Dataset Information

Three-dimensional guidance including shape sensing of a stentgraft system for endovascular aneurysm repair.

ABSTRACT: PURPOSE:During endovascular aneurysm repair (EVAR) procedures, medical instruments are guided with two-dimensional (2D) fluoroscopy and conventional digital subtraction angiography. However, this requires X-ray exposure and contrast agent is used, and the depth information is missing. To overcome these drawbacks, a three-dimensional (3D) guidance approach based on tracking systems is introduced and evaluated. METHODS:A multicore fiber with fiber Bragg gratings for shape sensing and three electromagnetic (EM) sensors for locating the shape were integrated into a stentgraft system. A model for obtaining the located shape of the first 38 cm of the stentgraft system with two EM sensors is introduced and compared with a method based on three EM sensors. Both methods were evaluated with a vessel phantom containing a 3D-printed vessel made of silicone and agar-agar simulating the surrounding tissue. RESULTS:The evaluation of the guidance methods resulted in average errors from 1.35 to 2.43 mm and maximum errors from 3.04 to 6.30 mm using three EM sensors, and average errors from 1.57 to 2.64 mm and maximum errors from 2.79 to 6.27 mm using two EM sensors. Moreover, the videos made from the continuous measurements showed that a real-time guidance is possible with both approaches. CONCLUSION:The results showed that an accurate real-time guidance with two and three EM sensors is possible and that two EM sensors are already sufficient. Thus, the introduced 3D guidance method is promising to use it as navigation tool in EVAR procedures. Future work will focus on developing a method with less EM sensors and a detailed latency evaluation of the guidance method.

SUBMITTER: Jackle S

PROVIDER: S-EPMC7303070 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Three-dimensional guidance including shape sensing of a stentgraft system for endovascular aneurysm repair.

Jäckle Sonja S García-Vázquez Verónica V Eixmann Tim T Matysiak Florian F von Haxthausen Felix F Sieren Malte Maria MM Schulz-Hildebrandt Hinnerk H Hüttmann Gereon G Ernst Floris F Kleemann Markus M Pätz Torben T

International journal of computer assisted radiology and surgery 20200507 6

<h4>Purpose</h4>During endovascular aneurysm repair (EVAR) procedures, medical instruments are guided with two-dimensional (2D) fluoroscopy and conventional digital subtraction angiography. However, this requires X-ray exposure and contrast agent is used, and the depth information is missing. To overcome these drawbacks, a three-dimensional (3D) guidance approach based on tracking systems is introduced and evaluated.<h4>Methods</h4>A multicore fiber with fiber Bragg gratings for shape sensing an ...[more]

PMID: 32383105

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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: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.

Dataset Information

Three-dimensional guidance including shape sensing of a stentgraft system for endovascular aneurysm repair.

Publications

Three-dimensional guidance including shape sensing of a stentgraft system for endovascular aneurysm repair.

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