RESUMO
Cardiac electrophysiology is an evolving field that relies heavily on costly device- and catheter-based technologies. An increasing number of patients with heart rhythm disorders are becoming eligible for cardiac interventions, not least due to the rising prevalence of atrial fibrillation and increased longevity in the population. Meanwhile, the expansive costs of healthcare face finite societal resources, and a cost-conscious approach to new technologies is critical. Cost-effectiveness analyses support rational decision-making in healthcare by evaluating the ratio of healthcare costs to health benefits for competing therapies. They may, however, be subject to significant uncertainty and bias. This paper aims to introduce the basic concepts, framework, and limitations of cost-effectiveness analyses to clinicians including recent examples from clinical electrophysiology and device therapy.
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Fibrilação Atrial , Técnicas Eletrofisiológicas Cardíacas , Humanos , Análise Custo-Benefício , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/terapia , Custos de Cuidados de Saúde , Resultado do Tratamento , Anos de Vida Ajustados por Qualidade de VidaRESUMO
AIMS: Contact force (CF)-sensing radiofrequency (RF) catheters with an ablation index have shown reproducible outcomes for the treatment of atrial fibrillation (AF) in large multicentre studies. A dual-energy (DE) focal CF catheter to deliver RF and unipolar/biphasic pulsed field ablation (PFA), integrated with a three-dimensional (3D) mapping system, can provide operators with additional flexibility. The SmartfIRE study assessed the safety and efficacy of this novel technology for the treatment of drug-refractory, symptomatic paroxysmal AF. Results at 3 months post-ablation are presented here. METHODS AND RESULTS: Pulmonary vein isolation (PVI) was performed using a DE focal, irrigated CF-sensing catheter with the recommendation of PFA at posterior/inferior and RF ablation at the anterior/ridge/carina segments. Irrespective of energy, a tag size of 3â mm; an inter-tag distance ≤6â mm; a target index of 550 for anterior, roof, ridge, and carina; and a target index of 400 for posterior and inferior were recommended. Cavotricuspid isthmus ablation was permitted in patients with documented typical atrial flutter. The primary effectiveness endpoint was acute procedural success. The primary safety endpoint was the rate of primary adverse events (PAEs) within 7 days of the procedure. A prespecified patient subset underwent oesophageal endoscopy (EE; 72â h post-procedure), neurological assessment (NA; pre-procedure and discharge), and cardiac computed tomography (CT)/magnetic resonance angiogram (MRA) imaging (pre-procedure and 3 months post-procedure) for additional safety evaluation, and a mandatory remapping procedure (Day 75 ± 15) for PVI durability assessment. Of 149 patients enrolled between February and June 2023, 140 had the study catheter inserted (safety analysis set) and 137 had ablation energy delivered (per-protocol analysis set). The median (Q1/Q3) total procedure and fluoroscopy times were 108.0 (91.0/126.0) and 4.2 (2.3/7.7) min (n = 137). The acute procedural success rate was 100%. First-pass isolation was achieved in 89.1% of patients and 96.8% of veins. Cavotricuspid isthmus ablations were successfully performed in 12 patients [pulsed field (PF) only: 6, RF only: 5, and RF/PF: 1]. The PAE rate was 4.4% [6/137 patients; 2 pulmonary vein (PV) stenoses, 2 cardiac tamponades/perforations, 1 stroke, and 1 pericarditis]. No coronary artery spasm was reported. No oesophageal lesion was seen in the EE subset (0/31, 0%). In the NA subset (n = 30), microemboli lesions were identified in 2 patients (2/30, 6.7%), both of which were resolved at follow-up; only 1 was symptomatic (silent cerebral lesion, 3.3%). In the CT/MRA subset (n = 30), severe PV narrowing (of >70%) was detected in 2 patients (2/30, 6.7%; vein level 2/128, 1.6%), of whom 1 underwent dilatation and stenting and 1 was asymptomatic; both were associated with high index values and a small inter-tag distance. In the PV durability subset (n = 30), 100/115 treated PVs (87%) were durably isolated and 18/30 patients (60.0%) had all PVs durably isolated. CONCLUSION: A DE focal CF catheter with 3D mapping integration showed a 100% acute success rate with an acceptable safety profile in the treatment of paroxysmal AF. Prespecified 3-month remapping showed notable PVI durability. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05752487.
Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Humanos , Veias Pulmonares/cirurgia , Fibrilação Atrial/cirurgia , Fibrilação Atrial/fisiopatologia , Masculino , Feminino , Ablação por Cateter/métodos , Ablação por Cateter/instrumentação , Pessoa de Meia-Idade , Resultado do Tratamento , Idoso , Imageamento Tridimensional , Cateteres Cardíacos , Fatores de Tempo , Desenho de Equipamento , Estudos Prospectivos , RecidivaRESUMO
BACKGROUND AND AIMS: High percentages of atrial pacing have been associated with an increased risk of atrial fibrillation. This study is aimed at evaluating whether atrial pacing minimization in patients with sinus node dysfunction reduces the incidence of atrial fibrillation. METHODS: In a nationwide, randomized controlled trial, 540 patients with sinus node dysfunction and an indication for first pacemaker implantation were assigned to pacing programmed to a base rate of 60 bpm and rate-adaptive pacing (DDDR-60) or pacing programmed to a base rate of 40 bpm without rate-adaptive pacing (DDD-40). Patients were followed on remote monitoring for 2 years. The primary endpoint was time to first episode of atrial fibrillation longer than 6 min. Secondary endpoints included longer episodes of atrial fibrillation, and the safety endpoint comprised a composite of syncope or presyncope. RESULTS: The median percentage of atrial pacing was 1% in patients assigned to DDD-40 and 49% in patients assigned to DDDR-60. The primary endpoint occurred in 124 patients (46%) in each treatment group (hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.76-1.25, P = .83). There were no between-group differences in atrial fibrillation exceeding 6 or 24 h, persistent atrial fibrillation, or cardioversions for atrial fibrillation. The incidence of syncope or presyncope was higher in patients assigned to DDD-40 (HR 1.71, 95% CI 1.13-2.59, P = .01). CONCLUSIONS: Atrial pacing minimization in patients with sinus node dysfunction does not reduce the incidence of atrial fibrillation. Programming a base rate of 40 bpm without rate-adaptive pacing is associated with an increased risk of syncope or presyncope.
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BACKGROUND: Cardiac resynchronization therapy (CRT) improves symptoms, health-related quality of life and long-term survival in patients with systolic heart failure (HF) and shortens QRS duration. However, up to one third of patients attain no measurable clinical benefit from CRT. An important determinant of clinical response is optimal choice in left ventricular (LV) pacing site. Observational data have shown that achieving an LV lead position at a site of late electrical activation is associated with better clinical and echocardiographic outcomes compared to standard placement, but mapping-guided LV lead placement towards the site of latest electrical activation has never been investigated in a randomized controlled trial (RCT). The purpose of this study was to evaluate the effect of targeted positioning of the LV lead towards the latest electrically activated area. We hypothesize that this strategy is superior to standard LV lead placement. METHODS: The DANISH-CRT trial is a national, double-blinded RCT (ClinicalTrials.gov NCT03280862). A total of 1,000 patients referred for a de novo CRT implantation or an upgrade to CRT from right ventricular pacing will be randomized 1:1 to receive conventional LV lead positioning preferably in a nonapical posterolateral branch of the coronary sinus (CS) (control group) or targeted positioning of the LV lead to the CS branch with the latest local electrical LV activation (intervention group). In the intervention group, late activation will be determined using electrical mapping of the CS. The primary endpoint is a composite of death and nonplanned HF hospitalization. Patients are followed for a minimum of 2 years and until 264 primary endpoints occurred. Analyses will be conducted according to the intention-to-treat principle. Enrollment for this trial began in March 2018, and per April 2023, a total of 823 patients have been included. Enrollment is expected to be complete by mid-2024. CONCLUSIONS: The DANISH-CRT trial will clarify whether mapping-guided positioning of the LV lead according to the latest local electrical activation in the CS is beneficial for patients in terms of reducing the composite endpoint of death or nonplanned hospitalization for heart failure. Results from this trial are expected to impact future guidelines on CRT. GOV IDENTIFIER: NCT03280862.
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Terapia de Ressincronização Cardíaca , Insuficiência Cardíaca , Humanos , Terapia de Ressincronização Cardíaca/métodos , Dispositivos de Terapia de Ressincronização Cardíaca , Incidência , Resultado do Tratamento , Ventrículos do Coração/diagnóstico por imagem , HospitalizaçãoRESUMO
AIMS: Use of an absorbable antibacterial envelope during implantation prevents cardiac implantable electronic device infections in patients with a moderate-to-high infection risk. Previous studies demonstrated that an envelope is cost-effective in high-risk patients within German, Italian, and English healthcare systems, but these analyses were based on limited data and may not be generalizable to other healthcare settings. METHODS AND RESULTS: A previously published decision-tree-based cost-effectiveness model was used to compare the costs per quality-adjusted life year (QALY) associated with adjunctive use of an antibacterial envelope for infection prevention compared to standard-of-care intravenous antibiotics. The model was adapted using data from a Danish observational two-centre cohort study that investigated infection-risk patients undergoing cardiac resynchronization therapy (CRT) reoperations with and without an antibacterial envelope (n = 1943). We assumed a cost-effectiveness threshold of 34 125/QALY gained, based on the upper threshold used by the National Institute for Health and Care Excellence (£30 000). An antibacterial envelope was associated with an incremental cost-effectiveness ratio (ICER) of 12 022 per QALY in patients undergoing CRT reoperations, thus indicating that the envelope is cost-effective when compared with standard of care. A separate analysis stratified by device type showed ICERS of 6227 (CRT defibrillator) and 29 177 (CRT pacemaker) per QALY gained. CONCLUSIONS: Cost-effectiveness ratios were favourable for patients undergoing CRT reoperations in the Danish healthcare system, and thus are in line with previous studies. Results from this study can contribute to making the technology available to Danish patients and align preventive efforts in the pacemaker and ICD area.
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Terapia de Ressincronização Cardíaca , Humanos , Reoperação , Terapia de Ressincronização Cardíaca/efeitos adversos , Análise Custo-Benefício , Estudos de Coortes , Antibacterianos/uso terapêutico , DinamarcaRESUMO
AIMS: Several studies have evaluated the use of electrically- or imaging-guided left ventricular (LV) lead placement in cardiac resynchronization therapy (CRT) recipients. We aimed to assess evidence for a guided strategy that targets LV lead position to the site of latest LV activation. METHODS AND RESULTS: A systematic review and meta-analysis was performed for randomized controlled trials (RCTs) until March 2023 that evaluated electrically- or imaging-guided LV lead positioning on clinical and echocardiographic outcomes. The primary endpoint was a composite of all-cause mortality and heart failure hospitalization, and secondary endpoints were quality of life, 6-min walk test (6MWT), QRS duration, LV end-systolic volume, and LV ejection fraction. We included eight RCTs that comprised 1323 patients. Six RCTs compared guided strategy (n = 638) to routine (n = 468), and two RCTs compared different guiding strategies head-to-head: electrically- (n = 111) vs. imaging-guided (n = 106). Compared to routine, a guided strategy did not significantly reduce the risk of the primary endpoint after 12-24 (RR 0.83, 95% CI 0.52-1.33) months. A guided strategy was associated with slight improvement in 6MWT distance after 6 months of follow-up of absolute 18 (95% CI 6-30) m between groups, but not in remaining secondary endpoints. None of the secondary endpoints differed between the guided strategies. CONCLUSION: In this study, a CRT implantation strategy that targets the latest LV activation did not improve survival or reduce heart failure hospitalizations.
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Terapia de Ressincronização Cardíaca , Insuficiência Cardíaca , Humanos , Terapia de Ressincronização Cardíaca/efeitos adversos , Ecocardiografia , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Ventrículos do Coração/diagnóstico por imagem , HospitalizaçãoRESUMO
AIMS: To describe safety and feasibility of magnetic resonance imaging (MRI) in patients with transvenous temporary external pacemakers and whether artefacts affect the diagnostic image quality during cardiac MRI. METHODS AND RESULTS: We reviewed records of all patients treated with temporary external pacing between 2016 and 2020 at a tertiary centre. Temporary pacing was established using a transvenous standard active fixation pacing lead inserted percutaneously and connected to a MRI-conditional pacemaker taped to the skin. All patients undergoing cardiac or non-cardiac MRI during temporary transvenous pacing were identified. Before MRI, devices were programmed according to guidelines for permanent pacemakers, and patients were monitored with continuous electrocardiogram during MRI. Of 827 consecutive patients receiving a temporary external pacemaker, a total of 44 (5%) patients underwent MRI (mean age 71 years, 13 [30%] females). Cardiac MRI was performed in 22 (50%) patients, while MRI of cerebrum, spine, and other regions was performed in the remaining patients. Median time from implantation of the temporary device to MRI was 6 (3-11) days. During MRI, we observed no device-related malfunction or arrhythmia. Nor did we detect any change in lead sensing, impedance, or pacing threshold. We observed no artefacts from the lead or pacemaker compromising the diagnostic image quality of cardiac MRI. MRI provided information to guide the clinical management in all cases. CONCLUSION: MRI is feasible and safe in patients with temporary external pacing established with a regular MRI-conditional pacemaker and a standard active fixation lead. No artefacts compromised the diagnostic image quality.
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Marca-Passo Artificial , Feminino , Humanos , Idoso , Masculino , Marca-Passo Artificial/efeitos adversos , Arritmias Cardíacas/diagnóstico por imagem , Arritmias Cardíacas/terapia , Imageamento por Ressonância Magnética/métodos , Artefatos , EletrocardiografiaRESUMO
AIMS: Cardiac resynchronization therapy (CRT) reoperations are associated with a particularly high risk of device-related infection (DRI). An antibacterial envelope reduces the occurrence of DRIs in a broad population of moderate-tohigh-risk patients. To investigate the efficacy of an antibacterial envelope in a very high-risk population of patients undergoing CRT reoperation. METHODS AND RESULTS: In this Danish two-centre, observational cohort study, we included consecutive patients who underwent a CRT pacemaker- or defibrillator reoperation procedure between January 2008 and November 2019. We obtained data from the Danish Pacemaker and ICD Register and through systematic medical chart review. Follow-up was restricted to 2 years. A total of 1943 patients were included in the study of which 736 (38%) received an envelope. Envelope patients had more independent risk factors for infection than non-envelope patients. Sixty-seven (3.4%) patients met the primary endpoint of DRI requiring device system extraction; 50 in the non-envelope group and 17 in the envelope group [4.1% vs. 2.3%, adjusted hazard ratio (HR) 0.52, 95% confidence interval (CI) 0.30-0.90; P = 0.021]. This difference persisted in propensity score analysis (HR 0.51, 95% CI 0.29-0.90; P = 0.019). CONCLUSION: Use of an antibacterial envelope was associated with a clinically and statistically significant reduction in DRIs in patients undergoing CRT reoperations. Our results were comparable to those recently reported from a large randomized controlled trial, which is suggestive of a proportional effect of the envelope even in very high-risk patients.
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Terapia de Ressincronização Cardíaca , Desfibriladores Implantáveis , Insuficiência Cardíaca , Marca-Passo Artificial , Antibacterianos/uso terapêutico , Terapia de Ressincronização Cardíaca/efeitos adversos , Dispositivos de Terapia de Ressincronização Cardíaca , Desfibriladores Implantáveis/efeitos adversos , Insuficiência Cardíaca/terapia , Humanos , Marca-Passo Artificial/efeitos adversos , Reoperação , Fatores de Risco , Resultado do TratamentoRESUMO
AIMS: This study aims to investigate the long-term occurrence of the composite endpoint of heart failure (HF) hospitalization or all-cause death (primary endpoint) in patients randomized to cardiac resynchronization therapy (CRT) using individualized multimodality imaging-guided left ventricular (LV) lead placement compared with a routine fluoroscopic approach. Furthermore, this study aims to evaluate whether inter-lead electrical delay (IED) is associated with improved response rate of this endpoint. METHODS AND RESULTS: We reviewed follow-up data until November 2020 for all 182 patients included in the ImagingCRT trial for the occurrence of HF hospitalization and all-cause death. During median (inter-quartile range) time to primary endpoint/censuring of 6.7 (3.3-7.9) years, the rate of the primary endpoint was 60% (n = 53) in the imaging group compared with 52% (n = 48) in the control group [hazard ratio (HR) 1.22, 95% confidence interval (CI) 0.83-1.81, P = 0.31]. Neither the risk of HF hospitalization (HR 1.11, 95% CI 0.62-1.99, P = 0.72) nor of all-cause death differed between treatment groups (HR 1.23, 95% CI 0.82-1.85, P = 0.32). The risk of the primary endpoint was significantly reduced among those with IED ≥100 ms when compared with those with IED <100 ms (HR 0.62, 95% CI 0.39-0.98, P = 0.04). CONCLUSIONS: In this study, an individualized multimodality imaging-guided strategy targeting LV lead placement towards the latest mechanically activated non-scarred myocardial segment during CRT implantation did not reduce HF hospitalization or all-cause death when compared with routine LV lead placement during long-term follow-up. Targeting the latest electrical activation should be studied as an alternative individualized strategy for optimizing LV lead placement in CRT recipients.
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Terapia de Ressincronização Cardíaca , Insuficiência Cardíaca , Terapia de Ressincronização Cardíaca/efeitos adversos , Terapia de Ressincronização Cardíaca/métodos , Dispositivos de Terapia de Ressincronização Cardíaca , Ecocardiografia , Insuficiência Cardíaca/diagnóstico por imagem , Insuficiência Cardíaca/terapia , Ventrículos do Coração/diagnóstico por imagem , Humanos , Resultado do TratamentoRESUMO
AIMS: To develop a suite of quality indicators (QIs) for the evaluation of the care and outcomes for adults undergoing cardiac pacing. METHODS AND RESULTS: Under the auspice of the Clinical Practice Guideline Quality Indicator Committee of the European Society of Cardiology (ESC), the Working Group for cardiac pacing QIs was formed. The Group comprised Task Force members of the 2021 ESC Clinical Practice Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy, members of the European Heart Rhythm Association, international cardiac device experts, and patient representatives. We followed the ESC methodology for QI development, which involved (i) the identification of the key domains of care by constructing a conceptual framework of the management of patients receiving cardiac pacing, (ii) the development of candidate QIs by conducting a systematic review of the literature, (iii) the selection of the final set of QIs using a modified-Delphi method, and (iv) the evaluation of the feasibility of the developed QIs. Four domains of care were identified: (i) structural framework, (ii) patient assessment, (iii) pacing strategy, and (iv) clinical outcomes. In total, seven main and four secondary QIs were selected across these domains and were embedded within the 2021 ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization therapy. CONCLUSION: By way of a standardized process, 11 QIs for cardiac pacing were developed. These indicators may be used to quantify adherence to guideline-recommended clinical practice and have the potential to improve the care and outcomes of patients receiving cardiac pacemakers.
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Terapia de Ressincronização Cardíaca , Cardiologia , Marca-Passo Artificial , Adulto , Comitês Consultivos , Terapia de Ressincronização Cardíaca/efeitos adversos , Humanos , Indicadores de Qualidade em Assistência à SaúdeRESUMO
Nearly one in ten patients experience complications in relation to cardiac implantable electronic device (CIED) implantations. CIED complications have serious implications for the patients and for the healthcare system. In light of the rising rates of new implants and consistent rate of complications, primary prevention remains a major concern. To guide future efforts, we sought to review the evidence base underlying common preventive actions made during a primary CIED implantation.
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Desfibriladores Implantáveis , Cardiopatias , Marca-Passo Artificial , Desfibriladores Implantáveis/efeitos adversos , Eletrônica , Humanos , Marca-Passo Artificial/efeitos adversos , Complicações Pós-OperatóriasRESUMO
BACKGROUND: Left atrial substrate modification targeting low voltage zones (LVZ) is an ablation strategy that-in addition to pulmonary vein (PV) isolation-tries to eliminate arrhythmogenic mechanisms harbored in such tissue. Electrophysiological findings at reablation include (a) PV reconnection, (b) reconnection over previous substrate ablation, and (c) de-novo LVZ. OBJECTIVE: To study, prevalence and contribution of these arrhythmogenic electrophysiological entities in patients with atrial fibrillation (AF) recurrences. METHODS: Consecutive patients with highly symptomatic AF undergoing index and reablation were included (n = 113). In all patients' PV reconnection, reconnection over previous substrate ablation and spontaneous de-novo LVZ were quantitatively assessed and integrated into an individual reablation strategy. Follow-up was based on continuous device monitoring. RESULTS: At re-do procedure, 45 out of 113 (39.8%) patients showed PV reconnection as the only electrophysiological abnormality. Reconduction over previous lines was the only electrophysiological abnormality in 8 out of 113 (7.1%) patients. Spontaneous de-novo LVZ was the only electrophysiological abnormality in 12 out of 113 (10.6%) patients. Combined findings of PV reconnection, line reconduction, and/or spontaneous de-novo LVZ were seen in 40 out of 113 (35.4%) patients. No detectable electrophysiological abnormality was observed in 8 out of 113 (7.1%) patients. In univariate analysis, none of the tested electrophysiological characteristics independently predicted the outcome after re-do. CONCLUSIONS: In patients undergoing reablation, we could show that reconduction over previous substrate ablation as well as the development of new low voltage areas are frequent findings besides classical PV reconnection-without a clear leading cause for recurrences. These findings impact reablation strategies as well as the strategic focus during index procedures.
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Potenciais de Ação , Fibrilação Atrial/cirurgia , Ablação por Cateter , Técnicas Eletrofisiológicas Cardíacas , Frequência Cardíaca , Veias Pulmonares/cirurgia , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Ablação por Cateter/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Veias Pulmonares/fisiopatologia , Recidiva , Reoperação , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
AIMS: Contact force (CF) sensing has emerged as a tool to guide and improve outcomes for catheter ablation (CA) for cardiac arrhythmias. The clinical benefit on patient outcomes remains unknown. To study whether CF-guided CA for typical atrial flutter (AFL) is superior to CA not guided by CF. METHODS AND RESULTS: In a double-blinded controlled superiority trial, we randomized patients 1:1 to receive CA for typical AFL guided by CF (intervention group) or blinded to CF (control group). In the intervention group, a specific value of the lesion size index (LSI), estimating ablation lesions size was targeted for each ablation lesion. Patients underwent electrophysiological study (EPS) after 3 months to assess occurrence of the primary endpoint of re-conduction across the cavo-tricuspid isthmus (CTI). We included 156 patients with typical AFL, median age was 68 [interquartile range (IQR) 61-74] years and 120 (77%) patients were male. At index procedure median LSI was higher in the intervention group [6.4 (IQR 5.1-7) vs. 5.6 (IQR 4.5-6.9), P < 0.0001]. After 3 months, 126 patients (58 in intervention group) underwent EPS for primary endpoint assessment. Thirty (24%) patients had CTI re-conduction, distributed with 15 patients in each treatment group (P = 0.62). We observed no difference between treatment groups with regard to fluoroscopy, ablation, or procedure times, nor peri-procedural complications. CONCLUSION: Contact force-guided ablation does not reduce re-conduction across the CTI after 3 months, nor does CF-guided ablation shorten fluoroscopy, ablation, or total procedure times.
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Flutter Atrial , Ablação por Cateter , Idoso , Flutter Atrial/diagnóstico , Flutter Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Fluoroscopia , Frequência Cardíaca , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
AIMS: Atrial fibrillation (AF) and heart failure (HF) often coexist. Catheter ablation has been reported to restore left ventricular (LV) function but patients benefit differently. This study investigated the correlation between left atrial (LA) fibrosis extent and LV ejection fraction (LVEF) recovery after AF ablation. METHODS AND RESULTS: In this study, 103 patients [64 years, 69% men, 79% persistent AF, LVEF 33% interquartile range (IQR) (25-38)] undergoing first time AF ablation were investigated. Identification of LA fibrosis and selection of ablation strategy were based on sinus rhythm voltage mapping. Continuous rhythm monitoring was used to assess ablation success. Improvement in post-ablation LVEF was measured as primary study endpoint. An absolute increase in post-ablation LVEF ≥10% was defined as 'Super Response'. Left atrial fibrosis was present in 38% of patients. After ablation LVEF increased by absolute 15% (IQR 6-25) (P < 0.001). Left ventricular ejection fraction improvement was higher in patients without LA fibrosis [15% (IQR 10-25) vs. 10% (IQR 0-20), P < 0.001]. An inverse correlation between LVEF improvement and the extent of LA fibrosis was found (R2 = 0.931). In multivariate analysis, the presence of LA fibrosis was the only independent predictor for failing LVEF improvement [odds ratio 7.2 (95% confidence interval 2.2-23.4), P < 0.001]. Echocardiographic 'Super Response' was observed in 55/64 (86%) patients without and 21/39 (54%) patients with LA fibrosis, respectively (P < 0.001). CONCLUSION: Presence and extent of LA fibrosis predict LVEF response in HF patients undergoing AF ablation. The assessment of LA fibrosis may impact prognostic stratification and clinical management in HF patients with AF.
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Fibrilação Atrial , Ablação por Cateter , Insuficiência Cardíaca , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Feminino , Fibrose , Insuficiência Cardíaca/diagnóstico , Humanos , Masculino , Volume Sistólico , Resultado do Tratamento , Função Ventricular EsquerdaRESUMO
OBJECTIVE: The objective of this study was to examine whether left atrial (LA) volumes and function were associated with atrial high-rate episodes (AHREs) in patients with cardiac resynchronization therapy (CRT). METHODS: Ninety-two consecutive patients without prior atrial fibrillation underwent clinical evaluation, echocardiograms, and cardiac computed tomography (CT) before CRT implantation and after 6 months. Left atrial volumes and LA emptying fraction (LAEF) were derived by CT images reconstructed at 5% phase increments of the cardiac cycle. Cox regression was used to assess associations between AHRE and LA anatomical and functional variables. RESULTS: Twenty-two patients (24%) developed AHRE during 1.9 years (SD, 1 year) At baseline, higher LAEF was associated with a lower risk of AHRE (hazard ratio [HR], 0.94; 95% confidence interval [CI], 0.91-0.98; P = 0.003), and large LA minimal (LAmin) volume was related to higher risk of AHRE (HR, 1.03; 95% CI, 1.00-1.06; P = 0.04). When combining LAEF and LAmin volume, only LAEF remained associated with occurrence of AHRE. Higher passive LAEF was associated with lower risk of AHRE (HR, 0.95; 95% CI, 0.91-0.98; P = 0.003). CONCLUSIONS: In patients with CRT, low preimplant LAEF measured by cardiac CT was independently associated with device-detected AHRE.
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Fibrilação Atrial , Função do Átrio Esquerdo/fisiologia , Terapia de Ressincronização Cardíaca/estatística & dados numéricos , Átrios do Coração/diagnóstico por imagem , Tomografia Computadorizada por Raios X/métodos , Idoso , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/epidemiologia , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de RiscoRESUMO
AIMS: To test in a double-blinded, randomized trial whether the combination of electrically guided left ventricular (LV) lead placement and post-implant interventricular pacing delay (VVd) optimization results in superior increase in LV ejection fraction (LVEF) in cardiac resynchronization therapy (CRT) recipients. METHODS AND RESULTS: Stratified according to presence of ischaemic heart disease, 122 patients were randomized 1:1 to LV lead placement targeted towards the latest electrically activated segment identified by systematic mapping of the coronary sinus tributaries during CRT implantation combined with post-implant VVd optimization (intervention group) or imaging-guided LV lead implantation by cardiac computed tomography venography, 82Rubidium myocardial perfusion imaging and speckle tracking echocardiography targeting the LV lead towards the latest mechanically activated non-scarred myocardial segment (control group). Follow-up was 6 months. Primary endpoint was absolute increase in LVEF. Additional outcome measures were changes in New York Heart Association class, 6-minute walk test, and quality of life, LV reverse remodelling, and device related complications. Analysis was intention-to-treat. A larger increase in LVEF was observed in the intervention group (11 ± 10 vs. 7 ± 11%; 95% confidence interval 0.4-7.9%, P = 0.03); when adjusting for pre-specified baseline covariates this difference did not maintain statistical significance (P = 0.09). Clinical response, LV reverse remodelling, and complication rates did not differ between treatment groups. CONCLUSION: Electrically guided CRT implantation appeared non-inferior to an imaging-guided strategy considering the outcomes of change in LVEF, LV reverse remodelling and clinical response. Larger long-term studies are warranted to investigate the effect of an electrically guided CRT strategy.
Assuntos
Dispositivos de Terapia de Ressincronização Cardíaca , Terapia de Ressincronização Cardíaca/métodos , Técnicas Eletrofisiológicas Cardíacas/métodos , Insuficiência Cardíaca/terapia , Implantação de Prótese/métodos , Cirurgia Assistida por Computador/métodos , Disfunção Ventricular Esquerda/terapia , Idoso , Idoso de 80 Anos ou mais , Seio Coronário/diagnóstico por imagem , Seio Coronário/fisiopatologia , Método Duplo-Cego , Ecocardiografia , Feminino , Insuficiência Cardíaca/diagnóstico por imagem , Insuficiência Cardíaca/fisiopatologia , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Imagem de Perfusão do Miocárdio , Tomografia por Emissão de Pósitrons , Qualidade de Vida , Radioisótopos de Rubídio , Volume Sistólico , Tomografia Computadorizada por Raios X , Resultado do Tratamento , Disfunção Ventricular Esquerda/diagnóstico por imagem , Disfunção Ventricular Esquerda/fisiopatologia , Remodelação Ventricular/fisiologia , Teste de CaminhadaRESUMO
Objectives. Left atrial flutter has been reported in up to 10% of patients following pulmonary vein isolation or cardiac surgery. Left atrial flutter is typically highly symptomatic, responds poorly to medical antiarrhythmic treatment, and is often treated by catheter ablation. We aimed to investigate midterm freedom from recurrent arrhythmia after catheter ablation for left atrial flutter. Design. In the National Danish Ablation Registry, we identified consecutive patients, who had undergone catheter ablation for left atrial flutter between 1 January 2014 and 1 April 2017 at our centre. Results. A total of 53 patients (median age 68 years (IQR 60-71) 37 (70%) male) were included. Forty-two patients had prior left atrial catheter ablation procedures (79%), one patient prior ablation for classic atrial flutter (2%), four patients had prior surgery for congenital heart disease (8%), and six patients (11%) had no previous cardiac intervention. Acute procedural success, defined as non-inducibility of any atrial arrhythmia, was achieved in 45 of 53 patients (85%). During midterm follow-up (mean 20 ± 12 months), 26 patients experienced an episode of recurrent atrial arrhythmia. Median EHRA-score was 3 (range 2-4) before catheter ablation and reduced to median 1 (range 1-3) evaluated at follow-up visits after three and twelve months (both p < .001, Wilcoxon rank test). Conclusion. Left atrial flutter is preceded by catheter ablation or cardiac surgery in 89% of patients. Acute procedural success is achieved in majority of patients and ablation reduces symptoms effectively. During midterm follow-up, almost half the patients experience recurrent atrial arrhythmia.
Assuntos
Flutter Atrial/cirurgia , Ablação por Cateter , Idoso , Flutter Atrial/diagnóstico , Flutter Atrial/fisiopatologia , Ablação por Cateter/efeitos adversos , Dinamarca , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: QRS narrowing after CRT is a predictor of patient outcome. Further narrowing can be obtained by interventricular pacing delay (VVd) optimization, raising interest to inter and intraobserver variation in manual measurements of QRS duration. METHODS: (a) Variation in intrinsic rhythm QRS duration in CRT patients with LBBB: In 40 intrinsic 12-lead ECGs, six observers measured QRS duration defined as widest QRS in any lead. In 20 of these ECGs, two observers repeated the measurements. (b) Variation in paced QRS duration at different VVd settings and agreement in selecting the narrowest QRS: In 20 CRT patients, five paced ECGs were recorded at different VVds. The most frequently selected VVd(s) estimated to cause the narrowest QRS in each patient defined the optimal VVd. Two observers repeated the measurements and VVd selections. RESULTS: Absolute interobserver difference in measured QRS duration in intrinsic rhythm ECGs was mean 2 ms, range (-40; 40 ms), mean limits of agreement (LoA): -21; 25 ms. Absolute interobserver difference in measured QRS duration in paced ECGs was mean 3 ms, range (-50; 60 ms), mean LoA: -20; 27 ms. There was no difference in LoA between intrinsic and paced QRS duration (lower limit p = 0.68; upper limit p = 0.44). The optimal VVd was included in 17/20 (85%) of the VVd selections by six observers. Interobserver variation was comparable with the intraobserver variation. CONCLUSIONS: Interobserver variation and intraobserver variation in manually measured paced and intrinsic rhythm QRS duration are clinically acceptable and comparable in a cohort of CRT patients. Inter and intraobserver reproducibility for selecting the optimal VVd is good and warrants manual VVd optimization for QRS narrowing in CRT.
Assuntos
Bloqueio de Ramo/diagnóstico por imagem , Terapia de Ressincronização Cardíaca/métodos , Causas de Morte , Eletrocardiografia/métodos , Insuficiência Cardíaca/diagnóstico por imagem , Insuficiência Cardíaca/terapia , Fatores Etários , Idoso , Bloqueio de Ramo/mortalidade , Bloqueio de Ramo/fisiopatologia , Terapia de Ressincronização Cardíaca/mortalidade , Estudos de Coortes , Ecocardiografia/métodos , Feminino , Insuficiência Cardíaca/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Estudos Prospectivos , Reprodutibilidade dos Testes , Medição de Risco , Índice de Gravidade de Doença , Fatores Sexuais , Taxa de SobrevidaRESUMO
Aims: To evaluate the impact of different right and left ventricular lead positions (RV-LP and LV-LP) on the risk of therapy for ventricular tachycardia/ventricular fibrillation in patients with a cardiac resynchronization therapy device (CRT-D). Methods and results: We performed a large nationwide cohort study on patients in Denmark receiving a CRT-D device from 2008 to 2012 from the Danish Pacemaker and implantable cardioverter defibrillator (ICD) registry. Lead positions were registered during the implantation and categorized as anterior/lateral/posterior and basal/mid-ventricular/apical for the LV-LP, and as apical/non-apical for the RV-LP. Appropriate and inappropriate therapies were registered during follow-up via remote monitoring or at device interrogations. Time to event was summarized with Kaplan-Meier plots, and competed risk regression analysis was used to calculate adjusted hazard ratios (aHR) with 95% confidence intervals (CI). Following variables were included in the analysis: gender, age, heart failure aetiology, New York heart association class, left ventricular ejection fraction, QRS duration, indication (secondary or primary prophylactic), RV-LP, LV-LP, and antiarrhythmic therapy. We included 1643 patients [mean age 68 (±10) years, 1343 (83%) men]. After a mean of 2.0 years, 322 (20%) patients received appropriate and 66 (4%) patients received inappropriate therapy. The aHR for appropriate therapy with a non-apical RV-LP was 0.70 95% CI (0.55-0.87, P = 0.002) as compared with an apical. We observed no significant association between appropriate therapy and LV-LP in left anterior oblique or right anterior oblique views or inappropriate therapy between any lead positions. Conclusion: An apical RV-LP is associated with an increased risk of appropriate therapy for ventricular tachyarrhythmia in patients with a CRT-D device.
Assuntos
Dispositivos de Terapia de Ressincronização Cardíaca , Terapia de Ressincronização Cardíaca/métodos , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Insuficiência Cardíaca/terapia , Implantação de Prótese/métodos , Taquicardia Ventricular/terapia , Fibrilação Ventricular/terapia , Idoso , Estudos de Coortes , Dinamarca , Feminino , Ventrículos do Coração , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Volume SistólicoRESUMO
Aims: To describe the extent and distribution of low voltage zones (LVZ) in a large cohort of patients undergoing ablation for paroxysmal and persistent atrial fibrillation (AF), and to explore baseline predictors of LVZ in these patients. Methods and results: Consecutive patients who underwent a bipolar voltage map guided AF ablation, were enrolled. Voltage maps were conducted for each patient using 3-dimensional electroanatomical mapping system and LVZ were defined as areas of bipolar voltage < 0.5 mV. A total of 539 patients (309 male, age 65 ± 10 years) were included. Low voltage zones was present in 58 out of 292 patients with paroxysmal and 134 out of 247 persistent AF (P < 0.001). The area of LVZ was larger in patients with persistent as compare to paroxysmal AF, 5 cm2 (IQR 3-18.6) vs. 12.1 cm2 (IQR 3.6-28.5), P = 0.026, respectively. In the multivariate analysis age (OR 1.07, 95%CI 1.05-1.10, P < 0.001), female gender (OR 2.18, 95%CI 1.38-3.43, P = 0.001), sinoatrial node dysfunction (OR 3.90, 95%CI 1.24-12.21, P = 0.020), larger surface area of left atrium pr. cm2 (OR 1.01, 95%CI 1.00-1.02, P = 0.016), and persistent AF (OR 5.03, 95%CI 3.20-7.90, P<0.001) were associated with presence of LVZ. Conclusion: In a large cohort of patients undergoing ablation for AF, the prevalence of LVZ was higher and LVZ areas larger in patients with persistent as compared with paroxysmal AF. The most frequent localization of LVZ was anterior wall, septum and posterior wall. Presence of LVZ was associated with higher age, female gender, larger LA surface area, and sinoatrial node dysfunction.