42 results on '"Santobuono VE"'
Search Results
2. Association between atrial fibrillation and cardiac implantable defibrillator detected heart failure status
- Author
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Vitali, F, primary, Tavoletta, V, additional, Giano, A, additional, Calo, L, additional, Santini, L, additional, Savarese, G, additional, Dello Russo, A, additional, Santobuono, VE, additional, Mattera, A, additional, Lavalle, C, additional, Amellone, C, additional, Pecora, D, additional, and Bertini, M, additional
- Published
- 2022
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3. CarDiac magnEtic Resonance for prophylactic Implantable-cardioVerter defibrillAtor ThErapy in Non-Ischaemic dilated CardioMyopathy: an international Registry
- Author
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Guaricci, A, Masci, P, Muscogiuri, G, Guglielmo, M, Baggiano, A, Fusini, L, Lorenzoni, V, Martini, C, Andreini, D, Pavon, A, Aquaro, G, Barison, A, Todiere, G, Rabbat, M, Tat, E, Raineri, C, Valentini, A, Varga-Szemes, A, Schoepf, U, De Cecco, C, Bogaert, J, Dobrovie, M, Symons, R, Focardi, M, Gismondi, A, Lozano-Torres, J, Rodriguez-Palomares, J, Lanzillo, C, Di Roma, M, Moro, C, Di Giovine, G, Margonato, D, De Lazzari, M, Perazzolo Marra, M, Nese, A, Casavecchia, G, Gravina, M, Marzo, F, Carigi, S, Pica, S, Lombardi, M, Censi, S, Squeri, A, Palumbo, A, Gaibazzi, N, Camastra, G, Sbarbati, S, Pedrotti, P, Masi, A, Carrabba, N, Pradella, S, Timpani, M, Cicala, G, Presicci, C, Puglisi, S, Sverzellati, N, Santobuono, V, Pepi, M, Schwitter, J, Pontone, G, Guaricci AI, Masci PG, Muscogiuri G, Guglielmo M, Baggiano A, Fusini L, Lorenzoni V, Martini C, Andreini D, Pavon AG, Aquaro GD, Barison A, Todiere G, Rabbat MG, Tat E, Raineri C, Valentini A, Varga-Szemes A, Schoepf UJ, De Cecco CN, Bogaert J, Dobrovie M, Symons R, Focardi M, Gismondi A, Lozano-Torres J, Rodriguez-Palomares JF, Lanzillo C, Di Roma M, Moro C, Di Giovine G, Margonato D, De Lazzari M, Perazzolo Marra M, Nese A, Casavecchia G, Gravina M, Marzo F, Carigi S, Pica S, Lombardi M, Censi S, Squeri A, Palumbo A, Gaibazzi N, Camastra G, Sbarbati S, Pedrotti P, Masi A, Carrabba N, Pradella S, Timpani M, Cicala G, Presicci C, Puglisi S, Sverzellati N, Santobuono VE, Pepi M, Schwitter J, Pontone G, Guaricci, A, Masci, P, Muscogiuri, G, Guglielmo, M, Baggiano, A, Fusini, L, Lorenzoni, V, Martini, C, Andreini, D, Pavon, A, Aquaro, G, Barison, A, Todiere, G, Rabbat, M, Tat, E, Raineri, C, Valentini, A, Varga-Szemes, A, Schoepf, U, De Cecco, C, Bogaert, J, Dobrovie, M, Symons, R, Focardi, M, Gismondi, A, Lozano-Torres, J, Rodriguez-Palomares, J, Lanzillo, C, Di Roma, M, Moro, C, Di Giovine, G, Margonato, D, De Lazzari, M, Perazzolo Marra, M, Nese, A, Casavecchia, G, Gravina, M, Marzo, F, Carigi, S, Pica, S, Lombardi, M, Censi, S, Squeri, A, Palumbo, A, Gaibazzi, N, Camastra, G, Sbarbati, S, Pedrotti, P, Masi, A, Carrabba, N, Pradella, S, Timpani, M, Cicala, G, Presicci, C, Puglisi, S, Sverzellati, N, Santobuono, V, Pepi, M, Schwitter, J, Pontone, G, Guaricci AI, Masci PG, Muscogiuri G, Guglielmo M, Baggiano A, Fusini L, Lorenzoni V, Martini C, Andreini D, Pavon AG, Aquaro GD, Barison A, Todiere G, Rabbat MG, Tat E, Raineri C, Valentini A, Varga-Szemes A, Schoepf UJ, De Cecco CN, Bogaert J, Dobrovie M, Symons R, Focardi M, Gismondi A, Lozano-Torres J, Rodriguez-Palomares JF, Lanzillo C, Di Roma M, Moro C, Di Giovine G, Margonato D, De Lazzari M, Perazzolo Marra M, Nese A, Casavecchia G, Gravina M, Marzo F, Carigi S, Pica S, Lombardi M, Censi S, Squeri A, Palumbo A, Gaibazzi N, Camastra G, Sbarbati S, Pedrotti P, Masi A, Carrabba N, Pradella S, Timpani M, Cicala G, Presicci C, Puglisi S, Sverzellati N, Santobuono VE, Pepi M, Schwitter J, and Pontone G
- Abstract
Aims: The aim of this registry was to evaluate the additional prognostic value of a composite cardiac magnetic resonance (CMR)-based risk score over standard-of-care (SOC) evaluation in a large cohort of consecutive unselected non-ischaemic cardiomyopathy (NICM) patients. Methods and results: In the DERIVATE registry (www.clinicaltrials.gov/registration: RCT#NCT03352648), 1000 (derivation cohort) and 508 (validation cohort) NICM patients with chronic heart failure (HF) and left ventricular ejection fraction [removed]3 segments with midwall fibrosis on late gadolinium enhancement (LGE) were the only independent predictors of all-cause mortality (HR: 1.036, 95% CI: 1.0117-1.056, P < 0.001 and HR: 2.077, 95% CI: 1.211-3.562, P = 0.008, respectively). For MAACE, the independent predictors were male gender, left ventricular end-diastolic volume index by CMR (CMR-LVEDVi), and >3 segments with midwall fibrosis on LGE (HR: 2.131, 95% CI: 1.231-3.690, P = 0.007; HR: 3.161, 95% CI: 1.750-5.709, P < 0.001; and HR: 1.693, 95% CI: 1.084-2.644, P = 0.021, respectively). A composite clinical and CMR-based risk score provided a net reclassification improvement of 63.7% (P < 0.001) for MAACE occurrence when added to the model based on SOC evaluation. These findings were confirmed in the validation cohort. Conclusion: In a large multicentre, multivendor cohort registry reflecting daily clinical practice in NICM work-up, a composite clinical and CMR-based risk score provides incremental prognostic value beyond SOC evaluation, which may have impact on the indication of implantable cardioverter-defibrillator implantation.
- Published
- 2021
4. Implantable cardioverter defibrillator multisensor monitoring during home confinement caused by the covid-19 pandemic
- Author
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Diemberger, I, primary, Guerra, F, additional, Calo", L, additional, D"onofrio, A, additional, Manzo, M, additional, Santini, L, additional, Giubilato, G, additional, Carriere, C, additional, Santobuono, VE, additional, Savarese, G, additional, La Greca, C, additional, Arena, G, additional, Talarico, A, additional, Valsecchi, S, additional, and Ziacchi, M, additional
- Published
- 2021
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5. A multiparametric ICD algorithm for heart failure risk stratification and management: an analysis in clinical practice
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Calo", L, primary, Bianchi, V, additional, Ferraioli, D, additional, Santini, L, additional, Dello Russo, A, additional, Carriere, C, additional, Santobuono, VE, additional, Andreoli, C, additional, La Greca, C, additional, Arena, G, additional, Talarico, A, additional, Pisano", E, additional, De Ruvo, E, additional, Campari, M, additional, and D"onofrio, A, additional
- Published
- 2021
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6. P997First experience in 19 months attain stability lv-lead extraction
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Mandurino, C., primary, Pinto, M., additional, Guido, A., additional, Sgarra, L., additional, Santobuono, VE., additional, Memeo, R., additional, Nacci, F., additional, Anaclerio, M., additional, Luzzi, G., additional, and Favale, S., additional
- Published
- 2017
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7. Differentiating sensor changes in a composite heart failure ICD monitoring index: clinical correlates and implications.
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Compagnucci P, Santobuono VE, D'Onofrio A, Vitulano G, Calò L, Bertini M, Santini L, Savarese G, Lavalle C, Viscusi M, Giammaria M, Pecora D, Calvanese R, Santoro A, Ziacchi M, Casella M, Averina V, Campari M, Valsecchi S, Capucci A, and Dello Russo A
- Abstract
Background: The HeartLogic algorithm (Boston Scientific, St Paul, MN) integrates data from implantable cardioverter-defibrillator (ICD) sensors to predict heart failure (HF) decompensation: first (S1) and third (S3) heart sounds, intrathoracic impedance, respiration rate, ratio of respiration rate to tidal volume (RSBI), and night heart rate., Objective: This study assessed the relative changes in ICD sensors at the onset of HeartLogic alerts, their association with patient characteristics, and outcomes., Methods: The study included 568 patients with HF carrying ICDs (CRT-D, n = 410) across 26 centers, with a median follow-up of 26 months. HeartLogic alerts triggered patient contact and potential treatment., Results: A total of 1200 HeartLogic alerts were recorded in 370 patients. The sensor with the highest change at the alert's onset was S3 in 27% of alerts, followed by S3/S1 (25%). Patients with atrial fibrillation (AF) and chronic kidney disease (CKD) at implantation had higher prevalence of alerts (AF, 84% vs no AF, 58%; CKD, 72% vs no CKD, 59%; P < .05) and rate (AF, 1.51 per patient-year vs no AF, 0.88 per patient-year; CKD, 1.30 per patient-year vs no CKD, 0.89 per patient-year; P < .05). During follow-up, 247 patients experienced more than 1 alert; in 85%, the sensor with the highest change varied between successive alerts. Of the 88 (7%) alerts associated with HF hospitalization or death, respiration rate or RSBI (11%, P = .007 vs S3/S1) and night heart rate (11%, P = .031 vs S3/S1) were more commonly the sensors showing the highest change. Clinical events were more common with the first alert (12.6%) than subsequent alerts (5.2%, P < .001)., Conclusion: HeartLogic alerts are mostly triggered by changes in heart sounds, but clinical events are more linked to respiration rate, RSBI, and night heart rate. Recurrent alerts often involve different sensors, indicating diverse mechanisms of HF progression., Competing Interests: Disclosures Dr Dello Russo is consultant for Abbott, Biosense Webster, and Boston Scientific. Dr Santini is consultant for Abbott, Boston Scientific, Medtronic, and Biotronik and is a speaker for Medtronic, Boston Scientific, Abbott, Microport, and Biotronik. Dr Bertini is a consultant for Boston Scientific and Microport; speaker and tutor in training courses for Boston Scientific, Microport, Medtronic, Abbott, Biotronik, Pfizer, Bayer, Daiichi-Sankyo, and Boehringer Ingelheim. Dr Casella has received speaker honoraria from Biosense Webster. Dr Averina, Dr Campari, and Dr Valsecchi are employees of Boston Scientific. The remaining authors have no conflicts of interest to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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8. Impact on ventricular arrhythmic burden of SGLT2 inhibitors in patients with chronic heart failure evaluated with cardiac implantable electronic device monitoring.
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Basile P, Monitillo F, Santoro D, Falco G, Carella MC, Khan Y, Moretti A, Santobuono VE, Memeo R, Pontone G, Forleo C, Ciccone MM, and Guaricci AI
- Abstract
Background: Sodium-glucose cotransporter 2 (SGLT2) inhibitors have revolutionized the therapeutic scenario of heart failure, demonstrating favorable effects on mortality and quality of life. Previous studies have yielded conflicting data regarding the effects on ventricular arrhythmias., Methods: A prospective observational study was conducted to investigate the anti-arrhythmic properties of SGLT2 inhibitors evaluating the intra-patient difference in major adverse arrhythmic cardiac events (MAACE) over a six-month period in patients with chronic heart failure who were undergoing continuous monitoring using a cardiac implantable electronic device., Results: From January 2022 to January 2023, 82 patients [median age 63 years (IQR 15), male 87 %] were enrolled in the study, with a median follow-up of 28 weeks (IQR 5). The rate of MAACE at baseline was 11 %, without relevant differences in the follow up in terms of major and minor arrhythmic events. In patients with an arrhythmic phenotype at baseline, a mild but non statistically significant reduction of MAACE (from 36 % to 28 %, p = 0.727) was observed and a significant decrease of non-sustained ventricular tachycardia (from 68 % to 32 %, p = 0.022)., Conclusions: Our findings suggest potential anti-arrhythmic properties of SGLT2 inhibitors, evident in patients with arrhythmic events before the initiation of the drug., Competing Interests: Declaration of competing interest The authors declare no conflict of interest., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2024
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9. Device-detected atrial sensing amplitudes as a marker of increased risk for new onset and progression of atrial high-rate episodes.
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Biffi M, Celentano E, Giammaria M, Curnis A, Rovaris G, Ziacchi M, Miracapillo G, Saporito D, Baroni M, Quartieri F, Marini M, Pepi P, Senatore G, Caravati F, Calvi V, Tomasi L, Nigro G, Bontempi L, Notarangelo F, Santobuono VE, Boggian G, Arena G, Solimene F, Giaccardi M, Maglia G, Perini AP, Volpicelli M, Giacopelli D, Gargaro A, and Iacopino S
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- Humans, Female, Male, Aged, Incidence, Disease Progression, Risk Assessment methods, Heart Atria physiopathology, Pacemaker, Artificial, Heart Rate physiology, Risk Factors, Middle Aged, Remote Sensing Technology instrumentation, Follow-Up Studies, Atrial Fibrillation physiopathology, Atrial Fibrillation diagnosis, Defibrillators, Implantable
- Abstract
Background: Atrial high-rate episodes (AHREs) are frequent in patients with cardiac implantable electronic devices. A decrease in device-detected P-wave amplitude may be an indicator of periods of increased risk of AHRE., Objective: The objective of this study was to assess the association between P-wave amplitude and AHRE incidence., Methods: Remote monitoring data from 2579 patients with no history of atrial fibrillation (23% pacemakers and 77% implantable cardioverter-defibrillators, of which 40% provided cardiac resynchronization therapy) were used to calculate the mean P-wave amplitude during 1 month after implantation. The association with AHRE incidence according to 4 strata of daily burden duration (≥15 minutes, ≥6 hours, ≥24 hours, ≥7 days) was investigated by adjusting the hazard ratio with the CHA
2 DS2 -VASc score., Results: The adjusted hazard ratio for 1-mV lower mean P-wave amplitude during the first month increased from 1.10 (95% confidence interval [CI], 1.05-1.15; P < .001) to 1.18 (CI, 1.09-1.28; P < .001) with AHRE duration strata from ≥15 minutes to ≥7 days independent of the CHA2 DS2 -VASc score. Of 871 patients with AHREs, those with 1-month P-wave amplitude <2.45 mV had an adjusted hazard ratio of 1.51 (CI, 1.19-1.91; P = .001) for progression of AHREs from ≥15 minutes to ≥7 days compared with those with 1-month P-wave amplitude ≥2.45 mV. Device-detected P-wave amplitudes decreased linearly during the 1 year before the first AHRE by 7.3% (CI, 5.1%-9.5%; P < .001 vs patients without AHRE)., Conclusion: Device-detected P-wave amplitudes <2.45 mV were associated with an increased risk of AHRE onset and progression to persistent forms of AHRE independent of the patient's risk profile., Competing Interests: Disclosures Mauro Biffi has held educational activity and participated in speaker’s bureau on behalf of Boston Scientific, Biotronik, and Medtronic. Matteo Ziacchi has held educational activity and participated in speaker’s bureau on behalf of Medtronic. Daniele Giacopelli and Alessio Gargaro are employees of Biotronik Italia S.p.a. The remaining authors have no major conflicts of interest to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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10. Missense and Non-Missense Lamin A/C Gene Mutations Are Similarly Associated with Major Arrhythmic Cardiac Events: A 20-Year Single-Centre Experience.
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Forleo C, Carella MC, Basile P, Carulli E, Dadamo ML, Amati F, Loizzi F, Sorrentino S, Dentamaro I, Dicorato MM, Ricci S, Bagnulo R, Iacoviello M, Santobuono VE, Caiati C, Pepe M, Desaphy JF, Ciccone MM, Resta N, and Guaricci AI
- Abstract
Arrhythmic risk stratification in patients with Lamin A/C gene (LMNA)-related cardiomyopathy influences clinical decisions. An implantable cardioverter defibrillator (ICD) should be considered in patients with an estimated 5-year risk of malignant ventricular arrhythmia (MVA) of ≥10%. The risk prediction score for MVA includes non-missense LMNA mutations, despite their role as an established risk factor for sudden cardiac death (SCD) has been questioned in several studies. The purpose of this study is to investigate cardiac features and find gene-phenotype correlations that would contribute to the evidence on the prognostic implications of non-missense vs. missense mutations in a cohort of LMNA mutant patients. An observational, prospective study was conducted in which 54 patients positive for a Lamin A/C mutation were enrolled, and 20 probands (37%) were included. The median age at first clinical manifestation was 41 (IQR 19) years. The median follow-up was 8 years (IQR 8). The type of LMNA gene mutation was distributed as follows: missense in 26 patients (48%), non-frameshift insertions in 16 (30%), frameshift deletions in 5 (9%), and nonsense in 7 (13%). Among the missense mutation carriers, two (8%) died and four (15%) were admitted onto the heart transplant list or underwent transplantation, with a major adverse cardiovascular event (MACE) rate of 35%. No statistically significant differences in MACE prevalence were identified according to the missense and non-missense mutation groups ( p value = 0.847). Our data shift the spotlight on this considerable topic and could suggest that some missense mutations may deserve attention regarding SCD risk stratification in real-world clinical settings.
- Published
- 2024
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11. Long-term clinical outcomes of patients with drug-induced type 1 Brugada electrocardiographic pattern: A nationwide cohort registry study.
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Russo V, Caturano A, Migliore F, Guerra F, Francia P, Nesti M, Conte G, Perini AP, Mascia G, Albani S, Marchese P, Santobuono VE, Dendramis G, Rossi A, Attena E, Ghidini AO, Sciarra L, Palamà Z, Baldi E, Romeo E, D'Onofrio A, and Nigro G
- Subjects
- Humans, Male, Female, Middle Aged, Retrospective Studies, Prognosis, Death, Sudden, Cardiac epidemiology, Death, Sudden, Cardiac etiology, Italy epidemiology, Follow-Up Studies, Defibrillators, Implantable, Switzerland epidemiology, Time Factors, Survival Rate trends, Adult, Brugada Syndrome physiopathology, Brugada Syndrome diagnosis, Brugada Syndrome epidemiology, Electrocardiography, Registries
- Abstract
Background: There are limited real-world data on the extended prognosis of patients with drug-induced type 1 Brugada electrocardiogram (ECG)., Objective: We assessed the clinical outcomes and predictors of life-threatening arrhythmias in patients with drug-induced type 1 Brugada ECG., Methods: This multicenter retrospective study, conducted at 21 Italian and Swiss hospitals from July 1997 to May 2021, included consecutive patients with drug-induced type 1 ECG. The primary outcome, a composite of appropriate ICD therapies and sudden cardiac death, was assessed along with the clinical predictors of these events., Results: A total of 606 patients (mean age 49.7 ± 14.7 years; 423 [69.8%] men) were followed for a median of 60.3 months (interquartile range 23.0-122.4 months). Nineteen patients (3.1%) experienced life-threatening arrhythmias, with a median annual event rate of 0.5% over 5 years and 0.25% over 10 years. The SCN5A mutation was the only predictor of the primary outcome (hazard ratio 4.54; P = .002), whereas a trend was observed for unexplained syncope (hazard ratio 3.85; P = .05). In patients who were asymptomatic at presentation, the median annual rate of life-threatening arrhythmias is 0.24% over 5 years and increases to 1.2% if they have inducible ventricular fibrillation during programmed ventricular stimulation., Conclusion: In patients with drug-induced type 1 Brugada ECG, the annual risk of life-threatening arrhythmias is low, with the SCN5A mutation as the only independent predictor. Unexplained syncope correlated with worse clinical outcomes. Ventricular fibrillation inducibility at programmed ventricular stimulation significantly increases the median annual rate of life-threatening arrhythmias from 0.24% to 1.2% over 5 years., Competing Interests: Disclosures The authors have no conflicts of interest to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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12. The Beneficial Role of Telemedicine for Arrhythmic Risk Stratification in Asymptomatic Brugada Syndrome: An Exemplary Case Report.
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Santobuono VE, Carella MC, Guaricci AI, Carulli E, Basile P, Dicorato MM, Ciccone MM, and Forleo C
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- Humans, Male, Adolescent, Risk Assessment methods, NAV1.5 Voltage-Gated Sodium Channel genetics, Tachycardia, Ventricular diagnosis, Tachycardia, Ventricular therapy, Electrocardiography, Electrocardiography, Ambulatory instrumentation, Electrocardiography, Ambulatory methods, Mutation, Missense, Death, Sudden, Cardiac prevention & control, Death, Sudden, Cardiac etiology, Brugada Syndrome diagnosis, Brugada Syndrome genetics, Brugada Syndrome therapy, Telemedicine methods, Defibrillators, Implantable
- Abstract
Telemedicine and remote monitoring devices, including implantable loop recorders (ILR), are increasingly adopted in the cardiologic setting. These are valuable tools in the arrhythmic stratification of patients at risk of sudden cardiac death, providing a tailored therapeutic management to prevent lethal arrhythmias. We report a case of an asymptomatic 18-year-old boy with a family history of syncope and cardiac arrest, who had a diagnosis of Brugada syndrome with an inducible type 1 pattern and carrier of a missense mutation of the SCN5A gene. In light of the risk factors, although not recommended by current guidelines, we decided to proceed with the implantation of an ILR with remote monitoring service. A few months later, an episode of asymptomatic sustained polymorphic ventricular tachycardia was promptly observed by the remote monitoring, leading to a timely implantation of a subcutaneous cardiac implantable defibrillator.
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- 2024
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13. The Role of Magnetic Resonance Imaging in Cardiomyopathies in the Light of New Guidelines: A Focus on Tissue Mapping.
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Forleo C, Carella MC, Basile P, Mandunzio D, Greco G, Napoli G, Carulli E, Dicorato MM, Dentamaro I, Santobuono VE, Memeo R, Latorre MD, Baggiano A, Mushtaq S, Ciccone MM, Pontone G, and Guaricci AI
- Abstract
Cardiomyopathies (CMPs) are a group of myocardial disorders that are characterized by structural and functional abnormalities of the heart muscle. These abnormalities occur in the absence of coronary artery disease (CAD), hypertension, valvular disease, and congenital heart disease. CMPs are an increasingly important topic in the field of cardiovascular diseases due to the complexity of their diagnosis and management. In 2023, the ESC guidelines on cardiomyopathies were first published, marking significant progress in the field. The growth of techniques such as cardiac magnetic resonance imaging (CMR) and genetics has been fueled by the development of multimodal imaging approaches. For the diagnosis of CMPs, a multimodal imaging approach, including CMR, is recommended. CMR has become the standard for non-invasive analysis of cardiac morphology and myocardial function. This document provides an overview of the role of CMR in CMPs, with a focus on tissue mapping. CMR enables the characterization of myocardial tissues and the assessment of cardiac functions. CMR sequences and techniques, such as late gadolinium enhancement (LGE) and parametric mapping, provide detailed information on tissue composition, fibrosis, edema, and myocardial perfusion. These techniques offer valuable insights for early diagnosis, prognostic evaluation, and therapeutic guidance of CMPs. The use of quantitative CMR markers enables personalized treatment plans, improving overall patient outcomes. This review aims to serve as a guide for the use of these new tools in clinical practice.
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- 2024
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14. Bifocal coronary sinus pacing and transcatheter tricuspid valve-in-valve implantation: an innovative combined approach.
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Santobuono VE, Basile P, Gentile M, Logiacco A, Amati F, Carella MC, Memeo R, Cillis E, Bortone AS, Forleo C, Ciccone MM, and Guaricci AI
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- Adult, Humans, Male, Atrioventricular Block therapy, Atrioventricular Block etiology, Bioprosthesis, Heart Valve Prosthesis, Pacemaker, Artificial, Tricuspid Valve Insufficiency surgery, Tricuspid Valve Insufficiency diagnosis, Cardiac Catheterization methods, Cardiac Pacing, Artificial methods, Coronary Sinus surgery, Heart Valve Prosthesis Implantation methods, Tricuspid Valve surgery
- Abstract
One of the most common complications of tricuspid valve replacement is atrioventricular block (AVB), often requiring permanent pacing. The endocardial pacemaker lead, placed in the right ventricle, may sometimes interfere with the implanted prosthesis, causing its early dysfunction and the need for alternative sites of pacing. To the best of our knowledge, we present the first case of a successful combined percutaneous procedure consisting of the implantation of two leads in the coronary sinus for univentricular bifocal pacing and a transcatheter tricuspid valve-in-valve implantation in a young patient with severe dysfunction of the tricuspid bioprosthesis, requiring permanent pacing for a postsurgical complete atrioventricular block.
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- 2024
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15. Association between amount of biventricular pacing and heart failure status measured by a multisensor implantable defibrillator algorithm.
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Santini L, Calò L, D'Onofrio A, Manzo M, Dello Russo A, Savarese G, Pecora D, Amellone C, Santobuono VE, Calvanese R, Viscusi M, Pisanò E, Pangallo A, Rapacciuolo A, Bertini M, Lavalle C, Santoro A, Campari M, Valsecchi S, and Boriani G
- Abstract
Background: Achieving a high biventricular pacing percentage (BiV%) is crucial for optimizing outcomes in cardiac resynchronization therapy (CRT). The HeartLogic index, a multiparametric heart failure (HF) risk score, incorporates implantable cardioverter-defibrillator (ICD)-measured variables and has demonstrated its predictive ability for impending HF decompensation., Objective: This study aimed to investigate the relationship between daily BiV% in CRT ICD patients and their HF status, assessed using the HeartLogic algorithm., Methods: The HeartLogic algorithm was activated in 306 patients across 26 centers, with a median follow-up of 26 months (25th-75th percentile: 15-37)., Results: During the follow-up period, 619 HeartLogic alerts were recorded in 186 patients. Overall, daily values associated with the best clinical status (highest first heart sound, intrathoracic impedance, patient activity; lowest combined index, third heart sound, respiration rate, night heart rate) were associated with a BiV% exceeding 99%. We identified 455 instances of BiV% dropping below 98% after consistent pacing periods. Longer episodes of reduced BiV% (hazard ratio: 2.68; 95% CI: 1.02-9.72; P = .045) and lower BiV% (hazard ratio: 3.97; 95% CI: 1.74-9.06; P =.001) were linked to a higher risk of HeartLogic alerts. BiV% drops exceeding 7 days predicted alerts with 90% sensitivity (95% CI [74%-98%]) and 55% specificity (95% CI [51%-60%]), while BiV% ≤96% predicted alerts with 74% sensitivity (95% CI [55%-88%]) and 81% specificity (95% CI [77%-85%])., Conclusion: A clear correlation was observed between reduced daily BiV% and worsening clinical conditions, as indicated by the HeartLogic index. Importantly, even minor reductions in pacing percentage and duration were associated with an increased risk of HF alerts., (© 2024 Heart Rhythm Society.)
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- 2024
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16. Percutaneous extraction of a Micra AV transcatheter pacing system due to a rare sudden battery failure after 19 months from implantation: A first experience worldwide.
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Santobuono VE, Basile P, Carella MC, Pomarico F, Favale S, Ciccone MM, and Guaricci AI
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- Humans, Treatment Outcome, Equipment Design, Cardiac Pacing, Artificial, Arrhythmias, Cardiac, Pacemaker, Artificial adverse effects
- Abstract
Introduction: Micra AV Transcatheter Pacing System (TPS) represents an innovative second-generation leadless pacemaker which represents an effective alternative to conventional devices in selected cases. Intrinsic malfunctions of these devices are rare, requiring sometimes their retrieval. When performed in experienced centers, this procedure is safe., Case Presentation: We describe a case of sudden battery malfunction of a Micra AV TPS, which required the extraction and the placement of a new pacing system in the right ventricle., Discussion: This case, which has never been reported, highlights the need to a careful fluoroscopic evaluation and the usefulness of remote monitoring., (© 2023 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)
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- 2024
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17. Left atrial strain is a good predictor of atrio-ventricular synchrony in leadless pacemaker pacing.
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Troisi F, Caccavo VP, Santobuono VE, Sgarra L, Carella MC, Basile P, Guaricci AI, and Grimaldi M
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- Male, Humans, Heart Ventricles, Echocardiography, Arrhythmias, Cardiac, Heart Atria diagnostic imaging, Pacemaker, Artificial
- Abstract
Introduction: The importance of atrio-ventricular synchrony pacing in sinus rhythm patients is known. To identify patients in whom leadless pacemakers are able to guarantee this atrio-ventricular synchrony, we explored correlations among echocardiographic measures of left atrial (LA) size and function (doppler parameter and strain) with A4 amplitude in patients implanted with new generation Micra-AV device., Methods: After implantation with Micra-AV system, patients underwent device interrogation to evaluate AV synchrony based on the sensing of atrial mechanics and echocardiographic exam to assess LA morphology and LA function., Results: In the 21 studied patients (14 males, 72 ± 13 years), the A4 wave amplitude values inversely correlated with LA antero-posterior diameter, LA volume, LA contraction strain and LA conduit strain, while they were positively related with LA reservoir strain., Discussion: Our results indicate a statistically significant relationship between morphological echocardiographic LA parameters and atrial contraction signal (A4), detected by leadless pacemakers and used to synchronize ventricular pacing with the atrium. Instantaneous LA function assessment obtained with LA strain provides incremental information over morphological parameters. LA strain evaluates atrial myocardial deformation during the whole cardiac cycle. We found higher value of A4 in patients that have grater absolute value of LAsr, LAscd and LAsct, that are simple and measurable parameters of LA functional capacity., Conclusion: Preimplant echocardiographic evaluation of the atrial contractility may be useful in predicting adequate A4 sensing and consequently a good atrio-ventricular synchrony pacing. Echocardiography LA strain study seems promising in Micra-AV patient selection., (© 2023 Wiley Periodicals LLC.)
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- 2024
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18. Improvement of myocardial contractility with leadless endocardial single-lead atrial sensing ventricular pacing in patients with prolonged PQ interval.
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Guaricci AI, Santobuono VE, Soldato N, Basile P, Bozza N, Carella MC, Siena P, Forleo C, Pontone G, and Ciccone MM
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- Humans, Heart Ventricles diagnostic imaging, Cardiac Pacing, Artificial methods, Heart Atria diagnostic imaging, Pacemaker, Artificial, Atrioventricular Block therapy, Heart Septal Defects
- Abstract
Aim: Micra AV represents a leadless endocardial pacing system able to detect atrial contractions providing atrioventricular synchrony. A reduction of myocardial contractility may be detected in case of first-degree atrioventricular block (AVB). Materials & methods: In six patients with first-degree AVB (PQ interval ≥220 msec) was evaluated the left ventricle global longitudinal strain (LV GLS) by speckle tracking (ST) echocardiography during single-lead atrial sensing ventricular pacing (VDD) stimulation as compared with spontaneous rhythm (SR), 24-48 h after Micra AV implantation. Results: A statistically significant difference between the two modalities was observed (LV GLS during SR: -14.7% [interquartile range (IQR) 5.5], LV GLS during VDD pacing: -16.1% [IQR 5.2]; p value = 0.041). Conclusion: Our preliminary results suggest an improvement of myocardial contractility with VDD pacing as compared with SR.
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- 2024
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19. Cardiac Magnetic Resonance as Risk Stratification Tool in Non-Ischemic Dilated Cardiomyopathy Referred for Implantable Cardioverter Defibrillator Therapy-State of Art and Perspectives.
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Argentiero A, Carella MC, Mandunzio D, Greco G, Mushtaq S, Baggiano A, Fazzari F, Fusini L, Muscogiuri G, Basile P, Siena P, Soldato N, Napoli G, Santobuono VE, Forleo C, Garrido EC, Di Marco A, Pontone G, and Guaricci AI
- Abstract
Non-ischemic dilated cardiomyopathy (DCM) is a disease characterized by left ventricular dilation and systolic dysfunction. Patients with DCM are at higher risk for ventricular arrhythmias and sudden cardiac death (SCD). According to current international guidelines, left ventricular ejection fraction (LVEF) ≤ 35% represents the main indication for prophylactic implantable cardioverter defibrillator (ICD) implantation in patients with DCM. However, LVEF lacks sensitivity and specificity as a risk marker for SCD. It has been seen that the majority of patients with DCM do not actually benefit from the ICD implantation and, on the contrary, that many patients at risk of SCD are not identified as they have preserved or mildly depressed LVEF. Therefore, the use of LVEF as unique decision parameter does not maximize the benefit of ICD therapy. Multiple risk factors used in combination could likely predict SCD risk better than any single risk parameter. Several predictors have been proposed including genetic variants, electric indexes, and volumetric parameters of LV. Cardiac magnetic resonance (CMR) can improve risk stratification thanks to tissue characterization sequences such as LGE sequence, parametric mapping, and feature tracking. This review evaluates the role of CMR as a risk stratification tool in DCM patients referred for ICD.
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- 2023
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20. Performance of a multi-sensor implantable defibrillator algorithm for heart failure monitoring in the presence of atrial fibrillation.
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Boriani G, Bertini M, Manzo M, Calò L, Santini L, Savarese G, Dello Russo A, Santobuono VE, Lavalle C, Viscusi M, Amellone C, Calvanese R, Santoro A, Rapacciuolo A, Ziacchi M, Arena G, Imberti JF, Campari M, Valsecchi S, and D'Onofrio A
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- Humans, Algorithms, Heart Atria, Atrial Fibrillation diagnosis, Atrial Fibrillation epidemiology, Atrial Fibrillation therapy, Defibrillators, Implantable, Heart Failure diagnosis, Heart Failure epidemiology, Heart Failure therapy
- Abstract
Aims: The HeartLogic Index combines data from multiple implantable cardioverter defibrillators (ICDs) sensors and has been shown to accurately stratify patients at risk of heart failure (HF) events. We evaluated and compared the performance of this algorithm during sinus rhythm and during long-lasting atrial fibrillation (AF)., Methods and Results: HeartLogic was activated in 568 ICD patients from 26 centres. We found periods of ≥30 consecutive days with an atrial high-rate episode (AHRE) burden <1 h/day and periods with an AHRE burden ≥20 h/day. We then identified patients who met both criteria during the follow-up (AHRE group, n = 53), to allow pairwise comparison of periods. For control purposes, we identified patients with an AHRE burden <1 h throughout their follow-up and implemented 2:1 propensity score matching vs. the AHRE group (matched non-AHRE group, n = 106). In the AHRE group, the rate of alerts was 1.2 [95% confidence interval (CI): 1.0-1.5]/patient-year during periods with an AHRE burden <1 h/day and 2.0 (95% CI: 1.5-2.6)/patient-year during periods with an AHRE-burden ≥20 h/day (P = 0.004). The rate of HF hospitalizations was 0.34 (95% CI: 0.15-0.69)/patient-year during IN-alert periods and 0.06 (95% CI: 0.02-0.14)/patient-year during OUT-of-alert periods (P < 0.001). The IN/OUT-of-alert state incidence rate ratio of HF hospitalizations was 8.59 (95% CI: 1.67-55.31) during periods with an AHRE burden <1 h/day and 2.70 (95% CI: 1.01-28.33) during periods with an AHRE burden ≥20 h/day. In the matched non-AHRE group, the rate of HF hospitalizations was 0.29 (95% CI: 0.12-0.60)/patient-year during IN-alert periods and 0.04 (95% CI: 0.02-0.08)/patient-year during OUT-of-alert periods (P < 0.001). The incidence rate ratio was 7.11 (95% CI: 2.19-22.44)., Conclusion: Patients received more alerts during periods of AF. The ability of the algorithm to identify increased risk of HF events was confirmed during AF, despite a lower IN/OUT-of-alert incidence rate ratio in comparison with non-AF periods and non-AF patients., Clinical Trial Registration: http://clinicaltrials.gov/Identifier: NCT02275637., Competing Interests: Conflict of interest: G.B. reported small speaker fees from Bayer, Boehringer Ingelheim, Boston, Daiichi Sankyo, Janssen, and Sanofi outside of the submitted work. L.S. is a consultant for Boston Scientific, Abbott, and Medtronic and reported small speaker fees from Zoll. M.Z. reported small speaker fees from Abbott, Boston Scientific, and Biotronik. M.C. and S.V. are employees of Boston Scientific, Inc. The other authors did not report other conflicts of interest to disclose., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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21. Performance of a multisensor implantable defibrillator algorithm for heart failure monitoring related to co-morbidities.
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Santobuono VE, Favale S, D'Onofrio A, Manzo M, Calò L, Bertini M, Savarese G, Santini L, Dello Russo A, Lavalle C, Viscusi M, Amellone C, Calvanese R, Arena G, Pangallo A, Rapacciuolo A, Porcelli D, Campari M, Valsecchi S, and Guaricci AI
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- Humans, Algorithms, Morbidity, Defibrillators, Implantable, Cardiac Resynchronization Therapy methods, Heart Failure epidemiology, Heart Failure therapy, Atrial Fibrillation etiology
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Aims: The HeartLogic algorithm combines multiple implantable defibrillator (ICD) sensor data and has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation in cardiac resynchronization therapy (CRT-D) patients. We evaluated the performance of this algorithm in non-CRT ICD patients and in the presence of co-morbidities., Methods and Results: The HeartLogic feature was activated in 568 ICD patients (410 with CRT-D) from 26 centres. The median follow-up was 26 months [25th-75th percentile: 16-37]. During follow-up, 97 hospitalizations were reported (53 cardiovascular) and 55 patients died. We recorded 1200 HeartLogic alerts in 370 patients. Overall, the time IN the alert state was 13% of the total observation period. The rate of cardiovascular hospitalizations or death was 0.48/patient-year (95% CI: 0.37-0.60) with the HeartLogic IN the alert state and 0.04/patient-year (95% CI: 0.03-0.05) OUT of the alert state, with an incidence rate ratio of 13.35 (95% CI: 8.83-20.51, P < 0.001). Among patient characteristics, atrial fibrillation (AF) on implantation (HR: 1.62, 95% CI: 1.27-2.07, P < 0.001) and chronic kidney disease (CKD) (HR: 1.53, 95% CI: 1.21-1.93, P < 0.001) independently predicted alerts. HeartLogic alerts were not associated with CRT-D versus ICD implantation (HR: 1.03, 95% CI: 0.82-1.30, P = 0.775). Comparisons of the clinical event rates in the IN alert state with those in the OUT of alert state yielded incidence rate ratios ranging from 9.72 to 14.54 (all P < 0.001) in all groups of patients stratified by: CRT-D/ICD, AF/non-AF, and CKD/non-CKD. After multivariate correction, the occurrence of alerts was associated with cardiovascular hospitalization or death (HR: 1.92, 95% CI: 1.05-3.51, P = 0.036)., Conclusions: The burden of HeartLogic alerts was similar between CRT-D and ICD patients, while patients with AF and CKD seemed more exposed to alerts. Nonetheless, the ability of the HeartLogic algorithm to identify periods of significantly increased risk of clinical events was confirmed, regardless of the type of device and the presence of AF or CKD., (© 2023 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
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- 2023
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22. Predicting all-cause mortality by means of a multisensor implantable defibrillator algorithm for heart failure monitoring.
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D'Onofrio A, Vitulano G, Calò L, Bertini M, Santini L, Savarese G, Dello Russo A, Santobuono VE, Lavalle C, Viscusi M, Amellone C, Calvanese R, Santoro A, Ziacchi M, Palmisano P, Pisanò E, Bianchi V, Tavoletta V, Campari M, Valsecchi S, and Boriani G
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- Humans, Algorithms, Defibrillators, Implantable, Cardiac Resynchronization Therapy adverse effects, Heart Failure diagnosis, Heart Failure therapy, Heart Failure etiology, Atrial Fibrillation therapy
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Background: The HeartLogic algorithm (Boston Scientific) has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation., Objective: The purpose of this study was to determine whether remotely monitored data from this algorithm could be used to identify patients at high risk for mortality., Methods: The algorithm combines implantable cardioverter-defibrillator (ICD)-measured accelerometer-based heart sounds, intrathoracic impedance, respiration rate, ratio of respiration rate to tidal volume, night heart rate, and patient activity into a single index. An alert is issued when the index crosses a programmable threshold. The feature was activated in 568 ICD patients from 26 centers., Results: During median follow-up of 26 months [25th-75th percentile 16-37], 1200 alerts were recorded in 370 patients (65%). Overall, the time IN-alert state was 13% of the total observation period (151/1159 years) and 20% of the follow-up period of the 370 patients with alerts. During follow-up, 55 patients died (46 in the group with alerts). The rate of death was 0.25 per patient-year (95% confidence interval [CI] 0.17-0.34) IN-alert state and 0.02 per patient-year (95% CI 0.01-0.03) OUT of the alert state, with an incidence rate ratio of 13.72 (95% CI 7.62-25.60; P <.001). After multivariate correction for baseline confounders (age, ischemic cardiomyopathy, kidney disease, atrial fibrillation), the IN-alert state remained significantly associated with the occurrence of death (hazard ratio 9.18; 95% CI 5.27-15.99; P <.001)., Conclusion: The HeartLogic algorithm provides an index that can be used to identify patients at higher risk for all-cause mortality. The index state identifies periods of significantly increased risk of death., (Copyright © 2023. Published by Elsevier Inc.)
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- 2023
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23. Subcutaneous versus transvenous implantable cardioverter-defibrillator among drug-induced type-1 ECG pattern Brugada syndrome: a propensity score matching analysis from IBRYD study.
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Russo V, Caturano A, Guerra F, Migliore F, Mascia G, Rossi A, Nesti M, Santobuono VE, Attena E, Tola G, Sciarra L, Conte G, Paoletti Perini A, Francia P, Dendramis G, Palamà Z, Albani S, Ottonelli Ghidini A, Calò L, D'Onofrio A, and Baldi E
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- Humans, Propensity Score, Electric Countershock adverse effects, Electrocardiography methods, Death, Sudden, Cardiac epidemiology, Treatment Outcome, Defibrillators, Implantable adverse effects, Brugada Syndrome diagnosis, Brugada Syndrome therapy, Brugada Syndrome etiology
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No real-world data are available about the complications rate in drug-induced type 1 Brugada Syndrome (BrS) patients with an implantable cardioverter-defibrillator (ICD). Aim of our study is to compare the device-related complications, infections, and inappropriate therapies among drug-induced type 1 BrS patients with transvenous- ICD (TV-ICD) versus subcutaneous-ICD (S-ICD). Data for this study were sourced from the IBRYD (Italian BRugada sYnDrome) registry which includes 619 drug-induced type-1 BrS patients followed at 20 Italian tertiary referral hospitals. For the present analysis, we selected 258 consecutive BrS patients implanted with ICD. 198 patients (76.7%) received a TV-ICD, while 60 a S-ICD (23.4%). And were followed-up for a median time of 84.3 [46.5-147] months. ICD inappropriate therapies were experienced by 16 patients (6.2%). 14 patients (7.1%) in the TVICD group and 2 patients (3.3%) in S-ICD group (log-rank P = 0.64). ICD-related complications occurred in 31 patients (12%); 29 (14.6%) in TV-ICD group and 2 (3.3%) in S-ICD group (log-rank P = 0.41). ICD-related infections occurred in 10 patients (3.88%); 9 (4.5%) in TV-ICD group and 1 (1.8%) in S-ICD group (log-rank P = 0.80). After balancing for potential confounders using the propensity score matching technique, no differences were found in terms of clinical outcomes between the two groups. In a real-world setting of drug-induced type-1 BrS patients with ICD, no significant differences in inappropriate ICD therapies, device-related complications, and infections were shown among S-ICD vs TV-ICD. However, a reduction in lead-related complications was observed in the S-ICD group. In conclusion, our evidence suggests that S-ICD is at least non-inferior to TV-ICD in this population and may also reduce the risk of lead-related complications which can expose the patients to the necessity of lead extractions., (© 2022. The Author(s).)
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- 2023
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24. Correction to: Subcutaneous versus transvenous implantable cardioverter-defibrillator among drug-induced type-1 ECG pattern Brugada syndrome: a propensity score matching analysis from IBRYD study.
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Russo V, Caturano A, Guerra F, Migliore F, Mascia G, Rossi A, Nesti M, Santobuono VE, Attena E, Tola G, Sciarra L, Conte G, Paoletti Perini A, Francia P, Dendramis G, Palamà Z, Albani S, Ottonelli Ghidini A, Calò L, D'Onofrio A, and Baldi E
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- 2023
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25. Implantable defibrillator-detected heart failure status predicts ventricular tachyarrhythmias.
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Compagnucci P, Casella M, Bianchi V, Franculli F, Vitali F, Santini L, Savarese G, Santobuono VE, Chianese R, Lavalle C, Amellone C, Pecora D, Calvanese R, Stronati G, Santoro A, Ziacchi M, Campari M, Valsecchi S, Calò L, Guerra F, and Dello Russo A
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- Humans, Defibrillators, Implantable, Tachycardia, Ventricular diagnosis, Tachycardia, Ventricular therapy, Tachycardia, Ventricular complications, Heart Failure diagnosis, Heart Failure therapy, Heart Failure complications, Cardiac Resynchronization Therapy adverse effects, Ventricular Dysfunction, Left therapy
- Abstract
Introduction: The prediction of ventricular tachyarrhythmias among patients with implantable cardioverter defibrillators is difficult with available clinical tools. We sought to assess whether in patients with heart failure (HF) and reduced ejection fraction with defibrillators, physiological sensor-based HF status, as summarized by the HeartLogic index, could predict appropriate device therapies., Methods: Five hundred and sixty-eight consecutive HF patients with defibrillators (n = 158, 28%) or cardiac resynchronization therapy-defibrillators (n = 410, 72%) were included in this prospective observational multicenter analysis. The association of both HeartLogic index and its physiological components with defibrillator shocks and overall appropriate therapies was assessed in regression and time-dependent Cox models., Results: Over a follow-up of 25 (15-35) months, 122 (21%) patients received an appropriate device therapy (shock, n = 74, 13%), while the HeartLogic index crossed the threshold value (alert, HeartLogic ≥ 16) 1200 times (0.71 alerts/patient-year) in 370 (65%) subjects. The occurrence of ≥1 HeartLogic alert was significantly associated with both appropriate shocks (Hazard ratios [HR]: 2.44, 95% confidence interval [CI]: 1.49-3.97, p = .003), and any appropriate defibrillator therapies. In multivariable time-dependent Cox models, weekly IN-alert state was the strongest predictor of appropriate defibrillator shocks (HR: 2.94, 95% CI: 1.73-5.01, p < .001) and overall therapies. Compared with stable patients, patients with appropriate shocks had significantly higher values of HeartLogic index, third heart sound amplitude, and resting heart rate 30-60 days before device therapy., Conclusion: The HeartLogic index is an independent dynamic predictor of appropriate defibrillator therapies. The combined index and its individual physiological components change before the arrhythmic event occurs., (© 2023 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)
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- 2023
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26. Combination of an implantable defibrillator multi-sensor heart failure index and an apnea index for the prediction of atrial high-rate events.
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Bertini M, Vitali F, D'Onofrio A, Vitulano G, Calò L, Savarese G, Santobuono VE, Dello Russo A, Mattera A, Santoro A, Calvanese R, Arena G, Amellone C, Ziacchi M, Palmisano P, Santini L, Mazza A, Campari M, Valsecchi S, and Boriani G
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- Humans, Risk Assessment, Defibrillators, Implantable adverse effects, Atrial Fibrillation diagnosis, Atrial Fibrillation epidemiology, Atrial Fibrillation therapy, Sleep Apnea Syndromes, Heart Failure diagnosis, Heart Failure epidemiology, Heart Failure therapy
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Aims: Patients with atrial fibrillation frequently experience sleep disorder breathing, and both conditions are highly prevalent in presence of heart failure (HF). We explored the association between the combination of an HF and a sleep apnoea (SA) index and the incidence of atrial high-rate events (AHRE) in patients with implantable defibrillators (ICDs)., Methods and Results: Data were prospectively collected from 411 consecutive HF patients with ICD. The IN-alert HF state was measured by the multi-sensor HeartLogic Index (>16), and the ICD-measured Respiratory Disturbance Index (RDI) was computed to identify severe SA. The endpoints were as follows: daily AHRE burden of ≥5 min, ≥6 h, and ≥23 h. During a median follow-up of 26 months, the time IN-alert HF state was 13% of the total observation period. The RDI value was ≥30 episodes/h (severe SA) during 58% of the observation period. An AHRE burden of ≥5 min/day was documented in 139 (34%) patients, ≥6 h/day in 89 (22%) patients, and ≥23 h/day in 68 (17%) patients. The IN-alert HF state was independently associated with AHRE regardless of the daily burden threshold: hazard ratios from 2.17 for ≥5 min/day to 3.43 for ≥23 h/day (P < 0.01). An RDI ≥ 30 episodes/h was associated only with AHRE burden ≥5 min/day [hazard ratio 1.55 (95% confidence interval: 1.11-2.16), P = 0.001]. The combination of IN-alert HF state and RDI ≥ 30 episodes/h accounted for only 6% of the follow-up period and was associated with high rates of AHRE occurrence (from 28 events/100 patient-years for AHRE burden ≥5 min/day to 22 events/100 patient-years for AHRE burden ≥23 h/day)., Conclusions: In HF patients, the occurrence of AHRE is independently associated with the ICD-measured IN-alert HF state and RDI ≥ 30 episodes/h. The coexistence of these two conditions occurs rarely but is associated with a very high rate of AHRE occurrence., Clinical Trial Registration: URL: http://clinicaltrials.gov/Identifier: NCT02275637., Competing Interests: Conflict of interest: M. Campari and S. Valsecchi are employees of Boston Scientific, Inc. G. Boriani reports receiving small speaker's fees from Bayer, Boston, Janssen, and Sanofi. No other conflicts of interest exist., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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27. Prognostic significance of remotely monitored nocturnal heart rate in heart failure patients with reduced ejection fraction.
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D'Onofrio A, Marini M, Rovaris G, Zanotto G, Calvi V, Iacopino S, Biffi M, Solimene F, Della Bella P, Caravati F, Pisanò EC, Amellone C, D'Alterio G, Pedretti S, Santobuono VE, Russo AD, Nicolis D, De Salvia A, Baroni M, Quartieri F, Manzo M, Rapacciuolo A, Saporito D, Maines M, Marras E, Bontempi L, Morani G, Giacopelli D, Gargaro A, and Giammaria M
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- Humans, Middle Aged, Aged, Heart Rate, Prognosis, Stroke Volume, Ventricular Fibrillation therapy, Arrhythmias, Cardiac therapy, Risk Factors, Tachycardia, Ventricular etiology, Tachycardia, Ventricular therapy, Heart Failure complications, Heart Failure diagnosis, Heart Failure therapy, Cardiac Resynchronization Therapy adverse effects, Defibrillators, Implantable adverse effects, Ventricular Dysfunction, Left complications
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Background: Elevated resting heart rate is a risk factor for cardiovascular events., Objective: The purpose of this study was to investigate the clinical significance of nocturnal heart rate (nHR) and 24-hour mean heart rate (24h-HR) obtained by continuous remote monitoring (RM) of implantable devices., Methods: We analyzed daily-sampled trends of nHR, 24h-HR, and physical activity in patients on β-blocker therapy for chronic heart failure and with implantable cardioverter-defibrillators or cardiac resynchronization therapy defibrillators (CRT-Ds). Patients were grouped by average nHR and 24h-HR quartile during follow-up to estimate the respective incidence of nonarrhythmic death and device-treated ventricular tachycardia/fibrillation (VT/VF)., Results: The study cohort included 1330 patients (median age 69 years [interquartile range 61-77 years]; 41% [n = 550] with CRT-D; median follow-up 25 months [interquartile range 13-42 months]). Compared with patients in the lowest nHR quartile (≤57 beats/min) group, patients in the highest quartile group (>65 beats/min) had an increased risk of nonarrhythmic death (adjusted hazard ratio [AHR] 2.25; 95% confidence interval [CI] 1.13-4.50; P = .021) and VT/VF (AHR 1.98; 95% CI 1.40-2.79; P < .001) and were characterized by the lowest level of physical activity (P ≤ .0004 vs every other nHR quartiles). The highest 24h-HR quartile group (>75 beats/min) showed an increased risk of VT/VF (AHR 2.13; 95% CI 1.52-2.99; P < .001) and a weaker though significant association with nonarrhythmic mortality (AHR 1.80; 95% CI 1.00-3.22; P = .05) as compared with the lowest 24h-HR quartile group (≤65 beats/min)., Conclusion: In remotely monitored patients with implantable cardioverter-defibrillator/CRT-D on β-blocker therapy for heart failure, elevated heart rates (nHR >65 beats/min and 24h-HR >75 beats/min) were associated with increased mortality and VT/VF risk. nHR showed a stronger association than 24h-HR with worst prognosis and lowest physical activity., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)
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- 2023
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28. Ventricular Arrhythmias and Implantable Cardioverter-Defibrillator Therapy in Women: A Propensity Score-Matched Analysis.
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Maglia G, Giammaria M, Zanotto G, D'Onofrio A, Della Bella P, Marini M, Rovaris G, Iacopino S, Calvi V, Pisanò EC, Ziacchi M, Curnis A, Senatore G, Caravati F, Saporito D, Forleo GB, Pedretti S, Santobuono VE, Pepi P, De Salvia A, Balestri G, Maines M, Orsida D, Bisignani G, Baroni M, Lissoni F, Bertini M, Giacopelli D, Gargaro A, and Biffi M
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- Humans, Male, Female, Aged, Propensity Score, Treatment Outcome, Arrhythmias, Cardiac epidemiology, Arrhythmias, Cardiac therapy, Electric Countershock, Defibrillators, Implantable adverse effects
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Background: Causes of sex differences in incidence of sustained ventricular arrhythmias (SVAs) are poorly understood., Objectives: This study aims to investigate sex-specific risk of SVAs and device therapies by balancing sex groups in relation to several baseline characteristics with the propensity score (PS)., Methods: We used a large remote monitoring dataset from implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Study endpoints were time to the first appropriate SVA, time to the first device therapy for SVA, and time to the first ICD shock. Results were compared between females and a PS-matched male subgroup., Results: In a cohort of 2,532 patients with an ICD or CRT-D (median age, 70 years), 488 patients (19.3%) were women. After selecting 488 men PS-matched for 19 variables relative to baseline demographics, implant indications, principal comorbidities, and concomitant therapy, yet the SVA rate at the 2.1-year median follow-up was significantly lower in women than in man (adjusted HR: 0.65; 95% CI: 0.51-0.81; P < 0.001). Women also showed a reduced risk of any device therapy (HR: 0.59; 95% CI: 0.45-0.76; P < 0.001) and shocks (HR: 0.66; 95% CI: 0.47-0.94; P = 0.021). Differences in sex-specific SVA risk profile were not confirmed in CRT-D patients (HR: 0.78; 95% CI: 0.55-1.09; P = 0.14) nor in those with an ejection fraction <30% (HR: 0.80; 95% CI: 0.52-1.23; P = 0.31)., Conclusions: After matching demographics, indications, principal comorbidities, and concomitant therapy, women still exhibited a lower SVA risk profile than men, except in the subgroups of CRT-D or/and ejection fraction <30%., Competing Interests: Funding Support and Author Disclosures Manuscript editing was partially supported by BIOTRONIK Italia S.p.A. (V.le delle Industrie 11, 20055, Vimodrone [MI], Italy), which also provided assistance in statistical analysis but had no role in data collection and interpretation. Mr Giacopelli and Mr Gargaro are employees of BIOTRONIK Italia. All other authors have reported that they have relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2022
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29. Leadless transcatheter pacemaker: Indications, implantation technique and peri-procedural patient management in the Italian clinical practice.
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Palmisano P, Iacopino S, De Vivo S, D'Agostino C, Tomasi L, Startari U, Ziacchi M, Pisanò ECL, Santobuono VE, Caccavo VP, Sgarito G, Rillo M, Nicosia A, and Zucchelli G
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- Equipment Design, Female, Humans, Male, Prospective Studies, Time Factors, Treatment Outcome, Pacemaker, Artificial adverse effects, Pericardial Effusion etiology
- Abstract
Background: Safety and efficacy of leadless pacemakers (L-PM) have been demonstrated in multiple clinical trials, but real-world data on patient selection, implantation technique, and peri-procedural patient management in a clinical practice setting are lacking., Methods: Consecutive patients undergoing L-PM implantation in 14 Italian centers were followed in a prospective, multicentre, observational project. Data on baseline patient characteristics, clinical indications, implantation procedure, and peri-procedural patient management were collected. The rate and nature of device-related complications were also recorded., Results: A total of 782 L-PM patients (68.4% male, 75.6 ± 12.4 years) were included in the analysis. The main patients-related reason leading to the choice of implanting a L-PM rather than a conventional PM was the high-risk of device infection (29.5% of cases). The implantation success rate was 99.2%. The median duration of the procedure was 46 min. In 90% of patients the device was implanted in the septum. Of patients on oral anticoagulant therapy (OAT) (n = 498) the implantation procedure was performed without interrupting (17.5%) or transiently interrupting OAT without heparin bridging (60.6%). During a median follow-up of 20 months major device-related complications occurred in 7 patients (0.9%): vascular access-site complications in 3 patients, device malfunction in 2 patients, pericardial effusion/cardiac tamponade in one patient, device migration in one patient., Conclusions: In the real world setting of Italian clinical practice L-PM is often reserved for patients at high-risk of infection. The implantation success rate was very high and the risk of major complications was low. Peri-procedural management of OAT was consistent with available scientific evidence., (Copyright © 2022 Elsevier B.V. All rights reserved.)
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- 2022
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30. Association Between Device-Detected Sleep-Disordered Breathing and Implantable Defibrillator Therapy in Patients With Heart Failure.
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Mazza A, Bendini MG, Bianchi V, Esposito C, Calò L, Andreoli C, Santobuono VE, Dello Russo A, Viscusi M, La Greca C, Baiocchi C, Talarico A, Albanese R, Arena G, Giubilato G, Ziacchi M, Rapacciuolo A, Campari M, Valsecchi S, and Boriani G
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- Aged, Humans, Middle Aged, Arrhythmias, Cardiac epidemiology, Defibrillators, Implantable, Heart Failure epidemiology, Heart Failure therapy, Sleep Apnea Syndromes diagnosis, Sleep Apnea Syndromes epidemiology
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Background: Sleep-disordered breathing is highly prevalent in heart failure (HF) and has been suggested as a risk factor for malignant ventricular arrhythmias. The Respiratory Disturbance Index (RDI) computed by an implantable cardioverter-defibrillator (ICD) algorithm accurately identifies severe sleep apnea., Objectives: In the present analysis, the authors evaluated the association between ICD-detected sleep apnea and the incidence of appropriate ICD therapies in patients with HF., Methods: We enrolled 411 HF patients who had received an ICD endowed with an algorithm that calculates the RDI each night. In this analysis, the weekly mean RDI value was considered. The endpoint was the first appropriate ICD shock., Results: The median follow-up was 26 months (25th to 75th percentile: 16-35 months). During follow-up, 1 or more ICD shocks were documented in 58 (14%) patients. Patients with shocks were younger (age 66 ± 13 years vs 70 ± 10 years; P = 0.038), and had more frequently undergone implantation for secondary prevention (21% vs 10%; P = 0.026). The maximum RDI value calculated during the entire follow-up period did not differ between patients with and without shocks (55 ± 15 episodes/h vs 54 ± 14 episodes/h; P = 0.539). However, the ICD-detected RDI showed considerable variability during follow-up. The overall median of the weekly RDI was 33 episodes/h (25th to 75th percentile: 24-45 episodes/h). A time-dependent Cox regression model revealed that a continuously measured weekly mean RDI of ≥45 episodes/h was independently associated with shock occurrence (HR: 4.63; 95% CI: 2.54-8.43; P < 0.001), after correction for baseline confounders (age, secondary prevention)., Conclusions: In HF patients, appropriate ICD shocks were more likely to be delivered during periods when patients exhibited more sleep-disordered breathing. (Arrhythmias Detection in a Real World Population [RHYTHM DETECT]; NCT02275637)., Competing Interests: Funding Support and Author Disclosures Drs Campari and Valsecchi are employees of Boston Scientific, Inc. Dr Boriani has received small speaker fees from Boston, Biotronik, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2022
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31. One-year mortality after implantable defibrillator implantation: do risk stratification models help improving clinical practice?
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Calvi V, Zanotto G, D'Onofrio A, Bisceglia C, Iacopino S, Pignalberi C, Pisanò EC, Solimene F, Giammaria M, Biffi M, Maglia G, Marini M, Senatore G, Pedretti S, Forleo GB, Santobuono VE, Curnis A, Russo AD, Rapacciuolo A, Quartieri F, Bertocchi P, Caravati F, Manzo M, Saporito D, Orsida D, Santamaria M, Bottaro G, Giacopelli D, Gargaro A, and Bella PD
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- Cardiac Resynchronization Therapy Devices adverse effects, Female, Humans, Male, Risk Assessment, Risk Factors, Treatment Outcome, Cardiac Resynchronization Therapy methods, Defibrillators, Implantable adverse effects, Heart Failure therapy
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Purpose: The purpose of this study was to assess the available mortality risk stratification models for implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) patients., Methods: We conducted a review of mortality risk stratification models and tested their ability to improve prediction of 1-year survival after implant in a database of patients who received a remotely controlled ICD/CRT-D device during routine care and included in the independent Home Monitoring Expert Alliance registry., Results: We identified ten predicting models published in peer-reviewed journals between 2000 and 2021 (Parkash, PACE, MADIT, aCCI, CHA2DS2-VASc quartiles, CIDS, FADES, Sjoblom, AAACC, and MADIT-ICD non-arrhythmic mortality score) that could be tested in our database as based on common demographic, clinical, echocardiographic, electrocardiographic, and laboratory variables. Our cohort included 1,911 patients with left ventricular dysfunction (median age 71, 18.3% female) from sites not using any risk stratification score for systematic patient screening. Patients received an ICD (53.8%) or CRT-D (46.2%) between 2011 and 2017, after standard physician evaluation. There were 56 deaths within 1-year post-implant, with an all-cause mortality rate of 2.9% (95% confidence interval [CI], 2.3-3.8%). Four predicting models (Parkash, MADIT, AAACC, and MADIT-ICD non-arrhythmic mortality score) were significantly associated with increased risk of 1-year mortality with hazard ratios ranging from 3.75 (CI, 1.31-10.7) to 6.53 (CI 1.52-28.0, p ≤ 0.014 for all four). Positive predictive values of 1-year mortality were below 25% for all models., Conclusion: In our analysis, the models we tested conferred modest incremental predicting power to ordinary screening methods., (© 2021. Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2022
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32. The Applications of Artificial Intelligence in Cardiovascular Magnetic Resonance-A Comprehensive Review.
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Argentiero A, Muscogiuri G, Rabbat MG, Martini C, Soldato N, Basile P, Baggiano A, Mushtaq S, Fusini L, Mancini ME, Gaibazzi N, Santobuono VE, Sironi S, Pontone G, and Guaricci AI
- Abstract
Cardiovascular disease remains an integral field on which new research in both the biomedical and technological fields is based, as it remains the leading cause of mortality and morbidity worldwide. However, despite the progress of cardiac imaging techniques, the heart remains a challenging organ to study. Artificial intelligence (AI) has emerged as one of the major innovations in the field of diagnostic imaging, with a dramatic impact on cardiovascular magnetic resonance imaging (CMR). AI will be increasingly present in the medical world, with strong potential for greater diagnostic efficiency and accuracy. Regarding the use of AI in image acquisition and reconstruction, the main role was to reduce the time of image acquisition and analysis, one of the biggest challenges concerning magnetic resonance; moreover, it has been seen to play a role in the automatic correction of artifacts. The use of these techniques in image segmentation has allowed automatic and accurate quantification of the volumes and masses of the left and right ventricles, with occasional need for manual correction. Furthermore, AI can be a useful tool to directly help the clinician in the diagnosis and derivation of prognostic information of cardiovascular diseases. This review addresses the applications and future prospects of AI in CMR imaging, from image acquisition and reconstruction to image segmentation, tissue characterization, diagnostic evaluation, and prognostication.
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- 2022
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33. Implantable defibrillator-detected heart failure status predicts atrial fibrillation occurrence.
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Bertini M, Vitali F, Santini L, Tavoletta V, Giano A, Savarese G, Russo AD, Santobuono VE, Mattera A, Lavalle C, Amellone C, Pecora D, Calvanese R, Rapacciuolo A, Campari M, Valsecchi S, and Calò L
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- Algorithms, Humans, Monitoring, Physiologic, Atrial Fibrillation complications, Atrial Fibrillation diagnosis, Atrial Fibrillation epidemiology, Defibrillators, Implantable, Heart Failure complications, Heart Failure diagnosis, Heart Failure therapy
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Background: In heart failure (HF) patients, atrial fibrillation (AF) is associated with a worse prognosis. Implantable cardioverter-defibrillator (ICD) diagnostics allow continuous monitoring of AF and are equipped with algorithms for HF monitoring., Objective: We evaluated the association between the values of the multisensor HF HeartLogic index and the incidence of AF, and assessed the performance of the index in detecting follow-up periods of significantly increased AF risk., Methods: The HeartLogic feature was activated in 568 ICD patients. Median follow-up was 25 months [25th-75th percentile (15-35)]. The HeartLogic algorithm calculates a daily HF index and identifies periods of IN-alert state on the basis of a configurable threshold. The endpoints were daily AF burden ≥5 minutes, ≥6 hours, and ≥23 hours., Results: The HeartLogic index crossed the threshold value 1200 times. AF burden ≥5 minutes/day was documented in 183 patients (32%), ≥6 hours/day in 118 patients (21%), and ≥23 hours/day in 89 patients (16%). The weekly time of IN-alert state was independently associated with AF burden ≥5 minutes/day (hazard ratio [HR] 1.95; 95% confidence interval [CI] 1.22-3.13; P = .005), ≥6 hours/day (HR 2.66; 95% CI 1.60-4.44; P <.001), and ≥23 hours/day (HR 3.32; 95% CI 1.83-6.02; P <.001), after correction for baseline confounders. Comparison of the episode rates in the IN-alert state with those in the OUT-of-alert state yielded HR ranging from 1.57 to 3.11 for AF burden from ≥5 minutes to ≥23 hours., Conclusions: The HeartLogic alert state was independently associated with AF occurrence. The intervals of time defined by the algorithm as periods of increased risk of HF allow risk stratification of AF according to various thresholds of daily burden., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)
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- 2022
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34. Implantable Cardioverter Defibrillator Multisensor Monitoring during Home Confinement Caused by the COVID-19 Pandemic.
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Ziacchi M, Calò L, D'Onofrio A, Manzo M, Dello Russo A, Santini L, Giubilato G, Carriere C, Santobuono VE, Savarese G, La Greca C, Arena G, Talarico A, Pisanò E, Giammaria M, Pangallo A, Campari M, Valsecchi S, and Diemberger I
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Aims: The utilization of remote monitoring platforms was recommended amidst the COVID-19 pandemic. The HeartLogic index combines multiple implantable cardioverter defibrillator (ICD) sensors and has proved to be a predictor of impending heart failure (HF) decompensation. We examined how multiple ICD sensors behave in the periods of anticipated restrictions pertaining to physical activity., Methods: The HeartLogic feature was active in 349 ICD and cardiac resynchronization therapy ICD patients at 20 Italian centers. The period from 1 January to 19 July 2020, was divided into three phases: pre-lockdown (weeks 1-11), lockdown (weeks 12-20), post-lockdown (weeks 21-29)., Results: Immediately after the implementation of stay-at-home orders (week 12), we observed a significant drop in median activity level whereas there was no difference in the other contributing parameters. The median composite HeartLogic index increased at the end of the Lockdown. The weekly rate of alerts was significantly higher during the lockdown (1.56 alerts/week/100 pts, 95%CI: 1.15-2.06; IRR = 1.71, p = 0.014) and post-lockdown (1.37 alerts/week/100 pts, 95%CI: 0.99-1.84; IRR = 1.50, p = 0.072) than that reported in pre-lockdown (0.91 alerts/week/100 pts, 95%CI: 0.64-1.27). However, the median duration of alert state and the maximum index value did not change among phases, as well as the proportion of alerts followed by clinical actions at the centers and the proportion of alerts fully managed remotely., Conclusions: During the lockdown, the system detected a significant drop in the median activity level and generated a higher rate of alerts suggestive of worsening of the HF status.
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- 2022
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35. Electrophysiological Study Prognostic Value and Long-Term Outcome in Drug-Induced Type 1 Brugada Syndrome: The IBRYD Study.
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Russo V, Pafundi PC, Caturano A, Dendramis G, Ghidini AO, Santobuono VE, Sciarra L, Notarstefano P, Rucco MA, Attena E, Floris R, Romeo E, Sarubbi B, Nigro G, D'Onofrio A, Calò L, and Nesti M
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- Electrocardiography, Humans, Prognosis, Retrospective Studies, Brugada Syndrome chemically induced, Brugada Syndrome epidemiology, Pharmaceutical Preparations
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Objectives: This study aimed to retrospectively assess long-term outcome and the prognostic role of electrophysiological study (EPS) for risk stratification of drug-induced type 1 Brugada syndrome (BrS) patients., Background: BrS is a hereditary cardiac disease, predisposing to sudden cardiac death. Few real-world data are available on long-term outcomes of drug-induced type 1 BrS patients, and questions about risk stratification still remain unanswered., Methods: The IBRYD (Italian Brugada Syndrome) study is a multicenter observational retrospective study. A total of 226 drug-induced type 1 BrS patients were enrolled from 9 Italian tertiary referral institutions. Primary endpoint was a composite of appropriate implantable cardioverter-defibrillator (ICD) therapy and sudden cardiac death. The authors further assessed clinical predictors to ICD implantation, as well as for arrhythmia induction at EPS, along with EPS as potential risk factor for the outcomes of interest., Results: 142 patients (62.8%) received an ICD due to syncope and/or inducible ventricular tachyarrhythmias at EPS. During a median follow-up of 106 months, 11 patients (4.9%) experienced primary outcome events. The ICD therapy median annual incidence over 8 years was 0.38% (interquartile range: 0% to 1.47%). Ventricular tachyarrhythmia inducibility during EPS was not predictive of arrhythmic events in ICD recipients versus non-ICD patients and in symptomatic versus asymptomatic subgroups, showing a low positive predictive value (9.6% and 8.9%, respectively) versus a high negative predictive value (96.6% and 95%, respectively). The authors reported 29 ICD-related complications and 4.9% inappropriate shocks., Conclusions: Drug-induced type 1 BrS patients have a very low arrhythmic risk. Clinical decision for implantation is supported by syncope and/or EPS positivity, though they fail to stratify high-risk patients. A better risk-to-benefit ratio should be pursued, considering both arrhythmic risk and ICD-related complications., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2021
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36. Multiparametric Implantable Cardioverter-Defibrillator Algorithm for Heart Failure Risk Stratification and Management: An Analysis in Clinical Practice.
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Calò L, Bianchi V, Ferraioli D, Santini L, Dello Russo A, Carriere C, Santobuono VE, Andreoli C, La Greca C, Arena G, Talarico A, Pisanò E, Santoro A, Giammaria M, Ziacchi M, Viscusi M, De Ruvo E, Campari M, Valsecchi S, and D'Onofrio A
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- Aged, Aged, 80 and over, Cardiac Resynchronization Therapy Devices, Female, Heart Rate physiology, Hospitalization statistics & numerical data, Humans, Male, Risk Factors, Algorithms, Cardiac Resynchronization Therapy methods, Defibrillators, Implantable, Heart Failure physiopathology, Heart Failure therapy
- Abstract
Background: The HeartLogic algorithm combines multiple implantable cardioverter-defibrillator sensors to identify patients at risk of heart failure (HF) events. We sought to evaluate the risk stratification ability of this algorithm in clinical practice. We also analyzed the alert management strategies adopted in the study group and their association with the occurrence of HF events., Methods: The HeartLogic feature was activated in 366 implantable cardioverter-defibrillator and cardiac resynchronization therapy implantable cardioverter-defibrillator patients at 22 centers. The median follow-up was 11 months [25th-75th percentile: 6-16]. The HeartLogic algorithm calculates a daily HF index and identifies periods IN alert state on the basis of a configurable threshold., Results: The HeartLogic index crossed the threshold value 273 times (0.76 alerts/patient-year) in 150 patients. The time IN alert state was 11% of the total observation period. Patients experienced 36 HF hospitalizations, and 8 patients died of HF during the observation period. Thirty-five events were associated with the IN alert state (0.92 events/patient-year versus 0.03 events/patient-year in the OUT of alert state). The hazard ratio in the IN/OUT of alert state comparison was (hazard ratio, 24.53 [95% CI, 8.55-70.38], P <0.001), after adjustment for baseline clinical confounders. Alerts followed by clinical actions were associated with less HF events (hazard ratio, 0.37 [95% CI, 0.14-0.99], P =0.047). No differences in event rates were observed between in-office and remote alert management., Conclusions: This multiparametric algorithm identifies patients during periods of significantly increased risk of HF events. The rate of HF events seemed lower when clinical actions were undertaken in response to alerts. Extra in-office visits did not seem to be required to effectively manage HeartLogic alerts. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02275637.
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- 2021
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37. Cardiac electrophysiology and pacing educational and training needs among early-career cardiologists: a national survey of the Young Committee of the Italian Association of Arrhythmology and Cardiac Pacing.
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Russo V, Nesti M, Brunacci M, Tola G, Santobuono VE, Dendramis G, Picciolo G, Lucciola MT, D'Onofrio A, Ricci R, and de Ponti R
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- Fellowships and Scholarships methods, Fellowships and Scholarships standards, Humans, Italy, Needs Assessment, Societies, Medical, Surveys and Questionnaires, Cardiac Electrophysiology education, Cardiology education, Cardiology methods, Clinical Competence standards, Education methods, Education standards
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Background: Over the past three decades, cardiac electrophysiology and pacing, including device therapy and catheter ablation of arrhythmias, has rapidly developed as a subspecialty in cardiology. Currently, there is no clear perception about the needs in cardiac electrophysiology and pacing among early-career cardiologists., Methods: To address these concerns, the Young Committee of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) carried out a survey among those under the age of 40 years to obtain detailed information on practical activities and formal lessons during the fellowship in cardiology and their satisfaction and proficiency level at the end of the fellowship., Results: We obtained 334 answers to the survey. In invasive cardiac electrophysiology and pacing, the percentage of participants attending the activity for a longer time (3-6 months) is lower compared with those in noninvasive subspecialties. About 40% of participants did not receive lessons on interventional cardiology, cardiac electrophysiology and pacing. On the contrary, 71% of participants received an adequate number of lessons on clinical arrhythmology. The vast majority of the participants expressed satisfaction for the education received in the echocardiographic, cardiac interventional laboratories and clinical arrhythmology, but about half of the participants were unsatisfied with the education received in cardiac electrophysiology and pacing. In interventional arrhythmology, the majority of the participants declare their lack of proficiency with two peaks for more complex procedures, namely interventional electrophysiology procedures (82%) and cardiac resynchronization therapy (CRT) procedures (76%)., Conclusion: The present survey among Italian early-career cardiologists suggests that the majority of participants consider themselves not confident in performing cardiac electrophysiology and pacing procedures. Due to the complexity of the treatment for heart rhythm disorders and the long learning curve, structured additional training in cardiac electrophysiology and pacing procedures is required after cardiology fellowship., (Copyright © 2021 Italian Federation of Cardiology - I.F.C. All rights reserved.)
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- 2021
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38. Importance of clinical suspicion and multidisciplinary management for early diagnosis of a cardiac laminopathy patient: A case report.
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Santobuono VE, Guaricci AI, Carulli E, Bozza N, Pepe M, Ranauro A, Ranieri C, Carella MC, Loizzi F, Resta N, Favale S, and Forleo C
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Background: Laminopathies are rare diseases, whose cardiac manifestations are heterogeneous and, especially in their initial stage, similar to those of more common conditions, such as ischemic heart disease. Early diagnosis is essential, as these conditions can first manifest themselves with sudden cardiac death. Electrical complications usually appear before structural complications; therefore, it is important to take into consideration these rare genetic disorders for the differential diagnosis of brady and tachyarrhythmias, even when left ventricle systolic function is still preserved., Case Summary: A 60-year-old man, without history of previous disorders, presented in September 2019 to the emergency department because of the onset of syncope associated with hypotension. The patient was diagnosed with a high-grade atrioventricular block. A dual chamber pacemaker was implanted, but after the onset of a sustained ventricular tachycardia during physical exertion, a drug eluting stent was implanted on an intermediate stenosis on the left anterior descending artery, which had previously been considered non-haemodynamically significant. During the follow-up, the treating cardiologist, suspicious of the overall clinical picture, recommended a genetic test for the diagnosis of cardiomyopathies, which tested positive for a pathogenetic mutation of the lamin A/C gene. While awaiting the result of the genetic test and, later, the pacemaker to be upgraded to a biventricular defibrillator, a remote monitoring device was given to the patient in order to minimize in-person clinical evaluations during the coronavirus disease 2019-related lockdown., Conclusion: This case aims to raise awareness of the cardiological manifestations of laminopathies, which can be dangerously misdiagnosed as other, more common conditions., Competing Interests: Conflict-of-interest statement: No conflicts of interest to declare., (©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.)
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- 2021
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39. Circadian periodicity affects the type of ventricular arrhythmias and efficacy of implantable defibrillator therapies.
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Vergara P, Pignalberi C, Pisanò EC, Maglia G, Della Bella P, Zanotto G, Iacopino S, Solimene F, Calvi V, Marini M, Giammaria M, Biffi M, Rovaris G, Caravati F, Quartieri F, Curnis A, Rapacciuolo A, Senatore G, Pedretti S, Saporito D, Dello Russo A, Santobuono VE, Pepi P, Duca A, Baroni M, Falasconi G, Giacopelli D, Gargaro A, and D'Onofrio A
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- Arrhythmias, Cardiac, Humans, Treatment Outcome, Cardiac Resynchronization Therapy, Defibrillators, Implantable, Tachycardia, Ventricular diagnosis, Tachycardia, Ventricular therapy
- Abstract
Introduction: Factors influencing malignant arrhythmia onset are not fully understood. We explored the circadian periodicity of ventricular arrhythmias (VAs) in patients with implantable cardioverter and cardiac resynchronization defibrillators (ICD/CRT-D)., Methods: Time, morphology (monomorphic/polymorphic), and mode of termination (anti-tachycardia pacing [ATP] or shock) of VAs stored in a database of remote monitoring data were adjudicated. Episodes were grouped in six 4-h timeslots from 00:00 to 24:00. Circadian distributions and adjusted marginal odds ratios (ORs), with 95% confidence interval (CI), were analyzed using mixed-effect models and logit generalized estimating equations, respectively, to account for within-subject correlation of multiple episodes., Results: Among 1303 VA episodes from 446 patients (63% ICD and 37% CRT-D), 120 (9%) self-extinguished, and 842 (65%) were terminated by ATP, 343 (26%) by shock. VAs clustered from 08:00 to 16:00 with 44% of episodes, as compared with 22% from 00:00 to 08:00 (p < .001) and 34% from 16:00 to 24:00 (p = .005). Episodes were more likely to be polymorphic at night with an adjusted marginal OR of 1.66 (CI, 1.15-2.40; p = .007) at 00:00-04:00 versus other timeslots. Episodes were less likely to be terminated by ATP in the 00:00-04:00 (success-to-failure ratio, 0.67; CI, 0.46-0.98; p = .039) and 08:00-12:00 (0.70; CI, 0.51-0.96; p = .02) timeslots, and most likely to be terminated by ATP between 12:00 and 16:00 (success-to-failure ratio 1.42; CI, 1.06-1.91; p = .02)., Conclusion: VAs did not distribute uniformly over the 24 h, with a majority of episodes occurring from 08:00 to 16:00. Nocturnal episodes were more likely to be polymorphic. The efficacy of ATP depended on the time of delivery., (© 2021 Wiley Periodicals LLC.)
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- 2021
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40. CarDiac magnEtic Resonance for prophylactic Implantable-cardioVerter defibrillAtor ThErapy in Non-Ischaemic dilated CardioMyopathy: an international Registry.
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Guaricci AI, Masci PG, Muscogiuri G, Guglielmo M, Baggiano A, Fusini L, Lorenzoni V, Martini C, Andreini D, Pavon AG, Aquaro GD, Barison A, Todiere G, Rabbat MG, Tat E, Raineri C, Valentini A, Varga-Szemes A, Schoepf UJ, De Cecco CN, Bogaert J, Dobrovie M, Symons R, Focardi M, Gismondi A, Lozano-Torres J, Rodriguez-Palomares JF, Lanzillo C, Di Roma M, Moro C, Di Giovine G, Margonato D, De Lazzari M, Perazzolo Marra M, Nese A, Casavecchia G, Gravina M, Marzo F, Carigi S, Pica S, Lombardi M, Censi S, Squeri A, Palumbo A, Gaibazzi N, Camastra G, Sbarbati S, Pedrotti P, Masi A, Carrabba N, Pradella S, Timpani M, Cicala G, Presicci C, Puglisi S, Sverzellati N, Santobuono VE, Pepi M, Schwitter J, and Pontone G
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- Contrast Media, Female, Gadolinium, Humans, Magnetic Resonance Imaging, Cine, Magnetic Resonance Spectroscopy, Male, Predictive Value of Tests, Prognosis, Registries, Stroke Volume, Ventricular Function, Left, Cardiomyopathy, Dilated diagnostic imaging, Cardiomyopathy, Dilated therapy, Defibrillators, Implantable
- Abstract
Aims: The aim of this registry was to evaluate the additional prognostic value of a composite cardiac magnetic resonance (CMR)-based risk score over standard-of-care (SOC) evaluation in a large cohort of consecutive unselected non-ischaemic cardiomyopathy (NICM) patients., Methods and Results: In the DERIVATE registry (www.clinicaltrials.gov/registration: RCT#NCT03352648), 1000 (derivation cohort) and 508 (validation cohort) NICM patients with chronic heart failure (HF) and left ventricular ejection fraction <50% were included. All-cause mortality and major adverse arrhythmic cardiac events (MAACE) were the primary and secondary endpoints, respectively. During a median follow-up of 959 days, all-cause mortality and MAACE occurred in 72 (7%) and 93 (9%) patients, respectively. Age and >3 segments with midwall fibrosis on late gadolinium enhancement (LGE) were the only independent predictors of all-cause mortality (HR: 1.036, 95% CI: 1.0117-1.056, P < 0.001 and HR: 2.077, 95% CI: 1.211-3.562, P = 0.008, respectively). For MAACE, the independent predictors were male gender, left ventricular end-diastolic volume index by CMR (CMR-LVEDVi), and >3 segments with midwall fibrosis on LGE (HR: 2.131, 95% CI: 1.231-3.690, P = 0.007; HR: 3.161, 95% CI: 1.750-5.709, P < 0.001; and HR: 1.693, 95% CI: 1.084-2.644, P = 0.021, respectively). A composite clinical and CMR-based risk score provided a net reclassification improvement of 63.7% (P < 0.001) for MAACE occurrence when added to the model based on SOC evaluation. These findings were confirmed in the validation cohort., Conclusion: In a large multicentre, multivendor cohort registry reflecting daily clinical practice in NICM work-up, a composite clinical and CMR-based risk score provides incremental prognostic value beyond SOC evaluation, which may have impact on the indication of implantable cardioverter-defibrillator implantation., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)
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- 2021
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41. Late gadolinium enhancement role in arrhythmic risk stratification of patients with LMNA cardiomyopathy: results from a long-term follow-up multicentre study.
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Peretto G, Barison A, Forleo C, Di Resta C, Esposito A, Aquaro GD, Scardapane A, Palmisano A, Emdin M, Resta N, Santoni A, Guaricci AI, Santobuono VE, Pepe M, Favale S, Ferrari M, Benedetti S, Della Bella P, and Sala S
- Subjects
- Adolescent, Adult, Contrast Media, Female, Follow-Up Studies, Gadolinium, Humans, Lamin Type A genetics, Male, Middle Aged, Predictive Value of Tests, Risk Assessment, Risk Factors, Stroke Volume, Ventricular Function, Left, Young Adult, Cardiomyopathies diagnostic imaging, Cardiomyopathies genetics, Defibrillators, Implantable
- Abstract
Aims: We aimed at addressing the role of late gadolinium enhancement (LGE) in arrhythmic risk stratification of LMNA-associated cardiomyopathy (CMP)., Methods and Results: We present data from a multicentre national cohort of patients with LMNA mutations. Of 164 screened cases, we finally enrolled patients with baseline cardiac magnetic resonance (CMR) including LGE sequences [n = 41, age 35 ± 17 years, 51% males, mean left ventricular ejection fraction (LVEF) by echocardiogram 56%]. The primary endpoint of the study was follow-up (FU) occurrence of malignant ventricular arrhythmias [MVA, including sustained ventricular tachycardia (VT), ventricular fibrillation, and appropriate implantable cardioverter-defibrillator (ICD) therapy]. At baseline CMR, 25 subjects (61%) had LGE, with non-ischaemic pattern in all of the cases. Overall, 23 patients (56%) underwent ICD implant. By 10 ± 3 years FU, eight patients (20%) experienced MVA, consisting of appropriate ICD shocks in all of the cases. In particular, the occurrence of MVA in LGE+ vs. LGE- groups was 8/25 vs. 0/16 (P = 0.014). Of note, no significant differences between LGE+ and LGE- patients were found in currently recognized risk factors for sudden cardiac death (male gender, non-missense mutations, baseline LVEF <45% and non-sustained VT), all P-value >0.05., Conclusions: In LMNA-CMP patients, LGE at baseline CMR is significantly associated with MVA. In particular, as suggested by this preliminary experience, the absence of LGE allowed to rule-out MVA at 10 years mean FU., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)
- Published
- 2020
- Full Text
- View/download PDF
42. Preliminary experience with the multisensor HeartLogic algorithm for heart failure monitoring: a retrospective case series report.
- Author
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Capucci A, Santini L, Favale S, Pecora D, Petracci B, Calò L, Molon G, Cipolletta L, Bianchi V, Schirripa V, Santobuono VE, La Greca C, Campari M, Valsecchi S, Ammirati F, and D'Onofrio A
- Subjects
- Aged, Equipment Design, Female, Follow-Up Studies, Heart Failure diagnosis, Heart Failure therapy, Hospitalization trends, Humans, Male, Reproducibility of Results, Retrospective Studies, Time Factors, Algorithms, Cardiac Resynchronization Therapy methods, Heart Failure physiopathology, Heart Rate physiology, Monitoring, Physiologic instrumentation, Transducers
- Abstract
Aims: In the Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients study, a novel algorithm for heart failure (HF) monitoring was implemented. The HeartLogic (Boston Scientific) index combines data from multiple implantable cardioverter defibrillator (ICD)-based sensors and has proved to be a sensitive and timely predictor of impending HF decompensation. The remote monitoring of HF patients by means of HeartLogic has never been described in clinical practice. We report post-implantation data collected from sensors, the combined index, and their association with clinical events during follow-up in a group of patients who received a HeartLogic-enabled device in clinical practice., Methods and Results: Patients with ICD and cardiac resynchronization therapy ICD were remotely monitored. In December 2017, the HeartLogic feature was activated on the remote monitoring platform, and multiple ICD-based sensor data collected since device implantation were made available: HeartLogic index, heart rate, heart sounds, thoracic impedance, respiration, and activity. Their association with clinical events was retrospectively analysed. Data from 58 patients were analysed. During a mean follow-up of 5 ± 3 months, the HeartLogic index crossed the threshold value (set by default to 16) 24 times (over 24 person-years, 0.99 alerts/patient-year) in 16 patients. HeartLogic alerts preceded five HF hospitalizations and five unplanned in-office visits for HF. Symptoms or signs of HF were also reported at the time of five scheduled visits. The median early warning time and the time spent in alert were longer in the case of hospitalizations than in the case of minor events of clinical deterioration of HF. HeartLogic contributing sensors detected changes in heart sound amplitude (increased third sound and decreased first sound) in all cases of alerts. Patients with HeartLogic alerts during the observation period had higher New York Heart Association class (P = 0.025) and lower ejection fraction (P = 0.016) at the time of activation., Conclusions: Our retrospective analysis indicates that the HeartLogic algorithm might be useful to detect gradual worsening of HF and to stratify risk of HF decompensation., (© 2019 The Authors ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.)
- Published
- 2019
- Full Text
- View/download PDF
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