European Multicenter Study for the Evaluation of a Dual-Layer Flow-Diverting Stent for Treatment of Wide-Neck Intracranial Aneurysms: The European Flow-Redirection Intraluminal Device Study

Killer‐Oberpfalzer, Monika; Koçer, Naci; Griessenauer, Christoph J.; Janssen, Hendrik; Engelhorn, Tobias; Holtmannspoetter, Markus; Buhk, Jan‐Hendrik; Finkenzeller, Thomas; Fesl, Gunther; Trenkler, Johannes; Reith, Wolfgang; Berlis, Ansgar; Hausegger, K. A.; Augustin, Matthias; Işlak, Civan; Minnich, Bernd; Möhlenbruch, Markus

doi:10.3174/ajnr.a5592

Cited by 75 publications

(73 citation statements)

References 19 publications

(23 reference statements)

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“…We have compiled here our experience using the FRED stent, evaluating its efficacy for the treatment of intracranial aneurysms. After more than 1 year we observed aneurysm occlusion/near occlusion (OKM C–D) of 92.7%, slightly lower than the 95.3% reported by Killer-Oberpfalzer et al (with a first-year rate of 91.3%) in the European retrospective multicenter study, which compiled the experience of 15 high-volume neurovascular centers 12. Similarly, the Italian FRED Registry, which included 169 aneurysms treated in 30 Italian centers, reported a high rate of occlusion (94% in the first year, increasing to 96% at 12–24 months).…”

Section: Discussioncontrasting

confidence: 62%

“…FD stents are an important development in the endovascular approach to the treatment of intracranial aneurysms, shifting the aim of the procedure from occluding the dome of the aneurysm to repairing the parent vessel wall. Stent therapy is now an alternative treatment for intracranial aneurysms because of its efficacy and safety profile 12–17…”

Section: Discussionmentioning

confidence: 99%

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Efficacy and safety of the dual-layer flow-diverting stent (FRED) for the treatment of intracranial aneurysms

Guimaraens

Vivas

Saldaña

et al. 2019

J NeuroIntervent Surg

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PurposeTo describe the efficacy and complications of treating cerebral aneurysms with the Flow Re-direction Endoluminal Device (FRED) and to identify predictors for aneurysm occlusion.MethodsA prospective observational registry including all consecutive aneurysms treated with FRED between December 2015 and July 2018 was designed in one therapeutic neuroangiography department. The primary endpoint for treatment efficacy was complete or near-complete occlusion (O’Kelly–Marotta (OKM) C–D), assessed by three-dimensional digital subtraction angiography. Major (all symptomatics) and minor complications were described and those with modified Rankin Scale scores 3–6 were considered clinically relevant. Univariate and multivariate analyses were performed to identify predictors of efficacy.ResultsA total of 185 aneurysms were analyzed in 150 patients (mean age 54.3±11.5 years). Mean follow-up was 18.99±11.32 months (range 0–43). Efficacy was evaluated in 156 (84.32%) cases: 132 (84.6%) had OKM C–D occlusion, 31/47 (66%) within the first year and 101/109 (92.7%) later on. Major complications were observed in 12 (6.5%) cases: three strokes (one transient ischemic accident, two minor strokes), six intra-stent thrombosis, and three with bleeding, but only one (0.5%) was clinically relevant. Minor complications (all asymptomatic) were observed in 10 (5.4%) cases: three shortening/repositioning of stent; two arterial dissection, two arterial occlusion, and three intra-stent stenosis. Independent predictors of occlusion were immediate OKM grade B–C–D (OR 4.01, 95% CI 1.51 to 10.62), single aneurysm (OR 3.29, 95% CI 1.05 to 10.32), and small size aneurysm (OR 4.74, 95% CI 1.57 to 14.30).ConclusionThe FRED stent fully complied with efficacy and safety requirements for treatment of intracranial aneurysms. Three predictors of aneurysm occlusion were identified.

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Section: Discussioncontrasting

confidence: 62%

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of the dual-layer flow-diverting stent (FRED) for the treatment of intracranial aneurysms

Guimaraens

Vivas

Saldaña

et al. 2019

J NeuroIntervent Surg

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“…Therefore, using a tool like the CMS Human Health Services (HHS) Hierarchical Condition Category (HCC) risk adjustment model can be helpful. This model uses patients' demographic data and coded diagnoses to produce a risk score that will help with financial estimation [20]. Turcot et al recently published a report where they tested this model on patients that underwent different spinal surgical interventions.…”

Section: Discussionmentioning

confidence: 99%

Economics of the Management of Craniospinal Chordoma and Chondrosarcoma and the feasibility of the bundled payment model

et al. 2020

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Background: The Centers for Medicare and Medicaid Services (CMS) created a new reimbursement model "Bundled Payment for Care Improvement (BPCI)" which reimburses providers a predetermined payment in advance to cover all possible services rendered within a certain time window. Chordoma and Chondrosarcoma are locally aggressive malignant primary bony tumors. Treatment includes surgical resection and radiotherapy with substantial risk for recurrence which necessitates monitoring and further treatment. We assessed the feasibility of the BPCI model in these neurosurgical diseases. Methods: We selected patients with chordoma/chondrosarcoma from inpatient admission table using the International Classification of Disease, 9th (ICD-9), and 10th (ICD-10) revision codes. We collected the patients' demographics and insurance type at the index hospitalization. We recorded the following outcomes length of stay, total payment, discharge disposition, and complications for the index hospitalization. For post-discharge, we collected the 30 days and 3/6/12 months inpatient admission, outpatient service, and medication refills. Continuous variables were summarized by means with standard deviations, median with interquartile and full ranges (minimum-maximum); Continuous outcomes were compared by nonparametric Wilcoxson rank-sum test. All tests were 2-sided with a significance level of 0.05. Statistical data analysis was performed in SAS 9.4 (SAS Institute, Inc, Cary, NC). Results: The population size was 2041 patients which included 1412 patients with cranial (group1), 343 patients with a mobile spine (group 2), and 286 patients with sacrococcygeal (group 3) chordoma and chondrosarcoma. For index hospitalization, the median length of stay (days) was 4, 6, and 7 for groups 1, 2, and 3 respectively (P<.

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“…This model uses patients' demographic data and coded diagnoses to produce a risk score that will help with financial estimation. [23] Turcot et al recently published a report where they tested this model on patients that underwent different spinal surgical interventions.…”

Section: Discussionmentioning

confidence: 99%

Economics of the Management of Craniospinal Chordoma and Chondrosarcoma and the Feasibility of the Bundled Payment Model

Aljuboori

Ugiliweneza

Wang

et al. 2020

Preprint

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Background Healthcare expenditures are continuously rising in the United States. The Centers for Medicare and Medicaid Services (CMS) created a new reimbursement model called the “Bundled Payment for Care Improvement (BPCI)”. This model reimburses providers a predetermined payment in advance to cover all possible services delivered to patients within a certain time window. Chordoma and Chondrosarcoma are locally aggressive malignant primary bony tumors. Treatment includes surgical resection and radiotherapy with substantial risk for recurrence which necessitates monitoring and further treatment. We assess the BPCI model in complex neurosurgical diseases. Methods We obtained data from the United States MarketScan database. Patients were identified patients using the International Classification of Diseases 10 codes. Results A total of 2041 patients were included. 1412 patients had cranial, 343 patients had a mobile spine, and 286 patients had sacrococcygeal chordoma and chondrosarcoma. For Index hospitalization, the median length of stay (days) was 4, 6, and 7, mean total payments were ($58,130), ($84,854), and ($82,440), and complication rates were 30%, 35%, and 43% for groups 1, 2, and 3, respectively. The payments during the first 6 months after discharge were comparable to the amounts reimbursed during the index hospitalization for all groups. Conclusion The management of craniospinal chordoma and chondrosarcoma is costly and sustained over time. The success of BPCI requires a joint effort between insurers and hospitals. It should consider patients’ comorbidities, the complexity of the disease. Finally, adoption of quality improvement programs by hospitals can help with cost reduction.

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European Multicenter Study for the Evaluation of a Dual-Layer Flow-Diverting Stent for Treatment of Wide-Neck Intracranial Aneurysms: The European Flow-Redirection Intraluminal Device Study

Cited by 75 publications

References 19 publications

Efficacy and safety of the dual-layer flow-diverting stent (FRED) for the treatment of intracranial aneurysms

Efficacy and safety of the dual-layer flow-diverting stent (FRED) for the treatment of intracranial aneurysms

Economics of the Management of Craniospinal Chordoma and Chondrosarcoma and the feasibility of the bundled payment model

Economics of the Management of Craniospinal Chordoma and Chondrosarcoma and the Feasibility of the Bundled Payment Model

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