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AIMS: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have become established in preventing sudden cardiac death, with some advantages over transvenous defibrillator systems, including a lower incidence of lead failures. Despite technological advancements, S-ICD carriers may suffer from significant complications, such as premature battery depletion (PBD), that led to an advisory for nearly 40 000 patients. This multicentre study evaluated the incidence of PBD in a large set of S-ICD patients. METHODS AND RESULTS: Data from patients implanted with S-ICD models A209 and A219 between October 2012 and July 2023 across nine centres in Europe and the USA were reviewed. Incidence and implications of PBD, defined as clinically observed sudden drop in battery longevity, were analysed and compared to PBD with the definition of battery depletion within 60 months. Prospectively collected clinical data were obtained retrospectively from medical records, device telemetry, and manufacturer reports. This registry is listed on ClinicalTrials.gov (NCT05713708). Of the 1112 S-ICD devices analysed, 547 (49.2%) were equipped with a potentially affected capacitor linked to PBD occurrence, currently under Food and Drug Administration advisory. The median follow-up time for all patients was 46 [inter-quartile range (IQR) 24-63] months. Clinically suspected PBD was observed in 159 (29.1%) of cases, with a median time to generator removal or replacement of 65 (IQR 55-72) months, indicative of significant deviations from expected battery lifespan. Manufacturer confirmation of PBD was made in 91.7% of devices returned for analysis. No cases of PBD were observed in devices that were not under advisory. CONCLUSION: This manufacturer-independent analysis highlights a notable incidence of PBD in patients equipped with S-ICD models under advisory, and the rate of PBD in this study corresponds to the rate currently estimated by the manufacturer. To the best of our knowledge, this provides the largest contemporary peer-reviewed study cohort investigating the actual incidence of PBD in S-ICD patients. These findings emphasize the importance of post-market registries in collaboration between clinicians and the manufacturer to optimize safety and efficacy in S-ICD treatment.
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Desfibriladores Implantáveis , Fontes de Energia Elétrica , Sistema de Registros , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Estudos Retrospectivos , Idoso , Estados Unidos/epidemiologia , Morte Súbita Cardíaca/prevenção & controle , Morte Súbita Cardíaca/epidemiologia , Europa (Continente)/epidemiologia , Cardioversão Elétrica/instrumentação , Cardioversão Elétrica/efeitos adversos , Falha de Equipamento/estatística & dados numéricos , Fatores de Tempo , Análise de Falha de Equipamento/estatística & dados numéricos , AdultoRESUMO
AIMS: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) offer potentially distinct advantages over transvenous defibrillator systems. Recent randomized trials showed significantly lower lead failure rates than transvenous ICD. Still, S-ICDs remain associated with the risk of inappropriate shocks (IAS). While previous studies have reported varying causes of IAS, this study explores a rare cause of IAS, referred to as 'sense-B-noise.' It was recently described in case series, but its incidence has not been studied in a large cohort of S-ICD patients. METHODS AND RESULTS: We retrospectively reviewed data from patients implanted with S-ICD models 1010, A209, and A219 between October 2009 and July 2023 across nine centres in Europe and the USA. The analysis concentrated on determining the incidence and understanding the implications of sense-B-noise events. Sense-B-noise represents a rare manifestation of distinct electrogram abnormalities within the primary and alternate sensing vectors. Data were collected from medical records, device telemetry, and manufacturer reports for investigation. This registry is registered on clinicaltrials.gov (NCT05713708). Subcutaneous implantable cardioverter-defibrillator devices of the 1158 patients were analysed. The median follow-up time for all patients was 46 (IQR 23-64) months. In 107 patients (9.2%) ≥1 IAS was observed during follow-up. Sense-B-noise failure was diagnosed in six (0.5 and 5.6% of all IAS) patients, in all patients, the diagnosis was made after an IAS episode. Median lead dwell time in the affected patients was 23 (2-70) months. To resolve the sense-B-noise defect, in three patients reprogramming to the secondary vector was undertaken, and two patients underwent system removal with subsequent S-ICD reimplantation due to low amplitude in the secondary vector. In one patient, the secondary vector was initially programmed, and subsequently, an S-ICD system exchange was performed due to T-wave-oversensing IAS episodes. CONCLUSION: This multicentre analysis' findings shed light on a rare but clinically highly significant adverse event in S-ICD therapy. To our knowledge, we provide the first systematic multicentre analysis investigating the incidence of sense-B-noise. Due to being difficult to diagnose and limited options for resolution, management of sense-B-noise is challenging. Complete system exchange may be the only option for some patients. Educating healthcare providers involved in S-ICD patient care is crucial for ensuring accurate diagnosis and effective management of sense-B-noise issues.
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Desfibriladores Implantáveis , Cardioversão Elétrica , Sistema de Registros , Humanos , Masculino , Estudos Retrospectivos , Feminino , Pessoa de Meia-Idade , Incidência , Cardioversão Elétrica/instrumentação , Cardioversão Elétrica/efeitos adversos , Idoso , Europa (Continente)/epidemiologia , Falha de Equipamento/estatística & dados numéricos , Estados Unidos/epidemiologia , Fatores de RiscoRESUMO
Unlimited access to ECGs using an over-the-counter smartwatch constitutes a real revolution for our discipline, and the application is rapidly expanding to include patients with cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs) and implantable cardioverter defibrillators (ICDs). CIEDs require periodic evaluation and adjustment by healthcare professionals. In addition, implanted patients often present with symptoms that may be related to their PMs or ICDs. An ECG smartwatch could reveal information about device functioning, confirm normal device function, or aid in the case of device troubleshooting. In this review, we delve into the available evidence surrounding smartwatches with ECG registration and their integration into the care of patients with implanted pacemakers and ICDs. We explore safety considerations and the benefits and limitations associated with these wearables, drawing on relevant studies and case series from our own experience. By analyzing the current landscape of this emerging technology, we aim to provide a comprehensive overview that facilitates informed decision-making for both healthcare professionals and patients.
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Desfibriladores Implantáveis , Eletrocardiografia , Humanos , Coração , Eletricidade , EletrônicaRESUMO
OBJECTIVE: The objective of this study was to evaluate the agreement of smartwatch-derived single-lead electrocardiogram (ECG) recordings with 12-lead ECGs for diagnosing electrocardiographic abnormalities. STUDY DESIGN: A 12-lead ECG and an ECG using Apple Watch were obtained in 110 children (aged 1 week to 16 years) with normal (n = 75) or abnormal (n = 35) 12-lead ECGs (atrioventricular block [7], supraventricular tachycardia [SVT] {5}, bundle branch block [12], ventricular preexcitation [6], long QT [5]). In children aged <6 years, the ECG recording was performed with the active participation of an adult who applied the neonate or child's finger to the crown of the watch. In older children, tracings were obtained after brief teaching without adult guidance. All 12-lead ECGs were independently evaluated by 2 blinded cardiologists. Apple Watch ECGs were independently evaluated by another blinded cardiologist. RESULTS: In 109 children (99.1%), the smartwatch tracing was of sufficient quality for evaluation. Smartwatch tracings were 84% sensitive and 100% specific for the detection of an abnormal ECG. All 75 normal tracings were correctly identified. Of the 35 children with abnormalities on 12-lead ECGs, 5 (14%) were missed, most often because of baseline wander and artifacts. Rhythm disorders (atrioventricular block or SVT) and bundle branch blocks were correctly detected in most cases (11 of 12 and 11 of 12, respectively); preexcitation and long QT was detected in 4 of 6 and 4 of 5, respectively. CONCLUSION: Smartwatch ECGs recorded with parental assistance in children aged up to 6 years and independently in older children have the potential to detect clinically relevant conditions.
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Bloqueio Atrioventricular , Taquicardia Supraventricular , Adulto , Recém-Nascido , Humanos , Criança , Estudos de Viabilidade , Arritmias Cardíacas/diagnóstico , Eletrocardiografia , Taquicardia Supraventricular/diagnósticoRESUMO
AIMS: Leadless pacing has emerged as an alternative to conventional transvenous pacemakers to mitigate the risks of pocket- and lead-related complications but its use remains controversial in young adults mostly because experience in this patient population is limited. We sought to examine the feasibility and safety of implanting leadless single chamber pacemakers in young adults. METHODS: This multicenter, retrospective, observational study sought to evaluate the safety, efficacy, and electrical performance of the Micra VR Transcatheter Pacemaker System (Medtronic) in patients between 18 and 40 years who underwent implantation of a leadless pacemaker for any indication at the university medical centers of Bordeaux, Clermont-Ferrand, Toulouse, and Tours (France), between 2015 and 2021. The primary safety endpoint was freedom from system-related or procedure-related major complications at 6 months. The primary efficacy endpoint was the combination of a low (≤2 V) and stable (increase within 1.5 V) pacing capture threshold at 6 months. RESULTS: Leadless pacemaker implantation was successful in all 35 patients. At 6 months, safety endpoint was met for 35 (100%) and efficacy endpoint for 34 (97%) patients. During a follow-up of 26 ± 15 months (range: 6-60 months), Safety endpoint remained 100% and efficacy endpoint was 94%. Leadless pacemaker retrieval was not required in any patient. Approximately one-third of patients (n = 13, 37%) had >40% ventricular pacing burdens at 1 year, including all 10 patients with a complete AV block but also 3 patients with normal AV conduction during implantation. One patient reported symptoms of pacemaker syndrome which was confirmed using Holter recording and successfully treated using reprogramming. CONCLUSION: In this observational study, leadless pacemakers demonstrated favorable short- and intermediate-term safety and effectiveness in young adults.
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Marca-Passo Artificial , Humanos , Adulto Jovem , Estudos Retrospectivos , Resultado do Tratamento , Desenho de Equipamento , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/terapiaRESUMO
AIMS: To allow timely initiation of anticoagulation therapy for the prevention of stroke, the European guidelines on atrial fibrillation (AF) recommend remote monitoring (RM) of device-detected atrial high-rate episodes (AHREs) and progression of arrhythmia duration along pre-specified strata (6 min <1â h, 1 h <24 h, ≥ 24â h). We used the MATRIX registry data to assess the capability of a single-lead implantable cardioverter-defibrillator (ICD) with atrial sensing dipole (DX ICD system) to follow this recommendation in patients with standard indication for single-chamber ICD. METHODS AND RESULTS: In 1841 DX ICD patients with daily automatic RM transmissions, electrograms of first device-detected AHREs per patient in each duration stratum were adjudicated, and the corresponding positive predictive values (PPVs) for the detections to be true atrial arrhythmia were calculated. Moreover, the incidence and progression of new-onset AF was assessed in 1451 patients with no AF history. A total of 610 AHREs ≥6â min were adjudicated. The PPV was 95.1% (271 of 285) for episodes 6min <1â h, 99.6% (253/254) for episodes 1 h <24â h, 100% (71/71) for episodes ≥24â h, or 97.5% for all episodes (595/610). The incidence of new-onset AF was 8.2% (119/1451), and in 31.1% of them (37/119), new-onset AF progressed to a higher duration stratum. Nearly 80% of new-onset AF patients had high CHA2DS2-VASc stroke risk, and 70% were not on anticoagulation therapy. Age was the only significant predictor of new-onset AF. CONCLUSION: A 99.7% detection accuracy for AHRE ≥1â h in patients with DX ICD systems in combination with daily RM allows a reliable guideline-recommended screening for subclinical AF and monitoring of AF-duration progression.
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Fibrilação Atrial , Desfibriladores Implantáveis , Acidente Vascular Cerebral , Humanos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/terapia , Fibrilação Atrial/epidemiologia , Desfibriladores Implantáveis/efeitos adversos , Átrios do Coração , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , AnticoagulantesRESUMO
AIMS: Mapping data of human ventricular fibrillation (VF) are limited. We performed detailed mapping of the activities underlying the onset of VF and targeted ablation in patients with structural cardiac abnormalities. METHODS AND RESULTS: We evaluated 54 patients (50 ± 16 years) with VF in the setting of ischaemic (n = 15), hypertrophic (n = 8) or dilated cardiomyopathy (n = 12), or Brugada syndrome (n = 19). Ventricular fibrillation was mapped using body-surface mapping to identify driver (reentrant and focal) areas and invasive Purkinje mapping. Purkinje drivers were defined as Purkinje activities faster than the local ventricular rate. Structural substrate was delineated by electrogram criteria and by imaging. Catheter ablation was performed in 41 patients with recurrent VF. Sixty-one episodes of spontaneous (n = 10) or induced (n = 51) VF were mapped. Ventricular fibrillation was organized for the initial 5.0 ± 3.4â s, exhibiting large wavefronts with similar cycle lengths (CLs) across both ventricles (197 ± 23 vs. 196 ± 22â ms, P = 0.9). Most drivers (81%) originated from areas associated with the structural substrate. The Purkinje system was implicated as a trigger or driver in 43% of patients with cardiomyopathy. The transition to disorganized VF was associated with the acceleration of initial reentrant activities (CL shortening from 187 ± 17 to 175 ± 20â ms, P < 0.001), then spatial dissemination of drivers. Purkinje and substrate ablation resulted in the reduction of VF recurrences from a pre-procedural median of seven episodes [interquartile range (IQR) 4-16] to 0 episode (IQR 0-2) (P < 0.001) at 56 ± 30 months. CONCLUSIONS: The onset of human VF is sustained by activities originating from Purkinje and structural substrate, before spreading throughout the ventricles to establish disorganized VF. Targeted ablation results in effective reduction of VF burden. KEY QUESTION: The initial phase of human ventricular fibrillation (VF) is critical as it involves the primary activities leading to sustained VF and arrhythmic sudden death. The origin of such activities is unknown. KEY FINDING: Body-surface mapping shows that most drivers (≈80%) during the initial VF phase originate from electrophysiologically defined structural substrates. Repetitive Purkinje activities can be elicited by programmed stimulation and are implicated as drivers in 37% of cardiomyopathy patients. TAKE-HOME MESSAGE: The onset of human VF is mostly associated with activities from the Purkinje network and structural substrate, before spreading throughout the ventricles to establish sustained VF. Targeted ablation reduces or eliminates VF recurrence.
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Síndrome de Brugada , Ablação por Cateter , Mapeamento Potencial de Superfície Corporal , Ablação por Cateter/métodos , Eletrocardiografia , Ventrículos do Coração , Humanos , Fibrilação VentricularRESUMO
Smartwatches that support the recording of a single-lead electrocardiogram (ECG) are increasingly being used beyond the wrist, by placement on the ankle and on the chest. However, the reliability of frontal and precordial ECGs other than lead I is unknown. This clinical validation study assessed the reliability of an Apple Watch (AW) to obtain conventional frontal and precordial leads as compared to standard 12-lead ECGs in both subjects without known cardiac anomalies and patients with underlying heart disease. In 200 subjects (67% with ECG anomalies), a standard 12-lead ECG was performed, followed by AW recordings of the standard Einthoven leads (leads I, II, and III) and precordial leads V1, V3, and V6. Seven parameters (P, QRS, ST, and T-wave amplitudes, PR, QRS, and QT intervals) were compared through a Bland-Altman analysis, including the bias, absolute offset, and 95% limits of agreement. AW-ECGs recorded on the wrist but also beyond the wrist had similar durations and amplitudes compared to standard 12-lead ECGs. Significantly greater amplitudes were measured by the AW for R-waves in precordial leads V1, V3, and V6 (+0.094 mV, +0.149 mV, +0.129 mV, respectively, all p < 0.001), indicating a positive bias for the AW. AW can be used to record frontal, and precordial ECG leads, paving the way for broader clinical applications.
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Eletrocardiografia , Cardiopatias , Humanos , Reprodutibilidade dos Testes , Arritmias Cardíacas , TóraxRESUMO
Smartwatches equipped with automatic atrial fibrillation (AF) detection through electrocardiogram (ECG) recording are increasingly prevalent. We have recently reported the limitations of the Apple Watch (AW) in correctly diagnosing AF. In this study, we aim to apply a data science approach to a large dataset of smartwatch ECGs in order to deliver an improved algorithm. We included 723 patients (579 patients for algorithm development and 144 patients for validation) who underwent ECG recording with an AW and a 12-lead ECG (21% had AF and 24% had no ECG abnormalities). Similar to the existing algorithm, we first screened for AF by detecting irregularities in ventricular intervals. However, as opposed to the existing algorithm, we included all ECGs (not applying quality or heart rate exclusion criteria) but we excluded ECGs in which we identified regular patterns within the irregular rhythms by screening for interval clusters. This "irregularly irregular" approach resulted in a significant improvement in accuracy compared to the existing AW algorithm (sensitivity of 90% versus 83%, specificity of 92% versus 79%, p < 0.01). Identifying regularity within irregular rhythms is an accurate yet inclusive method to detect AF using a smartwatch ECG.
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Fibrilação Atrial , Humanos , Fibrilação Atrial/diagnóstico , Eletrocardiografia/métodos , Frequência Cardíaca , AlgoritmosRESUMO
AIMS: Smartwatch electrocardiograms (ECGs) could facilitate the detection of sudden cardiac arrest (SCA)-associated abnormalities. We evaluated the feasibility of using smartwatch-derived ECGs for detecting SCA-associated abnormalities in young adults and its agreement with 12-lead ECGs. METHODS AND RESULTS: Twelve-lead and Apple Watch ECGs were registered in 155 healthy volunteers and 67 patients aged 18-45 years with diagnosis and ECG signs of long-QT syndrome (n = 10), Brugada syndrome (n = 12), ventricular pre-excitation (n = 19), hypertrophic cardiomyopathy (HCM, n = 13), and arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVC/D, n = 13). Cardiologists separately analysed 12-lead ECGs and the smartwatch ECGs taken from the left wrist (AW-I) and then from chest positions V1, V3, and V6 (AW-4). Compared with AW-I, AW-4 improved the classification of ECGs as 'abnormal', increasing the sensitivity from 64% to 89% (P < 0.01). Pre-excitation was detected in most cases using AW-I (sensitivity 89%) and in all cases using AW-4 (sensitivity 100%, P = 0.48 compared with AW-I, specificity 100% for both). Brugada was missed using AW-I but was detected in 11/12 patients using AW-4 (sensitivity 92%, specificity 100%, P = 0.003). Long QT was detected in 8/10 cases using AW-I (sensitivity 80%, specificity 100%) and in 9 patients using AW-4 (sensitivity 90%, specificity 100%, P > 0.99). Hypertrophic cardiomyopathy was correctly suspected using AW-I and AW-4 (sensitivity 92% and 85%, specificity 85%, and 100%, P > 0.99). AW-I was mostly (62%) considered normal in ARVC/D whereas AW-4 was useful in suspecting ARVC/D (100% sensitivity, 99% specificity, P = 0.004). CONCLUSIONS: Detection of SCA-associated ECG abnormalities (pre-excitation, Brugada patterns, long QT, and signs suggestive of HCM and ARVC/D) is possible with an ECG smartwatch.
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Displasia Arritmogênica Ventricular Direita , Síndrome de Brugada , Síndrome do QT Longo , Adolescente , Adulto , Morte Súbita Cardíaca/etiologia , Eletrocardiografia/métodos , Humanos , Pessoa de Meia-Idade , Adulto JovemRESUMO
The accuracy of smartwatch ECG recordings in adults has been demonstrated primarily in the automated diagnosis of atrial fibrillation. While the detection of atrial fibrillation is a priority among adults given the arrhythmia's prevalence and actionable ramifications, the potential value of smartwatch ECG recordings in children differs considerably. In this case series, we will describe some examples of smartwatch ECGs recorded in children, highlighting the feasibility and potential indications of this technology in the pediatric population.
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Fibrilação Atrial , Dispositivos Eletrônicos Vestíveis , Adulto , Fibrilação Atrial/diagnóstico , Criança , Eletrocardiografia , HumanosRESUMO
BACKGROUND: Temporary transvenous pacing in critically ill patients requiring prolonged cardiac pacing is associated with a high risk of complications. We sought to evaluate the safety and efficacy of self-contained intracardiac leadless pacemaker (LPM) implantation in this population. METHODS AND RESULTS: Consecutive patients implanted with a Micra LPM during the hospitalization in an intensive care unit were retrospectively included. Inclusion criteria were: more than or equal to 1 supracaval central venous line, or a ventilation tube, or intravenous antibiotic therapy for ongoing sepsis or bacteremia. Patients with a history of the previous implantation of a pacemaker were excluded. Out of 1016 patients implanted with an LPM, 99 met the inclusion criteria. Mean age was 75 years and Charlson comorbidity index 7. LPM implantation was successfully performed in 98% of cases, with a perioperative complication rate of 5%, mainly cardiac injuries. In-hospital mortality rate was 6%. No late (>30 days) device-related complication occurred, especially no infection. CONCLUSIONS: LPM appears as an acceptable alternative to conventional temporary transvenous pacing in selected critically ill patients requiring prolonged cardiac pacing, especially regarding the risk of infection.
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Estado Terminal , Marca-Passo Artificial , Idoso , Arritmias Cardíacas/terapia , Estimulação Cardíaca Artificial/efeitos adversos , Desenho de Equipamento , Humanos , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Morphology algorithms are currently recommended as a standalone discriminator in single-chamber implantable cardioverter defibrillators (ICDs). However, these proprietary algorithms differ in both design and nominal programming. OBJECTIVE: To compare three different algorithms with nominal versus advanced programming in their ability to discriminate between ventricular (VT) and supraventricular tachycardia (SVT). METHODS: In nine European centers, VT and SVTs were collected from Abbott, Boston Scientific, and Medtronic dual- and triple-chamber ICDs via their respective remote monitoring portals. Percentage morphology matches were recorded for selected episodes which were classified as VT or SVT by means of atrioventricular comparison. The sensitivity and related specificity of each manufacturer discriminator was determined at various values of template match percentage from receiving operating characteristics (ROC) curve analysis. RESULTS: A total of 534 episodes were retained for the analysis. In ROC analyses, Abbott Far Field MD (area under the curve [AUC]: 0.91; P < .001) and Boston Scientific RhythmID (AUC: 0.95; P < .001) show higher AUC than Medtronic Wavelet (AUC: 0.81; P < .001) when tested for their ability to discriminate VT from SVT. At nominal % match threshold all devices provided high sensitivity in VT identification, (91%, 100%, and 90%, respectively, for Abbott, Boston Scientific, and Medtronic) but contrasted specificities in SVT discrimination (85%, 41%, and 62%, respectively). Abbott and Medtronic's nominal thresholds were similar to the optimal thresholds. Optimization of the % match threshold improved the Boston Scientific specificity to 79% without compromising the sensitivity. CONCLUSION: Proprietary morphology discriminators show important differences in their ability to discriminate SVT. How much this impact the overall discrimination process remains to be investigated.
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Algoritmos , Desfibriladores Implantáveis , Cardioversão Elétrica/instrumentação , Técnicas Eletrofisiológicas Cardíacas/instrumentação , Processamento de Sinais Assistido por Computador , Taquicardia Supraventricular/diagnóstico , Taquicardia Ventricular/diagnóstico , Telemetria/instrumentação , Potenciais de Ação , Diagnóstico Diferencial , Desenho de Equipamento , Europa (Continente) , Frequência Cardíaca , Humanos , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Estudos Retrospectivos , Taquicardia Supraventricular/fisiopatologia , Taquicardia Supraventricular/terapia , Taquicardia Ventricular/fisiopatologia , Taquicardia Ventricular/terapiaRESUMO
INTRODUCTION: We investigated whether pacing-induced electrical dyssynchrony at the time of cardiac resynchronization therapy (CRT) device implantation was associated with chronic CRT response. METHODS AND RESULTS: We included a total of 69 consecutive heart failure patients who received a CRT device. Left (LVp-RVs) and right (RVp-LVs) pacing-induced interlead delays were measured intraoperatively and used to determine if there was paced left ventricular (LV) dyssynchrony, defined as present when LVp-RVs is larger than RVp-LVs. CRT response was defined as a reduction in LV end-systolic volume ≥15%, 6 months after implantation. Paced left ventricular dyssynchrony (PLVD) was associated with ischemic cardiomyopathy (ICM) (χ2 : 8; P = .005) but not with QRS morphology nor with pacing lead positions. In a univariate analysis, PLVD (odds ratio [OR], 6.53; 95% confidence interval [CI], 2.2-18.9; P = .001), atypical left bundle branch block (LBBB) (OR, 3.3; 95% CI, 1.2-9.4; P = .022), and ICM (OR, 5.2; 95% CI, 1.6-17; P = .006) were associated with nonresponse. In a multivariate analysis, both PLVD (OR, 9.74; 95% CI, 2.8-33.9; P < .0001) and atypical LBBB (OR, 5.6; 95% CI, 1.5-20.3; P = .009) were independently associated with nonresponse. Adding PLVD to a model based on QRS morphology provided a significant and meaningful incremental value to predict LV reverse remodeling after CRT (χ2 to enter: 8; P < .005). Computer simulations corroborate these findings by showing that, while intrinsic electrical dyssynchrony is a prerequisite, the level of pacing-induced dyssynchrony modulates acute CRT response. CONCLUSION: In addition to the intrinsic electrical substrate, PLVD is strongly associated with less LV reverse remodeling, demonstrating that measuring the electrical substrate during pacing has additional value for prediction of CRT response in an already well-selected patient population.
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Terapia de Ressincronização Cardíaca , Insuficiência Cardíaca/terapia , Disfunção Ventricular Esquerda/terapia , Função Ventricular Esquerda , Remodelação Ventricular , Adulto , Idoso , Idoso de 80 Anos ou mais , Simulação por Computador , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Hemodinâmica , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Cardiovasculares , Estudos Prospectivos , Recuperação de Função Fisiológica , Fatores de Tempo , Resultado do Tratamento , Disfunção Ventricular Esquerda/diagnóstico , Disfunção Ventricular Esquerda/fisiopatologiaRESUMO
BACKGROUND: Loss of biventricular stimulation can result in nonresponse to cardiac resynchronization therapy (CRT). Problems associated with the left ventricular (LV) lead and LV sensing can be challenging to detect and their incidence is unclear. The purpose of this study was to investigate mechanisms of loss of biventricular pacing due to LV lead- and LV sensing-associated problems. METHODS: In this bicentric study, CRT patients were surveilled using a novel remote monitoring algorithm from Biotronik (Germany) that registers LV electrograms (EGMs) during intermittent loss of resynchronization. The episodes were analyzed to assess the mechanisms of resynchronization interruptions. RESULTS: We analyzed 582 EGMs from 61 patients. During a median follow-up of 6 months, 59% of the patients had such episodes. The majority of the episodes (61%) were related to inappropriate inhibition of LV pacing, mostly due to upper rate lock-in caused by LV sensing (58%). In contrast, 8% of episodes showed intermittent loss of LV capture, which was identified thanks to LV sensing. The remaining 31% of episodes were due to physiological reasons for resynchronization interruptions (eg, supraventricular tachycardia [18%], premature beats [8%], and others [5%]). Patients with CRT interruption episodes had lower resynchronization rates (median: 98.5% vs 100%, P = .044). CONCLUSIONS: Inadequate programming (active LV sensing with T-wave protection) is the main cause of impaired resynchronization in devices with LV sensing. In general, we recommend the deactivation of the LV T-wave protection function.
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Dispositivos de Terapia de Ressincronização Cardíaca , Terapia de Ressincronização Cardíaca/métodos , Disfunção Ventricular Esquerda/terapia , Idoso , Algoritmos , Eletrocardiografia , Falha de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Monitorização Ambulatorial , Disfunção Ventricular Esquerda/fisiopatologiaRESUMO
BACKGROUND: Haloperidol at high dosage is associated with QTc prolongation and polymorphic ventricular arrhythmia but the effects of low-dose haloperidol remain unknown. OBJECTIVE: To evaluate the effects of low-dose haloperidol on QTc-duration in frail hospitalized elderly patients with delirium. METHODS: A prospective observational study including hospitalized patients aged ≥70 years with Groningen Frailty Index-score > 3. We included 150 patients who received haloperidol and 150 age- and frailty-matched control patients. Serial ECG recordings were performed at hospital admission and during hospitalization. QT-interval was corrected according to Framingham (QTc). Patients were grouped according to baseline QTc in normal (nQTc), borderline (bQTc) or abnormal (aQTc). Primary outcome was change in QTc-duration between first and second ECG. Potentially dangerous QTc was defined as QTc >500 ms or an increase of >50 ms. RESULTS: Patients in the haloperidol group (48% male, mean age 85y, nQT n = 98, bQT n = 31, aQT n = 20) received an average dose of 1.5 mg haloperidol per 24 hours. QTc decreased in patients with borderline (mean - 15 ± 29 ms, P < 0.05) or abnormal (-19 ± 27 ms, P < 0.05) QTc at baseline, no patients developed dangerous QTc-duration. In the control group (41% male, mean age 84y, nQT n = 99 bQT n = 29, aQT n = 22) QTc decreased to a similar extent (bQT -7 ± 16 ms, aQTc -23 ± 20 ms). CONCLUSION: A trend to QTc shortening was seen, especially in patients with borderline or abnormal QTc at baseline, regardless of haloperidol use. These findings suggest that ECG monitoring of frail elderly patients who receive low-dose haloperidol, may not be necessary.
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Antipsicóticos , Síndrome do QT Longo , Idoso , Idoso de 80 Anos ou mais , Antipsicóticos/efeitos adversos , Eletrocardiografia , Feminino , Idoso Fragilizado , Haloperidol/efeitos adversos , Humanos , Síndrome do QT Longo/induzido quimicamente , Síndrome do QT Longo/diagnóstico , Masculino , Estudos ProspectivosRESUMO
INTRODUCTION: Some cardiac resynchronization therapy (CRT) device manufacturers (Biotronik, Germany; Boston Scientific, United States) have implemented left ventricular (LV) sensing functionality to prevent pacing into the vulnerable phase. Physicians are only partially aware of programming pitfalls related to LV sensing and general programming advice is lacking. METHODS AND RESULTS: We provide an illustrative case-series-based review of the variety of potential problems with LV sensing. LV sensing may inappropriately impair CRT delivery due to LV-sensing issues or improper device programming. This can cause beat-wise loss of resynchronization but also ongoing desynchronization. On the other hand, LV sensing provides additional diagnostic information, which may reveal intermittent problems of the LV lead such as capture loss. We summarize the available evidence to provide manufacturer-specific recommendations on device programming and troubleshooting for daily clinical practice. CONCLUSION: CRT devices with LV sensing may suffer from impaired resynchronization due to programming pitfalls. If LV sensing is active (nominal setting in Biotronik and Boston Scientific devices), careful lookout for related problems and resynchronization percentage is required. Optimization is mandatory and even deactivation of LV sensing may have to be considered.
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Dispositivos de Terapia de Ressincronização Cardíaca , Terapia de Ressincronização Cardíaca , Insuficiência Cardíaca/terapia , Tecnologia de Sensoriamento Remoto/instrumentação , Processamento de Sinais Assistido por Computador , Volume Sistólico , Função Ventricular Esquerda , Terapia de Ressincronização Cardíaca/efeitos adversos , Desenho de Equipamento , Falha de Equipamento , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Humanos , Valor Preditivo dos Testes , Tecnologia de Sensoriamento Remoto/efeitos adversos , Fatores de Risco , Resultado do TratamentoRESUMO
Algorithms designed to reduce the burden of right ventricular pacing are widely available in modern implantable pacing devices. To ensure safe and optimal utilization, understanding the properties of these algorithms as well as their possible unfavourable effects is essential. In this review, we discuss in detail the technical and clinical aspects of rhythm management algorithms and update on their significant recent modifications. In addition, we highlight possible adverse phenomena that may be induced by these different pacing algorithms intended to minimize pacing.
Assuntos
Algoritmos , Arritmias Cardíacas/terapia , Estimulação Cardíaca Artificial/métodos , Ventrículos do Coração , Bloqueio Atrioventricular/terapia , Cardiomiopatias/prevenção & controle , Humanos , Disfunção Ventricular Esquerda/prevenção & controleRESUMO
SecureSense is an implantable cardioverter defibrillator algorithm that differentiates lead-related oversensing from ventricular tachycardia/ventricular fibrillation by continuous comparison between the near-field (NF) and the far-field (FF) electrogram. If lead noise is identified, inappropriate therapy is withheld. Undersensing on the FF channel could result in inappropriate inhibition of life-saving therapy. Thus, the device automatically switches SecureSense to passive mode if undersensing on the FF channel is suspected. We report here the first cases of inappropriate automatic SecureSense deactivation due to misdiagnosed FF undersensing in pacemaker-dependent patients. Physicians should be aware that SecureSense does not withhold an inappropriate therapy for sustained oversensing in pacemaker-dependent patients.