None listed
Conditions
Brief summary
Atrial fibrillation (AF) is the most common abnormal heart rhythm occurring after surgery and acute medical admissions. Postoperative AF patients, discharged home in normal heart rhythm, have 5 times the stroke risk of those without postoperative AF. Postoperative AF after general surgery has been little studied. After cardiac surgery, patients frequently attend cardiac rehabilitation, and are routinely followed by cardiac professionals. The same support is seldom available after non-cardiac surgery, New AF, secondary to acute medical illness, is associated with higher long and short term mortality & stroke rates, & increased length of hospital stay. New AF occurs in 7.2% of medical ICU patients; 10% with sepsis; 44% with septic shock; & 10% with acute respiratory distress syndrome. Patients with infections have increased risk of developing new-AF (odds ratio [OR] 1.54), specifically: pneumonia OR 2.6, urinary tract infection OR 1.4, and intra-abdominal infection OR 1.6. We predict that if AF recurrence is identified early after discharge, strokes can be prevented by effective treatment. Currently, monitoring for recurrence falls mostly on the patient recognising AF symptoms. Unfortunately, AF recurrence is largely asymptomatic or has non-specific symptoms confused with normal recovery and therefore unlikely to be identified by the patient. We hypothesise patients can self-identify early recurrent secondary AF post-discharge, by taking multiple daily recordings for a month using a simple handheld smartphone ECG which provides an accurate, immediate AF diagnosis. Before commencing a larger expensive trial it is necessary to test the feasibility of the intervention, and provide an estimate of the rate of symptomatic and asymptomatic secondary AF. Results from this feasibility study will inform and refine the design of a larger intervention study. Primary aims are to provide data regarding feasibility of patient self-monitoring for AF recurrence post discharge using an iECG. The secondary end-points relate to the incidence of secondary AF following non-cardiac surgery or acute medical illness, and the incidence of AF recurrence following discharge. This cross sectional feasibility study will recruit 50 patients with new-onset post-operative AF following non-cardiac surgery, who have returned to normal sinus rhythm prior to discharge. Participants will be provided with a handheld smartphone; and will record an ECG ~5 x/day for 4 weeks. Participants experiencing possible AF symptoms will keep a diary of these and perform additional ECG recordings. Each ECG is analysed by the ‘on-device algorithm’. If ‘possible AF’ is diagnosed, the participant will take additional ECG recordings, and contact their treating doctor for review as soon as practicable. The research assistant will review each ECG and the algorithm diagnosis, and will contact participants to ensure they have appropriately followed up any abnormal ECG’s.
Interventions
STUDY POPULATION:
All patients with an in-hospital episode of new-onset atrial fibrillation (AF), secondary to admission for non-cardiac surgery or acute medical illness (i.e. admitted to hospital in sinus rhythm; no AF history); AND reversion or successful cardioversion to sinus rhythm prior to discharge; AND age >or= 40 years. Patients must be able to provide informed consent. Patients will be excluded if they are non-English speaking; or have insufficient cognitive capacity for the consent an
STUDY POPULATION: All patients with an in-hospital episode of new-onset atrial fibrillation (AF), secondary to admission for non-cardiac surgery or acute medical illness (i.e. admitted to hospital in sinus rhythm; no AF history); AND reversion or successful cardioversion to sinus rhythm prior to discharge; AND age >or= 40 years. Patients must be able to provide informed consent. Patients will be excluded if they are non-English speaking; or have insufficient cognitive capacity for the consent and interview process; or are unable to be contacted in the post-discharge period INTERVENTION: All consenting patients will receive approximately 10 minutes of AF education from the research cardiac nurse, during their inpatient stay. The education will be one-on-one, and will specifically cover what AF is, the associated health risks (particularly stroke), AF symptoms, and AF treatment. Patients will be offered the choice of either a 2-page education handout from the Australian Atrial fibrillation Association (i.e. AF Fact sheet: http://www.atrialfibrillation-au.org/files/file/Publications/02082013%20AFA%20Australia%20Atrial%20Fibrillation%20-%20(P).pdf); or a more detailed 15-page handout from the Australian National Heart Foundation (https://heartfoundation.org.au/images/uploads/publications/CON-175_Atrial_Fibrillation_WEB.PDF). Participants will also be provided with a handheld smartphone ECG device called the Kardia (AliveCor) Heart monitor which is an approved medical device (ARTG Identifier 208100). The Kardia Heart monitor is a special cover that attaches to a smartphone, which enables a single lead ECG reading to be taken using an application on the smartphone. Participants will be taught how to record their own ECG recording. Following hospital discharge, participants will commence recording an ECG ~5 times/day, continuing for four weeks. Recordings will be spread out through the day at times suitable to the participant (e.g. Immediately before breakfast, lunch, dinner and sleep). Participants experiencing symptoms possibly due to AF (including palpitations, dizziness and syncope) will record these in a diary and perform additional ECG recordings. Each ECG will be analysed by the validated ‘on-device algorithm’ to give them a rhythm diagnosis. If ‘possible AF’ is diagnosed, the participant will take additional ECG recordings, and contact their treating doctor for review as soon as practicable. Each ECG recording automatically transmits to a secure server. All ECG data on the server are coded for each participant and therefore are not identifiable by a third party. The research assistant will review each ECG and the algorithm diagnosis, and will contact participants to ensure they have appropriately followed up any abnormal ECG’s with their treating general practitioner. FOLLOW UP: A follow-up assessment will be performed 4 weeks post hospital discharge. On completion, a letter summarising the participant’s specific outcomes will be sent to their treating doctors. The participant will also be invited to participate in semi-structured interviews to explore their experience using the handheld ECG and factors related to future sustainability. All participants will receive a final follow-up phone call at 3 months.
Sponsors
University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients with an in-hospital episode of new-onset secondary AF following admission for non-cardiac surgery or an acute medical illness (i.e. admitted to hospital in sinus rhythm; no AF history); AND reversion or successful cardioversion to sinus rhythm prior to discharge; AND age > or =40 years. Patients must be able to provide informed consent.
Exclusion criteria
Patients will be excluded if they are non-English speaking; or have insufficient cognitive capacity for the consent and interview process; or are unable to be contacted in the post-discharge period.
Outcome results
None listed