Ten years of physician-modified endografts

Abstract

Objectives: Physician-modified endografts (PMEGs) have expanded the scope of endovascular abdominal aortic repair beyond the infrarenal aorta. Patients with prohibitively high surgical risk and visceral segment disease are often candidates for this intervention, which mitigates much of the morbidity and mortality associated with conventional open repair. Here we present the institutional PMEG experience of a high-volume aortic center.

Methods: We studied all PMEGs performed at our institution from 2012 to 2023. We included cases that were submitted to the US Food sand Drug Administration in support of an investigational device exemption (IDE) trial, as well as those in the subsequently approved IDE trial. Over this 11-year period, we assessed the changes in operative characteristics and perioperative outcomes over time. Additionally, we compared the outcomes from PMEG cases to those of Zenith fenestrated (ZFEN) grafts (done by the surgeon with the PMEG IDE), an alternative device used for aneurysms involving the lower visceral segment. Here we assessed operative characteristics, perioperative outcomes, and 5-year survival and reintervention rates.

Results: When assessing the change over time for PMEG operative characteristics, we found a trend toward decreased fluoroscopy time and decreased proportions of completion type I and type III endoleaks (all P < .05). Perioperative outcomes have remained stable over this period, with an overall perioperative mortality rate of 4.9% (noting that this registry also includes cases that were urgent and emergent). Despite the increased complexity of PMEGs relative to ZFENs, we found comparable perioperative outcomes with regard to mortality (4.9% vs 4.3%; P = .86), permanent spinal cord ischemia (1.1% vs 0%; P = .38), postoperative myocardial infarction (4.3% vs 2.9%; P = .60), postoperative respiratory failure (7.1% vs 4.3%; P = .43), and new dialysis use (2.2% vs 4.3%; P = .35). Additionally, 5-year survival (PMEG 54% vs ZFEN 65%; P = .15) and freedom from reintervention (63% vs 74%; P = .07) were similar between these cohorts.

Conclusions: Throughout our >10-year experience with PMEGs, we have noted improvements in operative outcomes, which can likely be attributed to technological advances and increased physician experience. Additionally, we have found that PMEGs perform well when compared with ZFENs, despite being a more complicated repair that is able to treat a larger segment of the aorta. PMEGs are crucial for the comprehensive care of vascular patients with complex aortic disease. As further operative advancements are made, we only expect the use of this intervention to increase.

Keywords: PMEG; ZFEN; long term outcomes.