Initial experience with an insertable loop recorder in patients with recurrent unexplained syncope

Abstract Aims The newer insertable loop recorder device (Reveal Plus 9526, Medtronic Inc, Minneapolis MN, U.S.A.) is equipped with auto-activation capabilities. In this study we investigated whether the new device encounters sensitivity problems in the form of oversensing or undersensing. We also tested whether body position changes influence the sensed electrogram's amplitude, therefore affecting the device's autosensing ability. Methods and results We enrolled 32 patients aged 58·1±11·7 years with a loop recorder implanted either in the left parasternal or in the heart's apex area, to investigate undiagnosed syncopal episodes after initial assessment. During the follow-up period (5·7±2·7 months), that began 6 months after the device implantation, we analysed 284 auto-recorded episodes (103 undersensed and 181 correctly sensed). No oversensing episodes were recorded. The recorded QRS amplitude in five different body positions: supine, left and right lateral, sitting and standing was measured. No statistically significant changes were observed in the different postures. Even when patients were divided into subgroups according to implant site or the occurrence of undersensing episodes, no significant inter- or intra-group differences of the sensed electrogram were observed. Conclusion Undoubtedly this device is the current gold standard for the diagnosis of unexplained syncope. In the population we studied though, the device faced undersensing problems. Consequently, the device should be equipped with more advanced software for QRS morphology recognition, to improve the diagnostic accuracy of the recorder.

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Study of diagnosing unexplained syncope with insertable loop recorder system

Heart ◽

10.1136/heartjnl-2011-300867.510 ◽

2011 ◽

Vol 97 (Suppl 3) ◽

pp. A174-A174

Author(s):

L. Zhongmei ◽

G. Tao ◽

L. Zhiping

Keyword(s):

Loop Recorder ◽

Insertable Loop Recorder ◽

Unexplained Syncope

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Faculty Opinions recommendation of Discrepancy between clinical practice and standardized indications for an implantable loop recorder in patients with unexplained syncope.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.5490956.5490065 ◽

2010 ◽

Author(s):

Panos Vardas ◽

Dimitris Arfanakis

Keyword(s):

Clinical Practice ◽

Implantable Loop Recorder ◽

Loop Recorder ◽

Unexplained Syncope

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Patients with recurrent syncope and implantable loop recorder exhibit better survival than the control group without implantable loop recorder

European Heart Journal ◽

10.1093/ehjci/ehaa946.3546 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

C Perings ◽

C Wolff ◽

A Wilk ◽

A Witthohn ◽

R Voss ◽

...

Keyword(s):

Life Expectancy ◽

Control Group ◽

Funding Source ◽

Implantable Loop Recorder ◽

Loop Recorder ◽

Cardiac Device ◽

Unexplained Syncope ◽

Care Costs

Abstract Introduction In 30% of patients with syncope, the underlying cause remains unexplained after clinical investigations. Unexplained syncope tends to recur, significantly impacting patients' quality of life of patients and mortality. Thus, there is a need for timely and more accurate diagnosis to initiate treatment. Dedicated care pathways are recommended by ESC guidelines. Purpose Patients with recurrent syncope were followed over time and patient outcomes with ILR were compared to patients with the same syncope burden, age, gender and mortality risk score who did not receive an ILR. Method A representative database of 4.9 million patients insured by German company statuary health insurances (BKK) was analysed over a time period of 10 years, 2007–17. Patients with recurrent syncope (two times ICD-10 GM diagnosis codes R55), age between 45–84 and no diagnosis code for the syncope were included in the analysis and followed for at least 2 years. Patients with ILR were matched to patients without ILR based on age, gender and Charlson Comorbidity index (CCI) using mahalanobis distances. The index event was the device implant in the ILR group and the second syncope event in the control group. Life expectancy, syncope hospitalisations, fall related injuries, health care costs, diagnoses and treatment rates were compared between the groups. Results A total of 412 patients with ILR for recurrent unexplained syncope were matched to the control group. Overall mean age was 68, mean was CCI 2.7, 42% were females. The risk of death was 2.35 times higher in the control group during follow up as shown in Figure 1 (p-value logrank test <0.0001). Cardiovascular related diagnosis and treatment rates were higher in the ILR group with 69% of patients having a cardiology diagnosis compared to 41% in the control group. Over a quarter (27%) of ILR patients received an implantable cardiac device compared to 5% in the control group. Ablation rates were 7% in the ILR group compared to 0% in the control group. Median health care costs were € 3,847 higher in the ILR group including the costs of the ILR implant, follow up and higher rates of cardiac treatments. These extra costs appear moderate given the substantially higher mortality risk in the control group. Conclusion This study of patients with recurrent unexplained syncope shows a remarkable difference in life expectancy in patients with ILR compared to a matched control group. Two large claim data analysis have recently shown higher rates of cardiovascular death as well as all-cause mortality in patients with unexplained syncope. A more vigilant cardiac workup might be needed to identify a possible underlying cardiac condition. Higher rates of cardiac device therapy in the ILR group were likely to play an important role for their better life expectancy. Cardiac therapies such as pacemakers, defibrillators and ablation have also been shown to significantly improve patients' quality of life. Life Expectancy Comparison Funding Acknowledgement Type of funding source: Private company. Main funding source(s): The data analysis was funded by Medtronic

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Implantable loop recorder follow-up

European Heart Journal ◽

10.1093/eurheartj/ehab724.0318 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

J Pena Mellado ◽

R Macias ◽

L Tercedor ◽

M Alvarez Lopez

Keyword(s):

Head Trauma ◽

Type I ◽

Av Block ◽

Implantable Loop Recorder ◽

Ecg Monitoring ◽

Loop Recorder ◽

Tertiary Center ◽

Unexplained Syncope ◽

Baseline Characteristics

Abstract Introduction Long ambulatory ECG monitoring can be a useful component in the evaluation of the patient with unexplained syncope or syncope with suspected arrhythmic origin, as well as a sensitive tool for detecting asymptomatic spontaneous cardiac arrhythmias or conduction abnormalities in predisposed patients. Purpose To determine the diagnostic cost-effectiveness of the implantable loop recorder (ILR) in the origin of unexplained syncope in our center. Methods A retrospective observational study was carried out in a tertiary center, those patients with an ILR between August 2014 and March 2021 were included. Baseline characteristics of the population and their previous ECG, arrythmias detected during follow-up and pacemaker implant rate were evaluated. Results One hundred twenty-seven patients with a ILR were included (age 67 years, 49.6% males). Most often cause of ILR was unexplained syncope (90.6%) followed by monitoring after TAVI implant (3.9%). Normal LVEF (>50%) was present in 85.6%,and 75.6% had NYHA I functional class. 118 patients (92.9%) presented sinus rhythm at implant time, and 8 (6.3%) presented AF. 12.6% presented first degree atrioventricular (AV) block, 2 patients (1.6%) had presented previously Mobitz Type I AV block and one patient 2:1 block. Left bundle branch block (LBBB) was present in 13.4%,RBBB in 3.1%,LAFB in 9.4%, RBBB+LAFB in 11% and RBBB+LPFB in 2.4%. Median time of follow-up was 21 months. 3rd degree AV block was the most frequent arrhythmia detected (12.1%), followed by >3s pause (8%) and previously unknown AF (2.4%).The patients with syncope who suffered head trauma (33%) presented a higher rate of pacemaker (PCM) implant compared to those without head trauma: 31.6% vs 14.7%. In total,19.8% PCM rate implant during follow-up. No complications ILR related. Conclusion In conclusion, long home ECG monitoring with ILR is a powerful and helpful tool to find out or rule out potentially dangerous arrhythmias as cause of syncope, with no complications in our experience. FUNDunding Acknowledgement Type of funding sources: None. Baseline characteristics Arrhythmias detected during follow-up

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A novel device in evaluating syncope

American Journal of Critical Care ◽

10.4037/ajcc2000.9.4.288 ◽

2000 ◽

Vol 9 (4) ◽

pp. 288-293 ◽

Cited By ~ 3

Author(s):

LG Futterman ◽

L Lemberg

Keyword(s):

Physical Examination ◽

Patient Activation ◽

Cost Effective ◽

The Elderly ◽

Loop Recorder ◽

Novel Device ◽

Cardiac Syncope ◽

Common Causes ◽

Insertable Loop Recorder ◽

Automatic Capture

Syncope may be a manifestation of many diseases. The etiology is often difficult to determine. Much effort, time, and expense have been required to determine a diagnosis. A thorough history and physical examination are essential (Table 3). Several clinical pearls may be of help in the diagnosis of syncope: (a) the most important elements in the evaluation of syncope are a detailed history and physical examination; (b) syncope is a common problem in young healthy adults and the elderly; (c) a heavy meal is a specific cause of syncopy in the elderly (postprandial), however this etiology often goes unrecognized; (d) syncope is caused by 1 of 3 mechanisms: decreased cardiac output, systemic vascular resistance, or cerebrovascular disease; (e) reflex-mediated syndromes (vasovagal) are common causes of syncope in young adults, and orthostatic hypotension is an important cause of syncope in the elderly; and (f) the 1-year mortality of cardiac syncope (18%-33%) is significantly higher than that from non-cardiac syncope (0%-12%). A proven and useful tool has recently been advanced to aid in the evaluation of syncope. The Reveal Plus insertable loop recorder has auto activation that allows automatic capture and recording of arrhythmic events. Patient activation is an option. The recorder lasts 12 to 14 months and has proven to be a valuable and reliable cost-effective asset in our quest to evaluate syncope.

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