Chen Yonghui, Liu Zongwei, Wang Shuaishuai, D'Oria Mario, Zhang Xiaoxing, Bi Jiaxue, Cui Dongsheng, Dai Xiangchen
Department of Vascular Surgery, Tianjin Medical University General Hospital, Tianjin, China.
Division of Vascular and Endovascular Surgery, Cardio-thoraco-vascular Department, University Hospital of Trieste Azienda Sanitaria Universitaria Giuliano Isontina, Trieste, Italy.
J Endovasc Ther. 2023 Dec 29:15266028231220322. doi: 10.1177/15266028231220322.
To conduct a meta-analysis to assess the safety and efficacy of t-Branch off-the-shelf multibranched endograft for the treatment of thoracoabdominal aortic aneurysm (TAAA).
PubMed, Embase, and Web of Science.
Online databases were searched from June 2012 to March 2023. The data were pooled together using a random-effects model of proportions. The outcomes overall included technical success, spinal cord ischemia, target vessel occlusion, type I or III endoleak, reintervention, early mortality (30-day), and mid-term outcomes. Subgroup meta-analyses and meta-regression were performed to explore variation among studies.
A total of 15 studies containing 1238 patients were included in the meta-analysis. The overall study quality assessment was found to be moderate to good. The pooled technical success was 97.0% (95% confidence interval [CI]=95.5-98.6, =53.01%, 1185/1238 cases, 15 studies). Overall, early mortality was 7.3% (95% CI=4.4-10.1, =74.48%, 124/1238 cases, 15 studies). Early spinal cord ischemia was 13.4% (95% CI=9.6-17.2, 67.24%, 160/1238 cases, 15 studies), and early type I or III endoleak was 6.0% (95% CI=3.4-8.5, =53.71%, 68/1032 cases, 9 studies). Mid-term outcomes showed target vessel occlusion was 4% (95% CI=1.4-6.5, =65.18%, 28/528 cases, 10 studies, 5-21.2 months), type I or III endoleak was 4.7% (95% CI=2-7.5, =49.74%, 38/512 cases, 10 studies, 5-21.2 months), reintervention was 11.2% (95% CI=8.1-14.3, =31.06%, 85/650 cases, 10 studies, 5-21.2 months), and pooled mortality was 13.9% (95% CI=7.2-20.7, 76.32%, 84/550 cases, 11 studies, 5-21.2 months). Meta-regression found a significant linear association between higher technical success and earlier publication year (p=0.014) and studies with anatomic inclusion criteria (p=0.037). Urgent patients (p=0.021) and later publication year (p=0.048) were significantly associated with higher early mortality.
The use of the off-the-shelf t-Branch multibranched endograft for elective or urgent endovascular TAAA repair is associated with high technical success rates and proved to be safe and effective at early and mid-term follow-up. However, the heterogeneity between the included studies is high, and prospective, randomized studies along with future larger studies with long-term follow-up are needed.
The Zenith t-Branch (Cook Medical, Bloomington, Ind) was approved as a commercially available device in Europe in June 2012. Although a decade has past, the outcomes of t-Branch have rarely been synthesized at the global level. This meta-analysis included 15 studies containing 1238 patients. The meta-analyses included technical success, major adverse events, reintervention, early mortality, and mid-term outcomes. The outcome was very meaningful and representative for the use of t-Branch. It is helpful for endovascular surgeons to make decisions on the treatment of TAAA patients.
进行一项荟萃分析,以评估即用型t分支多分支血管内移植物治疗胸腹主动脉瘤(TAAA)的安全性和有效性。
PubMed、Embase和科学网。
检索2012年6月至2023年3月的在线数据库。使用随机效应比例模型汇总数据。总体结果包括技术成功率、脊髓缺血、靶血管闭塞、I型或III型内漏、再次干预、早期死亡率(30天)和中期结果。进行亚组荟萃分析和荟萃回归以探索研究间的差异。
荟萃分析共纳入15项研究,包含1238例患者。总体研究质量评估为中等至良好。汇总的技术成功率为97.0%(95%置信区间[CI]=95.5 - 98.6,=53.01%,1185/1238例,15项研究)。总体而言,早期死亡率为7.3%(95% CI=4.4 - 10.1,=74.48%,124/1238例,15项研究)。早期脊髓缺血为13.4%(95% CI=9.6 - 17.2,67.24%,160/1238例,15项研究),早期I型或III型内漏为6.0%(95% CI=3.4 - 8.5,=53.71%,68/1032例,9项研究)。中期结果显示靶血管闭塞为4%(95% CI=1.4 - 6.5,=65.18%,28/528例,10项研究,5 - 21.2个月),I型或III型内漏为4.7%(95% CI=2 - 7.5,=49.74%,38/512例,10项研究,5 - 21.2个月),再次干预为11.2%(95% CI=8.1 - 14.3,=31.06%,85/650例,10项研究,5 - 21.2个月),汇总死亡率为13.9%(95% CI=7.2 - 20.7,76.32%,84/550例,11项研究,5 - 21.2个月)。荟萃回归发现较高的技术成功率与较早的发表年份(p=0.014)以及具有解剖纳入标准的研究(p=0.037)之间存在显著的线性关联。急诊患者(p=0.021)和较晚的发表年份(p=0.048)与较高的早期死亡率显著相关。
使用即用型t分支多分支血管内移植物进行择期或急诊血管内TAAA修复具有较高的技术成功率,并且在早期和中期随访中被证明是安全有效的。然而,纳入研究之间的异质性较高,需要进行前瞻性、随机研究以及未来更大规模的长期随访研究。
Zenith t分支(库克医疗公司,印第安纳州布卢明顿)于2012年6月在欧洲被批准为商用设备。尽管已经过去了十年,但t分支的结果在全球范围内很少被综合分析。这项荟萃分析包括15项研究,包含1238例患者。荟萃分析包括技术成功率、主要不良事件、再次干预、早期死亡率和中期结果。该结果对于t分支的使用非常有意义且具有代表性。有助于血管内外科医生对TAAA患者的治疗做出决策。