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Table 4 Adverse events in the six randomised studies of PFO closure in cryptogenic stroke

From: Cryptogenic stroke and patent foramen ovale (abridged and translated version)

Parameters Group Closure I PC Trial RESPECT REDUCE CLOSE Defense PFO
Device   STARFlex Amplatzer PFO Amplatzer PFO HELEX/Cardioform Different devices Amplatzer PFO
1. General Adverse Events
  M 16.9 17.6 40.3 27.8 33.2
 Overall SAE (%) C 16.6 21.1 36.0 23.1 35.7
  P 0.90 0.37 0.17 0.22 0.56
 Atrial fibrillation or flutter (%) M 0.7* 1.0 1.5 0.4* 0.9* 0
C 5.7* 2.9 3.0 6.6* 4.6* 3.3
P <  0.001 0.17 0.13 <  0.0001 0.02
 Overall major bleeding (%) M 1.1 1.4 0.2 2.7 2.1 4.9
C 2.6 0.5 0.6 1.8 0.8 0
P 0.11 0.62 0.6 0.57 0.28 0.15
  M 0 0 0.6* 0.4 0 0
 Pulmonary embolism (%) C 0 0 2.4* 0.5 0.4 0
  P 0.034 1.0
2. Procedural and occluder-associated complications
 Atrial fibrillation or flutter (%) C 3.5 0.5 1.4 5.4 4.2 3.0
 Bleeding (%) C 2.5 1 0.6 0.9 0 0
 Pericardial tamponade (%) C 0 0 0.4 0.2 0 0
 Cardiac thrombus (%) C 1.1 0 0.2 0.5 0.4 0
 Cardiac perforation (%) C 0.25 0 0.2 0 0 0
 Occluder embolisation (%) C 0 0 0 0.7 0 0
 Rare complications classified as procedural or occluder-associated (%) C 0.5a 0 2.8b 2.3c 1.7d 3.3e
  1. SAE = serious adverse events; M = medical treatment; C = PFO Closure
  2. *significant difference for p < 0.05
  3. a1 x peripheral nerve lesion and 1 x vessel injury requiring surgical intervention
  4. b1 x pericardial effusion without tamponade, 1 x allergic drug reaction, 1 x vasovagal reaction, 2 x ischaemic stroke, 1 x chest tightness, 1 x infectious endocarditis, 2 x pulmonary embolism, 1 x deep vein thrombosis, 2 x residual shunt requiring re-closure, 1 x sepsis, 1 x transient ventricular tachycardia
  5. c1 x aortic dissection, 1 x AV fistula, 2 x hypotension, 1 x anxiety, 1 x chest tightness, 1 x non-cardiac chest pain, 1 x fatigue, 1 x hemiparesis, 1 x respiratory arrest
  6. d2 x supraventricular tachycardia, 1 x air embolism, 1 x hyperthermia
  7. e1 x pericardial effusion without tamponade, 1 x ischaemic stroke