A Novel Sutureless Integrated Stented (SIS) Graft Prosthesis for Type A Aortic Dissection: A Pilot Study for a Prospective, Singer Arm, Multi-Center Clinical Trial

Abstract

Background: 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-extent repair of pathological aorta with satisfactory outcomes is hard to achieve. The aim of this study was to investigate effectiveness and safety of a novel Sutureless Integrated Stented (SIS) graft prosthesis on TAAD patients undergoing total arch replacement (TAR) combined with frozen elephant trunk (FET) surgeries. Methods: All patients admitted to Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College were screened according to inclusion and exclusion criteria after signing written informed consent. Urgent or scheduled surgery was arranged for eligible patients. Before operation, candidate size of the SIS graft prosthesis was chosen comprehensively according to aortic diameter on different levels measured on aortic computed tomography angiography (CTA). During operation, final appropriate-sized SIS graft prosthesis was implanted under direct vision. The primary endpoint was operative mortality. Secondary endpoints included postoperative rate of stroke, spinal cord injury, unexpected aortic reoperation and so on. All variables related to this study were collected prospectively and classified into preoperative, intraoperative, postoperative and follow-up data. Discharged patients were contacted by telephone 1 month after surgery and were asked to return to hospital 3 months, 6 months and 12 months after surgery. Inquiry, physical examination, aortic computed tomography angiography (CTA) examinations and transthoracic echocardiography (TTE) were performed on the occasion of the return visit. Effectiveness and safety analyses were done in these patients. Findings: Between Aug 1 and Sep 3, 2020, 10 TAAD patients were enrolled in this study. The SIS graft prostheses were successfully implanted in all patients. The median (IQR) age was 56.50 (43.75, 66.75) years (range from 31 to 75), and 7 patients were male (70.0%). All patients were performed with ascending aorta replacement + TAR + FET. Concomitant procedure included Bentall procedure, David procedure, adventitial inversion technique and ascending aorta-femoral artery bypass. The median (IQR) operation time, CPB 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) CA time was 9.00 (8.00, 9.00) min (range from 4 to 12). The median (IQR) lowest nasopharynx temperature was 26.75 (25.98, 27.67) °C. The median (IQR) platelets transfusion was 1.00 (1.00, 1.00) U. The median (IQR) platelets transfusion was 0.00 (0.00, 0.00) U. The median (IQR) platelets transfusion was 0.00 (0.00, 0.00) mL. No patients died after surgery and no severe postoperative complications occurred. Follow-up was 100% completed. Survival rate at 1-year follow-up was 100%. No patients have ever experienced any major organ complication. Freedom from prosthesis related adverse events and aortic reintervention was both 100%. Interpretation: The SIS graft prosthesis could be implanted in a novel sutureless way, which simplified surgery procedure, reduced CA time and avoided DHCA. The preliminary clinical outcomes and follow-up outcomes were satisfactory and with 0 death, 0 severe complication and 0 reintervention until 1 year postoperatively, which demonstrated effectiveness and safety of this prosthesis. Large-sample size trial has been conducted to further identify our findings. Trial Registration: This study was registered with Chinese Clinical Trial Registry, ChiCTR2000032264. Funding: Beijing Science and Technology Program (Z191100007619042), Capital Health Development and Scientific Research Foundation (2018-2-4035), CAMS Initiative for Innovative Medicine (2016-I2M-1-016), Special Subject Development Foundation of Fuwai Hospital (2015-FWTS01). Declaration of Interest: We declare no competing interests. Ethical Approval: This study was approved by Ethic Committee of Fuwai Hospital, Chinese Academy of Medical Sciences.