Time Frame |
1 year
|
Adverse Event Reporting Description |
[Not Specified]
|
|
Arm/Group Title
|
Surgical Aortic Valve Replacement (SAVR)
|
Transcatheter Aortic Valve Replacement (TAVR)
|
Arm/Group Description |
SAVR with a commercially available ...
|
TAVR with the Edwards SAPIEN 3 Tran...
|
Arm/Group Description |
SAVR with a commercially available bioprosthetic valve.
|
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
|
|
|
Surgical Aortic Valve Replacement (SAVR)
|
Transcatheter Aortic Valve Replacement (TAVR)
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
11/454 (2.42%)
|
|
5/496 (1.01%)
|
|
|
|
Surgical Aortic Valve Replacement (SAVR)
|
Transcatheter Aortic Valve Replacement (TAVR)
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
221/454 (48.68%)
|
|
153/496 (30.85%)
|
|
Blood and lymphatic system disorders |
|
|
Anaemia |
5/454 (1.10%)
|
5 |
2/496 (0.40%)
|
2 |
Haemolysis |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Haemorrhagic anaemia |
9/454 (1.98%)
|
9 |
3/496 (0.60%)
|
3 |
Heparin-induced thrombocytopenia |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Hypercoagulation |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Leukocytosis |
3/454 (0.66%)
|
3 |
0/496 (0.00%)
|
0 |
Thrombocytopenia |
5/454 (1.10%)
|
5 |
1/496 (0.20%)
|
1 |
Cardiac disorders |
|
|
Acute left ventricular failure |
4/454 (0.88%)
|
4 |
1/496 (0.20%)
|
1 |
Acute myocardial infarction |
2/454 (0.44%)
|
2 |
1/496 (0.20%)
|
1 |
Angina pectoris |
4/454 (0.88%)
|
4 |
4/496 (0.81%)
|
4 |
Arrhythmia |
1/454 (0.22%)
|
1 |
1/496 (0.20%)
|
1 |
Arrhythmia supraventricular |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Atrial fibrillation |
42/454 (9.25%)
|
43 |
11/496 (2.22%)
|
12 |
Atrial flutter |
12/454 (2.64%)
|
13 |
2/496 (0.40%)
|
2 |
Atrial tachycardia |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Atrioventricular block |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Atrioventricular block complete |
15/454 (3.30%)
|
15 |
22/496 (4.44%)
|
23 |
Atrioventricular block first degree |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Atrioventricular block second degree |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Bradyarrhythmia |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Bradycardia |
1/454 (0.22%)
|
1 |
1/496 (0.20%)
|
1 |
Bundle branch block left |
1/454 (0.22%)
|
1 |
12/496 (2.42%)
|
12 |
Cardiac arrest |
5/454 (1.10%)
|
6 |
4/496 (0.81%)
|
4 |
Cardiac failure |
4/454 (0.88%)
|
4 |
0/496 (0.00%)
|
0 |
Cardiac failure acute |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Cardiac failure congestive |
7/454 (1.54%)
|
7 |
1/496 (0.20%)
|
1 |
Cardiac tamponade |
3/454 (0.66%)
|
3 |
1/496 (0.20%)
|
1 |
Cardiogenic shock |
6/454 (1.32%)
|
6 |
2/496 (0.40%)
|
2 |
Cardiomyopathy |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Coronary artery disease |
1/454 (0.22%)
|
1 |
2/496 (0.40%)
|
2 |
Coronary artery occlusion |
1/454 (0.22%)
|
1 |
1/496 (0.20%)
|
1 |
Coronary artery stenosis |
2/454 (0.44%)
|
2 |
0/496 (0.00%)
|
0 |
Defect conduction intraventricular |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Diastolic dysfunction |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Dressler's syndrome |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Left ventricular enlargement |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Mitral valve incompetence |
3/454 (0.66%)
|
3 |
0/496 (0.00%)
|
0 |
Myocardial infarction |
2/454 (0.44%)
|
2 |
0/496 (0.00%)
|
0 |
Nodal arrhythmia |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Paravalvular aortic regurgitation |
2/454 (0.44%)
|
2 |
4/496 (0.81%)
|
4 |
Pericardial effusion |
6/454 (1.32%)
|
6 |
2/496 (0.40%)
|
2 |
Pericardial haemorrhage |
8/454 (1.76%)
|
8 |
0/496 (0.00%)
|
0 |
Pericarditis constrictive |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Prosthetic cardiac valve thrombosis |
0/454 (0.00%)
|
0 |
2/496 (0.40%)
|
2 |
Pulseless electrical activity |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Sinus arrest |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Sinus bradycardia |
2/454 (0.44%)
|
2 |
1/496 (0.20%)
|
1 |
Sinus node dysfunction |
2/454 (0.44%)
|
2 |
2/496 (0.40%)
|
2 |
Sinus tachycardia |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Supraventricular tachycardia |
1/454 (0.22%)
|
1 |
1/496 (0.20%)
|
1 |
Systolic anterior motion of mitral valve |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Tricuspid valve incompetence |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Ventricular extrasystoles |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Ventricular fibrillation |
5/454 (1.10%)
|
5 |
0/496 (0.00%)
|
0 |
Ventricular hypokinesia |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Ventricular tachycardia |
1/454 (0.22%)
|
1 |
3/496 (0.60%)
|
3 |
Congenital, familial and genetic disorders |
|
|
Arteriovenous malformation |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Haemorrhagic arteriovenous malformation |
1/454 (0.22%)
|
1 |
1/496 (0.20%)
|
1 |
Ventricular septal defect |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Ear and labyrinth disorders |
|
|
Vertigo positional |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Endocrine disorders |
|
|
Thyroid disorder |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Eye disorders |
|
|
Amaurosis fugax |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Cataract |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Retinal detachment |
0/454 (0.00%)
|
0 |
2/496 (0.40%)
|
2 |
Gastrointestinal disorders |
|
|
Colitis |
2/454 (0.44%)
|
2 |
0/496 (0.00%)
|
0 |
Diarrhoea |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Gastritis |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Gastrointestinal haemorrhage |
2/454 (0.44%)
|
2 |
10/496 (2.02%)
|
11 |
Gastrointestinal ulcer haemorrhage |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Gastrointestinal vascular malformation haemorrhagic |
1/454 (0.22%)
|
2 |
0/496 (0.00%)
|
0 |
Haematochezia |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Ileus |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Ileus paralytic |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Inguinal hernia |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Intestinal ischaemia |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Lower gastrointestinal haemorrhage |
1/454 (0.22%)
|
1 |
1/496 (0.20%)
|
1 |
Oroantral fistula |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Rectal haemorrhage |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Retroperitoneal haemorrhage |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Small intestinal obstruction |
2/454 (0.44%)
|
2 |
0/496 (0.00%)
|
0 |
Umbilical hernia |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Upper gastrointestinal haemorrhage |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
General disorders |
|
|
Asthenia |
3/454 (0.66%)
|
3 |
1/496 (0.20%)
|
1 |
Chest pain |
2/454 (0.44%)
|
2 |
1/496 (0.20%)
|
1 |
Complication associated with device |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Death |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Gait disturbance |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Localised oedema |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Mass |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Multiple organ dysfunction syndrome |
1/454 (0.22%)
|
1 |
1/496 (0.20%)
|
1 |
Non-cardiac chest pain |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Oedema peripheral |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Pyrexia |
2/454 (0.44%)
|
2 |
0/496 (0.00%)
|
0 |
Sudden cardiac death |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Systemic inflammatory response syndrome |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Hepatobiliary disorders |
|
|
Bile duct stone |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Biliary dyskinesia |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Cholecystitis |
1/454 (0.22%)
|
2 |
0/496 (0.00%)
|
0 |
Cholelithiasis |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Ischaemic hepatitis |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Immune system disorders |
|
|
Anaphylactic reaction |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Infections and infestations |
|
|
Alpha haemolytic streptococcal infection |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Arthritis infective |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Bacteraemia |
0/454 (0.00%)
|
0 |
3/496 (0.60%)
|
3 |
Biliary sepsis |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Bronchitis |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Cellulitis |
0/454 (0.00%)
|
0 |
3/496 (0.60%)
|
3 |
Cholecystitis infective |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Chronic sinusitis |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Diverticulitis |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Endocarditis |
2/454 (0.44%)
|
2 |
0/496 (0.00%)
|
0 |
Endocarditis enterococcal |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Escherichia urinary tract infection |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Influenza |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Pneumonia |
5/454 (1.10%)
|
5 |
3/496 (0.60%)
|
3 |
Pneumonia streptococcal |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Post procedural infection |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Postoperative wound infection |
3/454 (0.66%)
|
3 |
0/496 (0.00%)
|
0 |
Respiratory tract infection |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Sepsis |
0/454 (0.00%)
|
0 |
2/496 (0.40%)
|
2 |
Septic shock |
2/454 (0.44%)
|
2 |
0/496 (0.00%)
|
0 |
Serratia sepsis |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Streptococcal infection |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Urinary tract infection |
3/454 (0.66%)
|
3 |
1/496 (0.20%)
|
1 |
Vascular access site infection |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
Anaemia postoperative |
3/454 (0.66%)
|
3 |
0/496 (0.00%)
|
0 |
Ankle fracture |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Arterial injury |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Cardiac valve replacement complication |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Fall |
0/454 (0.00%)
|
0 |
3/496 (0.60%)
|
3 |
Hip fracture |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Humerus fracture |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Incision site haemorrhage |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Incisional hernia |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Post procedural haemorrhage |
4/454 (0.88%)
|
4 |
0/496 (0.00%)
|
0 |
Post procedural myocardial infarction |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Postoperative delirium |
2/454 (0.44%)
|
2 |
1/496 (0.20%)
|
1 |
Postoperative ileus |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Procedural haemorrhage |
13/454 (2.86%)
|
14 |
0/496 (0.00%)
|
0 |
Procedural hypotension |
0/454 (0.00%)
|
0 |
2/496 (0.40%)
|
2 |
Procedural pneumothorax |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Subdural haematoma |
0/454 (0.00%)
|
0 |
2/496 (0.40%)
|
2 |
Tibia fracture |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Transfusion reaction |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Vascular access site bruising |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Vascular access site complication |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Vascular access site haematoma |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Vascular access site pseudoaneurysm |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Vascular pseudoaneurysm |
0/454 (0.00%)
|
0 |
2/496 (0.40%)
|
2 |
Vasoplegia syndrome |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Venous injury |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Investigations |
|
|
Anticoagulation drug level below therapeutic |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Blood pressure systolic increased |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Cardiac murmur |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Ejection fraction decreased |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
International normalised ratio increased |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Pulmonary arterial pressure increased |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Troponin increased |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
White blood cell count increased |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Metabolism and nutrition disorders |
|
|
Dehydration |
1/454 (0.22%)
|
1 |
1/496 (0.20%)
|
1 |
Electrolyte imbalance |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Fluid overload |
2/454 (0.44%)
|
3 |
1/496 (0.20%)
|
1 |
Gout |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Hyperkalaemia |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Hypervolaemia |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Hyponatraemia |
1/454 (0.22%)
|
1 |
2/496 (0.40%)
|
2 |
Musculoskeletal and connective tissue disorders |
|
|
Arthralgia |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Arthritis |
1/454 (0.22%)
|
1 |
2/496 (0.40%)
|
2 |
Back pain |
1/454 (0.22%)
|
1 |
1/496 (0.20%)
|
1 |
Fracture nonunion |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Groin pain |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Intervertebral disc protrusion |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Lumbar spinal stenosis |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Muscular weakness |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Musculoskeletal pain |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Osteoarthritis |
0/454 (0.00%)
|
0 |
5/496 (1.01%)
|
5 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
Basal cell carcinoma |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Bone cancer metastatic |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Gastrointestinal stromal tumour |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Lung cancer metastatic |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Malignant melanoma |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Myelodysplastic syndrome |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Neoplasm malignant |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Non-small cell lung cancer |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Prostate cancer |
0/454 (0.00%)
|
0 |
3/496 (0.60%)
|
3 |
Rectal cancer |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Squamous cell carcinoma of skin |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Thyroid cancer |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Nervous system disorders |
|
|
Ataxia |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Cerebral haemorrhage |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Cerebral infarction |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Cerebrovascular accident |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Embolic stroke |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Encephalopathy |
1/454 (0.22%)
|
1 |
1/496 (0.20%)
|
1 |
Facial paralysis |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Generalised tonic-clonic seizure |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Haemorrhage intracranial |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Haemorrhagic stroke |
2/454 (0.44%)
|
2 |
1/496 (0.20%)
|
1 |
Hypoaesthesia |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Ischaemic stroke |
7/454 (1.54%)
|
7 |
4/496 (0.81%)
|
4 |
Lacunar infarction |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Metabolic encephalopathy |
2/454 (0.44%)
|
2 |
1/496 (0.20%)
|
1 |
Nerve compression |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Presyncope |
0/454 (0.00%)
|
0 |
2/496 (0.40%)
|
2 |
Sciatica |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Syncope |
4/454 (0.88%)
|
4 |
2/496 (0.40%)
|
2 |
Toxic encephalopathy |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Transient ischaemic attack |
3/454 (0.66%)
|
3 |
0/496 (0.00%)
|
0 |
Product Issues |
|
|
Device breakage |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Lead dislodgement |
1/454 (0.22%)
|
1 |
1/496 (0.20%)
|
1 |
Psychiatric disorders |
|
|
Alcohol withdrawal syndrome |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Confusional state |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Depression |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Hallucination, visual |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Renal and urinary disorders |
|
|
Acute kidney injury |
7/454 (1.54%)
|
7 |
3/496 (0.60%)
|
3 |
Haematuria |
3/454 (0.66%)
|
3 |
0/496 (0.00%)
|
0 |
Nephrolithiasis |
1/454 (0.22%)
|
3 |
1/496 (0.20%)
|
1 |
Renal failure |
2/454 (0.44%)
|
2 |
0/496 (0.00%)
|
0 |
Renal injury |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Renal mass |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Renal tubular necrosis |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Ureterolithiasis |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Urinary retention |
3/454 (0.66%)
|
3 |
2/496 (0.40%)
|
2 |
Reproductive system and breast disorders |
|
|
Benign prostatic hyperplasia |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Scrotal haematocoele |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Respiratory, thoracic and mediastinal disorders |
|
|
Acquired diaphragmatic eventration |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Acute respiratory distress syndrome |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Acute respiratory failure |
4/454 (0.88%)
|
4 |
1/496 (0.20%)
|
1 |
Asthma |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Atelectasis |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Bronchial hyperreactivity |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Chronic obstructive pulmonary disease |
2/454 (0.44%)
|
2 |
0/496 (0.00%)
|
0 |
Dyspnoea |
5/454 (1.10%)
|
5 |
3/496 (0.60%)
|
4 |
Dyspnoea exertional |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Epistaxis |
0/454 (0.00%)
|
0 |
2/496 (0.40%)
|
2 |
Haemothorax |
2/454 (0.44%)
|
2 |
0/496 (0.00%)
|
0 |
Hypoxia |
2/454 (0.44%)
|
2 |
0/496 (0.00%)
|
0 |
Mediastinal haematoma |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Mediastinal haemorrhage |
3/454 (0.66%)
|
3 |
0/496 (0.00%)
|
0 |
Pharyngeal haemorrhage |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Pleural effusion |
18/454 (3.96%)
|
20 |
1/496 (0.20%)
|
1 |
Pneumothorax |
7/454 (1.54%)
|
7 |
0/496 (0.00%)
|
0 |
Pulmonary embolism |
2/454 (0.44%)
|
2 |
2/496 (0.40%)
|
2 |
Pulmonary sarcoidosis |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Respiratory acidosis |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Respiratory failure |
6/454 (1.32%)
|
6 |
1/496 (0.20%)
|
1 |
Skin and subcutaneous tissue disorders |
|
|
Eczema |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Surgical and medical procedures |
|
|
Appendicectomy |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Cardiac pacemaker replacement |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Hip arthroplasty |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Knee arthroplasty |
1/454 (0.22%)
|
1 |
2/496 (0.40%)
|
2 |
Knee operation |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Percutaneous coronary intervention |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Pericardial excision |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Stent placement |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Vascular disorders |
|
|
Aortic dissection |
0/454 (0.00%)
|
0 |
2/496 (0.40%)
|
2 |
Aortic rupture |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Arterial haemorrhage |
1/454 (0.22%)
|
1 |
1/496 (0.20%)
|
1 |
Deep vein thrombosis |
3/454 (0.66%)
|
3 |
1/496 (0.20%)
|
1 |
Femoral artery dissection |
0/454 (0.00%)
|
0 |
3/496 (0.60%)
|
3 |
Femoral artery perforation |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Haematoma |
4/454 (0.88%)
|
4 |
2/496 (0.40%)
|
2 |
Haemorrhage |
2/454 (0.44%)
|
2 |
0/496 (0.00%)
|
0 |
Hypertension |
1/454 (0.22%)
|
1 |
2/496 (0.40%)
|
2 |
Hypertensive crisis |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Hypotension |
6/454 (1.32%)
|
6 |
1/496 (0.20%)
|
1 |
Peripheral artery stenosis |
0/454 (0.00%)
|
0 |
3/496 (0.60%)
|
3 |
Peripheral embolism |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Peripheral ischaemia |
1/454 (0.22%)
|
1 |
2/496 (0.40%)
|
2 |
Renovascular hypertension |
0/454 (0.00%)
|
0 |
1/496 (0.20%)
|
1 |
Temporal arteritis |
1/454 (0.22%)
|
1 |
0/496 (0.00%)
|
0 |
Vessel perforation |
1/454 (0.22%)
|
1 |
1/496 (0.20%)
|
1 |
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Surgical Aortic Valve Replacement (SAVR)
|
Transcatheter Aortic Valve Replacement (TAVR)
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
305/454 (67.18%)
|
|
133/496 (26.81%)
|
|
Blood and lymphatic system disorders |
|
|
Anaemia |
28/454 (6.17%)
|
29 |
0/496 (0.00%)
|
0 |
Haemorrhagic anaemia |
59/454 (13.00%)
|
60 |
0/496 (0.00%)
|
0 |
Thrombocytopenia |
24/454 (5.29%)
|
24 |
0/496 (0.00%)
|
0 |
Cardiac disorders |
|
|
Atrial fibrillation |
145/454 (31.94%)
|
154 |
36/496 (7.26%)
|
38 |
Atrioventricular block first degree |
26/454 (5.73%)
|
26 |
26/496 (5.24%)
|
26 |
Bundle branch block left |
37/454 (8.15%)
|
37 |
92/496 (18.55%)
|
93 |
Bundle branch block right |
28/454 (6.17%)
|
28 |
0/496 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
Procedural haemorrhage |
88/454 (19.38%)
|
89 |
0/496 (0.00%)
|
0 |
Renal and urinary disorders |
|
|
Acute kidney injury |
40/454 (8.81%)
|
41 |
0/496 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
Pleural effusion |
39/454 (8.59%)
|
40 |
0/496 (0.00%)
|
0 |
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
|