Table 1.
Design and HrQoL outcomes reported in TAVR-related studies.
| Study/Year/ Reference | Number of pts. [n] | Mean age [years ± SD] | Mean logEuroScore [% ± SD] | Follow-up [months ± SD] | HrQoL Instrument | Control Group | Valve/Access Site | Main Findings | |
|---|---|---|---|---|---|---|---|---|---|
| Ussia et al. 2009, [43] | 57/30 | 81.7 ± 4.7 | 25.3 ± 8.1 | 5 | SF-12 | no | Medtronic CoreValve/TF | Mean NYHA: 2.7±0.6 to 1.8±0.5 (p<0.001); Improved (p<0.001) PCS and MCS, return to population norms, greatest change in PF | |
| Gotzmann et al. 2010, [45] | 44 | 79.1 ± 7 | 18.3 ± 12.4 | 1 | MLHFQ | no | Medtronic CoreValve/TF, SC | NYHA III/IV: 90% vs. 16% (p<0.001); 25%increase in 6-minute walk time (p<0.005); significant improvement of MLHFQ overall score 44± 19.1 vs. 28±17.5 (p <0.001); NTpro:BNP: 725 ± 837 pg/ml vs. 423±320 pg/ml (p<0.005) | |
| Krane et al. 2010, [47] | 99/86 | 81 ± 6 | 20 | 3 | SF-36 | no | Edwards SAPIEN/TA Medtronic CoreValve/TF | Mean NYHA: 3.1±0.25 vs. 1.7±0.62 (p<0.001); More class I/II at 3 months (NYHA functional class III/IV from 98%to 2% at 3 months) Improved physical health and vitality at 3 months (all p<0.01). No change mental health. | |
| Bekeredjian et al. 2010, [49] | 87/80 | 86 ± 2.9 | 24 ± 15.1 | 6 | SF-36 | no | Medtronic CoreValve/TF | Mean NYHA: 3.1±0.5 vs. 1.9±0.6 (p<0.0001); Significant improvements in all 8 health components, PCS and MCS, greatest change in PF (190% increase); NTpro-BNP: 5,8 ± 8,0 ng/L vs. 1,6 ± 3,7 ng/L p < 0.0001). | |
| LefÈvre et al. EU PARTNER 2011, [50] | 130/107 | 82.1 ± 5.5 | 30.0 ± 13.7 | 1/6/12 | KCCQ, EQ-5D | no | Edwards SAPIEN/TF, TA | NYHA III/IV: 84.6% vs. 10.4%,. Of the TF patients, KCCQ score improved in 72.7% and EQ-5D in 51.6%. Among TA patients, KCCQ score improved in 73.9% and EQ-5D in 60.0%. | |
| GonÇalves et al. 2011, [51] | 74/53 | 81.6 ± 8 | 19.3 ± 9.9 | 6.5 | MLHFQ | no | Edwards SAPIEN/TA Medtronic CoreValve/TF | Mean NYHA: 2.9±0.4 to 1.4±0.7 (p<0.001); Significant improvement in MLHFQ scores [overall (37.0±14.7 vs. 14.4±10.1; p<0.001)] | |
| Gotzmann et al. 2011, [46] | 51 | 78 ± 6.6 | 19.6 ± 11.3 | 1/12 | MLHFQ | no | Medtronic CoreValve/TF | NYHA III/IV: 94%, 18%, to 26% (p<0.001); 6MW-Test: 185 ± 106 vs. 248 ± 119 vs. 266 ± 118 (p<0.001); significantly improved MLHFQ score 39.6 ± 19 vs. 26.1 ± 18, p <0.001); NTpro-BNP: 642 ± 634 vs. 323 ± 266 pg/ml (p <0.001) | |
| Georgiadou et al. 2011, [52] | 36 | 80.5 ± 5.9 | 29.7 ± 13.7 | 11.3 ± 4.9 | SF-36, SF-12 | no | Medtronic CoreValve/TF, SC | Mean NYHA: 3 ± 0.7 vs 1.2 ± 0.4, (p<0 .001). significant improvement in all domains and summary scale scores, higher than general population norms | |
| Ussia et al. 2011, [44] | 143/138 | 81.0±4.6 | 23.4 ± 14.7 | 5/12 | SF-12 | no | Edwards SAPIEN/TF Medtronic CoreValve/TF | NYHA III/IV: 64.3% to 4.2% (p<0.001); marked mid-term improvement in functional status and physical and mental health; PCS 28.3 vs. 44.0 at five vs. 42.4 (p<0.001). MCS 38.0 vs. 47.3 vs. 48.2 (p<0.001). | |
| Reynolds et al. PARTNER B 2011, [41] |
179 | 83 ± 9 | 11.2± 5.8 (STS-Score) | 1/6/12 | KCCQ, SF-12 | Medical n=179 | Edwards SAPIEN/TF,TA | Improved 6-MW-Test pre/post at 1 year; no change in no-TAVR group KCCQ; Marked improvement with TAVR at 1 year; improvement in physical and mental HRQOL with TAVR; fewer rehospitalizations at 1 year | |
| Fairbairne et al. 2012, [53] | 102 | 80 ± 0.6 | 20 ± 13 | 1/6/12 | SF-12 EQ-5D, SF-6D | no | Medtronic CoreValve/TF, SC | HRQOL significantly improved over 1 year (SF-12 PCS p = 0.02; EQ-5D p = 0.02; SF-6D p=0.03); similar to age-adjusted U.S. population norms; greatest change from baseline to 30 days (p < 0.001), with further significant improvements to 6 months (p < 0.01). | |
| Amonn et al. 2012, [54] |
144 | 79.7 ± 9.2 | 26.5 ± 16.1 | 15 ± 10 | SF-36 | SAVR n=93 | Edwards SAPIEN/TA | Similar health metascore in both groups (65.6 ± 19 vs. 68.8 ± 22, P = 0.29), while a significant difference was observed in the physical health metascore (49.7 ± 21 vs. 62.0 ± 21, P = 0.015). After adjustment for baseline characteristics, this difference disappeared. | |
| Krane et al. 2012, [48] | 186/106 | 81 ± 6.8 | 19.74 ± 12.1 | 3/12 | SF-36 | no | Edwards SAPIEN/TA Medtronic CoreValve/TF | Mean NYHA: 3.1 vs. 1.9 vs. 2.0 (p<0.001) significant increase in physical scores with a minor change in mental scores, both comparable with age-matched standard population; high degree of independence; 88.6% reaffirmation to undergo TAVR again standard population. | |
| Reynolds et al. 2012, [42] PARTNER A |
328 | 83.8 ± 6.8 (TAVR-TF) 82.6 ± 7.0 (TAVR-TA) |
11.8 ± 3.2 (STS-Score) | 1/6/12 | KCCQ, EQ-5D SF-12 | SAVR n=216 (TAVR-TF) n=84 (TAVR-TA) | Edwards SAPIEN/TF, TA | Substantial health status improvment between baseline and 1 year after either TAVR or SAVR. TAVR via the transfemoral, but not the transapical route, was associated with a short-term advantage compared with surgery. KCCQ difference TAVR vs. SAVR at 1 month 9.9 (p>0.001). | |
| Taramasso et al. 2012, [55] | 100 | 79.7± 6.1 | 27.9±15.9 | 12/24 | SF-36, MLHFQ | no | Edwards SAPIEN/TF, TA Medtronic CoreValve/TF SC, TAx | Significant improvement in functional status sustained up to two years, 20-point increase in the SF-36 PCS score, 34-point decrease in the MLHFQ | |
| Stortecky et al. 2012, [56] |
176/62 | 83±5 | 22 ± 13 | 9 | SF-36 | no | Medtronic CoreValve/TF Edwards SAPIEN/TF | Mean NYHA: 2.6±0.8 to 1.4±0.6 (p<0.0001). improvments in all components of physical and mental health | |