第一部分 Stanford A型主动脉夹层手术管理现状-一项全国多中心注册登记研究

中文摘要

背景：主动脉夹层是一种危及生命的疾病，许多国家和地区建立了多中心的主动脉夹层注册登记数据库。但这些数据库并没有包含中国的数据，目前中国主动脉夹层的临床特点及外科管理并不明确，所以我们建立中国A型主动脉夹层多中心注册登记研究。

方法：此项研究数据来自中国A型主动脉夹层多中心注册登记研究，该研究是一项全国性多中心研究，主要纳入了Stanford A型主动脉夹层的患者。数据库中的变量包括Stanford A型主动脉夹层患者的院前急救、急诊管理、手术资料和术后资料。本次研究纳入时间为2018年1月至2021年5月。

结果：本研究共纳入了1166例接受手术治疗的Stanford A型主动脉夹层患者，其中急诊Stanford A型主动脉夹层为955例，占比81.9%。整组患者的平均年龄为51.3 ±12岁。患者从发病至转运到急诊室的中位时间为10小时（四分位IQR：6-24小时）；从急诊室到手术室的急诊处理中位时间为11.89小时（IQR：3-25.01小时）。患者的平均转运距离为305358.83米。这些患者中有962人接受了全主动脉弓置换（82.5%），冰冻象鼻使用例数为814例（69.8%）。在院死亡率为8%。

结论：在这项回顾性多中心队列研究中，中国接受手术治疗的Stanford A型主动脉夹层患者群体较年轻，从发病到住院的时间间隔和转运距离较长，接受了更为激进的主动脉弓修复策略，早期死亡率相对较低。这一发现表明，中国TAAD患者应加强院前急救和术前管理，并需要更长的随访时间来研究年轻患者行全主动脉弓手术的预后。

背景：众所周知，心脏外科术后心房颤动与不良事件相关。但目前对于主动脉术后新发房颤的关注较少，本篇研究旨在探究全主动脉弓置换（total arch repair，TAR）术后新发房颤（postoperative atrial fibrillation，POAF）的发生率，以及新发心房颤动是否与在院死亡率相关。

方法：本研究连续纳入2012年9月至2019年12月在中国医学科学院阜外医院行全主动脉弓置换术的患者共1280例。术前既往心房颤动病史的患者排除在外。术后房颤定义为手术后在心电监护下心房颤动或者心房扑动持续时间大于5分钟。使用Logistic回归模型来确定在院死亡率的危险因子。使用逆概率加权（inverse probability of treatment weighting， IPTW）及倾向性评分匹配法（propensity score matching， PSM）调整混杂，并使用亚组分析来确定各个因素之间的交互作用以及敏感性分析。

结果：在此队列中，共411人出现术后新发房颤，发生率为32.3%。术后房颤与年龄（OR= 1.05, 95%CI: 1.04-1.06, P < 0.001）、男性（OR=0.72, 95%CI:0.52-0.98, P=0.035）与手术时间（OR=1.2, 95%CI: 1.12-1.28, P < 0.001）相关。术后房颤组在院死亡率相比房颤组明显增高（10.7% vs 2.4%, P < 0.001）。IPTW与PSM分析肯定了这一结果。亚组分析中，术后房颤在不同年龄段，不同性别，是否高血压、是否吸烟、是否合并低钾血症、是否合并心脏手术、是否进行停循环均增加了在院死亡率。

结论：全主动脉弓置换术后应警惕术后房颤的发生，TAR术后POAF发生率为32.3%并且与在院死亡率相关。经历长时间全主动脉弓置换手术的高龄女性最容易发生POAF。

目的：目前许多医疗中心取得相对较为满意的手术结果，而微创切口有着更快的术后恢复和生存质量，所以许多中心开展了微创切口进行手术，然而保留主动脉瓣的主动脉根部置换术（Valve Sparing Root Replacement, VSRR）具有较高的手术难度，目前针对此种术式的微创切口手术还未广泛开展。本研究的目的是评估经胸骨上段切口行保留主动脉瓣的主动脉根部置换术的安全性和可行性。

方法：本研究共纳入2016年1月至2021年4月，共269名接受保留主动脉瓣的主动脉根部置换术的患者。这些患者根据术者术前评估选择微创切口或者传统切口，共52名患者接受了胸骨上段切口。我们比较了胸骨上段小切口（Partial Upper Sternotomy, PUS）组和传统胸骨正中切口完全胸骨切开术（Complete Sternotomy, CS）组的临床结果。主要结局终点为死亡率。其他终点包括主动脉瓣关闭不全的程度、术中失血量、血制品使用量、术后并发症和住院期间的花费。术后1月、3月、1年内进行常规随访。Kaplan–Meier法用于评估随访周期内主动脉瓣返流的程度。使用倾向评分匹配（Propensity Score Matching，PSM）进行减少研究中混杂因素引起的偏倚。

结果：全组患者仅传统切口组有1例患者出现在院期间死亡（p=1），两组患者术后均无中重度主动脉瓣关闭不全。PUS组的失血量和血制品消耗量也低于CS组，尤其是血浆使用。由于胸液增多开胸探查、急性肾损伤、心包积液、胸腔积液、24小时内的引流量、机械通气时间和心律失常，两组并没有统计学差异。CS组患者ICU时间较长（74.20±47.21 vs.50.94±30.16 h，p=0.001）并且住院花费较多(135,649.52 ± 29,992.21 vs. 123,380.15 ± 27,062.82 元, p < 0.001)。随访期间没有患者死亡或再次手术。匹配后，两组中度或重度主动脉瓣关闭不全没有统计学差异（p=0.97）。

结论：经胸骨上段小切口的微创保留主动脉瓣主动脉置换术可安全地用于一部分适合的患者。

目的：在保留主动脉瓣的主动脉根部置换术（VSRR）中选择正确尺寸的人工血管十分关键。目前选择血管的方法多种多样，传统的方法需要复杂的测量及计算且没有考虑人工血管与主动脉瓣叶是否匹配。因此，我们提出了一种简便易行的计算方法来帮助我们选择VSRR手术中尺寸合适的人工血管，并以人工血管尺寸来确定主动脉瓣游离缘的长度，确保人工血管与自身解剖结构相匹配。

方法：我们回顾了2021年1月至6月 18例行植入法VSRR手术的患者，所有患者均用此种测量计算方法进行了人工血管的选择。我们的测量计算方法如下：我们在术中测量了三个主动脉窦的几何高度（gH）。以三个瓣叶中最小几何高度作为基础，将此高度减去2-3mm，得到的数值的两倍即为人工血管的直径（D）（D=（gH-（2~3）*2））。然后对主动脉瓣叶进行折叠，使得折叠之后的主动脉瓣叶游离缘长度与人工血管直径加上3-5mm相等（FML=D+（3~5））。术前及术后出院前使用超声测量患者主动脉返流程度。主要终点为全因死亡及主动脉瓣再次干预。

结果：18例行VSRR手术患者的平均年龄为50.1±11.9岁，男性为15例（83.3%），BMI为26.19±2.46，马凡氏综合征1例（5.6%），主动脉瓣二瓣化畸形 1例（5.6%）。术前主动脉瓣返流为18例（100%），其中轻度4例（22.2%）,中度9例（50%），重度5例（27.8%）。术中有7例应用了30mm（38.9%）、10例应用内了28mm(55.6%)，1例应用了26mm人工血管(5.6%)，手术即刻效果满意。术后（出院前）仅4例发生轻微度的返流。术后3个月内患者无死亡及二次手术；无主动脉瓣返流程度进展。

结论： 我们所提出的基于主动脉瓣几何高度来确定的人工血管尺寸及主动脉瓣游离缘长度的测量计算方法简单且效果满意，可以确保所选择的人工血管与患者相匹配。

目的：保留主动脉瓣的主动脉根部置换术（David手术）是目前国际上较为认可的保留瓣膜的手术。术中对主动脉根部的处理如能保持窦部壶腹状形态，可以使瓣膜的开合接近人体正常状态，本研究目的为尝试克服现有主动脉人工血管的缺陷，设计一种新型全仿生带主动脉窦人工血管，具有良好的窦部形态、力学弹性、顺应性、结构稳定性、组织相容性。

方法及结果：我们提取主动脉根部结构正常的人群影像学信息用于模具构建，将研究对象的影像学数据导入软件修复建模，若模型表面较粗糙，可以用Freeform软件进行平滑处理，最后导出3D打印用模型文件。使用3D打印技术制作模具。根据模具进行基于聚氨酯材料的三层结构制作，从而得出全仿生带主动脉窦人工血管。

结论： 部分研究基于正常人群主动脉根部解剖影像学数据及国内自主研发的聚氨酯合成材料，制作了全仿生三层结构的窦型人工血管，目前以攻克了工艺上难点，下一步将进行体外实验及动物实验，为下一步临床试验提供依据。

BACKGROUND

Many countries and regions have established multi center registration studies to improve the outcomes for type A aortic dissection (TAAD). However, it is unclear that actual clinical outcomes of surgical treatment for TAAD in China

METHODS

This cohort study uses data from the Registry of Type A Aortic

Dissection in China, a national clinical registry to investigate management of patients with Stanford type A aortic dissection. The data including surgical management and outcomes of TAAD patients including prehospital emergency care, preoperative management, surgery type and early mortality were analyzed from January 2018 and May 2021.

RESULTS

A total of 1166 patients with TAAD were enrolled in this study between January 2018 and May 2021, and 955 (81.9%) patients had acute TAAD. The mean age of all patients was 51.3 ±12 years. The median onset time in acute TAAD was 10 hours (IQR, 6–24 hours), and the median emergency room stay time was 11.89 hours (IQR, 3–25.01 hours). The mean transport distance of patients with acute TAAD was 305,358.83 meters. Extended arch repair, including total arch replacement, was performed in 962 patients (82.5%), and frozen elephant trunk repair was performed in 814 patients (69.8%). The incidence of early mortality was 8%.

CONCLUSIONS

In this retrospective cohort study, population of patients with TAAD in China undergoing surgery was younger, experienced a longer interval and distance from onset to arrival at hospital, received more extended aortic arch repair, and showed a relatively lower early mortality. This finding suggests more efforts should be made to promote prehospital emergency care and preoperative management of Chinese TAAD patients and longer follow-up need to be done to investigate the prognosis of extended aortic arch surgery in younger patients.

BACKGROUND:

It is well established that postoperative atrial fibrillation (POAF) is associated with adverse postoperative outcomes after major cardiac operations. The purpose of this study was to investigate the incidence of new-onset POAF after successful total arch repair (TAR) surgery and the association between POAF and in-hospital mortality.

METHODS：

All consecutive patients undergoing TAR from September, 2012 to December, 2019 in Fuwai hospital were enrolled (n=1280). Patients diagnosed with preoperative atrial fibrillation were excluded. POAF was diagnosed as the new-onset atrial fibrillation or flutter for more than 5 minutes based on continuous electrocardiogram monitoring. A logistic regression model was used to determine predictors of in-hospital mortality. Multivariable adjustment, inverse probability of treatment weighting (IPTW) and propensity score matching (PSM) were used to adjust for confounders.

RESULTS:

POAF was diagnosed in 32.3% (411/1271) of this cohort population. The occurrence of new-onset POAF was associated with age (OR= 1.05, 95%CI: 1.04-1.06, P < 0.001), male sex (OR=0.72, 95%CI:0.52-0.98, P=0.035), surgery duration (OR=1.2, 95%CI: 1.12-1.28, P < 0.001). The in-hospital mortality was significantly higher in patients with POAF than those without POAF (10.7% vs 2.4%, P < 0.001). IPTW and PSM analyses confirmed the results. The increased in-hospital mortality in POAF group still existed among subgroup analysis based on different age, sex, hypertension, smoking, hypokalemia, combined with cardiac surgery, and deep hypothermic circulatory arrest.

CONCLUSIONS

More careful attention should be given to POAF after TAR surgery. The incidence of POAF after TAR surgery was 32.3% and associated with increased in-hospital mortality. The elderly female patient who experienced longer operation duration was at highest risk for POAF.

Abstract

Objectives: Due to better postoperative convalescence and quality of life, experienced centers focus on minimally invasive surgical techniques and approaches, but this approach is not routinely performed for valve-sparing root replacement procedures. The purpose of this study was to assess the safety and feasibility of valve-sparing root replacement via partial upper sternotomy.

Methods: Between January 2016 and April 2021, two hundred and sixty-nine patients underwent a valve-sparing root replacement procedure, and partial upper sternotomy was performed in 52 patients. The clinical outcomes of the partial upper sternotomy (PUS) and complete sternotomy (CS) groups, including mortality, degree of aortic insufficiency, blood loss and consumption of blood products, postoperative complications and hospitalization expenses, were compared. The Kaplan–Meier method was used to assess the degree of aortic regurgitation. Propensity score matching was performed as a sensitivity analysis.

Results: There was only 1 in-hospital death (in the CS group, p = 1) and no postoperative moderate to severe aortic insufficiency in either group. The blood loss and consumption of blood products in the PUS group were also lower than in the CS group, especially for plasma use. Regarding the need for re-exploration because of bleeding, acute kidney injury, pericardial pleural effusion, drainage volume within the first 24 hours, mechanical ventilation time and arrhythmia, the 2 groups were comparable. Patients in the CS group showed a longer ICU time (74.20±47.21 vs. 50.94±30.16 h, p=0.001) and higher hospitalization expenses (135649.52 ±29992.21 vs. 123380.15 ±27062.82yuan, p<0.001). None of the patients died or reoperated during the follow-up. Freedom from moderate or severe aortic insufficiency remained comparable after matching (p=0.97).

Conclusions: Minimally invasive valve-sparing aortic replacement via partial upper sternotomy can be safely performed in selected patients.

Objective: It is very important to select the correct size of graft in valve sparing root replacement (VSRR) procedure. At present, there are many methods to select the graft. The traditional methods need complex measurement and calculation, and do not consider the matching between graft and aortic leaflets. Therefore, we propose a simple and easy calculation method to help us select the appropriate graft in VSRR procedure and use this size to determine the free margin length, so as to ensure that the graft matches its own anatomical structure.

Methods: From January to June 2021, 18 patients who underwent reimplantation VSRR were included in this study. All patients used this measurement and calculation method to select graft. Our measurement and calculation method is that the geometric height (gH) of three aortic sinuses during operation were measured. Based on the minimum geometric height of the three leaflets, minus 2-3mm from this height, and double the value is the diameter of the graft (d) (d = (gH - (2 ~ 3) )* 2). Then the aortic valve leaflet underwent cusp plication so that the free margin length (FML) of the plicated aortic leaflet is equal to the diameter of the artificial vessel plus 3-5mm (FML = d + (3 ~ 5)). The degree of aortic regurgitation was measured by ultrasound before operation and after discharge. The primary end points were all-cause death and re intervention of aortic valve.

Results: The mean age of 18 patients undergoing VSRR procedure was 50.1 ± 11.9 years, and 15 patients was male (83.3%), BMI was 26.19 ± 2.46. One patient was diagnosed with Marfan's syndrome (5.6%), and one patient was diagnosed bicuspid aortic valve (5.6%). All 18 cases had preoperative aortic regurgitation (100%), including 4 mild (22.2%), 9 moderate (50%) and 5 severe (27.8%). During the operation, 7 patients were treated with 30mm (38.9%), 10 patients with 28mm (55.6%), and 1 patient with 26mm graft (5.6%). Only 4 patients had mild aortic regurgitation after operation (before discharge). There was no death and reoperation within 3 months after discharge; There was no progression in the degree of aortic regurgitation.

Conclusions: The new measurement and calculation method of graft size and aortic valve free margin length determined based on aortic valve geometric height is simple and satisfactory, which can ensure that the selected graft matches the patient.

Exploratory study on full bionic artificial blood vessel with aortic sinus

Objective: Aortic root replacement with aortic valve preservation (David operation) is an internationally recognized valve preservation operation. The purpose of this study is to try to overcome the defects of existing aortic graft and design a new fully bionic aortic sinus artificial blood vessel, which has good sinus morphology, mechanical elasticity, compliance, structural stability and histocompatibility.

Methods and results: We extracted the computed tomography imaging information of people with normal aortic root structure for mold construction, imported the imaging data of the research object into software repair modeling, if the model surface is rough, we can use freeform software for smoothing, and finally export the model file for 3D printing. Use 3D printing technology to make molds. According to the mold, the three-layer structure based on polyurethane material is made, and the full bionic aortic sinus artificial blood vessel is obtained.

Conclusion: Based on the anatomical and imaging data of aortic root in normal people and polyurethane synthetic materials independently developed in China, some studies have made a fully bionic three-layer sinus artificial blood vessel. At present, in order to overcome the technical difficulties, in the next step, in vitro experiments and animal experiments will be carried out to provide a basis for the next clinical trial.