Table 4. Information on survival.
Reference | Survival |
---|---|
Clegg et al., 2005 (5) | Kaplan-Meier (KM) survival curve using censored data from the REMATCH randomised trial + extrapolation |
The survival gain of the LVAD arm over medical therapy was 6.84 months per person | |
Adang et al., 2006 (6) | Survival based on the results of the REMATCH trial |
Girling et al., 2007 (7) | Exponential (constant hazard) distribution for patient survival with mean survival as suggested by the REMATCH trial |
For OMT: mean survival 7.8 months (Samson et al., 2004) (12) | |
For LVAD patients: | |
LVAD failure: mean survival 2 months | |
Life expectancy LVAD group depends on: | |
Proportion of LVAD success/failure (π) | |
Mean survival time for successes (μS) | |
In the REMATCH trial (1st generation device): | |
π is estimated as 0.33 (=17/51) (Oz et al., 2003) (13) | |
μS is estimated as 35 months | |
Based on expert opinion: | |
Median survival: 25 months (range, 12-40 months) | |
30-day mortality: 10% (range, 3-16%) | |
Messori et al., 2009 (9) | Baseline life expectancy without LVAD: 150 days |
Individual survival times after LVAD implantation for the published 68 patients receiving the HeartMate device were derived by a computerized analysis of the original KM curve (Messori et al., 2008) (14) | |
An additional survival time of 12 months was determined by extrapolating the published survival curves | |
Rogers et al., 2012 (10) | OMT: KM survival curve from the REMATCH trial |
Continuous-flow LVAD: KM survival curve from the HeartMate II Destination Therapy trial | |
Extrapolation past 24 months: based on exponential survival curve using the constant hazard rate observed within 24 months | |
OMT: 0.105 per month | |
Continuous-flow LVAD: 0.023 per month (base case analysis) | |
LVAD vs. OMT: 2.42 versus 0.64 life years | |
Neyt et al., 2013 (11) | OMT: survival from the REMATCH trial |
Continuous-flow LVAD: survival from the HeartMate II Destination Therapy trial | |
Extrapolation past 24 months (base case scenario): | |
OMT group: 2-year survival of 13%; no survival after 3 years | |
Continuous-flow LVAD: the monthly mortality during the second year is used to extrapolate results. | |
Age and gender-adjusted increase in monthly mortality risk is applied according to Dutch life table | |
Discounted incremental effect: 3.23 life-years gained (LYG) (95% CI, 2.18-4.49) |
LVADs, left ventricular assist devices; OMT, optimal medical therapy.