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. 2023 Jul 17;19(4):e352–e362. doi: 10.4244/EIJ-D-23-00282

Table 3. Cumulative events at 30-day, 6-month and 1-year follow-up.

Event 30-day follow-up n=13 6-month follow-up n=13 1-year follow-up</p> n=5
Primary safety endpoints
All-cause mortality 0 (0) 0 (0) 0 (0)
Myocardial infarction 0 (0) 0 (0) 0 (0)
Disabling stroke 0 (0) 0 (0) 0 (0)
Life-threatening bleeding 0 (0) 0 (0) 0 (0)
VARC-3 endpoints*
Valve-related mortality 0 (0) 0 (0) 0 (0)
All strokes 0 (0) 0 (0) 0 (0)
Neurological dysfunctions 0 (0) 0 (0) 0 (0)
All bleeding 0 (0) 0 (0) 0 (0)
Major vascular complications 1 (7.69) 0 (0) 0 (0)
Minor vascular complications 0 (0) 0 (0) 0 (0)
Cardiac complications 0 (0) 0 (0) 0 (0)
Permanent pacemaker implant 1 (7.69) 0 (0) 0 (0)
Bioprosthetic valve dysfunction 0 (0) 0 (0) 0 (0)
Structural valve deterioration 0 (0) 0 (0) 0 (0)
Reoperations/reinterventions on the study valve 0 (0) 0 (0) 0 (0)
Acute kidney injury 0 (0) 0 (0) 0 (0)
Major paravalvular leak (moderate or severe) 0 (0) 0 (0) 0 (0)
Major aortic regurgitation (moderate or severe) 1 (7.69) 1 (7.69) 0 (0)
Values are n (%). *Study endpoints are defined according to the VARC-3 guidelines16. VARC: Valve Academic Research Consortium