Early and mid-term outcomes of domestic third-generation magnetically levitated left ventricular assist device implantation with concomitant mitral valvuloplasty
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摘要: 目的 对比分析国产第3代磁悬浮左心室辅助装置(left ventricular assist device，LVAD)植入是否同期行二尖瓣成形术(mitral valvuloplasty，MVP)的早、中期临床结果。方法 选取13例接受LVAD植入并合并术前中重度二尖瓣反流的终末期心力衰竭患者，根据是否同期行MVP分为LVAD+MVP组9例和LVAD组4例。对比分析两组患者的基线资料、手术资料和早、中期随访资料。结果 与LVAD组相比，LVAD+MVP组手术数量显著增多(P < 0.01)，手术时间、体外循环时间、主动脉阻断时间、术中出血量、术后呼吸机使用时间和住院时间均有所增加，ICU停留时间有所减少，但均差异无统计学意义。LVAD组1例患者术后早期死亡，两组术后早期病死率、并发症发生率比较均差异无统计学意义。术后成功随访12例患者，随访时间6~58个月，随访期间无患者死亡，NYHA心功能分级均为Ⅰ~Ⅱ级。与LVAD组相比，LVAD+MVP组术后1、3个月肺动脉收缩压均显著较低(均P < 0.05)。两组术后中重度二尖瓣反流、中重度三尖瓣反流、再入院率及早中期并发症发生率比较均差异无统计学意义。结论 国产第3代磁悬浮LVAD植入同期行MVP是安全且可行的，术后早、中期血流动力学更好。同期行MVP对LVAD患者术后早、中期病死率、再入院率和并发症发生率可能无明显影响。Abstract: Objective To analyze the early and mid-term outcomes of domestic third-generation magnetically levitated left ventricular assist device(LVAD) with or without concomitant mitral valvuloplasty(MVP).Methods A total of 13 end-stage heart failure patients who underwent LVAD implantation with pre-operative moderate to severe mitral regurgitation were included. According to whether MVP was performed concurrently or not, there were 9 patients in the LVAD+MVP group and 4 patients in the LVAD group. The baseline data, surgical data, and early and mid-term follow-up data between the two groups were compared. Results Compared with the LVAD group, the LVAD+MVP group had significantly more concomitant surgeries(P < 0.01); and there were increases in operation time, cardiopulmonary bypass time, aortic cross-clamping time, blood loss, ventilator support time, and postoperative hospital stay, and decreases in ICU stay time, but none of the differences were statistically significant. One patient in the LVAD group died early after surgery, and there was no statistically significant difference in early postoperative mortality and complication incidence between the two groups. Twelve patients were followed up for 6 to 58 months. During the follow-up period, no patient died and all patients had NYHA cardiac function class Ⅰ-Ⅱ. Compared with the LVAD group, the LVAD+MVP group had significantly lower pulmonary artery systolic pressure at 1 and 3 months after surgery, with statistically significant differences(both P < 0.05). There was no significant difference in the incidences of moderate to severe mitral regurgitation, moderate to severe tricuspid regurgitation, readmission, and early and mid-term complications between the two groups after surgery.Conclusion Concomitant MVP during domestic third-generation magnetically levitated LVAD implantation is safe and feasible, with better hemodynamics in the early and mid-term postoperative period, and concomitant MVP may not have a significant effect on the early and mid-term postoperative mortality, readmission rate, and complication rate in patients with LVAD.
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Key words:
- heart failure /
- left ventricular assist device /
- mitral regurgitation /
- mitral valvuloplasty /
- follow up
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表 1 两组患者围手术期临床资料比较
Table 1. Comparison of perioperative clinical data
例(%), X±S, M(P25, P75) 项目 LVAD组(4例) LVAD+MVP组(9例) t/Z/χ2 P 男性 4(100.0) 7(77.8) 0.462 年龄/岁 43.5±5.9 45.3±13.8 -0.250 0.807 BMI/(kg/m2) 26.0±4.4 23.4±3.5 1.156 0.272 CKD 3期 3(75.0) 5(55.6) 0.490 肺动脉高压 2(50.0) 6(66.7) 0.510 INTERMACS分级 0.580 1级 1(25.0) 1(11.1) 2级 1(25.0) 5(55.6) 3级 2(50.0) 3(33.3) 术前经胸超声心动图 LVEF/% 23.0±5.8 21.1±4.1 0.675 0.514 LVEDD/mm 84.5±8.7 82.3±11.8 0.325 0.751 中度MR 2(50.0) 2(22.2) 0.530 重度MR 2(50.0) 7(77.8) 0.530 中重度主动脉瓣反流 2(50.0) 0 0.077 中重度三尖瓣反流 2(50.0) 5(55.6) 0.657 LVAD类型 0.014 EVAHEARTⅠ 1(25.0) 0 CH-VAD 2(50.0) 0 Corheart-6 1(25.0) 9(100.0) 伴随的手术 0.006 AVR 1(25.0) 0 MVP 0 5(55.6) MVP+TVP 0 3(33.3) MVP+PFO 0 1(11.1) 术中出血量/mL 400.0(225.0，1475.0) 900.0(725.0，1 400.0) -1.238 0.216 手术时间/min 370.0(270.0，586.3) 370.0(347.5，455.0) -0.309 0.757 体外循环时间/min 109.5(68.8，359.5) 207.0(181.5，231.0) -1.389 0.165 主动脉阻断时间/min 52.0(35.5，154.0) 135.0(116.5，146.5) -1.389 0.165 呼吸机使用时间/h 21.5(19.5，35.5) 28.0(22.5，84.5) -1.080 0.280 ICU停留时间/h 292.4(230.9，313.8) 139.6(94.2，237.9) -1.852 0.064 术后住院时间/d 26.0(23.0，74.0) 31.0(20.5，39.5) -0.077 0.938 CKD 3期：慢性肾脏病3期，肾小球滤过率 < 60 mL/min/1.73 m2；INTERMACS：机械循环支持机构间注册登记；AVR：主动脉瓣置换术；TVP：三尖瓣成形术；PFO：卵圆孔未闭封堵术。 
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表 2 两组患者早期并发症及死亡事件比较
Table 2. Comparison of early complications and death
例(%) 项目 整体(13例) LVAD组(4例) LVAD+MVP组(9例) P 术后早期并发症 0.853 二次开胸 1(7.7) 0 1(11.1) 中重度MR 1(7.7) 1(25.0) 0 急性肾损伤 3(23.1) 1(25.0) 2(22.2) 消化道出血 1(7.7) 0 1(11.1) 死亡 1(7.7) 1(25.0) 0 0.308
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表 3 两组患者术后早中期随访资料比较
Table 3. Comparison of early and mid-term follow-up data
例(%) 项目 整体(12例) LVAD组(3例) LVAD+MVP组(9例) P 再入院 0.500 肢体、面部麻木 1(8.3) 1(33.3) 0 心律失常 2(16.7) 1(33.3) 1(11.1) 消化道出血 1(8.3) 0 1(11.1) 切口感染 1(8.3) 0 1(11.1) 新冠肺炎 1(8.3) 0 1(11.1) 超声心动图 中重度MR 3(25) 2(66.7) 1(11.1) 0.127 中重度三尖瓣反流 4(33.3) 2(66.7) 2(22.2) 0.236
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