Systematic Review on the Mid-Term Outcomes of Elective Endovascular Aneurysm Sealing in Comparison to Endovascular Aneurysm Repair

Introduction The Nellix endovascular aneurysm sealing (EVAS) system has been a topic of discussion. Early results were promising but did not deliver on the long-term and the device has been recalled from the market. This study compares literature for EVAS and conventional endovascular aneurysm repair (EVAR). Methods A systematic review and analysis was conducted according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. PubMed, Embase, and Cochrane Library were searched and identified the eligible studies. Proportion rates for the outcomes of interest were extracted. Subgroup analyses were performed for EVAS and EVAR. Results A total of 12 studies were included (EVAS n = 4, EVAR n = 8) including 10,255 patients (EVAS n = 784, EVAR n = 9441). The longest duration of follow-up was 3.4 years for EVAS and 5.0 years for EVAR studies. Throughout follow-up the overall all-cause mortality rates were 6% for EVAS and 13% for EVAR, and endoleak of any type was described in 10% of EVAS and 17% of EVAR patients. The migration rate >10 mm was 8% for EVAS and 0% for EVAR and aneurysm growth >5 mm was found in 11% of EVAS and 3% of EVAR cases. Total reintervention rate was 13% for EVAS and 7% for EVAR patients. For all analyzed outcome parameters heterogeneity was >50%. Conclusion There is a tendency toward lower mortality and overall endoleak rates for EVAS compared to EVAR but with a higher rate of migration, aneurysm growth, and reintervention. Despite lower overall endoleak rates there was a tendency toward less type II and more type I endoleaks after EVAS compared to EVAR. Substantial heterogeneity however limits robust statistical analyses, and is probably caused by significant instructions for use breach in EVAS-treated patients. We call for more high-quality and long-term follow-up studies on both EVAS and EVAR in order to confirm the trends found in this study.

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Onyx™ Cast Fragmentation After Embolization of Endoleaks

Journal of Endovascular Therapy ◽

10.1177/15266028211045701 ◽

2021 ◽

pp. 152660282110457

Author(s):

Christopher Keegan ◽

Symeon Lechareas ◽

Francesco Torella ◽

Tze Yuan Chan ◽

Robert Fisher ◽

...

Keyword(s):

Morphological Changes ◽

Endovascular Aneurysm Repair ◽

Outcome Data ◽

Single Fracture ◽

Electronic Patient Records ◽

Primary Success ◽

Aneurysm Growth ◽

Aneurysm Repair

Purpose: Endoleaks are common following endovascular aneurysm repair (EVAR), and the liquid embolic material Onyx has been widely used in their treatment. We report our experience of long-term morphological changes of Onyx casts on surveillance imaging. Materials and Methods: We identified 10 patients over 10 years who underwent Onyx embolization in our institution. Morphological changes of Onyx casts were assessed on surveillance radiographs and computed tomography (CT) scans. Relevant outcome data and sequelae were obtained via electronic patient records. Results: Twelve procedures were performed on 10 cases, 9 for type 2, and 1 for a type 1a endoleak. Five cases showed evidence of Onyx fragmentation on follow-up imaging ranging from a single fracture to gross fragmentation with migration of fragments. Of these 5, 3 had achieved primary success but 2 went on to develop recurrence of endoleak. Onyx volume ranged from 4 to 46.5 ml (median 10.5 ml) per patient with larger volumes demonstrating the most marked fragmentation on follow-up. Follow-up ranged from 9 months to 8 years (median 2.25 years). Conclusion: To our knowledge, this is the first report of Onyx fragmentation after endoleak embolization. If long-term morphological stability of the Onyx cast is necessary to maintain aneurysm seal, then Onyx may not offer a permanent solution to some patients with post-EVAR endoleaks. Our study cannot ascertain whether the observed changes were the cause or the effect of ongoing aneurysm growth, persistent endoleak, and/or other forces acting on the solidified polymer, but it raises important questions on the use of Onyx in this setting.

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Effectiveness of adult community-based physical activity interventions with objective physical activity measurements and long-term follow-up: a systematic review and meta-analysis

BMJ Open ◽

10.1136/bmjopen-2019-034541 ◽

2020 ◽

Vol 10 (5) ◽

pp. e034541

Author(s):

Charlotte Wahlich ◽

Umar A R Chaudhry ◽

Rebecca Fortescue ◽

Derek G Cook ◽

Shashivadan Hirani ◽

...

Keyword(s):

Physical Activity ◽

Systematic Review ◽

Meta Analysis ◽

Risk Of Bias ◽

Cochrane Library ◽

Community Based ◽

Intervention Effects ◽

Meta Analyses

ObjectiveTo identify randomised controlled trials (RCTs) of physical activity (PA) interventions with objective PA outcomes in adults and to evaluate whether intervention effects were sustained beyond 12 months.DesignSystematic review and meta-analysis.Data sourcesSeven databases (Medline, Embase, PsycINFO, Web of Science, Cochrane library, CINAHL (Cumulative Index of Nursing and Allied Health Literature) and ASSIA (Applied Social Sciences Index and Abstracts)) were searched from January 2000 until December 2019.Eligibility criteriaRCTs reporting objective PA outcomes beyond 12 months with community-based participants aged ≥18 years were included; those where controls received active interventions, including advice to increase PA levels, were excluded.Data extraction and synthesisTwo independent reviewers completed extraction of aggregate data and assessed risk of bias. Meta-analyses used random-effects models at different follow-up points. Primary outcomes were daily steps and weekly minutes of moderate-to-vigorous PA (MVPA).ResultsOf 33 282 records identified, nine studies (at generally low risk of bias) were included, five in meta-analyses with 12 months to 4 year follow-up. We observed 12 month increases for intervention vs control participants in steps/day (mean difference (MD)=554 (95% CIs: 384 to 724) p<0.0001, I2=0%; 2446 participants; four studies) and weekly MVPA minutes (MD=35 (95% CI: 27 to 43) p<0.0001, I2=0%; 2647 participants; four studies). Effects were sustained up to 4 years for steps/day (MD=494 (95% CI: 251 to 738) p<0.0001, I2=0%; 1944 participants; four studies) and weekly MVPA minutes (MD=25 (95% CI: 13 to 37) p<0.0001, I2=0%; 1458 participants; three studies).ConclusionsThere are few PA interventions with objective follow-up beyond 12 months, more studies are needed. However, this review provided evidence of PA intervention effects beyond 12 months and sustained up to 4 years for both steps/day and MVPA. These findings have important implications for potential long-term health benefits.PROSPERO registration numberCRD42017075753.

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A Long-Time Follow-Up Study of a Single-Center Endovascular Aneurysm Repair (Evar) Endoleak Outcomes

Vascular and Endovascular Surgery ◽

10.1177/1538574418779667 ◽

2018 ◽

Vol 52 (7) ◽

pp. 505-511 ◽

Cited By ~ 4

Author(s):

Rosa Marie Andersen ◽

Daniel P. Henriksen ◽

Hossein Mohit Mafi ◽

Sten Langfeldt ◽

Jacob Budtz-Lilly ◽

...

Keyword(s):

Endovascular Aneurysm Repair ◽

Plasma Creatinine ◽

National Database ◽

Type I ◽

Type Ii ◽

Single Center ◽

Iliac Arteries ◽

Internal Iliac ◽

Aneurysm Repair

Purpose: The aim of this study was to evaluate the incidence, risk factors, and outcome of endoleaks related to endovascular aneurysm repair (EVAR) procedure at a single center with up to 10 years’ surveillance. Materials and Methods: All patients treated with EVAR for an abdominal aorta or iliac aneurysm in a 10-year period at a single cardiovascular center in Denmark were included. Data were collected from a national database and patient journals. Follow-up computed tomography angiography and plain abdominal X-ray reports were reviewed. Results: A total of 421 patients were included. There were 125 endoleaks observed in 117 (27.8%) patients after a median 95 days (interquartile range: 90-106 days). There were 16 type I, 107 type II, 1 type III, and 1 type V endoleaks. A total of 33 (7.8%) patients had at least 1 reintervention. Patients with type II endoleaks had significantly fewer active smokers and lower plasma creatinine at baseline. They also more often had one, or both, internal iliac arteries embolized as well as an identified endoleak at the procedural completion angiogram. Non-type II endoleaks were associated with internal iliac artery embolization. There was no association between the occurrence of endoleaks and increased mortality. Conclusion: Type II endoleaks are common after EVAR, yet few lead to reintervention. Absence of smoking, low plasma creatinine, embolized iliac arteries, and endoleak on completion angiogram were associated with type II endoleaks, whereas only embolized iliac arteries were associated with non-type II endoleaks. Overall, endoleaks are not associated with increased mortality.

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Initial Clinical Experience Using the Low-Profile Altura Endograft System With Double D-Shaped Proximal Stents for Endovascular Aneurysm Repair

Journal of Endovascular Therapy ◽

10.1177/1526602818771973 ◽

2018 ◽

Vol 25 (3) ◽

pp. 379-386 ◽

Cited By ~ 6

Author(s):

Dainis Krievins ◽

Albrecht Krämer ◽

Janis Savlovskis ◽

Georgij Oszkinis ◽

E. Sebastian Debus ◽

...

Keyword(s):

Clinical Investigation ◽

Clinical Success ◽

Endovascular Aneurysm Repair ◽

Clinical Results ◽

Type I ◽

Midterm Outcome ◽

Early Results ◽

Low Profile ◽

Type I Endoleak ◽

Aneurysm Repair

Purpose: To report the initial clinical results of endovascular aneurysm repair (EVAR) using the low-profile (14-F) Altura Endograft System, which features a double “D-shaped” stent design with suprarenal fixation and modular iliac components that are deployed from distal to proximal. Methods: From 2011 to 2015, 90 patients (mean age 72.8±8.3 years; 79 men) with abdominal aortic aneurysm (AAA; mean diameter 53.8±5.7 mm) were treated at 10 clinical sites in 2 prospective, controlled clinical studies using the Altura endograft. Outcomes evaluated included mortality, major adverse events (MAEs: all-cause death, stroke, paraplegia, myocardial infarction, respiratory failure, bowel ischemia, and blood loss ≥1000 mL), and clinical success (freedom from procedure-related death, type I/III endoleak, migration, thrombosis, and reintervention). Results: Endografts were successfully implanted in 89 (99%) patients; the single failure was due to delivery system malfunction before insertion in the early-generation device. One (1%) patient died and 4 patients underwent reinterventions (1 type I endoleak, 2 iliac limb stenoses, and 1 endograft occlusion) within the first 30 days. During a median follow-up of 12.5 months (range 11.5–50.9), there were no aneurysm ruptures, surgical conversions, or AAA-related deaths. The cumulative MAE rates were 3% (3/89) at 6 months and 7% (6/89) at 1 year. Two patients underwent coil embolization of type II endoleaks at 6.5 months and 2.2 years, respectively. Clinical success was 94% (84/89) at 30 days, 98% (85/87) at 6 months, and 99% (82/83) at 1 year. Conclusion: Early results suggest that properly selected AAA patients can be safely treated using the Altura Endograft System with favorable midterm outcome. Thus, further clinical investigation is warranted to evaluate the role of this device in the treatment of AAA.

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Type IIIb Endoleak After Endovascular Aneurysm Repair Using the Zenith Stent Graft

Vascular and Endovascular Surgery ◽

10.1177/1538574419858824 ◽

2019 ◽

Vol 53 (6) ◽

pp. 515-519

Author(s):

Toshiya Nishibe ◽

Toru Iwahashi ◽

Kentaro Kamiya ◽

Masaki Kano ◽

Keita Maruno ◽

...

Keyword(s):

Stent Graft ◽

Endovascular Aneurysm Repair ◽

Aneurysm Rupture ◽

Type I ◽

Stent Grafts ◽

System Type ◽

Type Iiib ◽

Type I Endoleak ◽

Aneurysm Repair

We present 3 cases of type IIIb endoleak after endovascular aneurysm repair (EVAR) using the Zenith stent graft system. Type III endoleak, like type I endoleak, is a high-pressure, high-risk leak that increases sac pressure up to or even above arterial pressure, and is associated with an increased frequency of open conversions or risk of aneurysm rupture. Type IIIb endoleak is rare but there is much concern that the incidence of type IIIb endoleak is likely to increase hereafter; the mechanism of type IIIb endoleak is deterioration of graft fabric in conjunction with stent sutures. Type IIIb endoleak is difficult to diagnose before rupture. The possibility of type IIIb endoleak should be highly suspected when the continued growth of an excluded aneurysm sac without direct radiologic evidence is observed during follow-up. Type IIIb endoleak can be repaired by relining of the stent graft with additional stent grafts.

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Risk of malignancies in patients with spondyloarthritis treated with biologics compared with those treated with non-biologics: a systematic review and meta-analysis

Therapeutic Advances in Musculoskeletal Disease ◽

10.1177/1759720x20925696 ◽

2020 ◽

Vol 12 ◽

pp. 1759720X2092569

Author(s):

Yu Heng Kwan ◽

Ka Keat Lim ◽

Warren Fong ◽

Hendra Goh ◽

Linkai Ng ◽

...

Keyword(s):

Meta Analysis ◽

Risk Of Bias ◽

Cochrane Library ◽

Interleukin 17 ◽

Randomized Controlled ◽

Risk Of Malignancy ◽

Meta Analyses ◽

Analytical Approaches

Background: The aim of our study was to synthesize evidence on the occurrence of malignancy in spondyloarthritis (SpA), from randomized controlled trials (RCTs) comparing biologics with non-biologics and biologics to each other. Methods: We systematically searched Medline, Cochrane Library, EMBASE, Scopus and ClinicalTrials.gov from inception until 31 October 2018. RCTs with ⩾24-week follow-up were included. We extracted data using standardized forms and assessed the risk of bias using the Cochrane Risk of Bias Tool. We performed pair-wise meta-analyses and network meta-analyses to compare the risk of malignancy for each biologics class and SpA type. We reported the Peto odds ratio (OR) of any malignancy along with 95% confidence intervals (95% CI). Bayesian posterior probabilities comparing risk of malignancy of each biologic class with non-biologics were computed as supplementary measures. Results: Fifty-four trials were included; most (44/54) had follow-up <1 year. Among 14,245 patients, 63 developed a malignancy. While most Peto ORs were >1, they had wide 95% CI and p >0.05. The overall Peto OR comparing biologics with non-biologics was 1.42 (95% CI 0.80–2.53). Only interleukin-17 inhibitors in peripheral SpA had p <0.05 (Peto OR 2.77, 95% CI 1.07–7.13); the posterior probability that the risk was higher than non-biologics was 98%. Stratified analyses revealed no consistent trend by prior exposure to biologics, duration of follow-up, study quality, study-arm crossover, analytical approaches and type of malignancy. Conclusions: Our findings indicate no overall elevated risk of malignancy with biologics in SpA. As our meta-analyses are unable to conclude on the long-term risk, long-term pharmacovigilance of biologics in SpA may still be warranted.

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Long-Term Complications of Appendectomy: A Systematic Review

Scandinavian Journal of Surgery ◽

10.1177/1457496918772379 ◽

2018 ◽

Vol 107 (3) ◽

pp. 189-196 ◽

Cited By ~ 7

Author(s):

T. Rasmussen ◽

S. Fonnes ◽

J. Rosenberg

Keyword(s):

Systematic Review ◽

Ulcerative Colitis ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Incisional Hernia ◽

Opposite Pattern ◽

Meta Analyses ◽

Low Prevalence

Background and Aims: Appendectomy is a common surgical procedure, but no overview of the long-term consequences exists. Our aim was to systematically review the long-term complications of appendectomy for acute appendicitis. Materials and Methods: This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A protocol was registered on PROSPERO (CRD42017064662). The databases PubMed and EMBASE were searched for original reports on appendectomy with n ≥ 500 and follow-up >30 days. The surgical outcomes were ileus and incisional hernia; other outcomes were inflammatory bowel disease, cancer, fertility, and mortality. Results: We included 37 studies. The pooled estimate of the ileus prevalence was 1.0% over a follow-up period of 4.6 (range, 0.5–15) years. Regarding incisional hernia, we found a pooled estimate of 0.7% prevalence within a follow-up period of 6.5 (range, 1.9–10) years. Ulcerative colitis had a pooled estimate of 0.15% prevalence in the appendectomy group and 0.19% in controls. The opposite pattern was found regarding Crohn’s disease with a pooled estimate of 0.20% prevalence in the appendectomy group and 0.12% in controls. No clear pattern was found regarding most of the examined cancers in appendectomy groups compared with background populations. Pregnancy rates increased after appendicitis compared with controls in most studies. Mortality was low after appendectomy. Conclusion: Appendectomy had a low prevalence of long-term surgical complications. We did not find any significant other long-term complications, though the prevalence of Crohn’s disease was higher and the prevalence of ulcerative colitis was lower after appendectomy than in controls. Appendectomy did not impair fertility.

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Endovascular abdominal aortic aneurysm repair in patients with Marfan syndrome

Vascular ◽

10.1177/1708538119858045 ◽

2019 ◽

Vol 28 (1) ◽

pp. 48-52

Author(s):

Allan Marc Conway ◽

Khalil Qato ◽

Gautam Anand ◽

Laurie Mondry ◽

Gary Giangola ◽

...

Keyword(s):

Marfan Syndrome ◽

Open Repair ◽

Aortic Surgery ◽

Endovascular Aneurysm Repair ◽

Aortic Aneurysms ◽

Type I ◽

Femoral Access ◽

Abdominal Aortic ◽

Aneurysm Repair

Objectives Marfan syndrome patients are at risk for aortic degeneration. Repair is traditionally performed with open surgery as this is deemed more durable. Endovascular aneurysm repair remains controversial. We report on the outcomes of Marfan syndrome patients with abdominal aortic aneurysms undergoing endovascular aneurysm repair. Methods The Vascular Quality Initiative registry identified 35,889 patients, including 29 with Marfan syndrome, treated with endovascular aneurysm repair from January 2003 to December 2017. Outcomes were analyzed per the Society for Vascular Surgery reporting standards. Results Median age was 70.0 years (IQR, 57.0–75.0), and 22 (75.9%) were male. Median aneurysm diameter was 5.3 cm (IQR, 4.9–6.3 cm), with an aortic neck length and diameter of 2.0 cm (IQR, 1.6–2.8 cm) and 2.5 cm (IQR, 2.2–2.8 cm), respectively. Twenty-one (72.4%) patients were asymptomatic, seven (24.1%) symptomatic, and one (3.4%) presented with rupture. Ten (34.5%) patients had prior aortic surgery. Six (20.7%) were unfit for open surgical repair. Length of stay was 2.0 days (IQR, 1.0–3.0 days). Percutaneous femoral access was performed in 15 (51.7%) patients with no complications. A type IA endoleak was present in one (3.4%), type IB in one (3.4%), and type II endoleak in two (6.9%) patients. There were no postoperative pulmonary, cardiac, or neurological complications. In-hospital mortality occurred in one (3.4%) patient who presented with a rupture and had been deemed unfit for open repair. A conversion to open repair was required. The patient expired on post-operative day 0. Early clinical success was achieved in 26 (89.7%) patients. Follow-up was available for 15 (51.7%) patients at a median time of 766 days (IQR, 653–937). There were no reinterventions or mortalities. Change in sac diameter was −0.6 cm (IQR, −1.1 to −0.2 cm), with no type I or III endoleaks. Discussion Endovascular aneurysm repair for patients with Marfan syndrome is feasible, and can be performed safely. Mid-term outcomes suggest this technique is durable. More robust long-term follow-up is needed.

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