Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Lung Neoplasms

Atrial Fibrillation

Arrhythmias, Cardiac

Heart Diseases

Sadeesh Srinathan, MD

Emma Poole

Atrial fibrillation (AF) is a common and serious complication after lung resection. The incidence is likely underestimated, and risk may persist after leaving hospital. Recent development of simple wearable patch ECG devices may provide sensitive detection of AF in the extended postoperative period. Specific biomarkers may allow us to predict which patients are at risk of developing postoperative AF.

Postoperative atrial fibrillation (POAF) is a serious complication that can occur after thoracic surgery. A substantial proportion of AF is clinically silent, detectable only by ECG monitoring. Despite the lack of symptoms, it is still associated with increased risk of stroke, and may partly explain the risk of postoperative mortality after discharge from hospital.

No studies have been completed investigating the occurrence of AF in an extended period of monitoring following non-cardiac surgery, including thoracic surgery. In the limited literature on extended ECG monitoring following cardiac surgery, recurrent AF affected 24% of patients after discharge from hospital, and only 30% had symptoms. In total, 49% of patients in these studies had POAF up to two weeks after surgery.

Detection of POAF increases with more intensive monitoring. Therefore investigators believe that the incidence of POAF is underestimated, and extended monitoring using a patch ECG device will allow increased detection of clinically evident and silent POAF.

Investigators will place CardioSTAT (Icentia Inc, QC, Canada) patch ECG devices on patients immediately after thoracic surgery. They will be worn for two weeks continuously, following which they are returned by mail to the manufacturer. These devices are simple to apply and can be worn even in the shower and while exercising. Technologist interpretation is provided by the manufacturer, and will be corroborated by our study cardiologist.

Patients will also wear the patch ECG for 14 days prior to surgery. This will provide information on how many patients have silent AF at baseline, and will make it possible to determine whether AF after surgery is new or is an exacerbation of a pre-existing but unknown condition.

A total of 100 patients will allow a 95% confidence interval of 21-40% around an assumed true POAF incidence of 30%. The lower limit exceeds conventional estimates of POAF following thoracic surgery, and would provide strong support for our hypothesis.

Continuous Ambulatory ECG Monitoring for Detection of Postoperative Atrial Fibrillation Following Thoracic Surgery

Determined by proportion of patients enrolled

Determined by telephone follow-up and check of medical records

Number of atrial fibrillation events per patient developing POAF

Duration of atrial fibrillation events per patient developing POAF

Number of patients with subclinical AF prior to surgery

Number of patients completing full 14-day use of CardioSTAT device

Number of days CardioSTAT device worn per patient

Number of patients completing symptom journal

University of Manitoba

Nervous System Diseases

Stroke

This is the only arm in the study and patients within it will have a small, pebble shaped device adhered to their chests. This is an ECG (electrocardiogram) monitor and will measure the incidence of atrial fibrillation. It will have to be worn for 14 days before and after the lung resection procedure

The iRhythm ZIO XT patch is an ECG monitor that has to be worn by study participants. It will be used to track any incidence of atrial fibrillation.

iRhythm ZIO XT patch

Yaron Shargall, MD FRCSC

Lung resections for pulmonary malignancies offer the best chance of survival for patients, but these procedures carry a significant burden of post-operative morbidity and mortality. Patients are particularly at high risk for post-operative atrial fibrillation (a condition involving irregular heart rhythm). Atrial fibrillation with symptoms can increase the risk of stroke - a blockage in a major blood vessel in the brain, which can potentially result in a disability or even death. The objective of this study is to establish the feasibility of using ambulatory heart rate monitoring to determine the total incidence of atrial fibrillation in the peri-operative period before and after anatomic lung resection for malignancies. The study will also investigate the correlation between atrial fibrillation and rates of stroke and other adverse events, as well as serve to identify the patients that are at a higher risk of developing atrial fibrillation.

Novel literature suggests that atrial fibrillation that is asymptomatic may just be as problematic as atrial fibrillation that presents itself with symptoms. The objective of the study is to establish the feasibility of tracking the total incidence of atrial fibrillation in the peri-operative period, including both symptomatic and asymptomatic events, using an ambulatory heart monitor. Additionally, the study aims to estimate the overall incidence of peri- and post-operative atrial fibrillation. These will be accomplished through usage of iRhythm ZIO XT, a small pebble shaped device that will be adhered to the patient's chest for 14 days before and after surgery, to measure how often atrial fibrillation occurs.

Determining the True Incidence of Atrial Fibrillation Before and After Lung Resection

Proportion of patients who are determined to be eligible for study relative to the number of patients actually enrolled and consented for participation in the study. This will help to inform the willingness of patients to participate in this study

Patient adherence to the device attachment requirements as stated in the study protocol, defined as the device remaining in place for at least 90% of the expected 28 day patch period (14 days before surgery and 14 days after) to determine feasibility of the study protocol in clinical context and patient tolerability. This will be measured by the iRhythm ZIO XT patch output.

Patient adherence to the symptomatic atrial fibrillation event logging task as stated in the study protocol, defined as the successful manual triggering of the device by the patient to note at least 80% of symptomatic events over the expected 28 day patch period (14 days before surgery and 14 days after) to determine feasibility of the study protocol in clinical context and patient tolerability. This will be measured by the iRhythm ZIO XT patch output.

Number of patients who choose to withdraw from the study, defined as those who fail to complete the 14-day baseline monitoring period before surgery, decline to wear the device post-operatively, or drop out partway through the 14-day post-operative monitoring period. This will be measured by ongoing discussion with the patient and will help to determine the feasibility of the study protocol in clinical context and patient tolerability.

Number of unknown/asymptomatic/occult atrial fibrillation in the high-risk malignant lung resection population before surgery so that we know whether any differences in the event rate after surgery are likely to be as a result of the surgery itself. This will be measured by having patients wear the iRhythm ZIO XT patch for the 2 weeks before surgery

Number of symptomatic and asymptomatic atrial fibrillation cases that occurred within 14 days of lung resection surgery, automatically measured by the iRhythm ZIO patch device for 2 weeks from the day after surgery

To compare the difference in post-operative atrial fibrillation rates between those who experienced any atrial fibrillation pre- and intra-operatively (recurrent atrial fibrillation) with those who did not as measured by a comparison of the two 14 day readings assessed by the iRhythm ZIO XT patch device.

Number of asymptomatic atrial fibrillation events during the 28 day monitoring period, adjudicated by cardiology consultation of the ZIO XT patch output

Number of non- atrial fibrillation arrhythmias during the 14-day post-discharge time interval following lung resection, adjudicated by cardiology consultation of the ZIO XT patch output

Measure whether there is a difference in the number of recurrent, asymptomatic and/or symptomatic atrial fibrillation events depending on the amount of lung tissue removed as part of the resection, measured as per review of surgical characteristics noted in patient records

Measure whether there is a difference in the number of recurrent, asymptomatic and/or symptomatic atrial fibrillation events depending on whether an open or a minimally invasive technique was used to complete resection, measured as per review of surgical characteristics noted in patient records

Number of deaths within 90 days of surgery, comparing between event-free and peri-operative atrial fibrillation sub-cohorts as determined by patient chart review

Number of strokes in untreated patients in the 30 and 90 day follow up periods, comparing between event-free and peri-operative atrial fibrillation cohorts as measured by the validated Questionnaire for Verifying Stroke-Free Status (QVSFS)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Continuous Ambulatory ECG Monitoring for Detection of Postoperative Atrial Fibrillation Following Thoracic Surgery	NCT04325269	Lung Cancer Atrial Fibrilla...		55 Years -	University of Manitoba
Determining the True Incidence of Atrial Fibrillation Before and After Lung Resection	NCT02547168	Lung Cancer Atrial Fibrilla... Stroke	iRhythm ZIO XT ...	18 Years -	McMaster University
Continuous Ambulatory ECG Monitoring for Detection of Postoperative Atrial Fibrillation Following Thoracic Surgery	NCT04325269	Lung Cancer Atrial Fibrilla...		55 Years -	University of Manitoba
Continuous Ambulatory ECG Monitoring for Detection of Postoperative Atrial Fibrillation Following Thoracic Surgery	NCT04325269	Lung Cancer Atrial Fibrilla...		55 Years -	University of Manitoba

Spots Global Cancer Trial Database for symptomatic atrial fibrillation