Mayo Clinic Aortic Center, Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minn.
Mayo Clinic Aortic Center, Advanced Endovascular Aortic Research Program, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, Minn; Division of Vascular and Endovascular Surgery, Department of Surgery and Anatomy, Ribeirao Preto Medical School, University of São Paulo, São Paulo, Brazil.
J Vasc Surg. 2019 Jul;70(1):31-42.e7. doi: 10.1016/j.jvs.2018.09.063. Epub 2018 Dec 21.
OBJECTIVE: The purpose of this study was to review treatment trends and outcomes of patients who underwent fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal aneurysms (PRAs) or thoracoabdominal aortic aneurysms (TAAAs) using physician-modified endografts (PMEGs) or company-manufactured devices (CMDs). METHODS: We reviewed the clinical data of 316 consecutive patients (242 male patients; mean age, 75 ± 8 years) who underwent F-BEVAR between 2007 and 2016. F-BEVAR was performed under two prospective investigational device exemption protocols since 2013. End points were mortality, major adverse events (MAEs), patient survival, reintervention, branch instability, aneurysm-related mortality, renal function deterioration, and target vessel patency. RESULTS: There were 145 patients (46%) treated by PMEGs (84 PRAs, 26 extent IV and 35 extent I-III TAAAs) and 171 patients (54%) who had CMDs (88 PRAs, 42 extent IV and 41 extent I-III TAAAs). Choice of endograft evolved from PMEGs in 131 patients (83%) treated in the first half of experience to CMDs in 144 patients (91%) treated in the second half of experience (P < .001). Patients treated by PMEGs had significantly (P < .05) larger aneurysms, more chronic pulmonary and kidney disease, and higher comorbidity severity scores. A total of 1081 renal-mesenteric arteries were targeted in both groups. Technical success was lower for PMEGs (98% vs 99.5%; P = .02). Thirty-day mortality was 5.5% for PMEGs (PRAs, 1.2%; extent IV 3.8% and extent I-III, 17.1%) and 0% for CMDs (P = .0018). Patients treated by PMEGs had significantly more (P < .001) MAEs (48% vs 23%) and longer hospital stay (9 ± 10 days vs 6 ± 6 days; P = .001). Mean follow-up was significantly longer for patients treated by PMEGs (38 ± 26 months vs 14 ± 12 months; P < .001). At 3 years, patient survival (68% ± 4% vs 67% ± 8%; P = .11), freedom from reintervention (68% ± 4% vs 68% ± 8%; P = .17), primary (94% ± 2% vs 92% ± 2%; P = .64) and secondary target vessel patency (98% ± 1% vs 98% ± 1%; P = .89), and freedom from renal function deterioration (75% ± 4% vs 65% ± 6%; P = .24) were similar for patients treated by PMEGs or CMDs, respectively. CONCLUSIONS: Choice of F-BEVAR evolved from PMEGs to almost exclusively CMDs under physician-sponsored investigational device exemption protocols. PMEG patients had more comorbidities and larger aneurysms. CMDs were performed with higher technical success, no mortality, and fewer MAEs.
目的：本研究旨在回顾使用医生改良的内置移植物（PMEG）或公司制造的设备（CMD）行腔内分支型腹主动脉瘤修复术（F-BEVAR）治疗肾周动脉瘤（PRA）或胸腹主动脉瘤（TAAA）患者的治疗趋势和结果。
方法：我们回顾了 2007 年至 2016 年间连续 316 例接受 F-BEVAR 治疗的患者的临床数据。自 2013 年以来，F-BEVAR 是根据两项前瞻性研究器械豁免协议进行的。终点是死亡率、主要不良事件（MAE）、患者生存率、再次干预、分支不稳定、动脉瘤相关死亡率、肾功能恶化和靶血管通畅性。
结果：145 例患者（46%）接受了 PMEG（84 例 PRA，26 例 IV 型和 35 例 I-III 型 TAAA）治疗，171 例患者（54%）接受了 CMD（88 例 PRA，42 例 IV 型和 41 例 I-III 型 TAAA）治疗。在经验的前半段，有 131 例（83%）患者选择了 PMEG，在后半段，有 144 例（91%）患者选择了 CMD（P<0.001）。接受 PMEG 治疗的患者的动脉瘤明显更大（P<0.05），慢性肺和肾脏疾病更多，合并症严重程度评分更高。两组共定位了 1081 个肾肠系膜动脉。PMEG 的技术成功率较低（98%对 99.5%；P=0.02）。PMEG 的 30 天死亡率为 5.5%（PRA，1.2%；IV 型 3.8%和 I-III 型 17.1%），CMD 为 0%（P=0.0018）。接受 PMEG 治疗的患者的 MAE 发生率明显更高（48%对 23%），住院时间更长（9±10 天对 6±6 天；P=0.001）。接受 PMEG 治疗的患者的平均随访时间明显更长（38±26 个月对 14±12 个月；P<0.001）。在 3 年时，患者生存率（68%±4%对 67%±8%；P=0.11）、无再干预率（68%±4%对 68%±8%；P=0.17）、原发性（94%±2%对 92%±2%；P=0.64）和继发性靶血管通畅率（98%±1%对 98%±1%；P=0.89）以及肾功能恶化率（75%±4%对 65%±6%；P=0.24）相似。
结论：在医生发起的研究器械豁免协议下，F-BEVAR 的选择从 PMEG 演变几乎完全是 CMD。PMEG 患者的合并症更多，动脉瘤更大。CMD 的技术成功率更高，无死亡率，MAE 更少。
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