Relevant safety outcomes are displayed in Table 3, and additional outcomes in Supplementary Material, Table S3. Notably, only SAVI-2 outcomes were categorized by VARC-2 criteria. In general, outcomes were similar between SAVI-1 and SAVI-2. Mortality at 30 days was 6.4% [95% CI: 3.3–9.4] for SAVI-1 and 7.2% [95% CI:3.9–10.4] for SAVI-2, and at 1 year 18.9% [95% CI:13.9–23.7] and 20.8% [95% CI:15.6–25.8] respectively, P = 0.64 (Fig. 4).
Figure 4: All-cause mortality per Kaplan–Meier estimate.
Table 3: Kaplan–Meier estimates of relevant clinical outcomes at 30 days and 1 year
SAVI-1a SAVI-2 Total HR
30 days
  Mortality 16 (6.4) [3.3–9.4] 18 (7.2) [3.9–10.4] 34 (6.8) [4.6–9.0] 1.12 (0.57:2.2)
   Cardiovascular 5 (2.0) [0.3–3.8] 9 (3.6) [1.3–5.9] 14 (2.8) [1.4–4.3] 1.80 (0.60:5.37)
   Non-cardiovascular 11 (4.5) [1.9–7.0] 9 (3.7) [1.3–6.0] 20 (4.1) [2.3–5.8] 0.82 (0.34:2.00)
  Strokeb 7 (2.9) [0.8–4.9] 4 (1.6) [0.0–3.2] 11 (2.2) [0.9–3.5] 0.57 (0.17:1.95)
  Myocardial infarction 1 (0.4) [0.0–2.0] 1 (0.4) [0.0–1.2] 2 (0.4) [0.0–1.0] 1.00 (0.06:15.99)
  AKI stage 3 NA 7 (2.8) [0.7–4.9] – NA
  Other TAVI-related complications post-discharge 0 0 0 NA
  New onset of atrial fibrillation/atrial flutter NA 20 (8.2) [4.7–11.5] – NA
  Permanent pacemaker 25 (10.2) [6.3–14.0] 25 (10.2) [6.3–13.9] 50 (10.2) [7.5–12.9] 1.01 (0.58:1.76)
1 year n = 241 n = 243 n = 484
  Mortality 47 (18.9) [13.9–23.7] 51 (20.8) [15.6–25.8] 98 (19.9) [16.3–23.3] 1.10 (0.74:1.64)
   Cardiovascular 15 (6.4) [3.2–9.4] 19 (8.2) [4.5–11.6] 34 (7.3) [4.9–9.6] 1.31 (0.66:2.57)
   Non-cardiovascular 32 (13.2) [8.9–17.4] 32 (13.8) [9.2–18.1] 64 (13.5) [10.4–16.5] 1.02 (0.62:1.66)
  Stroke 10 (4.2) [1.6–6.7] 7 (3.2) [0.8–5.5] 17 (3.7) [1.9–5.4] 0.72 (0.27:1.89)
  Other TAVI-related complications post-discharge 0 0 0 NA
Data are presented as n (%) [95% CI], and HR. AKI-acute kidney injury, HR-hazard ratio, calculated using the Cox proportional hazards regression analysis, NA-not assessed, TAVI-transcatheter aortic valve implantation, ano VARC classification, bnot further specified if disabling or not disabling.