Slide 1: Reveal AF Study Results
STUDY RESULTS Medtronic
Slide 2: Atrial Fibrillation (AF) and Risk for Stroke
ATRIAL FIBRILLATION (AF) AND RISK FOR STROKE Stroke In 2013, the prevalence of stroke was 25.7 million and 6.5 million Prevalence died of stroke1 AF independently increases the risk of stroke 5-fold1 AF accounts for 1 in 4 strokes (80-89 years of age)1 Clinical Ischemic strokes associated with A
Slide 3: Stroke and AF: Similarities Among Risk Factors
STROKE AND AF SIMILARITIES AMONG RISK FACTORS CHADS2 Score CHA2DS2-VASc Score Evaluates ischemic stroke risk in Evaluates ischemic stroke risk in patients with AF patients with AF Congestive heart failure Congestive heart failure Hypertension Hypertension Age Age Diabetes Diabetes
Slide 4: Challenges in Diagnosing AF
CHALLENGES IN DIAGNOSING AF Symptoms are not a reliable indicator of AF AF episodes are frequently asymptomatic1-2 Approximately 1 out of 5 symptoms thought to be AF are actually due to AF1,3 AF is often paroxysmal • Difficult to detect with short-term and intermittent cardiac monitoring4-6
Slide 5: Reveal AF Study Objectives
REVEAL AF STUDY OBJECTIVES GOAL: To demonstrate the value of early screening and detection of AF via ICM monitoring in high-risk patients. Primary Determine the incidence rate of AF lasting greater than or equal to six minutes in patients who are at high risk of having AF. Secondary Identify pre
Slide 6: Reveal AF Study Design and Patient Inclusion Criteria
REVEAL AF STUDY DESIGN AND PATIENT INCLUSION CRITERIA Enrollment Prospective, single-arm, open- label, multi-center, post-market Baseline study Successful Reveal™ ICM insertion A CHADS2 score of ≥ 3 or CHADS2 = CareLink™ 2 and at least 1 of the following: transmissions Coronary artery disease
Slide 7: Reveal AF Study Enrollment
446 Assessed 52 Excluded REVEAL AF STUDY 25 Requested withdrawal 14 Inclusion/exclusion ENROLLMENT criteria not met 13 Other 394 Inserted 385 patients 9 Subjects inserted excluded from primary Analysis met the primary 3 deaths analysis cohort 6 CHADS2 ≤ 2 w/o 17 exited endpoint cohort ad
Slide 8: Subject Demographics and Medical History
SUBJECT DEMOGRAPHICS AND MEDICAL HISTORY Characteristic Subjects with device insertion (N = 394) Device inserted/attempted Reveal LINQ™ ICM 272 (69.0%) Reveal™ XT ICM 122 (31.0%) Gender: male 206 (52.3%) Age Mean ± standard deviation (years) 71.6 ± 9.8 Under 65 88 (22.3%) 65 to 75 131 (33.3%) 75 and
Slide 9: CHADS2 and CHA2DS2-VASc Scores
CHADS2 AND CHA2DS2-VASc SCORES Characteristic Subjects with device insertion (N = 394) CHADS2 score Mean ± standard deviation 2.9 ± 0.8 1 1 (0.3%) 2 158 (40.0%) 3 130 (33.2%) 4 or more 105 (26.6%) CHA2DS2-VASc score Mean ± standard deviation 4.4±1.3 2 25 (6.3%) 3 79 (20.1%) 4 112 (28.4%) 5 100 (25.4
Slide 10: Incidence of Adjudicated AF Lasting ≥6 Minutes in Duration
INCIDENCE OF ADJUDICATED AF LASTING ≥ 6 MINUTES IN DURATION Reiffel JA, et al. Heart Rhythm Society Scientific Sessions. 2017. 10
Slide 11: Incidence of Adjudicated AF Lasting ≥6 Minutes in Duration
INCIDENCE OF ADJUDICATED AF LASTING ≥ 6 MINUTES IN DURATION 40% 123 Days 84.5% AF detection rate was the median time of patients with AF at 30 months. to AF detection in would have been high-risk patients. missed if only monitored for 30 days. Reiffel JA, et al. Heart Rhythm Society Scientific Sessi
Slide 12: AF Incidence by CHADS2 Subgroup
AF INCIDENCE BY CHADS2 SUBGROUP There was no significant difference in detection rates between patients with CHADS2 2, 3, and 4 or more. Reiffel JA, et al. Heart Rhythm Society Scientific Sessions. 2017. 12
Slide 13: AF Episode Duration and Clinical Actions
AF EPISODE DURATION AND CLINICAL ACTIONS Among patients who met the primary outcome of ≥6 minutes of AF: 10.2% 56.3% 14.8% had at least one were prescribed were prescribed episode lasting OAC during rhythm-control ≥24 hours follow-up medication during follow-up AF detected through ICM monitoring was
Slide 14: Time to Onset of Daily AF Burden
TIME TO ONSET OF DAILY AF BURDEN Reiffel JA, et al. Heart Rhythm Society Scientific Sessions. 2017. 14
Slide 15: Subject Characteristics Predictive of AF Onset
SUBJECT CHARACTERISTICS PREDICTIVE OF AF ONSET Age and BMI were the only clinical characteristics independently predictive of AF, with AF incidence higher in older and more obese patients. Characteristics Hazard Ratio P-value Age (years) 1.079 <.0001 Body mass index 1.042 0.0198 Gender (male) 1.122
Slide 16: Reveal AF Study Summary
REVEAL AF STUDY SUMMARY AF is common in 84.5% of patients AF detected through AF detection did not patients at high risk with AF would Reveal ICM was differ between for AF and stroke. have been missed found to be actionable CHADS2 subgroups. with just 30 days by physicians. of monitoring. “Data from
Slide 17: Indications, Safety, and Warnings
INDICATIONS, SAFETY, AND WARNINGS If you are located in the United States, please refer to the brief statement below to review applicable indications, safety, and warning information. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warn
Slide 18: Indications, Safety, and Warnings
INDICATIONS, SAFETY, AND WARNINGS Patient Assistant Operation of the Patient Assistant near sources of electromagnetic interference, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device. Potential Complications Potential complications include, but are