经导管二尖瓣“瓣中瓣”置换术治疗人工二尖瓣生物瓣衰败的安全性和有效性分析

doi:10.11958/20251926

天津医药 ›› 2025, Vol. 53 ›› Issue (9): 993-999.doi: 10.11958/20251926

经导管二尖瓣“瓣中瓣”置换术治疗人工二尖瓣生物瓣衰败的安全性和有效性分析

牛书林¹(), 王宙明¹, 刘茗宇¹, 关欣¹, 李梦琦², 田轶魁², 杨振文¹, 杜鑫¹^,^△()

1 天津医科大学总医院心血管内科（邮编300052）
2 天津医科大学总医心血管外科（邮编300052）

收稿日期:2025-05-13 修回日期:2025-06-10 出版日期:2025-09-15 发布日期:2025-09-16
通讯作者: ^△E-mail：xindu@tmu.edu.cn
作者简介:牛书林（1992），女，医师，主要从事瓣膜病及超声心动图方面研究。E-mail：18345198921@163.com
基金资助:
国家自然科学基金面上项目(82470256)

Analysis of the safety and efficacy of transcatheter mitral valve-in-valve replacement for the bioprosthetic mitral valve failure

NIU Shulin¹(), WANG Zhouming¹, LIU Mingyu¹, GUAN Xin¹, LI Mengqi², TIAN Yikui², YANG Zhenwen¹, DU Xin¹^,^△()

1 Department of Cardiovasology, Tianjin Medical University General Hospital, Tianjin 300052, China
2 Department of Cardiac Surgery, Tianjin Medical University General Hospital, Tianjin 300052, China

Received:2025-05-13 Revised:2025-06-10 Published:2025-09-15 Online:2025-09-16
Contact: ^△E-mail: xindu@tmu.edu.cn

牛书林, 王宙明, 刘茗宇, 关欣, 李梦琦, 田轶魁, 杨振文, 杜鑫. 经导管二尖瓣“瓣中瓣”置换术治疗人工二尖瓣生物瓣衰败的安全性和有效性分析[J]. 天津医药, 2025, 53(9): 993-999.

NIU Shulin, WANG Zhouming, LIU Mingyu, GUAN Xin, LI Mengqi, TIAN Yikui, YANG Zhenwen, DU Xin. Analysis of the safety and efficacy of transcatheter mitral valve-in-valve replacement for the bioprosthetic mitral valve failure[J]. Tianjin Medical Journal, 2025, 53(9): 993-999.

摘要/Abstract

摘要：

目的评估经导管二尖瓣“瓣中瓣”置换术（ViV-TMVR）治疗人工二尖瓣生物瓣衰败的安全性和有效性。方法选取17例因二尖瓣生物瓣衰败需行ViV-TMVR的患者，收集患者的年龄、性别、体质量指数（BMI）、二尖瓣生物瓣使用年限，合并症（高血压、冠心病、陈旧性脑梗死、心房颤动、糖尿病），美国纽约心脏病学会（NYHA）心功能分级；术前超声心动图评估左心室舒张末期内径（LVEDD）、右心房内径（RA）、肺动脉收缩压（PASP）、左心室射血分数（LVEF），二尖瓣生物瓣衰败类型，二尖瓣生物瓣反流程度、狭窄程度，术前生物瓣峰值流速、平均跨瓣压差，三尖瓣反流程度；美国胸外科医师协会（STS）评分；术中穿刺路径、瓣膜类型、术中并发症、手术时间、术后即刻经食管超声心动图（TEE）评估（瓣中瓣峰值流速、瓣中瓣平均跨瓣压差、瓣中瓣反流或瓣周反流）；术后进入重症监护室（ICU）/心血管内科重症监护室（CCU）的时间，术后住院时间，以及术后30 d超声心动图复查结果，NYHA心功能分级。根据使用瓣膜不同分为国产纽脉瓣膜组（国产组，10例）与进口爱德华瓣膜组（进口组，7例）。分析ViV-TMVR的安全性和有效性，并对比国产瓣膜和进口瓣膜的效果。结果 17例患者均成功通过穿刺房间隔途径接受ViV-TMVR治疗，且未发生严重并发症，术后30 d再住院率为0。国产组与进口组手术时间、瓣中瓣瓣周轻度反流、术后即刻及术后30 d瓣中瓣峰值流速、术后即刻及术后30 d瓣中瓣平均跨瓣压差、术后ICU/CCU监护时间、术后住院时间，术后30 d NYHA心功能Ⅲ—Ⅳ级患者占比差异无统计学意义。术后30 d随访中1例患者因脑出血死亡，主要不良心血管事件（MACE）为脑出血1例。相较于术前，术后即刻及术后30 d瓣中瓣峰值流速、瓣中瓣平均跨瓣压差、LVEF、PASP下降；相较于术后即刻，术后30 d瓣中瓣峰值流速、平均跨瓣压差升高（P<0.01），LVEF、PASP差异无统计学意义。结论经房间隔穿刺ViV-TMVR对于生物瓣衰败患者短期安全且有效，且国产瓣膜与进口瓣膜疗效相当。

关键词: 二尖瓣, 心脏瓣膜疾病, 心脏瓣膜假体植入, 房间隔, 导管, 生物瓣衰败, “瓣中瓣”置换术

Abstract:

Objective To evaluate the safety and efficacy of transcatheter mitral valve-in-valve replacement (ViV-TMVR) in the treatment of bioprosthetic mitral valve failure. Methods Seventeen patients with bioprosthetic mitral valve failure who required ViV-TMVR were selected. Preoperative data including age, gender, body mass index (BMI), usage time of bioprosthetic mitral valve, comorbidities (hypertension, coronary heart disease, old cerebral infarction, atrial fibrillation and diabetes) and New York Heart Association (NYHA) functional class were recorded, and left ventricular end-diastolic diameter (LVEDD), right atrial diameter (RA), pulmonary artery systolic pressure (PASP), left ventricular ejection fraction (LVEF), type of bioprosthetic mitral valve failure, degree of bioprosthetic mitral valve regurgitation and stenosis, peak velocity and mean transvalvular pressure gradient of the bioprosthetic mitral valve, and Society of Thoracic Surgeons (STS) score were also collected. Intraoperative data included puncture route, valve type, intraoperative complications, operation time and immediate postoperative transesophageal echocardiography (TEE) assessment (peak velocity and mean transvalvular pressure gradient of the valve-in-valve, valve-in-valve regurgitation or paravalvular regurgitation) were collected. Postoperative data included time in the intensive care unit (ICU)/cardiovascular intensive care unit (CCU), total postoperative hospital stay and 30-day postoperative echocardiographic results and NYHA functional class were recorded. Patients were divided into the domestic NewMed valve group (10 cases) and the imported Edwards valve group (7 cases) based on the type of valve used. The safety and efficacy of ViV-TMVR were analyzed, and the efficacy of domestic valves and imported valves was compared. Results All 17 patients successfully underwent ViV-TMVR via the transseptal approach without serious complications, and the 30-day readmission rate was 0%. There were no significant differences in operation time of domestic valves and imported valves, mild paravalvular regurgitation of the valve-in-valve, peak velocity and mean transvalvular pressure gradient of the valve-in-valve immediately after surgery and at 30-day postoperatively, time in ICU/CCU, total postoperative hospital stay and the proportion of patients with NYHA functional class Ⅲ-Ⅳ at 30-day postoperatively between the domestic valve group and the imported valve group. During the 30-day follow-up, one patient died of cerebral hemorrhage, and one patient had major adverse cardiovascular events (MACE, cerebral hemorrhage). Compared with before the operation, the peak velocity and mean transvalvular pressure gradient of the valve-in-valve, LVEF, and PASP decreased immediately after surgery and at 30 days after surgery. Compared with immediately after surgery, the peak velocity and mean transvalvular pressure gradient of the valve-in-valve increased at 30 days postoperatively (P < 0.01), while there were no significant differences in LVEF and PASP. Conclusion Transseptal ViV-TMVR is safe and effective in the short term for patients with bioprosthetic mitral valve failure who are at high risk of re-thoracotomy, and the efficacy of domestic valves is comparable to that of imported valves.

Key words: mitral valve, heart valve diseases, heart valve prosthesis implantation, atrial septum, catheters, bioprosthetic mitral valve failure, "valve-in-valve" replacement

中图分类号:

R542.51

图/表 5

参考文献 21

[1]	CHEN C Y, LIN C P, HUNG K C, et al. Durability of biological valves implanted in aortic or mitral positions:a nationwide cohort study[J]. Ann Thorac Surg, 2023, 116(4):751-757. doi:10.1016/j.athoracsur.2023.05.038.
[2]	ZWISCHENBERGER B A, GACA J G, HANEY J C, et al. Late outcomes of porcine and pericardial bioprostheses after mitral valve replacement in 1162 patients[J]. Ann Thorac Surg, 2024, 118(4):882-888. doi:10.1016/j.athoracsur.2024.04.002.
[3]	BOURGUIGNON T, BOUQUIAUX-STABLO A L, LOARDI C, et al. Very late outcomes for mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis:25-year follow-up of 450 implantations[J]. J Thorac Cardiovasc Surg, 2014, 148(5):2004-2011.e1. doi:10.1016/j.jtcvs.2014.02.050.
[4]	MEHAFFEY H J, HAWKINS R B, SCHUBERT S, et al. Contemporary outcomes in reoperative mitral valve surgery[J]. Heart, 2018, 104(8):652-656. doi:10.1136/heartjnl-2017-312047.
[5]	EJIOFOR J I, HIRJI S A, RAMIREZ-DEL VAL F, et al. Outcomes of repeat mitral valve replacement in patients with prior mitral surgery:a benchmark for transcatheter approaches[J]. J Thorac Cardiovasc Surg, 2018, 156(2):619-627.e1. doi:10.1016/j.jtcvs.2018.03.126.
[6]	UEYAMA H A, MIYAMOTO Y, WATANABE A, et al. Cardiac reoperation or transcatheter mitral valve replacement for patients with failed mitral prostheses[J]. J Am Coll Cardiol, 2024, 83(2):317-330. doi:10.1016/j.jacc.2023.10.014.
[7]	TRUONG S, PETERSEN J, HAVERS-BORGERSEN E, et al. Outcomes of mitral valve reoperation and first-time surgery for mitral regurgitation:a nationwide study[J]. Int J Cardiol, 2025, 430:133175. doi:10.1016/j.ijcard.2025.133175.
[8]	ZUBAREVICH A, SZCZECHOWICZ M, ARJOMANDI RAD A, et al. Mitral surgical redo versus transapical transcatheter mitral valve implantation[J]. PLoS One, 2021, 16(8):e0256569. doi:10.1371/journal.pone.0256569.
[9]	GUERRERO M, PURSNANI A, NARANG A, et al. Prospective evaluation of transseptal TMVR for failed surgical bioprostheses:MITRAL trial valve-in-valve Arm 1-year outcomes[J]. JACC Cardiovasc Interv, 2021, 14(8):859-872. doi:10.1016/j.jcin.2021.02.027.
[10]	NASIR M M, AMIR S, SHAHID A, et al. Valve-in-valve transcatheter mitral valve replacement versus redo-surgical mitral valve replacement for degenerated bioprosthetic mitral valves:a systematic review and meta-analysis[J]. Int J Cardiol, 2024, 415:132448. doi:10.1016/j.ijcard.2024.132448.
[11]	COISNE A, LANCELLOTTI P, HABIB G, et al. ACC/AHA and ESC/EACTS guidelines for the management of valvular heart diseases:JACC Guideline Comparison[J]. J Am Coll Cardiol, 2023, 82(8):721-734. doi:10.1016/j.jacc.2023.05.061.
[12]	YOON S H, WHISENANT B K, BLEIZIFFER S, et al. Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses,failed annuloplasty rings,and mitral annular calcification[J]. Eur Heart J, 2019, 40(5):441-451. doi:10.1093/eurheartj/ehy590.
[13]	ELEID M F, WHISENANT B K, CABALKA A K, et al. Early outcomes of percutaneous transvenous transseptal transcatheter valve implantation in failed bioprosthetic mitral valves,ring annuloplasty,and severe mitral annular calcification[J]. JACC Cardiovasc Interv, 2017, 10(19):1932-1942. doi:10.1016/j.jcin.2017.08.014.
[14]	PIRELLI L, HONG E, STEFFEN R, et al. Mitral valve-in-valve and valve-in-ring: tips, tricks,and outcomes[J]. Ann Cardiothorac Surg, 2021, 10(1):96-112. doi:10.21037/acs-2019-mv-169.
[15]	张靖男, 万俊义, 宋会军, 等. 经导管“瓣中瓣”置换术治疗二尖瓣置换术后生物瓣衰败的疗效评价[J]. 中国循环杂志, 2023, 38(2):165-170.
	ZHANG J N, WAN J Y, SONG H J, et al. Clinical efficacy of transcatheter mitral valve-in-valve replacement in patients with degenerated bioprosthesi[J]. Chinese Circulation Journal, 2023, 38(2):165-170. doi:10.3969/j.issn.1000-3614.2023.02.008.
[16]	PIBAROT P, DUMESNIL J G, LEBLANC M H, et al. Changes in left ventricular mass and function after aortic valve replacement:a comparison between stentless and stented bioprosthetic valves[J]. J Am Soc Echocardiogr, 1999, 12(11):981-987. doi:10.1016/s0894-7317(99)70152-5.
[17]	AL-TAWIL M, BUTT S, REAP S, et al. Transseptal vs transapical transcatheter mitral valve-in-valve and valve-in-ring implantation:a systematic review and meta-analysis[J]. Curr Probl Cardiol, 2023, 48(7):101684. doi:10.1016/j.cpcardiol.2023.101684.
[18]	BAPAT V, MYDIN I, CHADALAVADA S, et al. A guide to fluoroscopic identification and design of bioprosthetic valves:a reference for valve-in-valve procedure[J]. Catheter Cardiovasc Interv, 2013, 81(5):853-861. doi:10.1002/ccd.24419.
[19]	SCHAMROTH PRAVDA N, MISHAEV R, LEVI A, et al. Five-year outcomes of patients with mitral structural valve deterioration treated with transcatheter valve in valve implantation - a single center prospective registry[J]. Front Cardiovasc Med, 2022, 9:883242. doi:10.3389/fcvm.2022.883242.
[20]	AKODAD M, TRPKOV C, CHEUNG A, et al. Valve-in-valve transcatheter mitral valve replacement:a large first-in-human 13-year experience[J]. Can J Cardiol, 2023, 39(12):1959-1970. doi:10.1016/j.cjca.2023.08.018.
[21]	GOEL K, MAKKAR R, KRISHNASWAMY A, et al. Contemporary outcomes and trends for the transseptal mitral valve-in-valve procedure using balloon expandable transcatheter valves in the United States[J]. Circulation, 2024, 150(19):1493-1504. doi:10.1161/CIRCULATIONAHA.124.068847.

组别	n		年龄/岁		男性	BMI/ （kg/m2）		生物瓣使用年限/年		术前生物瓣峰值流速/（m/s）		平均跨瓣压差/mmHg		LVEDD/mm		RA/mm	PASP/mmHg
国产组	10		71.80±5.88		6（60.0）	23.20±2.15		12.60±3.10		2.79±0.46		15.38±5.42		48.90±5.41		48.40±7.69	61.40±19.02
进口组	7		67.86±10.45		1（14.3）	21.55±2.50		11.86±3.34		2.87±0.48		11.50±3.87		44.43±5.53		42.29±7.25	56.57±15.20
t或P			0.997		0.134^▲	1.452		0.472		0.309		1.263		1.663		1.650	0.557
组别		LVEF/%		STS评分/%			NYHAⅢ—Ⅳ级		高血压		冠心病		陈旧性脑梗死		心房颤动			糖尿病
国产组		64.00±3.83		6.54±1.03			9（90.0）		4（40.0）		3（30.0）		1（10.0）		4（40.0）			3（30.0）
进口组		63.86±2.48		6.34±1.41			6（85.7）		2（28.6）		1（14.3）		1（14.3）		4（57.1）			1（14.3）
t或P		0.086		0.341			1.000^▲		1.000^▲		0.603^▲		1.000^▲		0.637^▲			0.603^▲

组别	n		年龄/岁		男性	BMI/ （kg/m2）		生物瓣使用年限/年		术前生物瓣峰值流速/（m/s）		平均跨瓣压差/mmHg		LVEDD/mm		RA/mm	PASP/mmHg
国产组	10		71.80±5.88		6（60.0）	23.20±2.15		12.60±3.10		2.79±0.46		15.38±5.42		48.90±5.41		48.40±7.69	61.40±19.02
进口组	7		67.86±10.45		1（14.3）	21.55±2.50		11.86±3.34		2.87±0.48		11.50±3.87		44.43±5.53		42.29±7.25	56.57±15.20
t或P			0.997		0.134^▲	1.452		0.472		0.309		1.263		1.663		1.650	0.557
组别		LVEF/%		STS评分/%			NYHAⅢ—Ⅳ级		高血压		冠心病		陈旧性脑梗死		心房颤动			糖尿病
国产组		64.00±3.83		6.54±1.03			9（90.0）		4（40.0）		3（30.0）		1（10.0）		4（40.0）			3（30.0）
进口组		63.86±2.48		6.34±1.41			6（85.7）		2（28.6）		1（14.3）		1（14.3）		4（57.1）			1（14.3）
t或P		0.086		0.341			1.000^▲		1.000^▲		0.603^▲		1.000^▲		0.637^▲			0.603^▲

组别	n		手术时间/min	瓣中瓣瓣周轻度反流	术后即刻瓣中瓣峰值流速/（m/s）		术后即刻瓣中瓣平均跨瓣压差/mmHg	术后ICU/CCU监护时间/h		术后住院时间/d
国产组	10		251.50±24.04	3（30.0）	1.43±0.28		2.90±1.10	17.30±8.46		5.50±3.50
进口组	7		234.28±42.86	1（14.3）	1.63±0.28		3.86±1.95	15.93±15.10		5.29±1.70
t或P			1.062	0.603^▲	1.389		1.295	0.240		0.149
组别		术后30 d NYHA心功能分级Ⅲ—Ⅳ级				术后30 d瓣中瓣平均跨瓣压差/mmHg			术后30 d瓣中瓣峰值流速/（m/s）
国产组		2（22.2）				5.63±1.51			1.85±0.26
进口组		3（50.0）				5.00±2.83			2.18±0.48
t或P		0.596^▲				0.458			1.746

组别	n		手术时间/min	瓣中瓣瓣周轻度反流	术后即刻瓣中瓣峰值流速/（m/s）		术后即刻瓣中瓣平均跨瓣压差/mmHg	术后ICU/CCU监护时间/h		术后住院时间/d
国产组	10		251.50±24.04	3（30.0）	1.43±0.28		2.90±1.10	17.30±8.46		5.50±3.50
进口组	7		234.28±42.86	1（14.3）	1.63±0.28		3.86±1.95	15.93±15.10		5.29±1.70
t或P			1.062	0.603^▲	1.389		1.295	0.240		0.149
组别		术后30 d NYHA心功能分级Ⅲ—Ⅳ级				术后30 d瓣中瓣平均跨瓣压差/mmHg			术后30 d瓣中瓣峰值流速/（m/s）
国产组		2（22.2）				5.63±1.51			1.85±0.26
进口组		3（50.0）				5.00±2.83			2.18±0.48
t或P		0.596^▲				0.458			1.746

组别	n	生物瓣/瓣中瓣峰值流速/（m/s）		生物瓣/瓣中瓣平均跨瓣压差/mmHg	LVEF/%
术前	17	2.81±0.47		15.29±6.42	64.38±2.80
术后即刻	17	1.49±0.30^a		3.00±1.15^a	59.25±4.83^a
术后30 d	16	1.96±0.39^ab		5.86±1.68^ab	61.06±4.23^a
F		49.554^＊＊		16.310^＊＊	5.812^＊
组别			LVEDD/mm	RA/mm	PASP/mmHg
术前			47.00±5.93	45.00±7.26	58.67±18.16
术后即刻			45.63±4.66	45.37±7.39	42.07±14.58^a
术后30 d			45.88±3.52	43.06±7.44	41.80±14.05^a
F			0.574	2.814	11.927^＊＊

经导管二尖瓣“瓣中瓣”置换术治疗人工二尖瓣生物瓣衰败的安全性和有效性分析

Analysis of the safety and efficacy of transcatheter mitral valve-in-valve replacement for the bioprosthetic mitral valve failure

引用本文

RichHTML

PDF (PC)

可视化

摘要/Abstract

使用本文

图/表 5

参考文献 21

相关文章 15

编辑推荐

Metrics

本文评价

[1]	王慧, 潘晴, 王宙明, 张娜, 杨振文, 魏蔚. 混合性结缔组织病相关肺动脉高压临床特点分析[J]. 天津医药, 2024, 52(7): 701-703.
[2]	朱刚明, 董永德, 朱瑞婷, 谭源满, 陶娟, 刘晓, 陈德成, 杨概. 磁共振弛豫时间定量成像预测乳腺浸润性导管癌分子亚型的价值[J]. 天津医药, 2024, 52(7): 770-774.
[3]	李朝园, 赵富浩, 陈莎, 吕睿倩, 武子霞. 不同血管通路对老年维持性血液透析患者的效果比较[J]. 天津医药, 2024, 52(12): 1266-1269.
[4]	刘丹, 万南生, 王杰, 李广生, 谢巍, 田羽, 冯靖. 气管内超声引导纵隔肿瘤激光多点消融操作流程[J]. 天津医药, 2024, 52(1): 80-82.
[5]	李树满, 李建国, 刘立志, 李岩欣, 李权. 胸腔延期置管引流治疗钝性创伤性中等量血胸的临床价值[J]. 天津医药, 2023, 51(2): 213-215.
[6]	平静, 周东华, 朱大江, 田杰, 陈莹, 范菊花. Musashi2在不同分子分型乳腺浸润性导管癌中的表达及临床意义[J]. 天津医药, 2022, 50(9): 907-911.
[7]	张宇, 刘梁生, 马文娟, 韩敏, 朱鹰, 路红. 早期肿块型乳腺浸润性导管癌超声征象与分子分型的相关性研究[J]. 天津医药, 2022, 50(8): 853-858.
[8]	赵紫薇, 陆苏, 吴楠, 张世超, 赵晶, 刘俊田△. 乳腺放射状瘢痕与乳腺癌的临床及超声影像对比研究[J]. 天津医药, 2021, 49(9): 992-995.
[9]	郭振江, 王宁, 张媛媛, 郭伟, 王晶, 王金荣, 崔朝勃△. 利伐沙班预防经外周静脉穿刺中心静脉置管相关上肢静脉血栓疗效探讨#br#[J]. 天津医药, 2021, 49(9): 963-967.
[10]	由万宁, 赖永洁. 主动脉瓣膜间质细胞分化机制研究进展[J]. 天津医药, 2021, 49(7): 778-784.
[11]	王宁, 郭振江, 张媛媛, 郭伟, 崔朝勃. 利伐沙班与低分子肝素治疗中心静脉置入设备相关性上肢深静脉血栓的疗效比较#br#[J]. 天津医药, 2021, 49(4): 432-435.
[12]	张蕾, 杨丽红, 潘叶, 翟文娟, 孙春华, 赵红△. 泪道扩张引流管与一次性使用泪道引流管在泪道不同部位阻塞治疗中的价值#br#[J]. 天津医药, 2021, 49(1): 74-78.
[13]	赵颖, 田秀英, 边希云△, 张婉娴. 早产儿动脉导管未闭的治疗进展[J]. 天津医药, 2021, 49(1): 103-106.
[14]	姜薇, 孙微, 关莹莹, 程小磊. 二维斑点追踪成像技术评价缺血性二尖瓣反流患者PCI 治疗前后乳头肌功能的变化[J]. 天津医药, 2020, 48(2): 124-127.
[15]	曹月诚 , 羡海英 , 石秋林 , 王金星 , 王小祥 , 叶杰 , 陈登峰 . 经房间隔穿刺途径行卵圆孔未闭封堵术患者的临床疗效及预后观察[J]. 天津医药, 2019, 47(9): 971-974.