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Endovascular Aneurysm Repair in Patients with Conical Neck Anatomy.

ABSTRACT: Cone shape neck is regarded as non-instruction for use (IFU) in most commercial stent graft. However, in real practice, liberal application of endovascular aneurysm repair (EVAR) for outside of IFU happens. We investigate non-adherence to conical neck anatomy in terms of early aneurysmal exclusion results.From January 2010 to December 2013, 105 patients with abdominal aortic aneurysm (AAA) underwent EVAR in Daegu Catholic University Medical Center. Among them, 38 patients (36.2%) had AAA with conical neck. We investigated the clinical characteristics of patients and the details of conical neck. We also analyzed the clinical results, such as endoleak, migration, procedure failure, perioperative mortality, and admission duration between conical neck and non-conical neck.The maximum diameter of AAA was larger (60.95 mm vs. 52.68 mm, P=0.016) and the infrarenal neck length was shorter (25.07 mm vs. 38.13 mm, P=0.000) in conical neck group. During the procedure, type Ia endoleak occurred more in conical neck group (23.7% vs. 6.0%, P=0.013) and it could be successfully solved with additional adjunctive treatments, such as balloon or Palmaz stent. Although there was no statistical significance, mortality was higher and admission duration was longer in the conical neck (15.8% vs. 6.0%, 16.62±13.12 days vs. 13.03±13.13 days). Mean follow-up duration was 319.2±366.45 days. Successful aneurysmal exclusion was achieved.The presence of conical neck may not be a contraindication for EVAR. However, conical neck requires careful observation for additional adjunctive treatments because it increases the risk of type Ia endoleak.

SUBMITTER: Lee JH

PROVIDER: S-EPMC5493188 | biostudies-other | 2017 Jun

REPOSITORIES: biostudies-other

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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.

Project description:Endovascular aneurysm repair (EVAR) is commonly used as a minimally invasive technique for repairing infrarenal aortic aneurysms. There have been recent concerns that a subset of high-risk patients experience unfavorable outcomes with this intervention. To determine whether such a high-risk cohort exists and to identify the characteristics of these patients, we analyzed the outcomes of Medicare patients treated with EVAR from 2000-2006.We identified 66,943 patients who underwent EVAR from Inpatient Medicare database. The overall 30-day mortality was 1.6%. A risk model for perioperative mortality was developed by randomly selecting 44,630 patients; the other one third of the dataset was used to validate the model. The model was deemed reliable (Hosmer-Lemeshow statistics were P = .25 for the development, P = .24 for the validation model) and accurate (c = 0.735 and c = 0.731 for the development and the validation model, respectively).In our scoring system, where scores ranged between 1 and 7, the following were identified as significant baseline factors that predict mortality: renal failure with dialysis (score = 7); renal failure without dialysis (score = 3); clinically significant lower extremity ischemia (score = 5); patient age >or=85 years (score = 3), 75-84 years (score = 2), 70-74 years (score = 1); heart failure (score = 3); chronic liver disease (score = 3); female gender (score = 2); neurological disorders (score = 2); chronic pulmonary disease (score = 2); surgeon experience in EVAR <3 procedures (score = 1); and hospital annual volume in EVAR <7 procedures (score = 1). The majority of Medicare patients who were treated (96.6%, n = 64,651) had a score of 9 or less, which correlated with a mortality <5%. Only 3.4% of patients had a mortality >or=5% and 0.8% of patients (n = 509) had a score of 13 or higher, which correlated with a mortality >10%.We conclude that there is a high-risk cohort of patients that should not be treated with EVAR because of prohibitively high mortality; however, this cohort is small. Our scoring system, which is based on patient and institutional factors, provides criteria that can be easily used by clinicians to quantify perioperative risk for EVAR candidates.

Project description:BackgroundWomen with abdominal aortic aneurysms less often meet anatomic criteria for endovascular repair and experience worse perioperative and long-term survival.MethodsWe compared long-term survival, aneurysm-related mortality, and rates of endoleaks and reinterventions between male and female patients in the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) using 2:1 propensity score matching.ResultsThere were 1130 male patients and 133 female patients, yielding 399 patients after matching (266 male patients, 133 female patients). Female patients were older, with smaller aneurysms, smaller iliac arteries, and shorter, more angulated necks, and they were more often treated outside the device instructions for use (all P < .001). Through 5 years, female patients experienced overall mortality comparable to that of well-matched male patients (34% vs 38%, respectively; hazard ratio, 0.89 [0.61-1.29]; P = .54) and lower aneurysm-related mortality (0% vs 3%; P = .047). Female patients experienced higher rates of any postoperative type IA endoleak through 5 years (10% vs 1%; P < .001) but comparable rates of secondary endovascular procedures (14% vs 16%; P = .40). Female sex was independently associated with significantly higher risk of long-term type IA endoleaks (hazard ratio, 4.8 [1.2-20.8]; P = .04), even after accounting for anatomic factors. No female patient experienced aneurysm rupture during follow-up, and only one female patient underwent conversion to open repair.ConclusionsDespite more challenging anatomy, female patients in the ENGAGE registry had long-term outcomes comparable to those of male patients. However, female patients experienced higher rates of type IA endoleaks. Although standard endovascular aneurysm repair remains a viable solution for most women, whether high-risk patients may be better served with open surgery, custom-made devices, EndoAnchors (Aptus Endosystems, Sunnyvale, Calif), or chimneys is worthy of further study.

Project description:ObjectiveEffective strategies to reduce costs associated with endovascular aneurysm repair (EVAR) remain elusive for many medical centers. In this study, targeted interventions to reduce inpatient EVAR costs were identified and implemented.MethodsFrom June 2015 to February 2016, we analyzed the EVAR practice at a high-volume academic medical center to identify, to rank, and ultimately to reduce procedure-related costs. In this analysis, per-patient direct costs to the hospital were compared before (September 2013-May 2015) and after (March 2016-January 2017) interventions were implemented. Improvement efforts concentrated on three categories that accounted for a majority of costs: implants, rooming costs, and computed tomography scans performed during the index hospitalization.ResultsCosts were compared between 141 EVAR procedures before implementation (PRE period) and 47 EVAR procedures after implementation (POST period). Based on data obtained through the Society for Vascular Surgery EVAR Cost Demonstration Project, it was determined that implantable device costs were higher than those at peer institutions. New purchasing strategies were implemented, resulting in a 30.8% decrease in per-case device costs between the PRE and POST periods. Care pathways were modified to reduce use of and costs for computed tomography scans obtained during the index hospitalization. Compared with baseline, per-case imaging costs decreased by 92.9% (P < .001), including a 99.0% (P = .001) reduction in postprocessing costs. Care pathways were also implemented to reduce preprocedural rooming for patients traveling long distances the day before surgery, resulting in a 50% decrease in utilization rate (35.4% PRE to 17.0% POST; P = .021), without having a significant impact on median postprocedural length of stay (PRE, 2 days [interquartile range, 1-11 days]; POST, 2 days [1-7 days]; P = .185). Medication costs also decreased by 38.2% (P < .001) as a hospital-wide effort.ConclusionsExcessive costs associated with EVAR threaten the sustainability of these procedures in health care organizations. Targeted cost reduction efforts can effectively reduce expenses without compromising quality or limiting patients' access.

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Endovascular Aneurysm Repair in Patients with Conical Neck Anatomy.

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