Anatomical Predictors of Endoleaks or Migration After Endovascular Aneurysm Sealing

2018 ◽  
Vol 25 (6) ◽  
pp. 719-725 ◽  
Author(s):  
Kim van Noort ◽  
Johannes T. Boersen ◽  
Aleksandra C. Zoethout ◽  
Richte C. L. Schuurmann ◽  
Jan M. M. Heyligers ◽  
...  

Purpose: To identify preoperative anatomical aortic characteristics that predict seal failures after endovascular aneurysm sealing (EVAS) and compare the incidence of events experienced by patients treated within vs outside the instructions for use (IFU). Methods: Of 355 patients treated with the Nellix EndoVascular Aneurysm Sealing System (generation 3SQ+) at 3 high-volume centers from March 2013 to December 2015, 94 patients were excluded, leaving 261 patients (mean age 76±8 years; 229 men) for regression analysis. Of these, 83 (31.8%) suffered one or more of the following events: distal migration ⩾5 mm of one or both stent frames, any endoleak, and/or aneurysm growth >5 mm. Anatomical characteristics were determined on preoperative computed tomography (CT) scans. Patients were divided into 3 groups: treated within the original IFU (n=166), outside the original IFU (n=95), and within the 2016 revised IFU (n=46). Categorical data are presented as the median (interquartile range Q1, Q3). Results: Neck diameter was significantly larger in the any-event cohort vs the control cohort [23.7 mm (21.7, 26.3) vs 23.0 mm (20.9, 25.2) mm, p=0.022]. Neck length was significantly shorter in the any-event cohort [15.0 mm (10.0, 22.5) vs 19.0 mm (10.0, 21.8), p=0.006]. Maximum abdominal aortic aneurysm (AAA) diameter and the ratio between the maximum AAA diameter and lumen diameter in the any-event group were significantly larger than the control group (p=0.041 and p=0.002, respectively). Regression analysis showed aortic neck diameter (p=0.006), neck length (p=0.001), and the diameter ratio (p=0.011) as significant predictors of any event. In the comparison of events to IFU status, 52 (31.3%) of 166 patients in the inside the original IFU group suffered an event compared to 13 (28.3%) of 46 patients inside the 2016 IFU group (p=0.690). Conclusion: Large neck diameter, short aortic neck length, and the ratio between the maximum AAA and lumen diameters are preoperative anatomical predictors of the occurrence of migration (⩾5 mm), any endoleak, and/or aneurysm growth (>5 mm) after EVAS. Even under the refined 2016 IFU, more than a quarter of patients suffered from an event. Improvements in the device seem to be necessary before this technique can be implemented on a large scale in endovascular AAA repair.

2022 ◽  
pp. 152660282110687
Author(s):  
Jordan R. Stern ◽  
Céline Deslarzes-Dubuis ◽  
Kenneth Tran ◽  
Jason T. Lee

Objectives: The aim of this study was to compare outcomes of patients treated with the Cook Zenith Fenestrated (ZFEN) device for juxtarenal aortic aneurysms inside versus outside the IFU. Methods: We retrospectively reviewed our institutional ZFEN database for cases performed between 2012 and 2018, with analysis performed in 2020 in order to report midterm outcomes. The cohort was stratified based on treatment inside (IFU group) and outside (non-IFU group) the IFU for criteria involving the proximal neck: neck length 4 to 14 mm, neck diameter 19 to 31 mm, and neck angulation ≤45°. Patients with thoracoabdominal aneurysms or concurrent chimney grafting were excluded. The primary outcomes in question were mortality, type 1a endoleak, and reintervention. Univariate and multivariate analyses were performed to determine associations between adherence to IFU criteria and outcomes. Results: We identified 100 consecutive patients (19% female, mean age 73.6 years) for inclusion in this analysis. Mean follow-up was 21.6 months. Fifty-four patients (54%) were treated outside the IFU because of inadequate neck length (n=48), enlarged neck diameter (n=10), and/or excessive angulation (n=16). Eighteen patients were outside IFU for two criteria, and one patient was outside IFU for all three. Non-IFU patients were exposed to higher radiation doses (3652 vs 5445 mGy, p=0.008) and contrast volume (76 vs 95 mL, p=0.004). No difference was noted between IFU and non-IFU groups for 30-day mortality (0% vs 3.7%, p=0.18), or type 1a endoleak (0% vs 1.9%, p=0.41). Reintervention was also similar between cohorts (13% vs 27.8%, p=0.13). Being outside IFU for neck diameter or length was each borderline significant for higher reintervention on univariate analysis (p=0.05), but this was not significant on multivariate Cox proportional hazard modeling (HR 1.82 [0.53–6.25]; 2.03 [0.68–7.89]), respectively. No individual IFU deviations were associated with the primary outcomes on multivariate analysis, nor being outside IFU for multiple criteria. Conclusions: Patients with juxtarenal aortic aneurysms may be treated with the ZFEN device with moderate deviations from the IFU. While no differences were seen in mortality or proximal endoleak, larger studies are needed to examine the potential association between IFU nonadherence and reinterventions and close follow-up is warranted for all patients undergoing such repair.


2020 ◽  
Author(s):  
Kyu Hye Choi ◽  
Jin Ho Song ◽  
Yoo-Kang Kwak ◽  
Eun Young Park ◽  
Jong Hoon Lee ◽  
...  

Abstract Background: Positron-emission tomography (PET)-CT has recently been used for diagnostic imaging and radiotherapy for myeloid sarcoma, but there is little research on predicting the response of radiotherapy. The aim of this study was to analyze the association between PET-CT variables and the response to radiotherapy in patients with myeloid sarcoma.Methods: This study was conducted in myeloid sarcoma patients who received radiotherapy and PET-CT before and after radiotherapy. The response to radiotherapy was evaluated based on the European Organization for Research and Treatment of Cancer PET response criteria, and binary regression analysis was performed to assess the factors predicting reductions in the SUVmax.Results: Twenty-seven sites in 12 patients were included in the study. The 27 irradiated sites included 14 soft tissues, 11 bones, and two organs. Complete metabolic responses were seen in 24 patients after radiotherapy, a partial metabolic response in one, and progressive metabolic disease in two patients. The prescribed dose of more than 3000 cGy10 was significantly greater in the treatment control group (P = 0.024). In binary logistic regression analysis predicting reductions in the SUVmax of more than 70% after radiotherapy, the pretreatment SUVmax (≥ 7.5) and further chemotherapy after radiotherapy showed significant differences in univariate and multivariate analyses.Conclusions: Good metabolic responses (complete or partial) to radiotherapy were achieved in 92.6% of the myeloid sarcoma patients. Radiation doses < 3000 cGy10 and increased SUVmax were related to treatment failure and high SUVmax before radiotherapy was a factor influencing SUVmax reduction. Further large-scale studies are needed.


2017 ◽  
Vol 24 (2) ◽  
pp. 191-197 ◽  
Author(s):  
Gianmarco de Donato ◽  
Francesco Setacci ◽  
Luciano Bresadola ◽  
Patrizio Castelli ◽  
Roberto Chiesa ◽  
...  

Purpose: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks <7 mm long. Methods: A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76.4±2.4 years; 84 men) with a mean follow-up of 32 months (range 24–50). Standard CT scans (preoperative, 1-month postoperative, and latest follow-up) were reviewed by an independent core laboratory for morphological changes. For analysis, patients were stratified into 2 groups based on proximal neck length ≥7 mm (IFU group, n=57) or <7 mm (OL group, n=32). Outcome measures included freedom from type Ia endoleak, any device-related reintervention, migration, and neck enlargement (>2 mm). Results: At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was −0.05±0.8 mm in the IFU group and −0.1±0.5 mm in the OL group. Conclusion: Use of the Ovation stent-graft in patients with neck length <7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration–approved changes to the IFU.


2018 ◽  
Vol 25 (3) ◽  
pp. 270-281 ◽  
Author(s):  
Aleksandra C. Zoethout ◽  
Johannes T. Boersen ◽  
Jan M. M. Heyligers ◽  
Jean-Paul P. M. de Vries ◽  
Clark J. A. M. Zeebregts ◽  
...  

Purpose: To analyze the 2-year outcomes of endovascular aneurysm sealing (EVAS) according to 2 versions of the instructions for use (IFU). Methods: A retrospective study was conducted involving 355 consecutive patients treated with the first-generation EVAS device from April 2013 to December 31, 2015, at 3 high-volume centers. Out of 355 patients treated with EVAS, 264 were elective asymptomatic infrarenal EVAS procedures suitable for analysis. In this cohort, 168 (63.3%) patients were treated within the IFU 2013 criteria; of these 48 (18.2%) were in compliance with the revised IFU 2016 version. Results: Overall technical success was 98.2% (165/168) in the IFU 2013 group and 97.9% (47/48) in the IFU 2016 subgroup (p=0.428). The 2-year freedom from reintervention estimates were 89.7% (IFU 2013) and 95.7% (IFU 2016), with significantly more reinterventions in the first 45 cases (p=0.005). The stenosis/occlusion estimates were 6.5% (IFU 2013) and 4.2% (IFU 2016; p=0.705). Nine (5.4%) endoleaks (8 type Ia and 1 type Ib) were observed within the IFU 2013 cohort; 3 (2.1%) were in the IFU 2016 subgroup (p=0.583). Migration ≥10 mm or ≥5 mm requiring intervention was reported in 12 (7.1%) patients in the IFU 2013 cohort but none within the IFU 2016 subgroup. Ten (6.0%) patients demonstrated aneurysm growth in the IFU 2013 cohort, of which 2 (4.2%) were in the IFU 2016 subgroup. Overall survival and freedom from aneurysm-related death estimates at 2 years were 90.9% and 97.6% in the IFU 2013 cohort (IFU 2016: 95.5% and 100.0%). The prevalence of complications seemed lower within IFU 2016 without significant differences. Conclusion: This study shows acceptable 2-year results of EVAS used within the IFU, without significant differences between the 2 IFU versions, though longer follow-up is indicated. The refined IFU significantly reduced the applicability of the technique.


2021 ◽  
Author(s):  
Casey Patrick ◽  
Remle Crowe ◽  
Brad Ward ◽  
Ali Mohammed ◽  
Kelly Rogers Keene ◽  
...  

Abstract Background: We aimed to assess the feasibility of prehospital bolus dose esmolol for patients with out-of-hospital cardiac arrest (OHCA) and refractory ventricular fibrillation (RVF) treated by a single, high-volume, ground-based emergency medical services (EMS) agency. Methods: This retrospective observational study evaluated EMS patients with RVF treated from June 10, 2017 to June 10, 2020. Esmolol (0.5mg/kg bolus) was added to the RVF protocol at the mid-point of the study period on December 10, 2018. Results: We analyzed 61 patients treated with prehospital esmolol and 63 patients treated without esmolol. Median time from EMS arrival to esmolol administration was 17 minutes (interquartile range: 13-22 minutes). Prehospital return of spontaneous circulation (ROSC) was higher in the esmolol group compared to the control group, though statistical significance was not reached (38% versus 24%, p=0.09). Overall, few patients survived to 24 hours (esmolol n=15, pre-esmolol n=16) and fewer survived to hospital discharge (esmolol n=5, pre-esmolol n=5), precluding stable statistical comparisons. Conclusion: Our findings suggest that esmolol is feasible in the prehospital setting and may lead to increased ROSC. Further large-scale studies are needed to determine the effect of prehospital esmolol for RVF as it relates to survival to hospital discharge.Trial Registration: This study was approved by the institutional review board at The Baylor College of Medicine and a waiver of informed consent was granted - protocol number H-48383.


Author(s):  
Miriam Kliewer ◽  
Elisabeth Pelanek-Völk ◽  
Markus Plimon ◽  
Fadi Taher ◽  
Afshin Assadian ◽  
...  

Abstract OBJECTIVES The Medtronic Endurant II stent graft has recently received Conformité Européenne (CE) approval for the use in chimney endovascular aortic repair (ChEVAR) for the treatment for juxtarenal aortic aneurysms. The aim of this study was to assess the percentage of patients treated by fenestrated endovascular repair who would have been alternatively suitable for the treatment by the CE approved Medtronic ChEVAR. METHODS Preoperative computed tomography scans of 100 patients who underwent fenestrated endovascular aortic repair (FEVAR) between April 2013 and February 2017 were retrospectively assessed for the applicability of the ChEVAR technique according to the Medtronic instructions for use. Eligibility criteria included an aortic neck diameter of 19–30 mm, a minimum infrarenal neck length of 2 mm, a total proximal sealing zone of at least 15 mm, thrombus in the aortic neck in ˂25% of the circumference, and maximum aortic angulations of 60° in the infrarenal, 45° in the suprarenal segment and ˂45° above the superior mesenteric artery. RESULTS According to CE-approved inclusion criteria, 19 individuals (19%) would have been eligible for ChEVAR. In 81 patients, at least 1 measure was found outside instructions for use: (i) excluding factor was detected in 26 patients, (ii) incongruous measures in 28 patients and in 27 patients, 3–5 measures were outside the instructions for use. The most frequently identified excluding factor was an insufficient infrarenal neck at ˂2 mm length (n = 63; 63%). CONCLUSIONS Patients with juxta- or pararenal aneurysm treated by FEVAR are in 19% of the cases alternatively suitable for the treatment by ChEVAR within CE-approved instructions for use. While ChEVAR is suitable in many emergency cases, FEVAR offers a broader applicability in an elective setting.


PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0261550
Author(s):  
Kyu Hye Choi ◽  
Jin Ho Song ◽  
Yoo-Kang Kwak ◽  
Jong Hoon Lee ◽  
Hong Seok Jang

Purpose Positron-emission tomography (PET)-CT has recently been used for diagnostic imaging and radiotherapy for myeloid sarcoma, but there is little research on predicting the response of radiotherapy. The aim of this study was to analyze the association between PET-CT variables and the response to radiotherapy in patients with myeloid sarcoma. Materials and methods This study was conducted in myeloid sarcoma patients who received radiotherapy and PET-CT before and after radiotherapy. The response to radiotherapy was evaluated based on the European Organization for Research and Treatment of Cancer PET response criteria, and binary regression analysis was performed to assess the factors predicting reductions in the maximum standardized uptake value (SUVmax). Results Twenty-seven sites in 12 patients were included in the study. Complete metabolic responses were seen in 24 patients after radiotherapy, a partial metabolic response in one, and progressive metabolic disease in two patients. The prescribed dose of more than 3000 cGy10 was significantly greater in the treatment control group (P = 0.024). In binary logistic regression analysis predicting reductions in the SUVmax of more than 70% after radiotherapy, the pretreatment SUVmax (≥ 7.5) and further chemotherapy after radiotherapy showed significant differences in univariate and multivariate analyses. Conclusion Good metabolic responses (complete or partial) to radiotherapy were achieved in 92.6% of the myeloid sarcoma patients. Radiation doses < 3000 cGy10 and increased SUVmax were related to treatment failure and high SUVmax before radiotherapy was a factor influencing SUVmax reduction. Further large-scale studies are needed.


2020 ◽  
Vol 25 (45) ◽  
pp. 4827-4834 ◽  
Author(s):  
Limin Zhang ◽  
Xingang Li ◽  
Dongzhi Wang ◽  
Hong Lv ◽  
Xuezhong Si ◽  
...  

Background: A considerable proportion of acute noncardiogenic ischemic stroke patients continue to experience recurrent ischemic events after standard therapy. Aim: We aimed to identify risk factors for recurrent ischemic event prediction at an early stage. Methods : 286 non-cardioembolic ischemic stroke patients with the onset of symptoms within 24 hours were enrolled. Vascular risk factors, routine laboratory data on admission, thromboelastography test seven days after clopidogrel therapy and any recurrent events within one year were assessed. Patients were divided into case group (patients with clinical adverse events, including ischemic stokes, transient ischemic attack, myocardial infarction and vascular related mortality) and control group (events-free patients). The risk of the recurrent ischemic events was determined by the receiver operating characteristic curve and multivariable logistic regression analysis. Results: Clinical adverse events were observed in 43 patients (case group). The mean levels of Mean Platelet Volume (MPV), Platelet/Lymphocyte Ratio (PLR), Lymphocyte Count (LY) and Fibrinogen (Fib) on admission were significantly higher in the case group as compared to the control group (P<0.001). Seven days after clopidogrel therapy, the ADP-induced platelet inhibition rate (ADP%) level was lower in the case group, while the Maximum Amplitude (MA) level was higher in the case group as compared to the control group (P<0.01). The Area Under the Curve (AUC) of receiver operating characteristic(ROC) curve of LY, PLR, , Fib, MA, ADP% and MPV were 0.602, 0.614, 0.629, 0.770, 0.800 and 0.808, respectively. The logistic regression analysis showed that MPV, ADP% and MA were indeed predictive factors. Conclusion: MPV, ADP% and MA were risk factors of recurrent ischemic events after acute noncardiogenic ischemic stroke. Urgent assessment and individual drug therapy should be offered to these patients as soon as possible.


Author(s):  
Aysegul Altunkeser ◽  
Zeynep Ozturk Inal ◽  
Nahide Baran

Background: Shear wave electrography (SWE) is a novel non-invasive imaging technique which demonstrate tissue elasticity. Recent research evaluating the elasticity properties of normal and pathological tissues emphasize the diagnostic importance of this technique. Aims: Polycystic ovarian syndrome (PCOS), which is characterized by menstrual irregularity, hyperandrogenism, and polycystic overgrowth, may cause infertility. The aim of this study was to evaluate the elasticity of ovaries in patients with PCOS using SWE. Methods: 66 patients diagnosed with PCOS according to the Rotterdam criteria (PCOS = group I) and 72 patients with non-PCOS (Control = group II), were included in the study. Demographic and clinical characteristics of the participants were recorded. Ovarian elasticity was assessed in all patients with SWE, and speed values were obtained from the ovaries. The elasticity of the ovaries was compared between the two groups. Results: While there were statistically significant differences between the groups in body mass index (BMI), right and left ovarian volumes, luteinizing hormone and testosterone levels (p<0.05), no significant differences were found between groups I and II in the velocity (for the right ovary 3.89±1.81 vs. 2.93±0.72, p=0.301; for the left ovary 2.88±0.65 vs. 2.95±0.80, p=0.577) and elastography (for the right ovary 36.62±17.78 vs. 36.79±14.32, p=0.3952; for the left ovary 36.56±14.15 vs. 36.26±15.10, p=0.903) values, respectively. Conclusion: We could not obtain different velocity and elastography values from the ovaries of the patients with PCOS using SWE. Therefore, further large-scale studies are needed to elucidate this issue.


Materials ◽  
2020 ◽  
Vol 13 (7) ◽  
pp. 1670 ◽  
Author(s):  
Wölfle-Roos JV ◽  
Katmer Amet B ◽  
Fiedler J ◽  
Michels H ◽  
Kappelt G ◽  
...  

Background: Uncemented implants are still associated with several major challenges, especially with regard to their manufacturing and their osseointegration. In this study, a novel manufacturing technique—an optimized form of precision casting—and a novel surface modification to promote osseointegration—calcium and phosphorus ion implantation into the implant surface—were tested in vivo. Methods: Cylindrical Ti6Al4V implants were inserted bilaterally into the tibia of 110 rats. We compared two generations of cast Ti6Al4V implants (CAST 1st GEN, n = 22, and CAST 2nd GEN, n = 22) as well as cast 2nd GEN Ti6Al4V implants with calcium (CAST + CA, n = 22) and phosphorus (CAST + P, n = 22) ion implantation to standard machined Ti6Al4V implants (control, n = 22). After 4 and 12 weeks, maximal pull-out force and bone-to-implant contact rate (BIC) were measured and compared between all five groups. Results: There was no significant difference between all five groups after 4 weeks or 12 weeks with regard to pull-out force (p > 0.05, Kruskal Wallis test). Histomorphometric analysis showed no significant difference of BIC after 4 weeks (p > 0.05, Kruskal–Wallis test), whereas there was a trend towards a higher BIC in the CAST + P group (54.8% ± 15.2%), especially compared to the control group (38.6% ± 12.8%) after 12 weeks (p = 0.053, Kruskal–Wallis test). Conclusion: In this study, we found no indication of inferiority of Ti6Al4V implants cast with the optimized centrifugal precision casting technique of the second generation compared to standard Ti6Al4V implants. As the employed manufacturing process holds considerable economic potential, mainly due to a significantly decreased material demand per implant by casting near net-shape instead of milling away most of the starting ingot, its application in manufacturing uncemented implants seems promising. However, no significant advantages of calcium or phosphorus ion implantation could be observed in this study. Due to the promising results of ion implantation in previous in vitro and in vivo studies, further in vivo studies with different ion implantation conditions should be considered.


Sign in / Sign up

Export Citation Format

Share Document