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OBJECTIVES: The aim of this multicentre study was to demonstrate the safety and clinical performance of E-vita OPEN NEO Stent Graft System (Artivion, Inc.) in the treatment of aneurysm or dissection, both acute and chronic, in the ascending aorta, aortic arch and descending thoracic aorta. METHODS: In this observational study of 12 centres performed in Europe and in Asia patients were enrolled between December 2020 and March 2022. All patients underwent frozen elephant trunk using E-vita OPEN NEO Stent Graft System. Primary end point was the rate of all-cause mortality at 30 days and secondary end points included further clinical and safety data are reported up to 3-6 months postoperatively. RESULTS: A total of 100 patients (66.7% male; mean age, 57.7 years) were enrolled at 12 sites. A total of 99 patients underwent surgery using the E-vita OPEN NEO for acute or subacute type A aortic dissection (n = 37), chronic type A aortic dissection (n = 33) or thoracic aortic aneurysm (n = 29), while 1 patient did not undergo surgery. Device technical success at 24 h was achieved in 97.0%. At discharge, new disabling stroke occurred in 4.4%, while new paraplegia and new paraparesis was reported in 2.2% and 2.2%, respectively. Renal failure requiring permanent (>90 days) dialysis or hemofiltration at discharge was observed in 3.3% of patients. Between discharge and the 3-6 months visit, no patients experienced new disabling stroke, new paraplegia or new paraparesis. The 30-day mortality was 5.1% and the estimated 6-month survival rate was 91.6% (standard deviation: 2.9). CONCLUSIONS: Total arch replacement with the E-vita OPEN NEO can be performed with excellent results in both the acute and chronic setting. This indicates that E-vita OPEN NEO can be used safely, including in the setting of acute type A aortic dissection.

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OBJECTIVES: We present our first experience of using a new dissection-specific hybrid stent graft (SG) (the 'Soft Elephant Trunk') in the frozen elephant trunk technique, in patients with non-acute DeBakey type I aortic dissection. METHODS: Between September 2016 and February 2021, patients with non-acute DeBakey type I aortic dissection underwent the frozen elephant trunk procedure at our centre using 3 SG types: group Z used stiff, distal Z-shaped nitinol SGs (E-Vita, Medtronic); group R used a stiff, ring-shaped nitinol SG (Thoraflex); and group S used a soft, distal dissection-specific SG. Predictors of distal SG-induced new entry were analysed. End points were hospital- and midterm-follow-up results. RESULTS: The study comprised 109 patients with 46 (42.2%), 22 (20.2%) and 41 (37.6%) patients in groups Z, R and S, respectively. No significant differences were found in early outcomes. Freedom from distal SG-induced new entry was comparable in groups Z, R and S (68.9% vs 92.9% vs 100%, log-rank = 0.14). There was no significant difference in follow-up between the groups. Four-year survival rates were 80.44%, 71.59% and 95.06% in groups Z, R and S, respectively. On multivariable analysis, the presence of connective tissue disorders [hazard ratio (HR) = 5.62, P = 0.11] and SG diameter (HR = 1.37, P = 0.034) were strong predictors of distal SG-induced new entry. CONCLUSIONS: Dissection-specific hybrid SG with a soft distal end is effective in patients with non-acute DeBakey type I aortic dissection. Compared to non-soft distal SGs, this can reduce the incidence of distal complications. Long-term outcomes are necessary to determine the potential advantages and disadvantages of the new prosthesis.

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BACKGROUND: The frozen elephant trunk (FET) technique is increasingly used for the treatment of acute and chronic aortic arch disease. This study reports our single center experience with the FET technique in patients with complex aortic disease. METHODS: Between 2009 and 2019, 111 consecutive patients underwent aortic arch surgery in our institution using the FET technique for acute type A dissection (AAD group; n=75) or non-acute type A dissection (non-AAD group; n=36; 10 patients with chronic type A dissection; 26 patients with aneurysm), respectively. Relevant perioperative data, including 30-day mortality and neurological complications, were retrospectively obtained from our electronic patient's records, including follow-up (FU) data of outpatient clinical visits and computed tomography (CT). RESULTS: Thirty-day mortality in the entire FET cohort was 16.2% (AAD 18.7% vs. non-AAD 11.1%; n=0.414). Severe brain injury was the leading cause of death in AAD patients (12.0% vs. 0% non-AAD; P=0.030). Overall permanent stroke and spinal cord injury was 12.6% and 3.6%. Four patients in the AAD group developed paraplegia and permanent stroke rate was significantly higher in AAD compared to non-AAD patients (17.3% vs. 2.8%; P=0.034). One, 3- and 5-year survival rates were 78.7%±4.0%, 72.2%±4.8%, and 64.3%±6.8% for the total cohort; survival at 1-, 3- and 5-year was 76.7%±5.0%, 71.0%±6.1%, and 64.5%±8.3% for the AAD cohort compared to 83.1%±6.3%, 75.0%±7.9% and 66.7% for non-AAD patients (P=0.579), respectively. CONCLUSIONS: Our single-center experience confirms good early and mid-term survival after the FET procedure in patients presenting with AAD, CAD and aneurysm. Future efforts should focus on reduction of severe neurological complication.

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OBJECTIVES: Our goal was to present our experience with a hybrid approach to the frozen elephant trunk (FET) technique for the treatment of patients with chronic type B aortic dissection. METHODS: Between January 2013 and July 2019, 86 patients underwent the FET procedure at our centre. In 20 patients, the indication was chronic type B aortic dissection with a concomitant proximal aortic lesion. We evaluated the sites of proximal and distal entries, luminal communication and originating visceral branches in the computed tomography scan data. Primary end points were hospital deaths, complications and follow-up survival. Secondary end points included reintervention, thrombosis of the false lumen and aortic remodelling. RESULTS: There were no deaths, neurological complications or paraplegia during hospitalization; however, a few patients (10%) had temporary acute renal failure or required secondary aortic reintervention during the follow-up period. We performed thoracic endovascular aortic repair with stable aortic remodelling during follow-up. The follow-up survival rate was 92.3%, and 87.5% of cases did not require aortic reintervention. CONCLUSIONS: The FET technique is an effective method for treating chronic Stanford type B aortic dissection in patients at high risk of retrograde type A aortic dissection, concomitant disease of the proximal aorta and unsuitable anatomy for thoracic endovascular aortic repair, which allows for single-stage radical correction. Compared with thoracic endovascular aortic repair, the FET technique excludes the risk of type Ia endoleak, retrograde type A aortic dissection and possible stent graft migration. This technique provides comparable midterm follow-up outcomes and freedom from reintervention.

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BACKGROUND: Traditional aortic arch replacement surgery must be performed under moderate or deep hypothermia (22-28 °C) and circulatory arrest. Hypothermia and hypoperfusion can cause damage to the nervous system; therefore, postoperative brain and spinal cord complications are common. Improvements in surgical techniques are necessary to solve this problem. Herein, we report a method of total aortic arch replacement that can be performed at a core temperature of 34 °C, similar to other simple cardiac operations. CASE PRESENTATION: Four patients underwent surgery with this technique (3 males and 1 female, aged 48 to 67 years). Computed tomography angiography performed at admission showed a total aortic dissection, resulting in a diagnosis of Stanford type A aortic dissection. The patients underwent emergency aortic sinus remodelling, ascending aortic replacement, modified aortic arch replacement, and elephant trunk stenting. No patients had neurological complications. During a follow-up of more than 1-month, no patients had aortic valve regurgitation or anastomotic leak. CONCLUSIONS: This technique can increase the operating temperature by approximately 6 to 12 °C and reduce the circulatory arrest time by approximately 18 to 28 min. All of the patients recovered well without any neurological complications, demonstrating the feasibility and safety of this technique. We believe that this technique can serve as a good alternative strategy for managing aortic dissection and aneurysm, especially for young surgeons who are acquiring experience in arch replacement surgery.

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OBJECTIVES: The goal was to investigate the prevalence of acute kidney injury (AKI) after total arch replacement with frozen elephant trunk procedure, which was achieved by antegrade cerebral perfusion and moderate hypothermic circulatory arrest (MHCA) or deep hypothermic circulatory arrest (DHCA) among patients with type A aortic dissection. METHODS: Overall, 627 adult type A aortic dissection patients who underwent total arch replacement with frozen elephant trunk from January 2013 until December 2016 at Fuwai Hospital were divided into the DHCA (14.1-20.0°C) and MHCA (20.1-28.0°C) groups. Postoperative AKI as the primary outcome was compared using propensity-matched scoring. RESULTS: Overall, 340 (54.2%) and 287 (45.8%) patients underwent DHCA and MHCA, respectively. The overall incidence of AKI was 75.4%. Age [odds ratio (OR) 1.02, 95% confidence interval (CI) 1.00-1.04; P = 0.022], body mass index (OR 1.06, 95% CI 1.01-1.12; P = 0.016), cardiopulmonary bypass duration (OR 1.01, 95% CI 1.00-1.01; P = 0.003) and hypertension history (OR 1.76, 95% CI 1.14-2.70; P = 0.010) were identified as independent risk factors for AKI onset with multivariable analysis. Postoperative AKI was not significantly different between the DHCA and MHCA groups regardless of the overall or propensity-matched cohort (overall data: P = 0.17; propensity score data: P = 0.88). Patients with MHCA experienced higher rates of postoperative stroke after propensity score analysis (DHCA 0.9% vs MHCA 3.7%; P = 0.034). CONCLUSIONS: MHCA was not superior to DHCA in decreasing postoperative AKI. Thus, MHCA should not definitively replace DHCA.

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OBJECTIVES: In patients with acute aortic dissection involving the arch and the descending aorta (AADA DeBakey type I), performing a total aortic arch replacement with the frozen elephant trunk (FET) procedure for supposedly better long-term results is still controversial. METHODS: From February 2004 to April 2016, 94 patients with AADA DeBakey type I had an FET procedure (80% men, age 58 ± 12 years). During the early period (Group 1, 2004-10), the FET technique was performed using non-branched grafts. Thirty-two percent (9/28) underwent concomitant aortic valve-sparing root procedures. More recently (Group 2, 2010-16), branched FET grafts were used in 66 patients (76% men, age: 56 ± 12 years). Fifty-six percent (37/66) underwent concomitant aortic valve-sparing root procedures. RESULTS: Patients showed a high rate of malperfusion syndrome (Group 1: 29% vs Group 2: 38%, P = 0.48). In-hospital mortality was 12% (Group 1: 21% vs Group 2: 9%, P = 0.17). Stroke and rethoracotomy for bleeding occurred in 15% (Group 1: 11% vs Group 2: 17%) and 20% (Group 1: 21% vs Group 2: 20%; P = 1.00) of patients, respectively. Postoperative recurrent nerve palsy and spinal cord injury rates were 18% (Group 1: 14% vs Group 2: 20%) and 5% (Group 1: 7% vs Group 2: 5%; P = 0.63). During follow-up, 11 patients (12%) required reoperation on the downstream aorta (open surgical: n = 6/94, 6%, endovascular: n = 5/94; 5%). Survival tended to be superior in Group 2 (5 years: Group 1: 68% vs Group 2: 80%; P = 0.17). CONCLUSIONS: The FET procedure improves short- and long-term outcome, especially for AADA DeBakey I with malperfusion.

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