Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study

Nölker, Georg; Mayer, Julia; Boldt, Leif‐Hendrik; Seidl, Karlheinz; Driel, Vincent van; Massa, Thomas; Kollum, Marc; Brachmann, Johannes; Deneke, Thomas; Hindricks, Gerhard; Jung, Werner; Brunner, Kyle; Kraus, Sebastian; Hümmer, Alexander; Lewalter, Thorsten

doi:10.1111/jce.13089

Cited by 57 publications

(45 citation statements)

References 17 publications

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“…For example, in the Reveal XT Performance Trial (XPECT), the detection algorithm of the Reveal XT ICM (Medtronic, Minneapolis, MN, USA) identified AF patients with a sensitivity of 96.1% and specificity of 85.4% (R‐R interval variation analysis), compared with 100% sensitivity and 88.1% specificity for the patient‐based approach in our study. For the St. Jude Medical Confirm TM device (St. Jude Medical, St. Paul, MN, USA), 100% sensitivity and 85.7% specificity have been reported in a similar approach . The successor device to Reveal XT, Reveal LINQ, using both R‐R interval variation and a new P‐wave recognition algorithm for AF detection, demonstrated an improved sensitivity of 97.4% and specificity of 97.0% for patient‐based analysis of AF .…”

Section: Discussionmentioning

confidence: 95%

Clinical evaluation of a small implantable cardiac monitor with a long sensing vector

Piorkowski¹,

Busch

Nölker

et al. 2019

Pacing Clinical Electrophis

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IntroductionWe conducted this study to show the safety and efficacy of a new implantable cardiac monitor (ICM), the BioMonitor 2 (Biotronik SE & Co. KG; Berlin, Germany), and to describe the arrhythmia detection performance.MethodsThe BioMonitor 2 has an extended sensing vector and is implanted close to the heart. It can transmit up to six subcutaneous electrocardiogram strips by Home Monitoring each day. We enrolled 92 patients with a standard device indication for an ICM in a single‐arm, multicenter prospective trial. Patients were followed for 3 months, and 48‐h Holter recordings were used to evaluate the arrhythmia detection performance.ResultsOne patient withdrew consent and in one patient, the implantation failed. Two study device‐related serious adverse events were reported, satisfying the primary safety hypothesis. Implantations took 7.4 ± 4.4 min from skin cut to suture. At 1 week, the R‐wave amplitude was 0.75 ± 0.53 mV. In the 82 patients with completed Holter recordings, all patients with arrhythmias were correctly identified. False positive detections of arrhythmia were mostly irregular rhythms wrongly detected as atrial fibrillation (episode‐based positive predictive value 72.5%). Daily Home Monitoring transmission was 94.9% successful.ConclusionSafety and efficacy of the new device has been demonstrated. The detected R‐wave amplitudes are large, leading to a low level of inappropriate detections due to over‐ or undersensing.

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Section: Discussionmentioning

confidence: 95%

Clinical evaluation of a small implantable cardiac monitor with a long sensing vector

Piorkowski¹,

Busch

Nölker

et al. 2019

Pacing Clinical Electrophis

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“…Several approved ILR devices are available (fig 7 and fig 8). 82 In general, most automated algorithms use variability in the R-R interval to detect atrial fibrillation 838485. Some newer devices’ algorithms also incorporate the presence/absence of a P wave 86Table 7.…”

Section: Newer Detection Methodsmentioning

confidence: 99%

“…Some newer devices’ algorithms also incorporate the presence/absence of a P wave 86Table 7. summarizes studies evaluating the sensitivity and specificity of ILRs 83848587…”

Section: Newer Detection Methodsmentioning

confidence: 99%

Newer technologies for detection of atrial fibrillation

Zungsontiporn

Link

2018

BMJ

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Atrial fibrillation is a common arrhythmia that is associated with increased risk of stroke, which can be reduced with appropriate anticoagulation treatment. However, it remains underdiagnosed in contemporary clinical practice using conventional detection methods, resulting in missed opportunities to implement appropriate treatment. Newer technologies developed in recent years can potentially enhance the detection of atrial fibrillation and overcome certain limitations of the conventional methods. However, uncertainties remain about their use and the significance of atrial fibrillation detected by some of these newer technologies. This review examines the evidence supporting the use of some of these technologies and evaluates their applications in certain clinical scenarios.

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“…Both studies, however, showed that more than half of all AF episodes recorded on the ILR were false positives episodes, which resulted in a low positive predictive value. The DETECT-AF study evaluated the performance of the St. Jude Medical Confirm DM2102 ILR using the 48-hour Holter recording as a criterion standard [24]. There were no instances where the patients had an AF episode that was recorded by the Holter but missed by the ILR.…”

Section: Discussionmentioning

confidence: 99%

“…The improved detection of AF occurrence and AF characterization compared to intermittent ECG monitoring could significantly impact the clinical treatment decisions [16]. However, many studies on AF detection using ILRs have shown a lower-than-expected positive predictive value (PPV) due to a higher rate of false positive episodes [22][23][24][25].…”

Section: Introductionmentioning

confidence: 99%

Accuracy of implantable loop recorders for detecting atrial tachyarrhythmias after atrial fibrillation catheter ablation

et al. 2020

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Background: Implantable loop recorders (ILRs) can provide an enhanced possibility to detect atrial fibrillation (AF), but the accuracy, especially the positive predictive value (PPV), is controversial. This study aimed to evaluate the accuracy of ILRs for detecting AF through a comparison with Holter. Method and results: Thirteen patients who underwent AF ablation were enrolled. ILRs were implanted in all patients, who were scheduled to have Holter monitorings after the procedure. The incidence of AF was compared between the two modalities and analyzed for any correlations. A total of 51 Holters (67,985.5 min) and concomitant ILRs were available for the comparison. The judgment of the presence of AF did not perfectly correlate between the ILR and Holter (Kappa = 0.866, P < 0.001). In the ILR data, the sensitivity of detecting AF on the Holter was 81.6% (95% confidence interval [CI] 0.812-0.820; P < 0.001). The specificity was 99.9% (95% CI 0.998-0.999; P < 0.001). When the ILR detected AF, the PPV was 99.5% (95% CI 0.994-0.995), but the ILR did not detect AF, and the negative predictive value was 94.2% (95% CI 0.941-0.944). A separate analysis of AF/atrial tachycardia (AT) showed that the AT detection rate of the ILR was 2.3%. Conclusion: The ILR had a low false positive value and high PPV for AF events. However, it was limited in identifying AT.

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Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study

Abstract: The SJM Confirm DM2102 can accurately and repeatedly detect paroxysmal AF episodes of at least 2 minutes in length.

Cited by 57 publications

References 17 publications

Clinical evaluation of a small implantable cardiac monitor with a long sensing vector

Clinical evaluation of a small implantable cardiac monitor with a long sensing vector

Newer technologies for detection of atrial fibrillation

Accuracy of implantable loop recorders for detecting atrial tachyarrhythmias after atrial fibrillation catheter ablation

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