Surgery Clinical Trial
Official title:
Individualised Follow-up After Valve Surgery
This study aims to investigate the effect of an intervention consisting of early,
individualised outpatient follow-up after heart valve surgery on unplanned readmissions and
death within 180-days after discharge.
Furthermore, Health economics and health-related quality of life will be investigated.
The incidence of valvular heart disease is estimated to exceed 42 million people worldwide.
In Denmark 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.
Heart valve surgery can be a lifesaving procedure for patients with severe symptomatic heart
valve disease, but complications after heart valve surgery are common and readmissions
frequent with rates exceeding 40% in Denmark. Most frequent causes for readmission, includes
new onset atrial fibrillation, pleural and pericardial effusions, infections and acute heart
failure. These causes can potentially be detected by careful outpatient follow-up in order to
avoid unplanned readmission, and improve mental, physical and social health outcomes. 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 PROs. PROs'
include validated patient health status surveys that allow quantification of critical
patient-centered outcomes. Further previous studies have suggested an association between
PROs and prolonged hospital stay, morbidity and mortality in cardiac patients. Knowledge
about PROs can potentially be used to identify patients that especially may benefit from
intensified follow-up after heart valve surgery.
Existing guidelines recommend that patients following valve surgery are reviewed on a regular
basis by a cardiologist with special knowledge about heart valve diseases. A recent European
study demonstrate though, a gap between the existing guidelines and clinical practice. A
plausible way to improving the postoperative care could be to introduce a multidisciplinary
heart valve clinic (HVC), where specialized nurses educates the patients while intervening
and supporting the patients after surgery in collaboration with cardiologist and surgeons.
This has proven efficient in improving outcomes such as, mortality, readmission and quality
of life in patients with heart failure.3 A multidisciplinary teamwork can provide a timely
access to a clinical review of the patient and simultaneously look for signs and symptoms of
valve dysfunction.18 Although, previous studies have described the HVCs. Although, previous
studies have described the HVCs, the effect gained from HVC compared to usual care on
readmission, mortality, cost-utility and patient-reported outcomes have not yet
systematically been investigated.
The aim for this study is firstly to describe PROs after heart valve surgery, incorporate the
knowledge into a structured intervention, and secondly to evaluate a HVC and its association
to PRO's, readmission, mortality and cost-utility.
The study consist of two parts,
- Matched cohort study comparing HVC to a historical control group to evaluate the effect
of the HVC on readmission, mortality and HRQoL.
- A health economic analysis of effect of the HVC compared to a historical control Group.
The intervention and collection of clinical data: Introducing a HVC to gain knowledge of its
effect on readmission, mortality and health economics.
Preoperative: Clinical data regarding the patient will be gathered at admission including
calculated Euroscore II, pulmonary function measured with spirometry, status on nutrition,
smoking and alcohol consumption, BMI, electrocardiography (ECG), and most recent
echocardiography. Furthermore, the patients' frailty status will be assessed with a gait
speed test the day before surgery and will be used in the risk model.
Postoperative: Before discharge a trained cardiac nurse will perform a screening for pleural
and pericardial effusion, volume overload, risk for atrial fibrillation and repeat frailty
assessment. Before discharge the patients' medication will be evaluated and adapted according
to their clinical status, and the patients will be educated in warning signs after surgery.
The surgical status will be evaluated before discharge. Based on these data and the PROs the
patients' follow-up will be individualized.
Follow-up: The specific follow-up will be planed according to the patients' status where
patients considered at high risk of being readmitted based on the clinical evaluation at
discharge (e.g. atrial fibrillation) will have a more intensive follow-up. The focus of the
follow-up will be a status on the patients' physical condition regarding; weight, pain and
shortness of breath in combination with the areas of the PROs from study I. Consideration on
further follow-up will be made depending on the condition of the patient.
After 1 month all patients will be seen in the HVC where ECG and echocardiography will be
performed. At each visit the patient will be educated and informed regarding the disease and
illnesses, which should lead to a better understanding and self-management of care in the
post-operative period. The aim of the education is to give the patient the insight to
promptly identify and report the symptoms and signs for progression of their valve disease or
dysfunction of their prosthetic or repaired valve. The patient education thereby also aims to
improve the patients' wellbeing and psychological condition by an increase of the feeling of
security and by preventing poor physical outcomes.
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