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The Impact of Endograft Selection on Outcomes Following Treatment Outside of Instructions for Use (IFU) in Endovascular Abdominal Aortic Aneurysm Repair (EVAR).

ABSTRACT: Background Endovascular aneurysm repair (EVAR) has become the treatment modality of choice in patients with abdominal aortic aneurysms. This has resulted in endograft utilization within instructions for use (IFU) and in cases with proximal neck anatomy outside of IFU. Purpose To identify whether graft selection influences outcomes following EVAR outside of IFU. Methodology A retrospective analysis was conducted from previously published data for 636 patients, collated from the Endurant Stent Graft Natural Selection Global Post-Market Registry (ENGAGE) and the Global Registry for Endovascular Aortic Treatment (GREAT). Patients were recruited into the ENGAGE registry between 2009 and 2011 and into the GREAT registry between August 2010 and October 2016. In ENGAGE, they received the Medtronic Endurant stent graft (Medtronic Vascular Inc, Dublin, Ireland) for infrarenal AAA repair while patients analyzed in GREAT received the Gore Excluder stent-graft (W. L. Gore & Associates, Flagstaff, Arizona). Analyses were performed to evaluate all-cause mortality, aneurysm-related mortality, endoleak occurrence, and surgical reintervention rates between the two cohorts. Results Of the 636 patients, 225 were from ENGAGE (mean age 73 years) and 411 were from GREAT (mean age 75 years). 17.8% were treated outside of IFU in the ENGAGE registry, while 12.4% were treated outside IFU in the GREAT cohort. Five-year freedom from all-cause mortality was similar in both cohorts (65.6% vs. 63.8%). The rate of type IA endoleak development was lower in the Excluder cohort, although this may have been impacted by the fact that only endoleaks that underwent reintervention were recorded within GREAT analysis (Endurant 10.6% vs. Excluder 7.0%). The reintervention rate was 16% at five years following the Endurant aortic graft while it was 13.3% at five years with the Excluder. Conclusion Treatment outside of IFU, be it with a suprarenal or an infrarenal fixation device, is associated with worse outcomes. This analysis reinforces the importance of the consideration of either fenestrated or open repair in those aneurysms that fail to satisfy IFU while endovascular repair in such a setting should be reserved as a last resort strategy.

SUBMITTER: Barry IP

PROVIDER: S-EPMC8095383 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background Abdominal aortic aneurysms (AAA) are far more common in male than female gender, although they appear to have a more aggressive pathophysiology in females. Given the lower incidence of AAA in females, it has been difficult to assess the impact of graft selection for endovascular aortic aneurysm repair (EVAR) in this cohort. Purpose To identify whether graft selection influences outcomes following AAA endoluminal repair in female patients. Methodology A retrospective analysis of published data for 711 female patients was conducted, collating data from three cohorts - Endurant Stent Graft Natural Selection Global post-market registry (ENGAGE), Global Registry for Endovascular Aortic Treatment (GREAT) and U.S. Zenith multicenter trial in combination with the Zenith female registry. Patients were recruited into the ENGAGE registry between 2009 and 2011, the GREAT registry between August 2010 and October 2016, and into the Zenith registry between 2000 and 2003. Patients from ENGAGE received the Medtronic Endurant stent graft for infrarenal AAA repair, patients analysed in GREAT received the Gore Excluder stent graft and the Zenith group received the Cook Zenith stent graft. Analyses were performed to evaluate all-cause mortality, aorta-related mortality, endoleak occurrence and surgical reintervention rates between the three cohorts. Results Of the 711 females, 133 were from ENGAGE (mean age 76 years), 538 were from GREAT (mean age 75 years) and 40 were from Zenith (mean age 74 years). The rates of co-morbidities between the three groups were broadly similar except for atherosclerotic disease which was more commonly observed in those treated with the GORE Excluder. The rate of endoleaks was lower when the Excluder stent was utilised as compared to the other two stents (Excluder 6.7% vs. Zenith 12.5% vs. Endurant 35.3%) even considering the limited follow-up of the Zenith group to two years as compared to five years for both ENGAGE and GREAT. All-cause mortality was similar in all three groups across the period examined while aorta-related mortality was uncommon. Reintervention rate was 15% at two years following the utilisation of the Zenith aortic graft while the rate of intervention at five years was broadly similar between ENGAGE and GREAT. Conclusion The newer generation, lower profile aortic endografts appear to have provided a safe and successful tool in the management of AAA in female patients, despite more complex aortic anatomy with shorter infrarenal neck length and larger aortic neck angulation.

Project description:Background and Objective Abdominal aortic aneurysm (AAA) is a common pathology with a prevalence of 4.8%. AAA rupture is associated with significant mortality and so early diagnosis followed by regular monitoring is needed until treatment might be considered and plan intervention. Endovascular aneurysm repair (EVAR) is an established and effective alternative to open surgical repair (OSR) in the treatment of AAAs. Key parameters in defining conventional EVAR suitability include the infrarenal neck length and angulation for the fixation of the proximal graft component. Endograft fixation can be either suprarenal or infrarenal and much debate exists as to which approach is associated with optimum renal outcomes. This study aims to review the current literature with respect to the renal outcomes associated with conventional EVAR using suprarenal fixation (SRF) vs. infrarenal fixation (IRF). Methods A search was conducted from major search indices (PubMed, Google Scholar and EMBASE) to identify relevant literature pertaining to renal outcomes in EVAR. Recent papers comparing SRF and IRF were evaluated and their findings discussed. Key Content and Findings The mechanism of renal function decline (RFD) following EVAR is uncertain and likely multifactorial. Aortic morphology, endograft type and surgical technique may all contribute to RFD. There is a significant degree of heterogeneity within the literature regarding study design and definitions of RFD. Recent literature suggests that RFD is more acute for SRF than IRF in the first post-operative year, but the clinical significance of this decline in patients with normal kidney function is questionable. Studies indicate that SRF is associated with accelerated RFD at 5 years, and that the RFD is worse in patients who are female and who have pre-existing renal insufficiency. Conclusions SRF is associated with a greater decline in renal function than IRF in both short- and long-terms. Although clinically insignificant in the short-term, the limited available long-term evidence suggests that SRF results in a relatively accelerated decline in renal function when compared to IRF, but it is possibly partially explained by the higher prevalence of advanced degenerative/atherosclerotic disease in SRF cohorts. These trends are noted particularly in female patients and in patients with baseline renal insufficiency.

Project description:BackgroundSince 2010, the Ovation Abdominal Stent Graft System has offered an innovative sealing option for abdominal aortic aneurysm (AAA) by including a sealing ring filled with polymer 13 mm from the renal arteries. In August 2020, the redesigned Ovation Alto, with a sealing ring 6 mm closer to the top of the fabric, received CE Mark approval.ObjectiveThis registry study aims to evaluate intraoperative, perioperative, and postoperative results in patients treated by the Alto stent graft (Endologix Inc.) for elective AAA repair in a multicentric consecutive experience.MethodsAll consecutive eligible patients submitted to endovascular aneurysm repair (EVAR) by Alto Endovascular AAA implantation will be included in this analysis. Patients will be submitted to EVAR procedures based on their own preferences, anatomical features, and operators experience. An estimated number of 300 patients submitted to EVAR with Alto stent graft should be enrolled. It is estimated that the inclusion period will be 24 months. The follow-up period is set to be 5 years. Full data sets and cross-sectional images of contrast-enhanced computed tomography scan performed before EVAR, at the first postoperative month, at 24 or 36 months, and at 5-year follow-up interval will be reported in the central database for a centralized core laboratory review of morphological changes. The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with the Alto stent graft in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will be also addressed: operative time; intraoperative radiation exposure; contrast medium usage; AAA sac shrinkage at 12-month and 5-year follow-up; any potential role of patients' baseline characteristics, valuated on preoperative computed tomography angiographic study, and of device configuration (number of component) in the primary endpoint.ResultsThe study is currently in the recruitment phase and the final patient is expected to be treated by the end of 2023 and then followed up for 5 years. A total of 300 patients will be recruited. Analyses will focus on primary and secondary endpoints. Updated results will be shared at 1- and 3-5-year follow-ups.ConclusionsThe results from this registry study could validate the safety and effectiveness of the new design of the Ovation Alto Stent Graft. The technical modifications to the endograft could allow for accommodation of a more comprehensive range of anatomies on-label.Trial registrationClinicalTrials.gov NCT05234892; https://clinicaltrials.gov/ct2/show/NCT05234892.International registered report identifier (irrid)PRR1-10.2196/36995.

Project description:ObjectivesThe primary aim of this study was to investigate the rate of sac enlargement and secondary procedures after 5 years when instructions for use are strictly applied with endovascular aortic repair. The secondary aim was to investigate if strict indications with endovascular aortic repair, rendering more open operations, would change the general outcome of patients with abdominal aortic aneurysm.Materials and methodsPatients having their abdominal aortic aneurysm procedure in a single institution between 01 January 2002 and 31 December 2006 were included. Indications for endovascular aortic repair were as follows: aortic neck: length 15 mm or more, diameter 32 mm or less and straight configuration; iliac arteries: length > 10 mm, 7.5-20 mm in diameter. Sac enlargement was defined as an increase in diameter of 5 mm or more.ResultsA total of 123 patients were intended to be treated electively with endovascular aortic repair from 2002 to 2007 using Cook Zenith stent grafts. In the same period, 147 patients were treated with elective open repair. At 5 years, 7.3% (N = 9) of the elective intended-to-treat patients with endovascular aortic repair had a sac enlargement. Thirty-five percent of the patients were registered with endoleaks, 13% of the patients had secondary procedures, 12.2% of the patients had early and 6.5% late complications during the follow-up period. Aneurysm rupture was seen in 1.6% of the patients. During the 5-year follow-up period, 34 (27.6%) of the endovascular aortic repair patients died. Five-year mortality for open repair was 23.8%, and 12.2% of the open repair patients had secondary procedures.ConclusionEndovascular aortic repair for abdominal aortic aneurysm in accordance with instructions for use gives a low long-term risk for increased diameter and low rate of secondary procedures. There was similar mortality after elective endovascular aortic repair and open repair for abdominal aortic aneurysm. Applying endovascular aortic repair according to instructions for use does not seem to change the general outcome of patients with abdominal aortic aneurysm but improves the outcome with the method.

Project description:BackgroundAbdominal aortic aneurysm (AAA) repair has been performed by various surgical specialties for many years. Endovascular aneurysm repair (EVAR) may be a disruptive technology, having an impact on which specialties care for patients with AAA. Therefore, we examined the proportion of AAA repairs performed by various specialties over time in the United States and evaluated the impact of the introduction of EVAR.MethodsThe Nationwide Inpatient Sample (2001-2009) was queried for intact and ruptured AAA and for open repair and EVAR. Specific procedures were used to identify vascular surgeons (VSs), cardiac surgeons (CSs), and general surgeons (GSs) as well as interventional cardiologists and interventional radiologists for states that reported unique treating physician identifiers. Annual procedure volumes were subsequently calculated for each specialty.ResultsWe identified 108,587 EVARs and 85,080 open AAA repairs (3011 EVARs and 12,811 open repairs for ruptured AAA). VSs performed an increasing proportion of AAA repairs during the study period (52% in 2001 to 66% in 2009; P < .001). GSs and CSs performed fewer repairs during the same period (25% to 17% [P < .001] and 19% to 13% [P < .001], respectively). EVAR was increasingly used for intact (33% to 78% of annual cases; P < .001) as well as ruptured AAA repair (5% to 28%; P < .001). The proportion of intact open repairs performed by VSs increased from 52% to 65% (P < .001), whereas for EVAR, the proportion went from 60% to 67% (P < .001). The proportion performed by VSs increased for ruptured open repairs from 37% to 53% (P < .001) and for ruptured EVARs from 28% to 73% (P < .001). Compared with treatment by VSs, treatment by a CS (0.55 [0.53-0.56]) and GS (0.66 [0.64-0.68]) was associated with a decreased likelihood of undergoing endovascular rather than open AAA repair.ConclusionsVSs are performing an increasing majority of AAA repairs, in large part driven by the increased utilization of EVAR for both intact and ruptured AAA repair. However, GSs and CSs still perform AAA repair. Further studies should examine the implications of these national trends on the outcome of AAA repair.

Dataset Information

The Impact of Endograft Selection on Outcomes Following Treatment Outside of Instructions for Use (IFU) in Endovascular Abdominal Aortic Aneurysm Repair (EVAR).

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