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Journal of Peking University (Health Sciences) ›› 2020, Vol. 52 ›› Issue (3): 547-556. doi: 10.19723/j.issn.1671-167X.2020.03.023

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Safety of biological valves for aortic valve replacement: A systematic review and meta-analysis

Bao-qi ZENG1,Shu-qing YU1,Yao CHEN1,Wei ZHAI2,Bin LIU2,Si-yan ZHAN1,Feng SUN1,△()   

  1. 1. Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China
    2. Beijing Center for ADR Monitoring, Beijing 100024, China
  • Received:2020-02-13 Online:2020-06-18 Published:2020-06-30
  • Contact: Feng SUN E-mail:sunfeng@bjmu.edu.cn
  • Supported by:
    National Natural Science Foundation of China(71673003)

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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

CLC Number: 

  • R654.2

Figure 1

Flow chart of studies considered for inclusion and exclusion CNKI, China national knowledge infrastructure database; VIP, Chinese scientific and technical journals database; SinoMed, Chinese biomedical literature database; CENTRAL, Cochrane Central Registry of Controlled Trials; MVR, mitral valve replacement."

Table 1

Study characteristics and patient demographics of 57 included study groups"

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

Table 2

Meta-analysis results of biological aortic valves"

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

Table 3

Subgroup analysis of stented valves"

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

Figure 2

Meta-regression for late mortality"

Figure 3

Funnel plot for late mortality"

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