explant all stroke (disabling and non-disabling) life threatening bleeding (note: bleeding should be classified as either haemorrhage’ or ‘all haemorrhage’) acute kidney injury (stage 2 or 3, including renal replacement therapy) peri-procedural myocardial infarction endocarditis vascular complication coronary obstruction requiring intervention valve-related dysfunction (note: valve regurgitation should be reported as paravalvular ‘all leaks’ and paravalvular leaks’) ‘major In addition, it is recommended the following outcomes be reported after 30 days: mortality all stroke (disabling and non-disabling) hospitalisation for symptoms or worsening congestive heart failure a quality of life measure e.g. the New York Heart Association Classification (NYHA) or the Minnesota Living with Heart Failure Questionnaire (MLHF) prosthetic valve endocarditis prosthetic valve thrombosis bleeding, unless unrelated to valve therapy (e.g. trauma) (note: bleeding should be classified as either haemorrhage’ or haemorrhage’ ‘all ‘major ‘anticoagulant-related haemorrhage’ reoperation thromboembolic events (e.g. stroke) structural valve deterioration non-structural valve dysfunction/valve related dysfunction (note: valve regurgitation should be reported as paravalvular leaks’ and paravalvular leaks’ and it should be ‘all ‘major noted if the dysfunction required a repeat At one year the following should be reported: Structural valve deterioration Thromboembolism (Major, reversible ischemic neurological deficit (RIND)) Valve thrombosis Anticoagulant-related haemorrhage Prosthetic valve endocarditis Non-structural valve dysfunction/paravalvular leak Re-operation
explant all stroke (disabling and non-disabling) life threatening bleeding (note: bleeding should be classified as either ‘all haemorrhage’ or haemorrhage’) acute kidney injury (stage 2 or 3, including renal replacement therapy) peri-procedural myocardial infarction endocarditis vascular complication coronary obstruction requiring intervention valve-related dysfunction (note: valve regurgitation should be reported as ‘all paravalvular leaks’ and ‘major paravalvular leaks’) In addition, it is recommended the following outcomes be reported after 30 days: mortality all stroke (disabling and non-disabling) hospitalisation for symptoms or worsening congestive heart failure a quality of life measure e.g. the New York Heart Association Classification (NYHA) or the Minnesota Living with Heart Failure Questionnaire (MLHF) prosthetic valve endocarditis prosthetic valve thrombosis bleeding, unless unrelated to valve therapy (e.g. trauma) (note: bleeding should be classified as either ‘all haemorrhage’ or ‘major haemorrhage’ ‘anticoagulant-related haemorrhage’ reoperation thromboembolic events (e.g. stroke) structural valve deterioration non-structural valve dysfunction/valve related dysfunction (note: valve regurgitation should be reported as ‘all paravalvular leaks’ and ‘major paravalvular leaks’ and it should be noted if the dysfunction required a repeat At one year the following should be reported: Structural valve deterioration Thromboembolism (Major, reversible ischemic neurological deficit (RIND)) Valve thrombosis Anticoagulant-related haemorrhage Prosthetic valve endocarditis Non-structural valve dysfunction/paravalvular leak Re-operation
consult-draft-clinical-evidence-guidelines-medical-devices.docx