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Cardiac resynchronization therapy (CRT) can lead to marked symptom reduction and improved survival in selected patients with heart failure with reduced ejection fraction (HFrEF); however, many candidates for CRT based on clinical guidelines do not have a favorable response. A better way to identify patients expected to benefit from CRT that applies machine learning to accessible and cost-effective diagnostic tools such as the 12-lead electrocardiogram (ECG) could have a major impact on clinical care in HFrEF by helping providers personalize treatment strategies and avoid delays in initiation of other potentially beneficial treatments. This study addresses this need by demonstrating that a novel approach to ECG waveform analysis using functional principal component decomposition (FPCD) performs better than measures that require manual ECG analysis with the human eye and also at least as well as a previously validated but more expensive approach based on cardiac magnetic resonance (CMR). Analyses are based on five-fold cross validation of areas under the curve (AUCs) for CRT response and survival time after the CRT implant using Cox proportional hazards regression with stratification of groups using a Gaussian mixture model approach. Furthermore, FPCD and CMR predictors are shown to be independent, which demonstrates that the FPCD electrical findings and the CMR mechanical findings together provide a synergistic model for response and survival after CRT. In summary, this study provides a highly effective approach to prognostication after CRT in HFrEF using an accessible and inexpensive diagnostic test with a major expected impact on personalization of therapies.
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Terapia de Ressincronização Cardíaca , Eletrocardiografia , Insuficiência Cardíaca , Aprendizado de Máquina , Humanos , Terapia de Ressincronização Cardíaca/métodos , Masculino , Feminino , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/diagnóstico por imagem , Insuficiência Cardíaca/fisiopatologia , Idoso , Pessoa de Meia-Idade , Imageamento por Ressonância Magnética/métodos , Processamento de Sinais Assistido por ComputadorRESUMO
As the mechanism for worse prognosis after cardiac resynchronization therapy (CRT) upgrades in heart failure patients with RVP dependence (RVP-HF) has clinical implications for patient selection and CRT implementation approaches, this study's objective was to evaluate prognostic implications of cardiac magnetic resonance (CMR) findings and clinical factors in 102 HF patients (23.5% female, median age 66.5 years old, median follow-up 4.8 years) with and without RVP dependence undergoing upgrade and de novo CRT implants. Compared with other CRT groups, RVP-HF patients had decreased survival (p = 0.02), more anterior late-activated LV pacing sites (p = 0.002) by CMR, more atrial fibrillation (p = 0.0006), and higher creatinine (0.002). CMR activation timing at the LV pacing site predicted post-CRT LV functional improvement (p < 0.05), and mechanical activation onset < 34 ms by CMR at the LVP site was associated with decreased post-CRT survival in a model with higher pre-CRT creatinine and B-type natriuretic peptide (AUC 0.89; p < 0.0001); however, only the higher pre-CRT creatinine partially mediated (37%) the decreased survival in RVP-HF patients. In conclusion, RVP-HF had a distinct CMR phenotype, which has important implications for the selection of LV pacing sites in CRT upgrades, and only chronic kidney disease mediated the decreased survival after CRT in RVP-HF.
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The aim was to test the hypothesis that left ventricular (LV) and right ventricular (RV) activation from body surface electrical mapping (CardioInsight 252-electrode vest, Medtronic) identifies optimal cardiac resynchronization therapy (CRT) pacing strategies and outcomes in 30 patients. The LV80, RV80, and BIV80 were defined as the times to 80% LV, RV, or biventricular electrical activation. Smaller differences in the LV80 and RV80 (|LV80-RV80|) with synchronized LV pacing predicted better LV function post-CRT (p = 0.0004) than the LV-paced QRS duration (p = 0.32). Likewise, a lower RV80 was associated with a better pre-CRT RV ejection fraction by CMR (r = - 0.40, p = 0.04) and predicted post-CRT improvements in myocardial oxygen uptake (p = 0.01) better than the biventricular-paced QRS (p = 0.38), while a lower LV80 with BIV pacing predicted lower post-CRT B-type natriuretic peptide (BNP) (p = 0.02). RV pacing improved LV function with smaller |LV80-RV80| (p = 0.009). In conclusion, 3-D electrical mapping predicted favorable post-CRT outcomes and informed effective pacing strategies.
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Terapia de Ressincronização Cardíaca , Insuficiência Cardíaca , Humanos , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/complicações , Resultado do Tratamento , Função Ventricular Esquerda/fisiologia , Dispositivos de Terapia de Ressincronização Cardíaca , Ventrículos do CoraçãoRESUMO
Background: Cardiac resynchronization therapy (CRT) response is complex, and better approaches are required to predict survival and need for advanced therapies. Objective: The objective was to use machine learning to characterize multidimensional CRT response and its relationship with long-term survival. Methods: Associations of 39 baseline features (including cardiac magnetic resonance [CMR] findings and clinical parameters such as glomerular filtration rate [GFR]) with a multidimensional CRT response vector (consisting of post-CRT left ventricular end-systolic volume index [LVESVI] fractional change, post-CRT B-type natriuretic peptide, and change in peak VO2) were evaluated. Machine learning generated response clusters, and cross-validation assessed associations of clusters with 4-year survival. Results: Among 200 patients (median age 67.4 years, 27.0% women) with CRT and CMR, associations with more than 1 response parameter were noted for the CMR CURE-SVD dyssynchrony parameter (associated with post-CRT brain natriuretic peptide [BNP] and LVESVI fractional change) and GFR (associated with peak VO2 and post-CRT BNP). Machine learning defined 3 response clusters: cluster 1 (n = 123, 90.2% survival [best]), cluster 2 (n = 45, 60.0% survival [intermediate]), and cluster 3 (n = 32, 34.4% survival [worst]). Adding the 6-month response cluster to baseline features improved the area under the receiver operating characteristic curve for 4-year survival from 0.78 to 0.86 (P = .02). A web-based application was developed for cluster determination in future patients. Conclusion: Machine learning characterizes distinct CRT response clusters influenced by CMR features, kidney function, and other factors. These clusters have a strong and additive influence on long-term survival relative to baseline features.
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Background: Mechanisms of sex-based differences in outcomes following cardiac resynchronization therapy (CRT) are poorly understood. Objective: To use cardiac magnetic resonance (CMR) to define mechanisms of sex-based differences in outcomes after CRT and describe distinct CMR-based phenotypes of CRT candidates based on sex and non-ischemic/ischemic cardiomyopathy type. Materials and methods: In a prospective study, sex-based differences in three short-term CRT response measures [fractional change in left ventricular end-systolic volume index 6 months after CRT (LVESVI-FC), B-type natriuretic peptide (BNP) 6 months after CRT, change in peak VO2 6 months after CRT], and long-term survival were evaluated with respect to 39 baseline parameters from CMR, exercise testing, laboratory testing, electrocardiograms, comorbid conditions, and other sources. CMR was also used to quantify the degree of left-ventricular mechanical dyssynchrony by deriving the circumferential uniformity ratio estimate (CURE-SVD) parameter from displacement encoding with stimulated echoes (DENSE) strain imaging. Statistical methods included multivariable linear regression with evaluation of interaction effects associated with sex and cardiomyopathy type (ischemic and non-ischemic cardiomyopathy) and survival analysis. Results: Among 200 patients, the 54 female patients (27%) pre-CRT had a smaller CMR-based LVEDVI (p = 0.04), more mechanical dyssynchrony based on the validated CMR CURE-SVD parameter (p = 0.04), a lower frequency of both late gadolinium enhancement (LGE) and ischemic cardiomyopathy (p < 0.0001), a greater RVEF (p = 0.02), and a greater frequency of LBBB (p = 0.01). After categorization of patients into four groups based on cardiomyopathy type (ischemic/non-ischemic cardiomyopathy) and sex, female patients with non-ischemic cardiomyopathy had the lowest CURE-SVD (p = 0.003), the lowest pre-CRT BNP levels (p = 0.01), the lowest post-CRT BNP levels (p = 0.05), and the most favorable LVESVI-FC (p = 0.001). Overall, female patients had better 3-year survival before adjustment for cardiomyopathy type (p = 0.007, HR = 0.45) and after adjustment for cardiomyopathy type (p = 0.009, HR = 0.67). Conclusion: CMR identifies distinct phenotypes of female CRT patients with non-ischemic and ischemic cardiomyopathy relative to male patients stratified by cardiomyopathy type. The more favorable short-term response and long-term survival outcomes in female heart failure patients with CRT were associated with lower indexed CMR-based LV volumes, decreased presence of scar associated with prior myocardial infarction and ICM, and greater CMR-based dyssynchrony with the CURE-SVD.
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OBJECTIVES: The objective was to determine the feasibility and effectiveness of cardiac magnetic resonance (CMR) cine and strain imaging before and after cardiac resynchronization therapy (CRT) for assessment of response and the optimal resynchronization pacing strategy. BACKGROUND: CMR with cardiac implantable electronic devices can safely provide high-quality right ventricular/left ventricular (LV) ejection fraction (RVEF/LVEF) assessments and strain. METHODS: CMR with cine imaging, displacement encoding with stimulated echoes for the circumferential uniformity ratio estimate with singular value decomposition (CURE-SVD) dyssynchrony parameter, and scar assessment was performed before and after CRT. Whereas the pre-CRT scan constituted a single "imaging set" with complete volumetric, strain, and scar imaging, multiple imaging sets with complete strain and volumetric data were obtained during the post-CRT scan for biventricular pacing (BIVP), LV pacing (LVP), and asynchronous atrial pacing modes by reprogramming the device outside the scanner between imaging sets. RESULTS: 100 CMRs with a total of 162 imaging sets were performed in 50 patients (median age 70 years [IQR: 50-86 years]; 48% female). Reduction in LV end-diastolic volumes (P = 0.002) independent of CRT pacing were more prominent than corresponding reductions in right ventricular end-diastolic volumes (P = 0.16). A clear dependence of the optimal CRT pacing mode (BIVP vs LVP) on the PR interval (P = 0.0006) was demonstrated. The LVEF and RVEF improved more with BIVP than LVP with PR intervals ≥240 milliseconds (P = 0.025 and P = 0.002, respectively); the optimal mode (BIVP vs LVP) was variable with PR intervals <240 milliseconds. A lower pre-CRT displacement encoding with stimulated echoes (DENSE) CURE-SVD was associated with greater improvements in the post-CRT CURE-SVD (r = -0.69; P < 0.001), LV end-systolic volume (r = -0.58; P < 0.001), and LVEF (r = -0.52; P < 0.001). CONCLUSIONS: CMR evaluation with assessment of multiple pacing modes during a single scan after CRT is feasible and provides useful information for patient care with respect to response and the optimal pacing strategy.
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Terapia de Ressincronização Cardíaca , Insuficiência Cardíaca , Idoso , Terapia de Ressincronização Cardíaca/métodos , Feminino , Insuficiência Cardíaca/diagnóstico por imagem , Insuficiência Cardíaca/terapia , Humanos , Espectroscopia de Ressonância Magnética , Masculino , Valor Preditivo dos Testes , Volume Sistólico , Resultado do Tratamento , Função Ventricular EsquerdaRESUMO
INTRODUCTION: Thermally induced cardiac lesions result in necrosis, edema, and inflammation. This tissue change may be seen with ultrasound. In this study, we sought to use intracardiac echocardiography (ICE) to evaluate pulmonary vein tissue morphology and assess the acute tissue changes that occur following radiofrequency (RF) or laser ablation for atrial fibrillation (AF). METHODS AND RESULTS: Patients with AF underwent pulmonary vein isolation (PVI) using irrigated RF or laser balloon. Pre- and post-ablation ICE imaging was performed from within each pulmonary vein (PV). At least 10 transverse imaging planes per PV were evaluated and each plane was divided into eight segments. The PV/atrial wall thickness and the luminal area were measured at each segment. Twenty-seven patients underwent PVI (15 with laser, 12 with RF). Ninety-eight pulmonary veins were analyzed (58 PVs laser; 40 PVs RF). At baseline, there were no regional differences in PV wall thickness in the right-sided veins. The anterior regions of left superior pulmonary vein (LSPV) and left inferior pulmonary vein (LIPV) were significantly thicker compared with the posterior and inferior regions (p < .01). Post-ablation, PV wall thickness in RF group increased 24.1% interquartile range (IQR) (17.2%-36.7%) compared with 1.2% IQR (0.4%-8.9%) in laser group, p = .004. In all PVs, RF ablation resulted in significantly greater percent increase in wall thickness compared with laser. Additionally, RF resulted in more variable changes in regional PV wall thickness; with more increases in wall thickness in anterior versus posterior LSPV (75.4 ± 58.5% vs. 46.8 ± 55.6%, p < .01), anterior versus posterior right superior pulmonary vein (RSPV) (62.9 ± 63.9% vs. 44.6 ± 51.7%, p < .05), and superior versus inferior RSPV (69.1 ± 45.4% vs. 35.9 ± 45%, p < .05). There were no significant regional differences in PV wall thickness changes for the laser group. CONCLUSIONS: Rotational ICE can be used to measure acute tissue changes with ablation. Regional variability in baseline wall thickness was nonuniformly present in PVs. Acute tissue changes occurred immediately post-ablation. Compared with laser balloon, RF shows markedly more thickening post-ablation with significant regional variations.
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Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Humanos , Lasers , Veias Pulmonares/diagnóstico por imagem , Veias Pulmonares/cirurgia , Resultado do TratamentoRESUMO
OBJECTIVES: This study sought to determine if combining the Seattle Heart Failure Model (SHFM-D) and cardiac magnetic resonance (CMR) provides complementary prognostic data for patients with cardiac resynchronization therapy (CRT) defibrillators. BACKGROUND: The SHFM-D is among the most widely used risk stratification models for overall survival in patients with heart failure and implantable cardioverter-defibrillators (ICDs), and CMR provides highly detailed information regarding cardiac structure and function. METHODS: CMR Displacement Encoding with Stimulated Echoes (DENSE) strain imaging was used to generate the circumferential uniformity ratio estimate with singular value decomposition (CURE-SVD) circumferential strain dyssynchrony parameter, and the SHFM-D was determined from clinical parameters. Multivariable Cox proportional hazards regression was used to determine adjusted hazard ratios and time-dependent areas under the curve for the primary endpoint of death, heart transplantation, left ventricular assist device, or appropriate ICD therapies. RESULTS: The cohort consisted of 100 patients (65.5 [interquartile range 57.7 to 72.7] years; 29% female), of whom 47% had the primary clinical endpoint and 18% had appropriate ICD therapies during a median follow-up of 5.3 years. CURE-SVD and the SHFM-D were independently associated with the primary endpoint (SHFM-D: hazard ratio: 1.47/SD; 95% confidence interval: 1.06 to 2.03; p = 0.02) (CURE-SVD: hazard ratio: 1.54/SD; 95% confidence interval: 1.12 to 2.11; p = 0.009). Furthermore, a favorable prognostic group (Group A, with CURE-SVD <0.60 and SHFM-D <0.70) comprising approximately one-third of the patients had a very low rate of appropriate ICD therapies (1.5% per year) and a greater (90%) 4-year survival compared with Group B (CURE-SVD ≥0.60 or SHFM-D ≥0.70) patients (p = 0.02). CURE-SVD with DENSE had a stronger correlation with CRT response (r = -0.57; p < 0.0001) than CURE-SVD with feature tracking (r = -0.28; p = 0.004). CONCLUSIONS: A combined approach to risk stratification using CMR DENSE strain imaging and a widely used clinical risk model, the SHFM-D, proved to be effective in this cohort of patients referred for CRT defibrillators. The combined use of CMR and clinical risk models represents a promising and novel paradigm to inform prognosis and device selection in the future.
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Arritmias Cardíacas/prevenção & controle , Terapia de Ressincronização Cardíaca , Técnicas de Apoio para a Decisão , Cardioversão Elétrica , Insuficiência Cardíaca/terapia , Imagem Cinética por Ressonância Magnética , Idoso , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/mortalidade , Arritmias Cardíacas/fisiopatologia , Terapia de Ressincronização Cardíaca/efeitos adversos , Terapia de Ressincronização Cardíaca/mortalidade , Dispositivos de Terapia de Ressincronização Cardíaca , Desfibriladores Implantáveis , Cardioversão Elétrica/efeitos adversos , Cardioversão Elétrica/instrumentação , Cardioversão Elétrica/mortalidade , Feminino , Insuficiência Cardíaca/diagnóstico por imagem , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: ECG imaging (ECGI) with phase mapping has been used to identify rotational activity non-invasively that can be targeted during atrial fibrillation (AF) ablation. Acute termination of AF using this method has shown improved clinical outcomes. In this study we sought to evaluate whether patterns of rotational density are associated with acute procedural outcomes when using a step-wise ablation strategy. METHODS: 50 patients with persistent or long-standing persistent AF underwent non-invasive 3D mapping with CardioInsight™ prior to AF ablation. Composite maps of rotational activity were created and prioritized based on the density of rotations on a biatrial model. Stepwise ablation of pulmonary vein isolation (PVI)⯱â¯rotations ± linear lesions was done with AF termination as the procedural endpoint. RESULTS: Acute termination of AF was achieved in 34 patients (68%). Median number of rotations in the left atrium (LA), interatrial septum and right atrium (RA) were 22.2 (9.4 to 29.3), 12.0 (4.3 to 13.4), 25.0 (14.5 to 31.3), respectively. In patients with acute AF termination, a higher number of rotations in the LA was observed, 20.3 (10.0 to 37.1) compared to 10.6 (7.7 to 17.2) in the RA (pâ¯=â¯0.02). Additionally, high density of rotations in the posterior inferior right atrium (segment 2B on the biatrial model) was observed in patients without acute AF termination (pâ¯=â¯0.02). CONCLUSION: Acute termination of persistent and long-standing persistent AF using rotational ablation guided by ECGI phase mapping can be achieved in a high percentage of both index and re-do cases. The distribution and pattern of these rotations may be associated with procedural outcomes and could potentially be used to stratify patients.
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Fibrilação Atrial , Ablação por Cateter , Eletrocardiografia , Veias Pulmonares , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/cirurgia , Humanos , Veias Pulmonares/cirurgia , Resultado do TratamentoRESUMO
AIMS: Controversy on the optimal ablation strategy for persistent atrial fibrillation (AF) exists with limited work evaluating a strategy of pulmonary vein isolation (PVI) alone when AF terminates during PVI. Thirty-five patients had AF termination during PVI in the Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation (MAGIC-AF; ClinicalTrials.gov number: NCT01014741) study. The objective of the current study is to report the 1-year outcome after PVI alone in this unique patient group. METHODS AND RESULTS: The 1-year single procedure freedom from atrial arrhythmia off anti-arrhythmic drugs was reported for the 35 patients in the MAGIC-AF study with persistent AF termination during or upon completion of PVI. Freedom from recurrent atrial arrhythmia was achieved in 60% of patients where AF terminated during PVI. Cavotricuspid isthmus flutter was common when AF terminated to a macro re-entrant flutter during PVI, and responsible for 92% of all flutter circuits with AF termination. CONCLUSIONS: Persistent AF termination during PVI may identify a subgroup of patients who experience a similar long-term clinical outcome with PVI ablation alone when compared with other more extensive persistent AF ablation strategies. Pulmonary vein isolation alone may be an appropriate tactic in this subgroup of persistent AF patients.
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Fibrilação Atrial/cirurgia , Ablação por Cateter , Veias Pulmonares/cirurgia , Potenciais de Ação , Idoso , Antiarrítmicos/uso terapêutico , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Flutter Atrial/etiologia , Canadá , Ablação por Cateter/efeitos adversos , Intervalo Livre de Doença , Método Duplo-Cego , Eletrocardiografia Ambulatorial , Técnicas Eletrofisiológicas Cardíacas , Feminino , Frequência Cardíaca , Humanos , Masculino , Pessoa de Meia-Idade , Veias Pulmonares/fisiopatologia , Recidiva , Sistema de Registros , República da Coreia , Fatores de Tempo , Resultado do Tratamento , Estados UnidosRESUMO
INTRODUCTION: Atrial fibrillation (AF) ablation is less frequently performed in women when compared to men. There are conflicting data on the safety and efficacy of AF ablation in women. The objective of this study was to compare the clinical characteristics and outcomes in a contemporary cohort of men and women undergoing persistent AF ablation procedures. METHODS AND RESULTS: A total of 182 men and 53 women undergoing a first-ever persistent AF catheter ablation procedure in The Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation (MAGIC-AF) trial were evaluated. Clinical and procedural characteristics were compared between each gender. The primary efficacy endpoint was the 1-year single procedure freedom from atrial arrhythmia off anti-arrhythmic drugs. Women undergoing catheter ablation procedures were older than men (P < 0.001). The duration of AF and associated co-morbidities were similar between both genders. Single procedure drug-free atrial arrhythmia recurrence occurred in 53% of the cohort with no difference based on gender (men = 54%, women = 53%; P = 1.0). Procedural (P = 0.04), fluoroscopic (P = 0.02), and ablation times (P = 0.003) were shorter in women compared to men. Periprocedural complications and postablation improvement in quality of life were similar between men and women. CONCLUSION: Women undergoing a first-ever persistent AF ablation procedure were older but had similar clinical outcomes and complications when compared with men.
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AIMS: Complex fractionated atrial electrograms (CFAE) are targeted during persistent atrial fibrillation (AF) ablation. However, many CFAE sites are non-specific resulting in extensive ablation. Ibutilide has been shown to reduce left atrial surface area exhibiting CFAE. We hypothesized that ibutilide administration prior to CFAE ablation would identify sites critical for persistent AF maintenance allowing for improved procedural efficacy and long-term freedom from atrial arrhythmias. METHODS AND RESULTS: Two hundred patients undergoing a first-ever persistent AF catheter ablation procedure were randomly assigned to receive either 0.25 mg of intravenous ibutilide or saline placebo upon completion of pulmonary vein isolation. Complex fractionated atrial electrogram sites were then targeted with ablation. The primary efficacy endpoint was the 1-year single procedure freedom from atrial arrhythmia off anti-arrhythmic drugs. Similar procedural characteristics (procedure, fluoroscopy, and ablation times) were observed with both strategies despite a greater reduction in left atrial surface area with CFAE sites (8 vs. 1%, P < 0.0001) and AF termination during CFAE ablation with ibutilide compared with placebo (75 vs. 57%, P = 0.007). The primary efficacy endpoint was achieved in 56% of patients receiving ibutilide and 49% receiving placebo (P = 0.35). No significant differences in peri-procedural complications were observed in both groups. CONCLUSION: Despite a reduction in CFAE area and greater AF termination during CFAE ablation, procedural characteristics and clinical outcomes were unchanged when CFAE ablation was guided by ibutilide administration. CLINICAL TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov number: NCT01014741.
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Fibrilação Atrial/tratamento farmacológico , Sulfonamidas/uso terapêutico , Ablação por Cateter , Doença Crônica , Técnicas Eletrofisiológicas Cardíacas , Humanos , Veias Pulmonares , Resultado do TratamentoRESUMO
INTRODUCTION: Visually guided laser balloon (VGLB) ablation is unique in that the operator delivers ablative energy under direct visual guidance. In this multicenter study, we sought to determine the feasibility, efficacy, and safety of performing pulmonary vein isolation (PVI) using this VGLB. METHODS: Patients with symptomatic, drug-refractory paroxysmal atrial fibrillation (AF) underwent PVI using the VGLB with the majority of operators conducting their first-ever clinical VGLB cases. The primary effectiveness endpoint was defined as freedom from treatment failure that included: Occurrence of symptomatic AF episodes ≥1 minutes beyond the 90-day blanking, the inability to isolate 1 superior and 2 total PVs, occurrence of left atrial flutter or atrial tachycardia, or left atrial ablation/surgery during follow-up. RESULTS: A total of 86 patients (mean age 56 ± 10 years, 67% male) were treated with the VGLB at 10 US centers. Mean fluoroscopy, ablation, and procedure times were 39.8 ± 24.3 minutes, 205.2 ± 61.7 minutes, and 253.5 ± 71.3 minutes, respectively. Acute PVI was achieved in 314/323 (97.2%) of targeted PVs. Of 84 patients completing follow-up, the primary effectiveness endpoint was achieved in 50 (60%) patients. Freedom from symptomatic or asymptomatic AF was 61%. The primary adverse event rate was 16.3% (8.1% pericarditis, phrenic nerve injury 5.8%, and cardiac tamponade 3.5%). There were no cerebrovascular events, atrioesophageal fistulas, or significant PV stenosis. CONCLUSIONS: This multicenter study of operators in the early stage of the learning curve demonstrates that PVI can be achieved with the VGLB with a reasonable safety profile and an efficacy similar to radiofrequency ablation.
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Hybrid strategies involving surgical and catheter ablation of atrial fibrillation (AF) are rapidly evolving. Hybrid techniques may improve procedural success and minimize risks by combining the strengths and minimizing limitations of either surgical or catheter ablation alone. Further study, including randomized controlled trials, will be necessary to determine the optimal approach to hybrid ablation.
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Riata and Riata ST defibrillator leads (St. Jude Medical, Sylmar, California) were recalled in 2011 due to increased risk of insulation failure leading to externalized cables. Fluoroscopic screening can identify insulation failure, although the relation between mechanical failure and electrical failure is unclear. At the time of the recall, the University of Virginia developed a screening program, including fluoroscopic evaluation, education sessions, device interrogation, and remote monitoring for patients with this defibrillator lead. The aim of this study was to review the outcomes of the screening program, including costs, which were absorbed by our institution. Costs were calculated using Medicare reimbursement estimates. Forty-eight patients participated in the screening program. At initial screening, 31% were found to have evidence of insulation failure but electrical function was normal in all leads. The cost of this program was $35,358.72. The cost per diagnosis of mechanical lead failure was $2,357.25. During 2 years of follow-up, 1 patient experienced Riata lead electrical failure without fluoroscopic evidence of insulation failure. Patients were more likely to have a lead revision if there was evidence of insulation failure. Lead revisions occurred at the time of generator change in 88% of patients with insulation failure but in only 14% of patients with a fluoroscopically normal lead (p = 0.04). The cost of recall-related defibrillator lead revisions was $81,704.55. In conclusion, our Riata screening program added expense without clear benefit to patients. In fact, patients may have been put at more risk by undergoing defibrillator lead revisions based solely on the results of the fluoroscopic screening.
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Desfibriladores Implantáveis/economia , Recall de Dispositivo Médico , Custos e Análise de Custo , Desenho de Equipamento , Falha de Equipamento , Feminino , Humanos , Masculino , Estudos Retrospectivos , Estados Unidos , United States Food and Drug AdministrationRESUMO
OBJECTIVES: Using cardiac magnetic resonance (CMR), we sought to evaluate the relative influences of mechanical, electrical, and scar properties at the left ventricular lead position (LVLP) on cardiac resynchronization therapy (CRT) response and clinical events. BACKGROUND: CMR cine displacement encoding with stimulated echoes (DENSE) provides high-quality strain for overall dyssynchrony (circumferential uniformity ratio estimate [CURE] 0 to 1) and timing of onset of circumferential contraction at the LVLP. CMR DENSE, late gadolinium enhancement, and electrical timing together could improve upon other imaging modalities for evaluating the optimal LVLP. METHODS: Patients had complete CMR studies and echocardiography before CRT. CRT response was defined as a 15% reduction in left ventricular end-systolic volume. Electrical activation was assessed as the time from QRS onset to LVLP electrogram (QLV). Patients were then followed for clinical events. RESULTS: In 75 patients, multivariable logistic modeling accurately identified the 40 patients (53%) with CRT response (area under the curve: 0.95 [p < 0.0001]) based on CURE (odds ratio [OR]: 2.59/0.1 decrease), delayed circumferential contraction onset at LVLP (OR: 6.55), absent LVLP scar (OR: 14.9), and QLV (OR: 1.31/10 ms increase). The 33% of patients with CURE <0.70, absence of LVLP scar, and delayed LVLP contraction onset had a 100% response rate, whereas those with CURE ≥0.70 had a 0% CRT response rate and a 12-fold increased risk of death; the remaining patients had a mixed response profile. CONCLUSIONS: Mechanical, electrical, and scar properties at the LVLP together with CMR mechanical dyssynchrony are strongly associated with echocardiographic CRT response and clinical events after CRT. Modeling these findings holds promise for improving CRT outcomes.
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Terapia de Ressincronização Cardíaca/métodos , Sistema de Condução Cardíaco/fisiopatologia , Insuficiência Cardíaca/terapia , Função Ventricular Esquerda/fisiologia , Remodelação Ventricular , Idoso , Ecocardiografia , Eletrocardiografia , Feminino , Seguimentos , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/fisiopatologia , Humanos , Imagem Cinética por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Volume Sistólico , Resultado do TratamentoRESUMO
PURPOSE: Riata and Riata ST defibrillator leads (St. Jude Medical, Sylmar, CA, USA) have been recalled due to increased risk of insulation failure leading to externalized cables. As this mechanical failure does not necessarily correlate with electrical failure, it can be difficult to diagnose. Fluoroscopic screening can identify insulation failure. Studies have suggested that insulation failure is predominantly seen in 8-Fr, single-coil models. Our patients have exclusively dual-coil leads and a high proportion of 7-Fr leads. METHODS: Fluoroscopic screening was performed in 48 patients with recalled Riata leads. Twenty-three patients had 8-Fr Riata leads and 25 patients had 7-Fr Riata ST leads. Images were recorded in at least three projections and studies were reviewed by seven attending electrophysiologists. RESULTS: Externalized cables were seen in ten patients (21 %), and another five patients (10 %) had abnormal cable spacing. All device interrogations showed normal parameters. Patients with abnormal leads had more leads in situ (2.5 ± 0.7 vs. 1.6 ± 0.8 leads; P = 0.002) and a higher rate of nonischemic cardiomyopathy (80 vs. 24 %; P = 0.03). There were no differences between the groups with regards to patient age, body mass index, lead age, lead parameters, or vascular access site. There was no difference with regard to lead size (P = 0.76). CONCLUSIONS: The Riata family of leads has a high incidence of mechanical failure, as demonstrated on fluoroscopic screening. In this study, the 7-Fr models were just as likely to mechanically fail as the 8-Fr models. Increasing lead burden and a diagnosis of nonischemic cardiomyopathy correlated with insulation failure.
Assuntos
Desfibriladores Implantáveis , Eletrodos Implantados , Análise de Falha de Equipamento/métodos , Falha de Equipamento , Fluoroscopia/métodos , Coração/diagnóstico por imagem , Recall de Dispositivo Médico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição de Risco , Estatística como AssuntoRESUMO
BACKGROUND: The Congestive heart failure, Hypertension, Age ≥ 75 years, Diabetes mellitus, Stroke (CHADS(2)) score is used to predict the need for oral anticoagulation for stroke prophylaxis in patients with atrial fibrillation. The Congestive heart failure, Hypertension, Age ≥ 75 years, Diabetes mellitus, Stroke, Vascular disease, Age 65-74 years, Sex category (CHA(2)DS(2)-VASc) schema has been proposed as an improvement. Our objective is to determine how adoption of the CHA(2)DS(2)-VASc score alters anticoagulation recommendations. METHODS: Between 2004 and 2008, 1664 patients were seen at the University of Virginia Atrial Fibrillation Center. We calculated the CHADS(2) and CHA(2)DS(2)-VASc scores for each patient. The 2006 American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for atrial fibrillation management were used to determine anticoagulation recommendations based on the CHADS(2) score, and the 2010 European Society of Cardiology guidelines were used to determine anticoagulation recommendations based on the CHA(2)DS(2)-VASc score. RESULTS: The average age was 62±13 years, and 34% were women. Average CHADS(2) and CHA(2)DS(2)-VASc scores were 1.1±1.1 and 1.8±1.5, respectively (P<.0001). The CHADS(2) score classified 33% as requiring oral anticoagulation. The CHA(2)DS(2)-VASc score classified 53% as requiring oral anticoagulation. For women, 31% had a CHADS(2) score ≥ 2, but 81% had a CHA(2)DS(2)-VASc score ≥ 2 (P = .0001). Also, 32% of women with a CHADS(2) score of zero had a CHA(2)DS(2)-VASc score ≥ 2. For men, 25% had a CHADS(2) score ≥ 2, but 39% had a CHA(2)DS(2)-VASc score ≥ 2 (P<.0001). CONCLUSION: Compared with the CHADS(2) score, the CHA(2)DS(2)-VASc score more clearly defines anticoagulation recommendations. Many patients, particularly older women, are redistributed from the low- to high-risk categories.
Assuntos
Anticoagulantes/administração & dosagem , Fibrilação Atrial/complicações , Complicações do Diabetes/prevenção & controle , Insuficiência Cardíaca/complicações , Hipertensão/complicações , Guias de Prática Clínica como Assunto , Acidente Vascular Cerebral/prevenção & controle , Administração Oral , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Fibrilação Atrial/epidemiologia , Comorbidade , Complicações do Diabetes/epidemiologia , Complicações do Diabetes/etiologia , Esquema de Medicação , Europa (Continente) , Feminino , Insuficiência Cardíaca/epidemiologia , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto/normas , Valor Preditivo dos Testes , Prevenção Primária/métodos , Pontuação de Propensão , Medição de Risco , Fatores de Risco , Prevenção Secundária/métodos , Fatores Sexuais , Sociedades Médicas , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Estados Unidos , Varfarina/administração & dosagemRESUMO
BACKGROUND: Beyond pulmonary vein isolation (PVI), adjuvant ablation at the sites of complex fractionated atrial electrograms (CFAE) has been shown to improve the long-term success of catheter ablation of persistent atrial fibrillation (AF). However, this approach often requires extensive ablation due to the widespread distribution of CFAE within the left atrium. An optimal strategy would identify areas of CFAE which, when selectively targeted with ablation, result in AF termination with an acceptable long-term freedom from AF. It is possible that the intraprocedural administration of an antiarrhythmic drug may help accomplish this. OBJECTIVE: The Modified Ablation Guided by Ibutilide Use in Chronic AF (MAGIC-AF) Study is an international multicenter prospective randomized double-blinded clinical trial assessing the utility of the intraprocedural administration of 0.25 mg of intravenous ibutilide before performing CFAE ablation. The primary efficacy endpoint of this study will be the freedom from AF at 1 year after a single procedure off antiarrhythmic agents. Safety endpoints will include procedural and radiofrequency ablation time as well as overall procedural complication rate. METHODS: Patients undergoing a first ever catheter ablation procedure for persistent AF will be included. Individuals with hypertrophic cardiomyopathy, complex congenital heart disease including atrial septal defects, and ejection fraction <35% will be excluded from the study. All patients will first undergo PVI. Those patients who remain in AF will then be randomized in a 1:1 fashion to receive either 0.25 mg intravenous ibutilide or saline placebo followed by a CFAE based ablation strategy. Two hundred randomized patients will be enrolled in this study-100 in each study arm. CONCLUSION: The MAGIC-AF study will assess the utility of a combined pharmaco-ablative strategy in patients with persistent AF undergoing a CFAE based ablation strategy.
Assuntos
Antiarrítmicos/administração & dosagem , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/cirurgia , Ablação por Cateter , Projetos de Pesquisa , Sulfonamidas/administração & dosagem , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Canadá , Ablação por Cateter/efeitos adversos , Doença Crônica , Terapia Combinada , Método Duplo-Cego , Esquema de Medicação , Ecocardiografia , Eletrocardiografia Ambulatorial , Técnicas Eletrofisiológicas Cardíacas , Humanos , Infusões Intravenosas , Imageamento por Ressonância Magnética , Valor Preditivo dos Testes , Estudos Prospectivos , Veias Pulmonares/fisiopatologia , Veias Pulmonares/cirurgia , Recidiva , República da Coreia , Fatores de Tempo , Tomografia Computadorizada por Raios X , Resultado do Tratamento , Estados UnidosRESUMO
BACKGROUND: Management of symptomatic atrial arrhythmia in pregnancy remains a challenge. In this case report, a pregnant woman with incessant tachycardia underwent successful left atrial ablation. The entire procedure was performed without fluoroscopy. METHODS AND RESULTS: A 20-year-old woman, 27 weeks pregnant, was admitted with congestive cardiac failure and incessant atrial tachycardia. She had an elevated brain natriuretic peptide (BNP) and chest X-ray demonstrating heart failure. The 12-lead electrocardiogram (ECG) showed atrial tachycardia with a cycle length of 310 ms, inverted P waves in lead I and the inferior leads, and a ventricular rate of 84 bpm during 2:1 block. Echocardiogram showed a global reduction in left ventricular function with a left ventricular ejection fraction (LVEF) of 0.40. Electrical cardioversion failed. Rate control could not be achieved with beta-blockers and calcium antagonists. Amiodarone with repeat cardioversion was also unsuccessful. The patient then underwent catheter ablation. The entire procedure was performed using intracardiac echocardiography (ICE) and electroanatomical mapping with no fluoroscopy. Electrophysiology (EP) study and an activation map of the left atrium confirmed a focal left atrial tachycardia which was successfully ablated. Six weeks postablation, the left ventricular function had normalized and the patient delivered a healthy child at term, without complication. CONCLUSION: Ablation of left atrial tachycardia using ICE and electroanatomical guidance is feasible in pregnant women.