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 ImplantablesRESUMEN
AIMS: In subcutaneous implantable cardioverter defibrillator (S-ICD) recipients, the UNTOUCHED study demonstrated a very low inappropriate shock rate on programming a conditional zone between 200 and 250 bpm and a shock zone for arrhythmias >250 bpm. The extent to which this programming approach is adopted in clinical practice is still unknown, as is its impact on the rates of inappropriate and appropriate therapies. METHODS AND RESULTS: We assessed ICD programming on implantation and during follow-up in a cohort of 1468 consecutive S-ICD recipients in 56 Italian centres. We also measured the occurrence of inappropriate and appropriate shocks during follow-up. On implantation, the median programmed conditional zone cut-off was set to 200 bpm (IQR: 200-220) and the shock zone cut-off was 230 bpm (IQR: 210-250). During follow-up, the conditional zone cut-off rate was not significantly changed, while the shock zone cut-off was changed in 622 (42%) patients and the median value increased to 250 bpm (IQR: 230-250) (P < 0.001). UNTOUCHED-like programming of detection cut-offs was adopted in 426 (29%) patients immediately after device implantation, and in 714 (49%, P < 0.001) at the last follow-up. UNTOUCHED-like programming was independently associated with fewer inappropriate shocks (hazard ratio 0.50, 95%CI 0.25-0.98, P = 0.044), and had no impact on appropriate and ineffective shocks. CONCLUSIONS: In recent years, S-ICD implanting centres have increasingly programmed high arrhythmia detection cut-off rates, at the time of implantation in the case of new S-ICD recipients, and during follow-up in the case of pre-existing implants. This has contributed significantly to reducing the incidence of inappropriate shocks in clinical practice. Rordorf: Programming of the S-ICD. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/Identifier: NCT02275637.
Asunto(s)
Desfibriladores Implantables , Taquicardia Ventricular , Humanos , Desfibriladores Implantables/efectos adversos , Taquicardia Ventricular/diagnóstico , Estudios de Seguimiento , Estudios Prospectivos , Cardioversión Eléctrica , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/terapiaRESUMEN
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.
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Desfibriladores Implantables , Humanos , Desfibriladores Implantables/efectos adversos , Estudios de Casos y Controles , Muerte Súbita Cardíaca/etiología , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
AIMS: We developed and validated an algorithm for prediction of heart failure (HF) hospitalizations using remote monitoring (RM) data transmitted by implanted defibrillators. METHODS AND RESULTS: The SELENE HF study enrolled 918 patients (median age 69 years, 81% men, median ejection fraction 30%) with cardiac resynchronization therapy (44%), dual-chamber (38%), or single-chamber defibrillators with atrial diagnostics (18%). To develop a predictive algorithm, temporal trends of diurnal and nocturnal heart rates, ventricular extrasystoles, atrial tachyarrhythmia burden, heart rate variability, physical activity, and thoracic impedance obtained by daily automatic RM were combined with a baseline risk-stratifier (Seattle HF Model) into one index. The primary endpoint was the first post-implant adjudicated HF hospitalization. After a median follow-up of 22.5 months since enrolment, patients were randomly allocated to the algorithm derivation group (n = 457; 31 endpoints) or algorithm validation group (n = 461; 29 endpoints). In the derivation group, the index showed a C-statistics of 0.89 [95% confidence interval (CI): 0.83-0.95] with 2.73 odds ratio (CI 1.98-3.78) for first HF hospitalization per unitary increase of index value (P < 0.001). In the validation group, sensitivity of predicting primary endpoint was 65.5% (CI 45.7-82.1%), median alerting time 42 days (interquartile range 21-89), and false (or unexplained) alert rate 0.69 (CI 0.64-0.74) [or 0.63 (CI 0.58-0.68)] per patient-year. Without the baseline risk-stratifier, the sensitivity remained 65.5% and the false/unexplained alert rates increased by ≈10% to 0.76/0.71 per patient-year. CONCLUSION: With the developed algorithm, two-thirds of first post-implant HF hospitalizations could be predicted timely with only 0.7 false alerts per patient-year.
Asunto(s)
Terapia de Resincronización Cardíaca , Desfibriladores Implantables , Insuficiencia Cardíaca , Anciano , Terapia de Resincronización Cardíaca/efectos adversos , Terapia de Resincronización Cardíaca/métodos , Femenino , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/terapia , Hospitalización , Humanos , Masculino , Volumen SistólicoRESUMEN
BACKGROUND: The traditional technique for subcutaneous implantable cardioverter defibrillator (S-ICD) implantation involves three incisions and a subcutaneous (SC) pocket. An intermuscular (IM) 2-incision technique has been recently adopted. AIMS: We assessed acute defibrillation efficacy (DE) of S-ICD (DE ≤65 J) according to the implantation technique. METHODS: We analyzed consecutive patients who underwent S-ICD implantation and DE testing at 53 Italian centers. Regression analysis was used to determine the association between DFT and implantation technique. RESULTS: A total of 805 patients were enrolled. Four groups were assessed: IM + 2 incisions (n = 546), SC + 2 incisions (n = 133), SC + 3 incisions (n = 111), and IM + 3 incisions (n = 15). DE was ≤65 J in 782 (97.1%) patients. Patients with DE ≤65 J showed a trend towards lower body mass index (25.1 vs. 26.5; p = .12), were less frequently on antiarrhythmic drugs (13% vs. 26%; p = .06) and more commonly underwent implantation with the 2-incision technique (85% vs. 70%; p = .04). The IM + 2-incision technique showed the lowest defibrillation failure rate (2.2%) and shock impedance (66 Ohm, interquartile range: 57-77). On multivariate analysis, the 2-incision technique was associated with a lower incidence of shock failure (hazard ratio: 0.305; 95% confidence interval: 0.102-0.907; p = .033). Shock impedance was lower with the IM than with the SC approach (66 vs. 70 Ohm p = .002) and with the 2-incision than the 3-incision technique (67 vs. 72 Ohm; p = .006). CONCLUSIONS: In a large population of S-ICD patients, we observed a high defibrillation success rate. The IM + 2-incision technique provides lower shock impedance and a higher likelihood of successful defibrillation.
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Desfibriladores Implantables , Índice de Masa Corporal , Cardioversión Eléctrica/efectos adversos , Impedancia Eléctrica , Humanos , Implantación de Prótesis/efectos adversos , Tejido Subcutáneo , Resultado del TratamientoRESUMEN
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.
Asunto(s)
Terapia de Resincronización Cardíaca , Desfibriladores Implantables , Taquicardia Ventricular , Arritmias Cardíacas , Humanos , Taquicardia Ventricular/diagnóstico , Taquicardia Ventricular/terapia , Resultado del TratamientoRESUMEN
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 TratamientoRESUMEN
AIMS: The traditional technique for subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation involves three incisions and a subcutaneous pocket. Recently, a two-incision and intermuscular (IM) technique has been adopted. The PRAETORIAN score is a chest radiograph-based tool that predicts S-ICD conversion testing. We assessed whether the S-ICD implantation technique affects optimal position of the defibrillation system according to the PRAETORIAN score. METHODS AND RESULTS: We analysed consecutive patients undergoing S-ICD implantation. The χ2 test and regression analysis were used to determine the association between the PRAETORIAN score and implantation technique. Two hundred and thirteen patients were enrolled. The S-ICD generator was positioned in an IM pocket in 174 patients (81.7%) and the two-incision approach was adopted in 199 (93.4%). According to the PRAETORIAN score, the risk of conversion failure was classified as low in 198 patients (93.0%), intermediate in 13 (6.1%), and high in 2 (0.9%). Patients undergoing the two-incision and IM technique were more likely to have a low (<90) PRAETORIAN score than those undergoing the three-incision and subcutaneous technique (two-incision: 94.0% vs. three-incision: 78.6%; P = 0.004 and IM: 96.0% vs. subcutaneous: 79.5%; P = 0.001). Intermuscular plus two-incision technique was associated with a low-risk PRAETORIAN score (hazard ratio 3.76; 95% confidence interval 1.01-14.02; P = 0.04). Shock impedance was lower in PRAETORIAN low-risk patients than in intermediate-/high-risk categories (66 vs. 96 Ohm; P = 0.001). The PRAETORIAN score did not predict shock failure at 65 J. CONCLUSION: In this cohort of S-ICD recipients, combining the two-incision technique and IM generator implantation yielded the lowest PRAETORIAN score values, indicating optimal defibrillation system position. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov/ Identifier: NCT02275637.
Asunto(s)
Desfibriladores Implantables , Estudios de Cohortes , Impedancia Eléctrica , Humanos , Implantación de Prótesis/efectos adversos , Factores de RiesgoRESUMEN
INTRODUCTION: Clinical trials did not provide conclusive evidence concerning the benefit of prophylactic implantable cardioverter-defibrillators (ICDs) in patients with severe nonischemic cardiomyopathy (NICM). We aimed to compare incidence of appropriate sustained ventricular arrhythmia (SVA) and device therapy in ischemic cardiomyopathy (ICM) vs NICM ICD and/or cardiac resynchronization therapy (CRT-D) patients. METHODS AND RESULTS: We analyzed remote-monitoring data from devices of the Home Monitoring Expert Alliance network. SVA recordings were adjudicated by three independent electrophysiologists. Our cohort included 1,946 patients who received either an ICD (55%) or a CRT-D (45%) for primary prevention of sudden cardiac death. Median (interquartile range) age was 70 (62-77) years, 81% were male, and 52% were in the ICM group. Patients were remotely monitored for a maximum follow-up of 5 years. The 5-year product-limit estimate of SVA incidence in patients with an ICD was 47.3% (95% confidence interval [CI], 41.0%-53.9%) in the ICM group and 44.7% (36.9%-53.3%) in the NICM group. In patients with a CRT-D, SVA incidence was 45.7% (37.3%-55.0%) in ICM patients and 49.2% (40.4%-58.7%) in NICM patients. The adjusted hazard ratio for SVA in the ICM vs NICM group was 0.96 (95% CI: 0.70-1.30, P = .77) in ICD patients and 0.85 (95% CI: 0.61-1.18, P = .34) in CRT-D patients. SVAs triggered appropriate device therapies with similar incidence in all groups. CONCLUSION: In a large cohort of remotely monitored ICD and CRT-D recipients, SVA incidence did not significantly differ in ICM and NICM patients.
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Arritmias Cardíacas/terapia , Dispositivos de Terapia de Resincronización Cardíaca , Terapia de Resincronización Cardíaca , Cardiomiopatías/fisiopatología , Muerte Súbita Cardíaca/prevención & control , Desfibriladores Implantables , Cardioversión Eléctrica/instrumentación , Prevención Primaria/instrumentación , Tecnología de Sensores Remotos , Anciano , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/mortalidad , Arritmias Cardíacas/fisiopatología , Terapia de Resincronización Cardíaca/efectos adversos , Terapia de Resincronización Cardíaca/mortalidad , Cardiomiopatías/diagnóstico , Cardiomiopatías/mortalidad , Causas de Muerte , Bases de Datos Factuales , Muerte Súbita Cardíaca/epidemiología , Cardioversión Eléctrica/efectos adversos , Cardioversión Eléctrica/mortalidad , Femenino , Humanos , Incidencia , Italia/epidemiología , Masculino , Persona de Mediana Edad , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/mortalidad , Isquemia Miocárdica/fisiopatología , Valor Predictivo de las Pruebas , Falla de Prótesis , Factores de Riesgo , Procesamiento de Señales Asistido por Computador , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: We hypothesized that a negative microvolt T-wave alternans (MTWA) test would identify patients unlikely to benefit from primary prevention implantable cardioverter defibrillator (ICD) therapy in a prospective cohort. METHODSâANDâRESULTS: Data were pooled from 8 centers where MTWA testing was performed specifically for the purpose of guiding primary prevention ICD implantation. Cohorts were included if the ratio of ICDs implanted in patients who were MTWA "non-negative" to patients who were MTWA negative was >2:1, indicating that MTWA testing had a significant impact on the decision to implant an ICD. The pooled cohort included 651 patients: 371 MTWA non-negative and 280 MTWA negative. Among non-negative patients, 62% underwent ICD implantation whereas only 13% of MTWA-negative patients received an ICD (P<0.01). Despite a substantially lower prevalence of ICDs, long-term survival (6.9 years) was significantly better among MTWA-negative patients (68.2% non-negative vs. 87.1% negative, P=0.026). CONCLUSIONS: MTWA-negative patients had significantly better survival than MTWA non-negative patients, the majority of whom had ICDs. Despite a very low prevalence of ICDs, long-term survival among patients with left ventricular ejection fraction ≤40% and a negative MTWA test was better than in the ICD arm of any study to date that has demonstrated a benefit of ICDs. This provides further evidence that MTWA-negative patients are unlikely to benefit from primary prevention ICD therapy.
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Arritmias Cardíacas/mortalidad , Arritmias Cardíacas/terapia , Desfibriladores Implantables , Cardioversión Eléctrica , Adulto , Anciano , Anciano de 80 o más Años , Supervivencia sin Enfermedad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Tasa de SupervivenciaRESUMEN
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 CHA2DS2-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 CHA2DS2-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.
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Fibrilación Atrial , Desfibriladores Implantables , Humanos , Femenino , Masculino , Fibrilación Atrial/fisiopatología , Fibrilación Atrial/diagnóstico , Anciano , Incidencia , Progresión de la Enfermedad , Medición de Riesgo/métodos , Atrios Cardíacos/fisiopatología , Marcapaso Artificial , Frecuencia Cardíaca/fisiología , Factores de Riesgo , Persona de Mediana Edad , Tecnología de Sensores Remotos/instrumentación , Estudios de SeguimientoRESUMEN
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 ß-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 ß-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.
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Terapia de Resincronización Cardíaca , Desfibriladores Implantables , Insuficiencia Cardíaca , Taquicardia Ventricular , Disfunción Ventricular Izquierda , Humanos , Persona de Mediana Edad , Anciano , Frecuencia Cardíaca , Pronóstico , Volumen Sistólico , Taquicardia Ventricular/etiología , Taquicardia Ventricular/terapia , Fibrilación Ventricular/terapia , Arritmias Cardíacas/terapia , Factores de Riesgo , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/terapia , Terapia de Resincronización Cardíaca/efectos adversos , Desfibriladores Implantables/efectos adversos , Disfunción Ventricular Izquierda/complicacionesRESUMEN
AIM: To assess the predictive value of baseline ventricular dyssynchrony and myocardial contractile reserve (mCR) in identifying responders to cardiac resynchronization therapy (CRT). METHODS: We prospectively studied 57 patients selected for CRT according to current recommendations. Regional dyssynchrony was evaluated by parametric phase imaging of ecg-gated equilibrium radionuclide angiography (ERNA). The mean inter-ventricular phase delay and the standard deviation to mean left ventricular (LV) phase angle were used as a measure of inter- and intra-ventricular dyssynchrony, respectively. Change in LV ejection fraction (LVEF) during low-dose dobutamine (LDD) was measured to assess mCR. ERNA was repeated at 6 months to evaluate changes in LVEF after CRT. Combined end-points of re-hospitalization for heart failure, heart transplantation, and cardiac death were assessed over a period of 76 months (mean 43 ± 31). RESULTS: Baseline dyssynchrony was present in most patients (85%). After CRT only one half of patients showed a reduction in intra-ventricular dyssynchrony and 33% an increase in LVEF by >5%. Improvement of LVEF was not predicted by baseline LVEF, clinical presentation, dyssynchrony parameters or QRS duration. There was a significant relationship between changes in LVEF during LDD testing and after CRT (r = 0.65; P < .0001). Logistic regression analysis identified mCR as independent predictor of improvement in LVEF (P = .039; OR = 3.84; CI 95% = 1.06-13.9), resynchronization (P = .046; OR = 4.20; CI 95% = 1.03-17.2), and event-free survival (P = .002; OR = 0.10; CI 95% = 0.02-0.43). CONCLUSIONS: In patients with left ventricular dysfunction and baseline dyssynchrony as assessed by ERNA, evaluation of mCR during LDD may help predicting functional improvement and selecting potential responders to CRT.
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Terapia de Resincronización Cardíaca , Tomografía Computarizada por Emisión de Fotón Único Sincronizada Cardíaca , Reserva del Flujo Fraccional Miocárdico , Insuficiencia Cardíaca/diagnóstico por imagen , Insuficiencia Cardíaca/prevención & control , Disfunción Ventricular Izquierda/diagnóstico por imagen , Disfunción Ventricular Izquierda/prevención & control , Prueba de Esfuerzo , Femenino , Insuficiencia Cardíaca/complicaciones , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Pronóstico , Resultado del Tratamiento , Disfunción Ventricular Izquierda/etiologíaRESUMEN
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%.
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Desfibriladores Implantables , Humanos , Masculino , Femenino , Anciano , Desfibriladores Implantables/efectos adversos , Puntaje de Propensión , Resultado del Tratamiento , Arritmias Cardíacas/epidemiología , Arritmias Cardíacas/terapia , Cardioversión EléctricaRESUMEN
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.
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Terapia de Resincronización Cardíaca , Desfibriladores Implantables , Insuficiencia Cardíaca , Terapia de Resincronización Cardíaca/métodos , Dispositivos de Terapia de Resincronización Cardíaca/efectos adversos , Desfibriladores Implantables/efectos adversos , Femenino , Insuficiencia Cardíaca/terapia , Humanos , Masculino , Medición de Riesgo , Factores de Riesgo , Resultado del TratamientoRESUMEN
Late-onset migration of pacing leads in the left hemithorax is a rare but potentially life-threatening complication. Radiological examinations are required to detect any involvement of either left ventricle or lung parenchyma, prompting immediate surgical extraction in this setting. Identification of high-risk patients is mandatory to prevent this complex iatrogenic complication.
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Background: Resilience is proven as a protective factor against the development of psychiatric disorders, and it has gained clinical relevance in the development and progression of cardiovascular pathology. The authors performed a longitudinal study on patients with implantable cardioverter defibrillator (ICD) with the primary aim to highlight the possible existence of a correlation between individual resilience capacity, depressive and anxiety symptoms, and quality of life in terms of outcomes. The secondary aim was to analyze the differences between patients with major cardiac events in the follow-up and patients without cardiac events with respect to the previous variables. Materials and Methods: A total of 80 patients enrolled in the Cardiology Unit were evaluated at T0 and during the follow-up through the following scales: the 14-item Resilience Scale (RS-14), the Hospital Anxiety and Depression Scale (HADS), and the World Health Organization Quality of Life-Brief Version (WHOQOL-Bref). Results: A significant linear correlation between resilience and all the areas of quality of life at T0, T1, and T2 emerged. A negative correlation between resilience and anxiety and depressive symptoms emerged, as well as between depression and anxiety and quality of life. Patients with cardiac events during the follow up have shown a worse quality of life and the onset of anxiety-depressive symptoms over time, without changes to the resilience scores. Patients without cardiac events showed an increasing trend in resilience scores. Discussion: Given the speed and simplicity of use of the RS-14 scale, it seems promising to further investigate the real clinical usefulness of this instrument in the cardiology field.
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AIMS: There are conflicting data on the benefit of cardiac resynchronization therapy (CRT) in heart failure (HF) patients with permanent atrial fibrillation (AF). We aimed to compare patient outcomes according to the presence or absence of permanent AF at device implantation. METHODS AND RESULTS: We retrospectively analysed remote monitoring data from 1141 CRT defibrillators. Propensity score with inverse-probability weighting method was used to balance AF and sinus rhythm (SR) groups. Analysis endpoints included total mortality, appropriate defibrillation shocks, and CRT percentage. There were 229 patients (20.1%) in the AF group and 912 patients (79.9%) in the SR group. Compared with SR patients, AF patients were older (median age, 77 vs. 72 years, P < 0.001), more frequently male (82.5% vs. 75.5%, P = 0.02), and had higher heart rate (75.7 vs. 71.0 b.p.m., P < 0.001). Of the 229 AF patients, 162 (70.7%) received suboptimal CRT (<98%) and 67 (29.3%) had adequate CRT (≥98%). During a median follow-up of 24 months, total mortality did not differ between AF and SR groups (propensity-score-weighted hazard ratio, HR 1.32 [95% confidence interval, 0.82-2.15], P = 0.25). The risk of appropriate shocks was significantly higher in the AF group with <98% CRT than in the SR group (weighted-HR, 1.99 [1.21-3.26], P = 0.006) and was similar in the AF group with ≥98% CRT versus the SR group (1.29 [0.66-2.53], P = 0.45). During follow-up, sinus rhythm was recovered in 23 patients in the AF group (10%) after a median time of 106 (42-256) days. The rate of sinus rhythm recovery in the AF group was 4.5 (95% CI, 2.8-6.7) per 100 patient-years; the rate of permanent AF occurrence in the SR group was 2.5 (95% CI, 1.9-3.3) per 100 patient-years. CONCLUSIONS: Although mortality was similar across patient groups, patients with permanent AF and suboptimal CRT had twofold higher risk of appropriate shocks than SR patients or AF patients with CRT ≥ 98%.
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Fibrilación Atrial , Terapia de Resincronización Cardíaca , Anciano , Fibrilación Atrial/epidemiología , Fibrilación Atrial/terapia , Terapia de Resincronización Cardíaca/métodos , Desfibriladores , Humanos , Masculino , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
INTRODUCTION: Ablation of macroreentrant atrial tachycardia (MRAT) is demanding and identification of predictors of failure may be of help in patient management. This study compares the characteristics of successfully versus unsuccessfully treated patients undergoing electroanatomic mapping (EAM) and ablation of MRAT. METHODS AND RESULTS: Consecutive patients undergoing EAM and ablation of MRAT were included. Ablation was linearly placed at the mid-diastolic isthmus (MDI) to achieve arrhythmia interruption and conduction block. Variables were analyzed for predictors of both procedural failure and cumulative failure (procedural failure + early recurrences). Fifty-two patients (37 M; age 64 +/- 16 years) with 56 MRATs were considered. The MRAT was in the right atrium in 25 morphologies (45%) and 32 (57%) showed a double-loop reentry. Fifty-one morphologies (91%) in 47 patients were successfully treated; 3 patients had early recurrences of the same MRAT. None of the clinical variables considered significantly differed in the successfully treated group as compared to the unsuccessfully treated. Conversely, there was a significant difference as to the EAM characteristics: successfully treated cases showed a narrower target isthmus with a lower voltage amplitude and slower conduction velocity (CV). In the MDI, a CV >60 cm/sec and a width >40 mm were the strongest predictors of procedural failure and cumulative failure, respectively. CONCLUSIONS: In this patient population, while the clinical variables did not differ significantly, there was a significant difference in the EAM characteristics between successfully and unsuccessfully treated cases. CV and width of the isthmus target for ablation were the strongest independent predictors of procedure outcome.
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Mapeo del Potencial de Superficie Corporal/estadística & datos numéricos , Ablación por Catéter/estadística & datos numéricos , Taquicardia por Reentrada en el Nodo Atrioventricular/diagnóstico , Taquicardia por Reentrada en el Nodo Atrioventricular/cirugía , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Italia/epidemiología , Masculino , Persona de Mediana Edad , Prevalencia , Taquicardia por Reentrada en el Nodo Atrioventricular/epidemiología , Insuficiencia del Tratamiento , Resultado del Tratamiento , Adulto JovenRESUMEN
In patients with PLSVC, the use of an active fixation lead (like the Medtronic "Attain Stability") on the coronary sinus can lead to a successful and safe cardiac resynchronization, facilitating its positioning with a low long-term displacement rate.