Table 1 Study characteristics, patient demographics and postoperative clinical outcomes
Reference | Study design | Cardiovascular profile | TAVR intervention | Patient Outcomes / Complications | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
Complication / Study aim(s) | Recruitment [Retrospective (R)/ Prospective (P)] | Number of participants | Age range | Gender (%): male(M) / female (F) | AS Severity | Surgical risk score | In vivo | In 3D model | ||
Schmauss et al., 2012 [39] | CAO | R | 1 | 70 | M: 100% | Severe—very severe | N/A | 26-mm B-E Sapien | 26-mm B-E Sapien | Death due to CAO |
Ripley et al., 2016 [32] | PVL | R | 16 | 69–91 | F: 31% M: 69% | N/A | N/A | B-E Sapien / Sapien 3 Re-ballooning on 6 occasions | 3D printed closed based valve, valve diameter same as in vivo | 7 mild PVL, 2 Moderate PVL, 7 no PVL |
Fujita et al., 2016 [43] | Risk of injury to prosthetic mitral valve | P | 1 | 82 | F: 100% | Severe | STS—7.6% | 26-mm B-E Sapien XT, delivered via the same diameter guidewire as in vitro | Guidewire with small curve: 42 mm | Uneventful TAVI |
Qian et al., 2017 [37] | PVL | R | 18 | 56–95 | F: 56% M: 44% | N/A | N/A | First and second-generation S-E CoreValve, Re-ballooning in 7 cases | Same as in vivo | 6 none, 5 trace-to-mild, 6 moderate, 1 moderate-severe PVL. Post-ballooning reduced significant PVL in 3 cases |
Hosny et al., 2018 [36] | Prediction of valve size used in vivo, PVL | R | 30 | 71–92 | F: 57% M: 43% | N/A | N/A | B-E Sapien or Sapien XT, S-E CoreValve or Core Evolut R, S-E St. Jude Portico | 3D printed valve sizer based on Sapien XT specifications | 15 with at least mild PVL and 15 with no PVL |
Tanaka et al., 2018 [33] | PVL | R | 6 | 68–88 | F: 83% M: 17% | Severe | N/A | 23-mm B-E Sapien XT, ad hoc post-dilation on 2 cases | 23-mm B-E Sapien XT, filling volume of deployment balloon and ad hoc post-dilation as in vivo | 3 mild, 1 mild-moderate, 1 moderate,1 moderate-severe PVL 1 died 1.3 years post-TAVR due to considerate amount of PVL due to undersized valve |
Yaku et al., 2018 [42] | Safety of TAVR for a patient with high risk of injury to aorta | P | 1 | 90 | F: 100% | Severe | N/A | 23-mm B-E Sapien 3 | 26-mm B-E Sapien 3, 29-mm S-E CoreValve Evolut R | Uneventful TAVR Post-op CT on day 7: no changes in the intramural haematoma. Patient doing well at 6Â months |
Hatoum et al., 2019 [40] | CAO | R | 1 | 80 | M: 100% | Severe—very severe | N/A | 29-mm B-E Sapien 3 | 26, 29-mm B-E Sapien 3, 31-mm S-E CoreValve implanted in normal, supra- and sub-annular depth | Left CAO |
Zhang et al., 2019 [38] | CAO and aortic annulus rapture | R | 4 | N/A | N/A | N/A | N/A | B-E Sapien XT | Non-valve stent model consistent with B-E Sapien XT size and radial force support specifications. Balloon valvuloplasty and balloon dilation performed as in vivo | 2 died of CAO, 2 died of aortic annular rupture |
Haghiashtiani et al., 2020 [41] | New-onset conduction disturbances | R | 1 | N/A | N/A | N/A | N/A | 29-mm S-E CoreValve Evolut R at intermediate height | 29-mm S-E CoreValve Evolut R at intermediate, shallow and deep height and 26-, 29-, 31-mm S-E Evolut R at intermediate height | One patient with new-onset conduction disturbance |
Reiff et al., 2020 [35] | PVL | R | 20 | 74–84 | F: 30% M: 70% | N/A | STS—6.6% | 23, 26-mm B-E Sapien XT | Same Implantation depth and valve type as in vivo. Nominal volume for balloon expansion | 10 no PVL, 9 mild, and 1 moderate PVL |
Thorburn et al., 2020 [34] | PVL | R | 5 | 68–87 | F: 20% M: 80% | N/A | N/A | B-E Sapien 3 | Same valve type, size and implantation depth as in vivo | All patients had either none or trivial PVL |
Redondo et al., 2021 [44] | Alignment of native and TAV commissures | P | 3 | N/A | N/A | Severe | N/A | S-E ACURATE neo valve as in vitro | S-E ACURATE neo valve | No commissural misalignment or coronary ostia obstruction reported |