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

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

Event	Early events (≤30 days), n (%)			Late events (> 30 days), n (rate per 100 patient-years)
Event	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
Minor^e	0	0	0	1 (0.4)	1 (0.6)	0
Major^f	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)

^a Due to septicaemia
^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
^c 1 endocarditis, 2 non-structural valve disease
^d Non-disabling stroke
^e Any bleeding worthy of clinical mention (e.g. access site haematoma) that does not qualify as life-threatening, disabling, or major [19]
^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]
AE adverse event

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