Atrial Fibrillation, Nurse's Role, Risk Reduction
Conditions
Keywords
pulmonary vein isolation
Brief summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia and has a rising prevalence due to an aging population. AF increases the patient's risk of hospitalization, heart failure and stroke and results into deterioration of quality of life. Treatment of symptomatic AF consists of either antiarrhythmic medication or a pulmonary vein isolation (PVI) catheter ablation. However, lots of patients experience recurrence of AF in the first year after PVI. Previous studies showed that PVI outcomes depend on the presence of different treatable risk factors that influence the substrate for AF. Those risk factors include obesity, hypertension, cholesterol, diabetes mellitus, alcohol use, smoking and obstructive sleep apnea syndrome. However, research into the effect of treatment of those risk factors mainly consists of observational studies. Currently, it is not clear to what extent patients will benefit from comprehensive risk factor treatment prior to PVI in terms of ablation success and quality of life. The aim of the current randomized controlled trial is to determine the effect of a nurse-led, technology-supported, personalized care pathway on hospital admissions for cardioversions and re-ablation in patients with AF that are referred for ablation. Patients included in this study will be randomized to either the intervention group receiving the comprehensive risk treatment before PVI or the control group receiving standard usual care. Patients in the intervention group will visit the specialized AF nurse outpatient clinic and receive a personalized treatment plan (with a maximal duration of 6 months) including lifestyle interventions and medication. This includes sleep apnea screening with a Home Sleep Apnea Test (WatchPAT). Patients will also use the VitalHealth Engage platform. The digital platform can be used at home to report AF complaints, send home measurement and complete questionnaires. Furthermore, it supports the nurse in administering effective lifestyle changes by offering the patient personalized content and education. Both study groups will be followed up to 12 months after ablation, during which hospital admissions for cardioversion and re-ablation are evaluated. At baseline, AFEQT, EQ5D and TBQ quality of life questionnaires will be performed. The questionnaires will be repeated prior to ablation, at 3 and 12 months after ablation. At baseline, pre-ablation and after 12 months laboratory tests (such as cholesterol) will be performed to evaluate adherence to lifestyle interventions.
Interventions
OTHERComprehensive risk factor treatment
1. Apnea screening with Home Sleep Apnea Test. Referral to sleep physician if apnea-hypopnea index (AHI) is greater than 5 2. Weight management counseling by dietician if body mass index (BMI) is above 27 kg/m2 3. Physical activity program under supervision of physiotherapist at a specialized cardiac rehabilitation centre if BMI is over 27 or if there are complaints during exercise 4. Smoking cessation at specialized outpatient clinic 5. Blood pressure control, lipid management, glycaemic control, alcohol intake reduction by specialized AF nurse 6. Motivation and education through a digital health platform
OTHERStandard of care
Standard usual care: Treatment by cardiologist conform existing guidelines
Sponsors
Catharina Ziekenhuis Eindhoven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with paroxysmal or persistent symptomatic atrial fibrillation referred for initial catheter ablation * Patients should be native Dutch speakers * Patients are able to use the VitalHealth Engage platform on their own preferred device (tablet, mobile phone, computer) * The patient has at least one of the following risks 1. BMI ≥27 kg/m2, 2. hyperlipidaemia (LDL-cholesterol \>2.6 mmol/L or total cholesterol \>5.0 mmol/L), 3. hypertension (blood pressure \>130/90 mmHg), 4. diabetes mellitus with HbA1c ≥53 mmol/mol, 5. active smoking, 6. excess alcohol use (\>14 equivalent units of alcohol / week)
Exclusion criteria
* Longstanding persistent atrial fibrillation (persistent AF for more than 1 year) * Permanent atrial fibrillation * Asymptomatic atrial fibrillation * Prior catheter ablation * Paroxysmal atrial fibrillation consisting of one episode with a reversible cause (e.g. fever, surgery, thyroid crisis, ischemic) * Severe valvular heart disease * Prior or soon foreseen implantation of cardiac device such as pacemaker or internal cardioverter defibrillator * Unstable heart failure New York Heart Association (NYHA) IV, or heart failure necessitating admission \<3 months before inclusion * Cardiac surgery \<3 months before inclusion or planned cardiac surgery * Patient is not willing to use a mobile phone application or willing to undergo elaborate monitoring. * Malignancy * Life expectancy \<1 year * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of hospital visits for cardioversion of AF and re-ablations | Up to 12 months after ablation or finishing risk treatment | All events that occur between study inclusion and up to 12 months after ablation, including events prior to ablation. This means that events during the risk factor treatment period are also included |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The composite of mortality, stroke or hospitalization for heart failure or acute ischemic events. | Up to 12 months after ablation | Number of events. All events that occur between study inclusion and up to 12 months after ablation, including events prior to ablation. |
| All-cause mortality | Up to 12 months after ablation or finishing risk treatment | Any deaths occurring during the study. |
| Number of strokes | Up to 12 months after ablation or finishing risk treatment | All events that occur between study inclusion and up to 12 months after ablation, including events prior to ablation. |
| Hospitalizations for heart failure or acute ischemic events | Up to 12 months after ablation or finishing risk treatment | Number of events. All events that occur between study inclusion and up to 12 months after ablation, including events prior to ablation. |
| Quality of Life - EQ-5D | Up to 12 months after ablation or finishing risk treatment | Quality of Life as measured by the EuroQol 5 Dimensions (EQ-5D) questionnaire. The questionnaire compromises 5 dimensions describing different aspects of health and an overall health perception. The 5 dimensions can each be scored from level 1 to 5. Lower levels correspond with higher quality of life and higher levels correspond with lower quality of life. Overall health perception is scored with a visual analogue scale (VAS) ranging from 0 to 100, with lower values corresponding with worse outcomes and higher values corresponding to better outcomes. |
| Quality of Life - Atrial Fibrillation Effect on QualiTy of life survey (AFEQT) | Up to 12 months after ablation or finishing risk treatment | Quality of Life as measured by the AFEQT questionnaire. The questionnaire contains 21 questions on a seven point Likert scale. Overall score ranges from 0 to 100. A score of 0 corresponds with complete disability, while a score of 100 corresponds with no disability. |
| Treatment burden - Treatment Burden Questionnaire (TBQ) | Up to 12 months after ablation or finishing risk treatment | Treatment burden is the perception of cumulative work a patient has to perform to manage their health. The TBQ consists out of 15 items with a ten point rating scale. A higher score corresponds to a greater burden, while a lower score corresponds with a lower burden. |
| Rate of Success for ablation | From 3 months after ablation up to 12 months after ablation | The ablation is considered to be successful if patients could stop their antiarrhythmics after 3 months (the blanking period) without recurrent arrhythmia. If patients develop recurrent arrhythmia and had to restart antiarrhythmics after the blanking period, the index ablation is considered unsuccessful. |
| Number of Cancellations of index ablation | Up to 12 months after finishing risk factor treatment | Patients might experience absence of AF complaints after they have had effective treatment of their risk factors. The treating cardiologist might decide to cancel the index ablation if patients do not experience any AF complaints. |
| Number of hospital visits for cardioversion of AF | Up to 12 months after ablation or finishing risk treatment | All events that occur between study inclusion and up to 12 months after ablation, including events prior to ablation. |
| Number of reablations | Up to 12 months after ablation or finishing risk treatment | All events that occur between study inclusion and up to 12 months after ablation, including events prior to ablation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient value | Up to 12 months after ablation or finishing risk treatment | Patient value will be assessed from a Value-Based Healthcare perspective. This will be done by dividing patient relevant outcomes, the quality of life as assessed by EQ-5D and AFEQT, through the costs per patient to achieve these outcomes. |
| Ablation - procedure times | During ablation | Procedure time and fluoroscopy time |
| Ablation - DAP | During ablation | Dose area product (DAP) during ablation, presented in mGy·cm2 |
| Weight target achievement | Up to 12 months after finishing risk factor treatment | Weight (in kg) will be measured at follow-up to determine whether patients did reach the target of losing 10% of total body weight. |
| Blood pressure target achievement | Up to 12 months after finishing risk factor treatment | Blood pressure (in mmHg) will be measured at follow-up to determine whether the target of \<130/80 mmHg was reached. |
| Success of treatment of sleep apnea | Up to 12 months after finishing risk factor treatment | The apnea-hypopnea index (AHI) is used to determine the effect of sleep apnea treatment. AHI is determined at the start and end of sleep apnea treatment |
| Medical costs | Up to 12 months after ablation or finishing risk treatment | An economic evaluation will be performed by examining all study intervention and AF related hospital costs. The total costs for both study groups will be compared |
| Cost-effectiveness ratio | Up to 12 months after ablation or finishing risk treatment | Cost-effectiveness ratio will be analyzed by aggregating number of cardioversions and number of re-ablations and AF related medical costs. The cost-effectiveness ratio is the net costs per prevented cardioversion or re-ablation. |
Countries
Netherlands
Outcome results
None listed