Table 1

Studies involving new generations of TAVI valves

Device name and valve sizeValve structureDelivery system and access routeClinical evaluation studies
JenaValve (23, 25 and 27 mm for 21–27 mm aortic annuli)Porcine pericardial tissue valve, self-expanding nitinol stentSheathless 32 FrTransapical (transfemoral is under clinical evaluation)JUPITER registry65 (180 patients): 85% overall survival (30 days), 12.5% pacemaker implantation, no major strokes, 1.3% acute MI (30 days), 97.6% mild or absent perivalvular leakage
ACURATE (small 20–23 mm, medium 23–25 mm and large 25–27 mm aortic annuli)Porcine pericardial tissue valve, self-expanding nitinol alloy stentSheathless 28 FrTransapical (transfemoral is under clinical evaluation)ACURATE TA66 (40 patients): 92.5% device success rate, 82.5% survival (6 months), 7.5% pacemaker implantation, 97.5% small perivalvular leakage
ACURATE TF67 (20 patients): 95.6% procedural success, 13% pacemaker implantation, 95% mild or absent perivalvular leakage
Portico SJM (23 and 25 mm)Bovine pericardial tissue valve, self-expanding, nitinol frame, porcine pericardial cuffTransfemoral, transaortic or subclavian: 18 Fr
Transapical: sheathless 24 Fr (currently only transfemoral approved)
Multicenter clinical study68 (102 patients): 30-day mortality, disabling stroke and major vascular complications were 2.9%, 2.9% and 5.9%, respectively. Resheathing and repositioning (23.8%) was successful in all instances, 9.8% pacemaker implantation
Direct Flow Medical (25 and 27 mm)Bovine pericardial tissue valve, two polyester rings filled with polymer solutionTransfemoral, 18 Fr outer diameterDISCOVER trial69 (75 patients): 99% overall survival (30 days), 2.7% major strokes, 4% life-threatening bleeding, 16% pacemaker implantation, 99% mild or absent perivalvular leakage (30 days)
Engager Medtronic (23 and 26 mm for 21–26.5 mm aortic annuli)Bovine pericardial tissue valve, self-expanding, nitinol frame and a polyester skirtTransapical, transaortic access 29 Fr inner diameterEngager European pivotal trial70 (61 patients): all-cause mortality was 9.9% at 30 days and 16.9% at 6 months, no paravalvular regurgitation greater than mild through 6 months, implantation success and valve safety
CoreValve Evolut Medtronic (23 mm)Porcine pericardial tissue valve, self-expanding nitinol frameTransfemoral, transaortic and subclavian, AccuTrak stability layer (18 Fr outer diameter)Valve-in-valve study71 (126 patients): 100% procedural success rate, no deaths or adverse events related to the procedure or device (30 days), 0% pacemaker implantation
Lotus valve Boston Scientific 23 and 27 mmBovine pericardial tissue valve, self-expanding, braided nitinol frameTransfemoral 18 Fr, minimum vascular access diameter 6.0 mm (23 mm valve) or 6.5 mm (27 mm valve)REPRISE II trial72 (120 patients): at 1 year 88.6% patients had no or trivial paravalvular aortic regurgitation, all-cause mortality rate 10.9%, disabling stroke rate 3.4%, disabling bleeding rate 5.9%, with no repeat procedures for valve-related dysfunction and 31.9% pacemaker implantation
Edwards SAPIEN 3 26 mm (20, 23 and 29 mm sizes anticipated)Bovine pericardial tissue valve, balloon expandable cobalt chromium frameTransfemoral (transapical and transaortic under clinical evaluation)
Edwards sheath 14 Fr with dynamic expansion mechanism
SAPIEN 3 study73 (15 patients): 100% procedural success rate, 6.7% pacemaker implantation, no deaths/strokes/cardiovascular complications, 100% mild or absent perivalvular leakage (30 days)
Edwards CENTERA 23, 26 and 29 mmBovine pericardial tissue valve, self-expanding nitinol frame with polyethylene terephthalate skirtTransfemoral and subclavian access, Edwards sheath 14 Fr with dynamic mechanism and motorised handleFirst device (15 patients): 100% procedural success rate, 27% pacemaker implantation, 92% mild or absent perivalvular leakage (30 days)74
New configuration device (14 patients): 100% procedural success rate, 0% pacemaker implantation, 100% mild or absent perivalvular leakage75
Helio Edwards 25 mmSelf-expanding nitinol stent encased in polyethylene terephthalateTransfemoral Edwards sheath 16 FrHelio feasibility trial76 (4 patients): 100% implantation success, 100% freedom from all-cause mortality (30 days), 2 patients reached 12-month follow-up with no residual aortic regurgitation
  • TA, transapical; TAVI, transcatheter aortic valve implantation; TF, transfemoral.