Midterm outcomes of side branch embolization and endovascular abdominal aortic aneurysm repair.

OBJECTIVE: To analyze the effects of total side branch embolization at endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms on the incidences of persistent type 2 endoleak (pT2EL), changes in sac diameter, and reintervention. METHODS: Between 2013 and 2021, all patients who underwent primary EVAR with a few exceptions were included. Side branch embolization was considered during EVAR for inferior mesenteric artery (IMA) or IMA plus lumbar artery (LA) when feasible for contrast agent use. Outcomes measured were pT2EL, sac diameters, reintervention, ruptures, and aneurysm-related mortality. Radiation exposure and safety outcomes were also reported. RESULTS: Among 732 patients who underwent EVAR, 616 (84.2%) were included. Of the 616 patients, 223 (36.2%) did not undergo side branch embolization (NO-E), whereas 228 (37.0%) underwent IMA only (IMA-E) and 165 (26.8%) underwent IMA+LA including median sacral artery (IMA+LA-E). The technical success rate of IMA and LA embolization was 97.0% and 74.7%, respectively. Crude incidences of pT2EL were significantly different from 6 months through 3 years (NO-E, 27.8%; IMA-E, 31.7%; IMA+LA-E, 9.4% at 3 years; P = .007). In the multivariate analysis adjusted for background differences, the incidences of pT2EL were significantly higher in the NO-E (odds ratio [OR], 3.21; 95% confidence intervals [CIs], 1.08-9.57; P = .004) and IMA-E (OR, 4.86; 95% CIs, 1.68-14.11; P = .004) compared with the IMA+LA-E group. Similarly, any reintervention until 3 years was significantly frequent in the NO-E (OR, 5.26; 95% CIs, 1.76-15.70; P = .003) and IMA-E group (OR, 4.19; 95% CIs, 1.38-12.67; P = .01). Surgical conversion and secondary rupture were seen only in 1 patient without any aneurysm-related mortality. Percent sac shrinkage from the baseline was significantly promoted in the IMA+LA group (NO-E, 12.1% ± 16.6%; IMA-E, 11.4% ± 16.7%; IMA+LA-E, 18.0% ± 18.8%; P = .047). Fluoroscopy time was significantly longer in the IMA+LA-E group (NO-E, 60.2 ± 47.4 minutes; IMA-E, 59.3 ± 39.5 minutes; IMA+LA-E, 75.5 ± 42.8 minutes; P < .0001), and so do the dose-area product (NO-E, 424.6 ± 333.4 Gy cm2; IMA-E, 477.7 ± 342.4 Gy cm2; IMA+LA-E, 631.8 ± 449.1 Gy cm2; P < .0001). No embolization-related complications or radiation-related adverse events were recorded. CONCLUSIONS: Pre-emptive embolization of IMA, LAs, and median sacral artery at the time of EVAR reduced the incidences of pT2EL and any reintervention and promoted sac shrinkage during the follow-up period of 3 years.

Prevalence of type II endoleak after elective endovascular aneurysm repair with polytetrafluoroethylene- or polyester-based endografts.

OBJECTIVE: Type II endoleak is the most frequent complication after endovascular abdominal aneurysm repair. Polytetrafluoroethylene and polyester (PE) are the two most commonly used graft materials in endovascular aneurysm repair (EVAR) devices. Biological properties of the material might influence the appearance and persistence of type II endoleak (T2EL). Therefore, the aim of this study was to evaluate potential differences in the prevalence of T2EL after EVAR between polytetrafluoroethylene (PTFE) and PE endografts in patients electively treated for an infrarenal abdominal aortic aneurysm. METHODS: A single-center, retrospective, observational study was conducted between January 2011 and January 2022. Preoperative, procedural, and follow-up data were derived from electronic health records. Imaging included computed tomography scans, and/or duplex ultrasound examination. The primary end point was the prevalence of T2EL diagnosed within 1 year after EVAR. Secondary end points included the prevalence of T2EL throughout follow-up, early (≤30 days) and late (>30 days) T2EL, the rate of T2EL disappearance during the follow-up period, the prevalence of type I and III endoleak, and T2EL-related reinterventions. RESULTS: Follow-up was available for 394 patients, 245 in the PE and 149 in the PTFE group. The prevalence of T2EL diagnosed within 1 year after endovascular repair was 11.8% in the PE group and 21.5% in the PTFE group (P = .010). There was no significant difference in early (≤30 days) and late (>30 days) T2EL between groups (P = .270 and P = .311). There was no difference in the freedom from endoleak type II reinterventions between groups (P = .877). CONCLUSIONS: The prevalence of T2EL after elective EVAR is significantly higher with the use of PTFE-based endografts compared with PE-based endografts. This difference is mostly based on T2EL diagnosed after 30 days of follow-up.

Initial two-day blood pressure management after endovascular aneurysm repair improves midterm outcomes by reducing the incidence of early type II endoleak.

OBJECTIVE: The aim of this study was to evaluate midterm outcomes of our novel strategy of postoperative initial 2-day blood pressure management (BPM) after endovascular aneurysm repair (EVAR) for the prevention of subsequent type II endoleak (T2EL) in a single-center series. METHODS: Between 2008 and 2014, 137 patients who underwent EVAR for abdominal aortic aneurysm (AAA) were reviewed. Starting from 2013, the mean blood pressure was maintained between 75 and 90 mmHg for the initial 24 hours after EVAR followed by systolic pressure controlled below 120 mmHg during the next 24 hours in the treatment group (n = 76). The incidence of T2EL detected at 7 days, reintervention, and AAA sac diameter up to 5 years after EVAR were compared with those of the control group comprising of 60 consecutive patients who underwent standard EVAR without BPM prior to 2013. RESULTS: Between the treatment group and the control group, significant differences were achieved in the incidence of T2EL at 7 days (19.7% vs 40.0%; P = .009), a mean decrease of AAA sac diameter at 1-year (-5.1 ± 4.9 vs -2.2 ± 6.7 mm; P = .013) and 2-year (-5.4 ± 7.7 vs -1.7 ± 10.8 mm; P = .045). In addition, there was a significant decrease in the incidence of T2EL detected at 7 days with the use of the Gore Excluder with 22.7% in the treatment group vs 80.0% in the control group (P < .001), which resulted in a significant decrease in the aneurysm sac diameter up to 4 years after EVAR. Survival rate without AAA sac enlargement at 5 years after EVAR (83.0% vs 70.0%; P = .021) in the treatment group was significantly higher than that of the control group, whereas no significant differences were observed in the freedom rates of reintervention, T2EL-related reintervention, and all-cause mortality between the groups. CONCLUSIONS: Postoperative initial 2-day BPM had a preventive effect on AAA sac enlargement until midterm periods, by reducing the incidence of T2EL at 7 days after EVAR. The usage of Gore Excluder under BPM was especially associated with sustained positive effects until the midterm follow-up.

Hybrid Technique Outcomes for High-Risk Uncomplicated Type B Aortic Dissection With Landing Zone 1.

In this report, we analyzed the outcomes of the hybrid technique for high-risk uncomplicated type B aortic dissection with landing zone 1. We enrolled 80 patients from January 2016 to January 2020 and retrospectively analyzed their outcomes, including mortality, aortic-related adverse events, and aortic remodeling. The mean age was 51.6 ± 9.9 years, and 68.0% (54 of 80) were men. Technical success was achieved in 100% of cases (80 of 80), and 30-day mortality was 4% of patients (n = 3), including 2 dissection-related deaths. Immediate endoleaks occurred in 16 patients, including 11 type Ia and 5 type II. Four patients (5%) developed minor strokes postoperatively, and no short-term spinal cord ischemia and re-intervention occurred. The average length of stay was 20 ± 8 days. The overall mortality was 8% after a median follow-up of 44 months (38 to 52). Five patients (7%) developed strokes, and 11 (16%) had late endoleaks, including 1 type Ia, 5 type Ib, and 3 type II. Four re-interventions (5%) were necessary, 3 for endoleaks and 1 for retrograde type A dissection. Three bypass graft occlusions (5%) and 5 stoma stenoses (8%) were observed in the latest follow-up computed tomography. In conclusion, the hybrid technique with landing zone 1 might be a viable alternative to open aortic arch replacement in patients at high risk with uncomplicated type B aortic dissection with acceptable early and late outcomes. However, stroke and endoleak complications should be further addressed.

Proximal Instructions for Use Violations in Elective Endovascular Aneurysm Repair in the Vascular Quality Initiative: Retrospective Analysis.

BACKGROUND: Endovascular aneurysm repair (EVAR) is often attempted in patients with marginal anatomy. These patients' midterm outcomes are available in the Vascular Quality Initiative for analysis. STUDY DESIGN: Retrospective analysis of prospectively collected data in the Vascular Quality Initiative from patients who underwent elective infrarenal EVAR between 2011 and 2018. Each EVAR was identified as either on- or off-instructions for use (IFU) based on aortic neck criteria. Multivariable logistic regression models were used to assess associations between aneurysm sac enlargement, reintervention, and type Ia endoleak with IFU status. Kaplan-Meier time-to-event models estimated reintervention, aneurysm sac enlargement, and overall survival. RESULTS: We identified 5,488 patients with at least 1 follow-up recorded. Those treated off-IFU included 1,236 patients ([23%] mean follow-up 401 days) compared with 4,252 (77%) treated on-IFU (mean follow-up 406 days). There was no evidence of significant differences in crude 30-day survival (96% vs 97%; p = 0.28) or estimated 2-year survival (97% vs 97%; log-rank p = 0.28). Crude type Ia endoleak frequency was greater in patients treated off IFU (2% vs 1%; p = 0.03). Off-IFU EVAR was associated with type Ia endoleak on multivariable regression model (odds ratio 1.84 [95% CI 1.23 to 2.76]; p = 0.003). Patients treated off IFU vs on IFU experienced had increased risk of reintervention within 2 years (7% vs 5%; log-rank p = 0.02), a finding consistent with results from the Cox modeling (hazard ratio 1.38 [95% CI 1.06 to 1.81]; p = 0.02). CONCLUSIONS: Patients treated off IFU were at greater risk for type Ia endoleak and reintervention, although they had similar 2-year survival compared with those treated on IFU. Patients with anatomy outside IFU should be considered for open surgery or complex endovascular repair to reduce the probability for revision.

Impact of Patent Lumbar Arteries on Aneurysm Sac Enlargement with Type II Endoleak after Endovascular Aneurysm Repair.

OBJECTIVE: This study aimed to investigate the impact of the number of patent lumbar arteries (LAs) on sac enlargement after endovascular aneurysm repair (EVAR). METHODS: This was a retrospective cohort single centre registry study. Between January 2006 and December 2019, 336 EVARs were reviewed using a commercially available device excluding type I or type III endoleaks during a follow up of ≥ 12 months. Patients were divided into four groups based on the pre-operative patency of the inferior mesenteric artery (IMA) and high (≥ 4) or low (≤ 3) number of patent LAs: Group 1, patent IMA and high number of patent LAs; Group 2, patent IMA and low number of patent LAs; Group 3, occluded IMA and a high number of patent LAs; Group 4, occluded IMA and low number of patent LAs. RESULTS: Groups 1, 2, 3, and 4 included 124, 104, 45, and 63 patients, respectively. The median follow up duration was 65.1 months. Significant differences in the incidence of overall type II endoleak (T2EL) at discharge between Group 1 and Group 2 (59.7% vs. 36.5%, p < .001) and between Group 3 and Group 4 (33.3% vs. 4.8%, p < .001) were observed. In patients with a pre-operatively patent IMA, the rate of freedom from aneurysm sac enlargement was significantly lower in Group 1 than in Group 2 (69.0% vs. 81.7% five years after EVAR, p < .001). In patients with a pre-operatively occluded IMA, the freedom rate from aneurysm sac enlargement was not significantly different between Groups 3 and Group 4 (95.0% vs. 100% five years after EVAR, p = .075). CONCLUSION: A high number of patent LAs seemed to have a significant role in sac enlargement with T2EL when the IMA was patent pre-operatively, whereas a high number of patent LAs seemed to have limited influence on sac enlargement when the IMA was occluded pre-operatively.

Incidence, Risk Factors, and Prognostic Impact of Type Ib Endoleak Following Endovascular Repair for Abdominal Aortic Aneurysm: Scoping Review.

OBJECTIVE: The primary objectives of this scoping review were to assess the rate of and risk factors for type Ib endoleak and to evaluate the extent of the evidence base that links type Ib endoleak to short and long term outcomes in patients undergoing endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA). METHODS: Potentially eligible studies were searched in the Cochrane Central Register of Controlled Trials, MEDLINE, Web of Science Core Collection, SciELO Citation Index, Russian Science Citation Index, and KCI-Korean Journal Database. A scoping review was performed according to PRISMA extension for Scoping Reviews. RESULTS: A total of 27 articles (four prospective registries and 23 retrospective cohort studies) dealing with type Ib endoleak were included in the final analysis. The number of patients reported on was 7 197, with follow up ranging between 12 months and 93 months. The reported frequency of type Ib endoleak in patients treated with EVAR ranged from 0% to 8%, Patient and or procedure related factors associated with risk of type Ib endoleak were (1) common iliac artery (CIA) diameter ˃ 18 mm requiring use of flared stent graft limbs (FLs) ˃ 20 mm, (2) length of CIA landing zone ˂ 20 mm, (3) marked iliac tortuosity, and (4) large initial AAA diameter. Depending on the study, 50 - 100% of type Ib endoleaks were corrected by endovascular means, with a reported immediate technical success of 100% in the studies providing this information. CONCLUSION: Type Ib endoleak after EVAR has been reported to occur in 0 - 8% of cases. Several anatomical features, including CIA diameter ˃ 18 mm or requiring the use of FLs ˃ 20 mm, length of CIA landing zone ˂ 20 mm, marked iliac tortuosity, and large initial AAA diameter, could increase the risk of type Ib endoleak and may require alternative therapeutic options and or more stringent follow up. Therefore, this updated scoping review provides a comprehensive summary of the frequency, risk factors, prognosis, and treatment of type Ib endoleaks, and has identified knowledge gaps in the literature to guide further studies.

Incidence, reintervention, and survival associated with type II endoleak at hospital discharge after elective endovascular aneurysm repair in the Vascular Quality Initiative.

BACKGROUND: The longitudinal clinical significance of type II endoleaks (T2ELs) remains controversial. Specifically, the real-world incidence, need for reintervention, and associated mortality referable to T2ELs remain unknown. Moreover, current professional society clinical practice guidelines recommend differing aneurysm sac growth thresholds to prompt intervention. Therefore, the purpose of this analysis was to better quantify the prevalence of early T2ELs after infrarenal endovascular aortic aneurysm repair (EVAR) and determine its association with reintervention and survival. METHODS: All elective EVARs from the Vascular Quality Initiative (2010-2020) were examined to identify patients with isolated T2ELs vs no endoleak (NONE) at discharge. Procedures with a type I or III endoleak were excluded. A subgroup analysis was performed on patients surviving beyond the first postoperative year with follow-up data available on endoleaks. The primary outcome was overall survival. Secondary outcomes included perioperative mortality and reinterventions. Outcomes were assessed by multivariable logistic and Cox proportional hazards regression to adjust for covariates. RESULTS: We identified 53,697 patients who underwent EVAR. The overall incidence of isolated T2ELs at discharge was 16%. In-hospital mortality was lower for those with isolated T2ELs vs NONE (0.8% vs 1.9%, odds ratio: 0.6, 95% confidence interval: 0.5-0.8, P < .0001). Unadjusted overall survival was marginally higher at 5 years for patients with T2ELs vs NONE (84% vs 82%); however, after risk adjustment, survival was similar (hazard ratio: 0.95, 95% confidence interval: 0.9-1.0). Among 44,345 patients with 1-year follow-up, 66% had data on endoleak status for assessment. Survival was similar regardless of endoleak status (NONE, at discharge only, at follow-up only, or at both time points). Among patients with documented T2ELs during follow-up, 6.1% and 2.5% had abdominal aortic aneurysm sac diameter growth ≥5 mm and ≥10 mm, respectively. Reinterventions occurred in 12%. Rupture (1%) and any open reintervention (4%) were rare among patients with 1-year follow-up. For patients with T2ELs, 5-year survival was similar between those with and without reintervention by 1 year (89% vs 91%, log-rank P = .06). CONCLUSIONS: T2ELs remain common after EVAR within the Vascular Quality Initiative and are not associated with long-term mortality. Reinterventions for T2ELs were not associated with improved overall survival among patients with T2ELs. Although additional data surrounding the appropriate role of reintervention for T2ELs remain necessary, it appears that the natural history of T2ELs is benign.

Incidence, Long Term Clinical Outcomes, and Risk Factor Analysis of Type III Endoleaks Following Endovascular Repair of Abdominal Aortic Aneurysm.

OBJECTIVE: To assess the real world incidence, outcomes, and risk factors of type III endoleaks (TIIIEL) after endovascular aneurysm repair (EVAR). METHODS: This was a single centre, retrospective, observational, cohort study. All patients with abdominal aortic aneurysms (AAAs) receiving EVAR between 1994 and 2020 were collected prospectively and reviewed. The primary outcome was the cumulative incidence and impact on survival of TIIIELs, either defined as disconnections of modular graft components (TIIIaEL) or fabric defects (TIIIbEL). Secondary outcomes included risk factor analysis evaluating baseline morphological and stent graft details, as well as a comparison of TIIIaEL and TIIIbEL. RESULTS: In total, 2 565 EVARs were performed and 95 (3.7%) TIIIELs were diagnosed at a median interval of 49.5 months (interquartile range [IQR] 19.4, 67.6). Estimated TIIIEL incidence at five years was 6.8%, 2.2%, and 3.6% for first and second generation, third and fourth generation, and fifth and sixth generation, respectively. The survival rate in patients without any high flow endoleak was 88.0%, 67.9%, 56.9%, and 52.1%, while in TIIIEL patients it was 98.6%, 77.2%, 49.8%, and 32.3% at one, five, 10, and 15 years, respectively (p = .77). The distribution of TIIIaEL and TIIIbEL was 70.5% and 29.5%, respectively. TIIIbEL received a higher rate of open treatment (28.6% vs. 7.5%; p = .005) and device or procedure related re-interventions (35.7% vs. 13.4%; p = .013). Fourteen (15.4%) recurrent TIIIELs were diagnosed at a median of 16.8 months (IQR 7.6, 32.1). Old generation endografts (hazard ratio [HR] 2.1, 95% confidence interval [CI] 1.3 - 3.4; p = .002) and non-proprietary extensions (HR 3.6, 95% CI 1.9 - 6.8; p < .001), and angulated and calcified aneurysm neck (HR 3.6, 95% CI 1.2 - 10.6; p = .017) were risk factors for TIIIEL. Every 10 mm maximum AAA diameter increase presented a 1.4 fold higher risk of TIIIEL. CONCLUSION: TIIIEL is a severe condition that is often fatal if left untreated. Old endografts, the implantation of non-proprietary extensions, large AAAs, and angulated and calcified necks are risk factors for TIIIEL that require careful follow up due to the high rate of recurrence.

An updated systematic review and meta-analysis of pre-emptive aortic side branch embolization to prevent type II endoleaks after endovascular aneurysm repair.

OBJECTIVE: Pre-emptive embolization of aortic side branches may be effective in preventing type II endoleaks (T2EL) based on a previous systematic review and meta-analysis by our group. Data up to 2019 was, however, only based on retrospective studies. The aim of the current study was to update the meta-analysis and evaluate the current evidence on this treatment strategy. METHODS: A systematic literature search was performed with the same keywords and strategies used in the previous study. The complementary search included all articles published from January 1, 2019, through May 29, 2022. The incidence of aneurysm sac growth was the primary outcome of interest. RESULTS: Four new studies were identified, including one randomized controlled study and one nationwide registry-based retrospective study. Overall, the incidence of sac size enlargement was 4.3% in the embolization group compared with 6.8% in the control group (odds ratio [OR], 0.38; 95% confidence interval [CI], 0.26-0.55), the incidence of T2EL was 19.7% vs 37.4% (OR, 0.38; 95% CI, 0.30-0.47), and the incidence of reintervention for T2EL was 1.2% vs 11.2% (OR, 0.12; 95% CI, 0.06-0.23). CONCLUSIONS: Current evidence confirms lower incidence of aneurysm sac growth, T2EL, and reinterventions when pre-emptive embolization of aortic side branches is performed in conjunction with endovascular aneurysm repair, compared with no embolization. However, a higher level of evidence is still required to support a broad change of practice, including data on cost-effectiveness and on the potential effect on rupture.

Routine Inferior Mesenteric Artery Embolisation is Unnecessary Before Endovascular Aneurysm Repair.

OBJECTIVE: A type II endoleak is the most common complication during surveillance after endovascular aneurysm repair (EVAR), and a patent inferior mesenteric artery (IMA) is a known risk factor for an endoleak. The effect of routine IMA embolisation prior to EVAR on overall outcome is unknown. The aim of the study was to compare two strategies: routine attempted IMA embolisation prior to EVAR (strategy in centre A) and leaving the IMA untouched (strategy in centre B). METHODS: Patients were treated with EVAR in two centres during the period 2005 - 2015, and the data were reviewed retrospectively. The primary endpoints were re-intervention rate due to type II endoleaks and the late IMA embolisation rate. Secondary endpoints included EVAR related re-intervention, sac enlargement, aneurysm rupture, and open conversion rates. RESULTS: Strategy A was used to treat 395 patients. The IMA was patent in 268 (67.8%) patients, and embolisation was performed in 164 (41.5%). The corresponding figures for strategy B were 337 patients with 279 (82.8%) patent IMAs, two (0.6%) of which were embolised. The mean duration of follow up was 70 months for strategy A and 68.2 months for strategy B. The re-intervention rates due to a type II endoleak were 12.9% and 10.4%, respectively (p = .29), with no significant difference in the rate of re-interventions to occlude a patent IMA (2.0% and 4.7%, respectively; p = .039). The EVAR related re-intervention rate was similar, regardless of strategy (24.1% and 24.6%, respectively; p = .93). Significant sac enlargement was seen in 20.3% of cases treated with strategy A and in 19.6% treated with strategy B (p = .82). The rupture and conversion rates were 2.5% and 2.1% (p = .69) and 1.0% and 1.5% (p = .40), respectively. CONCLUSION: The strategy of routinely embolising the IMA does not seem to yield any significant clinical benefit and should therefore be abandoned.

European Multicentric Experience With Fenestrated-branched ENDOvascular Stent Grafting After Previous FAILed Infrarenal Aortic Repair: The EU-FBENDO-FAIL Registry.

OBJECTIVE: To report the mid-term outcomes of fenestrated-branched endovascular aneurysm repair (F-BEVAR) following a failed previous endovascular aneurysm repair (pEVAR) or previous open aneurysm repair (pOAR). METHODS: Data from consecutive patients who underwent F-BEVAR for pEVAR or pOAR from 2006 to 2021 from 17 European vascular centers were analyzed. Endpoints included technical success, major adverse events, 30-day mortality, and 5-year estimates of survival, target vessel primary patency, freedom from reinterventions, type I/III endoleaks, and sac growth >5 mm. BACKGROUND: Treatment of a failed previous abdominal aortic aneurysm repair is a complex undertaking. F-BEVAR is becoming an increasingly attractive option, although comparative data are limited regarding associated risk factors, indications for treatment, and various outcomes. RESULTS: There were 526 patients included, 268 pOAR and 258 pEVAR. The median time from previous repair to F-BEVAR was 7 (interquartile range, 4-12) years, 5 (3-8) for pEVAR, and 10 (6-14) for pOAR, P <0.001. Predominant indication for treatment was type Ia endoleak for pEVAR and progression of the disease for pOAR. Technical success was 92.8%, pOAR (92.2%), and pEVAR (93.4%), P =0.58. The 30-day mortality was 6.5% overall, 6.7% for pOAR, and 6.2% for pEVAR, P =0.81. There were 1853 treated target vessels with 5-year estimates of primary patency of 94.4%, pEVAR (95.2%), and pOAR (94.4%), P =0.03. Five-year estimates for freedom from type I/III endoleaks were similar between groups; freedom from reintervention was lower for pEVAR (38.3%) than for pOAR (56.0%), P =0.004. The most common indication for reinterventions was for type I/III endoleaks (37.5%). CONCLUSIONS: Repair of a failed pEVAR or pOARis safe and feasible with comparable technical success and survival rates. While successful treatment can be achieved, significant rates of reintervention should be anticipated, particularly for issues related to instability of target vessels/bridging stents.

Three-year follow-up of aortic arch endovascular stent grafting with the Nexus device: results from a prospective multicentre study.

OBJECTIVES: Endovascular aortic arch stent grafting with branched devices has shown initial promising results. The aim of this prospective, multicentre study was to evaluate 3-year outcomes of aortic arch stent grafting with NEXUS® Aortic Arch Stent Graft System (Nexus), a single-branch, bi-modular, off-the-shelf aortic arch stent graft system in high-risk patients. METHODS: Patients treated with Nexus, either under the feasibility clinical study or as compassionate use procedures in 5 centres, were included in this study. The primary end point was overall survival. The secondary end points included the incidence of procedure-related unplanned intervention, stroke, paraplegia and endoleak. Clinical and radiologic follow-up was performed at each study site at 30 days, 6 months and on a yearly basis thereafter up to 3 years postoperatively. RESULTS: We analysed data from a total of 28 patients. The overall median follow-up was 1132 (interquartile range: 809-1537). There were no device or procedure-related deaths between 1 and 3 years. Overall survival at 1 and 3 years was 89% and 71%, respectively. The cumulative incidence of unplanned reintervention at 1 and 3 years was 11% and 29%, respectively. There were no reports of stroke, paraplegia, aneurysm rupture, myocardial infarction or new aortic valve insufficiency. In this study's 1-3 year follow-up period, 1 type Ib (4%), 1 type II (4%) and 2 type III (8%; between Nexus' distal end and Thoracic endovascular aortic repair (TEVAR) extensions) endoleak were detected. CONCLUSIONS: Endovascular aortic arch exclusion with the single-branch, off-the-shelf Nexus system provides promising clinical and radiologic results at 3-year follow-up in a high-risk patient cohort.

Aortic remodeling, distal stent-graft induced new entry and endoleak following frozen elephant trunk: A systematic review and meta-analysis.

BACKGROUND: The introduction of the frozen elephant trunk (FET) technique for total arch replacement (TAR) has revolutionized the field of aortovascular surgery. However, although FET yields excellent results, the risk of certain complications requiring secondary intervention remains present, negating its one-step hybrid advantage over conventional techniques. This systematic review and meta-analysis sought to evaluate controversies regarding the incidence of FET-related complications, with a focus on aortic remodeling, distal stent-graft induced new entry (dSINE) and endoleak, in patients with type A aortic dissection (TAAD) and/or thoracic aortic aneurysm. MATERIALS AND METHODS: A comprehensive literature search was conducted using multiple electronic databases including EMBASE, Scopus, and PubMed/MEDLINE to identify evidence on TAR with FET in patients with TAAD and/or aneurysm. Studies published up until January 2022 were included, and after applying exclusion criteria, a total of 43 studies were extracted. RESULTS: A total of 5068 patients who underwent FET procedure were included. The pooled estimates of dSINE and endoleak were 2% (95% confidence interval [CI] 0.01-0.06, I2 = 78%) and 3% (95% CI 0.01-0.11, I2 = 89%), respectively. The pooled rate of secondary thoracic endovascular aortic repair (TEVAR) post-FET was 7% (95% CI 0.05-0.12, I2 = 89%) while the pooled rate of false lumen thrombosis at the level of stent-graft was 91% (95% CI 0.75-0.97, I2 = 92%). After subgroup analysis, heterogeneity for distal stent-graft induced new entry (dSINE) and endoleak resolved among European patients, where Thoraflex Hybrid (THP) and E-Vita stent-grafts were used (both I2 = 0%). In addition, heterogeneity for secondary TEVAR after FET resolved among Asians receiving Cronus (I2 = 15.1%) and Frozenix stent-grafts (I2 = 1%). CONCLUSION: Our results showed that the FET procedure in patients with TAAD and/or aneurysm is associated with excellent results, with a particularly low incidence of dSINE and endoleak as well as highly favorable aortic remodeling. However the type of stent-graft and the study location were sources of heterogeneity, emphasizing the need for multicenter studies directly comparing FET grafts. Finally, THP can be considered the primary FET device choice due to its superior results.

Coverage of the Coeliac Artery During Thoracic Endovascular Aortic Repair: A Systematic Review and Meta-Analysis.

OBJECTIVE: To investigate the clinical impact of coeliac artery (CA) coverage during thoracic endovascular aortic repair (TEVAR). METHODS: This systematic review and meta-analysis was conducted according to the PRISMA guidelines. Electronic databases were searched from 1989 to 2020 for studies reporting visceral ischaemia, spinal cord ischaemia (SCI), 30 day/in hospital mortality, endoleaks, re-intervention, and caudal stent graft migration following CA coverage in patients undergoing TEVAR. Meta-analysis was conducted using random effects modelling. The quality of the evidence was graded using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. RESULTS: Fifteen observational studies with 236 patients (108 male, age range 61.3 - 79 years) were included. The pooled visceral ischaemia rate was 13% with significant heterogeneity between studies (95% confidence intervals [CI] 4 - 24; I2 = 72%, p < .001). The SCI rate was 5% (95% CI 2 - 9; I2 = 0%); the 30 day/in hospital mortality was 4% (95% CI 1 - 7; I2 = 0%); the overall endoleak rate was 21% (95% CI 13 - 29; I2 = 35%) with a 5% (95% CI 0 - 13; I2 = 38%) rate of type Ib and 2% (95% CI 0 - 8; I2 = 43%) rate of type II endoleak from retrograde CA flow. The re-intervention rate was 13% (95% CI 6 - 22; I2 = 54%); the caudal stent graft migration rate was 3% (95% CI 0 - 9, I2 = 0%). The certainty of the body of evidence was judged to be very low for all outcomes. CONCLUSION: CA coverage during TEVAR is associated with high rates of visceral ischaemia, spinal cord ischaemia, 30 day/in hospital mortality, endoleaks, and re-intervention. Although the literature is of poor quality and questions remain over effects estimates, there is evidence that CA coverage should be avoided if at all possible, during TEVAR. REGISTRATION: PROSPERO registration number 244084.

Nationwide Analysis of Persistent Type II Endoleak and Late Outcomes of Endovascular Abdominal Aortic Aneurysm Repair in Japan: A Propensity-Matched Analysis.

BACKGROUND: We reviewed the results of endovascular aneurysm repair in patients from the Japanese Committee for Stentgraft Management registry to determine the significance of persistent type II endoleak (p-T2EL) and the risk of late adverse events, including aneurysm sac enlargement. METHODS: The prospectively captured medical records of 17 099 patients <75 years of age who underwent endovascular aneurysm repair for abdominal aortic aneurysm from 2006 to 2015 were reviewed. Patients were divided into 2 groups (with or without p-T2EL) and compared to examine the correlation between p-T2EL and the occurrence of aneurysm sac enlargement after endovascular aneurysm repair. RESULTS: Of the patients, 4957 (29.0%) had p-T2EL and 12 142 (71.0%) had no p-T2EL (non-T2EL). Mean age was significantly higher (P<0.001), and there were fewer men (P<0.001) in the p-T2EL group. Among comorbidities, hypertension (P=0.019) and chronic kidney disease (P=0.040) were more prevalent and respiratory disorders were less prevalent (P<0.001) in the p-T2EL group. From each group, 4957 patients were matched according to propensity score to adjust for differences in patient characteristics. The cumulative incidence rates of abdominal aortic aneurysm-related mortality (p-T2EL: 52 of 4957 [1.0%] versus non-T2EL: 21 of 12 142 [0.2%]), rupture (p-T2EL: 38 of 4957 [0.8%] versus non-T2EL: 13 of 12 142 [0.1%]), sac enlargement (≥5 mm; p-T2EL: 1359 of 4957 [27.4%] versus non-T2EL: 332 of 12 142 [2.7%]), and reintervention (p-T2EL: 739 of 4957 [14.9%] versus non-T2EL: 91 of 12 142 [0.7%]) were significantly higher in the p-T2EL than the nonpT2EL group (P<0.001). Propensity score matching yielded higher estimated incremental risk, including abdominal aortic aneurysm-related mortality, rupture, sac enlargement (≥5 mm), and reintervention for p-T2EL (P<0.001). Cox regression analysis revealed older age (P=0.010), proximal neck diameter (P=0.003), and chronic kidney disease (P<0.001) as independent positive predictors and male sex as an independent negative predictor (P=0.015) of sac enlargement. CONCLUSIONS: The Japanese Committee for Stentgraft Management registry data show a correlation between p-T2EL and late adverse events, including aneurysm sac enlargement, reintervention, rupture, and abdominal aortic aneurysm-related mortality after endovascular aneurysm repair. Besides p-T2EL, older age, female sex, chronic kidney disease, and dilated proximal neck were associated with sac enlargement.

Significance of preoperative thrombus burden in the prediction of a persistent type II and reintervention after infrarenal endovascular aneurysm repair.

BACKGROUND: Persistent type II endoleak has necessitated prolonged surveillance and is a reason for reintervention after infrarenal endovascular aneurysm repair (EVAR). The aim of this study was to assess the association of thrombus burden (TB) within the aneurysmal sac in the prediction of a persistent type II endoleaks. METHODS: Consecutive patients who underwent infrarenal EVAR from October 2009 to October 2017 in a single vascular network were included. TB was assessed on preoperative computed tomography angiogram and was defined as a percentage of thrombus across the maximal sac diameter in comparison with the luminal diameter measured orthogonally at the same level. Patients were categorized into three groups: low TB (<25%), medium TB (25%-50%), and high TB (>50%). All patients underwent postoperative EVAR surveillance comprising computed tomographic angiography or duplex ultrasound imaging. Type II endoleak observed for more than 1 year was defined as persistent type II endoleak. Odds ratio (OR) and Student's t-test were used to determine significance. RESULTS: Some 275 EVARs were performed in the study period. A total of 45 procedures were excluded because of either iliac-only intervention (n = 9), no preoperative information (n = 7), abandoned (n = 1), or less than 1 year's follow-up data (n = 28). For the 230 procedures included, the median follow-up was 43 (12-102) months. There were no significant differences between the groups for age, gender, and comorbidities nor preoperative sac diameter. There was high interobserver reliability with a kappa value of 0.89 (0.84-0.94) with a total discordance of 7% across the cohorts. Persistent type II endoleak occurred significantly more frequently with reduced TB: 41% of the low TB cohort compared with 4% of the high TB cohort (OR, 15.36 [3.5-67.3]; P = .0003). Reintervention was also significantly more likely to occur in the presence of a persistent type II endoleak compared with its absence; n = 12 of 13 (92%) patients who underwent reintervention had a persistent type II endoleak (OR, 43.4 [5.5-242]; P = .0003). Sac size reduction was significantly greater in medium TB and high TB cohorts when compared with low TB: -25% and -27% vs -15% (P = .0046 and P < .0001). Decreased TB was associated with a significant increase in inferior mesenteric artery (IMA) patency, the mean TB, where the IMA was patent, being 29% compared with 40% where the IMA was occluded P < .0001. When considered together, patients with a low TB and a patent IMA were even more likely to have a persistent type II endoleak when compared with those with a high TB and an occluded IMA (OR, 34.1 [1.99-583]; P = .015). CONCLUSIONS: Low TB is associated with increased rates of persistent type II endoleak, especially in the presence of a patent IMA. High TB is associated with increased sac regression and low reintervention rates. TB can be assessed reliably and could be used for risk stratification in the planning of infrarenal EVAR. Pre-emptive embolization of IMA or lumbar vessels in those with low TB may be beneficial. TB could be a useful tool for designing a post-EVAR surveillance regimen.

Long-term results of treatment of infrarenal aortic aneurysms with low-profile stent grafts in a multicenter registry.

OBJECTIVE: In recent years, manufacturers have developed new stent grafts with lower profiles to increase the endovascular aneurysm repair applicability. As reported by the current European Society for Vascular Surgery guidelines, long-term evaluation of such low-profile platforms is strongly recommended. This study aims to report outcomes beyond 5 years from a multicenter registry, including a real-world cohort of patients electively treated with low-profile stent grafts. METHODS: A retrospective data collection of patients who had undergone elective implantation of low-profile endograft ≤16 Fr. (Zenith LP, Ovation, Incraft) was performed in nine centers. The primary endpoint was a long-term primary clinical success. Secondary endpoints were survival rate, freedom from abdominal aortic aneurysm (AAA)-related death, freedom from type I to III endoleak, limb patency, and freedom from all reinterventions. The Kaplan-Meier curves were stratified for investigative devices. A multivariate analysis evaluated predictors of primary clinical success and reintervention rate. RESULTS: A total of 619 patients were enrolled (Ovation, n = 373; Incraft, n = 111; and Zenith LP, n = 135), with a mean follow-up of 56.8 ± 22.8 months. The overall primary and the secondary clinical success rate at 8 years was 72.1% and 93.8%, respectively. At 8 years, overall survival was 53.2%, freedom from AAA-related death was 94.4%, freedom from reintervention was 74%, freedom from type I/III endoleak was 86.9%, and limb patency was 90.4%. A significantly worse primary clinical success of the Zenith LP was recorded as dependent on more limb-related events. No differences between platforms were registered in the rate of AAA-related deaths, open conversion, sac enlargement, and type I/III endoleaks (P = .26). Multivariate analysis identified iliac tortuosity (hazard ratio, 2.053) and Zenith LP (hazard ratio, 3.818) as significant independent predictors of clinical failure and reintervention. CONCLUSIONS: Low-profile stent grafts have acceptable long-term outcomes. Overall survival and AAA-related death were in line with those reported for traditional devices. Long-term surveillance and reintervention, when necessary, remain crucial to guarantee durability.

Outcomes of intramural hematoma involving the ascending aorta and extending into the descending thoracic aorta.

OBJECTIVE: The optimal treatment of intramural hematoma (IMH) involving the ascending aorta remains controversial. This study aimed to analyze the results of the management of patients with acute IMH involving the ascending aorta and extending into the descending thoracic aorta, to compare outcomes of descending thoracic endovascular aortic repair (TEVAR) with that of medical therapy (MT), and to assess the risk factors associated with adverse aortic events. METHODS: We retrospectively analyzed all patients diagnosed with acute IMH involving the ascending aorta and extending into the descending thoracic aorta from January 2012 to December 2019. The primary end points during follow-up were aortic disease-related death and adverse aorta-related events that required surgical or endovascular treatment, such as aortic rupture, the progression of aortic disease, or endoleak. RESULTS: We identified a total of 135 patients with acute IMH involving the ascending aorta and extending into the descending thoracic aorta, of whom 104 underwent descending TEVAR (group 1) and 31 were managed with MT (group 2). Freedom from adverse aorta-related events at 1, 3, and 5 years was significantly higher for patients who underwent descending TEVAR compared with those managed with MT (89.2%, 88.2%, and 84.0% vs 74.2%, 74.2%, and 74.2%, respectively; P = .026). The 1-, 3-, and 5-year survival rates for patients in the descending TEVAR group was 100%, 100%, and 100%, respectively, which was significantly higher than the survival of the MT group: 93.5%, 93.5%, and 81.9%, respectively (P = .002). On a univariate analysis among patients receiving MT, those who suffered adverse aorta-related events showed a higher prevalence of renal insufficiency (55.6% vs 9.1%; P = .003). In MT patients, multivariate analysis showed that renal insufficiency was the only independent risk factor associated with adverse aorta-related events (hazard ratio, 8.691; 95% confidence interval, 2.056-36.737; P = .003). CONCLUSIONS: Based on our study, compared with MT, descending TEVAR might be the more favorable treatment for patients with IMH involving the ascending aorta and extending into the descending thoracic aorta. Patients with renal insufficiency are more likely to experience adverse aorta-related events, which implies the need for subsequent intervention or an increased risk of mortality. The risk factor would be helpful for clinical decision-making.

Long-term outcomes and interventions of postoperative type 1a endoleak following elective endovascular aortic aneurysm repair.

OBJECTIVE: This study evaluated the incidence and long-term outcomes of postoperative type 1a endoleak (PT1a) following endovascular aortic aneurysm repair (EVAR). METHODS: A retrospective review of consecutive aortoiliac EVARs performed at a single institution from June 2006 to June 2012 was conducted. Patients with PT1a were identified by postoperative imaging and compared with those who did not develop a PT1a. Late outcomes were also studied of a subset of patients with PT1a who had persistent intraoperative type 1a endoleak (iT1a) on completion angiogram during EVAR that had resolved on initial follow-up imaging. RESULTS: Three hundred eighty-nine patients underwent EVAR with median follow-up of 87 months (interquartile range, 64-111 months). The incidence of PT1a was 8.2% (n = 32) with a median follow-up of 74 months (interquartile range, 52-138 months). Compared with the total cohort, those who developed PT1a were statistically more likely to be female (32% vs 17%; P = .03) and have a higher all-cause mortality (71% vs 40%; P < .01) and aneurysm-related mortality (15.6% vs 1.7%; P < .01). Median time to presentation was 52 months. Of the 32 patients with PT1a, five (15.6%) presented with aortic rupture, of which three underwent extension cuff placement, one had open graft explant, and one declined intervention. Six patients in total (18.7%) declined intervention; five of these died of nonaneurysmal causes and one remains alive. Of the 26 patients with PT1a who had intervention, 21 (80.7%) showed resolution of PT1a, and five (19.2%) had recurrence. For patients with recurrent PT1a, two had resulting aneurysm-related mortality, two endoleaks resolved after relining with an endograft, and one patient declined intervention but remains alive. Patients with PT1a who had intervention with resolution showed no significant difference in median survival estimates (140.0 months) compared with the remaining EVAR cohort (120.0 months; P = .80). Within the PT1a cohort, 6 (18.7%) had also experienced iT1a with a mean time to presentation of the late PT1a of 45 months. iT1a was associated with a significantly increased likelihood of developing a PT1a (P < .01) and decreased median survival (P < .01), but there was no known aneurysm-related mortality. CONCLUSIONS: Development of PT1a following elective EVAR is associated with increased all-cause and aneurysm-related mortality and presents an average of 52 months postoperatively. This underscores the importance of long-term surveillance. Patients with PT1a who had a successful intervention showed no significant difference in median survival. Those with iT1a had a higher risk for PT1a compared with the EVAR cohort overall and had decreased median survival, without increased aneurysm-related mortality.