multilevel multivariable analyses using a Poisson regression model. Results- Mean age was 69.5±9.2 years (70.7% men). The 30-day stroke or death rate was 4.3%. In the multivariable regression analysis, local anesthesia was associated with a lower primary outcome rate (versus general anesthesia; aRR, 0.70 [95% CI, 0.50-0.99]). Shunting (aRR, 1.43 [95% CI, 1.05-1.95]), a contralateral high-grade carotid stenosis or occlusion (aRR, 1.58 [95% CI, 1.02-2.47]), and a more severe neurological deficit (mRS, 3-5 versus 0-2: aRR, 2.51 [95% CI, 1.30-4.83]) were associated with higher primary outcome rates. None of the other characteristics were significantly associated with the perioperative stroke or death risk. Conclusions- The current results indicate lower perioperative stroke or death rates in patients operated upon under local anesthesia, whereas a more severe neurological deficit and a contralateral high-grade carotid stenosis or occlusion were identified as potential risk factors. Despite a possible selection bias and patients not having been randomized, these findings might be useful to guide surgeons and anesthetists when treating patients with symptomatic carotid disease.

Safety of Carotid Revascularization in Patients With a History of Coronary Heart Disease.

Background and Purpose- We investigated whether procedural stroke or death risk of carotid artery stenting (CAS) compared with carotid endarterectomy (CEA) is different in patients with and without history of coronary heart disease (CHD) and whether the treatment-specific impact of age differs. Methods- We combined individual patient data of 4754 patients with symptomatic carotid stenosis from 4 randomized trials (EVA-3S [Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis], SPACE [Stent-Protected Angioplasty Versus Carotid Endarterectomy], ICSS [International Carotid Stenting Study], and CREST [Carotid Revascularization Endarterectomy Versus Stenting Trial]). Procedural risk was defined as any stroke or death ≤30 days after treatment. We compared procedural risk between both treatments with Cox regression analysis, stratified by history of CHD and age (<70, 70-74, ≥75 years). History of CHD included myocardial infarction, angina, or coronary revascularization. Results- One thousand two hundred ninety-three (28%) patients had history of CHD. Procedural stroke or death risk was higher in patients with history of CHD. Procedural risk in patients treated with CAS compared with CEA was consistent in patients with history of CHD (8.3% versus 4.6%; hazard ratio [HR], 1.96; 95% CI, 0.67-5.73) and in those without (6.9% versus 3.6%; HR, 1.93; 95% CI, 1.40-2.65; Pinteraction=0.89). In patients with history of CHD, procedural risk was significantly higher after CAS compared with CEA in patients aged ≥75 (CAS-to-CEA HR, 2.78; 95% CI, 1.32-5.85), but not in patients aged <70 (HR, 1.71; 95% CI, 0.79-3.71) and 70 to 74 years (HR, 1.09; 95% CI, 0.45-2.65). In contrast, in patients without history of CHD, procedural risk after CAS was higher in patients aged 70 to 74 (HR, 3.62; 95% CI, 1.80-7.29) and ≥75 years (HR, 2.64; 95% CI, 1.52-4.59), but equal in patients aged <70 years (HR, 1.05; 95% CI, 0.63-1.73; 3-way Pinteraction=0.09). Conclusions- History of CHD does not modify procedural stroke or death risk of CAS compared with CEA. CAS might be as safe as CEA in patients with history of CHD aged <75 years, whereas for patients without history of CHD, risk after CAS compared with CEA was only equal in those aged <70 years.

Editor's Choice - Five Year Outcomes of the Endurant Stent Graft for Endovascular Abdominal Aortic Aneurysm Repair in the ENGAGE Registry.

OBJECTIVE/BACKGROUND: Endovascular abdominal aortic aneurysm repair (EVAR) is commonly used to treat abdominal aortic aneurysm (AAA). However, the incidence of long-term complications and the need for re-interventions after EVAR remain a concern. Newer generation stent grafts have encouraging short and mid-term outcomes, but thorough analysis of their long-term performance is necessary. METHODS: The ENGAGE registry includes a total of 1263 patients with AAA enrolled from March 2009 to April 2011 at 79 centres across 30 countries. The aim of this study is to present standard EVAR outcomes in the registry after five years. RESULTS: A significant proportion of the ENGAGE patients presented with challenging features, such as 15.2% with an AAA diameter >7 cm, 12.0% with proximal neck lengths <15 mm, and 10.2% with infrarenal neck angles >60°. Of the 1263 enrolled subjects, 17.8% were implanted outside of the instructions for use for the device. At the five year follow up, the Kaplan-Meier overall survival rate was 67.4% and the freedom from aneurysm related mortality was 97.8%. Freedom from aneurysm rupture, secondary procedures, and conversion to open repair at five years were 98.6%, 84.3%, and 97.9% respectively. The five year freedom from type IA endoleaks was 95.2% and for type III endoleaks 97.4%. Aneurysm sac diameter at five years was observed to have either decreased ≥5 mm in diameter or remained stable in 89.4% of the patients. CONCLUSION: Five year follow up of patients in the ENGAGE registry demonstrates sustained safety, effectiveness, and durability in an international cohort that is reflective of real world experience. Additional follow up is expected through to 10 years.

Immediate and Delayed Procedural Stroke or Death in Stenting Versus Endarterectomy for Symptomatic Carotid Stenosis.

Background and Purpose- Stenting for symptomatic carotid stenosis (carotid artery stenting [CAS]) carries a higher risk of procedural stroke or death than carotid endarterectomy (CEA). It is unclear whether this extra risk is present both on the day of procedure and within 1 to 30 days thereafter and whether clinical risk factors differ between these periods. Methods- We analyzed the risk of stroke or death occurring on the day of procedure (immediate procedural events) and within 1 to 30 days thereafter (delayed procedural events) in 4597 individual patients with symptomatic carotid stenosis who underwent CAS (n=2326) or CEA (n=2271) in 4 randomized trials. Results- Compared with CEA, patients treated with CAS were at greater risk for immediate procedural events (110 versus 42; 4.7% versus 1.9%; odds ratio, 2.6; 95% CI, 1.9-3.8) but not for delayed procedural events (59 versus 46; 2.5% versus 2.0%; odds ratio, 1.3; 95% CI, 0.9-1.9; interaction P=0.006). In patients treated with CAS, age increased the risk for both immediate and delayed events while qualifying event severity only increased the risk of delayed events. In patients treated with CEA, we found no risk factors for immediate events while a higher level of disability at baseline and known history of hypertension were associated with delayed procedural events. Conclusions- The increased procedural stroke or death risk associated with CAS compared with CEA was caused by an excess of events occurring on the day of procedure. This finding demonstrates the need to enhance the procedural safety of CAS by technical improvements of the procedure and increased operator skill. Higher age increased the risk for both immediate and delayed procedural events in CAS, mechanisms of which remain to be elucidated. Clinical Trial Registration- URL: https://clinicaltrials.gov . Unique identifier: NCT00190398. URL: http://www.isrctn.com . Unique identifier: ISRCTN57874028. URL: http://www.isrctn.com . Unique identifier: ISRCTN25337470. URL: https://clinicaltrials.gov . Unique identifier: NCT00004732.

Prediction Models for Clinical Outcome After a Carotid Revascularization Procedure.

Background and Purpose- Prediction models may help physicians to stratify patients with high and low risk for periprocedural complications or long-term stroke risk after carotid artery stenting or carotid endarterectomy. We aimed to evaluate external performance of previously published prediction models for short- and long-term outcome after carotid revascularization in patients with symptomatic carotid artery stenosis. Methods- From a literature review, we selected all prediction models that used only readily available patient characteristics known before procedure initiation. Follow-up data from 2184 carotid artery stenting and 2261 carotid endarterectomy patients from 4 randomized trials (EVA-3S [Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis], SPACE [Stent-Protected Angioplasty Versus Carotid Endarterectomy], ICSS [International Carotid Stenting Study], and CREST [Carotid Revascularization Endarterectomy Versus Stenting Trial]) were used to validate 23 short-term outcome models to estimate stroke or death risk ≤30 days after the procedure and the original outcome measure for which the model was developed. Additionally, we validated 7 long-term outcome models for the original outcome measure. Predictive performance of the models was assessed with C statistics and calibration plots. Results- Stroke or death ≤30 days after the procedure occurred in 158 (7.2%) patients after carotid artery stenting and in 84 (3.7%) patients after carotid endarterectomy. Most models for short-term outcome after carotid artery stenting (n=4) or carotid endarterectomy (n=19) had poor discriminative performance (C statistics ranging from 0.49-0.64) and poor calibration with small absolute risk differences between the lowest and highest risk groups and overestimation of risk in the highest risk groups. Long-term outcome models (n=7) had a slightly better performance with C statistics ranging from 0.59 to 0.67 and reasonable calibration. Conclusions- Current models did not reliably predict outcome after carotid revascularization in a trial population of patients with symptomatic carotid stenosis. In particular, prediction of short-term outcome seemed to be difficult. Further external validation of existing prediction models or development of new prediction models is needed before such models can be used to support treatment decisions in individual patients.

A propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms.

OBJECTIVE: This study investigated the outcomes of a current series of patients treated with fenestrated and branched endovascular aneurysm repair (F-BEVAR) or open surgical repair (OSR) for pararenal abdominal aortic aneurysms (pr-AAAs), including juxtarenal, suprarenal, and type IV thoracoabdominal aneurysms. This study compares the outcomes of these procedures from two high-volume centers without the bias induced by a learning curve. METHODS: All patients with pr-AAAs undergoing repair at two centers between January 2010 and June 2016 were included in a prospective database. Patients undergoing F-BEVAR and OSR were propensity matched for age, sex, anatomic criteria (aortic clamp site), coronary artery disease, chronic obstructive pulmonary disease, diabetes, smoking, chronic kidney disease, aneurysm diameter, and previous aortic surgery. The primary end points were mortality and dialysis. Secondary end points included any myocardial ischemia, respiratory and early procedural complications, acute kidney injury (AKI) according to RIFLE criteria (Risk, Injury, Failure, Loss of kidney function, and End-stage renal failure), spinal cord ischemia, a composite of these complications, and postoperative intensive care unit length of stay. During follow-up, all-cause survival and freedom from reintervention were compared, as was the patency of stented vessels and renal and visceral bypasses. Late renal function deterioration was evaluated. RESULTS: In this period, 157 F-BEVAR patients and 119 OSR patients were operated on. After 1:1 propensity matching, the study cohort consisted of 102 F-BEVARs and 102 OSRs. In the matched population, an average of 2.5 vessels were treated per patient. Univariate analysis demonstrated no significant difference in 30-day mortality (2.9% vs 2.0%; P = .68), dialysis (4.9% vs 3.9%; P = 1), cardiac ischemic complications (3.8% vs 5.9%; P = .52), pulmonary complications (5.9% vs 5.9%; P = 1), or any complications (28.4% vs 30.4%; P = .63) in the F-BEVAR and OSR groups, respectively. AKI was significantly lower in the F-BEVAR group than in the OSR group (19.6% vs 52%; P < .001), as was severe AKI (>50% decrease in glomerular filtration rate, 6.9% vs 16.7%; P = .03). There was no spinal cord ischemia. The median intensive care unit length of stay was 1 day in both groups (P = .33). During follow-up, we found occlusions of five stented vessels and three surgical bypasses. Late renal function deterioration was comparable between the two groups. According to Kaplan-Meier estimates, all-cause survival at 24, 48, and 72 months was 85.6%, 66.8%, and 55.8% after F-BEVAR and 90.5%, 82.9%, and 68.5% after OSR (P = .04). Rates of freedom from reintervention were 97.6% vs 97.5% at 24 months, 90.1% vs 93.4% at 48 months, and 63.9% vs 93.4% at 72 months in the F-BEVAR and OSR groups (P = .05), respectively. Thus, both all-cause survival and freedom from reintervention were lower in the F-BEVAR group. CONCLUSIONS: This propensity score analysis in patients with pr-AAA undergoing F-BEVAR or OSR suggests no difference in terms of 30-day mortality, dialysis, or organ-specific postoperative complications, with the exception of AKI. Postoperative AKI was significantly higher after OSR, although most patients had recovered before discharge. Our data suggest similar outcomes after F-BEVAR or OSR for pr-AAA.

Editor's Choice - A Study of the Cost-effectiveness of Fenestrated/branched EVAR Compared with Open Surgery for Patients with Complex Aortic Aneurysms at 2 Years.

OBJECTIVES: The aim was to assess the cost-effectiveness of fenestrated and branched stent grafts (f/b EVAR) compared with open surgical repair (OSR) in thoraco-abdominal or complex abdominal aortic aneurysms (TAAA/AAA) at 2 years. METHODS: Two matched cohorts of patients with TAAA or complex AAA were compared after a follow-up of two years. Patients included in the WINDOW French multicentre prospective registry were treated by f/b EVAR, and OSR patients were extracted from the French national hospital discharge database. All cause mortality was assessed along with readmissions and hospital costs. The association between treatment and 2 year mortality was assessed by uni/multivariate Cox regression analyses using pre- and post-operative characteristics. Incremental cost-effectiveness ratios (ICER) were estimated for para/juxtarenal AAA, and infra- and supra-diaphragmatic TAAA. RESULTS: A total of 268 high risk patients were treated by f/b EVAR and 1678 average or low risk patients were treated with OSR during the same period. Mortality did not significantly differ between the groups (14.9% vs. 11.8%, p = .150) and multivariate Cox regressions did not find an association between 2 year mortality and treatment. Similar proportions of patients were readmitted at least once (69.7% with f/b EVAR vs. 64.2% with OSR, p = .096) but f/b EVAR patients had more readmissions on average (2.2 vs. 1.7, p = .001). Two year hospital costs were higher in the f/b EVAR group (€46,039 vs. €22,779, p < .001). At 2 years, f/b EVAR was dominated (more expensive and less effective), except in the supra-diaphragmatic TAAA subgroup with an ICER of €42,195,800 per death averted. CONCLUSIONS: f/b EVAR in high risk patients offers similar 2 year mortality to OSR performed in lower risk patients but at a higher cost. The cost is mainly driven by the cost of the stent graft, which is not compensated for by lower healthcare resource consumption. Further studies are necessary to evaluate the cost-effectiveness in low risk f/b EVAR patients who may experience fewer complications.

Impact of Stent-Graft Oversizing on Gutter Areas after Chimney Graft Repair for Complex Abdominal Aortic Aneurysms.

BACKGROUND: The aim of this retrospective study was to examine the impact of graft oversizing on gutter area and stent compression in chimney graft (CG) for complex abdominal aortic aneurysm (CAAA) repair. The influence of stent-graft oversizing on type Ia endoleaks and bridging stent occlusion rates was also examined. METHODS: Preoperative and postoperative computed tomographic angiography scans of patients requiring CGs for CAAA between June 2009 and April 2013 in our institution were analyzed. Two groups were identified: proximal oversizing of the stent-graft component < 25% (group 1) and >25% (group 2). Relative gutter areas were calculated and compared between both groups. Incidence of target vessel stent compression, target vessel occlusions, and type Ia endoleaks was also analyzed. RESULTS: Of 39 patients treated with CG during the study period, 23 fulfilled the selection criteria for analysis. Group 1 included 10 patients and group 2 included 13 patients (mean oversizing: 18.4 ± 4.9% and 34.5 ± 6% respectively). Relative gutter areas were significantly higher in group 1 when compared with group 2 (6.1 ± 2.1% vs. 4.2 ± 3.2%, P = 0.03). No stent compression and no target vessel occlusion occurred in either groups. There was no statistical difference in type Ia endoleak in both groups (group 1 n = 0, group 2 n = 2; P = 0.48). CONCLUSIONS: In our study, a >25% stent-graft oversizing reduced the gutter area without modifying the bridging stent patency. However, no benefit in terms of type Ia endoleak was observed.

Early Endarterectomy Carries a Lower Procedural Risk Than Early Stenting in Patients With Symptomatic Stenosis of the Internal Carotid Artery: Results From 4 Randomized Controlled Trials.

BACKGROUND AND PURPOSE: Patients undergoing carotid endarterectomy (CEA) for symptomatic stenosis of the internal carotid artery benefit from early intervention. Heterogeneous data are available on the influence of timing of carotid artery stenting (CAS) on procedural risk. METHODS: We investigated the association between timing of treatment (0-7 days and >7 days after the qualifying neurological event) and the 30-day risk of stroke or death after CAS or CEA in a pooled analysis of individual patient data from 4 randomized trials by the Carotid Stenosis Trialists' Collaboration. Analyses were done per protocol. To obtain combined estimates, logistic mixed models were applied. RESULTS: Among a total of 4138 patients, a minority received their allocated treatment within 7 days after symptom onset (14% CAS versus 11% CEA). Among patients treated within 1 week of symptoms, those treated by CAS had a higher risk of stroke or death compared with those treated with CEA: 8.3% versus 1.3%, risk ratio, 6.7; 95% confidence interval, 2.1 to 21.9 (adjusted for age at treatment, sex, and type of qualifying event). For interventions after 1 week, CAS was also more hazardous than CEA: 7.1% versus 3.6%, adjusted risk ratio, 2.0; 95% confidence interval, 1.5 to 2.7 (P value for interaction with time interval 0.06). CONCLUSIONS: In randomized trials comparing stenting with CEA for symptomatic carotid artery stenosis, CAS was associated with a substantially higher periprocedural risk during the first 7 days after the onset of symptoms. Early surgery is safer than stenting for preventing future stroke. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00190398; URL: http://www.controlled-trials.com. Unique identifier: ISRCTN57874028; Unique identifier: ISRCTN25337470; URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.

Association between age and risk of stroke or death from carotid endarterectomy and carotid stenting: a meta-analysis of pooled patient data from four randomised trials.

BACKGROUND: Age was reported to be an effect-modifier in four randomised controlled trials comparing carotid artery stenting (CAS) and carotid endarterectomy (CEA), with better CEA outcomes than CAS outcomes noted in the more elderly patients. We aimed to describe the association of age with treatment differences in symptomatic patients and provide age-specific estimates of the risk of stroke and death within narrow (5 year) age groups. METHODS: In this meta-analysis, we analysed individual patient-level data from four randomised controlled trials within the Carotid Stenosis Trialists' Collaboration (CSTC) involving patients with symptomatic carotid stenosis. We included only trials that randomly assigned patients to CAS or CEA and only patients with symptomatic stenosis. We assessed rates of stroke or death in 5-year age groups in the periprocedural period (between randomisation and 120 days) and ipsilateral stroke during long-term follow-up for patients assigned to CAS or CEA. We also assessed differences between CAS and CEA. All analyses were done on an intention-to-treat basis. FINDINGS: Collectively, 4754 patients were randomly assigned to either CEA or CAS treatment in the four studies. 433 events occurred over a median follow-up of 2·7 years. For patients assigned to CAS, the periprocedural hazard ratio (HR) for stroke and death in patients aged 65-69 years compared with patients younger than 60 years was 2·16 (95% CI 1·13-4·13), with HRs of roughly 4·0 for patients aged 70 years or older. We noted no evidence of an increased periprocedural risk by age group in the CEA group (p=0·34). These changes underpinned a CAS-versus CEA periprocedural HR of 1·61 (95% CI 0·90-2·88) for patients aged 65-69 years and an HR of 2·09 (1·32-3·32) for patients aged 70-74 years. Age was not associated with the postprocedural stroke risk either within treatment group (p≥0·09 for CAS and 0·83 for CEA), or between treatment groups (p=0·84). INTERPRETATION: In these RCTs, CEA was clearly superior to CAS in patients aged 70-74 years and older. The difference in older patients was almost wholly attributable to increasing periprocedural stroke risk in patients treated with CAS. Age had little effect on CEA periprocedural risk or on postprocedural risk after either procedure. FUNDING: None.