Sanders Andrew P, Gomez-Mayorga Jorge, Manchella Mohit K, Swerdlow Nicholas J, Schermerhorn Marc L
Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.
Department of Surgery, Division of Vascular and Endovascular Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
J Vasc Surg. 2025 Jan;81(1):1-12.e1. doi: 10.1016/j.jvs.2024.07.108. Epub 2024 Aug 23.
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.
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.
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.
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.
医生改良型腔内移植物（PMEG）已将血管腔内腹主动脉修复的范围扩展至肾下主动脉以外。手术风险极高且存在内脏段疾病的患者通常是这种干预措施的适用对象，该措施可减轻许多与传统开放修复相关的发病率和死亡率。在此，我们介绍一家大型主动脉中心机构的PMEG经验。
我们研究了2012年至2023年在本机构进行的所有PMEG手术。我们纳入了提交给美国食品药品监督管理局以支持研究性器械豁免（IDE）试验的病例，以及随后获批的IDE试验中的病例。在这11年期间，我们评估了手术特征和围手术期结局随时间的变化。此外，我们将PMEG病例的结局与Zenith开窗（ZFEN）移植物（由进行PMEG IDE手术的外科医生操作）的结局进行了比较，ZFEN移植物是用于涉及下内脏段动脉瘤的另一种器械。在此，我们评估了手术特征、围手术期结局以及5年生存率和再次干预率。
在评估PMEG手术特征随时间的变化时，我们发现透视时间有减少的趋势，I型和III型终末内漏的完成比例也有所下降（所有P <.05）。在此期间围手术期结局保持稳定，总体围手术期死亡率为4.9%（请注意，该登记册还包括急诊和紧急情况的病例）。尽管PMEG相对于ZFEN更为复杂，但我们发现围手术期死亡率（4.9%对4.3%；P =.86）、永久性脊髓缺血（1.1%对0%；P =.38）、术后心肌梗死（4.3%对2.9%；P =.60）、术后呼吸衰竭（7.1%对4.3%；P =.43）以及新的透析使用情况（2.2%对4.3%；P =.35）方面的结局具有可比性。此外，这两组人群的5年生存率（PMEG为54%，ZFEN为65%；P =.15）和无需再次干预的比例（63%对74%；P =.07）相似。
在我们超过10年的PMEG经验中，我们注意到手术结局有所改善，这可能归因于技术进步和医生经验的增加。此外，我们发现尽管PMEG修复更为复杂且能够治疗更大范围的主动脉，但与ZFEN相比表现良好。PMEG对于患有复杂主动脉疾病的血管患者的综合治疗至关重要。随着进一步的手术进展，我们预计这种干预措施的使用只会增加。
