Diagnostic assessment of recurrent unexplained syncope with a new subcutaneously implantable loop recorder. Reveal-Investigators.

AIM: Patients with recurrent syncope undiagnosed after extensive non-invasive and invasive testing pose a diagnostic and therapeutic dilemma. Holter monitoring is nondiagnostic in 90% of cases. Recent developments in loop recorder technology permit long-term ECG monitoring in patients with recurrent unexplained syncope. The aim of this study was to report the worldwide experience with a new subcutaneously implantable loop recorder, implanted in 133 patients with unexplained syncope and negative laboratory investigations. METHODS AND RESULTS: The implantable loop recorder monitors continuously a single lead electrogram using two sensing electrodes on the device shell. The device was implanted in 133 patients, 67 male and 66 female with recurrent syncope. During a mean follow-up of 10.8 +/- 4.3 months after device implantation, 83 patients (62%) experienced syncope or pre-syncope. In the remaining 50 patients no diagnosis could be made because either no events occurred, the patients were lost to follow-up, had adverse events, or died prior to diagnosis. In 72 of the 83 patients with syncope during follow-up (87%), loop recording definitively determined whether an arrhythmia was the cause of symptoms or not. Diagnosis included bradycardia in 21 patients, pacemaker dysfunction in one patient, and tachycardia in 10 patients. One patient experienced multiple rhythm disturbances. Syncope was non-arrhythmic in 40 patients. The remaining 11 patients failed to press the activator. Therapy was instituted in all patients, in whom an arrhythmic cause was found. Severe anticipated device related complications occurred in three patients. CONCLUSION: An implantable loop recorder is useful for establishing a diagnosis when symptoms are recurrent but too infrequent for conventional monitoring techniques.     

Use of the implantable loop recorder in patients with unexplained syncope

Syncope is a complex clinical syndrome with multiple etiologies that can be very difficult to diagnose. The major obstacles to diagnosis are the periodic and unpredictable nature of events and the high spontaneous remission rate. Conventional testing is often unproductive in patients when initial non-invasive testing is negative, particularly when a paroxysmal ar-rhythmia is suspected. Holter monitoring is often employed initially, with limited utility. Holter monitoring provides a rhythm profile, but rarely achieves the gold standard of a symptom rhythm correlation. The external loop re-corder extends the period of monitoring, enhancing the diagnostic yield to as high as 60% in patients with symptoms likely to recur during a month of device use. Finally, implantable loop recorders further extend the ability to monitor cardiac patients, enhancing the diagnostic yield to as high as 85% in difficult to diagnose syncope. Several recent studies suggest that prolonged monitoring with an implantable loop recorder has a role in patients with syncope and conduction disturbances, negative tilt testing, unexplained seizures and may be superior to conventional testing with tilt and electrophysiologic studies in select patients.     

植入型心电事件记录仪在不明原因晕厥中的应用价值:单中心经验

目的探讨植入型心电事件记录仪(ILR)在不明原因晕厥患者中的应用价值,并筛选可能的心律失常源性晕厥预测因素。方法连续入选2013年1月至2018年10月在大连医科大学附属第一医院诊断为不明原因晕厥,且植入ILR的患者37例,年龄(59±19)岁,男24例。植入后进行常规随访,每3~6个月进行1次随访,主要随访内容:症状、程控事件、是否发生晕厥。如患者发生晕厥,通知回院就诊,接受程控和心电学检查,分析晕厥病因及心律失常类型和相关危险因素。结果共22例(59.46%,22/37)患者记录到晕厥事件,其中9例为窦性心动过缓或窦性停搏,6例为三度或高度房室传导阻滞,1例为室性心动过速,2例为室上性心动过速,4例为心房颤动(房颤)伴RR长间歇(>2 s),在植入后(187.73±177.12)d发生晕厥事件。1例患者记录到房颤伴RR长间歇,但未发生晕厥。16例患者植入永久起搏器,1例患者植入心律转复除颤器,2例患者行导管消融治疗。对性别、年龄、合并基础疾病、植入前晕厥次数、心电信息等进行分析发现,动态心电图中存在RR长间歇(>2 s)是预测晕厥发作的影响因素。结论植入ILR可使不明原因晕厥患者获得明确诊断并接受相应治疗,ILR是明确晕厥病因的有效手段之一。动态心电图中存在RR长间歇(>2 s)是心律失常原因晕厥的重要预测因素。     

Initial experience with an implantable loop recorder in patients with unexplained syncope

Patients with recurrent syncope undiagnosed after extensive noninvasive and invasive testing pose a diagnostic and therapeutic dilemma. Holter monitoring is non-diagnostic in 90% of cases. Recent developments in loop recorder technology permit longterm ECG monitoring in patients with recurrent unexplained syncope. The implantable loop recorder monitors a single lead electrogram continuously using 2 sensing electrodes on the device shell. The device was implanted in 20 patients (11 male, 9 female) with the history of recurrent syncope. During a mean follow-up of 12+/-6 months after device implantation, 11 patients (55%) experienced syncope (8 pts) or presyncope (3 pts). In the remaining 9 patients, no syncope occurred. In all 11 patients with syncope or presyncope during follow-up, loop recording definitively determined whether an arrhythmia was the cause of symptoms or not. Diagnosis included bradycardia in one patient, tachycardia in two patients, in one patient two rhythm disturbances were revealed: frequent ventricular premature beats with bigemini and atrial flutter. Two patients had a neurocardiogenic syncope. Syncope was nonarrhythmic in 5 patients. An implantable loop recorder is useful for establishing the diagnosis if symptoms are recurrent but too infrequent for conventional monitoring techniques.     

The use of an implantable loop recorder in the investigation of unexplained syncope in older people

INTRODUCTION: Reveal is a patient activated implantable loop recorder device with an 18 month battery life now available to assist in the diagnosis of suspected syncope or arrhythmias. We present our experience using this device in older subjects referred to a dedicated falls and syncope clinic in whom usual clinical assessment had not satisfactorily identified an attributable diagnosis but where we still suspected a cardiovascular cause for syncope or falls. METHODS AND RESULTS: during the past 3 years 15 subjects (mean age 73 years, range 61-89 years) had Reveal implanted for symptoms of syncope alone (n=6; 40%) and unexplained falls (n=3; 20%) or symptoms of syncope and unexplained falls (n=6; 40%). Symptom duration was long (mean 48 months; range 4-200 months). Subjects had experienced significant morbidity, 6 subjects (40%) required A&E attendance or hospital admission and 4 (27%) experienced a fracture. Despite extensive and repeated investigations, which included 12-lead ECG, echocardiogram, 24-h ambulatory heart rate monitor, 24-h ambulatory blood pressure monitor, orthostatic blood pressure measurement, supine and erect carotid sinus massage, electroencephalogram, and passive and GTN head up tilt testing, the attributable diagnosis remained unexplained. Of the 15 subjects, 7 have activated the device at 4 (range 0-14) months after implantation. Bradycardia was identified in 3 and ventricular tachycardia in 1 subject. Two subjects did not activate the device during the 18 months it was in-situ. Four people had problems with device activation. This is comparable to rates noted using Reveal in younger subjects. CONCLUSION: Reveal offers additional diagnostic yield in complex elderly subjects with suspected cardiovascular causes of syncope or unexplained falls which have not been previously satisfactorily diagnosed despite extensive investigations.     

High incidence of tachyarrhythmias detected by an implantable loop recorder in patients with unexplained syncope

BACKGROUND: Syncope is a complex clinical syndrome that may be challenging with respect to a definite diagnosis. The implantable loop recorder (ILR) is a useful tool to define but also to exclude an arrhythmic aetiology. AIM: To investigate the causes of recurrent syncope or near-syncope with respect to underlying arrhythmias in non-selected consecutive patients monitored with an ILR. METHODS: A retrospective study was conducted including 55 patients (34 men, 21 women; age 60+/-19 years) with unexplained syncope who received an ILR for prolonged monitoring at our institution between April 1998 and October 2006. RESULTS: Forty (73%) patients had a recurrence of syncope or near-syncope. Structural heart disease was present in 18 (33%) patients, 4 of them having an ejection fraction <35%. An arrhythmia was detected as the cause of syncope in 25 (46%) patients. The ILR was successful in establishing a symptom-rhythm correlation in 63%. The mean follow-up period from implantation to occurrence of the detected arrhythmias was 9+/-8 months. Bradyarrhythmias were recorded in 12 (22%) patients, whereas tachyarrhythmias were found in 13 (24%) patients. Narrow QRS tachycardia was the underlying arrhythmia in 6 patients and wide QRS tachycardia in 7 patients. A pacemaker was implanted in all 12 patients with bradyarrhythmias. Implantable cardioverter defibrillator (ICD) therapy was indicated in 6 patients with adjunctive catheter ablation in 3 of them. Four patients presenting with paroxysmal supraventricular tachycardia were treated with radiofrequency catheter ablation. CONCLUSION: The ILR helped efficaciously to determine the correct diagnosis and appropriate treatment of recurrent syncope. A considerably high proportion of tachyarrhythmias was detected in this non-selected consecutive population. The majority of patients with tachyarrhythmic syncope required defibrillator implantation and/or radiofrequency ablation.     

Value of the implantable loop recorder for the management of patients with unexplained syncope.

AIM: Recurrent syncope often remains unexplained despite extensive multidisciplinary screening. The implantable loop recorder (ILR) may be a tool to define the cardiac arrhythmias underlying syncope. METHODS AND RESULTS: The study population consisted of 43 consecutive patients with unexplained syncope who underwent extensive cardiological screening and were followed with an ILR. During follow-up, 5 patients had only presyncope, 4 had palpitations, and 15 had a true recurrence of syncope. In all patients with palpitations, 3 with presyncope, and 7 with a recurrence of syncope, the ILR excluded arrhythmias. In the patients with a true recurrence, 1 had symptomatic paroxysmal atrial fibrillation (PAF) treated with drugs, 1 had polymorphic ventricular tachycardia (VT) and received an implantable cardioverter defibrillator (ICD), and 7 had asystole and received a pacemaker. Two patients with presyncope received a pacemaker for Mobitz II block and PAF with brady-tachycardia syndrome. One asymptomatic patient received a pacemaker for significant nocturnal asystole recorded by ILR. Abnormalities in the cardiac screening were observed both in patients with and without syncope, but none of these had a predictive value. CONCLUSION: The ILR is a valuable and effective tool to establish an arrhythmic cause for unexplained syncope. The results of head-up tilt testing (HUTT) and electrophysiological study (EPS) are neither sufficiently sensitive nor specific enough in this patient group.     

Additional diagnostic value of very prolonged observation by implantable loop recorder in patients with unexplained syncope

Long‐Term Observation with ILR . Introduction : In the literature, the average diagnostic yield of the implantable loop recorder (ILR) is reported to be 35% over an observation period generally less than 18 months. The aim of this study was to evaluate the diagnostic value of ILR during very prolonged observation. Methods and Results: Consecutive patients who had received one or more (in the case of battery exhaustion before diagnosis) ILR (Reveal/plus/DX, Medtronic Inc.) from 2001 to 2010 were included. The diagnostic ECG was classified according to the ISSUE classification. We analyzed 157 patients (87 males, 69 ± 14 years): 70 of these were followed up for ≥18 months. The estimated cumulative diagnostic rates were 30%, 43%, 52%, and 80% at 1, 2, 3, and 4 years, respectively; 26% of diagnoses were made after 18 months. The diagnostic yield was independent of structural heart disease, bundle branch block, number of syncopes, age, and gender; the median time to diagnosis of ISSUE type 1 patients was shorter than that of the others (4 [2;10] vs. 16 [6;23] months; P = 0.003). During the observation period, 3 patients (1.9%) died and none suffered arrhythmic death. Conclusions: Prolonging observation up to 4 years increased the diagnostic value of ILR in syncopal patients and was safe. A quarter of patients diagnosed needed more than 18 months of follow‐up. As consequence, when a strategy of prolonging monitoring is chosen, monitoring should be maintained even for several years until diagnosis is established. (J Cardiovasc Electrophysiol, Vol. 23, pp. 67‐71, January 2012)     

Utility of implantable loop recorder (Reveal Plus) in the diagnosis of unexplained syncope.

AIMS: In about 30% of patients with syncope, the responsible mechanisms remain unrecognised. Nevertheless, the possibility of an arrhythmic aetiology remains, however, difficult to rule out. METHODS: We therefore monitored with an implantable loop recorder (ILR, Reveal Plus, Medtronic) 34 subjects (60+/-15 years) with at least two unexplained syncopal episodes and negative neurological and cardiovascular work-up. RESULTS: During a follow-up of 7+/-4 months, syncope occurred in 11 subjects. In nine of them the mechanisms responsible for these events were identified by ILR monitoring: marked bradycardia or asystole (n=6), atrial fibrillation with wide QRS tachycardia (n=1) and sinus rhythm with fine artifacts likely to be due to muscle contractions (n=2). Pre-syncope occurred in seven patients: advanced atrioventricular block (n=3), sinus tachycardia (n=1), and wide QRS tachycardia (n=1) were documented. Thus, when considering all 18 patients with recurrences, a diagnosis was achieved in 53% of subjects. Recognition of the rhythm disorder in seven patients with syncope and four patients with pre-syncope guided patient management. CONCLUSIONS: These data indicate that ILR monitoring facilitates the identification of mechanisms responsible for recurrences and therapeutic management in subjects with syncope or pre-syncope and negative traditional neurological and cardiovascular work-up.     

Clinical usefulness of implantable loop recorder in diagnosis of unexplained syncope--case report

Clinical usefulness of implantable loop recorder in diagnosis of unexplained syncope - case report. A case of a 67-year-old female with recurrent syncope is presented. In spite of extensive investigation, the cause of syncope remained unknown. The patient received insertable loop recorder (ILR). One month after implantation the patient suffered two syncopal episodes. ECG recorded by ILR showed asystolic pause of 8 seconds at the time of conversion of atrial fibrillation to sinus rhythm. This was the first ILR implantation in Poland which was covered by public health insurance and not by private funds.     

The high cost of syncope: cost implications of a new insertable loop recorder in the investigation of recurrent syncope

BACKGROUND: Patients with recurrent syncope frequently undergo extensive investigations that consume significant health care resources. Recent advances in long-term monitoring techniques have enhanced diagnostic yield in patients with infrequent symptoms. There is little information on the relative cost-effective profile of the investigative tools used in patients with syncope. METHODS: Two methods to determine health care costs in patients with syncope were used. In the first, health care resource utilization was determined in 24 patients with recurrent unexplained syncope and negative investigations who underwent insertion of the implantable loop recorder (ILR) during a pilot study of the feasibility of the device. The costs of investigations before, during, and after ILR implantation in each patient were calculated on the basis of median charges for an index investigation and a regression analysis of 1018 US Medicare hospital claims for syncope from 1993. Charges were converted to costs using a cost-to-charge ratio of 0.64. The second method was based on estimated costs per diagnosis and published diagnostic yields of 6 commonly applied tests in patients with syncope. A cohort simulation using theoretic models of 100 patients undergoing investigation for syncope was created to compare the diagnostic yield and cost per diagnosis of various diagnostic cascades. RESULTS: In the pilot study, the cost of investigation of syncope in the 2 years before ILR insertion was $7584 per patient. After the ILR was inserted, a diagnosis was obtained in 21 of 24 patients (diagnostic yield 88%). The cost of therapy was $2452, followed by a reduction in cost of care to $596 over 30 +/- 10 months of follow-up. In the second method, the diagnostic yield of individual tests ranged from 3% for echocardiography to 88% for the ILR. The cost per diagnosis obtained ranged from $529 for the external loop recorder to $73,260 for electrophysiologic testing in patients without structural heart disease. An approach to syncope similar to that of the ILR pilot study resulted in a cost per diagnosis of $3193 and a diagnostic yield of 98%. Performance of echocardiography in half of the patients and electrophysiologic testing only in the presence of structural heart disease reduced the cost to $2494 and retained a diagnostic yield of 98%. CONCLUSIONS: The cost of investigation of syncope is high. The ILR may reduce health care resource utilization by providing a diagnosis permitting definitive therapy. The cost per diagnosis profile of current diagnostic tests commonly used in patients with syncope is highly variable. A cost-effective approach to diagnosing this disorder can retain a high diagnostic yield with a reduction in resource utilization compared with a conventional approach.