Five-year outcomes of fenestrated and branched endovascular repair of complex aortic aneurysms based on aneurysm extent.

OBJECTIVE: The aim of this study was to evaluate the 5-year outcomes of fenestrated/branched endovascular aortic repair (F/BEVAR) for the treatment of complex aortic aneurysms stratified by the aneurysm extent. METHODS: Patients with the diagnosis of complex aortic aneurysm, who underwent F/BEVAR at a single center were included in this study and retrospectively analyzed. The cohort was divided according to the aneurysm extent, comparing group 1 (types I-III thoracoabdominal aneurysms [TAAAs]), group 2 (type IV TAAAs), and group 3 (juxtarenal [JRAAs], pararenal [PRAAs], or paravisceral [PVAAs] aortic aneurysms). The primary endpoints were 30-day and 5-year survival. The secondary endpoints were technical success, occurrence of spinal cord ischemia, primary patency of the visceral arteries, freedom from target vessel instability, and secondary interventions. RESULTS: Of 436 patients who underwent F/BEVAR between July 2012 and May 2023, 131 presented with types I to III TAAAs, 69 with type IV TAAAs, and 236 with JRAAs, PRAAs, or PVAAs. All cases were treated under a physician-sponsored investigational device exemption protocol with a patient-specific company-manufactured or off-the-shelf device. Group 1 had significantly younger patients than group 2 or 3 respectively (69.6 ± 8.7 vs 72.4 ± 7.1 vs 73.2 ± 7.3 years; P < .001) and had a higher percentage of females (50.4% vs 21.7% vs 17.8%; P < .001). Prior history of aortic dissection was significantly more common among patients in group 1 (26% vs 1.4% vs 0.9%; P < .001), and mean aneurysm diameter was larger in group 1 (64.5 vs 60.7 vs 63.2 mm; P = .033). Comorbidities were similar between groups, except for coronary artery disease (P < .001) and tobacco use (P = .003), which were less prevalent in group 1. Technical success was similar in the three groups (98.5% vs 98.6% vs 98.7%; P > .99). The 30-day mortality was 4.5%, 1.4%, and 0.4%, in groups 1, 2, and 3, respectively, and was significantly higher in group 1 when compared with group 3 (P = .01). The incidence of spinal cord ischemia was significantly higher in group 1 compared with group 3 (5.3% vs 4.3% vs 0.4%; P = .004). The 5-year survival was significantly higher in group 3 when compared with group 1 (P = .01). Freedom from secondary intervention was significantly higher in group 3 when compared with group 1 (P = .003). At 5 years, there was no significant difference in freedom from target vessel instability between groups or primary patency in the 1652 target vessels examined. CONCLUSIONS: Larger aneurysm extent was associated with lower 5-year survival, higher 30-day mortality, incidence of secondary interventions, and spinal cord ischemia. The prevalence of secondary interventions in all groups makes meticulous follow-up paramount in patients with complex aortic aneurysm treated with F/BEVAR.

Immediate Sequential Bilateral Surgery in Refractive Lens Exchange Patients: Clinical Outcomes and Adverse Events.

PURPOSE: To evaluate outcomes and the incidence of adverse events (AEs) in patients who underwent bilateral same-day refractive lens exchange (RLE). DESIGN: Retrospective case series. PARTICIPANTS: Patients of a private intraocular surgery provider in the United Kingdom who underwent RLE in both eyes on the same day with treatment dates between March 2018 and December 2021. METHODS: Clinical outcomes and AEs were collected for a continuous cohort of patients undergoing bilateral same-day RLE (in the absence of visually significant cataracts) or had mild cataracts (corrected visual acuity ≥ 20/40). One-month clinical outcomes were analyzed. MAIN OUTCOME MEASURES: Refractive outcomes and visual acuity, intraoperative and postoperative AEs, and secondary surgical interventions recorded within the first month after surgery. RESULTS: A total of 17 330 patients (34 660 eyes) were included in the analysis. Of these, 28 827 eyes received a multifocal intraocular lens (IOL), and 5833 eyes had a monofocal IOL. The percentage of eyes within ±0.50 diopters (D) of intended refraction was 85.5% and 86.2% for monofocal and multifocal IOL eyes, respectively. There was a total of 55 intraoperative AEs recorded in 55 eyes of 54 patients (per-eye incidence: 0.159%). Posterior capsule tear was the most common intraoperative event occurring in 37 eyes (0.107%). The number of AEs recorded within the first postoperative month was 267, occurring in 263 eyes of 177 patients (per-eye incidence: 0.759%). These included cystoid macular edema (CME) (172 eyes; 0.496%), significant corneal edema (28 eyes; 0.081%), persistent inflammation (27 eyes; 0.078%), significantly raised intraocular pressure (27 eyes; 0.078%), toxic anterior segment syndrome (8 eyes; 0.023%), wound leak (3 eyes; 0.009%), retinal detachment (1 eye; 0.003%), and retinal tear (1 eye; 0.003%). There were 56 secondary surgical interventions recorded within the first month of surgery, occurring in 54 eyes of 47 patients (per-eye incidence: 0.156%). The most common secondary intervention was the rotation of a misaligned toric IOL (24 eyes; 0.069%). CONCLUSIONS: Elective same-day bilateral RLE had a low incidence of serious AEs, and high refractive predictability. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

A Single Centre Long Term Follow Up of the Nellix Endovascular Aneurysm Sealing System.

OBJECTIVE: To evaluate the clinical performance at long term follow up of endovascular aneurysm sealing (EVAS, Endologix Inc. Nellix, Irvine, CA, USA) in the treatment of abdominal aortic aneurysm (AAA). METHODS: Observational, prospective, single centre study of primary AAA interventions with EVAS (n = 117) from November 2013 to November 2016. Endpoints were primary technical success, Nellix device failure, freedom from open surgical conversion (OSC), freedom from secondary intervention, sac rupture, total mortality, and aneurysm related mortality at long term follow up. RESULTS: The median age was 75 years (interquartile range [IQR] 70, 81 years) and 83% were male. The median AAA diameter was 58 mm (IQR 54, 60 mm). The median length of follow up was 6.2 years (IQR 5.6, 6.8 years). Primary technical success was 100%. Median time to Nellix failure was 5.6 years (IQR 3.3, 7.4 years). Freedom from Nellix failure at five and seven years was 54% (95% confidence interval [CI] 54.2 - 63.8%) and 36% (95% CI 22.3 - 49.7%), respectively. Freedom from OSC at five and seven years was 63% (95% CI 53.2 - 72.8%) and 59% (95% CI 47 - 71%), respectively. The secondary intervention rate was 11.4/100 person years. Freedom from secondary intervention at five and seven years was 52% (95% CI 42.2 - 61.8%) and 51% (95% CI 41.2 - 60.8%), respectively. The cumulative mortality rate at five and seven years was 36% and 54%, respectively. Secondary sac rupture occurred in 9.4% (11/117) with a rate of 2/100 person years. Aneurysm related mortality was 12% (14/117) with a rate of 2.5/100 person years. The median survival was four years (IQR 3, 5.6 years). Thirty day mortality for acute OSC was 67% (n = 3) and 17.1% (6/35) for elective OSC. CONCLUSION: Long term follow up showed an increased failure rate. Diligent surveillance after endovascular AAA treatment is mandatory, especially when promising new devices are put into clinical use.

Implications of secondary aortic intervention after thoracic endovascular aortic repair for acute and chronic type B dissection.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) has become a mainstay of therapy for acute and chronic type B aortic dissection (TBAD). Dynamic aortic morphologic changes, untreated dissected aorta, and persistent false lumen perfusion have significant consequences for reintervention after TEVAR for TBAD. However, few reports contrast differences in secondary aortic intervention (SAI) after TEVAR for TBAD or describe their influence on mortality. This analysis examined incidence, timing, and types of SAI after TEVAR for acute and chronic TBAD and determined their impact on survival. METHODS: All TEVAR procedures for acute and chronic TBAD (2005-2016) were retrospectively reviewed. Patients with staged (<30 days) or concomitant ascending aortic arch repair or replacement were excluded. Acuity was defined by symptom onset (0-30 days, acute; >30 days, chronic). SAI procedures were grouped into open (intended treatment zone or remote aortic site), major endovascular (TEVAR extension or endograft implanted at noncontiguous site), and minor endovascular (side branch or false lumen embolization) categories. Kaplan-Meier methodology was used to estimate freedom from SAI and survival. Cox proportional hazards were used to identify SAI predictors. RESULTS: TEVAR for TBAD was performed in 258 patients (acute, 49% [n = 128]; chronic, 51% [n = 130]). Mean follow-up was 17 ± 22 months with an overall SAI rate of 27% (n = 70; acute, 22% [28]; chronic, 32% [42]; odds ratio, 1.7; 95% confidence interval, 0.9-2.9; P = .07]. Median time to SAI was significantly less after acute than after chronic dissection (0.7 [0-12] vs 7 [0-91] months; P < .001); however, freedom from SAI was not different (1-year: acute, 67% ± 4%, vs chronic, 68% ± 5%; 3-year: acute, 65% ± 7%, vs chronic, 52% ± 8%; P = .7). Types of SAI were similar (acute vs chronic: open, 61% vs 55% [P = .6]; major endovascular, 36% vs 38% [P = .8]; minor endovascular, 21% vs 21% [P = 1]). The open conversion rate (either partial or total endograft explantation: acute, 10% [13/128]; chronic, 15% [20/130]; P = .2) and incidence of retrograde dissection (acute, 6% [7/128]; chronic, 4% [5/130]; P = .5) were similar. There was no difference in survival for SAI patients (5-year: acute + SAI, 55% ± 9%, vs acute without SAI, 67% ± 8% [P = .3]; 5-year: chronic + SAI, 72% ± 6%, vs chronic without SAI, 72% ± 7% [P = .7]). Factors associated with SAI included younger age, acute dissection with larger maximal aortic diameter at presentation, Marfan syndrome, and use of arch vessel adjunctive procedures with the index TEVAR. Indication for the index TEVAR (aneurysm, malperfusion, rupture, and pain or hypertension) or remote preoperative history of proximal arch procedure was not predictive of SAI. CONCLUSIONS: SAI after TEVAR for TBAD is common. Acute TBAD has a higher proportion of early SAI; however, chronic TBAD appears to have ongoing risk of remediation after the first postoperative year. SAI types are similar between groups, and the occurrence of aorta-related reintervention does not affect survival. Patients' features and anatomy predict need for SAI. These data should be taken into consideration for selection of patients, device design, and surveillance strategies after TEVAR for TBAD.

Impact of secondary interventions on mortality after fenestrated branched endovascular aortic aneurysm repair.

BACKGROUND: Fenestrated and branched endovascular aortic repair (F/BEVAR) is increasingly used to manage pararenal and thoracoabdominal aortic disease (TAAA). Device-related reintervention after F/BEVAR is common, but little is known about its impact on postoperative mortality. The purpose of this analysis was to describe secondary intervention (SI) after F/BEVAR and determine the impact of these procedures on patient survival. METHODS: A single-center review was done on all consecutive F/BEVARs performed from 2010 to 2016. Primary end points were incidence of secondary aortic, branch, and/or access vessel‒related SI, and survival. SI was categorized as minor endovascular (branch restenting, access vessel treatment, or percutaneous coil embolization), major endovascular (new aortic graft placement), or open (bleeding, access vessel, and/or aortic). Kaplan-Meier methodology was used to estimate freedom from SI and survival. Multivariable analysis was used to identify predictors of SI. RESULTS: A total of 308 F/BEVAR procedures were performed (75% physician-modified, 18% custom, 7% Zfen), with 1022 vessels revascularized (celiac, 228; superior mesenteric artery [SMA], 263; renal, 525). There were 117 (39%) extent I-III TAAA, 132 (44%) extent IV TAAA/4-vessel pararenal, and 54 (18%) <4-vessel pararenal repairs performed. Any type of SI occurred in 24% (74) of patients during the mean follow-up of 20 ± 21 months. The majority of reinterventions were endovascular (minor, 53% [n = 39]; major, 32% [n = 24]), whereas 12% (n = 9) were open and 3% (n = 2) hybrid. Primary indication for SI included: 22 (29%) with branch-related endoleaks (1C or III); 15 (22%) with proximal or distal aortic degeneration; 8 (12%) with branch vessel thrombosis/stenosis; 10 (11%) with aortic device type III endoleak/loss of overlap; 4 (6%) with postoperative mesenteric or renal bleeding events; 5 (5%) with type II endoleak; 3 (5%) with access vessel complication; and 2 (3%) with graft infection. Most SIs were elective (65%; n = 48) with the remainder occurring emergently (24%; n = 18) or for symptoms/urgently (11%; n = 8). Compared with endovascular remediation, open SI was more likely to be emergent (89%, 8 of 9; P = .001). Freedom from SI was 80 ± 3% and 64 ± 4% at 1 and 3 years, respectively. One- and 5-year survival with or without SI was: 1 year, 88 ± 4% vs 81 ± 3%; 5 years, 76 ± 5% vs 59 ± 4% (log rank test, P = .06). There was no survival difference based on type of SI (log rank test, P = .3). Extent I-III TAAA (HR, 1.6; 95% CI, 0.98-3.3; P = .06) and history of cerebrovascular disease (HR, 1.8; 95% CI, 0.97-2.6; P = .07) were predictive of SI. CONCLUSIONS: SIs after F/BEVAR most frequently involve branch vessel or aortic device remediation procedures; however, they do not negatively impact out-of-hospital survival. These results further highlight the crucial role of imaging surveillance after F/BEVAR to maintain durability. Discussions with patients, periprocedural planning, and the next generation of device design must focus on issues surrounding the risk of device-related SI events.

Challenging Anatomy Predicts Mortality and Complications After Endovascular Treatment of Ruptured Abdominal Aortic Aneurysm.

PURPOSE: To analyze the effects of aortic anatomy and endovascular aneurysm repair (EVAR) inside and outside the instructions for use (IFU) on outcomes in patients treated for ruptured abdominal aortic aneurysms (rAAA). METHODS: All 112 patients (mean age 73 years; 102 men) treated with standard EVAR for rAAA between 2000 and 2012 in 3 European centers were included in the retrospective analysis. Patients were grouped based on aortic anatomy and whether EVAR was performed inside or outside the IFU. Data on complications, secondary interventions, and mortality were extracted from the patient records. Cox regression analysis was performed to assess predictors of mortality and complications; results are presented as the hazard ratio (HR) with 95% confidence interval (CI). Survival was analyzed using the Kaplan-Meier method. RESULTS: Of the 112 patients examined, 61 (54%) were treated inside the IFU, 43 (38%) outside the IFU, and 8 patients lacked adequate preoperative computed tomography scans for determination. Median follow-up of those surviving 30 days was 2.5 years. Mortality at 30 days was 15% (95% CI 6% to 24%) inside the IFU vs 30% (95% CI 16% to 45%) outside (p=0.087). Three-year mortality estimates were 33.8% (95% CI 20.0% to 47.5%) inside the IFU vs 56% (95% CI 39.7% to 72.2%) outside (p=0.016). At 5 years, mortality was 48% (95% CI 30% to 66%) inside the IFU vs 74% (95% CI 54% to 93%) outside (p=0.015). Graft-related complications occurred in 6% (95% CI 0% to 13%) inside the IFU and 30% (95% CI 14% to 42%) outside (p=0.015). The rate of graft-related secondary interventions was 14% (95% CI 4% to 22%) inside the IFU vs 35% (95% CI 14% to 42%) outside (p=0.072). In the multivariate analysis, neck length <15 mm (HR 8.1, 95% CI 3.0 to 21.9, p<0.001) and angulation >60° (HR 3.1, 95% CI 1.0 to 9.3, p=0.045) were independent predictors of late graft-related complications. Aneurysm neck diameter >29 mm (HR 2.5, 95% CI 1.1 to 5.9, p=0.035) was an independent predictor of overall mortality. CONCLUSION: Long-term mortality and complications after rEVAR are associated with aneurysm anatomy. The role of adjunct endovascular techniques and the outcome of open repair in cases with challenging anatomy warrant further study.

Late Rupture of Abdominal Aortic Aneurysm After Previous Endovascular Repair: A Systematic Review and Meta-analysis.

PURPOSE: To report a systematic literature review of late rupture of abdominal aortic aneurysm (AAA) after endovascular aneurysm repair (EVAR) and the results of a pooled analysis of causes, treatment, and outcomes. METHODS: Electronic information sources and bibliographic reference lists were interrogated using a combination of free text and controlled vocabulary searches; 11 articles were ultimately identified that fulfilled the inclusion criteria. The articles reported a total of 190 patients who were included in the qualitative and quantitative synthesis. Mortality within 30 days or during the admission with aneurysm rupture was a primary endpoint; major perioperative morbidity was a secondary endpoint. A meta-analysis was performed for 30-day/in-hospital mortality using the random effects model. RESULTS: A total of 152 ruptures occurred after 16,974 EVAR procedures reported by 8 of the case series, giving an incidence of 0.9% [95% confidence interval (CI) 0.77 to 1.05]. The mean time to rupture was 37 months. Twenty-nine percent (95% CI 20 to 39) of the patients had at least one previous secondary endovascular intervention following the initial EVAR, and 37% (95% CI 30 to 45) were not compliant with surveillance. Type I and III endoleaks were the predominant causes of rupture. Open surgical treatment was undertaken in 61% (95% CI 53 to 68) of the patients who underwent treatment. The pooled estimate for perioperative mortality was 32% (95% CI 24 to 41). A significantly lower mortality was found with endovascular treatment than open surgical management (p=0.027). CONCLUSION: Graft-related endoleaks appear to be the predominant causes of late aneurysm rupture. Quality of and compliance with post-EVAR surveillance are important factors in late rupture; a large proportion of late ruptures are amenable to endovascular treatment.

[Endovascular aneurysm repair (EVAR) : Update D]. / Endovaskuläre Aneurysmareparatur (EVAR) : Update D.

BACKGROUND: Abdominal aortic aneurysms can either be treated by open surgery or endovascular repair. In both cases, prostheses are implanted to prevent potentially lethal aortic ruptures. OBJECTIVES: Studies seeking to identify the optimal treatment came to diverging conclusions. The goal of this article is to shed light on the discussion of which treatment option is to be preferred. MATERIALS AND METHODS: This article summarizes the relevant studies on elective and emergency abdominal aortic aneurysm repair. The presented studies are discussed, and results are interpreted and compared. RESULTS: While most studies indicate lower short-term mortality rates in endovascular aneurysm repair (EVAR), mortality rates converged in multiple trials and even showed a lower mortality rate for open repair in mid-term analyses. Most recent studies indicate long-term equivalence in terms of mortality and a higher rate of secondary interventions in EVAR patients. CONCLUSIONS: The current body of literature indicates no real advantage of one therapy over another. The choice of therapy should depend on anatomic, clinical, and logistic criteria.

Secondary Interventions After TEVAR for Aortic Dissection.

The goal of thoracic endograft placement in type B aortic dissection is to prevent aneurysmal degeneration and other complications. Although TEVAR is a highly effective tool for managing type B aortic dissection, many patients will require additional interventions. In this article, we present a case-based review of techniques for the management of persistent false lumen perfusion and stent-graft induced new entry tears after TEVAR for aortic dissection.

Tier II Interventions within the Framework of School-Wide Positive Behavior Support: Essential Features for Design, Implementation, and Maintenance.

To meet the complex social behavioral and academic needs of all students, schools benefit from having available multiple evidence-based interventions of varying intensity. School-wide positive behavior support provides a framework within which a continuum of evidence-based interventions can be implemented in a school. This framework includes three levels or tiers of intervention; Tier I (primary or universal), Tier II (secondary or targeted), and Tier III (tertiary or individualized) supports. In this paper we review the logic behind school-wide positive behavior support and then focus on Tier II interventions, as this level of support has received the least attention in the literature. We delineate the key features of Tier II interventions as implemented within school-wide positive behavior support, provide guidelines for matching Tier II interventions to school and student needs, and describe how schools plan for implementation and maintenance of selected interventions.