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1.
J Cardiovasc Electrophysiol ; 34(1): 44-53, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-36259713

RESUMEN

BACKGROUND: Renal denervation (RDN) can reduce cardiac sympathetic activity maintained by arterial hypertension (aHT). Its potential antiarrhythmic effect on rhythm outcome in patients with multi-drug resistant aHT undergoing catheter ablation for atrial fibrillation (AF) is unclear. METHODS: The RDN+AF study was a prospective, randomized, two-center trial. Patients with paroxysmal or persistent AF and uncontrolled aHT (mean systolic 24-h ambulatory BP > 135 mmHg) despite taking at least three antihypertensive drugs were enrolled. Patients were 1:2 randomized to either RDN+AF ablation or AF-only ablation. Primary endpoint was freedom from any AF episode > 2 min at 12 months assessed by implantable loop recorder (ILR) or 7d-holter electrocardiogram. Secondary endpoints included rhythm outcome at 24 months, blood pressure control, periprocedural complications, and renovascular safety. RESULTS: The study randomized 61 patients (mean age 65 ± 9 years, 53% men). At 12 months, RDN+AF patients tended to have a greater decrease in ambulatory BPs but did not reach statistical significance. No differences in rhythm outcome were observed. Freedom from AF recurrence in the RDN+AF and AF-only group measured 61% versus 53% p = .622 at 12 months and 39% versus 47% p = .927 at 24 months, respectively. Periprocedural complications occurred in 9/61 patients (15%). No patient died. CONCLUSION: Among patients with multidrug-resistant aHT and paroxysmal or persistent AF, concomitant RDN+AF ablation was not associated with better blood pressure control or rhythm outcome in comparison to AF-only ablation and medical therapy.


Asunto(s)
Fibrilación Atrial , Ablación por Catéter , Hipertensión , Masculino , Humanos , Persona de Mediana Edad , Anciano , Femenino , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Fibrilación Atrial/complicaciones , Estudios Prospectivos , Resultado del Tratamiento , Hipertensión/diagnóstico , Hipertensión/cirugía , Simpatectomía/efectos adversos , Ablación por Catéter/efectos adversos , Recurrencia
2.
Circ Res ; 129(8): 804-820, 2021 10.
Artículo en Inglés | MEDLINE | ID: mdl-34433292
3.
Europace ; 23(9): 1400-1408, 2021 09 08.
Artículo en Inglés | MEDLINE | ID: mdl-33693595

RESUMEN

AIMS: To characterize the association of phasic left atrial (LA) transport function and LA fibrosis guided by multimodality imaging containing cardiac magnetic resonance imaging (CMR) feature tracking and bipolar voltage mapping. METHODS AND RESULTS: Consecutive patients presenting for first-time ablation of atrial fibrillation (AF) were prospectively enrolled. Each patient underwent CMR prior to the ablation procedure. LA phasic indexed volumes (LA-Vi) and emptying fractions (LA-EF) were calculated and CMR feature tracking guided LA wall motion analysis was performed. LA bipolar voltage mapping was carried out in sinus rhythm to find areas of low voltage as a surrogate for fibrosis and arrhythmogenesis. One hundred and sixty-eight patients were enrolled. Low-voltage areas (LVAs) were present in 70 patients (42%). Contrary to LA volume, CMR based LA-EF [odds ratio (OR) 0.88, 95% confidence interval (CI) 0.80-0.96, P = 0.005] and LA booster pump strain rate (SR) (OR 0.98, 95% CI 0.97-0.99, P = 0.001) significantly predicted presence and extent of LVA in multivariate logistic regression analysis for patients scanned in SR. In receiver operating characteristic analysis, LA-EF <40% carried a sensitivity of 83% and specificity of 76% (area under the curve 0.8; 95% CI 0.71-0.89) to predict presence of LVA. For patients scanned in AF only minimal LA-Vi on CMR (OR: 1.06; 95% CI: 1.02-1.10; P = 0.002) predicted presence of LVA. CONCLUSION: For patients scanned in SR LA-EF and LA booster pump SR are closely linked to the presence and extent of LA LVA.


Asunto(s)
Fibrilación Atrial , Ablación por Catéter , Fibrilación Atrial/cirugía , Función del Atrio Izquierdo , Fibrosis , Atrios Cardíacos/cirugía , Humanos , Espectroscopía de Resonancia Magnética
4.
J Cardiovasc Electrophysiol ; 31(3): 705-711, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-31943494

RESUMEN

BACKGROUND: The role of atrial arrhythmia inducibility as an endpoint of catheter ablation of atrial fibrillation (AF) has been a controversial subject in many studies. Our goal is to evaluate the significance of inducibility, the impact of multiple sites or protocols of stimulation or the change in inducibility status in a prospective study including patients with AF undergoing first catheter ablation. METHODS: We studied 170 consecutive patients with AF (62.9% paroxysmal) undergoing catheter ablation. All patients underwent two separate stimulation protocols before and after the ablation from the coronary sinus ostium and the left atrial appendage: burst pacing at 300, 250, 200 milliseconds (or until refractoriness) for 10 seconds and ramp decrementing from 300 to 200 milliseconds in increments of 10 milliseconds every three beats for 10 seconds. Inducibility was defined as any sustained AF or organized atrial tachycardia (AT) lasting >30 seconds. RESULTS: We had AF/AT inducibility in 55 patients at baseline compared to 36 following ablation. After a mean of 41, 3 months follow-up, 115 patients were free of AF. Inducibility before or after the ablation or change in inducibility status did not influence AF recurrence. There were no significant differences regarding paroxysmal or persistent patients with AF. CONCLUSIONS: Non-inducibility of atrial arrhythmia or change in inducibility status following pulmonary vein (PV) isolation and substrate modification are not associated with long-term freedom from recurrent arrhythmia. Therefore, the use of induction of an endpoint in AF ablation is limited.


Asunto(s)
Fibrilación Atrial/cirugía , Estimulación Cardíaca Artificial , Ablación por Catéter , Técnicas Electrofisiológicas Cardíacas , Venas Pulmonares/cirugía , Potenciales de Acción , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/fisiopatología , Ablación por Catéter/efectos adversos , Femenino , Frecuencia Cardíaca , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Venas Pulmonares/fisiopatología , Recurrencia , Factores de Riesgo , Resultado del Tratamiento
5.
J Cardiovasc Electrophysiol ; 31(4): 885-894, 2020 04.
Artículo en Inglés | MEDLINE | ID: mdl-32037614

RESUMEN

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.


Asunto(s)
Potenciales de Acción , Fibrilación Atrial/cirugía , Ablación por Catéter , Técnicas Electrofisiológicas Cardíacas , Frecuencia Cardíaca , Venas Pulmonares/cirugía , Anciano , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/fisiopatología , Ablación por Catéter/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Venas Pulmonares/fisiopatología , Recurrencia , Reoperación , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
6.
Europace ; 22(12): 1812-1821, 2020 12 23.
Artículo en Inglés | MEDLINE | ID: mdl-32830233

RESUMEN

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.


Asunto(s)
Fibrilación Atrial , Ablación por Catéter , Insuficiencia Cardíaca , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Femenino , Fibrosis , Insuficiencia Cardíaca/diagnóstico , Humanos , Masculino , Volumen Sistólico , Resultado del Tratamiento , Función Ventricular Izquierda
7.
Europace ; 22(6): 924-931, 2020 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-32044994

RESUMEN

AIMS: We report the collective European experience of percutaneous left atrial appendage (LAA) suture ligation using the recent generation LARIAT+ suture delivery device. METHODS AND RESULTS: A total of 141 patients with non-valvular atrial fibrillation and contraindication to oral anticoagulation (OAC), thrombo-embolic events despite OAC or electrical LAA isolation were enrolled at seven European hospitals to undergo LAA ligation. Patients were followed up by clinical visits and transoesophageal echocardiography (TOE) following LAA closure. Left atrial appendage ligation was completed in 138/141 patients (97.8%). Three patients did not undergo attempted deployment of the LARIAT device due to pericardial adhesion after previous epicardial ventricular tachycardia ablation (n = 1), a pericardial access-related complication (n = 1), and multiple posterior LAA lobes (n = 1). Serious 30-day procedural adverse events occurred in 4/141 patients (2.8%). There were two device-related LAA perforations (1.4%) not resulting in any corrective intervention as the LAA was completely sealed with the LARIAT. Minor adverse events occurred in 19 patients (13.5%), including two pericardial effusions due to procedure-related pericarditis requiring pericardiocentesis. Transoesophageal echocardiography was performed after LAA ligation in 103/138 patients (74.6%) after a mean of 181 ± 72 days. Complete LAA closure was documented in 100 patients (97.1%). Two patients (1.8% of patients with follow-up) experienced a transient ischaemic attack at 4 and 7 months follow-up, although there was no leak observed with TOE. There were two deaths during long-term follow-up which were both not device related. CONCLUSION: Initial experience with the LARIAT+ device demonstrates feasibility of LAA exclusion. Further larger prospective studies with longer follow-up are warranted.


Asunto(s)
Apéndice Atrial , Fibrilación Atrial , Apéndice Atrial/diagnóstico por imagen , Apéndice Atrial/cirugía , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Humanos , Ligadura , Estudios Prospectivos , Suturas , Resultado del Tratamiento
8.
Europace ; 21(10): 1459-1467, 2019 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-31377792

RESUMEN

Self-terminating atrial arrhythmias are commonly detected on continuous rhythm monitoring, e.g. by pacemakers or defibrillators. It is unclear whether the presence of these arrhythmias has therapeutic consequences. We sought to summarize evidence on the prevalence of atrial high-rate episodes (AHREs) and their impact on risk of stroke. We performed a comprehensive, tabulated review of published literature on the prevalence of AHRE. In patients with AHRE, but without atrial fibrillation (AF), we reviewed the stroke risk and the potential risk/benefit of oral anticoagulation. Atrial high-rate episodes are found in 10-30% of AF-free patients. Presence of AHRE slightly increases stroke risk (0.8% to 1%/year) compared with patients without AHRE. Atrial high-rate episode of longer duration (e.g. those >24 h) could be associated with a higher stroke risk. Oral anticoagulation has the potential to reduce stroke risk in patients with AHRE but is associated with a rate of major bleeding of 2%/year. Oral anticoagulation is not effective in patients with heart failure or survivors of a stroke without AF. It remains unclear whether anticoagulation is effective and safe in patients with AHRE. Atrial high-rate episodes are common and confer a slight increase in stroke risk. There is true equipoise on the best way to reduce stroke risk in patients with AHRE. Two ongoing trials (NOAH-AFNET 6 and ARTESiA) will provide much-needed information on the effectiveness and safety of oral anticoagulation using non-vitamin K antagonist oral anticoagulants in patients with AHRE.


Asunto(s)
Anticoagulantes/uso terapéutico , Fibrilación Atrial/epidemiología , Atrios Cardíacos/fisiopatología , Frecuencia Cardíaca/fisiología , Medición de Riesgo/métodos , Accidente Cerebrovascular/epidemiología , Fibrilación Atrial/complicaciones , Fibrilación Atrial/tratamiento farmacológico , Salud Global , Humanos , Prevalencia , Factores de Riesgo , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control
9.
BMC Cardiovasc Disord ; 19(1): 132, 2019 05 31.
Artículo en Inglés | MEDLINE | ID: mdl-31151383

RESUMEN

BACKGROUND: Historically, the majority of insertable cardiac monitor (ICM) procedures were performed in the cardiac catheterization (cath) lab, electrophysiology (EP) lab, or operating room (OR). The miniaturization of ICMs allows the procedure to be relocated within the hospital without compromising patient safety. We sought to estimate the rate of untoward events associated with procedures performed within the hospital but outside the traditional settings and to characterize resource utilization, procedure time intervals, and physician experience. METHODS: The Reveal LINQ in-Office 2 (RIO 2) International study was a single arm, multicenter, prospective study. Patients indicated for an ICM and willing to undergo device insertion outside the cath/EP lab or OR were eligible and followed for 90 days after insertion. RESULTS: A total of 191 patients (45.5% female aged 63.8 ± 26.9 years) underwent successful Reveal LINQ ICM insertion at 17 centers in Europe, Canada and Australia. The median total visit duration was 106 min (interquartile range [IQR]: 55-61). Patient preparation and patient education accounted for 10 min (IQR: 5-20) and 10 min (IQR: 8-15) of total visit duration, respectively. Preparation and education occurred in the procedure room for 90.6 and 60.2% of patients, respectively. There were no untoward events (0.0, 95% CI: 0.0-2.1%) though four patients presented with procedure-related adverse events that did not require invasive intervention. Physicians rated procedure location as convenient or very convenient. CONCLUSIONS: The Reveal LINQ™ ICM insertion can be safely and efficiently performed in the hospital outside the cath/EP lab or OR. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02412488 ; registered on April 9, 2015.


Asunto(s)
Electrocardiografía Ambulatoria/instrumentación , Procedimientos Quirúrgicos Operativos , Transductores , Tecnología Inalámbrica/instrumentación , Adulto , Anciano , Anciano de 80 o más Años , Actitud del Personal de Salud , Australia , Canadá , Diseño de Equipo , Europa (Continente) , Femenino , Conocimientos, Actitudes y Práctica en Salud , Humanos , Masculino , Persona de Mediana Edad , Miniaturización , Tempo Operativo , Educación del Paciente como Asunto , Seguridad del Paciente , Estudios Prospectivos , Factores de Riesgo , Procedimientos Quirúrgicos Operativos/efectos adversos , Factores de Tiempo , Flujo de Trabajo
10.
Pacing Clin Electrophysiol ; 42(7): 1038-1046, 2019 07.
Artículo en Inglés | MEDLINE | ID: mdl-31119745

RESUMEN

INTRODUCTION: We conducted this study to show the safety and efficacy of a new implantable cardiac monitor (ICM), the BioMonitor 2 (Biotronik SE & Co. KG; Berlin, Germany), and to describe the arrhythmia detection performance. METHODS: The BioMonitor 2 has an extended sensing vector and is implanted close to the heart. It can transmit up to six subcutaneous electrocardiogram strips by Home Monitoring each day. We enrolled 92 patients with a standard device indication for an ICM in a single-arm, multicenter prospective trial. Patients were followed for 3 months, and 48-h Holter recordings were used to evaluate the arrhythmia detection performance. RESULTS: One patient withdrew consent and in one patient, the implantation failed. Two study device-related serious adverse events were reported, satisfying the primary safety hypothesis. Implantations took 7.4 ± 4.4 min from skin cut to suture. At 1 week, the R-wave amplitude was 0.75 ± 0.53 mV. In the 82 patients with completed Holter recordings, all patients with arrhythmias were correctly identified. False positive detections of arrhythmia were mostly irregular rhythms wrongly detected as atrial fibrillation (episode-based positive predictive value 72.5%). Daily Home Monitoring transmission was 94.9% successful. CONCLUSION: Safety and efficacy of the new device has been demonstrated. The detected R-wave amplitudes are large, leading to a low level of inappropriate detections due to over- or undersensing.


Asunto(s)
Arritmias Cardíacas/diagnóstico , Electrocardiografía Ambulatoria/instrumentación , Diseño de Equipo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos
11.
Europace ; 20(6): 956-962, 2018 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-28605524

RESUMEN

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.


Asunto(s)
Fibrilación Atrial , Ablación por Catéter/métodos , Técnicas Electrofisiológicas Cardíacas/métodos , Atrios Cardíacos , Factores de Edad , Anciano , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/fisiopatología , Fibrilación Atrial/cirugía , Femenino , Atrios Cardíacos/patología , Atrios Cardíacos/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Tamaño de los Órganos , Prevalencia , Pronóstico , Venas Pulmonares/fisiopatología , Venas Pulmonares/cirugía , Factores de Riesgo , Factores Sexuales , Nodo Sinoatrial/fisiopatología
12.
Europace ; 20(FI_3): f312-f320, 2018 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-29688326

RESUMEN

Aims: To study device performance, arrhythmia recurrence characteristics, and methods of outcome assessment using a novel implantable cardiac monitor (ICM) in patients undergoing ablation for atrial fibrillation (AF). Methods and results: In 419 consecutive patients undergoing first-time catheter ablation for symptomatic paroxysmal (n = 224) or persistent (n = 195) AF an ICM was injected at the end of the procedure. Telemedicine staff ensured full episode transmission coverage and manually evaluated all automatic arrhythmia episodes. Device detection metrics were calculated for ≥2, ≥6, and ≥10 min AF detection durations. Four methods of outcome assessment were studied: continuous recurrence analysis, discontinuous recurrence analysis, AF-burden analysis, and analysis of individual rhythm profiles. A total of 43 673 automatic AF episodes were transmitted over a follow-up of 15 ± 6 months. Episode-based positive predictive values changed significantly with longer AF detection durations (70.5% for ≥2 min, 81.8% for ≥6 min, and 85.9% for ≥10 min). Patients with exclusive short episode recurrences (≥2 to <6 min) were rare and their arrhythmia detection was clinically irrelevant. Different methods of outcome assessment showed a large variation (46-79%) in ablation success. Individual rhythm characteristics and subclinical AF added to this inconsistency. Analysis of AF-burden and individual rhythm profiles were least influenced and showed successful treatment in 60-70% of the patients. Conclusion: We suggest AF detection duration >6 min and AF burden >0.1% as a standardized outcome definition for AF studies to come in the future.


Asunto(s)
Fibrilación Atrial/cirugía , Ablación por Catéter , Electrocardiografía Ambulatoria/métodos , Frecuencia Cardíaca , Telemedicina/métodos , Telemetría/métodos , Anciano , Antiarrítmicos/uso terapéutico , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/fisiopatología , Ablación por Catéter/efectos adversos , Equipo para Diagnóstico , Electrocardiografía Ambulatoria/instrumentación , Diseño de Equipo , Femenino , Frecuencia Cardíaca/efectos de los fármacos , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Recurrencia , Telemedicina/instrumentación , Telemetría/instrumentación , Factores de Tiempo , Resultado del Tratamiento
13.
Europace ; 20(11): 1766-1775, 2018 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-29177475

RESUMEN

Aims: This randomized single-centre study sought to compare the efficacy and safety of pulmonary vein isolation (PVI) plus voltage-guided ablation vs. PVI with or without linear ablation depending on the type of atrial fibrillation (AF). Methods and results: Overall, 124 ablation-naive patients with paroxysmal or persistent AF were randomized to PVI with (persistent AF) or without (paroxysmal AF) additional linear ablation (control group) vs. PVI plus ablation of low-voltage areas (LVAs) irrespective of AF type. Bipolar voltage mapping was performed during stable sinus rhythm. An LVA consisted of ≥ 3 adjacent mapping points that each had a peak-to-peak amplitude ≤0.5 mV. After a mean follow-up of 12 ± 3 months, significantly more patients in the LVA ablation group were free from atrial arrhythmia recurrence >30 s off antiarrhythmic drugs (AADs) after a single procedure (primary endpoint) compared with control group patients [40/59 (68%) vs. 25/59 (42%), log-rank P = 0.003]. Arrhythmia-free survival on or off AADs was found in 33/59 control group patients (56%) and in 41/59 LVA ablation group patients (70%) (adjusted log-rank P = 0.10). During the 7 day Holter monitoring period at 12 months, significantly more patients in the LVA ablation group were free from arrhythmia recurrence on or off AADs [45/50 (90%) vs. 33/46 (72%), P = 0.04]. No between-group differences were observed regarding procedure duration, fluoroscopy time, and major complications. Conclusion: In this single-centre study, individually tailored substrate modification guided by voltage mapping was associated with a significantly higher arrhythmia-free survival rate compared with a conventional approach applying linear ablation according to AF type.


Asunto(s)
Fibrilación Atrial , Ablación por Catéter , Complicaciones Posoperatorias , Anciano , Antiarrítmicos/uso terapéutico , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Supervivencia sin Enfermedad , Electrocardiografía Ambulatoria/métodos , Técnicas Electrofisiológicas Cardíacas/métodos , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/terapia , Venas Pulmonares/cirugía , Recurrencia , Resultado del Tratamiento
14.
Eur Radiol ; 27(5): 1954-1962, 2017 May.
Artículo en Inglés | MEDLINE | ID: mdl-27553931

RESUMEN

OBJECTIVES: To evaluate the feasibility of performing comprehensive Cardiac Magnetic resonance (CMR) guided electrophysiological (EP) interventions in a porcine model encompassing left atrial access. METHODS: After introduction of two femoral sheaths 14 swine (41 ± 3.6 kg) were transferred to a 1.5 T MR scanner. A three-dimensional whole-heart sequence was acquired followed by segmentation and the visualization of all heart chambers using an image-guidance platform. Two MR conditional catheters were inserted. The interventional protocol consisted of intubation of the coronary sinus, activation mapping, transseptal left atrial access (n = 4), generation of ablation lesions and eventually ablation of the atrioventricular (AV) node. For visualization of the catheter tip active tracking was used. Catheter positions were confirmed by passive real-time imaging. RESULTS: Total procedure time was 169 ± 51 minutes. The protocol could be completed in 12 swine. Two swine died from AV-ablation induced ventricular fibrillation. Catheters could be visualized and navigated under active tracking almost exclusively. The position of the catheter tips as visualized by active tracking could reliably be confirmed with passive catheter imaging. CONCLUSIONS: Comprehensive CMR-guided EP interventions including left atrial access are feasible in swine using active catheter tracking. KEY POINTS: • Comprehensive CMR-guided electrophysiological interventions including LA access were conducted in swine. • Active catheter-tracking allows efficient catheter navigation also in a transseptal approach. • More MR-conditional tools are needed to facilitate left atrial interventions in humans.


Asunto(s)
Técnicas Electrofisiológicas Cardíacas/métodos , Imagen por Resonancia Magnética Intervencional/métodos , Animales , Catéteres , Atrios Cardíacos , Imagen por Resonancia Magnética/métodos , Porcinos
15.
Europace ; 19(10): 1700-1709, 2017 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-27738070

RESUMEN

AIMS: In times of evolving cardiac resynchronization therapy, intra-procedural characterization of left ventricular (LV) mechanical activation patterns is desired but technically challenging with currently available technologies. In patients with normal systolic function, we evaluated the feasibility of characterizing LV wall motion using a novel sensor-based, real-time tracking technology. METHODS AND RESULTS: Ten patients underwent simultaneous motion and electrical mapping of the LV endocardium during sinus rhythm using electroanatomical mapping and navigational systems (EnSite™ NavX™ and MediGuide™, SJM). Epicardial motion data were also collected simultaneously at corresponding locations from accessible coronary sinus branches. Displacements at each mapping point and times of electrical and mechanical activation were combined over each of the six standard LV wall segments. Mechanical activation timing was compared with that from electrical activation and preoperative 2D speckle tracking echocardiography (echo). MediGuide-based displacement data were further analysed to estimate LV chamber volumes that were compared with echo and magnetic resonance imaging (MRI). The lateral and septal walls exhibited the largest (12.5 [11.6-15.0] mm) and smallest (10.2 [9.0-11.3] mm) displacement, respectively. Radial displacement was significantly larger endocardially than epicardially (endo: 6.7 [5.0-9.1] mm; epi: 3.8 [2.4-5.6] mm), while longitudinal displacement was significantly larger epicardially (endo: 8.0 [5.0-10.6] mm; epi: 10.3 [7.4-13.8] mm). Most often, the anteroseptal/anterior and lateral walls showed the earliest and latest mechanical activations, respectively. 9/10 patients had concordant or adjacent wall segments of latest mechanical and electrical activation, and 6/10 patients had concordant or adjacent wall segments of latest mechanical activation as measured by MediGuide and echo. MediGuide's LV chamber volumes were significantly correlated with MRI (R2= 0.73, P < 0.01) and echo (R2= 0.75, P < 0.001). CONCLUSION: The feasibility of mapping-guided intra-procedural characterization of LV wall motion was established. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov; Unique identifier: CT01629160.


Asunto(s)
Potenciales de Acción , Fenómenos Electromagnéticos , Monitoreo Ambulatorio/instrumentación , Telemetría/instrumentación , Transductores , Función Ventricular Izquierda , Anciano , Ecocardiografía , Técnicas Electrofisiológicas Cardíacas , Diseño de Equipo , Estudios de Factibilidad , Femenino , Frecuencia Cardíaca , Humanos , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Monitoreo Ambulatorio/métodos , Proyectos Piloto , Valor Predictivo de las Pruebas , Estudios Prospectivos , Volumen Sistólico , Sístole , Telemetría/métodos , Factores de Tiempo
16.
Europace ; 18(4): 572-7, 2016 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-26316146

RESUMEN

AIMS: Recently cardiac magnetic resonance (CMR) imaging has been found feasible for the visualization of the underlying substrate for cardiac arrhythmias as well as for the visualization of cardiac catheters for diagnostic and ablation procedures. Real-time CMR-guided cavotricuspid isthmus ablation was performed in a series of six patients using a combination of active catheter tracking and catheter visualization using real-time MR imaging. METHODS AND RESULTS: Cardiac magnetic resonance utilizing a 1.5 T system was performed in patients under deep propofol sedation. A three-dimensional-whole-heart sequence with navigator technique and a fast automated segmentation algorithm was used for online segmentation of all cardiac chambers, which were thereafter displayed on a dedicated image guidance platform. In three out of six patients complete isthmus block could be achieved in the MR scanner, two of these patients did not need any additional fluoroscopy. In the first patient technical issues called for a completion of the procedure in a conventional laboratory, in another two patients the isthmus was partially blocked by magnetic resonance imaging (MRI)-guided ablation. The mean procedural time for the MR procedure was 109 ± 58 min. The intubation of the CS was performed within a mean time of 2.75 ± 2.21 min. Total fluoroscopy time for completion of the isthmus block ranged from 0 to 7.5 min. CONCLUSION: The combination of active catheter tracking and passive real-time visualization in CMR-guided electrophysiologic (EP) studies using advanced interventional hardware and software was safe and enabled efficient navigation, mapping, and ablation. These cases demonstrate significant progress in the development of MR-guided EP procedures.


Asunto(s)
Aleteo Atrial/cirugía , Función del Atrio Derecho , Cateterismo Cardíaco/instrumentación , Catéteres Cardíacos , Ablación por Catéter/instrumentación , Atrios Cardíacos/cirugía , Imagen por Resonancia Magnética Intervencional , Adulto , Anciano , Algoritmos , Aleteo Atrial/diagnóstico por imagen , Aleteo Atrial/fisiopatología , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/métodos , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Sedación Profunda/métodos , Electrocardiografía , Técnicas Electrofisiológicas Cardíacas , Diseño de Equipo , Fluoroscopía , Atrios Cardíacos/diagnóstico por imagen , Atrios Cardíacos/fisiopatología , Humanos , Hipnóticos y Sedantes , Interpretación de Imagen Asistida por Computador , Masculino , Persona de Mediana Edad , Tempo Operativo , Valor Predictivo de las Pruebas , Propofol , Factores de Tiempo , Resultado del Tratamiento
17.
Circulation ; 129(7): 728-36, 2014 Feb 18.
Artículo en Inglés | MEDLINE | ID: mdl-24211823

RESUMEN

BACKGROUND: Data on the outcomes of ventricular tachycardia (VT) ablation in nonischemic dilated cardiomyopathy (NIDCM) are insufficient. The Heart Center of Leipzig VT (HELP-VT) study was conducted prospectively to compare outcomes after radiofrequency catheter ablation of VT in patients with NIDCM compared with ischemic cardiomyopathy (ICM). METHODS AND RESULTS: Two hundred twenty-seven patients, 63 with NIDCM and 164 with ICM, presenting with sustained VT were ablated with radiofrequency catheter ablation. Noninducibility of any clinical and nonclinical VT was achieved in 66.7% of NIDCM and in 77.4% of ICM patients. Ablation of the clinical VT only was achieved in 18.3% of ICM and in 22.2% of NIDCM patients. There was no statistically significant difference in short-term outcomes between the 2 groups. At the 1-year follow-up, VT-free survival in NIDCM was 40.5% compared with 57% in ICM. In univariate analysis, the hazard ratio for VT recurrence was significantly higher for NIDCM (1.62; 95% confidence interval, 1.12- 2.34; P=0.01). In both the ICM and NIDCM subgroups, procedure failure and incomplete procedural success were independent predictors of VT recurrence. CONCLUSIONS: Although the short-term success rates after VT ablation in NIDCM and ICM patients were similar, the long-term outcomes in NIDCM patients were significantly worse. Complete VT noninducibility at the end of the ablation is associated with beneficial long-term outcome in NIDCM. Pursuing compete elimination of all inducible VTs is desirable and may improve the long-term success in NIDCM.


Asunto(s)
Cardiomiopatía Dilatada/cirugía , Ablación por Catéter , Isquemia Miocárdica/cirugía , Taquicardia Ventricular/cirugía , Anciano , Cardiomiopatía Dilatada/mortalidad , Femenino , Estudios de Seguimiento , Mortalidad Hospitalaria , Humanos , Estimación de Kaplan-Meier , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Isquemia Miocárdica/mortalidad , Evaluación de Procesos y Resultados en Atención de Salud , Complicaciones Posoperatorias/mortalidad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Taquicardia Ventricular/mortalidad , Resultado del Tratamiento
18.
Lancet ; 384(9943): 583-590, 2014 Aug 16.
Artículo en Inglés | MEDLINE | ID: mdl-25131977

RESUMEN

BACKGROUND: An increasing number of patients with heart failure receive implantable cardioverter-defibrillators (ICDs) or cardiac resynchronisation defibrillators (CRT-Ds) with telemonitoring function. Early detection of worsening heart failure, or upstream factors predisposing to worsening heart failure, by implant-based telemonitoring might enable pre-emptive intervention and improve outcomes, but the evidence is weak. We investigated this possibility in IN-TIME, a clinical trial. METHODS: We did this randomised, controlled trial at 36 tertiary clinical centres and hospitals in Australia, Europe, and Israel. We enrolled patients with chronic heart failure, NYHA class II-III symptoms, ejection fraction of no more than 35%, optimal drug treatment, no permanent atrial fibrillation, and a recent dual-chamber ICD or CRT-D implantation. After a 1 month run-in phase, patients were randomly assigned (1:1) to either automatic, daily, implant-based, multiparameter telemonitoring in addition to standard care or standard care without telemonitoring. Investigators were not masked to treatment allocation. Patients were masked to allocation unless they were contacted because of telemonitoring findings. Follow-up was 1 year. The primary outcome measure was a composite clinical score combining all-cause death, overnight hospital admission for heart failure, change in NYHA class, and change in patient global self-assessment, for the intention-to-treat population. The trial is registered with ClinicalTrials.gov, number NCT00538356. FINDINGS: We enrolled 716 patients, of whom 664 were randomly assigned (333 to telemonitoring, 331 to control). Mean age was 65·5 years and mean ejection fraction was 26%. 285 (43%) of patients had NYHA functional class II and 378 (57%) had NYHA class III. Most patients received CRT-Ds (390; 58·7%). At 1 year, 63 (18·9%) of 333 patients in the telemonitoring group versus 90 (27·2%) of 331 in the control group (p=0·013) had worsened composite score (odds ratio 0·63, 95% CI 0·43-0·90). Ten versus 27 patients died during follow-up. INTERPRETATION: Automatic, daily, implant-based, multiparameter telemonitoring can significantly improve clinical outcomes for patients with heart failure. Such telemonitoring is feasible and should be used in clinical practice. FUNDING: Biotronik SE & Co. KG.


Asunto(s)
Desfibriladores Implantables , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/terapia , Monitoreo Ambulatorio/instrumentación , Telemedicina/métodos , Anciano , Australia , Europa (Continente) , Femenino , Humanos , Israel , Masculino , Resultado del Tratamiento
20.
Europace ; 17(5): 778-86, 2015 May.
Artículo en Inglés | MEDLINE | ID: mdl-25825461

RESUMEN

AIMS: A discordant left ventricular (LV) lead position can be responsible for cardiac resynchronization therapy (CRT) non-response. In this study, tailored optimization of the individual LV wall motion was evaluated for the outcome in these patients. METHODS AND RESULTS: Two hundred and forty-six CRT outpatients were screened for non-response due to a discordant LV lead. In 17 patients, three-dimensional data of fluoroscopic rotation scan and echocardiography were integrated to analyse the individual LV wall motion with respect to the LV lead position. Optimization was guided by the systolic dyssynchrony index (SDI) and LV ejection fraction (LVEF) during different interventricular (VV)-delay programming. If re-programming failed, implantation of a second LV lead was performed. A discordant or partly concordant LV lead position was found in nearly all patients (16/17, 94%), which contributed to an unchanged baseline amount of LV dyssynchrony with either CRT on or off (SDI 11.3 vs. 11.0%; P = 0.744). In the majority of patients, VV-delay re-programming achieved better resynchronization, 4/17 patients needed implantation of a second LV lead. After 3 months, significant improvement of NYHA functional class (1 class; P = 0.004), peak oxygen consumption (10 vs. 13 mL/min/kg; P = 0.008), LVEF (27 vs. 39%; P = 0.003), and SDI (11.0 vs. 5.8; P = 0.02) was observed. Clinical and echocardiographic responses were found in 77 and 59%, respectively, with even good results on long-term follow-up. CONCLUSION: Tailored optimization of the individual LV wall motion can lead to significant clinical and echocardiographic improvements in previous CRT non-responders with a discordant LV lead position.


Asunto(s)
Dispositivos de Terapia de Resincronización Cardíaca , Insuficiencia Cardíaca/terapia , Función Ventricular Izquierda , Anciano , Terapia de Resincronización Cardíaca , Ecocardiografía Tridimensional , Diseño de Equipo , Falla de Equipo , Estudios de Factibilidad , Femenino , Fluoroscopía , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Recuperación de la Función , Factores de Riesgo , Volumen Sistólico , Sístole , Insuficiencia del Tratamiento
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