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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., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Background:  Stanford A acute aortic dissection (AAD) is a life-threatening emergency. The aim of this study was to compare the impact of three different aortic entry tear sites on early outcomes and long-term survival of patients with Stanford A AAD., Methods:  From January 2006 to April 2015, a total of 240 consecutive patients with diagnosed Stanford A AAD underwent emergent, isolated surgical aortic repair in our center. Patients were divided into three groups comprising isolated ascending aorta, proximal aortic arch, and distal aortic arch entry tear site and were followed up for up to 9 years., Results:  Thirty-day mortality as well as major cerebrovascular events were significantly different between the three groups ( p  = 0.007 and p  = 0.048, respectively). Overall cumulative short- and long-term survival of all patients revealed significant differences (Log-Rank p  = 0.002), whereas survival of all patients free from major cerebrovascular events was similar (Log-Rank p  = 0.780). Subgroup analysis of short- and long-term survival of patients showed significant differences in terms of men (Log-Rank p  = 0.043), women (Log-Rank p  = 0.004), patients over 65 years of age (Log-Rank p  = 0.007), and hypertensive patients (Log-Rank p  = 0.003). Kaplan-Meier survival estimation plots significantly showed poorest survival for distal aortic arch entry tear site group., Conclusion:  The location of the primary entry tear in patients with Stanford A AAD significantly influences early outcomes, short- and long-term survival of patients, whereas survival of patients free from major cerebrovascular events showed similar results among the three groups. Distal aortic entry tear site showed poorest outcomes and survival., Competing Interests: The authors declare that there is no conflict of interest., (Georg Thieme Verlag KG Stuttgart · New York.)

Objectives: The aim of this study was to evaluate independent risk factors predictive for mortality of patients with Stanford A acute aortic dissection., Methods: From January 2006 to March 2015, a total of 240 consecutive patients diagnosed with acute Stanford A acute aortic dissection underwent surgical aortic repair in our center. After analysis of pre- and perioperative variables, univariate logistic and multivariate logistic regression analyses were performed for mortality of patients. Subsequently, Kaplan-Meier estimation analysis of short- and long-term survival of these variables was carried out., Results: Primary entry tear in descending aorta (odds ratio = 4.71, p = 0.021), preoperative international normalized ratio higher than 1.2 (odds ratio = 7.36, p = 0.001), additional coronary artery bypass grafting (odds ratio = 3.39, p = 0.003), cannulation in ascending aorta (odds ratio = 3.22, p = 0.005), preoperative neurological coma (odds ratio = 3.30, p = 0.003), and reduced perfusion (odds ratio = 2.91, p = 0.006) as well as prolonged reperfusion time (odds ratio = 3.36, p = 0.002) showed to be independent predictors for early mortality as well as for late mortality (hazard ratio of all variables p < 0.05). Kaplan-Meier survival estimation analysis with up to 9-year-follow-up in terms of these risk factors showed significantly poorer short- and long-term survival (log-rank and Breslow test all p < 0.05)., Conclusion: Our study revealed that early and late mortality of patients with Stanford A acute aortic dissection surgery was significantly influenced by preoperative and perioperative variables as independent predictors especially of variables displaying coronary, cerebral, and visceral malperfusion. Also, short- and long-term survival of patients was significantly poorer in terms of these risk factors.

Background:: Stanford A acute aortic dissection (AAD) is a life-threatening emergency associated with major morbidity and mortality. The aim of this study was to compare outcomes of three different surgical approaches in patients with Stanford A AAD., Methods:: From January 2006 to March 2015 a total of 240 consecutive patients with diagnosed Stanford A AAD underwent elective, isolated surgical aortic repair in our centre. Patients were divided into three groups according to the extent of surgical repair: isolated replacement of the ascending aorta, hemiarch replacement and total arch replacement. Patients were followed up for up to 9 years. After univariate analysis multinomial logistic regression was performed for subgroup analysis. Baseline characteristics and endpoints as well as long-term survival were analysed., Results:: There were no statistically significant differences among the three groups in terms of demographics and preoperative baseline and clinical characteristics. Incidence of in-hospital stroke ( p = 0.034), need for reopening due to bleeding ( p = 0.031) and in-hospital mortality ( p = 0.017) increased significantly with the extent of the surgical approach. There was no statistical difference in terms of long-term survival ( p = 0.166) among the three groups. Applying multinomial logistic regression for subgroup analysis significantly higher odds for stroke ( p = 0.023), reopening for bleeding ( p = 0.010) and in-hospital mortality ( p = 0.009) for the arch surgery group in comparison to the ascending aorta surgery group as well as significantly higher odds for stroke ( p = 0.029) for the total arch surgery group in comparison to the hemiarch surgery group were identified., Conclusions:: With Stanford A AAD the incidence of perioperative complications increased significantly with the extent of the surgical approach. Subgroup analysis and long-term follow up in patients undergoing isolated ascending or hemiarch surgery showed a lower incidence of cerebrovascular events compared with surgery for total arch replacement.

Objectives: Stanford A acute aortic dissection (AAD) is a life-threatening emergency, typically occurring in older patients and requiring immediate surgical repair. The aim of this study was to evaluate early outcome and short- and long-term survival of patients under and above 65 years of age., Methods: Two hundred and forty patients with Stanford A AAD underwent aortic surgical repair from January 2006 to April 2015 in our center. After statistical analysis and logistic regression analysis, Kaplan-Meier survival estimation was performed, with up to 9-year follow-up, comprising patients under and above 65 years of age., Results: The proportion of patients above 65 years of age suffering from Stanford A AAD was 50% (n=120). The group of patients above 65 years of age compared to the group under 65 years of age showed statistically significant differences in terms of higher odds ratios (OR) for hypertension (p=0.012), peripheral vascular disease (p=0.026) and tachyarrhythmia absoluta (p=0.004). Patients over 65 years of age also showed significantly poorer short- and long-term survival. Our subgroup analysis revealed that male patients (Breslow p=0.001, Log-Rank p=0.001) and patients suffering with hypertension (Breslow p=0.003, Log-Rank p=0.001) were reasonable for these results whereas younger and older female patients showed similar short- and long-term outcome (Breslow p=0.926, Log-Rank p=0.724). After stratifying all patients into 4 age groups (<45; 55-65; 65-75; >75years), short-term survival of the patients appeared to be significantly poorer with increasing age (Breslow p=0.026, Log-Rank p=0.008) whereas long-term survival of patients free from cerebrovascular events (Breslow p=0.0494, Log-Rank p=0.489) remained similar., Conclusions: All patients referred to our hospital for repair of Stanford A AAD with higher age had poorer short- and long-term survival, caused by male patients and patients suffering from hypertension, whereas survival of women and survival free from cerebrovascular events of the entire patient cohort was similar, irrespective of age.

Background: The aim of the present study was to determine whether raised preoperative serum creatinine affected the long-term outcome in patients undergoing surgical aortic repair for Stanford A acute aortic dissection (AAD)., Methods: A total of 240 patients diagnosed with Stanford A AAD underwent surgical repair from January 2006 to April 2015. A propensity score matching was applied, resulting in 73 pairs consisting of one group with normal and one group with preoperative elevated creatinine levels. The cohorts were well balanced for baseline and preoperative clinical characteristics. Both groups were compared regarding their early postoperative variables, as well as estimated survival with up to 9-year follow up. Also, the impact of acute postoperative kidney injury and its severity on long-term survival was analyzed., Results: The proportion of patients suffering Stanford A AAD with raised creatinine levels was 31.3% ( n = 75). After propensity matching, there were no statistically significant differences regarding demographics, comorbidities, preoperative baseline and clinical characteristics. Postoperatively matched patients with elevated creatinine had longer intensive care unit ( p < 0.001) and total hospital stay ( p = 0.002), prolonged intubation times ( p = 0.014), higher need for hemofiltration ( p < 0.001), higher incidence of temporary neurological disorders ( p = 0.16), infection ( p = 0.005), and trend toward higher incidence of sepsis ( p = 0.097). However, there were no significant differences regarding 30-day mortality (20.5% versus 20.5%, p = 1.000) and long-term overall survival. Further, neither the incidence nor the different stages of acute kidney injury according to the Acute Kidney Injury Network showed any statistically significant differences in terms of long-term survival for both groups [log rank p = 0.636, Breslow (generalized Wilcoxon) p = 0.470, Tarone-Ware p = 0.558]., Conclusions: Patients with elevated creatinine levels undergoing surgical repair for Stanford A AAD demonstrate higher rate of early postoperative complications. However, 30-day mortality and long-term survival in this patient cohort is not significantly impaired.

Introduction: Stanford A acute aortic dissection (AAD) is a life-threatening emergency, typically occurring in hypertensive patients, requiring immediate surgical repair. The aim of this study was to evaluate early outcomes and long-term survival of hypertensive patients in comparison to normotensive patients suffering from Stanford A AAD., Methods: In our center, 240 patients with Stanford A AAD underwent aortic surgical repair from January 2006 to April 2015. After statistical and logistic regression analysis, Kaplan-Meier survival estimation was performed, with up to 9-year follow-up., Results: The proportion of hypertensive patients suffering from Stanford A AAD was 75.4% (n=181). There were only few statistically significant differences in terms of basic demographics, comorbidities, preoperative baseline and clinical characteristics of hypertensive patients in comparison to normotensive patients. Hypertensive patients were significantly older (p=0.008), more frequently received hemi-arch repair (p=0.028) and selective brain perfusion (p=0.001). Our study showed similar statistical results in terms of 30-day mortality (p=0.196), long-term overall cumulative survival of patients (Log-Rank p=0.506) and survival of patients free from cerebrovascular events (Log-Rank p=0.186). Furthermore, subgroup analysis for long-term survival in terms of men (Log-Rank p=0.853), women (Log-Rank p=0.227), patients under and above 65 years of age (Log-Rank p=0.188 and Log-Rank p=0.602, respectively) and patients undergoing one of the three types of aortic repair surgery showed similar results for normotensive and hypertensive patient groups. Subgroup analysis for long-term survival of patients free from cerebrovascular events for women, patients under 65 years of age and patients undergoing aortic arch repair showed significant differences between the two groups in favor of hypertensive patients., Conclusions: Hypertensive patients suffering from Stanford A AAD were older, more frequently received hemi-arch replacement and were not associated with increased risk of 30-day mortality and poorer long-term survival compared to normotensive patients.

Objectives: Previous research suggests that female gender is associated with increased mortality rates after surgery for Stanford A acute aortic dissection (AAD). However, women with AAD usually present with different clinical symptoms that may bias outcomes. Moreover, there is a lack of long-term results regarding overall mortality and freedom from major cerebrovascular events. We analysed the impact of gender on long-term outcomes after surgery for Stanford A AAD by comparing genders with similar risk profiles using propensity score matching., Methods: A total of 240 patients operated for Stanford A AAD were included in this study. To control for selection bias and other confounders, propensity score matching was applied to gender groups., Results: After propensity score matching, the gender groups were well balanced in terms of risk profiles. There were no statistically significant differences regarding duration of cardiopulmonary bypass ( P  = 0.165) and duration of aortic cross-clamp time ( P  = 0.111). Female patients received less fresh frozen plasma ( P  = 0.021), had shorter stays in the intensive care unit ( P  = 0.031), lower incidence of temporary neurological dysfunction ( P  < 0.001) and lower incidence of dialysis ( P  = 0.008). There were no significant differences regarding intraoperative mortality ( P  = 1.000), 30-day mortality ( P  = 0.271), long-term overall cumulative survival ( P  = 0.954) and long-term freedom from cerebrovascular events ( P  = 0.235) with up to a 9-year follow-up., Conclusions: Considering patients with similar risk profiles, female gender per se is not associated with worse long-term survival and freedom from stroke after surgical aortic repair. Moreover, female patients might even benefit from a smoother early postoperative course and lower incidence of early postoperative complications., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)