Skip to main content

Table 1 Characteristics of the included studies

From: Systematic review of first-in-human and early phase clinical trials for surgically implantable biological mitral valve substitutes

References

Prosthesis used

Duration

Number of patients

Place of study

Follow up range (years)

Follow up duration (years)

Follow up completeness

Relland [9]

Carpentier-Edwards 3rd generation supra-annular valve (porcine)

4 years 3 months

145

France

NA

7

NA

Jamieson [10]

Carpentier-Edwards 3rd generation supra-annular valve (porcine)

2 years 3 months

259

Canada

NA

NA

98.60%

Jamieson [11]

Medtronic Intact (porcine)

11 years

333

Canada

NA

10

95.30%

Williams [12]

Medtronic Intact (porcine)

3 years

114

South Africa

NA

1.66

NA

Loisance [13]

Sorin Mitroflow (pericardial)

2 years 9 months

52

France

2.9—5.5

3.5

100%

Bortolotti [14]

Medtronic Hancock II (porcine)

4 years 2 months

72

Italy

0.6—4.5

2.1 ± 1.2

100%

Garcia [15]

Labcor-Santiago (pericardial)

8 months

11

Spain

NA

NA

100%

Wheatley [16]

Bioflo (bovine pericardial)

3 years 1 month

31

Scotland

Max:7.47

5.45 ± 1.93

100%

Vermeulen [17]

Medtronic Intact (porcine)

2 years 11 months

438

Worldwide

Max: 5

N.A

NA

Mohr [18]

Quattro (stentless)

NA

52

Germany

0.08—5.41

0.26 ± 0.13

100%

Fradet [19]

Medtronic Mosaic (porcine)

6 years 7 months

366

Worldwide

Max: 6.1

2.5

NA

Hiremath [20]

Dafodil (stented, bovine, pericardial)

12 months

30

India

NA

1

93.33%

Firstenberg [21]

Carpentier-Edwards Perimount (pericardial)

1 year 1 month

69

Worldwide

0.30—2.44

1.62 ± 0.36

100%

Folliguet [22]

Sorin Pericarbon (bovine pericardial)

9 years 2 months

39

France

NA

4.9 ± 2.6

NA

Eichinger [23]

Medtronic Mosaic (porcine)

5 years 3 months

100

Europe

0—6.1

2.6

98%

Masters [24]

Medtronic Hancock II (porcine)

9 years 8 months

138

Canada

NA

8.33

97%

Pomerantz [25]

St Jude Medical Biocor (porcine)

17 years 9 months

546

Brazil

NA

4.35

NA

Frater [26]

Quattro (stentless)

7 years 11 months

175

South Africa, Germany, Saudi Arabia

0—7.5

3.4

91%

Riess [27]

Medtronic Mosaic (porcine)

5 years 8 months

47

USA

Max:10

5.4

70%

Jamieson [28]

St Jude Medical Epic (porcine)

4 years

175

USA

NA

NA

94.80%

Loor [29]

Carpentier-Edwards Perimount Magna (bovine pericardial)

4 years

70

USA

0—5.12

1.3

NA

Celiento [30]

Medtronic Mosaic (porcine)

16 years

100

Italy

Max: 17.7

6 ± 4.6

97%

  1. NB: italic: Older FIM; Bold: FIM; Bolditalic: Early Clinical trials; NA = Not applicable