Complex endovascular treatment of intact aortic aneurysms

Abstract

BackgroundThe complex endovascular repair of aortic aneurysms and dissections with fenestrated or branched stent grafts (FB-EVAR) remains challenging for interventional vascular surgery. To date, the evidence regarding treatment patterns and outcome measures consists of single center studies; however, it might be reasonable to validate results with multicenter real-world evidence.MethodsHealth insurance claims data from Germany’s third largest insurance provider, DAK-Gesundheit, were used to determine outcomes following FB-EVAR of non-ruptured thoracic aorta (TA) or thoracoabdominal including pararenal abdominal (TAA) aorta. The study included patients operated between January 2008 and April 2017.ResultsIncluded were 984 patients (18.1% female) who underwent FB-EVAR. Patients with treatment of the TA were younger (71.7 vs. 73.2 years, p < 0.001) and more often female (38.5% vs. 17.0%, p < 0.001) as compared to patients with treatment of TAA. In the TA group peripheral arterial disease was less frequent compared to the TAA group (67.3% vs. 80.4%, p = 0.036). Mortality was significantly (p < 0.001) higher following repair of the TAA compared to the TA at discharge (17.3% vs. 4.6%), at 30 days (26.9% vs. 8.2%) and at 90 days (34.6% vs. 10.1%). Patients with treatment of the TAA suffered more often from stroke as compared to the TA group (7.7% vs. 1.2%, p = 0.002).ConclusionIn this large-scale German analysis of claims data, multicenter real-world evidence was different from single center studies regarding patient risk-factors and outcome measures. Validated multicenter registry studies could help to further investigate this topic in times of increasing procedures.

The prospective GermanVasc cohort study

“…This was a prospective longitudinal multicentre cohort study. The rationale and methods of the GermanVasc registry study were published a priori [10,11] and additionally registered at Clinicaltrials.gov (NCT03098290) and the German Registry of Clinical Trials (DRKS00014649). A total of 18 ethical committees in affected German federal states confirmed the initial approval by the leading ethical committee at the medical association in Hamburg, Germany (PV5691).…”

“…The GermanVasc study included patients with symptomatic PAD who underwent either endovascular, opensurgical, or hybrid revascularisations between 1 st May 2018 and 31 st December 2020 at 31 German centres (Figure 1). The rationale and methods were published and registered a priori (clinicaltrials.gov NCT03098290) [10,11]. All indicators of outcome quality and additional variables collected in the current study were aligned by international Delphi consensus methods [12,13,14].…”