Reply to Bigs and Frags Re Impulse Dynamics

Couldn't get this to load on Yahoo so posting it here.
Location:- Impulse Dynamics, Physicians, Publications
1. (1) 41 Patients, Long Term Survival, Treatment compared to DB
2. (3) 81 Patients, Efficacy & Long Term Survival, Retrospective Analysis of previous trial (Data Mining)
3. (5) 641 Patients, Exercise Capacity & QOL, Meta Analysis of previous trials (Data Mining)
The Bigs Test:-
“Remember what I said Time & Again, "In general, what the company does NOT mention may be most harmful to you.”” quote from Bigsmartsta
The Frags Test:-
”To address this issue, the MOST ROBUST and OBJECTIVE primary efficacy end point, peak VO2, was chosen..." quote Abrahams re-quoted by Flagstrap
[C-Pulse and Optimiser trials appear to involve quite dissimilar populations. C-Pulse NYHA Class 3/4, Optimiser Class 2/3.
Class II one and three year survival ~ 80% , 50%
Class IV ~ 40% , 0%
C-Pulse anyone they can reasonably implant in the whole HF population.
Optimiser around 50% of HF population sub group.
Can’t directly compare trial outcomes between C-Pulse and Optimiser.
]
1. (1) 41 Patients, Survival, Treatment compared to DB
Interesting but small sample, Data Miming to find a sub group always a worry. Optimiser does well in comparisons with data base but less well in control trials. Lightweight result.
Little info so FAILS Bigs Test.
No VO2 max so FAILS Frags Test.
2. (3) 81 Patients, Efficacy & Long Term Survival, Retrospective Analysis of previous trial (Data Mining)
QOL endpoint not published so FAILS Bigs Test
VO2 max p=1 not statistically significant so FAILS Frags Test
VO2 max benefit <1 ml/kg/min, so FAILS Frags Test again
No p given for change in NYHA ranking so FAILS Bigs Test again.
Short and long term survival did improve dramatically but it was against a database and 3yr survival wasn’t statistically significant.
p values for EF and NT-pro just significant .(p=05) bit sus.
Against a DB is not a gold standard test.
The trial may indicate that optimiser patients are living longer( with the benefit dropping off over time i.e. HF coming back?) but without improvement in QOL.
3. (5) 641 Patients, Exercise Capacity & QOL, Meta Analysis of previous trials (Data Mining)
I think the conclusion says it all.
“Conclusion; Meta-analysis of individual patient data from randomized trials suggests that CCM has (statistically) significant if somewhat modest benefits in improving measures of functional capacity and quality of life.”
My take: Optimiser could extend your life (but this isn’t backed up in trials with a control arm) but you are not going to feel better.