Implantable Cardiac Monitor

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Gabriela Veigafernandez - One of the best experts on this subject based on the ideXlab platform.

  • arrhythmic burden in patients with new onset persistent left bundle branch block after transcatheter aortic valve replacement 2 year results of the mare study
    Europace, 2021
    Co-Authors: Guillem Muntanecarol, Marc W. Deyell, Marina Urena, Luis Nombelafranco, Ignacio J Amatsantos, Neal S Kleiman, Antonio J Munozgarcia, Felipe Atienza, Vicenc Serra, Gabriela Veigafernandez
    Abstract:

    Aims We determined the incidence and type of arrhythmias at 2-year follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR). Methods and results Multicentre prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR (SAPIEN XT/3: 53; CoreValve/Evolut R: 50). An Implantable Cardiac Monitor (Reveal XT, Reveal Linq) was implanted before hospital discharge and patients had continuous Monitoring for up to 2 years. Arrhythmic events were adjudicated in a central core lab. 1836 new arrhythmic events (tachyarrhythmias: 1655 and bradyarrhythmias: 181) occurred at 2 years. Of these, 283 (15%) occurred beyond 1 year (tachyarrhythmias 212, bradyarrhythmias 71) in 33 (36%) patients, without differences between valve type. Most late (>1 year) arrhythmic events were asymptomatic (94%) and led to a treatment change in 17 (19%) patients. A total of 71 late bradyarrhythmias [high-degree atrioventricular block (HAVB): 3, severe bradycardia: 68] were detected in 17 (21%) patients. At 2 years, 18 (17%) patients had received a permanent pacemaker (PPM) or Implantable Cardiac-defibrillator. PPM implantation due to HAVB predominated in the early phase post-TAVR, with only 1 HAVB event requiring PPM implantation after 1 year. Conclusion Patients with new-onset LBBB post-TAVR exhibited a very high burden of arrhythmic events within the 2 years post-procedure. While new tachyarrhythmic events were homogeneously distributed over time, the vast majority of new HAVB episodes leading to PPM implantation occurred early after the procedure. These results should help to guide the management of this challenging group of patients. (clinicaltrials.gov: NCT02153307).

  • arrhythmic burden as determined by ambulatory continuous Cardiac Monitoring in patients with new onset persistent left bundle branch block following transcatheter aortic valve replacement the mare study
    Jacc-cardiovascular Interventions, 2018
    Co-Authors: Josep Rodescabau, Marc W. Deyell, Marina Urena, Luis Nombelafranco, Ignacio J Amatsantos, Neal S Kleiman, Antonio J Munozgarcia, Felipe Atienza, Vicenc Serra, Gabriela Veigafernandez
    Abstract:

    Abstract Objectives The authors sought to determine: 1) the global arrhythmic burden; 2) the rate of arrhythmias leading to a treatment change; and 3) the incidence of high-degree atrioventricular block (HAVB) at 12-month follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR). Background Controversial data exist on the occurrence of significant arrhythmias in patients with LBBB post-TAVR. Methods This was a multicenter prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR with the balloon-expandable SAPIEN XT/3 valve (n = 53), or the self-expanding CoreValve/Evolut R system (n = 50). An Implantable Cardiac Monitor (Reveal XT, Reveal Linq) was implanted at 4 (3 to 6) days post-TAVR, and patients had continuous electrocardiogram Monitoring for 12 months. All arrhythmic events were adjudicated in a central electrocardiography core lab. Primary endpoints were the incidence of arrhythmias leading to a treatment change, and the incidence of HAVB at 12-month follow-up. Results A total of 1,553 new arrhythmic events were detected in 44 patients (1,443 episodes of tachyarrhythmia in 26 patients [atrial fibrillation/flutter/atrial tachycardia: 1,427, ventricular tachycardia 16]; 110 episodes of bradyarrhythmia in 21 patients [HAVB 54, severe bradycardia 56]). All arrhythmic events were silent in 34 patients (77%), the arrhythmic event led to a treatment change in 19 patients (18%), and 11 patients (11%) required pacemaker or Implantable cardioverter-defibrillator implantation (due to HAVB, severe bradycardia, or ventricular tachycardia episodes in 9, 1, and 1 patient, respectively). A total of 12 patients died at 1-year follow-up, 1 from sudden death. Conclusions A high incidence of arrhythmic events was observed at 1-year follow-up in close to one-half of the patients with LBBB post-TAVR. Significant bradyarrhythmias occurred in one-fifth of the patients, and PPM was required in nearly one-half of them. These data support the use of a Cardiac Monitoring device for close follow-up and expediting the initiation of treatment in this challenging group of patients. (Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation [MARE study]: NCT02153307)

Marc W. Deyell - One of the best experts on this subject based on the ideXlab platform.

  • arrhythmic burden in patients with new onset persistent left bundle branch block after transcatheter aortic valve replacement 2 year results of the mare study
    Europace, 2021
    Co-Authors: Guillem Muntanecarol, Marc W. Deyell, Marina Urena, Luis Nombelafranco, Ignacio J Amatsantos, Neal S Kleiman, Antonio J Munozgarcia, Felipe Atienza, Vicenc Serra, Gabriela Veigafernandez
    Abstract:

    Aims We determined the incidence and type of arrhythmias at 2-year follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR). Methods and results Multicentre prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR (SAPIEN XT/3: 53; CoreValve/Evolut R: 50). An Implantable Cardiac Monitor (Reveal XT, Reveal Linq) was implanted before hospital discharge and patients had continuous Monitoring for up to 2 years. Arrhythmic events were adjudicated in a central core lab. 1836 new arrhythmic events (tachyarrhythmias: 1655 and bradyarrhythmias: 181) occurred at 2 years. Of these, 283 (15%) occurred beyond 1 year (tachyarrhythmias 212, bradyarrhythmias 71) in 33 (36%) patients, without differences between valve type. Most late (>1 year) arrhythmic events were asymptomatic (94%) and led to a treatment change in 17 (19%) patients. A total of 71 late bradyarrhythmias [high-degree atrioventricular block (HAVB): 3, severe bradycardia: 68] were detected in 17 (21%) patients. At 2 years, 18 (17%) patients had received a permanent pacemaker (PPM) or Implantable Cardiac-defibrillator. PPM implantation due to HAVB predominated in the early phase post-TAVR, with only 1 HAVB event requiring PPM implantation after 1 year. Conclusion Patients with new-onset LBBB post-TAVR exhibited a very high burden of arrhythmic events within the 2 years post-procedure. While new tachyarrhythmic events were homogeneously distributed over time, the vast majority of new HAVB episodes leading to PPM implantation occurred early after the procedure. These results should help to guide the management of this challenging group of patients. (clinicaltrials.gov: NCT02153307).

  • The Cryoballoon vs Irrigated Radiofrequency Catheter Ablation (CIRCA-DOSE) Study Results in Context.
    Arrhythmia & electrophysiology review, 2020
    Co-Authors: Jason G. Andrade, Marc W. Deyell, Atul Verma, Laurent Macle, Paul Khairy
    Abstract:

    The Cryoballoon vs Irrigated Radiofrequency Catheter Ablation: Double Short vs Standard Exposure Duration (CIRCA-DOSE) study was a multicentre, randomised, single-blinded trial that compared contact-force radiofrequency ablation and two different regimens of cryoballoon ablation. All patients received an Implantable Cardiac Monitor for the purpose of continuous rhythm Monitoring, with all arrhythmia events undergoing independent adjudication by a committee blinded to treatment allocation. The study demonstrated there were no significant differences between contact-force radiofrequency ablation and cryoballoon ablation with respect to recurrence of any atrial tachyarrhythmia, symptomatic atrial tachyarrhythmia, asymptomatic AF, symptomatic AF or AF burden. While the results of the CIRCA-DOSE study are reviewed here, this article focuses on considerations around the design of the study and places the observed outcomes in context.

  • Clinical assessment of AF pattern is poorly correlated with AF burden and post ablation outcomes: A CIRCA-DOSE sub-study.
    Journal of electrocardiology, 2020
    Co-Authors: Jason G. Andrade, Marc W. Deyell, Umjeet Jolly, Robert R J Yao, Nathaniel M. Hawkins, Jacques Rizkallah, Clarence Khoo, Jean-marc Raymond, James Mckinney, Christopher C. Cheung
    Abstract:

    Abstract Background Contemporary guidelines recommend that atrial fibrillation (AF) be classified into paroxysmal and persistent AF based on clinical assessment, with these categorizations forming the basis of therapeutic recommendations. While pragmatic, clinical assessment may introduce misclassification errors, which may impact treatment decisions. We sought to determine the relationship between AF classification, baseline AF burden, and post-ablation arrhythmia outcomes. Design The current study is a sub-analysis of a prospective, parallel-group, multicenter, single-blinded randomized clinical trial. All 346 patients enrolled in CIRCA-DOSE received an Implantable Cardiac Monitor a median of 72 days prior to ablation. AF was classified as low burden paroxysmal, high burden paroxysmal, or persistent based on clinical assessment prior to device implantation. Prior to ablation patients were re-classified using the same definitions based on device Monitoring data. Correlation between classifications, AF burden, and post-ablation arrhythmia outcomes were assessed. Results There was poor agreement between clinical and device-based AF classification (Cohen's kappa: 0.192). AF classification derived from pre-ablation continuous Monitoring reflected baseline and post-ablation AF burden with greater accuracy and with less overlap between the AF classes (P  Conclusions Classification of AF pattern based on pre-ablation continuous Cardiac rhythm Monitoring better predicted AF burden and freedom from recurrent AF post ablation. Despite the use of standardized definitions, classification of AF based on clinical assessment did not predict baseline AF burden, post ablation AF burden, or freedom from recurrent AF post ablation. Trial registration: ClinicalTrials.gov NCT01913522 .

  • Prevalence and clinical impact of spontaneous and adenosine-induced pulmonary vein reconduction in the Contact-Force vs. Cryoballoon Atrial Fibrillation Ablation (CIRCA-DOSE) study
    Heart rhythm, 2020
    Co-Authors: Jason G. Andrade, Peter Leong-sit, Marc W. Deyell, Paul Khairy, Jean Champagne, Stanley Nattel, Marc Dubuc, Umjeet Jolly, Mariano Badra-verdu, John L Sapp
    Abstract:

    Background Use of intraprocedural observation and pharmacologic challenges have been proposed as means to differentiate permanent pulmonary vein (PV)–left atrial conduction block from inadequate ablation lesions. Objective The purpose of this study was to determine the prevalence and clinical impact of spontaneous and adenosine-provoked reconnection using contemporary atrial fibrillation (AF) ablation technologies. Methods The CIRCA-DOSE (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration) study enrolled 346 patients with paroxysmal AF and randomized them to contact force–guided radiofrequency ablation (CF-RF) or cryoballoon ablation. Patients underwent provocative testing with adenosine after a 20-minute observation period. All patients received an Implantable Cardiac Monitor for arrhythmia Monitoring. Results Spontaneous reconnection was observed in 5.4% of PVs (71/1318) during the 20-minute postprocedure observation period, and dormant conduction was elicited in 5.7% of PVs (75/1318). Both spontaneous reconnection and dormant conduction were more common after CF-RF compared to cryoballoon ablation (P = .03 and P Conclusion Patients without spontaneous or adenosine-provoked reconnection had better outcomes compared to those with acute PV reconnection, suggesting that efforts should be directed toward ensuring an ideal ablation lesion at the first attempt in order to achieve durable PV isolation.

  • A randomized clinical trial of early invasive intervention for atrial fibrillation (EARLY-AF) - methods and rationale.
    American heart journal, 2018
    Co-Authors: Jason G. Andrade, Marc W. Deyell, Jean Champagne, John L Sapp, Vidal Essebag, Carlos A Morillo, Sandra Lauck, Alan C. Skanes, Patricia Theoret-patrick, George A. Wells
    Abstract:

    Background The ideal management of patients with newly diagnosed symptomatic atrial fibrillation (AF) remains unknown. Current practice guidelines recommend a trial of antiarrhythmic drugs (AAD) prior to considering an invasive ablation procedure. However, earlier ablation offers an opportunity to halt the progressive patho-anatomical changes associated with AF, as well as impart other important clinical benefits. Objective The aim of this study is to determine the optimal initial management strategy for patients with newly diagnosed, symptomatic atrial fibrillation. Methods/Design The EARLY-AF study ( ClinicalTrials.gov NCT02825979 ) is a prospective, open label, multicenter, randomized trial with a blinded assessment of outcomes. A total of 298 patients will be randomized in a 1:1 fashion to first-line AAD therapy, or first-line cryoballoon-based pulmonary vein isolation. Patients with symptomatic treatment naive AF will be included. Arrhythmia outcomes will be assessed by Implantable Cardiac Monitor (ICM). The primary outcome is time to first recurrence of AF, atrial flutter, or atrial tachycardia (AF/AFL/AT) between days 91 and 365 following AAD initiation or AF ablation. Secondary outcomes include arrhythmia burden, quality of life, and healthcare utilization. Discussion The EARLY-AF study is a randomized trial designed to evaluate the optimal first management approach for patients with AF. We hypothesize that catheter ablation will be superior to drug therapy in prevention of AF recurrence.

Mirko De Melis - One of the best experts on this subject based on the ideXlab platform.

  • unsupervised classification of atrial fibrillation triggers using heart rate variability features extracted from Implantable Cardiac Monitor data
    International Conference of the IEEE Engineering in Medicine and Biology Society, 2020
    Co-Authors: Javier Saizvivo, Valentina D A Corino, Mirko De Melis, Luca T Mainardi
    Abstract:

    Catheter ablation is a common treatment of atrial fibrillation (AF), but its success rate is around 60%. It is believed that the success rate can be improved if the procedure were to be guided by the specific AF triggers found in the "Flashback", i.e. the trend of around 500 ventricular beats preceding the AF onset stored in an Implantable Cardiac Monitor (ICM). The need to automatically classify these different triggers: atrial tachycardia (AT), atrial flutter, premature atrial contractions (PAC) or Spontaneous AF has motivated the design in this paper of an unsupervised classification method evaluating statistical and geometrical Heart Rate Variability (HRV) features extracted from the Flashback. From a cohort of 132 patients (57± 12 years, male 67%), 528 Flashbacks were extracted and classified into 5 different clusters after the Principal Component Analysis (PCA) was computed on the HRV features. 2 principal components explained more than 95% of the variance and were a combination of the mean R-R interval, Square root of the mean squared differences of successive R-R intervals (RMSSD), Standard deviation of the R-R intervals (SDNN) and Poincare descriptors, SD1 and SD2. RMSSD and SD1 were significantly different among all clusters (p-value < 0.05, with Holm’s correction) showing that distinct patterns can be found using this method.Clinical Relevance-Preliminary step towards ablation strategy guidance using the AF trigger patterns to improve catheter ablation success rates.

  • EMBC - Unsupervised Classification of Atrial Fibrillation Triggers Using Heart Rate Variability Features Extracted from Implantable Cardiac Monitor Data
    Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Inte, 2020
    Co-Authors: Javier Saiz-vivo, Valentina D A Corino, Mirko De Melis, Luca T Mainardi
    Abstract:

    Catheter ablation is a common treatment of atrial fibrillation (AF), but its success rate is around 60%. It is believed that the success rate can be improved if the procedure were to be guided by the specific AF triggers found in the "Flashback", i.e. the trend of around 500 ventricular beats preceding the AF onset stored in an Implantable Cardiac Monitor (ICM). The need to automatically classify these different triggers: atrial tachycardia (AT), atrial flutter, premature atrial contractions (PAC) or Spontaneous AF has motivated the design in this paper of an unsupervised classification method evaluating statistical and geometrical Heart Rate Variability (HRV) features extracted from the Flashback. From a cohort of 132 patients (57± 12 years, male 67%), 528 Flashbacks were extracted and classified into 5 different clusters after the Principal Component Analysis (PCA) was computed on the HRV features. 2 principal components explained more than 95% of the variance and were a combination of the mean R-R interval, Square root of the mean squared differences of successive R-R intervals (RMSSD), Standard deviation of the R-R intervals (SDNN) and Poincare descriptors, SD1 and SD2. RMSSD and SD1 were significantly different among all clusters (p-value < 0.05, with Holm’s correction) showing that distinct patterns can be found using this method.Clinical Relevance-Preliminary step towards ablation strategy guidance using the AF trigger patterns to improve catheter ablation success rates.

  • COST-EFFECTIVENESS OF Implantable Cardiac Monitor FOR THE DETECTION OF ARRHYTHMIA IN UNEXPLAINED SYNCOPE PATIENTS IN THE UNITED STATES
    Journal of the American College of Cardiology, 2019
    Co-Authors: Brad Sutton, Mirko De Melis, Sarah L Bermingham, Sarah C Rosemas, Alex Diamantopoulos, Kate Lindborg, Stylianos I Tsintzos, Ying Xia, Matthew R. Reynolds
    Abstract:

    Clinical guidelines recommend use of Insertable Cardiac Monitors (ICM) early in the evaluation of unexplained syncope due to their superior ability to establish symptom-rhythm correlation compared to Conventional Testing (CONV). The aim of this study was to evaluate the cost-effectiveness of the ICM

  • letter by ravensbergen et al regarding article long term recording of Cardiac arrhythmias with an Implantable Cardiac Monitor in patients with reduced ejection fraction after acute myocardial infarction the Cardiac arrhythmias and risk stratification
    Circulation, 2012
    Co-Authors: Niels J Ravensbergen, Hence J M Verhagen, Mirko De Melis
    Abstract:

    To the Editor: Patients who suffer a myocardial infarction (MI) are at risk of late sudden Cardiac death. The underlying cause can be divided into 2 groups: recurrent acute MI or Cardiac rupture, and arrhythmias.1 The second group might benefit from an Implantable cardioverter-defibrillator, but identification of those patients who will benefit the most remains a continuous challenge. Recently, the 2-year follow-up of the Cardiac Arrhythmias and Risk Stratification After Acute Myocardial Infarction (CARISMA) trial was published in Circulation and commented on by Buxton.2 The study showed that, among 297 patients with a left ventricular ejection fraction ≤40% after an acute MI, a high-degree atrioventricular (AV) block was the most powerful predictor of Cardiac death, and secondarily, the heart rate variability analysis in …

Matthew R. Reynolds - One of the best experts on this subject based on the ideXlab platform.

  • Abstract 11310: Economic Impact of Increased Longevity in Insertable Cardiac Monitor Technology in Unexplained Syncope and Suspected Atrial Fibrillation Patients
    Circulation, 2019
    Co-Authors: Klaus K. Witte, L. Sawyer, Sarah L Bermingham, Claudia Rinciog, Sarah C Rosemas, Stelios I Tsintzos, Matthew R. Reynolds
    Abstract:

    Introduction: The initial indication for the Implantable Cardiac Monitor (ICM) was unexplained syncope; in this population early use of ICM is recommended following initial nondiagnostic workup. IC...

  • COST-EFFECTIVENESS OF Implantable Cardiac Monitor FOR THE DETECTION OF ARRHYTHMIA IN UNEXPLAINED SYNCOPE PATIENTS IN THE UNITED STATES
    Journal of the American College of Cardiology, 2019
    Co-Authors: Brad Sutton, Mirko De Melis, Sarah L Bermingham, Sarah C Rosemas, Alex Diamantopoulos, Kate Lindborg, Stylianos I Tsintzos, Ying Xia, Matthew R. Reynolds
    Abstract:

    Clinical guidelines recommend use of Insertable Cardiac Monitors (ICM) early in the evaluation of unexplained syncope due to their superior ability to establish symptom-rhythm correlation compared to Conventional Testing (CONV). The aim of this study was to evaluate the cost-effectiveness of the ICM

  • Cost Effectiveness of Implantable Cardiac Monitor-Guided Intermittent Anticoagulation for Atrial Fibrillation: An Analysis of the REACT.COM Pilot Study.
    Journal of cardiovascular electrophysiology, 2016
    Co-Authors: Daniel Steinhaus, Peter Zimetbaum, Peter Leong-sit, M.s.c.e. Rod Passman, Matthew R. Reynolds
    Abstract:

    Introduction Anticoagulation guidelines for patients with atrial fibrillation (AF) disregard AF burden. A strategy of targeted anticoagulation with novel oral anticoagulants (NOACs) based on continuous rhythm assessment with an Implantable Cardiac Monitor (ICM) has recently been explored. We evaluated the potential cost-effectiveness of this strategy versus projected outcomes with continuous anticoagulation. Methods and Results We developed a Markov model using data from the Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring (REACT.COM) pilot study (N = 59) and prior NOAC trials to calculate the costs and quality-adjusted life years (QALYs) associated with ICM-guided intermittent anticoagulation for AF vs. standard care over a 3-year time horizon. Health state utilities were estimated from the pilot study population using the SF-12. Costs were based on current Medicare reimbursement. Over 14±4 months of follow-up 18 of 59 patients had 35 AF episodes. The ICM-guided strategy resulted in a 94% reduction in anticoagulant use relative to continuous treatment. There were no strokes, 3 (5.1%) TIAs, 2 major bleeding events (on aspirin) and 3 minor bleeding events with the ICM-guided strategy. The projected total 3-year costs were $12,535 for the ICM-guided strategy vs. $13,340 for continuous anticoagulation. Projected QALYs were 2.45 for both groups. Conclusion Based on a pilot study, a strategy of ICM-guided anticoagulation with NOACs may be cost-saving relative to expected outcomes with continuous anticoagulation, with similar quality-adjusted survival. This strategy could be attractive from a health economic perspective if shown to be safe and effective in a rigorous clinical trial. This article is protected by copyright. All rights reserved

  • Abstract 336: Cost-effectiveness of Implantable Cardiac Monitor-guided Intermittent Anticoagulation for Paroxysmal Atrial Fibrillation
    Circulation-cardiovascular Quality and Outcomes, 2015
    Co-Authors: Daniel Steinhaus, Peter Zimetbaum, Rod S. Passman, Peter Leong-sit, Matthew R. Reynolds
    Abstract:

    Background: Patients with atrial fibrillation (AF) and stroke risk factors are recommended for treatment with long-term anticoagulation, even when rhythm control interventions result in a low AF burden. A strategy of guiding anticoagulation with novel oral anticoagulants (NOACs) based on daily transmissions from an Implantable Cardiac Monitor (ICM) in CHADS2 1 or 2 AF patients has recently been explored in a single-arm pilot study. The aim of our study was to evaluate the cost-effectiveness of this strategy versus projected outcomes with the current standard of continuous anticoagulation. Methods: We developed a Markov model using data from the Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring (REACT.COM) pilot study (N=59) and previously completed anticoagulant trials to calculate the costs and quality-adjusted life years (QALYs) associated with ICM-guided intermittent anticoagulation for AF vs. standard care. The model time horizon was 3 years (the battery life of an ICM). Health state utilities were estimated from the pilot study population using the SF-12. Costs were based on current Medicare reimbursement. Results: In the pilot study, over 14±4 months of follow-up 18/59 patients were observed to have 35 AF episodes, 60% of which spontaneously terminated and 63% were asymptomatic. The protocol resulted in a >90% reduction in anticoagulant use relative to standard continuous treatment. There were no strokes, 2 (3.4%) TIAs, 2 major bleeding events (on aspirin) and 3 minor bleeding events with the ICM-guided strategy. The model projected total 3-year costs of $10,558 for the ICM-guided strategy vs. $12,898 for literature-based expected outcomes with continuous anticoagulation. Projected QALYs were 2.46 for both groups. Detailed sensitivity and scenario analyses are ongoing. Conclusions: Based on the REACT.COM pilot study, a strategy of intermittent, ICM-guided oral anticoagulation with NOACs was cost-saving relative to expected outcomes with continuous anticoagulation, with equivalent quality-adjusted survival. This strategy requires validation in a larger, randomized study.

Luis Nombelafranco - One of the best experts on this subject based on the ideXlab platform.

  • arrhythmic burden in patients with new onset persistent left bundle branch block after transcatheter aortic valve replacement 2 year results of the mare study
    Europace, 2021
    Co-Authors: Guillem Muntanecarol, Marc W. Deyell, Marina Urena, Luis Nombelafranco, Ignacio J Amatsantos, Neal S Kleiman, Antonio J Munozgarcia, Felipe Atienza, Vicenc Serra, Gabriela Veigafernandez
    Abstract:

    Aims We determined the incidence and type of arrhythmias at 2-year follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR). Methods and results Multicentre prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR (SAPIEN XT/3: 53; CoreValve/Evolut R: 50). An Implantable Cardiac Monitor (Reveal XT, Reveal Linq) was implanted before hospital discharge and patients had continuous Monitoring for up to 2 years. Arrhythmic events were adjudicated in a central core lab. 1836 new arrhythmic events (tachyarrhythmias: 1655 and bradyarrhythmias: 181) occurred at 2 years. Of these, 283 (15%) occurred beyond 1 year (tachyarrhythmias 212, bradyarrhythmias 71) in 33 (36%) patients, without differences between valve type. Most late (>1 year) arrhythmic events were asymptomatic (94%) and led to a treatment change in 17 (19%) patients. A total of 71 late bradyarrhythmias [high-degree atrioventricular block (HAVB): 3, severe bradycardia: 68] were detected in 17 (21%) patients. At 2 years, 18 (17%) patients had received a permanent pacemaker (PPM) or Implantable Cardiac-defibrillator. PPM implantation due to HAVB predominated in the early phase post-TAVR, with only 1 HAVB event requiring PPM implantation after 1 year. Conclusion Patients with new-onset LBBB post-TAVR exhibited a very high burden of arrhythmic events within the 2 years post-procedure. While new tachyarrhythmic events were homogeneously distributed over time, the vast majority of new HAVB episodes leading to PPM implantation occurred early after the procedure. These results should help to guide the management of this challenging group of patients. (clinicaltrials.gov: NCT02153307).

  • arrhythmic burden as determined by ambulatory continuous Cardiac Monitoring in patients with new onset persistent left bundle branch block following transcatheter aortic valve replacement the mare study
    Jacc-cardiovascular Interventions, 2018
    Co-Authors: Josep Rodescabau, Marc W. Deyell, Marina Urena, Luis Nombelafranco, Ignacio J Amatsantos, Neal S Kleiman, Antonio J Munozgarcia, Felipe Atienza, Vicenc Serra, Gabriela Veigafernandez
    Abstract:

    Abstract Objectives The authors sought to determine: 1) the global arrhythmic burden; 2) the rate of arrhythmias leading to a treatment change; and 3) the incidence of high-degree atrioventricular block (HAVB) at 12-month follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR). Background Controversial data exist on the occurrence of significant arrhythmias in patients with LBBB post-TAVR. Methods This was a multicenter prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR with the balloon-expandable SAPIEN XT/3 valve (n = 53), or the self-expanding CoreValve/Evolut R system (n = 50). An Implantable Cardiac Monitor (Reveal XT, Reveal Linq) was implanted at 4 (3 to 6) days post-TAVR, and patients had continuous electrocardiogram Monitoring for 12 months. All arrhythmic events were adjudicated in a central electrocardiography core lab. Primary endpoints were the incidence of arrhythmias leading to a treatment change, and the incidence of HAVB at 12-month follow-up. Results A total of 1,553 new arrhythmic events were detected in 44 patients (1,443 episodes of tachyarrhythmia in 26 patients [atrial fibrillation/flutter/atrial tachycardia: 1,427, ventricular tachycardia 16]; 110 episodes of bradyarrhythmia in 21 patients [HAVB 54, severe bradycardia 56]). All arrhythmic events were silent in 34 patients (77%), the arrhythmic event led to a treatment change in 19 patients (18%), and 11 patients (11%) required pacemaker or Implantable cardioverter-defibrillator implantation (due to HAVB, severe bradycardia, or ventricular tachycardia episodes in 9, 1, and 1 patient, respectively). A total of 12 patients died at 1-year follow-up, 1 from sudden death. Conclusions A high incidence of arrhythmic events was observed at 1-year follow-up in close to one-half of the patients with LBBB post-TAVR. Significant bradyarrhythmias occurred in one-fifth of the patients, and PPM was required in nearly one-half of them. These data support the use of a Cardiac Monitoring device for close follow-up and expediting the initiation of treatment in this challenging group of patients. (Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation [MARE study]: NCT02153307)