Abstract
AimsVarious 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.MethodsAll 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.ResultsBetween 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%.ConclusionsThe 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.
Highlights
Aortic dissection (AD) is a fatal disease with high mortality worldwide
Between August 1, 2020, and September 3, 2020, 23 type A aortic dissection (TAAD) patients admitted to Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College were screened (Figure 3)
Using the Fu Wai classification scheme, nine (90.0%) patients were diagnosed with Type Ct AD, and the remaining one (10.0%) patient was diagnosed with Type A combined with Type Cd AD
Summary
Aortic dissection (AD) is a fatal disease with high mortality worldwide. It is well known that the patient population dying from AD is composed mainly of individuals with type A aortic dissection (TAAD). Surgery is still the mainstay of treatment for TAAD patients. Surgical strategies vary according to the extent of the dissecting aorta and the surgeon’s treatment concept. More experts abroad have advocated the application of this strategy for TAAD patients with aortic arch involvement [2]. This procedure is complex and difficult to carry out in low-volume centers, which limits the expansion of urgent TAAD treatment coverage
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