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.