Dai Lu, Qiu Jiawei, Zhao Rui, Cao Fangfang, Qiu Juntao, Wang De, Fan Shuya, Xie Enzehua, Song Jian, Yu Cuntao
Department of Aortic Surgery, National Center for Cardiovascular Disease, Peking Union Medical College, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Adult Surgical Intensive Care Unit, National Center for Cardiovascular Disease, Peking Union Medical College, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Front Cardiovasc Med. 2022 Feb 8;8:806104. doi: 10.3389/fcvm.2021.806104. eCollection 2021.
Various kinds of surgical strategies and prostheses have been advocated to improve short-term and long-term outcomes in type A aortic dissection (TAAD). Large-scale repair of the pathological aorta is hard to generalize due to complex procedures. We aimed to investigate the performance, effectiveness and safety of a novel Sutureless Integrated Stented (SIS) graft prosthesis in TAAD patients undergoing total arch replacement (TAR) and frozen elephant trunk (FET) implantation surgery.
All patients admitted to Fuwai Hospital were prospectively screened. Urgent or scheduled surgery was arranged for eligible patients. The primary endpoint was operative mortality. Key secondary endpoints included stroke, spinal cord injury, unexpected aortic reoperation, and 1-year survival. Discharged patients were followed up with computed tomography angiography and transthoracic echocardiography at 3 months, 6 months, and 1 year after surgery. Performance, effectiveness and safety analyses were performed in those patients.
Between August 1 and September 3, 2020, ten TAAD patients were enrolled in this study and successfully implanted with the SIS graft prosthesis. The median (IQR) age was 56.50 (43.75, 66.75) years (range from 31 to 75), and seven patients were male (70.0%). All patients underwent ascending aorta replacement + TAR + FET and additional procedures when necessary. The median (IQR) operation time, cardiopulmonary bypass time and cross clamp time were 270.50 (218.50, 312.50), 110.00 (88.00, 125.75), 69.50 (51.25, 82.75) min, respectively. Of note, the median (IQR) circulatory arrest time was 9.00 (8.00, 9.00) min (range from 4 to 12). The median (IQR) lowest nasopharyngeal temperature was 26.75 (25.98, 27.67) °C. Follow-up was 100% completed. During the 1-year follow-up, no patients died, no severe adverse events occurred, and rate of freedom from aortic reintervention was 100%.
The SIS graft prosthesis was implanted in a novel sutureless way, which simplified the surgical procedure, shortened the circulatory arrest time and avoided deep hypothermia. The preliminary clinical outcomes and follow-up outcomes demonstrated the effectiveness and safety of this prosthesis. A large-scale trial is being conducted to further assess these findings.
人们已经提出了各种手术策略和假体来改善A型主动脉夹层（TAAD）的短期和长期疗效。由于手术过程复杂，对病变主动脉进行大规模修复难以推广。我们旨在研究一种新型无缝合一体化带支架（SIS）移植物假体在接受全弓置换（TAR）和象鼻支架植入术（FET）的TAAD患者中的性能、有效性和安全性。
对所有入住阜外医院的患者进行前瞻性筛查。为符合条件的患者安排急诊或择期手术。主要终点是手术死亡率。关键次要终点包括中风、脊髓损伤、意外主动脉再次手术和1年生存率。对出院患者在术后3个月、6个月和1年进行计算机断层扫描血管造影和经胸超声心动图随访。对这些患者进行性能、有效性和安全性分析。
2020年8月1日至9月3日，10例TAAD患者纳入本研究并成功植入SIS移植物假体。年龄中位数（四分位间距）为56.50（43.75，66.75）岁（范围31至75岁），7例为男性（70.0%）。所有患者均接受升主动脉置换+TAR+FET，并在必要时进行其他手术。手术时间中位数（四分位间距）、体外循环时间和主动脉阻断时间分别为270.50（218.50，312.50）、110.00（88.00，125.75）、69.50（51.25，82.75）分钟。值得注意的是，体外循环停循环时间中位数（四分位间距）为9.00（8.00，9.00）分钟（范围4至12分钟）。最低鼻咽温度中位数（四分位间距）为26.75（25.98，27.67）℃。随访完成率为100%。在1年随访期间，无患者死亡，未发生严重不良事件，主动脉再次干预的无事件发生率为100%。
SIS移植物假体以一种新型无缝合方式植入，简化了手术过程，缩短了体外循环停循环时间，避免了深度低温。初步临床结果和随访结果证明了该假体的有效性和安全性。正在进行大规模试验以进一步评估这些发现。
