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BACKGROUND: Left bundle branch area pacing (LBBAP) may be associated with greater improvement in left ventricular ejection fraction and reduction in death or heart failure hospitalization compared with biventricular pacing (BVP) in patients requiring cardiac resynchronization therapy. We sought to compare the occurrence of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) and new-onset atrial fibrillation (AF) in patients undergoing BVP and LBBAP. METHODS: The I-CLAS study (International Collaborative LBBAP Study) included patients with left ventricular ejection fraction ≤35% who underwent BVP or LBBAP for cardiac resynchronization therapy between January 2018 and June 2022 at 15 centers. We performed propensity score-matched analysis of LBBAP and BVP in a 1:1 ratio. We assessed the incidence of VT/VF and new-onset AF among patients with no history of AF. Time to sustained VT/VF and time to new-onset AF was analyzed using the Cox proportional hazards survival model. RESULTS: Among 1778 patients undergoing cardiac resynchronization therapy (BVP, 981; LBBAP, 797), there were 1414 propensity score-matched patients (propensity score-matched BVP, 707; propensity score-matched LBBAP, 707). The occurrence of VT/VF was significantly lower with LBBAP compared with BVP (4.2% versus 9.3%; hazard ratio, 0.46 [95% CI, 0.29-0.74]; P<0.001). The incidence of VT storm (>3 episodes in 24 hours) was also significantly lower with LBBAP compared with BVP (0.8% versus 2.5%; P=0.013). Among 299 patients with cardiac resynchronization therapy pacemakers (BVP, 111; LBBAP, 188), VT/VF occurred in 8 patients in the BVP group versus none in the LBBAP group (7.2% versus 0%; P<0.001). In 1194 patients with no history of VT/VF or antiarrhythmic therapy (BVP, 591; LBBAP, 603), the occurrence of VT/VF was significantly lower with LBBAP than with BVP (3.2% versus 7.3%; hazard ratio, 0.46 [95% CI, 0.26-0.81]; P=0.007). Among patients with no history of AF (n=890), the occurrence of new-onset AF >30 s was significantly lower with LBBAP than with BVP (2.8% versus 6.6%; hazard ratio, 0.34 [95% CI, 0.16-0.73]; P=0.008). The incidence of AF lasting >24 hours was also significantly lower with LBBAP than with BVP (0.7% versus 2.9%; P=0.015). CONCLUSIONS: LBBAP was associated with a lower incidence of sustained VT/VF and new-onset AF compared with BVP. This difference remained significant after adjustment for differences in baseline characteristics between patients with BVP and LBBAP. Physiological resynchronization by LBBAP may be associated with lower risk of arrhythmias compared with BVP.
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Terapia de Ressincronização Cardíaca , Insuficiência Cardíaca , Taquicardia Ventricular , Humanos , Terapia de Ressincronização Cardíaca/efeitos adversos , Volume Sistólico , Função Ventricular Esquerda , Resultado do Tratamento , Taquicardia Ventricular/epidemiologia , Taquicardia Ventricular/etiologia , Taquicardia Ventricular/terapia , Fibrilação Ventricular/epidemiologia , Fibrilação Ventricular/etiologia , Fibrilação Ventricular/terapia , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/terapia , EletrocardiografiaRESUMO
INTRODUCTION: Left bundle branch area (LBBA) pacing (LBBAP) has been proposed as an alternative therapy option in patients indicated for cardiac pacing to treat bradycardia or heart failure. The aim of the study was to evaluate the safety and effectiveness of LBBAP in patients implanted with a Tendril 2088 stylet-driven lead. METHODS: The international retrospective data collection registry included 11 sites from 5 countries globally. Patients with attempted implants of the Tendril lead in the LBBA were followed for at least 6 months post the implant attempt. The primary safety and efficacy endpoints were freedom from LBBAP lead-related serious adverse events and the composite of LBBA capture threshold of ≤2.0 V and R-wave amplitudes ≥5 mV (or ≥value at implant), respectively. RESULTS: Of 221 patients with attempted implants of the Tendril 2088 lead in the LBBA, 91.4% (202/221) had successful implants for LBBAP. Regardless of the LBBAP implant success, all patients were followed for at least 6 months (8.7 ± 7.3 months). Baseline characteristics: 44% female, 84% ≥65 years old, 34% coronary artery disease, and 86% of primary indications for pacemaker implant. Both primary safety and effectiveness endpoints were met (freedom from LBBAP lead-related serious adverse device effects of 99.5% and electrical performance composite success rate of 93%). The capture thresholds in LBBAP at implant and 6 months were 0.8 ± 0.3 V@0.4 ± 0.1 ms and 0.8 ± 0.3 V@0.4 ± 0.1 ms. The rate of patients with capture threshold rise ≥1 V was 1.5% through 6 months. The R-wave amplitudes in LBBAP at implant and 6 months were 9.3 ± 3.2 mV and 10.6 ± 3.0 mV. CONCLUSIONS: This large multicenter study demonstrates that the stylet-driven Tendril™ STS 2088 lead is safe and effective for LBBAP with high success and low complication rates.
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Potenciais de Ação , Estimulação Cardíaca Artificial , Frequência Cardíaca , Marca-Passo Artificial , Sistema de Registros , Humanos , Feminino , Masculino , Idoso , Estudos Retrospectivos , Fatores de Tempo , Pessoa de Meia-Idade , Resultado do Tratamento , Idoso de 80 Anos ou mais , Bradicardia/fisiopatologia , Bradicardia/terapia , Bradicardia/diagnóstico , Fascículo Atrioventricular/fisiopatologia , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Fatores de Risco , Desenho de EquipamentoRESUMO
Conduction system pacing (CSP) has emerged as a more physiological alternative to right ventricular pacing and is also being used in selected cases for cardiac resynchronization therapy. His bundle pacing was first introduced over two decades ago and its use has risen over the last five years with the advent of tools which have facilitated implantation. Left bundle branch area pacing is more recent but its adoption is growing fast due to a wider target area and excellent electrical parameters. Nevertheless, as with any intervention, proper technique is a prerequisite for safe and effective delivery of therapy. This document aims to standardize the procedure and to provide a framework for physicians who wish to start CSP implantation, or who wish to improve their technique.
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Terapia de Ressincronização Cardíaca , Sistema de Condução Cardíaco , Humanos , América Latina , Canadá , Doença do Sistema de Condução Cardíaco , Fascículo AtrioventricularRESUMO
Conduction system pacing (CSP) has emerged as a more physiological alternative to right ventricular pacing and is also being used in selected cases for cardiac resynchronization therapy. His bundle pacing was first introduced over two decades ago and its use has risen over the last years with the advent of tools which have facilitated implantation. Left bundle branch area pacing is more recent but its adoption is growing fast due to a wider target area and excellent electrical parameters. Nevertheless, as with any intervention, proper technique is a prerequisite for safe and effective delivery of therapy. This document aims to standardize the procedure and to provide a framework for physicians who wish to start CSP implantation, or who wish to improve their technique. A synopsis is provided in this print edition of EP-Europace. The full document may be consulted online, and a 'Key Messages' App can be downloaded from the EHRA website.
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Sistema de Condução Cardíaco , Humanos , Canadá , Doença do Sistema de Condução Cardíaco , ÁsiaRESUMO
The conduction system of the human heart is composed of specialized cardiomyocytes that initiate and propagate the electric impulse with consequent rhythmic and synchronized contraction of the atria and ventricles, resulting in the normal cardiac cycle. Although the His-Purkinje system (HPS) was already described more than a century ago, there has been a recent resurgence of conduction system pacing (CSP), where pacing leads are positioned in the His bundle region and left bundle branch area to provide physiological cardiac activation as alternatives to the unnatural myocardial stimulation obtained with conventional right ventricular and biventricular pacing. In this review, we describe the fundamental anatomical and pathophysiological aspects of the specialized HPS along with the CSP technique's nuts and bolts to highlight its potential benefits in everyday clinical practice.
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AIMS: Permanent transseptal left bundle branch area pacing (LBBAP) is a promising new pacing method for both bradyarrhythmia and heart failure indications. However, data regarding safety, feasibility and capture type are limited to relatively small, usually single centre studies. In this large multicentre international collaboration, outcomes of LBBAP were evaluated. METHODS AND RESULTS: This is a registry-based observational study that included patients in whom LBBAP device implantation was attempted at 14 European centres, for any indication. The study comprised 2533 patients (mean age 73.9 years, female 57.6%, heart failure 27.5%). LBBAP lead implantation success rate for bradyarrhythmia and heart failure indications was 92.4% and 82.2%, respectively. The learning curve was steepest for the initial 110 cases and plateaued after 250 cases. Independent predictors of LBBAP lead implantation failure were heart failure, broad baseline QRS and left ventricular end-diastolic diameter. The predominant LBBAP capture type was left bundle fascicular capture (69.5%), followed by left ventricular septal capture (21.5%) and proximal left bundle branch capture (9%). Capture threshold (0.77â V) and sensing (10.6â mV) were stable during mean follow-up of 6.4 months. The complication rate was 11.7%. Complications specific to the ventricular transseptal route of the pacing lead occurred in 209 patients (8.3%). CONCLUSIONS: LBBAP is feasible as a primary pacing technique for both bradyarrhythmia and heart failure indications. Success rate in heart failure patients and safety need to be improved. For wider use of LBBAP, randomized trials are necessary to assess clinical outcomes.
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Fascículo Atrioventricular , Insuficiência Cardíaca , Humanos , Feminino , Idoso , Estimulação Cardíaca Artificial/efeitos adversos , Estimulação Cardíaca Artificial/métodos , Bloqueio de Ramo/terapia , Bloqueio de Ramo/etiologia , Bradicardia/terapia , Bradicardia/etiologia , Eletrocardiografia/métodos , Resultado do TratamentoRESUMO
INTRODUCTION: Restoring physiological cardiac electrical activity in patients with conduction disease can be crucial for the survival and quality of life. Conduction system pacing (CSP) is a valuable option, although it is limited by technical challenges in difficult anatomies. 3D electroanatomical mapping (3D-EAM) can support CSP ensuring high electro-anatomical precision and low fluoroscopy. OBJECTIVES: We evaluated the feasibility and effectiveness of a systematic 3D-EAM use to guide CSP in difficult anatomical scenarios (highly dilated atria, congenital cardiomyopathies, failed biventricular implants (BiV) and pacing-induced cardiomyopathy (PICM)). METHODS: Forty-three consecutive patients (27 males, 75 ± 10 years old) with standard pacing indications and difficult anatomical scenarios were included. The right atrium, His cloud, and atrio-ventricular septum were reconstructed by 3D-EAM. The His bundle (HB) was the initial target, while left bundle branch area pacing (LBBAP) was aimed at in case of unsatisfactory parameters, sub-optimally paced QRS, or impossibility of reaching the HB. RESULTS: CSP was successful in 37 (86%) patients (15 HBP; 22 LBBAP). Mean mapping, fluoroscopy, and procedural times were 18 ± 7 min, 7 ± 5 min, 98 ± 47 min, respectively. The mean pacing threshold, R wave sensing, and pacing impedance of CSP lead were 1.2 ± 0.5V@0.5ms, 11.4 ± 6.2 mV, 736 ± 306 Ω, respectively. Baseline and paced QRS were 139 ± 38 ms and 114 ± 23 ms, respectively. No procedural complications were observed. CONCLUSIONS: 3D-EAM allowed the accurate definition of the His cloud and high ventricular septum and effectively guided CSP. It facilitated CSP in complex anatomies, with a procedural success rate of 86%. The results were satisfactory and reproducible, with acceptable fluoroscopy and procedural times.
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INTRODUCTION: In patients with sinus node disease (SND), the dual-chamber pacemaker (PM) is programmed in DDDR mode with an algorithm to avoid unnecessary right ventricular (RV) pacing. This pacing mode may prolong PR interval with consequently atrioventricular (AV) asynchrony which is associated with a higher risk of atrial fibrillation (AF). We evaluate whether preserving AV synchrony by setting a fixed AV delay during physiological RV pacing, that is, His bundle pacing (HBP), could reduce the risk of AF occurrence in comparison with a standard pacing mode with an algorithm to avoid unnecessary RV pacing (DDD-VPA). METHODS AND RESULTS: We collected retrospective data from 313 consecutive patients who had undergone PM for SND. The first occurrence of persistent AF (>7 consecutive days) as a function of the pacing mode was evaluated. HBP and DDD-VPA were implemented in 82 and 231 patients, respectively. Persistent AF occurred in 128 (40.9%) patients over a median follow-up of 70 months (67-105). The DDD-VPA pacing mode was significantly correlated with the occurrence of persistent AF only when the basal PR was long (>180 ms). The risk of persistent AF was significantly lower in patients on HBP than in those on DDD-VPA, adjusted HR = .57 (95% CI, .36- .89, p=.014). Other independent predictors of persistent AF occurrence were: A history of AF (HR = 3.91; 95% CI, 2.48-6.19, p = .001), age, and long PR interval (HR = 2.98; 95% CI, 2.00-4.43, p=.001). CONCLUSION: In SND patients and long basal PR interval, the HBP may reduce the risk of persistent AF in comparison with the DDD-VPA.
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Fibrilação Atrial , Marca-Passo Artificial , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/terapia , Fascículo Atrioventricular , Estimulação Cardíaca Artificial , Humanos , Estudos Retrospectivos , Síndrome do Nó Sinusal/diagnóstico , Síndrome do Nó Sinusal/terapiaRESUMO
With the global increase in device implantations, there is a growing need to train physicians to implant pacemakers and implantable cardioverter-defibrillators. Although there are international recommendations for device indications and programming, there is no consensus to date regarding implantation technique. This document is founded on a systematic literature search and review, and on consensus from an international task force. It aims to fill the gap by setting standards for device implantation.
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Desfibriladores Implantáveis , Marca-Passo Artificial , Ásia , Consenso , Humanos , Estados UnidosRESUMO
Permanent His bundle pacing (HBP) has rapidly been adapted into clinical practice in recent years as a physiologic pacing. The 3830 (Medtronic Inc, MN, USA) pacing lead commonly used for HBP is lumenless, and there are limited reports available on extraction of this lead. No data exists on transvenous lead extraction (TLE) of very old HBP lead. Concerns remain about injury to the conduction system during extraction and the lack of lumen for placing a locking stylet for TLE when powered sheaths are required. We reported a unique case of TLE of very old HBP lead (14 years and 3 months) and other two leads, such as passive atrial and passive right ventricular apex backup.
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Fascículo Atrioventricular/fisiopatologia , Bloqueio de Ramo/terapia , Remoção de Dispositivo , Marca-Passo Artificial , Idoso de 80 Anos ou mais , Bloqueio de Ramo/fisiopatologia , Fluoroscopia , Humanos , MasculinoRESUMO
INTRODUCTION: His bundle pacing (HBP) is the most physiological pacing. The standard technique based on fluoroscopic approach might be challenging and fluoro consuming. Targeting the His guided exclusively by the electrical signals could enable a precise lead implant, thus reducing fluoroscopy time (FT) and X-ray dose, desirable both for patients and operators. The aim of the study is to evaluate the feasibility, efficacy, and safety both acutely and at 30 days of the electrogram (EGM)-guided HBP with minimal or no fluoroscopy. METHODS AND RESULTS: Between October and December 2018, 41 consecutive patients underwent EGM-guided HBP. Successful HBP was obtained in 39 (95%) patients, (30 males, 78 ± 10 years). Selective HBP (S-HBP) was achieved in 23 (59%), nonselective HBP (NS-HBP) in 16 (41%) patients. The final HBP lead position was reached in 31 (79.4%) patients without fluoroscopy, only guided by electrical signals. In eight patients a minimal fluoroscopy (mean, 8 seconds) has been required. The sheath's cutting and the slack of the lead were routinely performed under fluoroscopy. No difference was observed in FT for HBP lead placement in S-HBP and NS-HBP (mean, 8.1 ± 25 vs 7.5 ± 20 seconds, P = .8; median value 0 vs 0 seconds). No differences were observed in FT for the entire procedure, total dose area product and total procedural time in S-HBP and NS-HBP. Lead dislodgement occurred in one (2.6%) patient 1 day after the procedure. CONCLUSIONS: HBP could be performed safely and efficiently using the EGMs, with minimal or no fluoroscopy. Fluoroscopy was required during sheath removal and atrial lead placement.
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Potenciais de Ação , Arritmias Cardíacas/terapia , Fascículo Atrioventricular/fisiopatologia , Estimulação Cardíaca Artificial , Técnicas Eletrofisiológicas Cardíacas , Frequência Cardíaca , Marca-Passo Artificial , Radiografia Intervencionista , Idoso , Idoso de 80 Anos ou mais , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/fisiopatologia , Fascículo Atrioventricular/diagnóstico por imagem , Estimulação Cardíaca Artificial/efeitos adversos , Feminino , Fluoroscopia , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Prospectivos , Doses de Radiação , Exposição à Radiação/prevenção & controle , Radiografia Intervencionista/efeitos adversos , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
INTRODUCTION: Early evidence suggests that multipoint left ventricular pacing (MPP) may improve response to cardiac resynchronization therapy (CRT). It is unknown whether this benefit is sustained and cost-effective. We used real-world data to evaluate long-term impact of MPP-ON clinical status, heart failure hospitalizations (HFH) and costs. METHODS: The Italian registry on multipoint left ventricular pacing is a prospective, multicenter registry of patients implanted with MPP-enabled CRT devices. For this analysis, clinical and echocardiographic data were collected through 24 months and compared between patients with (MPP-ON) or without (MPP-OFF) early MPP activation at implant. The total cost of each HFH was estimated with national Italian reimbursement rates. RESULTS: The study included 190 MPP-OFF and 128 MPP-ON patients with similar baseline characteristics. At 1 and 2 years, the MPP-ON group had lower rates of HFH vs MPP-OFF (1-year hazard ratio [HR]: 0.14, P = .0014; 2-year HR: 0.38, P = .009). The finding persisted in a subgroup of patients with consistent MPP activation through follow-up (1-year HR: 0.19; P = .0061; 2-year HR: 0.39, P = .022). Total HFH per-patient costs were lower in the MPP-ON vs the MPP-OFF group at 1 year (101 ± 50 vs 698 ± 195, P < .001) and 2 years (366 ± 149 vs 801 ± 203, P = .038). More MPP-ON patients had ≥5% improvement in ejection fraction (76.8% vs 65.4%, P = .025) and clinical composite score (66.7% vs 47.5%, P = .01). CONCLUSIONS: In this multicenter clinical study, early MPP activation was associated with a significant reduction in cumulative HFH and related costs after 1 and 2 years of follow-up.
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Terapia de Ressincronização Cardíaca/economia , Custos de Cuidados de Saúde , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/terapia , Idoso , Idoso de 80 Anos ou mais , Terapia de Ressincronização Cardíaca/efeitos adversos , Redução de Custos , Análise Custo-Benefício , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Custos Hospitalares , Hospitalização/economia , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recuperação de Função Fisiológica , Sistema de Registros , Volume Sistólico , Fatores de Tempo , Resultado do Tratamento , Função Ventricular EsquerdaRESUMO
INTRODUCTION: Several single-center short-term studies have demonstrated the feasibility, safety, and positive clinical outcomes of permanent His bundle pacing (HBP). We performed a retrospective study to evaluate long-term technical and safety performances of HBP in a large population of pacemaker patients from two different centers. METHODS AND RESULTS: The analysis includes 844 patients (345 female, mean age = 75 ± 9 years) who underwent successful permanent HBP for pacemaker indications from 2004 to 2016. The main endpoints were long term electrical performances including pacing threshold, sensing, impedance, and freedom from pacing related complications. The pacing indication was AV Block in 348 (41.2%) patients, sinus node disease in 147 (17.4%), any bradycardia indication in patients with atrial fibrillation in 335 (39.7%) patients and need for cardiac resynchronization therapy in 14 (1.7%) patients. Mean pacing capture thresholds and sensed R waves were 1.6 V and 5.8 mV, respectively at implant and 2.0 V and 6.1 mV at chronic follow-up. During the median follow up of 3 years (interquartile range = 1-6 years), HBP was free of any complication in 91.6% of patients. In the first 368 patients, HBP was achieved using a deflectable curve delivery system, while in 476 using the fixed curve sheath. A significant difference was found in the thresholds (2.4 ± 1.0 V and 1.7 ± 1.1 V, P < .001, respectively) and complications (11.9% and 4.2%, P < .001, respectively) between the two groups. CONCLUSIONS: Permanent HBP was safe and effective during long-term follow-up. The fixed curved delivery sheath offered significantly better electrical parameters and reliability over time. The results of this multicenter study are consistent with recent studies.
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Bloqueio Atrioventricular/terapia , Bradicardia/terapia , Fascículo Atrioventricular/fisiopatologia , Estimulação Cardíaca Artificial , Marca-Passo Artificial , Síndrome do Nó Sinusal/terapia , Potenciais de Ação , Idoso , Idoso de 80 Anos ou mais , Bloqueio Atrioventricular/diagnóstico , Bloqueio Atrioventricular/fisiopatologia , Bradicardia/diagnóstico , Bradicardia/fisiopatologia , Estimulação Cardíaca Artificial/efeitos adversos , Falha de Equipamento , Feminino , Frequência Cardíaca , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Pennsylvania , Estudos Retrospectivos , Síndrome do Nó Sinusal/diagnóstico , Síndrome do Nó Sinusal/fisiopatologia , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Multipoint pacing (MPP) may improve clinical outcomes in patients with cardiac resynchronization therapy defibrillators (CRT-D), but its impact on battery longevity in a real-world population has not been investigated in large trials. OBJECTIVE: Compare projected battery longevity in CRT-D patients with and without MPP during long-term follow-up. METHODS: The Italian registry on multipoint left ventricular pacing (IRON-MPP) is a prospective, multicenter registry of patients implanted with MPP-capable CRT-D devices. Projected battery longevity during follow-up was compared for patients with MPP (MPP ON) vs single-site (MPP OFF) left ventricular pacing at CRT-D implantation. A sub-analysis excluded crossover patients with MPP activation or deactivation occurring after implantation. A second sub-analysis excluded patients with a right or left ventricular pacing amplitude >2.5 V. RESULTS: Out of 237 CRT-D patients (71 ± 9 years, 81% male) followed for 1.9 ± 0.8 years, 102 (43%) had MPP ON at implantation. Programmed atrial and ventricular outputs and percentage of pacing were similar between groups. MPP was associated with a 0.44 years reduction in projected battery longevity (P = .03) during long-term follow-up. Results were similar for the first and second sub-analyses, with a 0.57 years (P < .001) and 0.71 years (P < .001) reduction in projected longevity, respectively. CONCLUSION: In this long-term real-world registry, early MPP activation is associated with less than a 1-year reduction in projected battery life compared to single-site biventricular pacing.
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Dispositivos de Terapia de Ressincronização Cardíaca , Terapia de Ressincronização Cardíaca , Cardioversão Elétrica/instrumentação , Fontes de Energia Elétrica , Falha de Equipamento , Insuficiência Cardíaca/terapia , Idoso , Idoso de 80 Anos ou mais , Desfibriladores Implantáveis , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de Registros , Fatores de Tempo , Resultado do Tratamento , Função Ventricular EsquerdaRESUMO
INTRODUCTION: The recently developed second-generation subcutaneous implantable cardioverter defibrillator (S-ICD) and the intermuscular two-incision implantation technique demonstrate potential favorable features that reduce inappropriate shocks and complications. However, data concerning large patient populations are lacking. The aim of this multicentre prospective study was to evaluate the safety and outcome of second-generation S-ICD using the intermuscular two-incision technique in a large population study. METHODS AND RESULTS: The study population included 101 consecutive patients (75% male; mean age, 45 ± 13 years) who received second-generation S-ICD (EMBLEM; Boston Scientific, Marlborough, MA) implantation using the intermuscular two-incision technique as an alternative to the standard implantation technique. Twenty nine (29%) patients were implanted for secondary prevention. Twenty four (24%) patients had a previously implanted transvenous ICD. All patients were implanted without any procedure-related complications. Defibrillation testing was performed in 80 (79%) patients, and ventricular tachycardia was successfully converted at less than or equal to 65 J in 98.75% (79/80) of patients without pulse generator adjustments. During a median follow-up of 21 ± 10 months, no complications requiring surgical revision or local or systemic device-related infections were observed. Ten patients (9.9%) received appropriate and successful shocks for ventricular arrhythmias. Three (2.9%) patients experienced inappropriate shocks due to oversensing the cardiac signal (n = 1), noncardiac signal (n = 1), and a combination of both cardiac and noncardiac signals (n = 1), with one patient requiring device explantation. No patients required device explantation due to antitachycardia pacing indications. CONCLUSIONS: According to our multicentre study, second-generation S-ICD implanted with the intermuscular two-incision technique is an available safe combination and appears to be associated with a low risk of complications, such as inappropriate shocks.
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Arritmias Cardíacas/terapia , Desfibriladores Implantáveis , Cardioversão Elétrica/instrumentação , Sistema de Condução Cardíaco/fisiopatologia , Frequência Cardíaca , Implantação de Prótese/instrumentação , Prevenção Secundária/instrumentação , Potenciais de Ação , Adolescente , Adulto , Idoso , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/fisiopatologia , Remoção de Dispositivo , Cardioversão Elétrica/efeitos adversos , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Falha de Prótese , Implantação de Prótese/efeitos adversos , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
AIMS: The benefit of prolonged implantable cardioverter-defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) therapy following device replacement is hindered by clinical and procedure-related adverse events (AEs). Adverse events rate is highest in more complex devices and at upgrades, as per the REPLACE registry experience, but is changing owing to the improvement in device technology and medical care. We aimed at understanding the extent and type of AEs in a contemporary Italian population. METHODS AND RESULTS: Detect long-term complications after ICD replacement (DECODE) was a prospective, single-arm, multicentre cohort study aimed at estimating medium- to long-term AEs in a large population of patients undergoing ICD/cardiac resynchronization defibrillator replacement/upgrade from 2013 to 2015. We prospectively analysed all clinical and device-related AEs at 12-month follow-up (FU) of 983 consecutive patients (median age 71 years, 76% male, 55% ischaemic, 47% CRT-D) followed for 353 ± 49 days. Seven percent of the patients died (60.6% for cardiovascular reasons), whereas 104 AEs occurred; 43 (4.4%) patients needed at least one surgical action to treat the AE. Adverse events rates were 3.3/100 years lead-related, 3.4/100 years bleedings, and 1.6/100 years infective. The primary endpoint was predicted by hospitalization in the month prior to the procedure [hazard ratio (HR) = 2.23, 1.16-4.29; 0.0169] and by upgrade (HR = 1.75, 1.02-2.99, 0.0441). One hundred and twelve (11.4%) patients met the combined endpoint of death from any cause, cardiac implantable electronic device (CIED)-related infection, and surgical action/hospitalization required to treat the AE. Hospitalization within 30 days prior to the procedure (HR = 2.07, 1.13-3.81; 0.0199), anticoagulation (HR = 1.97, 1.26-3.07; 0.003), and ischaemic cardiomyopathy (HR = 1.67, 95% confidence interval 1.06-2.63; P = 0.0276) were associated with the combined endpoint during FU. CONCLUSIONS: Adverse events following CIED replacement/upgrade are lower than previously reported, possibly owing to improved patients care. Hospitalization in the month prior to the procedure, upgrade, and clinical profile (anticoagulation, ischaemic cardiomyopathy) hint to increased risk, suggesting an individualized planning of the procedure to minimize overall AEs. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/ Identifier: NCT02076789.
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Terapia de Ressincronização Cardíaca/métodos , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Insuficiência Cardíaca/terapia , Sistema de Registros , Idoso , Morte Súbita Cardíaca/epidemiologia , Remoção de Dispositivo , Feminino , Seguimentos , Humanos , Incidência , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Resultado do TratamentoRESUMO
Aims: Right bundle branch block (RBBB) typically presents with only delayed right ventricular activation. However, some patients with RBBB develop concomitant delayed left ventricular (LV) activation. Such patients may show a specific electrocardiographic (ECG) pattern resembling RBBB in the precordial leads in association with an insignificant S-wave in lateral limb leads (atypical RBBB). We therefore postulated that the ECG pattern of atypical RBBB might be able to identify a subgroup of patients likely to respond to cardiac resynchronization therapy (CRT). The purpose of this study was to assess the impact of RBBB ECG morphology on CRT response in patients with heart failure (HF). Methods and results: We evaluated the echocardiographic clinical response of 66 patients with RBBB treated with CRT and followed up for almost 2 years. The patients were divided electrocardiographically into 2 groups: 31 with typical RBBB and 35 with atypical RBBB. Responders were classified in terms of reduction in LV end-systolic volume index (ESVi) ≥ 15% or reduction in the New York Heart Association (NYHA) Class ≥ 1 or Packer score variation (NYHA response with no HF-related hospitalization events or death). The atypical RBBB group presented a longer LV activation time compared with the typical RBBB group (111.9 ± 17.6 vs. 73.2 ± 15.4 ms; P < 0.001). In the atypical and typical RBBB groups, respectively, 71.4% and 19.4% of patients were ESVi responders (P = 0.001) 74.3% and 32.3% were NYHA responders (P = 0.002); similarly, 71.4% and 29.0% of patients exhibited a 2-year Packer score of 0 (P = 0.002). Conclusion: Patients with atypical RBBB, which is a pattern highly suggestive of concomitant delayed LV conduction, may show a satisfactory response to CRT.
Assuntos
Bloqueio de Ramo , Terapia de Ressincronização Cardíaca , Ecocardiografia/métodos , Sistema de Condução Cardíaco/fisiopatologia , Insuficiência Cardíaca , Ventrículos do Coração/fisiopatologia , Idoso , Bloqueio de Ramo/complicações , Bloqueio de Ramo/diagnóstico , Bloqueio de Ramo/fisiopatologia , Bloqueio de Ramo/terapia , Terapia de Ressincronização Cardíaca/métodos , Terapia de Ressincronização Cardíaca/estatística & dados numéricos , Eletrocardiografia/métodos , Feminino , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de SaúdeRESUMO
Aims: Permanent cardiac pacing of the His-bundle restores and retains normal electrical activation of the ventricles. Data on His-bundle pacing (HBP) are largely limited to small single-centre reports, and clinical benefits and risks have not been systematically examined. We sought to systematically examine published studies of patients undergoing permanent HBP and quantify the benefits and risks of the therapy. Methods and results: PubMed, Embase, and Cochrane Library were searched for full-text articles on permanent HBP. Clinical outcomes of interest included implant success rate, procedural and lead complications, pacing thresholds, QRS duration, and ejection fraction at follow-up, and mortality. Data were extracted and summarized. Where possible, meta-analysis of aggregate data was performed. Out of 2876 articles, 26 met the inclusion criteria representing 1438 patients with an implant attempt. Average age of patients was 73 years and 62.1% were implanted due to atrioventricular block. Overall average implant success rate was 84.8% and was higher with use of catheter-delivered systems (92.1%; P < 0.001). Average pacing thresholds were 1.71 V at implant and 1.79 V at >3 months follow-up; although, pulse widths varied at testing. Average left ventricular ejection fractions (LVEFs) were 42.8% at baseline and 49.5% at follow-up. There were 43 complications observed in 907 patients across the 17 studies that reported safety information. Conclusion: Among 26 articles of permanent HBP, the implant success rate averaged 84.8% and LVEF improved by an average of 5.9% during follow-up. Specific reporting of our clinical outcomes of interest varied widely, highlighting the need for uniform reporting in future HBP trials.
Assuntos
Fascículo Atrioventricular , Bloqueio de Ramo/terapia , Estimulação Cardíaca Artificial , Fascículo Atrioventricular/fisiopatologia , Bloqueio de Ramo/fisiopatologia , Estimulação Cardíaca Artificial/efeitos adversos , Estimulação Cardíaca Artificial/métodos , Humanos , Medição de Risco , Resultado do TratamentoRESUMO
Aim: Ventricular tachycardia (VT)/ventricular fibrillation (VF) occurrence after cardiac resynchronization therapy-defibrillator (CRT-D) replacement is unknown; hence, there is no practical guideline to recommend either CRT-D or CRT-pacemaker at the time of device replacement. We observed the 1-year VT/VF occurrence after CRT-D replacement in a subanalysis of the Detect Long-term Complications after ICD Replacement (DECODE) registry. Methods and results: A total of 332 consecutive patients who had undergone CRT-D replacement from 2013 to 2015 were enrolled in 36 Italian centres. The primary endpoint was the number of patients with any appropriate implantable cardioverter-defibrillator (ICD) interventions during 12-month follow-up. The secondary endpoint comprised death from any cause and appropriate ICD interventions. At replacement, 214 (64.5%) patients had a left ventricular ejection fraction ≤ 35% and 138 (41.6%) patients had a secondary prevention indication for ICD. Seventy (21.1%) patients had no longer indication to ICD therapy. During a median follow-up period of 406.5 (362-533) days, VT/VF requiring therapy delivery occurred in 57 (17%) patients, specifically in 7% of those who no longer had an ICD indication. On multivariate analysis, number of criteria for ICD replacement independently predicted appropriate ICD intervention during follow-up [hazard ratio (HR) = 1.62, 95% confidence interval (CI) 1.07-2.46; log-rank P = 0.02]. The combined endpoint of death from any cause or appropriate ICD therapy occurred in 76 (23%) patients. Only NYHA class remained associated with this combined endpoint (HR = 1.97, 95% CI 1.23-3.14; P = 0.005). Conclusions: The DECODE registry showed the 'real-world' experience of CRT-D recipients approaching device replacement, in which 7% of patients who no longer had an indication for ICD therapy experienced appropriate ICD interventions.
Assuntos
Fibrilação Atrial/terapia , Dispositivos de Terapia de Ressincronização Cardíaca , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Implantação de Prótese , Taquicardia Ventricular/epidemiologia , Fibrilação Ventricular/epidemiologia , Idoso , Terapia de Ressincronização Cardíaca , Remoção de Dispositivo , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Modelos de Riscos Proporcionais , Volume SistólicoRESUMO
BACKGROUND: The recently developed quadripolar left ventricular (LV) leads have been developed to increase the benefit of cardiac resynchronization therapy (CRT). These leads offer the option to stimulate the LV on multiple sites (multipoint pacing, MPP). Invasive haemodynamic measurements have shown that MPP increases haemodynamic response. PURPOSE: To investigate whether the beneficial effect of MPP can be explained by better electrical resynchronization. METHODS: Different LV lead locations were tested during biventricular (BiV) pacing and MPP in 29 CRT candidates. The 12-lead electrocardiogram (ECG) and the invasive LV pressure curves were measured simultaneously. The Kors matrix was used to convert the ECG into a vectorcardiogram (VCG). The acute haemodynamic benefit of MPP was compared with the reduction in QRS duration and VCG-derived QRS area. RESULTS: Out of the 29 patients, three patients were excluded due to missing LV pressures or ECG measurements. In the remaining 26 patients MPP resulted in a significant haemodynamic improvement compared to BiV pacing without a significant change in QRS duration and QRS area. In only 5 out of the 26 patients the QRS area decreased during MPP compared to BiV pacing. In 17 patients MPP did not change QRS duration and significantly increased QRS area but moved the direction of the maximal QRS vector (azimuth) more opposite from baseline compared to BiV pacing. In 4 patients the QRS area was small during baseline, indicating limited electrical dyssynchrony. CONCLUSION: The acute haemodynamic benefit of MPP over BiV pacing is achieved by either electrical resynchronization (reduction in QRS area) or by a rotation of the maximal QRS vector, indicating a more LV dominated activation sequence. The latter property was found in two-thirds of the cohort studied.