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AIMS: Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)]. METHODS AND RESULTS: This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group. CONCLUSION: Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications.
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Fibrilación Atrial , Ablación por Catéter , Venas Pulmonares , Técnicas de Sutura , Humanos , Fibrilación Atrial/cirugía , Femenino , Masculino , Persona de Mediana Edad , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Estudios Prospectivos , Venas Pulmonares/cirugía , Técnicas de Sutura/efectos adversos , Anciano , Resultado del Tratamiento , Alemania , Factores de Tiempo , Dispositivos de Cierre Vascular , Ambulación Precoz , Técnicas Hemostáticas/instrumentaciónRESUMEN
PURPOSE: Single-session cardiac stereotactic body radiotherapy, called cardiac radiosurgery (CRS) or radioablation (RA), may offer a potential treatment option for patients with refractory ventricular tachycardia (VT) and electrical storm who are otherwise ineligible for catheter ablation. However, there is only limited clinical experience. We now present the first-in-patient treatment using (CRS/RA) for VT in Germany. METHODS: A 78-year-old male patient with dilated cardiomyopathy and significantly reduced ejection fraction (15%) presented with monomorphic VT refractory to poly-anti-arrhythmic medication and causing multiple implantable cardioverter-defibrillator (ICD) interventions over the course of several weeks, necessitating prolonged treatment on an intensive care unit. Ultra-high-resolution electroanatomical voltage mapping (EVM) revealed a re-entry circuit in the cardiac septum inaccessible for catheter ablation. Based on the EVM, CRS/RA with a single session dose of 25â¯Gy (83% isodose) was delivered to the VT substrate (8.1â¯cc) using a c-arm-based high-precision linear accelerator on November 30, 2018. RESULTS: CRS/RA was performed without incident and dysfunction of the ICD was not observed. Following the procedure, a significant reduction in monomorphic VT from 5.0 to 1.6 episodes per week and of ICD shock interventions by 81.2% was observed. Besides periprocedural nausea with a single episode of vomiting, no treatment-associated side effects were noted. Unfortunately, the patient died 57 days after CRS/RA due to sepsis-associated cardiac circulatory failure after Clostridium difficile-associated colitis developed during rehabilitation. Histopathologic examination of the heart as part of a clinical autopsy revealed diffuse fibrosis on most sections of the heart without apparent differences between the target area and the posterior cardiac wall serving as a control. CONCLUSION: CRS/RA appears to be a possible treatment option for otherwise untreatable patients suffering from refractory VT and electrical storm. A relevant reduction in VT incidence and ICD interventions was observed, although long-term outcome and consequences of CRS/RA remain unclear. Clinical trials are strongly warranted and have been initiated.
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Admisión del Paciente , Radiocirugia/métodos , Taquicardia Ventricular/radioterapia , Anciano , Cardiomiopatía Dilatada/complicaciones , Cardiomiopatía Dilatada/patología , Cardiomiopatía Dilatada/radioterapia , Terapia Combinada , Desfibriladores Implantables , Resultado Fatal , Tabiques Cardíacos/patología , Tabiques Cardíacos/efectos de la radiación , Humanos , Masculino , Aceleradores de Partículas , Taquicardia Ventricular/patologíaRESUMEN
Background: In patients with a total cavopulmonary connection in Fontan circulation, the access to the common atrium (CA) during a catheter ablation can be challenging, even in the presence of fenestration in an intra-atrial lateral tunnel (IALT). In our department, the fenestration is typically marked with metal clips (MCs). To the best of our knowledge, there is no previous report of balloonoplasty of clipped fenestration. Case summary: A 19-year-old male with hypoplastic left heart syndrome (HLHS) was scheduled for catheter ablation of recurrent atrial tachycardia. He was diagnosed with HLHS prenatally and underwent a stepwise surgical palliation. Fontan circulation was completed with the creation of a fenestrated IALT. The fenestration was marked by four MCs. During the ablation procedure, the passage of the steerable sheath with mapping catheter to the CA was prevented by a small fenestration size and rigidness of the edges of the fenestration caused by the MCs. Multiple attempts to dilate the fenestration using a peripheric angioplasty balloon failed. Only angioplasty with the 'balloon-against-dilator' technique was finally successful. Activation map showed a counterclockwise atrial flutter in the CA; successful ablation was performed. Discussion: We present a case of challenging access to the CA through a clipped fenestration in a polytetrafluoroethylene baffle for atrial tachycardia ablation. Even though a tunnel fenestration in Fontan patients facilitates access to the CA, the passage of a steerable introducer with a mapping catheter may be challenging due to diameter mismatch and the rigidity of its edges caused by MCs. The balloon-against-dilator technique might be helpful when conventional balloon angioplasty fails.
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BACKGROUND: Data about necessity of performing transesophageal echocardiography (TOE) prior to every catheter ablation (CA) of atrial fibrillation (AF) is scarce. We aimed to evaluate the safety of an individualized risk-based approach to TOE with respect to thromboembolic cerebrovascular events (CVE) in patients undergoing CA for AF or left atrial tachycardia (AT). METHODS: We performed a retrospective clinical study based on our institutional registry database. Patients undergoing CA for AF or left-sided AT following initial AF ablation at two participating centers were enrolled. Prior to the procedure, patients were scheduled for TOE only if they had a history of thromboembolic stroke, left atrial appendage (LAA) thrombus, or inappropriate anticoagulation regimen in the previous 3 to 4 weeks. The incidence of periprocedural cerebrovascular thromboembolic events was assessed. RESULTS: We analyzed 1155 patients (median age 70 years, 54.8% male, 48.1% had persistent AF/AT). In 261 patients, a TOE was performed; in 2 patients (0.7%), an LAA thrombus was detected, which led to cancellation of the catheter ablation; in 894 patients, the TOE was omitted. Of the 1153 (0.35%) patients who underwent ablation, 4 (0.35%) experienced a CVE (one TIA and three strokes). The rate of CVE in our study does not exceed that reported in most multicenter trials. The low event rates limited statistical analysis of possible risk factors for CVE. In all 4 patients with CVE, post-CVE imaging showed the absence of LAA thrombus. CONCLUSIONS: An individualized selective approach to TOE before catheter ablation of AF or left AT showed a very low risk of overt intraprocedural thromboembolic events for the population in our study. A further randomized controlled study is needed to determine whether TOE prior to catheter ablation without ICE could be omitted in patients with uninterrupted OAC without previous thromboembolic events or a history of left atrial thrombus.
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BACKGROUND: Local tissue impedance drop (LID) and lesion size index (LSI) technologies are valuable for predicting effective lesion formation. This study compares the acute and long-term efficacy of LID-guided versus LSI-guided pulmonary vein isolation (PVI) for atrial fibrillation treatment. METHODS: We retrospectively analyzed two patient groups undergoing radiofrequency PVI. In the LID-guided group (n = 35), ablation was performed without contact force monitoring, stopping at the LID plateau (target LID 12 Ohm posterior, 16 Ohm anterior). In the LSI-guided group (n = 31), ablation used contact force information with target LSI (5 anterior, 4 posterior). Both groups utilized a power of 40 W anterior and 30 W posterior, with < 6 mm inter-lesion distance. Gap mapping and touch-up ablation were done if necessary. RESULTS: PVI was achieved with a significantly shorter ablation time in the LSI-guided group (25 min [21;31] vs 30 [27;35], p = 0.035). PV gaps were more frequent in the LID-guided group (74% vs 42%, p = 0.016). Over 11.5 ± 2.9 months follow-up, arrhythmia recurrence was higher in the LID-guided group (34.3% vs 16.1%, p = 0.037). A redo procedure performed in 10 (28.6%) patients in the LID-guided group and 3 (9.7%) in the LSI-guided group showed chronic PV reconnections in 7 out of 10 (70%) and 2 out of 3 (67%) patients, respectively. CONCLUSIONS: LSI-guided ablation results in shorter ablation time and fewer PV gaps compared to LID-guided ablation. Despite initial success, LID-guided ablation had higher arrhythmia recurrence and PV reconnections during long-term follow-up compared to LSI-guided ablation.
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BACKGROUND: The PRAETORIAN score estimates the risk of failure of subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy by using generator and lead positioning on bidirectional chest radiographs. The PRospective randomized compArative trial of subcutanEous implanTable cardiOverter-defibrillatoR ImplANtation with and without DeFibrillation Testing (PRAETORIAN-DFT) investigates whether PRAETORIAN score calculation is noninferior to defibrillation testing (DFT) with regard to first shock efficacy in spontaneous events. OBJECTIVE: This prespecified subanalysis assessed the predictive value of the PRAETORIAN score for defibrillation success in induced ventricular arrhythmias. METHODS: This multicenter investigator-initiated trial randomized 965 patients between DFT and PRAETORIAN score calculation after de novo S-ICD implantation. Successful DFT was defined as conversion of induced ventricular arrhythmia in <5 seconds from shock delivery within 2 attempts. Bidirectional chest radiographs were obtained after implantation. The predictive value of the PRAETORIAN score for DFT success was calculated for patients in the DFT arm. RESULTS: In total, 482 patients were randomized to undergo DFT. Of these patients, 457 (95%) underwent DFT according to protocol, of whom 445 (97%) had successful DFT and 12 (3%) had failed DFT. A PRAETORIAN score of ≥90 had a positive predictive value of 25% for failed DFT, and a PRAETORIAN score of <90 had a negative predictive value of 99% for successful DFT. A PRAETORIAN score of ≥90 was the strongest independent predictor for failed DFT (odds ratio 33.77; confidence interval 6.13-279.95; P < .001). CONCLUSION: A PRAETORIAN score of <90 serves as a reliable indicator for DFT success in patients with S-ICD, and a PRAETORIAN score of ≥90 is a strong predictor for DFT failure.
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Desfibriladores Implantables , Cardioversión Eléctrica , Valor Predictivo de las Pruebas , Humanos , Femenino , Masculino , Persona de Mediana Edad , Cardioversión Eléctrica/métodos , Estudios Prospectivos , Anciano , Muerte Súbita Cardíaca/prevención & control , Muerte Súbita Cardíaca/etiología , Medición de Riesgo/métodos , Taquicardia Ventricular/terapia , Taquicardia Ventricular/fisiopatología , Fibrilación Ventricular/terapiaRESUMEN
AIMS: We assessed long-term effects of cardiac contractility modulation delivered by the Optimizer Smart system on quality of life, left ventricular ejection fraction (LVEF), mortality and heart failure and cardiovascular hospitalizations. METHODS AND RESULTS: CCM-REG is a prospective registry study including 503 patients from 51 European centres. Effects were evaluated in three terciles of LVEF (≤25%, 26-34% and ≥35%) and in patients with atrial fibrillation (AF) and normal sinus rhythm (NSR). Hospitalization rates were compared using a chi-square test. Changes in functional parameters of New York Heart Association (NYHA) class, Minnesota Living with Heart Failure Questionnaire (MLWHFQ) and LVEF were assessed with Wilcoxon signed-rank test, and event-free survival by Kaplan-Meier analysis. For the entire cohort and each subgroup, NYHA class and MLWHFQ improved at 6, 12, 18 and 24 months (P < 0.0001). At 24 months, NYHA class, MLWHFQ and LVEF showed an average improvement of 0.6 ± 0.7, 10 ± 21 and 5.6 ± 8.4%, respectively (all P < 0.001). LVEF improved in the entire cohort and in the LVEF ≤25% subgroup with AF and NSR. In the overall cohort, heart failure hospitalizations decreased from 0.74 [95% confidence interval (CI) 0.66-0.82] prior to enrolment to 0.25 (95% CI 0.21-0.28) events per patient-year during 2-year follow-up (P < 0.0001). Cardiovascular hospitalizations decreased from 1.04 (95% CI 0.95-1.13) events per patient-year prior to enrolment to 0.39 (95% CI 0.35-0.44) events per patient-year during 2-year follow-up (P < 0.0001). Similar reductions of hospitalization rates were observed in the LVEF, AF and NSR subgroups. Estimated survival was significantly better than predicted by MAGGIC at 1 and 3 years in the entire cohort and in the LVEF 26-34% and ≥35% subgroups. CONCLUSIONS: Cardiac contractility modulation therapy improved functional status, quality of life, LVEF and, compared to patients' prior history, reduced heart failure hospitalization rates. Survival at 1 and 3 years was significantly better than predicted by the MAGGIC risk score.
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Insuficiencia Cardíaca , Calidad de Vida , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/terapia , Humanos , Volumen Sistólico , Resultado del Tratamiento , Función Ventricular IzquierdaRESUMEN
Ventricular tachyarrhythmia is a severe and life-threatening potential side effect of pharmacotherapy. Substances with proarrhythmic potential belong to various groups of medication. Apart from antiarrhythmic agents, especially antibiotics and psychiatric drugs are worth mentioning owing to their broad application. Interaction with cardiac potassium channels is the most important reason for drug-induced ventricular tachyarrhythmia. Over 20 years of research in animal models and clinical studies have uncovered the underlying mechanisms. Findings in this field of research have also made a contribution to the understanding of genetic long QT syndromes. Clinical concerns that take drug interactions into account have been neglected due to the mechanistic research approach. For daily clinical practice, combination therapy of several potentially arrhythmogenic drugs is of predominant concern especially in situations when the therapeutic regime is changing such as admission to the hospital, admission to an intensive care unit or consultation of a new specialist. Especially in these situations, considerations about the arrhythmogenic potential of additionally administered drugs should be paid explicit attention. Additional concern should be paid to the fact that several proarrhythmogenic agents are metabolized over single pathways and are therefore prone to drug interactions that can severely raise the drug concentration and as a result arrhythmogenic potential.
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Electrocardiografía/efectos de los fármacos , Taquicardia Ventricular/inducido químicamente , Taquicardia Ventricular/prevención & control , Animales , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/diagnóstico por imagen , Medicina Basada en la Evidencia , Humanos , Taquicardia Ventricular/diagnóstico , Resultado del TratamientoRESUMEN
OBJECTIVES: We hypothesized that deceleration capacity (DC), a novel marker of cardiac autonomic modulation, is an independent predictor for mortality in patients with non-ischemic dilated cardiomyopathy (NICM). BACKGROUND: NICM is associated with a high risk for sudden cardiac death (SCD). However there are no clinically established parameters available for risk stratification beyond LVEF. DC has been previously shown to be a strong independent predictor for total mortality in patients after myocardial infarction. METHODS: Holter-ECG recordings of 201 patients NICM (83.1% male, mean age: 61.4years, mean LVEF: 33.3%) were analyzed by the method of phase-rectified-signal-averaging (PRSA) to obtain DC. RESULTS: During a minimum follow-up of 40month 59 patients died. Kaplan Meyer Analysis showed a significantly higher mortality in patients with a DC below 4.5ms (log rank p=0.012) irrespective to the presence of atrial fibrillation. CONCLUSIONS: Impaired DC is a powerful independent predictor for mortality in patients with NICM.
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Cardiomiopatía Dilatada/diagnóstico , Cardiomiopatía Dilatada/mortalidad , Desaceleración , Anciano , Cardiomiopatía Dilatada/fisiopatología , Electrocardiografía Ambulatoria/mortalidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Mortalidad/tendencias , Valor Predictivo de las Pruebas , Volumen Sistólico/fisiologíaRESUMEN
BACKGROUND: Nonischemic dilated cardiomyopathies (DCM) are the most common reason for heart failure in developed countries after ischemic disease. They often lead to device therapy. Left ventricular ejection fraction as a single parameter to identify patients at risk for sudden cardiac death revealed inconclusive data in patients with DCM. METHODS: Autonomic tone, measured by classical and innovative parameters of heart rate variability (HRV), heart rate turbulence or baroreceptor reflex, was demonstrated to give valuable prognostic information especially in patients with ischemic disease and after acute myocardial infarction. In patients with DCM, classical parameters of HRV showed inhomogeneous data in a heterogeneous patient collective caused by unsystematic measurement of single parameters in various patient collectives. RESULTS: Innovative parameters of HRV are promising in patients with DCM and showed prognostic relevance although patient numbers are limited and prospective data are missing. Further studies are needed in this field. CONCLUSION: Despite the in part convincing evidence for the relevance of autonomic tone as a prognostic marker in patients with DCM, their evaluation is still not part of clinical routine. Additional parameters to estimate the risk of sudden cardiac death are urgently needed.
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Arritmias Cardíacas/diagnóstico , Enfermedades del Sistema Nervioso Autónomo/diagnóstico , Cardiomiopatía Dilatada/diagnóstico , Muerte Súbita Cardíaca/prevención & control , Electrocardiografía/métodos , Arritmias Cardíacas/etiología , Enfermedades del Sistema Nervioso Autónomo/etiología , Cardiomiopatía Dilatada/etiología , Medicina Basada en la Evidencia , Humanos , Isquemia Miocárdica/complicaciones , Isquemia Miocárdica/diagnóstico , Reproducibilidad de los Resultados , Medición de Riesgo/métodos , Sensibilidad y EspecificidadRESUMEN
BACKGROUND: The aim of the present study was to assess potential differences in cardiac autonomic nervous modulation in patients with transient left ventricular apical ballooning syndrome (AB) and the midventricular variant (MB) of this syndrome. OBJECTIVE: We hypothesized that differences in regional distribution of cardiac autonomic innervation in AB and MB may induce alterations in autonomic modulation, and we tested this assumption by using a combination of traditional and novel nonlinear parameters of heart rate variability (HRV). METHODS: In a prospective single-center study, 49 consecutive patients with transient left ventricular dysfunction syndrome underwent Holter electrocardiographic recording on the third day after admission. A total of 27 recordings of patients with AB and 10 recordings of patients with MB were valid for analysis of HRV, nonlinear dynamic measures of HRV, detrended fluctuation analysis (DFA), and phase-rectified signal averaging (PRSA). RESULTS: There were no significant differences in baseline clinical characteristics between AB and MB patients. Patients with MB showed significantly lower values for mean RR interval (835 ± 104 ms vs. 908 ± 118 ms; P < .05), 1/f power law slope (-1.28 ± 0.2 vs. -1.13 ± 0.2; P < .01), and deceleration capacity (DC) (4.6 ± 1.4 ms vs. 6.0 ± 1.4 ms; P < .01), and significantly higher values for low-frequency (LF) spectral component (5.3 ± 0.5 ln ms(2)/Hz vs. 4.8 ± 0.5 ln ms(2)/Hz), LF/high-frequency (HF) (1.7 ± 0.9 ms vs. 1.3 ± 0.6 ms; P < .05), and DFA α1 (1.09 ± 0.1 vs. 0.99 ± 0.1; P < .01) than patients with AB. There were no significant correlations between parameters of HRV, DFA, 1/f power law slope, and PRSA. CONCLUSION: There are significant differences in heart rate dynamics between AB and MB syndromes. Patients with MB show stronger fractal correlations of heart rate dynamics. Thus, inhomogeneous efferent bilateral sympathetic coactivation and differences in reflex autonomic regulation may be underlying pathophysiological mechanisms for AB and MB syndromes.