Table 3.
Characteristics of the included in-vivo studies for mitral bioprosthesis pre-clinical evaluation.
Author, Year | Device | Cusp | Size of the New Prosthesis | ΔP (mmHg) | Number | Survival | D/T | Tx | Et | ST | C | Hx |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Collatusso [11] | S | 3 | 23mm | 10±2 | 16 | 8 | 8 | - | - | 0.5% glut | 2 | Macro |
Daebritz [12] | S | 2 | 29mm | 8.4±5.3 | 14 | 14 | 0 | 1 | - | - | 6 | Macro |
Flameng 2015 [13] | S | 3 | 25mm | 3.9±1.6 | 45 | 31 | 14 | - | 1 | 100% EO | - | H&E, VK |
Fukamachi [14] | S | 3 | 25mm, 27mm | - | 03 | NA | - | - | - | - | - | Macro |
Hassoulas [15,16] | S | 3 | 21mm | 9.73±4.93 | 37 | 33 | 4 | - | 0 | 0.2-0.4% glut | 4 | Nil |
Keeling [17] | SL | 3 | - | - | 02 | NA | - | - | - | - | - | Macro |
Navia [18] | SL | 2 | - | 2.1±1.2 | 10 | NA | - | - | - | 0.65% glut | - | - |
Paravicini [19] | S | 3 | 23mm | - | 09 | 9 | 0 | - | - | 0.3% glut | 0 | Macro |
Shemin [20] | S | 1 | 23mm | 2.4±0.3 | 09 | - | - | 0 | 2 | Chemically treated | 4 | H&E, VK |
Spy [21] | SL | 3 | Sh: 25mm D: 21mm |
Sh:2.51 [1.8-3.8] D:5.2 [5-5.5] |
18 | Sh:7 D:4 |
Sh:2 D:2 |
Sh:0 D:2 |
Sh:1 D:1 |
- | Sh:4 D:0 |
H&E, VK |
Thiene [22] | S | 3 | 25,27,29 mm | - | 22 | 11 | 11 | - | 2 | 0.5% glut | 4 | H&E, VK |
Wheatley [23] | S | 3 | 24mm | 3.0±0.95 | 14 | 6 | 8 | - | - | - | - | H&E, VK, SR |
Abbreviations: S=Stented; SL=Stentless; Tx= Throbmosis; D/T= Death/Termination; Et= Endocarditis; ST= Sterilization; C= Calcification; Sh= Sheep; NA= Not applicable; Glut= Gluteraldehyde; EO= Ethylene oxide; Hx= Histology; H&E= Hematoxylin and eosin; VK= Von Kossa; SR= Sirius Red; Macro= Macroscopic examination.