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ORLANDO – with other intermittent ambulatory monitoring strategies, in a secondary analysis from the REVEAL AF study.
“If you really want to look for atrial fibrillation because your concern is that the patient has a high-risk profile, and if you saw it you would anticoagulate it and maybe prophylactically use rate control, nothing beats the implanted monitor,” James A. Reiffel, MD, said at the annual meeting of the American College of Cardiology.
As previously reported (JAMA Cardiol. 2017 Oct 1;2[10]:1120-7), the primary outcome – an AF episode lasting for at least 6 minutes – occurred during the first 18 months of the study in 29% of participants. By 30 months, it was 40%. At ACC 2018, Dr. Reiffel presented a new analysis looking at how the insertable cardiac monitor (ICM) would have stacked up against other device-based strategies aimed at detecting silent AF, including a 30-day implantable memory loop, daily transtelephonic ECG monitoring, and one-time or periodic 24- or 48-hour Holter monitoring.
To accomplish this, he and his coinvestigators conducted modeling studies harnessing the REVEAL AF continuous monitoring data. They looked at how many of the real-world patients found to have AF in the study would have been identified had they instead undergone a one-time recording period lasting 1, 2, 7, 14, or 30 days beginning at the time they would have received their ICM. They also looked at the yield of repeated monitoring strategies, including monthly or quarterly 24- or 48-hour Holter monitoring sessions. They repeated the various simulated monitoring strategies 10,000 times each in order to beef up the sample size and stability of the results.
It was no contest, according to Dr. Reiffel, professor of clinical medicine at Columbia University in New York.
That’s because the median time to AF detection in REVEAL AF was 123 days. Thus, any monitoring strategy of 30 days duration or less was doomed to be of comparatively low yield. Indeed, the 12-month AF incidence rate as detected by ICM in REVEAL AF was 27.1%, compared with 1.1%-13.5% for the various modeled monitoring strategies.
Among patients who met the primary endpoint in REVEAL AF, 10.2% had one or more AF episodes lasting 24 hours or more. So a significant proportion of the asymptomatic episodes of AF were not brief.
The take-home lesson of this analysis is straightforward, he said. “While the incidence of screen-detected atrial fibrillation is dependent upon the population screened, it is also strongly dependent upon the duration and intensity of monitoring.”
Session cochair Jeanne E. Poole, MD, observed that while the new REVEAL AF analysis is informative, it leaves unanswered the big questions regarding the clinical importance of these silent episodes of subclinical device-detected AF. That is, are these episodes associated with significantly increased stroke risk, and if so are they just another nonmodifiable risk marker, or are they a risk factor that can be dampened via oral anticoagulation, like symptomatic AF? said Dr. Poole, professor of medicine and director of the clinical cardiac electrophysiology program at the University of Washington, Seattle.
“My own belief is that they are both a risk marker and a risk factor that contributes to stroke,” Dr. Reiffel replied.
He noted that there are two major ongoing clinical trials evaluating the impact of oral anticoagulation in patients with ICM-detected AF. The 3,400-patient German multicenter Non–vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes (NOAH–AFNET 6 ) trial is testing whether oral anticoagulation with edoxaban (Savaysa) is superior to aspirin or no antithrombotic therapy for prevention of stroke or cardiovascular death. And the 4,000-patient Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation (ARTESIA) trial is randomizing patients to apixaban (Eliquis) or aspirin.
“We’ll know within the next 3-4 years whether patients with high-risk profiles for atrial fibrillation but no clinically manifest atrial fibrillation should in fact be detected and should in fact be anticoagulated if atrial fibrillation is detected. Putting on my ‘Carnac The Magnificent’ hat [made famous by Johnny Carson on the ‘Tonight Show’], I predict the answer to both of those questions is likely to be yes,” the cardiologist added.
He noted that the Medtronic ICM, which is one-third the size of a AAA battery, is implanted via a small incision, which is then covered by a adhesive bandage.
“There’s no major surgical technique involved in putting [int ICM] in,” he said.
The REVEAL AF study was sponsored by Medtronic. Dr. Reiffel reported serving as a consultant to the company.
SOURCE: Reiffel JA et al. ACC 2018, Abstract 900-08.
ORLANDO – with other intermittent ambulatory monitoring strategies, in a secondary analysis from the REVEAL AF study.
“If you really want to look for atrial fibrillation because your concern is that the patient has a high-risk profile, and if you saw it you would anticoagulate it and maybe prophylactically use rate control, nothing beats the implanted monitor,” James A. Reiffel, MD, said at the annual meeting of the American College of Cardiology.
As previously reported (JAMA Cardiol. 2017 Oct 1;2[10]:1120-7), the primary outcome – an AF episode lasting for at least 6 minutes – occurred during the first 18 months of the study in 29% of participants. By 30 months, it was 40%. At ACC 2018, Dr. Reiffel presented a new analysis looking at how the insertable cardiac monitor (ICM) would have stacked up against other device-based strategies aimed at detecting silent AF, including a 30-day implantable memory loop, daily transtelephonic ECG monitoring, and one-time or periodic 24- or 48-hour Holter monitoring.
To accomplish this, he and his coinvestigators conducted modeling studies harnessing the REVEAL AF continuous monitoring data. They looked at how many of the real-world patients found to have AF in the study would have been identified had they instead undergone a one-time recording period lasting 1, 2, 7, 14, or 30 days beginning at the time they would have received their ICM. They also looked at the yield of repeated monitoring strategies, including monthly or quarterly 24- or 48-hour Holter monitoring sessions. They repeated the various simulated monitoring strategies 10,000 times each in order to beef up the sample size and stability of the results.
It was no contest, according to Dr. Reiffel, professor of clinical medicine at Columbia University in New York.
That’s because the median time to AF detection in REVEAL AF was 123 days. Thus, any monitoring strategy of 30 days duration or less was doomed to be of comparatively low yield. Indeed, the 12-month AF incidence rate as detected by ICM in REVEAL AF was 27.1%, compared with 1.1%-13.5% for the various modeled monitoring strategies.
Among patients who met the primary endpoint in REVEAL AF, 10.2% had one or more AF episodes lasting 24 hours or more. So a significant proportion of the asymptomatic episodes of AF were not brief.
The take-home lesson of this analysis is straightforward, he said. “While the incidence of screen-detected atrial fibrillation is dependent upon the population screened, it is also strongly dependent upon the duration and intensity of monitoring.”
Session cochair Jeanne E. Poole, MD, observed that while the new REVEAL AF analysis is informative, it leaves unanswered the big questions regarding the clinical importance of these silent episodes of subclinical device-detected AF. That is, are these episodes associated with significantly increased stroke risk, and if so are they just another nonmodifiable risk marker, or are they a risk factor that can be dampened via oral anticoagulation, like symptomatic AF? said Dr. Poole, professor of medicine and director of the clinical cardiac electrophysiology program at the University of Washington, Seattle.
“My own belief is that they are both a risk marker and a risk factor that contributes to stroke,” Dr. Reiffel replied.
He noted that there are two major ongoing clinical trials evaluating the impact of oral anticoagulation in patients with ICM-detected AF. The 3,400-patient German multicenter Non–vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes (NOAH–AFNET 6 ) trial is testing whether oral anticoagulation with edoxaban (Savaysa) is superior to aspirin or no antithrombotic therapy for prevention of stroke or cardiovascular death. And the 4,000-patient Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation (ARTESIA) trial is randomizing patients to apixaban (Eliquis) or aspirin.
“We’ll know within the next 3-4 years whether patients with high-risk profiles for atrial fibrillation but no clinically manifest atrial fibrillation should in fact be detected and should in fact be anticoagulated if atrial fibrillation is detected. Putting on my ‘Carnac The Magnificent’ hat [made famous by Johnny Carson on the ‘Tonight Show’], I predict the answer to both of those questions is likely to be yes,” the cardiologist added.
He noted that the Medtronic ICM, which is one-third the size of a AAA battery, is implanted via a small incision, which is then covered by a adhesive bandage.
“There’s no major surgical technique involved in putting [int ICM] in,” he said.
The REVEAL AF study was sponsored by Medtronic. Dr. Reiffel reported serving as a consultant to the company.
SOURCE: Reiffel JA et al. ACC 2018, Abstract 900-08.
ORLANDO – with other intermittent ambulatory monitoring strategies, in a secondary analysis from the REVEAL AF study.
“If you really want to look for atrial fibrillation because your concern is that the patient has a high-risk profile, and if you saw it you would anticoagulate it and maybe prophylactically use rate control, nothing beats the implanted monitor,” James A. Reiffel, MD, said at the annual meeting of the American College of Cardiology.
As previously reported (JAMA Cardiol. 2017 Oct 1;2[10]:1120-7), the primary outcome – an AF episode lasting for at least 6 minutes – occurred during the first 18 months of the study in 29% of participants. By 30 months, it was 40%. At ACC 2018, Dr. Reiffel presented a new analysis looking at how the insertable cardiac monitor (ICM) would have stacked up against other device-based strategies aimed at detecting silent AF, including a 30-day implantable memory loop, daily transtelephonic ECG monitoring, and one-time or periodic 24- or 48-hour Holter monitoring.
To accomplish this, he and his coinvestigators conducted modeling studies harnessing the REVEAL AF continuous monitoring data. They looked at how many of the real-world patients found to have AF in the study would have been identified had they instead undergone a one-time recording period lasting 1, 2, 7, 14, or 30 days beginning at the time they would have received their ICM. They also looked at the yield of repeated monitoring strategies, including monthly or quarterly 24- or 48-hour Holter monitoring sessions. They repeated the various simulated monitoring strategies 10,000 times each in order to beef up the sample size and stability of the results.
It was no contest, according to Dr. Reiffel, professor of clinical medicine at Columbia University in New York.
That’s because the median time to AF detection in REVEAL AF was 123 days. Thus, any monitoring strategy of 30 days duration or less was doomed to be of comparatively low yield. Indeed, the 12-month AF incidence rate as detected by ICM in REVEAL AF was 27.1%, compared with 1.1%-13.5% for the various modeled monitoring strategies.
Among patients who met the primary endpoint in REVEAL AF, 10.2% had one or more AF episodes lasting 24 hours or more. So a significant proportion of the asymptomatic episodes of AF were not brief.
The take-home lesson of this analysis is straightforward, he said. “While the incidence of screen-detected atrial fibrillation is dependent upon the population screened, it is also strongly dependent upon the duration and intensity of monitoring.”
Session cochair Jeanne E. Poole, MD, observed that while the new REVEAL AF analysis is informative, it leaves unanswered the big questions regarding the clinical importance of these silent episodes of subclinical device-detected AF. That is, are these episodes associated with significantly increased stroke risk, and if so are they just another nonmodifiable risk marker, or are they a risk factor that can be dampened via oral anticoagulation, like symptomatic AF? said Dr. Poole, professor of medicine and director of the clinical cardiac electrophysiology program at the University of Washington, Seattle.
“My own belief is that they are both a risk marker and a risk factor that contributes to stroke,” Dr. Reiffel replied.
He noted that there are two major ongoing clinical trials evaluating the impact of oral anticoagulation in patients with ICM-detected AF. The 3,400-patient German multicenter Non–vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes (NOAH–AFNET 6 ) trial is testing whether oral anticoagulation with edoxaban (Savaysa) is superior to aspirin or no antithrombotic therapy for prevention of stroke or cardiovascular death. And the 4,000-patient Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation (ARTESIA) trial is randomizing patients to apixaban (Eliquis) or aspirin.
“We’ll know within the next 3-4 years whether patients with high-risk profiles for atrial fibrillation but no clinically manifest atrial fibrillation should in fact be detected and should in fact be anticoagulated if atrial fibrillation is detected. Putting on my ‘Carnac The Magnificent’ hat [made famous by Johnny Carson on the ‘Tonight Show’], I predict the answer to both of those questions is likely to be yes,” the cardiologist added.
He noted that the Medtronic ICM, which is one-third the size of a AAA battery, is implanted via a small incision, which is then covered by a adhesive bandage.
“There’s no major surgical technique involved in putting [int ICM] in,” he said.
The REVEAL AF study was sponsored by Medtronic. Dr. Reiffel reported serving as a consultant to the company.
SOURCE: Reiffel JA et al. ACC 2018, Abstract 900-08.
REPORTING FROM ACC 2018
Key clinical point: Most patients at high risk for previously unidentified atrial fibrillation whose arrhythmia is detected by means of an insertable continuous ECG monitor would go unidentified by any other detection strategy.
Major finding: The median time to insertable cardiac monitor–based detection of a first episode of silent AF of at least 6 minutes length was 123 days.
Study details: This was a multicenter, prospective, single-arm study of 385 patients at high risk for AF who received an insertable cardiac monitor and were followed for 30 months.
Disclosures: The REVEAL AF study was sponsored by Medtronic. The presenter reported serving as a consultant to the company.
Source: Reiffel JA et al. ACC 2018, Abstract 900-08.