O'Donnell Thomas F X, Dansey Kirsten D, Schermerhorn Marc L, Zettervall Sara L, DeMartino Randall R, Takayama Hiroo, Patel Virendra I
Division of Cardiac, Thoracic, and Vascular Surgery, New York-Presbyterian/Columbia University Irving Medical Center/Columbia University Vagelos College of Physicians & Surgeons, New York, NY.
Division of Vascular and Endovascular Surgery, University of Washington, Seattle, WA.
J Vasc Surg. 2024 Jun;79(6):1276-1284. doi: 10.1016/j.jvs.2024.01.216. Epub 2024 Feb 13.
Custom-branched/fenestrated grafts are widely available in other countries, but in the United States, they are limited to a handful of centers, with the exception of a 3-vessel juxtarenal device (ZFEN). Consequently, many surgeons have turned to alternative strategies such as physician-modified endografts (PMEGs). We therefore sought to determine how widespread the use of these grafts is.
We studied all complex endovascular repairs of complex and thoracoabdominal aortic aneurysms in the Vascular Quality Initiative from 2014 to 2022 to examine temporal trends.
A total of 5826 repairs were performed during the study period: 1895 ZFEN, 3241 PMEG, 595 parallel grafting, and 95 where parallel grafting was used in addition to ZFEN, with a mean of 2.7 ± 0.98 vessels incorporated. Over time, the number of PMEGs steadily increased, both overall and for juxtarenal aneurysms, whereas the number of ZFENs essentially leveled off by 2017 and has remained steady ever since. In the most recent complete year (2021), PMEGs outnumbered ZFENs by over 2:1 overall (567 to 256) and nearly twofold for juxtarenal repairs. In three-vessel cases involving juxtarenal aneurysms, PMEGs were used as frequently as ZFENs (43% vs 43%), whereas the proportion of juxtarenal aneurysms repaired using a four-vessel graft configuration increased from 20% in 2014 to 29% in 2021 (P < .001). The differences in PMEG use were more pronounced as surgeon volume increased. Surgeons in the lowest quartile of volume performed <2 complex repairs annually, evenly split between PMEGs and ZFENs. However, surgeons in the highest quartile of volume performed a median of 18 (interquartile range: 10-21) PMEGs/y, but only 1.6 (interquartile range: 0.8-3.4) ZFENs/y. The number of physician-sponsored investigational device exemption trials of PMEGs has expanded from 1 in 2012 to 8 currently enrolling. As those data are not included in the Vascular Quality Initiative, the true number of PMEGs is likely substantially higher.
PMEGs have become the dominant endovascular repair modality of complex abdominal and thoracoabdominal aortic aneurysms outside of investigational device exemptions. The field of endovascular aortic surgery and patients with complex aneurysms would benefit from broader publication of PMEG techniques, outcomes, and comparisons to custom-manufactured grafts.
定制分支/开窗移植物在其他国家广泛应用，但在美国，除了一种三分支肾周装置（ZFEN）外，仅在少数几个中心可用。因此，许多外科医生转向了替代策略，如医生改良的腔内移植物（PMEG）。我们因此试图确定这些移植物的使用有多广泛。
我们研究了2014年至2022年血管质量倡议中所有复杂和胸腹主动脉瘤的复杂血管内修复，以检查时间趋势。
在研究期间共进行了5826例修复：1895例ZFEN、3241例PMEG、595例平行移植物以及95例除ZFEN外还使用了平行移植物的病例，平均纳入2.7±0.98支血管。随着时间的推移，PMEG的数量总体上以及肾周动脉瘤修复中的数量均稳步增加，而ZFEN的数量在2017年基本趋于平稳，此后一直保持稳定。在最近完整的一年（2021年），PMEG的数量总体上超过ZFEN超过2倍（分别为567例和256例），肾周修复中则接近两倍。在涉及肾周动脉瘤的三分支病例中，PMEG和ZFEN的使用频率相同（分别为43%和43%），而使用四分支移植物构型修复肾周动脉瘤的比例从2014年的20%增加到2021年的29%（P<0.001）。随着外科医生手术量的增加，PMEG使用的差异更为明显。手术量最低四分位数的外科医生每年进行少于2例复杂修复，PMEG和ZFEN平分。然而，手术量最高四分位数的外科医生每年进行PMEG的中位数为1十八例（四分位间距：10 - 21例），但每年仅进行1.6例（四分位间距：0.8 - 3.4例）ZFEN。医生赞助的PMEG研究性器械豁免试验数量已从2012年的1项增加到目前正在招募的8项。由于这些数据未包含在血管质量倡议中，PMEG的实际数量可能要高得多。
除研究性器械豁免外，PMEG已成为复杂腹主动脉瘤和胸腹主动脉瘤的主要血管内修复方式。血管内主动脉手术领域以及复杂动脉瘤患者将从更广泛地发表PMEG技术、结果以及与定制移植物的比较中受益。
