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Defining high-risk patients for endovascular aneurysm repair.

ABSTRACT: 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.

SUBMITTER: Egorova N

PROVIDER: S-EPMC3081634 | biostudies-literature | 2009 Dec

REPOSITORIES: biostudies-literature

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Defining high-risk patients for endovascular aneurysm repair.

Egorova Natalia N Giacovelli Jeannine K JK Gelijns Annetine A Greco Giampaolo G Moskowitz Alan A McKinsey James J Kent K Craig KC

Journal of vascular surgery 20090926 6

<h4>Background</h4>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.<h4>Methods</h4>We identified 66,943 pati ...[more]

PMID: 19782526

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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.

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: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.

Project description:BackgroundClinical and imaging surveillance practices following endovascular aneurysm repair (EVAR) for intact abdominal aortic aneurysm (AAA) vary considerably and compliance with recommended lifelong surveillance is poor. The aim of this study was to develop a dynamic prognostic model to enable stratification of patients at risk of future secondary aortic rupture or the need for intervention to prevent rupture (rupture-preventing reintervention) to enable the development of personalized surveillance intervals.MethodsBaseline data and repeat measurements of postoperative aneurysm sac diameter from the EVAR-1 and EVAR-2 trials were used to develop the model, with external validation in a cohort from a single-centre vascular database. Longitudinal mixed-effects models were fitted to trajectories of sac diameter, and model-predicted sac diameter and rate of growth were used in prognostic Cox proportional hazards models.ResultsSome 785 patients from the EVAR trials were included, of whom 155 (19·7 per cent) experienced at least one rupture or required a rupture-preventing reintervention during follow-up. An increased risk was associated with preoperative AAA size, rate of sac growth and the number of previously detected complications. A prognostic model using predicted sac growth alone had good discrimination at 2 years (C-index 0·68), 3 years (C-index 0·72) and 5 years (C-index 0·75) after operation and had excellent external validation (C-index 0·76-0·79). More than 5 years after operation, growth rates above 1 mm/year had a sensitivity of over 80 per cent and specificity over 50 per cent in identifying events occurring within 2 years.ConclusionSecondary sac growth is an important predictor of rupture or rupture-preventing reintervention to enable the development of personalized surveillance intervals. A dynamic prognostic model has the potential to tailor surveillance by identifying a large proportion of patients who may require less intensive follow-up.

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Defining high-risk patients for endovascular aneurysm repair.

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Defining high-risk patients for endovascular aneurysm repair.

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