2.3. Outcomes of interest
For the single-arm study, the primary outcome was the pooled event rates
for successful device implantation rate, 30-day mortality rate and
30- day mortality for primary closure at the acute phase, and
secondary outcomes were the pooled event rate of immediate shunt
reduction(ISR). While, odds ratios (OR) for ISR, presence of cardiogenic
shock(CS), n class IV, time from AMI to VSD, time to VSD closure were
estimated.
For the pairwise comparison with surgical closure, the primary outcome
was 30-day mortality rate and secondary outcomes were immediate shunt
reduction.