Table 4

Comparing our findings with EWOLUTION and the previously published RCTs

PROTECT-AFCAPPREVAILEWOLUTION cohortNIS
Total implants (n)40846026510255175
Overall complications (%)8.74.12.21.81.9
Pericardial effusion requiring surgery (%)1.60.20.40.090.29
Pericardial effusion with pericardiocentesis (%)2.41.21.50.290.68
Procedure-related ischaemic strokes (%)1.100.700
Mortality (%)0000.390.29
PROTECT-AFCAPPREVAILEWOLUTION cohortNIS
Total implants (n)40846026510255175
Overall complications (%)8.74.12.21.81.9
Pericardial effusion requiring surgery (%)1.60.20.40.090.29
Pericardial effusion with pericardiocentesis (%)2.41.21.50.290.68
Procedure-related ischaemic strokes (%)1.100.700
Mortality (%)0000.390.29

NIS, National Inpatient Sample; RCTs, randomized clinical trials.

Table 4

Comparing our findings with EWOLUTION and the previously published RCTs

PROTECT-AFCAPPREVAILEWOLUTION cohortNIS
Total implants (n)40846026510255175
Overall complications (%)8.74.12.21.81.9
Pericardial effusion requiring surgery (%)1.60.20.40.090.29
Pericardial effusion with pericardiocentesis (%)2.41.21.50.290.68
Procedure-related ischaemic strokes (%)1.100.700
Mortality (%)0000.390.29
PROTECT-AFCAPPREVAILEWOLUTION cohortNIS
Total implants (n)40846026510255175
Overall complications (%)8.74.12.21.81.9
Pericardial effusion requiring surgery (%)1.60.20.40.090.29
Pericardial effusion with pericardiocentesis (%)2.41.21.50.290.68
Procedure-related ischaemic strokes (%)1.100.700
Mortality (%)0000.390.29

NIS, National Inpatient Sample; RCTs, randomized clinical trials.

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