NICE (2011) HTA including Systematic review: Systematic review: Level II studies: 1 systematic n=2,375 greater than 1 year TAVI vs. standard review (all IV in 7 case series and therapy and TAVI Level II studies: studies)*, 2 level II 30 days in 22 case vs. surgical n=358 and n=699 studies, 1 Level III series implantation study and 6 Level III study: Level II studies: IV studies n=175 maximum of 2.8 Level IV studies: years and 1.4 years n=ranged from 70 (median) to 1,038 Level III study: median of 466 days Level IV studies: ranged from 30 days to a median of 3.7 years Tice (2014) HTA including 2 II studies: Level II studies: 19 II studies: Level II studies†, n=358 and n=699 months and 24 TAVI vs. standard 10 Level III months therapy and TAVI Level III studies: studies‡ and 16 vs. surgical ranged from n=51 Level III studies: Level IV studies§ placement to n=8,536 ranged 1 month to 24 months Level III studies: all Level IV studies: TAVI vs. surgical ranged from n=130 Level IV studies: implantation to n=10,037 ranged from 1 except one TAVI vs. month18 months surgical implantation vs. medical therapy Registries NA 132 to 4,571 events NA generally reported at 30 days and then yearly after that. Maximum of 3 years for the registries identified HTA: Health Technology Assessment; NA: not applicable *Note: given the systematic review is not on Level II studies it does not meet the Level I study classification as prescribed by the NHMRC II studies as included in NICE (2011)lxiii †Same Includes one Level III study which is a meta-analyses ‡ § Includes two Level IV studies which are meta-analyses
NICE (2011) HTA including 1 systematic review (all IV studies)*, 2 level II studies, 1 Level III study and 6 Level IV studies Systematic review: n=2,375 Level II studies: n=358 and n=699 III study: n=175 Level IV studies: n=ranged from 70 to 1,038 Systematic review: greater than 1 year in 7 case series and 30 days in 22 case series Level II studies: maximum of 2.8 years and 1.4 years (median) Level III study: median of 466 days Level IV studies: ranged from 30 days to a median of 3.7 years Level II studies: TAVI vs. standard therapy and TAVI vs. surgical implantation Tice (2014) HTA including 2 Level II studies†, 10 Level III studies‡ and 16 Level IV studies§ II studies: n=358 and n=699 Level III studies: ranged from n=51 to n=8,536 Level IV studies: ranged from n=130 to n=10,037 Level II studies: 19 months and 24 months Level III studies: ranged 1 month to 24 months Level IV studies: ranged from 1 month18 months II studies: TAVI vs. standard therapy and TAVI vs. surgical placement Level III studies: all TAVI vs. surgical implantation except one TAVI vs. surgical implantation vs. medical therapy Registries NA 132 to 4,571 events generally reported at 30 days and then yearly after that. Maximum of 3 years for the registries identified NA HTA: Health Technology Assessment; NA: not applicable *Note: given the systematic review is not on Level II studies it does not meet the Level I study classification as prescribed by the NHMRC †Same II studies as included in NICE (2011)lxiii ‡ Includes one Level III study which is a meta-analyses § Includes two Level IV studies which are meta-analyses