Personalised Decision Support for Heart Valve Disease
Personalised Decision Support for Heart Valve Disease
Valvular Heart Disease currently affects 2.5% of the population, but is overwhelmingly a
 disease of the elderly and consequently on the rise. It is dominated by two conditions,
 Aortic Stenosis and Mitral Regurgitation, both of which are associated with significant
 morbidity and mortality, yet which pose a truly demanding challenge for treatment
 optimisation. By combining multiple complex modelling components, a comprehensive,
 clinically-compliant decision-support system will be developed to meet this challenge, by
 quantifying individualised disease severity and patient impairment, predicting disease
 progression, ranking the effectiveness of alternative candidate procedures, and optimising
 the patient-specific intervention plan.

 In addition the DSS will improve knowledge of disease mechanisms by applying a holistic
 assessment of cardiovascular function that includes hemodynamic data at all cardiovascular
 compartments (ventricle, valve, vessels) and multiscale components that couple organ with
 cell function.

 DSS may have major impact on patients with borderline indications for treatment (valve
 replacement/repair), complex hemodynamic conditions such as combined aortic-mitral valve
 disease and valve geometries that are subject to valve repair.

 The target user of this Decision Support System is the healthcare professional, in this case
 the surgeon or cardiologist, who will make the decision on the nature and timing of the
 intervention. The major advance of this system over current practice is that it integrates
 and interprets all heterogeneous data available about the patient, integrates population data
 where needed, and provides a consistent, repeatable, quantitative and auditable record of the
 information that contributes to the decision process.
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:

 1. 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.

 2. Operation (valve replacement/repair): All patients will be treated according to current
 clinical guidelines.

 3. Virtual treatment: Patients will receive a virtual treatment

 4. 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)