Short summary

Heart valve disease is a serious condition, often requiring surgery. After surgery and discharge, the patients are at high risk of developing complications, such as atrial fibrillation, heart failure, pleural and pericardial effusions. With current practice these complications often leads to readmissions.

Early follow-up after discharge has shown to reduce readmissions among other cardiac patients groups, and this study aim to test the hypothesis that "that early, individualized follow-up in a Heart Valve Clinic after heart valve surgery can reduce readmissions, reduce overall health care costings and improve the physical and mental condition of the patient".

Rationale

The incidence of valvular heart disease is estimated to exceed 42 million people worldwide. In

Denmark more than 1700 patients undergo heart valve surgery every year and the number is increasing due to an ageing population. The most common heart valve diseases is aortic stenosis, followed by mitral regurgitation and aortic regurgitation, whereas only few patients are treated in Denmark for mitral stenosis and primary tricuspid valve and pulmonic valve diseases.

Guidelines recommend heart valve surgery in symptomatic patients and specific asymptomatic high risk patients with severe heart valve disease where the intervention improve outcome, but complications after heart valve surgery are common and readmissions frequent with rates exceeding 40% in Denmark. Most frequent causes for readmission, includes pleural and pericardial effusions, infections, acute heart failure and new onset atrial fibrillation,. Some of these causes can potentially be predicted by careful outpatient follow-up or managed in an outpatient setting in order to avoid unplanned readmission, and improve the wellbeing of the patient. A recent Danish study demonstrated that 56% of surgical heart valve patients were readmitted within a year and readmission was associated with low psychical and mental patient reported outcomes (PROs), which include validated patient health status surveys that allow quantification of critical patient-centered outcomes.

Existing guidelines recommend that patients following valve surgery are reviewed on a regular basis by a cardiologist with special knowledge about heart valve diseases in the first period after discharge. A recent European study demonstrates though, a gap between the existing guidelines and clinical practice. A plausible way to improve the postoperative care could be to introduce a follow-up in the setting of a multidisciplinary Heart Valve Clinic, where specialized nurses educate the patients while intervening and supporting the patients after surgery in collaboration with cardiologist. This has proven efficient in improving outcomes such as, mortality, readmission and quality of life in patients with heart failure. A multidisciplinary teamwork can provide a timely access to a clinical review of the patient and simultaneously look for signs and symptoms of complications to surgery. Although, previous studies have described Heart Valve Clinics, the effect gained from Heart Valve Clinics compared to usual care on readmission, mortality, cost-utility and patient-reported outcomes have not yet systematically been investigated.

Hypothesis: Early, individualized follow-up in a specialized Heart Valve Clinic can reduce hospital readmissions after heart valve surgery, and the intensified follow-up is cost effective.

Primary objective: To investigate the effect of individualized follow-up after heart valve surgery in a dedicated Heart Valve Clinic on non-planned readmissions after heart valve surgery and all-cause mortality.

Secondary objectives: To investigate the effect on a Heart Valve Clinic on health economics, and investigate possible changes in patient-reported outcomes before surgery, at discharge and 4 weeks after discharge.

Description of the cohort

Cohort:

Patient (under 18 years) undergoing Heart Valve Surgery at the Department of Cardiothoracic and Vascular Surgery at Odense University Hospital from 1.1.2013-15.11.2017

Data and biological material

Clinical data from electronical patient journals (Cosmic, Onbase and EPJ viewer)

Survey data (Patient-reported outcomes): EuroQol (Eq-5D-5L) and Kansas City Cardiomyopathy Questionnaire (KCCQ)

Registerbased data from the "Vestdansk Hjerteregister" 

Collaborating researchers and departments

Department of Cardiology, Odense University hospital

• Professor Jacob Eifer Møller, DmSc, PhD (supervisor)
• Consultant Jordi Dahl, MD, PhD

Department of Cardiothoracic and Vascular Surgery, Odense University Hospital

• Consultant Lars Peter Riber, MD, PhD (supervisor)

Department of Cardiology, Heart Centre, Rigshospitalet

• Associate Professor, Selina Kikkenborg Berg, PhD (supervisor)

National Institute of Public Health, University of Southern Denmark

• Statistician Ola Ekholm (supervisor)

Health Outcome Research Centre, Royal College of Surgeons in Ireland

• Director, Professor Jan Sørensen, PhD (supervisor)

Centre of Patient-Reported outcomes (CPROR), University of Birmingham

• Professor Melanie Calvert, PhD