Physician-modified Versus Custom-manufactured Fenestrated-branched Endografts In The Treatment Of Thoracoabominal And Pararenal Aneurysms: A Vqi-medicare Analysis
Asma Mathlouthi, MD1, Kevin Yei, BS1, Andrew R. Barleben, MD MPH1, Gustavo S. Oderich, MD2, Mahmoud B. Malas, MD MHS1.
1University of California, San Diego, San Diego, CA, USA, 2UTHealth, McGovern Medical School, Houston, TX, USA.
OBJECTIVES: Fenestrated and branched endovascular aneurysm repair (F-BEVAR) expanded the indications of endovascular repair to patients with thoracoabdominal (TAAAs) and pararenal aortic aneurysms (PRAs). Previous reports indicated that F-BEVAR can be performed with high technical success and lower morbidity and mortality when compared to open repair. While custom-manufactured devices (CMDs), which are tailored to the patient’s anatomy, proved to be effective, their widespread use is hampered by regulatory issues, cost and delay in device manufacturing. Physician-modified endografts (PMEGs) are created on a back table in the operating room (OR) by modifying a commercially available endograft, thereby making the device available to the surgeon without any delay for manufacturing. We sought to compare the mid-term outcomes between PMEG and CMD in the treatment of TAAAs and PRAs. METHODS: We identified all patients who underwent F-BEVAR for TAAA or PRA between January 2015 and December 2018 in the Vascular Quality Initiative-Medicare linked database. Patients who underwent repair with an “off the shelf” device and those with ruptured aneurysms were excluded. Outcomes were compared in patients with PMEGs and CMDs, including 3-year freedom from reintervention, rupture and all-cause mortality (ACM). RESULTS: Of 1,112 patients included, 294(26%) were treated with PMEGs and 818(74%) had CMDs. Patients treated with PMEGs were more likely to be symptomatic (20% vs. 6%, P<0.001) and to have TAAAs (58% vs. 39%, P<0.001) with a higher number of vessels incorporated per patient (mean±SD: 3.5±0.8 vs. 3.2±0.8, P<0.001). At 3 years, patients treated with CMDs had higher freedom from reintervention (79% vs. 70%, P=0.003) and showed a trend towards higher freedom from rupture (91% vs. 87%, P=0.06) and freedom from ACM (69% vs. 60%, P=0.09). After adjusting for potential confounders, an impact of the device modification approach on reintervention [aHR(95%CI): 1.4(0.96-2), P=0.07], rupture [aHR(95%CI): 1.49(0.86-2.6), P=0.15] and ACM [aHR(95%CI): 1.007(0.7-1.4), P=0.9] was not observed. CONCLUSIONS: The present study is the largest real-world analysis showing noninferiority of PMEGs in the treatment of thoracoabdominal and pararenal aneurysms based on similar reintervention, rupture and ACM rates when compared to CMDs. However, further prospective studies on the role of aneurysm repair strategy in these challenging patients are needed.
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