Initial Clinical Experience with the Modified Zenith “Pro-Form” TX2 Thoracic Endograft
Initial Clinical Experience with the Modified Zenith “Pro-Form” TX2 Thoracic Endograft
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DOI：
10.1583/10-3061.1
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发表时间：
2010-08
影响因子：
2.6
通讯作者：
G. Melissano;E. Civilini;L. Bertoglio;D. Logaldo;R. Chiesa
中科院分区：
文献类型：
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作者：
G. Melissano;E. Civilini;L. Bertoglio;D. Logaldo;R. Chiesa
目的：评估使用新引入的Zenith TX 2胸主动脉覆膜支架（带Pro-Form）进行胸主动脉腔内修复术（TEVAR）的安全性和有效性。研究方法：从2009年3月至今，使用Zenith TX 2和Pro-Form治疗了27例胸降主动脉疾病患者（23例男性;中位年龄65岁，范围22-77岁）：20例退行性动脉瘤、3例慢性B型夹层、2例既往覆膜支架修复后的I型内漏、1例主动脉溃疡和1例创伤性峡部破裂。根据Ishimaru的分类，近端着陆区的分布为0区4例，1区2例，2区9例，3区7例，4区5例。1例动脉瘤远端累及胸腹主动脉。在9名患者中发现了锐角（<90°）近端锚定区。结果：在所有病例中，器械均安全有效地展开，鞘管回收过程中未出现任何问题。所有病例的术后病程均无严重并发症，无围手术期死亡。术后并发呼吸衰竭1例，一过性急性肾功能衰竭3例，着床后综合征2例。术后1个月和6个月的计算机断层扫描证实了100%的临床成功，没有器械相关并发症。未记录I型内漏。在所有病例中，近端密封支架与主动脉轮廓吻合良好，但1例除外，在6个月随访时，在严重成角的主动脉中观察到贴壁不良。结论：基于该初步经验，带Pro-Form的TX 2胸主动脉覆膜支架可安全有效地展开，以满意地修复胸主动脉病变，包括主动脉弓病变。即使在解剖结构不良的病例中，覆膜支架与主动脉的贴合性也非常好。这些令人鼓舞的结果需要在更大规模的随访中得到证实。
Purpose: To assess the safety and efficacy of thoracic aortic endovascular repair (TEVAR) with the newly introduced Zenith TX2 thoracic stent-graft with Pro-Form. Methods: From March 2009 to present, the Zenith TX2 with Pro-Form was used to treat 27 patients (23 men; median age 65 years, range 22–77) suffering from descending thoracic aortic disease: 20 degenerative aneurysms, 3 chronic type B dissections, 2 type I endoleaks following previous endograft repair, 1 aortic ulcer, and 1 traumatic isthmic rupture. According to Ishimaru's classification, the distribution of the proximal landing zone was zone 0 in 4 cases, zone 1 in 2 cases, zone 2 in 9 cases, zone 3 in 7 cases, and zone 4 in 5 cases. One aneurysm distally involved the thoracoabdominal aorta. An acutely angulated (<90°) proximal landing zone was found in 9 patients. Results: The device was safely and effectively deployed in all cases, with no problems during sheath retrieval. The postoperative course was free from major complications in all cases, and there was no perioperative mortality. Postoperative morbidity included respiratory failure in 1 case, transient acute renal failure in 3 cases, and post-implantation syndrome in 2 cases. Postoperative computed tomography at 1 and 6 months confirmed 100% clinical success with the absence of device-related complications. No type I endoleak was documented. The proximal sealing stent fitted well with the aortic profile in all cases except one, in which malapposition was seen in a severely angulated aorta at 6-month follow-up. Conclusion: Based on this preliminary experience, the TX2 thoracic stent-graft with Pro-Form can be safely and effectively deployed to satisfactorily repair thoracic aortic pathology, including lesions in the arch. Stent-graft conformance to the aorta was excellent even in cases with unfavorable anatomy. These encouraging results will need to be confirmed in larger series with larger follow-up.