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1.
J Cardiovasc Electrophysiol ; 34(4): 947-956, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36709469

RESUMEN

INTRODUCTION: Thoracic impedance (TI) drops measured by implantable cardioverter-defibrillators (ICDs) have been reported to correlate with ventricular tachycardia/fibrillation (VT/VF). The aim of our study was to assess the temporal association of decreasing TI trends with VT/VF episodes through a longitudinal analysis of daily remote monitoring data from ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds). METHODS AND RESULTS: Retrospective data from 2384 patients were randomized 1:1 into a derivation or validation cohort. The TI decrease rate was defined as the percentage of rolling weeks with a continuously decreasing TI trend. The derivation cohort was used to determine a TI decrease rate threshold for a ≥99% specificity of arrhythmia prediction. The associated risk of VT/VF episodes was estimated in the validation cohort by dividing the available follow-up into 60-day assessment intervals. Analyses were performed separately for 1354 ICD and 1030 CRT-D patients. During a median follow-up of 2.0 years, 727 patients (30.4%) experienced 3298 confirmed VT/VF episodes. In the ICD group, a TI decrease rate of >60% was associated with a higher risk of VT/VF episode in a 60-day assessment interval (stratified hazard ratio, 1.42; 95% confidence interval (CI), 1.05-1.92; p = .023). The TI decrease preceded (40.8%) or followed (59.2%) the VT/VF episodes. In the CRT-D group, no association between TI decrease and VT/VF episodes was observed (p = .84). CONCLUSION: In our longitudinal analysis, TI decrease was associated with VT/VF episodes only in ICD patients. Preventive interventions may be difficult since episodes can occur before or after TI decrease.


Asunto(s)
Arritmias Cardíacas , Taquicardia Ventricular , Humanos , Arritmias Cardíacas/terapia , Impedancia Eléctrica , Estudios Retrospectivos , Fibrilación Ventricular , Desfibriladores Implantables
2.
Europace ; 25(4): 1423-1431, 2023 04 15.
Artículo en Inglés | MEDLINE | ID: mdl-36794691

RESUMEN

AIMS: A previous randomized study demonstrated that the subcutaneous implantable cardioverter defibrillator (S-ICD) was noninferior to transvenous ICD with respect to device-related complications and inappropriate shocks. However, that was performed prior to the widespread adoption of pulse generator implantation in the intermuscular (IM) space instead of the traditional subcutaneous (SC) pocket. The aim of this analysis was to compare survival from device-related complications and inappropriate shocks between patients who underwent S-ICD implantation with the generator positioned in an IM position in comparison with an SC pocket. METHODS AND RESULTS: We analysed 1577 consecutive patients who had undergone S-ICD implantation from 2013 to 2021 and were followed up until December 2021. Subcutaneous patients (n = 290) were propensity matched with patients of the IM group (n = 290), and their outcomes were compared. : During a median follow-up of 28 months, device-related complications were reported in 28 (4.8%) patients and inappropriate shocks were reported in 37 (6.4%) patients. The risk of complication was lower in the matched IM group than in the SC group [hazard ratio 0.41, 95% confidence interval (CI) 0.17-0.99, P = 0.041], as well as the composite of complications and inappropriate shocks (hazard ratio 0.50, 95% CI 0.30-0.86, P = 0.013). The risk of appropriate shocks was similar between groups (hazard ratio 0.90, 95% CI 0.50-1.61, P = 0.721). There was no significant interaction between generator positioning and variables such as gender, age, body mass index, and ejection fraction. CONCLUSION: Our data showed the superiority of the IM S-ICD generator positioning in reducing device-related complications and inappropriate shocks. CLINICAL TRIAL REGISTRATION: Clinical Trial Registration: ClinicalTrials.gov; NCT02275637.


Asunto(s)
Desfibriladores Implantables , Humanos , Desfibriladores Implantables/efectos adversos , Estudios de Casos y Controles , Muerte Súbita Cardíaca/etiología , Estudios Retrospectivos , Resultado del Tratamiento
3.
Europace ; 25(9)2023 08 02.
Artículo en Inglés | MEDLINE | ID: mdl-37536671

RESUMEN

AIMS: Patients with cardiomyopathies and channelopathies are usually younger and have a predominantly arrhythmia-related prognosis; they have nearly normal life expectancy thanks to the protection against sudden cardiac death provided by the implantable cardioverter defibrillator (ICD). The subcutaneous ICD (S-ICD) is an effective alternative to the transvenous ICD and has evolved over the years. This study aimed to evaluate the rate of inappropriate shocks (IS), appropriate therapies, and device-related complications in patients with cardiomyopathies and channelopathies who underwent modern S-ICD implantation. METHODS AND RESULTS: We enrolled consecutive patients with cardiomyopathies and channelopathies who had undergone implantation of a modern S-ICD from January 2016 to December 2020 and who were followed up until December 2022. A total of 1338 S-ICD implantations were performed within the observation period. Of these patients, 628 had cardiomyopathies or channelopathies. The rate of IS at 12 months was 4.6% [95% confidence interval (CI): 2.8-6.9] in patients with cardiomyopathies and 1.1% (95% CI: 0.1-3.8) in patients with channelopathies (P = 0.032). No significant differences were noted over a median follow-up of 43 months [hazard ratio (HR): 0.76; 95% CI: 0.45-1.31; P = 0.351]. The rate of appropriate shocks at 12 months was 2.3% (95% CI: 1.1-4.1) in patients with cardiomyopathies and 2.1% (95% CI: 0.6-5.3) in patients with channelopathies (P = 1.0). The rate of device-related complications was 0.9% (95% CI: 0.3-2.3) and 3.2% (95% CI: 1.2-6.8), respectively (P = 0.074). No significant differences were noted over the entire follow-up. The need for pacing was low, occurring in 0.8% of patients. CONCLUSION: Modern S-ICDs may be a valuable alternative to transvenous ICDs in patients with cardiomyopathies and channelopathies. Our findings suggest that modern S-ICD therapy carries a low rate of IS. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/Identifier: NCT02275637.


Asunto(s)
Cardiomiopatías , Canalopatías , Desfibriladores Implantables , Humanos , Desfibriladores Implantables/efectos adversos , Canalopatías/complicaciones , Canalopatías/terapia , Resultado del Tratamiento , Muerte Súbita Cardíaca/etiología , Muerte Súbita Cardíaca/prevención & control , Cardiomiopatías/complicaciones , Cardiomiopatías/terapia , Sistema de Registros
4.
J Cardiovasc Electrophysiol ; 33(1): 81-89, 2022 01.
Artículo en Inglés | MEDLINE | ID: mdl-34797012

RESUMEN

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is an effective alternative to the transvenous ICD. No study has yet compared S-ICD and transvenous ICD by assessing patient acceptance as a patient-centered outcome. OBJECTIVE: To evaluate the patient acceptance of the S-ICD and to investigate its association with clinical and implantation variables. In patients with symptomatic heart failure and reduced ejection fraction (HFrEF), the acceptance of the S-ICD was compared with a control group of patients who received a transvenous ICD. METHODS: Patient acceptance was calculated with the Florida Patient Acceptance Survey (FPAS) which measures four factors: return to function (RTF), device-related distress (DRD), positive appraisal (PA), and body image concerns (BIC). The survey was administered 12 months after implantation. RESULTS: 176 patients underwent S-ICD implantation. The total FPAS and the single factors did not differ according to gender, body habitus, or generator positioning. Patients with HFrEF had lower FPAS and RTF. Younger patients showed better RTF (75 [56-94] vs. 56 [50-81], p = .029). Patients who experienced device complications or device therapies showed higher DRD (40 [35-60] vs. 25 [10-50], p = .019). Patients with HFrEF receiving the S-ICD had comparable FPAS, RTF, DRD, and BIC to HFrEF patients implanted with the transvenous ICD while exhibited significantly better PA (88 [75-100] vs. 81 [63-94], p = .02). CONCLUSIONS: Our analysis revealed positive patient acceptance of the S-ICD, even in groups at risk of more distress such as women or patients with thinner body habitus, and regardless of the generator positioning. Among patients receiving ICDs for HFrEF, S-ICD was associated with better PA versus transvenous ICD.


Asunto(s)
Desfibriladores Implantables , Insuficiencia Cardíaca , Desfibriladores Implantables/efectos adversos , Femenino , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/etiología , Insuficiencia Cardíaca/terapia , Humanos , Volumen Sistólico , Encuestas y Cuestionarios , Resultado del Tratamiento
5.
J Cardiovasc Electrophysiol ; 32(2): 468-476, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33296533

RESUMEN

BACKGROUND: Current guidelines recommend defibrillation testing (DT) performance in patients with a subcutaneous implantable cardioverter defibrillator (S-ICD), theoretically to reduce the amount of ineffective shocks. DT, however, has been proven unnecessary in transvenous ICD and real-world data show a growing trend in avoidance of DT after S-ICD implantation. METHODS: All patients undergoing S-ICD implant at nine associated Italian centers joining in the ELISIR registry (ClinicalTrials.gov Identifier: NCT04373876) were enrolled and classified upon DT performance. Long-term follow-up events were recorded and compared to report the long-term efficacy and safety of S-ICD implantations without DT in a real-world setting. RESULTS: A total of 420 patients (54.0 ± 15.5 years, 80.0% male) were enrolled in the study. A DT was performed in 254 (60.5%) patients (DT+ group), while in 166 (39.5%) was avoided (DT- group). Over a median follow-up of 19 (11-31) months, a very low rate (0.7%) of ineffective shocks was observed, and no significant differences in the primary combined arrhythmic outcome were observed between the two groups (p = .656). At regression analysis, the only clinical predictor associated with the primary combined outcome was S-ICD placement for primary prevention (odds ratio: 0.42; p = .013); DT performance instead was not associated with a reduction in primary outcome (p = .375). CONCLUSION: Implanting an S-ICD without DT does not appear to impact the safety of defibrillation therapy and overall patients' survival.


Asunto(s)
Desfibriladores Implantables , Adulto , Anciano , Cardioversión Eléctrica , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sistema de Registros , Resultado del Tratamiento
6.
J Cardiovasc Electrophysiol ; 31(1): 144-149, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31778266

RESUMEN

BACKGROUND: A two-incision technique, in association with inter-muscular positioning of the subcutaneous defibrillator (S-ICD), is now the most frequently adopted implantation approach in Europe. Ultrasound-guided serratus anterior plane block (SAPB) has been proposed to provide anesthesia/analgesia during S-ICD implantation. OBJECTIVE: We performed a case-control analysis in which a standardized SAPB approach was compared with the typical local anesthesia and sedation approach. METHODS: Ninety-one consecutive patients underwent implantation of an S-ICD with the SAPB approach for anesthesia/analgesia at 10 centers. The control group consisted of 55 consecutive patients who underwent S-ICD implantation with a standard local approach. RESULTS: The mean procedure duration was 59 ± 15 minutes in the SAPB group and 76 ± 23 minutes in the control group (P < .001). No operative complications were reported in either group. During the procedure, 79 (87%) patients in the SAPB group and 25 (46%) patients in the control group (P < .001) remained awake. Lower values of pain intensity at the device pocket (P = .005) and the lateral tunneling site (P = .046) were reported in the SAPB group. The difference in static (P = .002) and dynamic (P = .007) pain intensity between the groups persisted at 1 hour, while no differences were observed 6 hours after the end of the procedure. CONCLUSIONS: SAPB is feasible and effective in providing anesthesia/analgesia during S-ICD implantation. The procedures were successfully accomplished and no complications occurred in either group. However, SAPB was associated with lower pain levels, enabling the need for sedation to be reduced and more patients to remain awake. Moreover, it resulted in shorter procedure durations.


Asunto(s)
Desfibriladores Implantables , Cardioversión Eléctrica/instrumentación , Músculo Esquelético/inervación , Bloqueo Nervioso , Dolor Postoperatorio/prevención & control , Implantación de Prótesis/instrumentación , Adulto , Anciano , Estudios de Casos y Controles , Cardioversión Eléctrica/efectos adversos , Femenino , Humanos , Italia , Masculino , Persona de Mediana Edad , Bloqueo Nervioso/efectos adversos , Tempo Operativo , Dimensión del Dolor , Dolor Postoperatorio/diagnóstico , Dolor Postoperatorio/etiología , Estudios Prospectivos , Implantación de Prótesis/efectos adversos , Sistema de Registros , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
7.
J Electrocardiol ; 59: 147-150, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32120081

RESUMEN

INTRODUCTION: Implantable cardiac monitor (ICM) is an established tool for the management of unexplained syncope and atrial fibrillation (AF) even if its accuracy of arrhythmia detection may be suboptimal. The aim of this study was to perform an intra-patient comparison of the diagnostic capability of ICM with a dual-chamber PM as a gold standard. METHODS: We included 19 patients with a previously implanted ICM (BioMonitor 2 Biotronik, Berlin, Germany), who received a dual-chamber PM for standard indications. ICM-detected arrhythmic events in a 6-month follow-up were compared with those detected by the PM and classified by visual inspection of intracardiac electrograms. RESULTS: During follow up, ICMs generated 15 false asystole and 39 false bradycardia detections in 5 patients (26.3%) due to recurrent premature ventricular contractions. A total of 34 true high ventricular rate (HVR) episodes were detected by the PM. Of them, 30 (88%) events were also recorded by the ICM, which further detected 14 false HVR snapshots, leading to a sensitivity and positive predictive value of 88% and 68%, respectively. In addition, PM identified 234 true AF episodes. Of them, 225 (96%) events were also detected by the ICM, while 8 (42%) ICMs stored 50 AF episodes classified as false positives. The ICM sensitivity for AF was 96% with a positive predictive value of 82%. CONCLUSION: Our intra-patient comparison with permanent PM confirmed that ICM is an effective tool for cardiac arrhythmias detection. ICM algorithms for AF and HVR detection were highly sensitive with an acceptable rate of false positive episodes.


Asunto(s)
Fibrilación Atrial , Marcapaso Artificial , Fibrilación Atrial/diagnóstico , Electrocardiografía , Electrocardiografía Ambulatoria , Alemania , Humanos
8.
Pacing Clin Electrophysiol ; 42(10): 1340-1346, 2019 10.
Artículo en Inglés | MEDLINE | ID: mdl-31429949

RESUMEN

BACKGROUND: The gold standard to treat cardiovascular implantable electronic devices (CIEDs) infections is the complete system removal. The aim of this retrospective analysis is to assess the feasibility and safety of an alternative conservative surgical system revision approach, to be applied in elderly patients who refused the extraction procedure, in case of no signs of systemic infection. METHODS: Between May 2009 and January 2019, we performed system revision of 25 patients (15 men and 10 women, median age 81 [IQ: 75-85] years) with negative blood culture, no signs of vegetation, who experienced CIED infections. RESULTS: In all patients the following surgical procedure was applied: the pocket was opened, the wound's necrotic tissue was dissected en bloc; fibrotic tissue was excised. The pocket was washed with hydrogen peroxide and saline solution. The pocket was then closed without implanting the device and left with a continuous infusion of antibiotics and normal saline for 4 days. Subsequently the new generator was implanted, possibly in a different pocket than the previous one. All patients underwent a median follow up of 24 [IQ: 14-34] months. In 24 patients out of the 25 observed the procedure was safe and effective, except for one patient who needed the extraction. CONCLUSIONS: The two-stage surgical revision technique is feasible and safe. It may be considered for elderly patients who refused extraction and presented no signs of systemic infection or in some categories of patients. In case of failure of the procedure, subsequent treatment with complete extraction of the system would not be precluded.


Asunto(s)
Tratamiento Conservador/métodos , Marcapaso Artificial , Infecciones Relacionadas con Prótesis/terapia , Anciano , Anciano de 80 o más Años , Antibacterianos/administración & dosificación , Remoción de Dispositivos , Femenino , Humanos , Masculino , Reoperación , Estudios Retrospectivos
9.
Pacing Clin Electrophysiol ; 41(3): 277-283, 2018 03.
Artículo en Inglés | MEDLINE | ID: mdl-29341174

RESUMEN

BACKGROUND: The recommended location for implantable cardiac monitor (ICM) insertion is the left pectoral region. We tested whether an innovative left axillary implantation approach could be applicable for a new ICM, characterized by a long sensing dipole. METHODS: We considered a series of 55 patients consecutively implanted with a long-dipole ICM (BioMonitor 2); the first 30 subjects underwent prepectoral location insertion, while the subsequent 25 received the ICM in the axillary region. Sensing performances collected at 1-month follow-up were compared between the two groups. During the visit, each patient was also asked to fill in a brief questionnaire to assess patient acceptability of the device. RESULTS: All patients had a successful insertion of ICM. Mean R-wave amplitude was 0.87 ± 0.44 mV in the prepectoral group and 1.00 ± 0.45 mV in the axillary one, without any significant difference. The percentage of patients with visible P wave was also comparable between the two approaches (65.5% vs 68.2%, P = 0.84). None of the patients reported device-related issues or discomfort, and ICM was generally well accepted and tolerated by all the involved patients. CONCLUSION: Axillary insertion may represent a valid alternative to the standard one for long-dipole ICM technology providing not only patient acceptability but also high-quality sensing performances.


Asunto(s)
Axila , Electrocardiografía Ambulatoria/instrumentación , Aceptación de la Atención de Salud , Seguridad del Paciente , Implantación de Prótesis/métodos , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Encuestas y Cuestionarios
12.
Front Cardiovasc Med ; 11: 1343424, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38322767

RESUMEN

Introduction: Implantable cardiac monitors (ICMs) provide long-term arrhythmia monitoring, but high rates of false detections increase the review burden. The new "SmartECG" algorithm filters false detections. Using large real-world data sets, we aimed to quantify the reduction in workload and any loss in sensitivity from this new algorithm. Methods: Patients with a BioMonitor IIIm and any device indication were included from three clinical projects. All subcutaneous ECGs (sECGs) transmitted via remote monitoring were classified by the algorithm as "true" or "false." We quantified the relative reduction in workload assuming "false" sECGs were ignored. The remote monitoring workload from five hospitals with established remote monitoring routines was evaluated. Loss in sensitivity was estimated by testing a sample of 2000 sECGs against a clinical board of three physicians. Results: Of our population of 368 patients, 42% had an indication for syncope or pre-syncope and 31% for cryptogenic stroke. Within 418.5 patient-years of follow-up, 143,096 remote monitoring transmissions contained 61,517 sECGs. SmartECG filtered 42.8% of all sECGs as "false," reducing the number per patient-year from 147 to 84. In five hospitals, nine trained reviewers inspected on average 105 sECGs per working hour. This results in an annual working time per patient of 83 min without SmartECG, and 48 min with SmartECG. The loss of sensitivity is estimated as 2.6%. In the majority of cases where true arrhythmias were rejected, SmartECG classified the same type of arrhythmia as "true" before or within 3 days of the falsely rejected sECG. Conclusion: SmartECG increases efficiency in long-term arrhythmia monitoring using ICMs. The reduction of workload by SmartECG is meaningful and the risk of missing a relevant arrhythmia due to incorrect filtering by the algorithm is limited.

13.
G Ital Cardiol (Rome) ; 24(3): 241-244, 2023 Mar.
Artículo en Italiano | MEDLINE | ID: mdl-36853162

RESUMEN

BACKGROUND: This report describes the findings of the 2020 Italian Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC). METHODS: Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers. RESULTS: A total of 10 378 ablation procedures were performed by 66 institutions. Most centers (70%) have an electrophysiology laboratory, and 23% a hybrid cardiac surgery laboratory. All centers have a 3D mapping system. The median number of electrophysiologists and nurses involved in the electrophysiology laboratory was 3.5 and 3, respectively. An electrophysiology technician was involved in 35% of all centers. In 88.2% of cases, catheter ablation was performed for supraventricular arrhythmias; the most frequently treated arrhythmia was atrial fibrillation (39.4%), followed by atrioventricular nodal reentrant tachycardia (18.6%), and common atrial flutter (10.6%). In 72.9% of patients, catheter ablation was performed using a 3D mapping system, with a "near-zero" fluoroscopic approach in 37.7% of all patients. CONCLUSIONS: The 2020 Italian Catheter Ablation Registry confirmed that the electrophysiology activity was markedly affected by the COVID-19 pandemic; atrial fibrillation is the most frequently treated arrhythmia with an increasing number of procedures performed with a 3D mapping system and a "near-zero" approach.


Asunto(s)
Fibrilación Atrial , COVID-19 , Ablación por Catéter , Humanos , Fibrilación Atrial/cirugía , Pandemias , Estudios Retrospectivos , Sistema de Registros
14.
Intern Emerg Med ; 18(1): 137-149, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-36352300

RESUMEN

BACKGROUND: The subsequent waves of the COVID-19 pandemic in Italy had a major impact on cardiac care. METHODS: A survey to evaluate the dynamic changes in arrhythmia care during the first five waves of COVID-19 in Italy (first: March-May 2020; second: October 2020-January 2021; third: February-May 2021; fourth: June-October 2021; fifth: November 2021-February 2022) was launched. RESULTS: A total of 127 physicians from arrhythmia centers (34% of Italian centers) took part in the survey. As compared to 2019, a reduction in 40% of elective pacemaker (PM), defibrillators (ICD), and cardiac resynchronization devices (CRT) implantations, with a 70% reduction for ablations, was reported during the first wave, with a progressive and gradual return to pre-pandemic volumes, generally during the third-fourth waves, slower for ablations. For emergency procedures (PM, ICD, CRT, and ablations), recovery from the initial 10% decline occurred in most cases during the second wave, with some variability. However, acute care for atrial fibrillation, electrical cardioversions, and evaluations for syncope showed a prolonged reduction of activity. The number of patients with devices which started remote monitoring increased by 40% during the first wave, but then the adoption of remote monitoring declined. CONCLUSIONS: The dramatic and profound derangement in arrhythmia management that characterized the first wave of the COVID-19 pandemic was followed by a progressive return to the volume of activities of the pre-pandemic periods, even if with different temporal dynamics and some heterogeneity. Remote monitoring was largely implemented during the first wave, but full implementation is needed.


Asunto(s)
Fibrilación Atrial , COVID-19 , Terapia de Resincronización Cardíaca , Desfibriladores Implantables , Humanos , Pandemias , Sistema de Registros , Italia/epidemiología , Electrofisiología
15.
J Clin Med ; 12(7)2023 Mar 27.
Artículo en Inglés | MEDLINE | ID: mdl-37048605

RESUMEN

Although real-time 3D echocardiography (RT3DE) has only been introduced in the last decades, its use still needs to be improved since it is a time-consuming and operator-dependent technique and acquiring a good quality data can be difficult. Moreover, the additive value of this important diagnostic tool still needs to be wholly appreciated in clinical practice. This review aims at explaining how, why, and when performing RT3DE is useful in clinical practice.

16.
Heart Rhythm O2 ; 4(2): 97-102, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-36873314

RESUMEN

Background: Insertable cardiac monitors (ICMs) are increasingly used for cardiac rhythm diagnosis with expanding indications. Little has been reported about their use and efficacy. Objective: The study sought to evaluate the clinical utility of a novel ICM (Biotronik BIOMONITOR III) including the time to diagnosis in unselected patients with different ICM indications. Methods: Patients from 2 prospective clinical studies were included to determine the diagnostic yield of the ICM. The primary endpoint was time to clinical diagnosis per implant indication or to the first change in atrial fibrillation (AF) therapy. Results: A total of 632 patients were included with a mean follow-up of 233 ± 168 days. Of 384 patients with (pre)syncope, 34.2% had a diagnosis at 1 year. The most frequent therapy was permanent pacemaker implantation. Of 133 patients with cryptogenic stroke, 16.6% had an AF diagnosis at 1 year, resulting in oral anticoagulation. Of 49 patients with an indication for AF monitoring, 41.0% had a relevant change in AF therapy based on ICM data at 1 year. Of 66 patients with other indications, 35.4% received a rhythm diagnosis at 1 year. Moreover, 6.5% of the cohort had additional diagnoses: 26 of 384 patients with syncope, 8 of 133 patients with cryptogenic stroke, and 7 of 49 patients with AF monitoring. Conclusion: In a large unselected patient population with heterogeneous ICM indications, the primary endpoint of rhythm diagnosis was achieved in ∼1 in 4, and additional clinically relevant findings was achieved in 6.5% of patients at short-term follow-up.

17.
Front Cardiovasc Med ; 10: 1148052, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37025684

RESUMEN

Background: Fat layers in obese patients can impair R-wave detection and diagnostic performance of a subcutaneous insertable cardiac monitor (ICM). We compared safety and ICM sensing quality between obese patients [body mass index (BMI) ≥ 30 kg/m2] and normal-weight controls (BMI <30 kg/m2) in terms of R-wave amplitude and time in noise mode (noise burden) detected by a long-sensing-vector ICM. Materials and methods: Patients from two multicentre, non-randomized clinical registries are included in the present analysis on January 31, 2022 (data freeze), if the follow-up period was at least 90 days after ICM insertion, including daily remote monitoring. The R-wave amplitudes and daily noise burden averaged intraindividually for days 61-90 and days 1-90, respectively, were compared between obese patients (n = 104) and unmatched (n = 268) and a nearest-neighbour propensity score (PS) matched (n = 69) normal-weight controls. Results: The average R-wave amplitude was significantly lower in obese (median 0.46 mV) than in normal-weight unmatched (0.70 mV, P < 0.0001) or PS-matched (0.60 mV, P = 0.003) patients. The median noise burden was 1.0% in obese patients, which was not significantly higher than in unmatched (0.7%; P = 0.056) or PS-matched (0.8%; P = 0.133) controls. The rate of adverse device effects during the first 90 days did not differ significantly between groups. Conclusion: Although increased BMI was associated with reduced signal amplitude, also in obese patients the median R-wave amplitude was >0.3 mV, a value which is generally accepted as the minimum level for adequate R-wave detection. The noise burden and adverse event rates did not differ significantly between obese and normal-weight patients.Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04075084 and NCT04198220.

18.
G Ital Cardiol (Rome) ; 24(9): 754-765, 2023 09.
Artículo en Italiano | MEDLINE | ID: mdl-37642128

RESUMEN

Nowadays, a progressive and exponential increase in the use of invasive and non-invasive instrumental diagnostics and therapeutic services has been shown. Although unnecessary, instrumental examinations are often largely prescribed, replacing clinical evaluation. Their correct use, on the contrary, would address precise epidemiological and clinical contexts. Therefore identifying whether a test or procedure is appropriate or not plays a crucial role in clinical practice. Several documents from scientific societies and expert groups indicate the most appropriate cardiovascular diagnostic and therapeutic procedures. The international Choosing Wisely campaign invited the main scientific societies to identify five techniques or treatments used in their field that are often unnecessary and may potentially damage patients. The Italian Association of Hospital Cardiologists (ANMCO) joined the project identifying the five cardiological practices in our country at greater risk of inappropriateness in 2014. This list has recently been updated. Moreover, possible solutions to this problem have been proposed.


Asunto(s)
Cardiólogos , Cardiología , Humanos , Hospitales
19.
G Ital Cardiol (Rome) ; 24(11): 915-932, 2023 Nov.
Artículo en Italiano | MEDLINE | ID: mdl-37901982

RESUMEN

In the last decades, because of the improvements in the percutaneous treatment of coronary heart disease, valvular heart disease, congenital heart defects, and the increasing number of cardiac resynchronization therapy and cardioverter-defibrillator implantations, the interventional cardiologists' radio-exposure has importantly risen, causing concerns for ionizing radiation-associated diseases such as cancer and neurodegenerative disorders. Consequently, the radiation exposure issue importantly affects operators' safety. However, our knowledge of this field is poor and most operators are unaware to be at risk, especially because of the absence of effective preventive measures. The aim of this ANMCO position paper is to improve the awareness of operators and identify new ways of reducing operator ionizing radiation dose and minimizing the risk.


Asunto(s)
Terapia de Resincronización Cardíaca , Cardiólogos , Exposición a la Radiación , Protección Radiológica , Humanos , Exposición a la Radiación/prevención & control , Radiación Ionizante
20.
J Clin Med ; 11(7)2022 Mar 30.
Artículo en Inglés | MEDLINE | ID: mdl-35407529

RESUMEN

AIMS: Telecardiology is one of the most widespread applications of telemedicine. We aimed to report the design and development of a telecardiology system in the sanitary district of Cosenza, one of the largest in Italy, with a complex orography, and healthcare reorganization needs, for the management of the emergency network and daily clinical practice. METHODS: Our telecardiology network connects 8 hospitals, 9 first aid centers, 20 local 118-EMS stations, 1 helicopter station, 8 hospital emergency departments, 59 hospital departments, and 3 catheterization laboratories. All data are centralized on a dedicated server, accessible from any location for real-time assessment. The quality, source, and timing of the electrocardiograms transmitted were evaluated. RESULTS: From October 2015 to December 2019, a total of 389,970 ECGs were transmitted. The quality of ECGs was optimal in 52%, acceptable in 42%, and poor in 6% of the cases. The number of poor-quality ECGs was only 3% in the last 2 years. Out of the total, 145,097 (37.2%) were transmitted from the emergency departments and 5318 (1.4%) from the 118-EMS. Of interest, a sizable part of the ECG was related to routine clinical practice, comprising 110,556 (28.3%) from the cardiology department and 79,256 (20.3%) from other noncardiovascular departments. Finally, the average reporting time was significantly decreased compared to reporting times without a telecardiology system (5-10 vs. 45-90 min). CONCLUSION: Our telecardiology system provides efficient cardiology assistance for all types, settings, and phases of cardiovascular diseases.

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