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Michele Brignole - One of the best experts on this subject based on the ideXlab platform.

  • the benefit of pacemaker therapy in patients with neurally mediated syncope and documented asystole a meta analysis of Implantable Loop Recorder studies
    Europace, 2018
    Co-Authors: Michele Brignole, Angel Moya, Carlo Menozzi, Richard Sutton, Jean Claude Deharo, Marco Tomaino, Andrea Ungar
    Abstract:

    Aim: Although the efficacy of cardiac pacing in patients with neurally mediated syncope (NMS) and documented asystole is established, a more robust point estimate of the benefit, which is not possible with any individual study, is lacking. Methods and results: We undertook a meta-analysis of individual participant data from four studies that reported follow-up data on syncope recurrence with cardiac pacing in patients with NMS who had had an electrocardiographic (ECG) documentation of an asystolic event by means of Implantable Loop Recorder (ILR). Of a total of 1046 patients, who had ILR implanted, 383 (36.6%) patients had an ECG documentation of a diagnostic event during mean follow-up of 13 ± 10 months. Of these, 201 (52%) patients, corresponding to 19.2% of the total ILRs, had an asystolic event of 12.8 ± 11.0 s duration documented and met the criteria for pacemaker therapy. Follow-up was available in 121 (60%) of those patients with asystolic events. Syncope recurred after pacing in 18 (14.9%) patients with an actuarial rate of 13% [95% confidence interval (CI) ±6] at 1 year, 21% (95%CI ±10) at 2 years, and 24% (95%CI ±11) at 3 years. On multivariable Cox regression analysis, positive tilt test response was the only significant predictor of syncope recurrence with a hazard ratio (95% CI) of 4.3 (1.4-13). On the contrary, type of asystolic event (sinus arrest or atrioventricular block), prodrome, cardiac abnormalities, number and duration of history of syncope, age, and gender were not predictors of recurrence of syncope. Conclusion: A long asystolic pause, suitable for pacemaker therapy, was found in one of five patients with ILR. After pacemaker implantation, most of these patients remained free of syncope recurrence for up to 3 years. The benefit of pacemaker was greater in patients with negative tilt test.

  • additional diagnostic value of Implantable Loop Recorder in patients with initial diagnosis of real or apparent transient loss of consciousness of uncertain origin
    Europace, 2014
    Co-Authors: Roberto Maggi, Michele Brignole, Martina Rafanelli, Alice Ceccofiglio, Diana Solari, Andrea Ungar
    Abstract:

    Aims Non-syncopal transient loss of consciousness (T-LOC) encompasses disorders that sometimes resemble syncope, and the differential diagnosis with true syncope may be challenging. The Implantable Loop Recorder (ILR) is potentially useful, but has never been systematically assessed. The aim of the study is to evaluate the diagnostic value of ILR in distinguishing syncope from non-syncopal forms of T-LOC. Methods and results We implanted an ILR in 58 patients (mean age 71 ± 17 years, 25 males) who had had 4.6 ± 2.3 episodes of real or apparent T-LOC, in order to distinguishing epilepsy from syncope (#28), unexplained fall from syncope (#29), or functional pseudo-syncope from syncope (#1). During 20 ± 13 months of follow-up, 33 patients (57%) had a spontaneous event documented by ILR. A diagnosis of syncope was established by ILR documentation of an arrhythmia in 15 (26%) patients: an asystole of 6 s (IQR 4–10 s) duration was documented at the time of the spontaneous event in seven patients with initial suspicion of epilepsy and in five patients with unexplained fall; atrial tachyarrhythmia was documented at the time of the spontaneous event in 1 and 1 patient, respectively, and ventricular tachycardia in 1 patient with unexplained fall. Conversely, in another 18 patients, ILR monitoring documented no significant rhythm abnormalities at the time of T-LOC recurrence, thus excluding an arrhythmic syncope. Finally, ILR was unable to document any syncopal episode in 25 (43%) patients. Among the 15 patients with an established diagnosis of arrhythmic syncope, syncope recurred during follow-up in 2 of 11 patients who were on pacemaker therapy and in 3 of 4 patients who were on other therapies. Conclusion Implantable Loop Recorder monitoring provides additional diagnostic value in ‘difficult’ patients with an initial diagnosis of non-syncopal real or apparent T-LOC.

  • additional diagnostic value of very prolonged observation by Implantable Loop Recorder in patients with unexplained syncope
    Journal of Cardiovascular Electrophysiology, 2012
    Co-Authors: Toshiyuki Furukawa, Roberto Maggi, Cristina Bertolone, Daniele Fontana, Michele Brignole
    Abstract:

    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)

  • early application of an Implantable Loop Recorder allows effective specific therapy in patients with recurrent suspected neurally mediated syncope
    European Heart Journal, 2006
    Co-Authors: Michele Brignole, Angel Moya, Carlo Menozzi, Roberto Garciacivera, Richard Sutton, Dietrich Andresen, David G Benditt, Wouter Wieling, Panos E Vardas
    Abstract:

    AIMS: This prospective multicentre observational study assessed the efficacy of specific therapy based on Implantable Loop Recorder (ILR) diagnostic observations in patients with recurrent suspected neurally mediated syncope (NMS). METHODS AND RESULTS: Patients with three or more clinically severe syncopal episodes in the last 2 years without significant electrocardiographic and cardiac abnormalities were included. Orthostatic hypotension and carotid sinus syncope were excluded. After ILR implantation, patients were followed until the first documented syncope (Phase I). The ILR documentation of this episode determined the subsequent therapy and commenced Phase II follow-up. Among 392 patients, the 1-year recurrence rate of syncope during Phase I was 33%. One hundred and three patients had a documented episode and entered Phase II: 53 patients received specific therapy [47 a pacemaker because of asystole of a median 11.5 s duration and six anti-tachyarrhythmia therapy (catheter ablation: four, Implantable defibrillator: one, anti-arrhythmic drug: one)] and the remaining 50 patients did not receive specific therapy. The 1-year recurrence rate in 53 patients assigned to a specific therapy was 10% (burden 0.07 +/- 0.2 episodes per patient/year) compared with 41% (burden 0.83 +/- 1.57 episodes per patient/year) in the patients without specific therapy (80% relative risk reduction for patients, P = 0.002, and 92% for burden, P = 0.002). The 1-year recurrence rate in patients with pacemakers was 5% (burden 0.05 +/- 0.15 episodes per patient/year). Severe trauma secondary to syncope relapse occurred in 2% and mild trauma in 4% of the patients. CONCLUSION: A strategy based on early diagnostic ILR application, with therapy delayed until documentation of syncope allows a safe, specific, and effective therapy in patients with NMS.

  • the usage and diagnostic yield of the Implantable Loop Recorder in detection of the mechanism of syncope and in guiding effective antiarrhythmic therapy in older people
    Europace, 2005
    Co-Authors: Michele Brignole, Carlo Menozzi, Francesco Croci, Roberto Maggi, Alberto Solano, Paolo Donateo, Nicola Bottoni, Gino Lolli, Fabio Quartieri, Daniele Oddone
    Abstract:

    Objectives To evaluate the usage and diagnostic yield of the Implantable Loop-Recorder (ILR) in detection of the mechanism of syncope and in guiding therapy in patients aged R65 years and comparing them with those !65 years. Design This was a two-hospital, observational, prospective study in consecutive patients with unexplained syncope who underwent an ILR implantation. Between November 1997 and December 2002, a total of 2052 patients with syncope were evaluated (local population of 590,000 inhabitants). The diagnosis remained unexplained in 371 (18%). Of these, 103 patients (5% of the total, 28% of those with unexplained syncope) received an ILR. Results There were 70 (76%) patients aged R65 years and 25 (24%) !65 years. ILR implantation was 110 and 9 per million inhabitants per year, respectively. During a mean follow-up of 14G 10 months, syncope was recorded in 52 patients. Compared with younger patients those older had a 2.7 higher syncope recurrence rate (56% vs 32%, P Z0.03); arrhythmias were 3.1 times more likely to be

Suneet Mittal - One of the best experts on this subject based on the ideXlab platform.

  • utility and limitations of long term monitoring of atrial fibrillation using an Implantable Loop Recorder
    Heart Rhythm, 2017
    Co-Authors: Suneet Mittal
    Abstract:

    Atrial fibrillation (AF) is the most common cardiac arrhythmia diagnosed and treated in the world. The treatment of patients' symptoms as well as the prevention of stroke and heart failure is dependent on accurate detection and characterization of AF. A variety of electrocardiographic (ECG) monitoring techniques are being used for these purposes. However, these intermittent ECG monitoring techniques have been shown to underdiagnose AF events while having limited ability to characterize AF burden and density. Continuous long-term Implantable Loop Recorder (ILR)-based ECG monitoring has been designed to overcome these limitations. This technology is being increasingly used to diagnose episodes of AF in high-risk patients and to improve characterization of AF episodes in patients with known AF. This review aims to review the potential clinical utility of ILR-based ECG monitoring while highlighting some inherent limitations of the current technology. An understanding of these limitations is important when considering the use of ILR-based ECG monitoring and clinical decision making based on the information being stored within these devices.

  • long term ecg monitoring using an Implantable Loop Recorder for the detection of atrial fibrillation after cavotricuspid isthmus ablation in patients with atrial flutter
    Heart Rhythm, 2013
    Co-Authors: Suneet Mittal, Evgeny Pokushalov, Alexander Romanov, Dan Musat, Martha Ferrara, Aysha Arshad
    Abstract:

    Background In patients with atrial flutter who undergo cavotricuspid isthmus ablation, long-term electrocardiographic (ECG) monitoring may identify new onset of atrial fibrillation (AF). Objectives To ascertain, through the use of an Implantable Loop Recorder (ILR) with a dedicated AF detection algorithm, the incidence, duration, and burden of new AF in these patients and to develop an optimal postablation ECG monitoring strategy. Methods We enrolled 20 patients with flutter, a CHADS 2 score of 2–3, and no prior episode of AF. After cavotricuspid isthmus ablation, we implanted an ILR, which was interrogated routinely; all stored ECGs were adjudicated. Results During a mean follow-up of 382 ± 218 days, 3 patterns were observed. First, in 11 (55%) patients, stored ECGs confirmed AF at 62 ± 38 days after ablation. Second, in 4 (20%) patients, although the ILR suggested AF, episodes actually represented sinus rhythm with frequent premature atrial contractions and/or oversensing. Third, in 5 (25%) patients, no AF was observed. Episodes 4 and >12 hours was 52% and 83%, respectively. Conclusions Our data show that many (but not all) patients develop new AF within the first 4 months of flutter ablation. Since external ECG monitoring for this duration is impractical, the ILR has an important role for long-term AF surveillance. Future research should be directed toward identifying the relationship between duration/burden of AF and stroke and improving existing ILR technology.

  • clinical utility of a novel wireless Implantable Loop Recorder in the evaluation of patients with unexplained syncope
    Heart Rhythm, 2011
    Co-Authors: Vijayapraveena Paruchuri, Mehul Adhaduk, Naga Vamsi Garikipati, Jonathan S Steinberg, Suneet Mittal
    Abstract:

    Background The Implantable Loop Recorder (ILR) is particularly useful for monitoring patients with syncope, given the episodic nature and unpredictable pattern of recurrent episodes. Current practice guidelines advocate ILR implantation in select patients with unexplained syncope. Objective The purpose of this study was to evaluate the clinical utility and potential advantages of a novel wireless ILR in a consecutive cohort of patients with unexplained syncope. Methods Patients with unexplained syncope despite a comprehensive evaluation who underwent implantation of a Transoma Medical Sleuth ILR were examined. ILR implantation was considered in these patients if left ventricular function was ≥40% and if syncope was recurrent, associated with trauma, and/or associated with an abnormal ECG (e.g., bifascicular block). Results The Sleuth ILR was implanted in 50 patients. During mean follow-up 293 ± 211 days, 16 (32%) patients had recurrent near-syncope or syncope. Only half of the patients self-activated the ILR; in the other half, a diagnosis was established based on autoactivation-initiated storage of a significant arrhythmia event. Overall, there were 5 patients with complete heart block, 3 with sinus node dysfunction, 3 with supraventricular tachycardia, 2 with neurally mediated syncope, and 3 with a nonarrhythmic cause of syncope. The median time from an event to physician notification was 150 minutes (interquartile range 99, 297 min). Median time from ILR implantation to final diagnosis was 71 days (interquartile range 24, 143 days; range 3–683 days). Conclusion A diagnosis of syncope was ultimately made in nearly one third of patients with unexplained syncope. Patients frequently did not activate their ILR at the time of recurrent syncope. However, the wireless ILR automatically transferred ECG data to a central monitoring station within minutes to hours of the arrhythmic event, virtually eliminating the possibility of data loss, thus greatly facilitating clinical decision making.

Andrea Ungar - One of the best experts on this subject based on the ideXlab platform.

  • the benefit of pacemaker therapy in patients with neurally mediated syncope and documented asystole a meta analysis of Implantable Loop Recorder studies
    Europace, 2018
    Co-Authors: Michele Brignole, Angel Moya, Carlo Menozzi, Richard Sutton, Jean Claude Deharo, Marco Tomaino, Andrea Ungar
    Abstract:

    Aim: Although the efficacy of cardiac pacing in patients with neurally mediated syncope (NMS) and documented asystole is established, a more robust point estimate of the benefit, which is not possible with any individual study, is lacking. Methods and results: We undertook a meta-analysis of individual participant data from four studies that reported follow-up data on syncope recurrence with cardiac pacing in patients with NMS who had had an electrocardiographic (ECG) documentation of an asystolic event by means of Implantable Loop Recorder (ILR). Of a total of 1046 patients, who had ILR implanted, 383 (36.6%) patients had an ECG documentation of a diagnostic event during mean follow-up of 13 ± 10 months. Of these, 201 (52%) patients, corresponding to 19.2% of the total ILRs, had an asystolic event of 12.8 ± 11.0 s duration documented and met the criteria for pacemaker therapy. Follow-up was available in 121 (60%) of those patients with asystolic events. Syncope recurred after pacing in 18 (14.9%) patients with an actuarial rate of 13% [95% confidence interval (CI) ±6] at 1 year, 21% (95%CI ±10) at 2 years, and 24% (95%CI ±11) at 3 years. On multivariable Cox regression analysis, positive tilt test response was the only significant predictor of syncope recurrence with a hazard ratio (95% CI) of 4.3 (1.4-13). On the contrary, type of asystolic event (sinus arrest or atrioventricular block), prodrome, cardiac abnormalities, number and duration of history of syncope, age, and gender were not predictors of recurrence of syncope. Conclusion: A long asystolic pause, suitable for pacemaker therapy, was found in one of five patients with ILR. After pacemaker implantation, most of these patients remained free of syncope recurrence for up to 3 years. The benefit of pacemaker was greater in patients with negative tilt test.

  • additional diagnostic value of Implantable Loop Recorder in patients with initial diagnosis of real or apparent transient loss of consciousness of uncertain origin
    Europace, 2014
    Co-Authors: Roberto Maggi, Michele Brignole, Martina Rafanelli, Alice Ceccofiglio, Diana Solari, Andrea Ungar
    Abstract:

    Aims Non-syncopal transient loss of consciousness (T-LOC) encompasses disorders that sometimes resemble syncope, and the differential diagnosis with true syncope may be challenging. The Implantable Loop Recorder (ILR) is potentially useful, but has never been systematically assessed. The aim of the study is to evaluate the diagnostic value of ILR in distinguishing syncope from non-syncopal forms of T-LOC. Methods and results We implanted an ILR in 58 patients (mean age 71 ± 17 years, 25 males) who had had 4.6 ± 2.3 episodes of real or apparent T-LOC, in order to distinguishing epilepsy from syncope (#28), unexplained fall from syncope (#29), or functional pseudo-syncope from syncope (#1). During 20 ± 13 months of follow-up, 33 patients (57%) had a spontaneous event documented by ILR. A diagnosis of syncope was established by ILR documentation of an arrhythmia in 15 (26%) patients: an asystole of 6 s (IQR 4–10 s) duration was documented at the time of the spontaneous event in seven patients with initial suspicion of epilepsy and in five patients with unexplained fall; atrial tachyarrhythmia was documented at the time of the spontaneous event in 1 and 1 patient, respectively, and ventricular tachycardia in 1 patient with unexplained fall. Conversely, in another 18 patients, ILR monitoring documented no significant rhythm abnormalities at the time of T-LOC recurrence, thus excluding an arrhythmic syncope. Finally, ILR was unable to document any syncopal episode in 25 (43%) patients. Among the 15 patients with an established diagnosis of arrhythmic syncope, syncope recurred during follow-up in 2 of 11 patients who were on pacemaker therapy and in 3 of 4 patients who were on other therapies. Conclusion Implantable Loop Recorder monitoring provides additional diagnostic value in ‘difficult’ patients with an initial diagnosis of non-syncopal real or apparent T-LOC.

  • atrial fibrillation and treatment changes in cryptogenic stroke patients with an Implantable Loop Recorder for continuous cardiac rhythm monitoring
    European Heart Journal, 2013
    Co-Authors: Andrea Ungar, Guido Rieger, Teena West, Helmut Purerfellner, J Bucx, R F Topper, S Kuster, H Nagele, M De Melis, Firat Duru
    Abstract:

    Introduction: This interim analysis evaluates the risk profile and incidence of atrial fibrillation (AF) in patients who underwent continuous monitoring with an Implantable Loop Recorder (ILR) for cryptogenic (unexplained) stroke or transient ischemic attack (TIA). Methods: The observational INSIGHT XT study prospectively enrolled patients who received an ILR with dedicated diagnostics for atrial fibrillation, irrespective of the clinical indication. Of 1002 patients enrolled in the study between Aug 2008 and Jan 2012, 121 received the ILR to evaluate cryptogenic stroke or TIA. The definition of cryptogenic stroke/TIA was at the investigators' appraisal and no unified approach to patient work-up was required. This analysis includes 74 patients with cryptogenic stroke or TIA for whom at least one follow-up visit was available at the time of interim analysis. Results: The mean age was 63±12 (50% female). Stroke was the index event in 46 of 74 (62%) of patients. 61% had hypertension, 14% diabetes, and none had heart failure. The mean CHADS2 score was 3.0±0.8 and the mean CHA2DS2VASc score 4.0±1.2. Most patients (72%) had no prior symptoms or cardiac rhythm disturbances, whereas 18% had a history of prior palpitations. Sixty-seven patients were taking antiplatelet medication and four were on oral anticoagulation (OAC) at enrollment. During a median follow up of 12 months (IQR 7 to 18) AF was reported in 17 patients (23%) and two patients were started on OAC and 10 patients were converted from antiplatelets to OAC. Five patients experienced a stroke or TIA (median time to event 1.2 months), of which one patient died. Three of the patients with stroke or TIA had AF detected prior to the recurrent event. Conclusion: Continuous monitoring with an ILR in patients with cryptogenic stroke of TIA detects a high proportion of AF; this can be attributed to longer continuous monitoring in this study. These patients have high CHADS2/CHA2DS2VASc scores; documenting AF in these cases may therefore be clinically relevant in order to decide appropriate treatment.

  • discrepancy between clinical practice and standardized indications for an Implantable Loop Recorder in patients with unexplained syncope
    Europace, 2010
    Co-Authors: Elena Vitale, Maurizio Lunati, Maura Francese, Roberto Maggi, Andrea Ungar, Roberto Colaceci, Attilio Del Rosso, Antonio Castro, Massimo Santini, Silvia Giuli
    Abstract:

    Aim An Implantable Loop Recorder (ILR) is indicated in patients with unexplained syncope after complete conventional work-up. Data from the literature imply that, in clinical practice, the ILR is underused. The aim of the study was to verify if there is any discrepancy between the use of ILRs in clinical practice and the potential indications based on the most potentially appropriate guideline indications. Method and results We compared the prevalence of ILRs actually implanted in patients with unexplained syncope in the Syncope Unit Project (SUP) study and the potential one using the standard given by the guidelines. In the SUP study, 28 (18%) out of 159 patients with unexplained syncope received an ILR. Appropriate criteria for implantation of ILRs according to guidelines were present in 110 (69%) patients. Moreover, 7 (25%) of ILRs actually implanted did not satisfy the guideline standards. During the follow-up, 32% of patients who had received an ILR had a diagnosis compared with 5% of those who did not ( P = 0.001). Conclusions The estimated indications were four times higher than those observed. Moreover, in about one quarter of the cases, the use of ILRs proved to be potentially inappropriate according to guideline indications. Two-thirds of patients with unexplained syncope had indications potentially appropriate for ILRs.

Andrew D Krahn - One of the best experts on this subject based on the ideXlab platform.

  • Use of the Implantable Loop Recorder in evaluation of patients with unexplained syncope.
    Journal of cardiovascular electrophysiology, 2020
    Co-Authors: Andrew D Krahn, George J Klein, Allan C Skanes
    Abstract:

    Syncope is a complex symptom with multiple potential etiologies that can be difficult to establish. The major obstacles to diagnosis are the periodic and unpredictable nature of events and the high spontaneous remission rate. Short-term ECG monitoring often is unproductive when initial noninvasive testing is negative due to the low probability of recurrence during the brief monitoring period. Implantable Loop Recorders 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, and unexplained seizures, and may be superior to conventional testing with tilt and electrophysiologic studies.

  • the use of monitoring strategies in patients with unexplained syncope role of the external and Implantable Loop Recorder
    Clinical Autonomic Research, 2004
    Co-Authors: Andrew D Krahn, George J Klein, Allan C Skanes
    Abstract:

    : 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. Short-term electrocardiographic monitoring is often unproductive in patients when initial non-invasive testing is negative, particularly when a paroxysmal arrhythmia is suspected. The external and Implantable Loop Recorders 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 selected patients.

  • use of the Implantable Loop Recorder in evaluation of patients with unexplained syncope
    Journal of Cardiovascular Electrophysiology, 2003
    Co-Authors: Andrew D Krahn, George J Klein, Allan C Skanes
    Abstract:

    Syncope is a complex symptom with multiple potential etiologies that can be difficult to establish. The major obstacles to diagnosis are the periodic and unpredictable nature of events and the high spontaneous remission rate. Short-term ECG monitoring often is unproductive when initial noninvasive testing is negative due to the low probability of recurrence during the brief monitoring period. Implantable Loop Recorders 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, and unexplained seizures, and may be superior to conventional testing with tilt and electrophysiologic studies. (J Cardiovasc Electrophysiol, Vol. 14, pp. S70-S73, September 2003, Suppl.)

  • Use of the Implantable Loop Recorder in patients with unexplained syncope.
    Minerva Cardioangiologica, 2003
    Co-Authors: Andrew D Krahn, Klein Gj, Yee R, Allan C Skanes
    Abstract:

    : 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.

  • diagnostic assessment of recurrent unexplained syncope with a new subcutaneously Implantable Loop Recorder
    Europace, 2000
    Co-Authors: K Seidl, Monika Rameken, S Breunung, Jochen Senges, W Jung, Dietrich Andresen, A Van Toor, Andrew D Krahn, George J Klein
    Abstract:

    Aim Patients with recurrent syncope undiagnosed after extensive non-invasive 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 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.

Carlo Menozzi - One of the best experts on this subject based on the ideXlab platform.

  • the benefit of pacemaker therapy in patients with neurally mediated syncope and documented asystole a meta analysis of Implantable Loop Recorder studies
    Europace, 2018
    Co-Authors: Michele Brignole, Angel Moya, Carlo Menozzi, Richard Sutton, Jean Claude Deharo, Marco Tomaino, Andrea Ungar
    Abstract:

    Aim: Although the efficacy of cardiac pacing in patients with neurally mediated syncope (NMS) and documented asystole is established, a more robust point estimate of the benefit, which is not possible with any individual study, is lacking. Methods and results: We undertook a meta-analysis of individual participant data from four studies that reported follow-up data on syncope recurrence with cardiac pacing in patients with NMS who had had an electrocardiographic (ECG) documentation of an asystolic event by means of Implantable Loop Recorder (ILR). Of a total of 1046 patients, who had ILR implanted, 383 (36.6%) patients had an ECG documentation of a diagnostic event during mean follow-up of 13 ± 10 months. Of these, 201 (52%) patients, corresponding to 19.2% of the total ILRs, had an asystolic event of 12.8 ± 11.0 s duration documented and met the criteria for pacemaker therapy. Follow-up was available in 121 (60%) of those patients with asystolic events. Syncope recurred after pacing in 18 (14.9%) patients with an actuarial rate of 13% [95% confidence interval (CI) ±6] at 1 year, 21% (95%CI ±10) at 2 years, and 24% (95%CI ±11) at 3 years. On multivariable Cox regression analysis, positive tilt test response was the only significant predictor of syncope recurrence with a hazard ratio (95% CI) of 4.3 (1.4-13). On the contrary, type of asystolic event (sinus arrest or atrioventricular block), prodrome, cardiac abnormalities, number and duration of history of syncope, age, and gender were not predictors of recurrence of syncope. Conclusion: A long asystolic pause, suitable for pacemaker therapy, was found in one of five patients with ILR. After pacemaker implantation, most of these patients remained free of syncope recurrence for up to 3 years. The benefit of pacemaker was greater in patients with negative tilt test.

  • recurrent unexplained palpitations rup study comparison of Implantable Loop Recorder versus conventional diagnostic strategy
    Journal of the American College of Cardiology, 2007
    Co-Authors: Franco Giada, Carlo Menozzi, Michele Gulizia, Maura Francese, Francesco Croci, Lucio Santangelo, Maurizio Santomauro, Eraldo Occhetta, Antonio Raviele
    Abstract:

    Objectives The aim of the study was to compare the diagnostic yield and the costs of Implantable Loop Recorder (ILR) with those of the conventional strategy in patients with unexplained palpitations. Background In patients with unexplained palpitations, especially in those with infrequent symptoms, the conventional strategy, including short-term ambulatory electrocardiogram (ECG) monitoring and electrophysiological study, sometimes fails to establish a diagnosis. Methods We studied 50 patients with infrequent (≤1 episode/month), sustained (>1 min) palpitations. Before enrollment, patients had a negative initial evaluation, including history, physical examination, and ECG. Patients were randomized either to conventional strategy (24-h Holter recording, a 4-week period of ambulatory ECG monitoring with an external Recorder, and electrophysiological study) (n = 24) or to ILR implantation with 1-year monitoring (n = 26). Hospital costs of the 2 strategies were calculated. Results A diagnosis was obtained in 5 patients in the conventional strategy group, and in 19 subjects in the ILR group (21% vs. 73%, p Conclusions In subjects without severe heart disease and with infrequent palpitations, ILR is a safe and more cost-effective diagnostic approach than conventional strategy.

  • early application of an Implantable Loop Recorder allows effective specific therapy in patients with recurrent suspected neurally mediated syncope
    European Heart Journal, 2006
    Co-Authors: Michele Brignole, Angel Moya, Carlo Menozzi, Roberto Garciacivera, Richard Sutton, Dietrich Andresen, David G Benditt, Wouter Wieling, Panos E Vardas
    Abstract:

    AIMS: This prospective multicentre observational study assessed the efficacy of specific therapy based on Implantable Loop Recorder (ILR) diagnostic observations in patients with recurrent suspected neurally mediated syncope (NMS). METHODS AND RESULTS: Patients with three or more clinically severe syncopal episodes in the last 2 years without significant electrocardiographic and cardiac abnormalities were included. Orthostatic hypotension and carotid sinus syncope were excluded. After ILR implantation, patients were followed until the first documented syncope (Phase I). The ILR documentation of this episode determined the subsequent therapy and commenced Phase II follow-up. Among 392 patients, the 1-year recurrence rate of syncope during Phase I was 33%. One hundred and three patients had a documented episode and entered Phase II: 53 patients received specific therapy [47 a pacemaker because of asystole of a median 11.5 s duration and six anti-tachyarrhythmia therapy (catheter ablation: four, Implantable defibrillator: one, anti-arrhythmic drug: one)] and the remaining 50 patients did not receive specific therapy. The 1-year recurrence rate in 53 patients assigned to a specific therapy was 10% (burden 0.07 +/- 0.2 episodes per patient/year) compared with 41% (burden 0.83 +/- 1.57 episodes per patient/year) in the patients without specific therapy (80% relative risk reduction for patients, P = 0.002, and 92% for burden, P = 0.002). The 1-year recurrence rate in patients with pacemakers was 5% (burden 0.05 +/- 0.15 episodes per patient/year). Severe trauma secondary to syncope relapse occurred in 2% and mild trauma in 4% of the patients. CONCLUSION: A strategy based on early diagnostic ILR application, with therapy delayed until documentation of syncope allows a safe, specific, and effective therapy in patients with NMS.

  • the usage and diagnostic yield of the Implantable Loop Recorder in detection of the mechanism of syncope and in guiding effective antiarrhythmic therapy in older people
    Europace, 2005
    Co-Authors: Michele Brignole, Carlo Menozzi, Francesco Croci, Roberto Maggi, Alberto Solano, Paolo Donateo, Nicola Bottoni, Gino Lolli, Fabio Quartieri, Daniele Oddone
    Abstract:

    Objectives To evaluate the usage and diagnostic yield of the Implantable Loop-Recorder (ILR) in detection of the mechanism of syncope and in guiding therapy in patients aged R65 years and comparing them with those !65 years. Design This was a two-hospital, observational, prospective study in consecutive patients with unexplained syncope who underwent an ILR implantation. Between November 1997 and December 2002, a total of 2052 patients with syncope were evaluated (local population of 590,000 inhabitants). The diagnosis remained unexplained in 371 (18%). Of these, 103 patients (5% of the total, 28% of those with unexplained syncope) received an ILR. Results There were 70 (76%) patients aged R65 years and 25 (24%) !65 years. ILR implantation was 110 and 9 per million inhabitants per year, respectively. During a mean follow-up of 14G 10 months, syncope was recorded in 52 patients. Compared with younger patients those older had a 2.7 higher syncope recurrence rate (56% vs 32%, P Z0.03); arrhythmias were 3.1 times more likely to be

  • proposed electrocardiographic classification of spontaneous syncope documented by an Implantable Loop Recorder
    Europace, 2005
    Co-Authors: Michele Brignole, Angel Moya, Carlo Menozzi, Roberto Garciacivera, Richard Sutton
    Abstract:

    Uniform data from the literature show that the mechanism of syncope recorded by Implantable Loop Recorder is extremely heterogeneous and a wide variety of rhythm disturbances is recorded at the time of syncope. Therefore, the proposed classification aims to group the observations into homogeneous patterns in order to define an acceptable standard useful for future studies and clinical practice.