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OBJECTIVE: To summarize available in-situ laser fenestration (ISLF) literature, including experimental studies with their subsequent recommendations regarding optimal fenestration technique and fabric; as well as the short and mid-term results of clinical studies.

METHODS: A systematic review of English articles was performed in MEDLINE, the Cochrane Database and EMBASE, following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines by two researchers. The search period was without starting date until the 31^st August 2020, and search terms included were in situ, laser, fenestration, and endograft. Quality assessment of the studies was performed using the Newcastle-Ottawa scale by two other independent researchers.

RESULTS: A total of 19 clinical studies were included, with a total of 428 patients (390 supra-aortic trunk ISLF, 38 visceral vessel ISLF). The technical success was 96.9% and 95.6% supra-aortic and visceral vessel ISLF, respectively. Most studies have less than 12-month follow-up, and the longest available follow-up (in one study) was 5-years for left-subclavian fenestration and 17-months for visceral vessel ISLF. Overall, the quality of the evaluated clinical studies was low. Six experimental studies were included, with the highest level of evidence suggesting fenestration of multifilament polyethylene terephthalate grafts, followed by dilation with either a 6- or 8-mm non-compliant balloon.

CONCLUSION: Experimental studies favour the use of multifilament polyethylene terephthalate , followed by dilation with non-compliant balloons as the most durable "in-vitro" technique for ISLF. Short-term outcomes for arch and visceral vessel revascularization are promising, with low rates of in-hospital mortality, stroke, and end-organ ischemia. Nonetheless, the long-term durability of ISLF is yet to be determined and they should be limited to selected symptomatic or urgent cases.

Background

The increasing proportion of elderly patients being treated for abdominal aortic aneurysm (AAA) in the endovascular era is controversial.

Objectives

This study compared 30-day outcomes of endovascular aortic repair (EVAR) in nonagenarians (NAs) with non-nonagenarians (NNAs).

Methods

This retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program database included EVAR procedures performed from 2011 to 2017. Multivariate logistic regression in the unadjusted cohort, followed by propensity-score matching (PSM), was performed. Primary outcomes were 30-day mortality and 30-day major adverse events.

Results

A total of 12,267 patients were included (365 NAs). Ruptured aneurysms accounted for 6.7% (n = 819): 15.7% (n = 57) in NAs versus 6.5% (n = 762) in NNAs (p < 0.001). Mean aneurysm diameter was 6.5 ± 1.8 cm in NAs versus 5.8 ± 1.7 cm in NNAs (p < 0.001). The unadjusted 30-day mortality was 9.9% in NA versus 2.2% in NNAs (p < 0.001). Multivariate analysis revealed age ≥90 years (odds ratio [OR]: 3.36), male sex (OR: 1.78), functional status (OR: 4.22), pre-operative ventilator dependency (OR: 3.80), bleeding disorders (OR: 1.52), dialysis (OR: 2.56), and ruptured aneurysms (OR: 17.21) as independent predictors of mortality. After PSM, no differences in 30-day mortality (intact AAA [iAAA]: 5.3% NA vs. 3% NNA [p = 0.15]; ruptured AAA [rAAA]: 38% NA vs. 28.6% NNA [p = 0.32]) or 30-day major adverse events (iAAA: 7% NA vs. 4.6% NNA [p = 0.22]; rAAA: 28% NA vs. 36.7% NNA [p = 0.35]) were observed.

Conclusions

Age was identified as an independent predictor of 30-day mortality after EVAR on multivariate analysis. However, no differences were found after PSM, suggesting that being ≥90 years of age but with similar comorbidities to younger patients is not associated with a higher short-term mortality after EVAR. Age ≥90 years alone should not exclude patients from EVAR, and tailored indications and carefully balanced risk assessment are advised.

Objective: To determine short and midterm outcomes of a pre-loaded fenestrated thoracic endograft (f-TEVAR) for exclusion of distal aortic arch pathologies.

Methods: This was a multicentre, retrospective study including consecutive patients from six experienced European vascular centres undergoing f-TEVAR for distal arch pathologies. Primary endpoints included peri-operative mortality and peri-operative stroke and/or spinal cord ischaemia rates. Secondary outcomes were technical success and mid to late events, including death and re-interventions. Statistical analysis was performed with SPSS 26. Mid to late term events were calculated using Kaplan-Meier survival analysis.

Results: One hundred and eight patients were included (mean age 68 ± 11 years, 70% men). A total of 38% (n = 42) had a prior history of aortic dissection, and 24% (n = 26) prior aortic surgery. The mean aneurysm diameter was 59 ± 12 mm and the most frequent indication for treatment was post-dissection aneurysms (n = 42, 39%). Technical success was 99% (n = 107) despite intra-operative wire entanglement occurring in 29% (n = 31). The 30 day mortality rate was 3.7% (n = 4), with a 5.6% major stroke incidence (n = 6) and 3.7% (n = 4) spinal cord ischaemia rate. Three cases of retrograde dissection occurred (two of which were fatal), all in post-type B dissecting aneurysm patients without prior aortic surgery (three of 19, 15.8%). Median follow up was 12 months (range, 1 - 26). Endoleaks were documented during follow up, with 3.5% type Ia (4/104) and 2.9% type Ib (3/104) as a result of persistent false lumen perfusion. The one, two, and three year survivals and freedom from re-intervention rates were 93.2% and 92.1%, 89.1% and 86.3%, and 84.4% and 73%, respectively.

Cconclusion: This multicentre study shows that treatment of the distal aortic arch by f-TEVAR is feasible, with promising 30 day mortality, stroke, and spinal cord ischaemia rates.

BACKGROUND: Acute occlusion of renal bridging stent grafts after fenestrated/branched endovascular aortic repair (F/B-EVAR) is an acknowledged complication with high morbidity that often results in chronic dialysis dependence. The feasibility and effect of timely or late (≥6 hours of ischemia) renal artery revascularization has not been adequately reported.

METHODS: We performed a retrospective, multicenter study across 11 tertiary institutions of all consecutive patients who had undergone revascularization of renal artery stent graft occlusions after complex EVAR. The end points were technical success, association between ischemia time and renal function salvage, interventional complications, mortality, and mid-term outcomes.

RESULTS: From 2009 to 2019, 38 patients with 46 target vessels (TVs; eight bilateral occlusions) were treated for renal artery occlusions after complex EVAR (mean age, 63.5 ± 10 years; 63.2% male). Six patients had a solitary kidney (15.8%). Of the 38 patients, 16 (42.1%) had undergone FEVAR and 22 (57.9%) had undergone BEVAR. The technical success rate was 95.7% (44 of 46 TVs). The recanalization technique used was sole aspiration thrombectomy in 5.3%, aspiration thrombectomy and stent graft relining in 52.6%, and sole stent graft relining in 36.8%. The median renal ischemia time was 27.5 hours (range, 4-720 hours; interquartile range, 4-36 hours). Most patients (94.4%) had been treated after ≥6 hours of renal ischemia time, and 55.6% had been treated after 24 hours. In 14 patients (36.8%), renal function had improved after intervention (mean glomerular filtration rate improvement, 14.2 ± 9 mL/min/1.73 m²). However, 24 patients (63.2%) showed no improvement. Improvement of renal function did not correlate with the length of renal ischemia time. Of the 14 patients with bilateral renal artery occlusion or a solitary kidney, 9 experienced partial recovery of renal function and no longer required hemodialysis. In-hospital mortality was 2.6%. The cause of renal stent graft occlusion could not be identified in 50% of the TVs (23 of 46). However, in 19 (41.3%), significant stenosis or a kink of the renal stent graft was found. The median follow-up was 11 months (interquartile range, 0-28 months). The estimated 1-year patient survival and patency rate of the renal stent grafts was 97.4% and 83.8%, respectively.

CONCLUSIONS: Revascularization of occluded renal bridging stent grafts after F/B-EVAR is a safe and feasible technique and can lead to significant improvement of renal function, even after long ischemia times (>24 hours) of the renal parenchyma or bilateral occlusion, as long as residual perfusion of the renal parenchyma has been preserved. Also, the long-term patency rates justify aggressive management of renal artery occlusion after F/B-EVAR.

Background

Ending the global tobacco epidemic is a defining challenge in global health. Timely and comprehensive estimates of the prevalence of smoking tobacco use and attributable disease burden are needed to guide tobacco control efforts nationally and globally.

Methods

We estimated the prevalence of smoking tobacco use and attributable disease burden for 204 countries and territories, by age and sex, from 1990 to 2019 as part of the Global Burden of Diseases, Injuries, and Risk Factors Study. We modelled multiple smoking-related indicators from 3625 nationally representative surveys. We completed systematic reviews and did Bayesian meta-regressions for 36 causally linked health outcomes to estimate non-linear dose-response risk curves for current and former smokers. We used a direct estimation approach to estimate attributable burden, providing more comprehensive estimates of the health effects of smoking than previously available.

Findings

Globally in 2019, 1·14 billion (95% uncertainty interval 1·13–1·16) individuals were current smokers, who consumed 7·41 trillion (7·11–7·74) cigarette-equivalents of tobacco in 2019. Although prevalence of smoking had decreased significantly since 1990 among both males (27·5% [26·5–28·5] reduction) and females (37·7% [35·4–39·9] reduction) aged 15 years and older, population growth has led to a significant increase in the total number of smokers from 0·99 billion (0·98–1·00) in 1990. Globally in 2019, smoking tobacco use accounted for 7·69 million (7·16–8·20) deaths and 200 million (185–214) disability-adjusted life-years, and was the leading risk factor for death among males (20·2% [19·3–21·1] of male deaths). 6·68 million [86·9%] of 7·69 million deaths attributable to smoking tobacco use were among current smokers.

Interpretation

In the absence of intervention, the annual toll of 7·69 million deaths and 200 million disability-adjusted life-years attributable to smoking will increase over the coming decades. Substantial progress in reducing the prevalence of smoking tobacco use has been observed in countries from all regions and at all stages of development, but a large implementation gap remains for tobacco control. Countries have a clear and urgent opportunity to pass strong, evidence-based policies to accelerate reductions in the prevalence of smoking and reap massive health benefits for their citizens.

Objectives: The optimal degree of proximal thoracic endograft oversizing when aiming for durable sealing in prosthetic grafts in unknown. The aim of this study was to create an in vitro model for testing different oversized thoracic endografts in a reproducible and standardized manner, and subsequently determining the optimal oversizing range when planning procedures with proximal landing in prosthetic zones in the descending thoracic aorta or aortic arch.

Materials and Methods: An in-vitro model consisting of a fixated 24mm polyethylene terephthalate (Dacron) graft sutured proximally and distally to two specifically designed 40mm rings, with four force sensing resistors attached at 4 equally distant positions and a USB camera attached proximally for photographic and video documentation was used for deployment of Zenith TX2 (Cook Medical, Bloomington, IN, USA) dissection platform endografts with diameters between 24 and 36mm. After deployment, ballooning with a 32mm compliant balloon was performed to simulate real life conditions. Assessment of oversizing included visual inspection, calculation of the valley areas created between the prosthetic wall and the stentgraft fabric, distance between stentgraft peaks, radial force exerted by the proximal sealing stent and the pull-out force necessary for endograft extraction.

Results: A total of 70 endografts were deployed: 10x 24mm, 10x 26mm, 10x 28mm, 10x30mm, 10x32mm, 10x34mm and 10x36mm, with oversizing ranging between 0-50%. Two cases of infolding occurred with 50% oversizing. Valley areas increased from 8.79 ± 0,23 mm with 16.7% oversizing to 14.26 ± 0.45 mmÇ for 50% oversizing (p<.001). There was a significant difference in the pull-out force required for endografts <10% oversizing vs. 10% oversizing or more (p<.001), which reached a plateau at approximately 4 N after oversizing > 15%. The mean radial force of the proximal sealing stent was greater after remodelling with a compliant balloon (.55 ± .02 N vs .60 ± .02 N after ballooning (p<.001)). However, larger oversizing did not lead to an increase in the radial force exerted by the proximal sealing stent.

Conclusion: The findings of this study offer additional insight into the mechanics of oversized stentgrafts in surgical grafts. In endografts with the z-stent design (TX2), oversizing below 16.7% resulted in reduced resistance to displacement forces, while oversizing > 50% was associated to major infolding in 20% of the cases. Long-term in vitro and in vivo testing are required to understand how these mechanical properties impact clinical outcomes of oversizing.

Objective: With an increasing life expectancy, more octogenarian patients are referred with complex aortic aneurysms (cAAA). The aim of this study was to evaluate short and mid-term outcomes following fenestrated aortic repair (FEVAR) in octogenarians.

Methods: Retrospective, multicentre cohort study including 8 centres across Europe and New Zealand. Consecutive patients undergoing elective FEVAR for the treatment of juxta/pararenal or type IV thoracoabdominal aortic aneurysms between 2013 and 2021 were included. The primary outcome was 30-day mortality. Secondary outcomes included 1, 2 and 5-year survival rates and mid-to-long term reintervention rates.

Results: A total of 729 patients were included, of which 169 were octogenarians. Octogenarian patients were more frequently male and had larger (61mm vs. 58mm) aneurysms. No differences in 30-day mortality (4.7% vs. 3.9%) or 30-day complication rates (29% vs 28.4%) were found. Median follow-up was 23.56 months. The 1, 2 and 5-year survival rates for octogenarian vs nonoctogenarian patients were 90.7%, 80.1% and 40.1% vs. 90.2%, 85.5% and 68.1%, respectively (p=.001). Cox regression analysis found a BMI ≥ 30 (HR 0.50, 95% CI 0.28-0.88), chronic heart failure (HR 2.14, 95% CI 1.04 – 4.39) and AAA diameter between 60-70mm (HR 2.35, 95% CI 1.31 – 4.23) to be predictors of longterm mortality.

Conclusions: Thirty-day outcomes after FEVAR were similar in octogenarians and younger patients. However, mid to long term survival rates, especially after 3 years, are considerably low in both groups. Whilst FEVAR in octogenarians can be performed safely and with good early outcomes, methods to improve case selection and ensure patient benefit in the long term are highly of interest.