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Table 4 Early and late adverse events in the overall population and according to type of mitral valve surgery

From: Clinical outcomes after implantation of a sutureless aortic bioprosthesis with concomitant mitral valve surgery: the SURE-AVR registry

Event Early events (≤30 days), n (%) Late events (> 30 days), n (rate per 100 patient-years)
Overall population (n = 78) Mitral repair (n = 45) Mitral replacement (n = 33) Overall population (n = 78; 282.5 patient-years) Mitral repair (n = 45; 160.6 patient-years) Mitral replacement (n = 33; 122.2 patient-years)
Death 1 (1.3) 0 1 (3.0) 12 (4.2) 6 (3.7) 6 (4.9)
 Cardiovascular 0 0 0 6 (2.1) 3 (1.9) 3 (2.5)
 Non-cardiovascular 1 (1.3)a 0 1 (3.0) 6 (2.1)b 3 (1.9) 3 (2.5)
Reintervention 2 (2.6) 0 2 (6.1) 4 (1.4) 3 (1.9) 1 (0.8)
 Valve related 0 0 0 3 (1.1)c 2 (1.2) 1 (0.8)
 Not valve related 2 (2.6) 0 2 (6.1) 1 (0.4) 1 (0.6) 0
Cerebrovascular accident 1 (1.3) 1 (2.2) 0 2 (0.7) 1 (0.6) 1 (0.8)
 Stroke 0 0 0 1 (0.4)d 0 1 (0.8)
 Transient ischaemic attack 1 (1.3) 1 (2.2) 0 1 (0.4) 1 (0.6) 0
Bleeding 1 (1.3) 0 1 (3.0) 2 (0.7) 2 (1.2) 0
 Minore 0 0 0 1 (0.4) 1 (0.6) 0
 Majorf 0 0 0 0 0 0
 Not classified 1 (1.3) 0 1 (3.0) 1 (0.4) 1 (0.6) 0
Non-structural valve dysfunction 10 (12.8) 1 (2.2) 9 (27.3) 13 (4.6) 8 (5.0) 5 (4.1)
 Intra-prosthetic regurgitation (1+) 6 (7.7) 0 6 (18.2) 9 (3.2) 6 (3.7) 3 (2.5)
 Paravalvular leak 1 (1.3) 1 (2.2) 0 2 (0.7) 1 (0.6) 1 (0.8)
 Paravalvular leak plus intra-prosthetic leak (no haemodynamic consequences) 3 (3.8) 0 3 (9.1) 2 (0.7) 1 (0.6) 1 (0.8)
Permanent pacemaker implant, due to: 6 (7.7) 3 (6.7) 3 (9.1) 3 (1.1) 1 (0.6) 2 (1.6)
 Atrioventricular block (third degree) 4 (5.1) 3 (6.7) 1 (3.0) 1 (0.4) 0 1 (0.8)
 Other reason 2 (2.6) 0 2 (6.1) 2 (0.7) 1 (0.6) 1 (0.8)
  1. a Due to septicaemia
  2. b Due to neoplasia (3 patients) in mitral replacement group, renal failure (1 patient) and non − valve-related death (2 patients) in mitral repair group
  3. c 1 endocarditis, 2 non-structural valve disease
  4. d Non-disabling stroke
  5. e Any bleeding worthy of clinical mention (e.g. access site haematoma) that does not qualify as life-threatening, disabling, or major [19]
  6. f Overt bleeding either associated with a drop in the haemoglobin level of ≥3.0 g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND does not meet criteria of life-threatening or disabling bleeding [19]
  7. AE adverse event