主动脉瓣生物瓣膜安全性的系统评价与meta分析

doi:10.19723/j.issn.1671-167X.2020.03.023

摘要/Abstract

摘要：

目的采用系统评价和meta分析的方法评价主动脉瓣置换术中使用生物瓣膜的远期安全性结局。方法计算机系统检索Medline、Embase、Web of Science、CENTRAL、ClinicalTrial.gov、SinoMed、中国知网、维普和万方数据库在2000年1月1日至2019年1月26日期间发表的随机临床试验、非随机临床试验、队列研究和病例系列研究,纳入标准还包括使用生物瓣膜进行主动脉瓣膜置换术、平均随访时间≥5年、报告了相关安全性结局等。提取研究特征和相关数据,使用Stata 14.0进行meta分析。结果最终纳入53篇文献共57个研究组,包含47 803名患者。(1)全因死亡率为6.33/100人年(95%CI:5.85~6.84),亚组分析结果显示,猪瓣膜和牛心包瓣膜的死亡率分别为5.69/100人年(95%CI:5.05~6.41)和7.29/100人年(95%CI:6.53~8.13);有支架和无支架瓣膜的死亡率分别为6.69/100人年(95%CI:6.12~7.30)和5.21/100人年(95%CI:4.43~6.14)。(2)血栓栓塞的发生率为1.16/100人年(95%CI:0.96~1.40),心脏起搏器植入率为1.08/100人年(95%CI:0.75~1.54),再手术率为0.77/100人年(95%CI:0.65~0.91),脑卒中的发生率为0.74/100人年(95%CI:0.51~1.06),结构性瓣膜退化的发生率为 0.73/100人年(95%CI:0.59~0.91),大出血的发生率为0.52/100人年(95%CI:0.41~0.65),心内膜炎的发生率为0.38/100人年(95%CI:0.33~0.44),非结构性瓣膜退化的发生率为0.20/100人年(95%CI:0.13~0.31)。结论生物瓣膜的全因死亡率为6.33/100人年,血栓栓塞、心脏起搏器植入、再手术、脑卒中和结构性瓣膜退化是主要的远期并发症。

关键词: 主动脉瓣置换, 生物瓣膜, 系统评价, Meta分析

Abstract:

Objective: To provide a comprehensive and contemporary overview of the long-term safety outcomes after aortic valve replacements (AVR) with conventional biological heart valve (stented or stentless).Methods: English databases (Medline, Embase, Web of Science, CENTRAL, and ClinicalTrial.gov) and Chinese databases (CNKI, VIP, WanFang, and SinoMed) were searched systemically from January 1, 2000 to January 26, 2019. Eligible randomized controlled trials, non-randomized clinical trials, cohort studies (retrospective or prospective), and unselected case series were included. Strict screening of the obtained literature was conducted to extract relevant data by two reviewers. Other inclusion criteria were studied reporting on outcomes of AVR with biological valves (stented or stentless), with or without coronary artery bypass grafting (CABG) or valve repair procedure, with mean follow-up length equal to or longer than 5 years. We excluded studies that reported only a specific patient group (e.g., patients with renal failure, or pregnancy), without the report of biological valve type, or with study population size less than 100. The meta-analysis was performed using Stata 14.0 software.Results: In this study, 53 papers (in total 57 study groups) involving 47 803 patients were included. (1) The all-cause mortality was 6.33/100 patient-years (95%CI: 5.85-6.84). Subgroup analysis showed that the mortality rates of porcine and bovine valve prostheses were 5.69/100 patient-years (95%CI: 5.05-6.41) and 7.29/100 patient-years (95%CI: 6.53-8.13), respectively. The all-cause mortality rates for stented and stentless valve were 6.69/100 patient-years (95%CI: 6.12-7.30) and 5.21/100 patient-years (95%CI: 4.43-6.14), respectively. (2) The incidence rate of thromboembolism was 1.16/100 patient-years (95%CI: 0.96-1.40), the incidence rate of permanent pacemaker (PPM) implantation was 1.08/100 patient-years (95%CI: 0.75-1.54), the incidence rate of stroke was 0.74/100 patient-years (95%CI: 0.51-1.06), the incidence rate of structural valve dysfunction (SVD) was 0.73/100 patient-years (95%CI: 0.59-0.91), the incidence rate of major bleeding was 0.52/100 patient-years (95%CI: 0.41-0.65), the incidence rate of endocarditis was 0.38/100 patient-years (95%CI: 0.33-0.44), and the incidence rate of non-structural valve dysfunction (NSVD) was 0.20/100 patient-years (95%CI: 0.13-0.31). The total reoperation rate for biological aortic valve was 0.77/100 patient-years (95%CI: 0.65-0.91), and the SVD related reoperation rate was 0.46/100 patient-years (95%CI: 0.36-0.58).Conclusion: The all-cause mortality for conventional biological AVR was 6.33/100 patient-years. Thromboembolism, PPM implantation, reoperation, stroke, and SVD were major long term complications.

Key words: Aortic valve replacement, Bioprosthesis, Systematic review, Meta-analysis

中图分类号:

R654.2

曾保起,于树青,陈瑶,翟伟,刘斌,詹思延,孙凤. 主动脉瓣生物瓣膜安全性的系统评价与meta分析[J]. 北京大学学报（医学版）, 2020, 52(3): 547-556.

Bao-qi ZENG,Shu-qing YU,Yao CHEN,Wei ZHAI,Bin LIU,Si-yan ZHAN,Feng SUN. Safety of biological valves for aortic valve replacement: A systematic review and meta-analysis[J]. Journal of Peking University (Health Sciences), 2020, 52(3): 547-556.

图/表 6

图1

表1

主动脉瓣生物瓣膜纳入的57个研究组的基本特征"

First author		Year of publication		Country		Implantation period		Follow-up/years		CABG/%		Mean age (range)/years		Female/%		Patient no.		Type of valve	Quality assessment
Aasbjerg- $1 [9] *$		2019		Denmark		2000-2014		8.4		58		75		48		1 241		Sorin Mitroflow	7
Aasbjerg- $2 [9] *$		2019		Denmark		2000-2014		5.1		62		74		35		3 212		Edwards Perimount	7
Accola^[10]		2008		United States		1989-2003		6.0		55		75 (65-89)		33		398		Edwards Perimount	5
Albert^[11]		2010		Germany		1996-2006		7.7		33		73		48		815		Medtronic Freestyle S	6
Amabile^[12]		2014		France		1997-2004		5.9		24		75		48		500		Medtronic Freestyle S	7
Andreas- $1 [13] *$		2015		Australia		2002-2008		6.0		0		73		54		295		Edwards Perimount	5
Andreas- $2 [13] *$		2015		Australia		2002-2008		6.0		0		74		57		163		Medtronic Mosaic	5
Anselmi^[14]		2014		France		1994-2004		8.5		15		75		-		1 005		Medtronic Mosaic	6
Bach^[15]		2014		North America/Europe		1992-2005		7.6		39		72 (36-91)		45		725		Medtronic Freestyle S	7
Benhameid^[16]		2008		Canada/Europe		1982-1992		8.6		24		70 (60-94)		-		161		Sorin Mitroflow	7
Biglioli^[17]		2004		Italy		1984-2000		6.0		23		67 (19-83)		48		327		Edwards Perimount	6
Bottio^[18]		2004		Italy		1992-2001		5.0		22		75 (45-91)		50		258		SJM Biocor	7
Bourguignon^[19]		2015		France		1984-2008		6.7		23		71 (16-91)		32		2 659		Edwards Perimount	7
Celiento^[20]		2018		Italy		1995-2016		8.2		15		74 (40-85)		24		254		Medtronic Mosaic	6
Chan^[21]		2010		Canada		1990-2007		5.6		52		73		30		1 021		Medtronic Hancock	7
Christ^[22]		2014		Germany		1993-2001		8.5		-		53		18		120		Edwards Prima Plus S	6
Corbineau^[23]		2001		France		1987-1990		7.2		0		72 (28-89)		34		188		Medtronic Mosaic	5
David^[25]		2008		Canada		1991-2004		7.7		32		65 (22-84)		32		357		SJM Toronto S	5
David^[24]		2010		Canada		1982-2004		12.4		50		67 (19-94)		24		1 134		Medtronic Hancock	7
de la Fuente^[26]		2003		Spain		1988-2000		6.0		0		69 (30-81)		-		124		Edwards Porcine	6
Dellgren^[27]		2002		Sweden		1990-2000		5.5		31		79 (61-89)		66		112		SJM Biocor S	6
Desai^[28]		2004		Canada		1992-2000		5.8		35		65 (33-82)		35		200		SJM Toronto S	5
Flameng^[29]		2006		Belgium		1985-2003		6.1		47		73 (57-87)		50		506		Edwards Perimount	5
Forcillo^[30]		2013		Canada		1981-2011		6.0		42		71 (18-90)		40		2 405		Edwards Perimount	6
Gansera^[31]		2014		Germany		1993-2007		6.1		0		79 (31-91)^b		54		272		Medtronic Mosaic	6
Gao^[32]		2004		United States		1974 -1996		6.4		41		74 (23-95)		38		518		Edwards Porcine	7
Glaser^[33]		2014		Sweden		2002-2010		6.9		53		76		40		355		Medtronic Mosaic	6
Grunkemeier^[34]		2012		United States		1976-1994		7.4		39		74		38		469		Edwards Porcine	7
Guenzinger^[35]		2015		Germany		1985-1996		8.4		38		73		48		455		SJM Biocor	6
Jamieson^[36]		2001		Canada		1986-1996		6.2		-		67 (9-91)		41		836		Medtronic Mosaic	7
First author	Year of publication		Country		Implantation period		Follow-up/years		CABG/%		Mean age (range)/years		Female/%		Patient no.		Type of valve		Quality assessment
Jamieson^[38]	2009		Canada/Germany		1992-2003		5.4		45		76 (53-91)		70		381		Sorin Mitroflow		7
Jamieson^[37]	2005		Canada		1981-1999		7.8		43		69 (19-89)		31		1 823		Edwards Porcine		6
Johnston^[39]	2015		United States		1982-2011		5.8		48		71 (18-91)		34		12 569		Edwards Perimount		7
Kurlansky^[40]	2007		United States		1976-1999		5.3		0		77 (65-91)		43		438		Edwards Porcine		5
Lootens^[41]	2017		Belgium		2003-2012		6.6		56		76		45		467		Sorin Mitroflow		6
Luciani^[42]	2001		Italy		1992-1996		5.8		25		70 (26-83)		55		106		SJM Biocor S		5
McClure^[43]	2010		United States		1991-2002		6.0		44		74 (19-95)		46		1 000		Edwards Perimount		6
Minakata^[44]	2014		Japan		1986-2001		8.2		20		72 (21-89)		47		574		Edwards Perimount		6
Minami^[45]	2005		Germany		1985-2004		5.5		54		76 (16-92)		70		1 516		Sorin Mitroflow		6
Mohammedi^[46]	2014		Canada		1993-2013		10.3		33		68		44		531		Medtronic Freestyle S		7
Myken^[47]	2009		Sweden		1983-2003		6.0		42		71 (16-88)		37		1 518		SJM Biocor		6
Nishida^[48]	2014		Japan		1981-2013		5.8		17		70		36		313		Edwards Perimount		6
Pavoni^[49]	2007		Italy		1994-2004		5.4		28		72		56		185		Cryolife O’Brien S		5
Kappetein^[50]	2007		North America/Europe		1992-2001		6.2		39		72 (36-92)		45		725		Medtronic Freestyle S		4
Repossini^[51]	2016		Europe		2004-2009		6.9		19		75		43		565		Sorin Freedom Solo S		7
Riess^[52]	2018		Europe/Canada		1994-2000		8.8		-		70		34		797		Medtronic Mosaic		8
Rizzoli^[53]	2006		Italy		1983-2002		6.4		29		68		42		809		Medtronic Hancock		7
Ruggieri^[54]	2012		France		1983-1994		13.7		15		74		49		1 002		Edwards Porcine		7
Sj?gren^[55]	2006		Sweden		1990-1993		6.2		49		80 (75-91)		61		152		Sorin Mitroflow		5
Sponga^[56]	2017		Italy		2004-2019		6.0		-		76		71		106		Sorin Freedom Solo S		6
Stanger^[57]	2015		Switzerland		2005-2009		5.9		40		74 (46-87)		46		149		Sorin Freedom Solo S		6
Wang^[58]	2016		China		2002-2009		8.7		12		53		39		153		Medtronic Hancock		5
Webb- $1 [59] *$	2018		United Kingdom		2002-2008		7.0		48		75		40		216		Medtronic Mosaic		5
Webb- $2 [59] *$	2018		United Kingdom		2002-2008		7.2		44		75		37		806		Edwards Perimount		5
Wilbring^[60]	2013		Germany		1998-2004		7.2		0		75 (55-89)		91		148		Sorin Mitroflow		5
Zibdeh- $1 [61] *$	2018		United Kingdom		2001-2005		9.0		48		75 (40-91)		46		191		Edwards Porcine		6
Zibdeh- $2 [61] *$	2018		United Kingdom		2001-2005		9.0		52		74 (51-91)		40		203		Medtronic Mosaic		6

表1

表2

表3

图2

图3

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Items	Total	n	Stented valve	n	Stentless valve	n	Porcine valve	n	Pericardial valve	n
Number of study	56		43		13		34		22
Number of patients	47 803		43 332		4 471		17 853		29 950
Mean follow-up/years	6.7		6.7		7.3		7.8		6.1
Mean age/years	71.8		71.9		71.1		71.1		72.3
Female/%	39.0		38.3		45.0		38.9		39.0
CABG/%	40.1		41.1		30.7		32.3		44.8
Early mortality/%^*	4.96 (4.42-5.54)	51	5.37 (4.76-6.01)	39	3.48 (2.45-4.67)	12	5.06 (4.34-5.83)	33	4.80 (3.96-5.71)	18
Late mortality/100 patient-years^*	6.33 (5.85-6.84)	54	6.69 (6.12-7.30)	41	5.21 (4.43-6.14)	13	5.69 (5.05-6.41)	33	7.29 (6.53-8.13)	21
Stroke/100 patient-years^*	0.74 (0.51-1.06)	10	0.71 (0.40-1.27)	6	0.73 (0.57-0.92)	4	0.92 (0.61-1.39)	5	0.50 (0.23-1.08)	5
Thromboembolism/100 patient-years^*	1.16 (0.96-1.40)	37	1.16 (0.94-1.42)	29	1.14 (0.69-1.88)	8	1.35 (1.11-1.63)	24	0.89 (0.68-1.17)	13
Major bleeding/100 patient-years^*	0.52 (0.41-0.65)	31	0.50 (0.39-0.66)	23	0.62 (0.41-0.91)	8	0.56 (0.43-0.75)	20	0.46 (0.32-0.67)	11
PPM/100 patient-years^*	1.08 (0.75-1.54)	5
SVD/100 patient-years^*	0.73 (0.59-0.91)	33	0.64 (0.52-0.77)	23	1.07 (0.64-1.80)	10	0.63 (0.47-0.85)	21	0.89 (0.64-1.25)	12
NSVD/100 patient-years^*	0.20 (0.13-0.31)	20	0.17 (0.11-0.27)	16	0.43 (0.16-1.11)	4	0.25 (0.16-0.39)	15	0.10 (0.03-0.31)	5
Endocarditis/100 patient-years^*	0.38 (0.33-0.44)	34	0.34 (0.29-0.41)	26	0.52 (0.42-0.65)	8	0.35 (0.29-0.43)	22	0.42 (0.33-0.54)	12
Reoperation/100 patient-years^*	0.77 (0.65-0.91)	48	0.67 (0.56-0.80)	36	1.21 (0.92-1.60)	12	0.81 (0.67-0.98)	30	0.70 (0.53-0.92)	19
Reoperation for SVD/100 patient-years^*	0.46 (0.36-0.58)	38	0.35 (0.27-0.47)	27	0.85 (0.60-1.20)	11	0.53 (0.41-0.67)	26	0.37 (0.23-0.60)	12

Items	Medtronic Mosaic	n	Medtronic Hancock	n	Edwards Perimount	n	Edwards Porcine	n	Sorin Mitroflow	n	SJM Biocor	n
Number of study	10		4		12		7		7		3
Number of patients	4 289		3 117		25 064		4 565		4 066		2 231
Mean follow-up/years	7.6		8.4		5.9		8.7		6.7		6.4
Mean age/years	72.3		68.5		71.7		72.2		75.6		71.6
Female/%	39.4		31.3		36.1		38.6		55.2		40.4
CABG/%	22.1		43.5		44.5		31.0		51.2		38.8
Early mortality/%^*	5.03 (3.95-6.23)	10	4.65 (3.67-5.74)	4	4.78 (3.63-6.07)	9	6.94 (4.94-9.24)	7	6.02 (5.07-7.04)	6	5.20 (4.31-6.17)	3
Late mortality/100 patient-years^*	5.87 (5.08-6.79)	9	3.80 (2.94-4.92)	4	6.50 (5.88-7.19)	11	7.71 (6.06-9.8)	7	9.56 (8.24-11.1)	7	7.12 (5.17-9.81)	3
Thromboembolism/100 patient-years^*	1.24 (0.81-1.89)	8	1.08 (0.77-1.50)	2	0.79 (0.57-1.09)	8	1.68 (1.14-2.48)	5	1.31 (0.62-2.80)	3	1.61 (1.12-2.32)	3
Major bleeding/100 patient-years^*	0.35 (0.18-0.70)	7	0.38 (0.25-0.58)	2	0.40 (0.22-0.72)	6	1.02 (0.28-3.72)	2	0.57 (0.25-1.28)	3	0.80 (0.65-0.98)	3
SVD/100 patient-years^*	0.54 (0.32-0.90)	6	0.53 (0.34-0.83)	2	0.50 (0.31-0.80)	5	0.68 (0.43-1.07)	4	1.20 (0.85-1.69)	4	0.48 (0.18-1.26)	2
NSVD/100 patient-years^*	0.19 (0.07-0.51)	6	0.03 (0.01-0.08)	1	0.06 (0.04-0.11)	2	0.26 (0.17-0.38)	3	0.23 (0.05-1.05)	2	0.40 (0.21-0.76)	2
Endocarditis/100 patient-years^*	0.32 (0.18-0.54)	7	0.31 (0.20-0.46)	3	0.33 (0.27-0.41)	6	0.28 (0.20-0.39)	5	0.54 (0.35-0.85)	3	0.36 (0.12-1.11)	2
Reoperation/100 patient-years^*	0.51 (0.31-0.84)	9	0.76 (0.64-0.90)	2	0.52 (0.38-0.72)	10	0.64 (0.41-1.01)	7	1.11 (0.78-1.60)	6	1.07 (0.75-1.53)	3