Open conversion after Nellix endovascular aneurysm sealing.
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ABSTRACT:
SUBMITTER: Tinelli G
PROVIDER: S-EPMC7475512 | biostudies-literature | 2020 Sep
REPOSITORIES: biostudies-literature
Publications
Open conversion after Nellix endovascular aneurysm sealing.
Tinelli Giovanni G Codispoti Francesco Alberto FA Sica Simona S Minelli Fabrizio F De Nigris Francesca F Tshomba Yamume Y
Journal of vascular surgery cases and innovative techniques 20200727 3
The Nellix endovascular aneurysm sealing system (Endologix, Irvine, Calif) was presented as a novel concept in the treatment of abdominal aortic aneurysm. After numerous adverse events, the device was voluntarily withdrawn from the market by the manufacturer. This video describes the technical approach of a successful explantation of the Nellix endograft in a patient who underwent endovascular aneurysm sealing for abdominal aortic aneurysm. ...[more]
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Project description:BackgroundEndovascular aneurysm sealing (EVAS), using the Nellix endovascular aneurysm sealing system, has been associated with high reintervention and migration rates. However, prior reports have suggested that EVAS might be related to a lower all-cause mortality compared with endovascular aneurysm repair (EVAR). In the present study, we examined the 5-year all-cause mortality trends after EVAS and EVAR.MethodsWe compared the 333 EVAS patients in the EVAS-1 Nellix U.S. investigational device exemption trial with 16,497 infrarenal EVAR controls from the Vascular Quality Initiative, treated between 2014 and 2016, after applying the exclusion criteria from the investigational device exemption trial (ie, hemodialysis, creatinine >2.0 mg/dL, rupture). As a secondary analysis, we stratified the patients by aneurysm diameter (<5.5 cm and ≥5.5 cm). We calculated propensity scores after adjusting for demographics, comorbidities, and anatomic characteristics and applied inverse probability weighting to compare the risk-adjusted long-term mortality using Kaplan-Meier and Cox regression analyses.ResultsAfter weighting, the EVAS group had experienced similar 5-year mortality compared with the controls from the Vascular Quality Initiative (EVAS vs EVAR, 18% vs 14%; hazard ratio [HR], 1.1; 95% confidence interval [CI], 0.71-1.7; P = .70). The subgroup analysis demonstrated that for patients with an aneurysm diameter of <5.5 cm, EVAS was associated with higher 5-year mortality compared with EVAR (19% vs 11%; HR, 2.4; 95% CI, 1.7-4.7; P = .013). In patients with an aneurysm diameter of ≥5.5 cm, EVAS was associated with lower mortality within the first 2 years (2-year mortality: HR, 0.29; 95% CI, 0.13-0.62; P = .002). However, compared with EVAR, EVAS was associated with higher mortality between 2 and 5 years (HR, 1.9; 95% CI, 1.2-3.0; P = .005), with no mortality difference at 5 years (18% vs 17%; HR, 0.82; 95% CI, 0.4-1.4; P = .46).ConclusionsWithin the overall population, EVAS was associated with similar 5-year mortality compared with EVAR. EVAS was associated with higher mortality for those with small aneurysms (<5.5 cm). For those with larger aneurysms (≥5.5 cm), EVAS was initially associated with lower mortality within the first 2 years, although this advantage was lost thereafter, with higher mortality after 2 years. Future studies are required to evaluate the specific causes of death and to elucidate the potential beneficial mechanism behind sac obliteration that leads to this potential initial survival benefit. This could help guide the development of future grafts with better proximal fixation and sealing that also incorporate sac obliteration.
| S-EPMC9974809 | biostudies-literature
Project description:IntroductionThe 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).MethodsA 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.ResultsA 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%.ConclusionThere 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.
| S-EPMC9096591 | biostudies-literature
Project description:ObjectiveRisk of open conversion after endovascular aortic aneurysm repair (EVAR-c) is poorly defined. The purpose of this analysis was to determine outcomes of elective EVAR-c compared with elective primary open abdominal aortic aneurysm repair (PAR) in the Vascular Quality Initiative.MethodsVascular Quality Initiative patients who underwent elective EVAR-c and PAR (2002-2014) were reviewed. Candidate predictors of major adverse cardiac event (MACE) and/or 30-day mortality were entered into a multivariable model, and stepwise elimination was used to reduce the number of covariates to a best subset of predictors. To estimate the additive risk of EVAR-c for MACE or 30-day mortality over PAR, this variable was added along with the best subset of predictors into generalized estimating equations logistic regression models.ResultsWe identified 159 EVAR-c and 3741 PAR patients. EVAR-c patients were older (73.5 ± 8.1 vs 69.5 ± 8.4 years; P < .0001), more likely to have diabetes (21% vs 15%; P = .03), and history of lower extremity bypass (9% vs 4%; P = .0006). EVAR-c was associated with a higher incidence of retroperitoneal aortic exposure (41%; n = 64 vs PAR, 26%, n = 976; P < .0001), use of a bifurcated graft (65%; n = 101 vs PAR, 52%; n = 1923; P = .001), greater blood loss (median [interquartile range], 2000 mL [1010-3500] vs PAR, 1200 mL [750-2000]; P < .0001) and longer procedure times (EVAR-c, 275 ± 122 minutes vs PAR, 232 ± 9 minutes; P < .0001). However, PAR more frequently was completed with a suprarenal and/or mesenteric cross-clamp (74%, n = 2749 vs EVAR-c, 53%, n = 83; P < .0001) and had a higher incidence of concomitant procedures (26%; n = 972 vs EVAR-c, 18%; n = 28; P = .03). Nonadjusted 30-day mortality was greater after EVAR-c: EVAR-c, 8% (n = 10) vs PAR, 3% (n = 105); P = .009. There was no difference in complication rates: EVAR-c, 33% (n = 52) vs PAR, 28% (n = 1056); P =.3. Preoperative 30-day mortality predictors included age (odds ratio [OR], 1.06/y, 95% confidence interval [CI], 1.04-1.1; P < .0001), chronic obstructive pulmonary disease (OR, 2.4; 95% CI, 1.6-3.5; P < .0001), history of leg bypass (OR, 2.3, 1.2-4.4;P =.01), suprarenal cross-clamp (OR 2.2, 1.2-4.1;P =.01), prior carotid revascularization (OR 2.2; 95% CI, 1.3-3.8; P = .0004), congestive heart failure (OR, 1.8; 95% CI, 0.9-3.5; P = .08), and female sex (OR, 1.6; 95% CI, 1.1-2.3; P = .02; area under the curve, 0.75). When controlling for covariates, EVAR-c was not significantly associated with MACE (OR, 1.2; 95% CI, 0.7-2.0; P = .4) or 30-day mortality (OR, 2.0; 0.9-4.2; P = .08).ConclusionsEVAR-c patients are typically older, have more comorbidities, and experience greater blood loss and longer procedure times compared with PAR patients. However, postoperative morbidity and mortality are primarily driven by patient covariates and intraoperative factors, rather than the need for endograft explantation. Several preoperative variables were identified as predictors of 30-day mortality after elective EVAR-c and should be considered during the decision-making process for remedial treatment of failed endovascular PAR.
| S-EPMC4808623 | biostudies-literature
Project description:Open surgery is the elective treatment for mycotic aneurysms of the aorta. This surgery consists of resection of the aneurysm, debridement and revascularization with an in situ or extra-anatomic bypass. Even when surgery has been successful, the morbi-mortality is raised and the endovascular treatment has become an alternative for specific patients. When mycotic aneurysms involved the visceral arteries, more complex techniques are necessary such as fenestrated endovascular aortic repair or chimmeny endovascular aortic repair and the most frequent complications of this are endoleaks and oclussion the visceral arteries. We present a case of a pacient with a paravisceral abdominal mycotic aneurysms that was result with 2 chimney technique (in the right renal and superior mesenteric arteries) and a single Nellix EVAS (Endologix, Irvine, Calif) of 12 cm long without evidence of endoleaks in the follow-up.
| S-EPMC5545147 | biostudies-other
Project description:Endovascular aneurysm repair (EVAR) has dramatically changed the management of abdominal aortic aneurysms (AAAs) as the number of open aneurysm repairs have declined over time. This report compares AAA-related demographics, operative data, complications, and mortality after treatment by open aneurysm repair or EVAR.We retrospectively reviewed 136 patients with AAAs who were treated over an 8-year time period with open aneurysm repair or EVAR.The mean age of the EVAR group was higher than that of the open repair group (p=0.001), and hospital mortality did not differ significantly between groups (p=0.360). However, overall survival was significantly lower in the EVAR group (p=0.033).Although EVAR is the primary treatment modality for elderly patients, it would be ideal to set slightly more stringent criteria within the anatomical guidelines contained in the instructions for use of the EVAR device when treating younger patients.
| S-EPMC5548202 | biostudies-other
Project description: Not available
| S-EPMC10267963 | biostudies-literature
Project description:This report introduces the reverse slider technique to obtain proximal sealing effectively in endovascular aneurysm repair in short or angulated necks. It is the deployment process of the stent graft main body by repeatedly rotating and reversing the external slider with slight loosening of the suprarenal stent. This method helps obtain accurate placement of the proximal edge and effective sealing on the greater curvature side even in short and angulated necks. It is an effective method of extending the proximal sealing zone. It is gained by changing the deployment process with the Endurant stent graft (Medtronic, Santa Rosa, Calif) as an existing popular device.
| S-EPMC6614706 | biostudies-literature
Project description:Purpose: To investigate the physiological uptake of hybrid fluorine-18-fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT) before and after an uncomplicated endovascular aneurysm sealing (EVAS) procedure as a possible tool to diagnose EVAS graft infection and differentiate from postimplantation syndrome. Materials and Methods: Eight consecutive male patients (median age 78 years) scheduled for elective EVAS were included in the prospective study (ClinicalTrials.gov identifier NCT02349100). FDG-PET/CT scans were performed in all patients before the procedure and 6 weeks after EVAS. The abdominal aorta was analyzed in 4 regions: suprarenal, infrarenal neck, aneurysm sac, and iliac. The following parameters were obtained for each region: standard uptake value (SUV), tissue to background ratio (TBR), and visual examination of FDG uptake to ascertain its distribution. Demographic data were obtained from medical files and scored based on reporting standards. Results: Visual examination showed no difference between pre- and postprocedure FDG uptake, which was homogenous. In the suprarenal region no significant pre- and postprocedure differences were observed for the SUV and TBR parameters. The infrarenal neck region showed a significant decrease in the SUV and no significant decrease in the TBR. The aneurysm sac and iliac regions both showed a significant decrease in SUV and TBR between the pre- and postprocedure scans. Conclusion: Physiological FDG uptake after EVAS was stable or decreased with regard to the preprocedure measurements. Future research is needed to assess the applicability and cutoff values of FDG-PET/CT scanning to detect endograft infection after EVAS.
| S-EPMC7288856 | biostudies-literature
Project description:BackgroundIt is often questioned if one physician can conduct both open and endovascular techniques successfully and safely.ObjectiveTo investigate the association of combined open and endovascular expertise with the outcomes of unruptured cerebral aneurysm clipping.MethodsWe performed a cohort study of 100% of Medicare fee-for-service claims data for elderly patients who underwent surgical clipping for unruptured cerebral aneurysms between 2007 and 2012. To control for confounding we used propensity score conditioning, and controlled for clustering at the physician level.ResultsDuring the study, 3247 patients underwent clipping for unruptured cerebral aneurysms, and met the inclusion criteria. Of these, 766 (23.6%) underwent treatment by hybrid neurosurgeons, and 2481 (76.4%) by proceduralists, who performed only clipping. Multivariable regression analysis with propensity score adjustment demonstrated a lack of association of combined practice with 1-year postoperative mortality (OR=0.81; 95% CI 0.51 to 1.28), discharge to rehabilitation (OR=0.95; 95% CI 0.72 to 1.25), length of stay (adjusted difference 0.85 days; 95% CI -0.31 to 2.00), or 30-day readmission rate (OR=1.05; 95% CI 0.80 to 1.39). Higher procedural volume was independently associated with improved outcomes.ConclusionsIn a cohort of Medicare patients with unruptured aneurysms, we did not demonstrate a difference in mortality, discharge to rehabilitation, or readmission rate between hybrid neurosurgeons and surgeons performing only clipping.
| S-EPMC5442387 | biostudies-literature
Project description:The improvement of available endovascular aortic aneurysm repair (EVAR) devices is critical for the advancement of patient care in vascular surgery. The goal of this article is to report a highly detailed, closely monitored, audited, pooled multicenter cohort of open surgical abdominal aortic aneurysm (AAA) repairs that has potential for use in future EVAR studies as a control data set.Open surgical AAA repair data from four investigational device exemption clinical aortic endograft trials were tested for poolability, merged, and analyzed for the intervals of 0 to 30 days and 31 to 365 days.The data set includes 323 open patients (83% men; mean age, 70 years). Operative mortality at 30 days was 2.8%. The mean age of women was 3 years older than men, and mortality at 30 days for women was 5.7% compared with 2.2% for men (P = .18). Operative mortality for patients with large AAAs (>/=5.5 cm, 3.6%) was not different than for patients with small aneurysms (<5.5 cm, 2.4%, P = .54). All-cause mortality at 1 year was 6.7%, with significant predictors including age, sex, and renal failure. Women had 2.6-fold greater 1-year all-cause mortality rate (13.2%) than men (5.4%, P = .04), but statistical significance was lost after correction for age. Two additional AAA-related deaths occurred between days 31 and 365, resulting in a 1-year AAA-related mortality of 3.5%.This data set provides a tightly controlled, thoroughly detailed, and audited experience that has the potential to serve as an open control group for future EVAR trials.
| S-EPMC5565842 | biostudies-other