Personalised Decision Support for Heart Valve Disease

Study design:

In the study a Decision Support System for aortic and mitral valve replacement/repair will be implemented and tested. Not all of the assessments listed will be performed on every patient, but sufficient to support the analysis processes.

The patients are enrolled in two subgroups:

• Group 1: patients with aortic valve disease
• Group 2: patients with mitral valve disease

The study has the following visits at all clinical centers:

• Visit 1: Patients will be investigated before valve intervention by imaging (MRI, Echocardiography, CT), ECG, laboratory tests, anthropometrics (blood pressure, body weight, clinical status). A subset of patients will wear a fitness tracker for at least one day and perform a 6-minute walk test.
• Operation (valve replacement/repair): All patients will be treated according to current clinical guidelines.
• Virtual treatment: Patients will receive a virtual treatment
• Visit 2: After treatment patients will be followed-up undergoing the study protocol again. This allows comparing the modeled (predicted) against measured outcome data.

Inclusion criteria

• The patient must give Informed Consent before being enrolled in the study.
• Only elective cases will be eligible for inclusion. For mitral disease, patients were recruited with;
• Severe degenerative or functional mitral regurgitation with the need for MVR according to the ESC/EACTS guidelines.
• Degenerative mitral regurgitation
• symptomatic patients with LVEF >30% and LVESD < 55mm (I B)
• asymptomatic patients with LV dysfunction (LVESD ≥45 mm and/or LVEF ≤60% (I C)
• asymptomatic patients with LVEF > 50%, new onset of atrial fibrillation or pulmonary hypertension (systolic pulmonary pressure at rest >50 mmHg) (IIa C)
• patients with severe LV dysfunction (LVEF < 30% and LVESD > 55 mm) refractory to medical therapy with high likelihood of durable repair and low comorbidity. (IIa C) Functional mitral regurgitation
• patients with severe MR (EROA >= 20 mm², Regurgitation volume > 30 ml) undergoing CABG, and LVEF >30% (I C)
• patients with moderate MR undergoing CABG (IIa C)
• symptomatic patients with severe MR, LVEF < 30 %, option for revascularisation, and evidence of viability (IIa C) For aortic valve disease, patients will be recruited with;
• Severe acquired degenerative aortic valve disease with the need for SAVR or TAVI according to the ESC/EACTS guidelines Severe Aortic stenosis
• symptomatic patients (I B)
• patients undergoing CABG or surgery of ascending aorta or another valve (I C)
• asymptomatic patients with abnormal exercise test (I C) / LVEF < 50% (I C) / blood pressure drop on exercise / peak gradient > 5.5 m/sec ( (IIa C)
• symptomatic patients with low flow, low gradient (< 40mmHg) and normal LVEF (IIa C)

Exclusion criteria

• Inability or unwillingness to give formal consent.
• Emergency interventions
• Active infective valvular disease or evidence of valvular damage by recent endocarditis
• Valvular malfunction directly associated with aortic root disease
• Aortic regurgitation as leading aortic valve pathology
• Inability or unwillingness to complete follow up
• MRI contraindications (Implanted pacemaker, Metallic foreign body, Severe claustrophobia)
• CT contraindications (Known iodine or contrast agent allergy, Hyperhidrosis, Pregnancy)