Comparison of the application of self expanding valve and bulbous valve in the treatment of severe bicuspid aortic valve stenosis in patients undergoing transcatheter aortic valve replacement
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摘要: 目的 比较自展瓣与球扩瓣在经导管主动脉瓣置换术(TAVR)治疗二叶式主动脉瓣重度狭窄患者中的应用效果。方法 收集2020年7月—2023年6月接受TAVR治疗的二叶式主动脉瓣重度狭窄患者128例的临床资料，根据置入瓣膜分为自展瓣组(72例)、球扩瓣组(56例)，采用1∶1倾向性评分匹配法筛选基线资料均衡两组病例(各52例)，比较两组一般资料、血流动力学、心肌损伤标志物、主要终点事件。结果 术后1个月、术后6个月、术后1年，自展瓣组患者主动脉瓣瓣口面积(AVA)高于球扩瓣组，平均跨瓣压差(MPG)、主动脉瓣前向血流峰值速度(Vmax)低于球扩瓣组(P<0.05)。术后48 h、术后1周、术后2周，自展瓣组患者血清肌酸激酶同工酶(CK-MB)、心肌肌钙蛋白T(cTnT)、肌红蛋白(MYO)高于球扩瓣组(P<0.05)。自展瓣组与球扩瓣组全因死亡(χ2=0.153，P=0.696)、脑卒中(χ2=0.343，P=0.588)、新发心房颤动(χ2=0.210，P=0.647)比较，差异无统计学意义(P>0.05)；自展瓣组血流动力学结构瓣膜功能障碍率(3.85% vs 21.25%，χ2=7.121，P=0.008)、瓣膜-患者不匹配率(3.85% vs 13.46%，χ2=9.983，P=0.046)低于球扩瓣组；新发传导阻滞率(23.38% vs 7.69%，χ2=4.727，P=0.030)、永久性起搏器置入率(19.23% vs 5.77%，χ2=4.308，P=0.038)、瓣周漏率(15.38% vs 3.85%，χ2=3.983，P=0.046)高于球扩瓣组。结论 自展瓣与球扩瓣行TAVR术治疗二叶式主动脉瓣重度狭窄效果均值得肯定，自展瓣血流动力学优于球扩瓣，但心肌损伤相对较重。在行TAVR治疗二叶式主动脉瓣重度狭窄时，自展瓣应注意预防新发传导阻滞、永久性起搏器置入、瓣周漏发生的风险，球扩瓣应注意预防生物瓣膜功能障碍。Abstract: Objective To compare the application effects of self expanding valve and bulbous valve in the treatment of severe bicuspid aortic valve stenosis in patients undergoing transcatheter aortic valve replacement(TAVR).Methods Clinical data of 128 patients with severe bicuspid aortic valve stenosis who received TAVR treatment from July 2020 to June 2023 were collected. The patients were divided into a self expanding valve group(72 cases) and a balloon dilation valve group(56 cases) based on the implanted valve. A 1: 1 propensity score matching method was used to screen for baseline data balance between the two groups(52 cases each). General data, hemodynamics, myocardial injury markers, and primary endpoint events were compared between the two groups.Results At 1 month, 6 months, and 1 year after surgery, the aortic valve area(AVA) of patients in the self expanding valve group was higher than that in the bulbous valve group, and the average transvalvular pressure gradient(MPG) and forward flow velocity(Vmax) of the aortic valve were lower than those in the bulbous valve group(P<0.05). At 48 hours, 1 week, and 2 weeks after surgery, the serum levels of creatine kinase isoenzyme(CK-MB), cardiac troponin T(cTnT), and myoglobin(MYO) in the self expanding valve group were higher than those in the balloon expanding valve group(P<0.05). There was no significant difference in all-cause mortality(χ2=0.153, P=0.696), stroke(χ2=0.343, P=0.588), and new onset atrial fibrillation(χ2=0.210, P=0.647) between the self expanding valve group and the balloon expanding valve group; The hemodynamic structural valve dysfunction rate(3.85% vs 21.25%) and valve patient mismatch rate(3.85% vs 13.46%) in the self expanding valve group were lower than those in the expanded valve group(χ2=7.121, P=0.008); χ2=9.983, P=0.046); The incidence of new conduction block(23.38% vs 7.69%), permanent pacemaker implantation rate(19.23% vs 5.77%), and perivalvular leakage rate(15.38% vs 3.85%) were higher in the group with balloon dilation than in the group with balloon dilation(χ2=4.727, P=0.030); χ2=4.308, P=0.038; χ2=3.983, P=0.046).Conclusion The therapeutic effect of TAVR on severe bicuspid aortic valve stenosis using both self expanding and balloon expanding valves is commendable. The hemodynamics of self expanding valves are superior to those of balloon expanding valves, but the myocardial damage is relatively severe. When performing TAVR treatment for severe bicuspid aortic valve stenosis, attention should be paid to preventing the risk of new conduction block, permanent pacemaker implantation, and perivalvular leakage in self expanding valves, and to preventing dysfunction of biological valves in balloon expansion valves.
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表 1 两组TAVR术患者倾向性评分匹配前后一般资料比较
Table 1. Comparison of general data of TAVR patients before and after PSM
例(%), X±S 项目 匹配前 匹配后 自展瓣组(72例) 球扩瓣组(56例) t/χ2/Z P 自展瓣组(52例) 球扩瓣组(52例) t/χ2/Z P 性别 1.710 0.191 0.630 0.427 男 38(52.78) 36(64.29) 28(53.85) 24(46.15) 女 34(47.22) 20(35.71) 24(46.15) 20(38.46) 年龄/岁 73.15±5.46 72.24±6.12 0.887 0.377 73.52±5.21 72.85±5.34 0.648 0.519 BMI/(kg/m2) 22.45±3.12 23.14±3.25 1.219 0.225 22.64±3.21 23.05±3.15 0.657 0.512 STS评分/分 6.74±1.04 6.54±1.12 1.044 0.299 6.71±1.10 6.57±1.05 0.664 0.508 NYHA分级 1.404 0.496 0.536 0.765 Ⅱ级 9(12.50) 10(17.86) 7(13.46) 9(17.31) Ⅲ级 51(70.83) 40(71.43) 37(71.15) 37(71.15) Ⅳ级 12(16.67) 6(10.71) 8(15.38) 6(11.54) LVEF/% 53.45±7.12 54.10±7.24 0.509 0.612 53.24±5.56 53.65±5.724 0.509 0.612 主动脉增强CT钙化积分/mm3 586.45±62.16 545.21±68.24 3.567 0.001 572.24±71.35 556.43±70.32 1.138 0.258 合并疾病 高血压 38(52.78) 27(48.21) 0.263 0.608 27(51.92) 25(48.08) 0.154 0.695 糖尿病 17(23.61) 10(17.86) 0.627 0.429 12(23.08) 9(17.31) 0.537 0.464 冠心病 26(36.11) 17(30.36) 0.468 0.494 19(36.54) 15(28.85) 0.699 0.403 慢性阻塞性肺疾病 17(23.61) 16(28.57) 0.405 0.525 12(23.08) 14(26.92) 0.205 0.651 慢性肾功能不全 7(9.72) 8(14.29) 0.634 0.426 4(7.69) 6(11.54) 0.443 0.506 心房颤动 11(15.28) 6(10.71) 0.570 0.450 8(15.38) 6(11.54) 0.330 0.566 
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表 2 两组TAVR术患者治疗前后血流动力学比较
Table 2. Comparison of hemodynamics of TAVR patients before and after treatment
X±S 指标 术前 术后1个月 术后6个月 术后1年 F值/P值 AVA/cm2 自展瓣组(52例) 0.60±0.08 1.72±0.221)2) 1.88±0.231)2) 1.84±0.241)2) F组间/P组间=2.007/0.157；
F时间点/P时间点=21.011/＜0.001；
F交互/P交互=0.095/0.999球扩瓣组(52例) 0.61±0.10 1.51±0.201) 1.64±0.211) 1.60±0.221)1.60±0.221) mPG/mmHg 自展瓣组(52例) 56.45±4.32 9.53±1.241)2) 8.12±1.021)2) 8.40±1.051) 2) F组间/P组间=0.586/0.444；
F时间点/P时间点=97.828/＜0.001；
F交互/P交互=0.069/1.000球扩瓣组(52例) 55.25±4.25 12.45±1.321) 10.65±1.131) 11.24±1.211) Vmax/(m/s) 自展瓣组(52例) 5.14±0.65 2.11±0.281)2) 2.02±0.261)2) 2.06±0.251)2) F组间/P组间=1.394/0.238；
F时间点/P时间点=28.814/＜0.001；
F交互/P交互=0.155/0.996球扩瓣组(52例) 4.95±0.62 2.62±0.311) 2.46±0.251) 2.51±0.261) 与本组术前比较，1)P<0.05；与同期球扩瓣组比较，2)P<0.05。
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表 3 两组TAVR术患者手术治疗前后心肌损伤指标比较
Table 3. Comparison of myocardial injury indexes of TAVR patients before and after treatment
X±S 项目 术前 术后48 h 术后1周 术后2周 F值/P值 CK-MB/(U/L) 自展瓣组(52例) 27.35±4.12 66.32±5.361)2) 48.28±4.251)2) 42.35±5.121)2) F组间/P组间=2.643/0.104；
F时间点/P时间点=18.051/＜0.001；
F交互/P交互=0.074/1.000球扩瓣组(52例) 26.13±4.25 60.14±5.451) 40.54±4.361) 34.14±5.251) cTnT/(μg/L) 自展瓣组(52例) 0.50±0.08 1.38±0.251)2) 0.90±0.161)2) 0.76±0.121)2) F组间/P组间=3.881/0.049；
F时间点/P时间点=20.366/＜0.001；
F交互/P交互=0.302/0.965球扩瓣组(52例) 0.54±0.10 1.13±0.241) 0.71±0.121) 0.61±0.101) MYO /(μg/L) 自展瓣组(52例) 92.35±7.25 168.34±6.321)2) 145.25±8.361)2) 130.32±8.541)2) F组间/P组间=2.135/0.144；
F时间点/P时间点=6.739/＜0.001；
F交互/P交互=0.124/0.998球扩瓣组(52例) 94.62±7.36 145.36±7.141) 123.44±9.451) 113.35±9.211) 与本组术前比较，1)P<0.05；与球扩瓣组同期比较，2)P<0.05。
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表 4 两组TAVR术患者主要终点事件比较
Table 4. Comparison of primary outcome of TAVR patients between two groups
例(%) 指标 自展瓣组(52例) 球扩瓣组(52例) χ2 P 全因死亡 4(7.69) 3(5.77) 0.153 0.696 脑卒中 2(3.85) 1(1.92) 0.343 0.558 新发心房颤动 3(5.77) 2(3.85) 0.210 0.647 新发传导阻滞 12(23.08) 4(7.69) 4.727 0.030 永久性起搏器置入 10(19.23) 3(5.77) 4.308 0.038 瓣周漏 8(15.38) 2(3.85) 3.983 0.046 血流动力学结构瓣膜功能障碍 2(3.85) 11(21.15) 7.121 0.008 瓣膜-患者不匹配 2(3.85) 7(13.46) 3.983 0.046
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