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OBJECTIVE: We aimed to assess the effect of SGLT2i on arrhythmias by conducting a meta-analysis using data from randomized controlled trials(RCTs). BACKGROUND: Sodium-glucose co-transporter 2 inhibitors (SGLT2i) have shown cardioprotective effects via multiple mechanisms that may also contribute to decrease arrhythmias risk. METHODS: We searched in databases (PubMed, Embase, Cochrane Library, and clinicaltrials.gov) up to April 2023. RCTs comparing SGLT2i with placebo were included. The effects of SGLT2i on atrial fibrillation(AF), atrial flutter(AFL), composite AF/AFL, ventricular fibrillation(VF), ventricular tachycardia(VT), ventricular extrasystoles(VES), sudden cardiac death(SCD) and composite VF/VT/SCD were evaluated. RESULTS: 33 placebo-controlled RCTs were included, comprising 88,098 patients (48,585 in SGLT2i vs. 39,513 in placebo). The mean age was 64.9 ± 9.4 years, 63.0% were male. The mean follow-up was 1.4 ± 1.1 years. The pooled-results showed that SGLT2i was associated with a significantly lower risk of AF [risk ratio(RR): 0.88, 95% confidence interval(CI) 0.78-1.00, P = 0.04] and composite AF/AFL (RR: 0.86, 95%CI 0.77-0.96, P = 0.01). This favorable effect appeared to be substantially pronounced in patients with HFrEF, male gender, dapagliflozin, and > 1 year follow-up. For SCD, only in heart failure patients, SGLT2i were found to be associated with a borderline lower risk of SCD (RR: 0.67, P = 0.05). No significant effects of SGLT2i on other ventricular arrhythmic outcomes were found. CONCLUSIONS: SGLT2i lowers the risks of AF and AF/AFL, and this favorable effect appeared to be particularly pronounced in patients with HFrEF, male gender, dapagliflozin, and longer follow-up (> 1 year). SGLT2i lowers the risk of SCD only in heart failure patients.
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Fibrilación Atrial , Compuestos de Bencidrilo , Glucósidos , Insuficiencia Cardíaca , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Masculino , Persona de Mediana Edad , Anciano , Femenino , Inhibidores del Cotransportador de Sodio-Glucosa 2/efectos adversos , Volumen Sistólico , Muerte Súbita Cardíaca/etiología , Muerte Súbita Cardíaca/prevención & control , Fibrilación VentricularRESUMEN
AIMS: Women have been historically underrepresented in implantable cardioverter-defibrillator (ICD) trials. No data on sex differences regarding subcutaneous ICDs (S-ICD) carriers have been described. Aim of our study was to investigate sex-related differences among unselected S-ICD recipients. METHODS AND RESULTS: Consecutive patients enrolled in the multicentre, international i-SUSI registry were analysed. Comparisons between sexes were performed using a 1:1 propensity matching adjusted analysis for age, body mass index (BMI), left ventricular function, and substrate. The primary outcome was the rate of appropriate shocks during follow-up. Inappropriate shocks and other device-related complications were deemed secondary outcomes. A total of 1698 patients were extracted from the i-SUSI registry; 399 (23.5%) were females. After propensity matching, two cohorts of 374 patients presenting similar baseline characteristics were analysed. Despite similar periprocedural characteristics and a matched BMI, women resulted at lower risk of conversion failure as per PRAETORIAN score (73.4% vs. 81.3%, P = 0.049). Over a median follow-up time of 26.5 [12.7-42.5] months, appropriate shocks were more common in the male cohort (rate/year 3.4% vs. 1.7%; log-rank P = 0.049), while no significant differences in device-related complications (rate/year: 6.3% vs. 5.8%; log-rank P = 0.595) and inappropriate shocks (rate/year: 4.3% vs. 3.1%; log-rank P = 0.375) were observed. After controlling for confounders, sex remained significantly associated with the primary outcome (aHR 1.648; CI 0.999-2.655, P = 0.048), while not resulting predictor of inappropriate shocks and device-related complications. CONCLUSION: In a propensity-matched cohort of S-ICD recipients, women are less likely to experience appropriate ICD therapy, while not showing higher risk of device-related complications. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT0473876.
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Desfibriladores Implantables , Cardioversión Eléctrica , Puntaje de Propensión , Sistema de Registros , Humanos , Femenino , Masculino , Persona de Mediana Edad , Anciano , Factores Sexuales , Cardioversión Eléctrica/instrumentación , Cardioversión Eléctrica/efectos adversos , Factores de Riesgo , Resultado del Tratamiento , Arritmias Cardíacas/terapia , Medición de Riesgo , Europa (Continente) , Factores de Tiempo , Muerte Súbita Cardíaca/prevención & controlRESUMEN
AIMS: Catheter ablation (CA) of ventricular tachycardia (VT) has become an important tool to improve clinical outcomes in patients with appropriate transvenous implantable cardioverter defibrillator (ICD) shocks. The aim of our analysis was to test whether VT ablation (VTA) impacts long-term clinical outcomes even in subcutaneous ICD (S-ICD) carriers. METHODS AND RESULTS: International Subcutaneous Implantable Cardioverter Defibrillator (iSUSI) registry patients who experienced either an ICD shock or a hospitalization for monomorphic VT were included in this analysis. Based on an eventual VTA after the index event, patients were divided into VTA+ vs. VTA- cohorts. Primary outcome of the study was the occurrence of a combination of device-related appropriate shocks, monomorphic VTs, and cardiovascular mortality. Secondary outcomes were addressed individually. Among n = 1661 iSUSI patients, n = 211 were included: n = 177 experiencing ICD shocks and n = 34 hospitalized for VT. No significant differences in baseline characteristics were observed. Both the crude and the yearly event rate of the primary outcome (5/59 and 3.8% yearly event rate VTA+ vs. 41/152 and 16.4% yearly event rate in the VTA-; log-rank: P value = 0.0013) and the cardiovascular mortality (1/59 and 0.7% yearly event rate VTA+ vs. 13/152 and 4.7% yearly event rate VTA-; log-rank P = 0.043) were significantly lower in the VTA + cohort. At multivariate analysis, VTA was the only variable remaining associated with a lower incidence of the primary outcome [adjusted hazard ratio 0.262 (0.100-0.681), P = 0.006]. CONCLUSION: In a real-world registry of S-ICD carriers, the combined study endpoint of arrhythmic events and cardiovascular mortality was lower in the patient cohort undergoing VTA at long-term follow-up. CLINICALTRIALS.GOV IDENTIFIER: NCT0473876.
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Ablación por Catéter , Desfibriladores Implantables , Taquicardia Ventricular , Humanos , Arritmias Cardíacas/etiología , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Cardioversión Eléctrica/efectos adversos , Taquicardia Ventricular/diagnóstico , Taquicardia Ventricular/cirugía , Resultado del TratamientoRESUMEN
AIMS: Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management, and outcome are sparse. METHODS AND RESULTS: This international multicentre registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation. A total of 553 729 catheter ablation procedures (radiofrequency: 62.9%, cryoballoon: 36.2%, other modalities: 0.9%) were performed, at 214 centres in 35 countries. In 78 centres 138 patients [0.025%, radiofrequency: 0.038%, cryoballoon: 0.0015% (P < 0.0001)] were diagnosed with an oesophageal fistula. Peri-procedural data were available for 118 patients (85.5%). Following catheter ablation, the median time to symptoms and the median time to diagnosis were 18 (7.75, 25; range: 0-60) days and 21 (15, 29.5; range: 2-63) days, respectively. The median time from symptom onset to oesophageal fistula diagnosis was 3 (1, 9; range: 0-42) days. The most common initial symptom was fever (59.3%). The diagnosis was established by chest computed tomography in 80.2% of patients. Oesophageal surgery was performed in 47.4% and direct endoscopic treatment in 19.8% and conservative treatment in 32.8% of patients. The overall mortality was 65.8%. Mortality following surgical (51.9%) or endoscopic treatment (56.5%) was significantly lower as compared to conservative management (89.5%) [odds ratio 7.463 (2.414, 23.072) P < 0.001]. CONCLUSION: Oesophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energy rather than cryoenergy. Mortality without surgical or endoscopic intervention is exceedingly high.
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Fibrilación Atrial , Ablación por Catéter , Fístula Esofágica , Humanos , Fibrilación Atrial/epidemiología , Fibrilación Atrial/cirugía , Fibrilación Atrial/diagnóstico , Resultado del Tratamiento , Incidencia , Factores de Riesgo , Fístula Esofágica/epidemiología , Fístula Esofágica/etiología , Fístula Esofágica/diagnóstico , Pronóstico , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodosRESUMEN
AIMS: Cryoballoon (CB)-based pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). The most frequent complication during CB-based PVI is right-sided phrenic nerve injury (PNI) which is leading to premature abortion of the freeze cycle. Here, we analysed reconnection rates after CB-based PVI and PNI in a large-scale population during repeat procedures. METHODS AND RESULTS: In the YETI registry, a total of 17 356 patients underwent CB-based PVI in 33 centres, and 731 (4.2%) patients experienced PNI. A total of 111/731 (15.2%) patients received a repeat procedure for treatment of recurrent AF. In 94/111 (84.7%) patients data on repeat procedures were available. A total of 89/94 (94.7%) index pulmonary veins (PVs) have been isolated during the initial PVI. During repeat procedures, 22 (24.7%) of initially isolated index PVs showed reconnection. The use of a double stop technique did non influence the PV reconnection rate (P = 0.464). The time to PNI was 140.5 ± 45.1 s in patients with persistent PVI and 133.5 ± 53.8 s in patients with reconnection (P = 0.559). No differences were noted between the two populations in terms of CB temperature at the time of PNI (P = 0.362). The only parameter associated with isolation durability was CB temperature after 30 s of freezing. The PV reconnection did not influence the time to AF recurrence. CONCLUSION: In patients with cryoballon application abortion due to PNI, a high rate of persistent PVI rate was found at repeat procedures. Our data may help to identify the optimal dosing protocol in CB-based PVI procedures. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT03645577?term=YETI&cntry=DE&draw=2&rank=1 ClinicalTrials.gov Identifier: NCT03645577.
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Fibrilación Atrial , Ablación por Catéter , Criocirugía , Venas Pulmonares , Humanos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/cirugía , Fibrilación Atrial/etiología , Ablación por Catéter/efectos adversos , Criocirugía/efectos adversos , Criocirugía/métodos , Nervio Frénico , Venas Pulmonares/cirugía , Recurrencia , Factores de Tiempo , Resultado del TratamientoRESUMEN
Sodium glucose cotransporter 2 (SGLT2) have proven profound positive effects in heart failure with reduced ejection fraction (HFrEF). These effects are independent from the presence of diabetes. Metabolic effects, antiinflammatory, and antifibrotic properties are discussed as underlying mechanisms. Despite a strong correlation of ventricular arrhythmias with HFrEF, the impact of ertugliflozin on the ventricular arrhythmic burden has not been investigated, yet. Therefore, the Ertugliflozin to Reduce Arrhythmic burden in ICD ± CRT patientS (ERASe) trial was designed to investigate the efficacy and safety of ertugliflozin in patients with reduced and midrange ejection fraction (EF) with or without diabetes. METHODS: Within a multicentre, national, randomized, double-blind, placebo-controlled, phase 3b trial we aim to enrol a total of 402 patients across Austria. Patients with reduced or midrange EF and ICD ± CRT therapy >3 months and previous ventricular tachycardia (at least 10 documented VT episodes within the last 12 months) are randomized in a 1:1 ratio to ertugliflozin (5 mg once daily orally administered) or matching placebo. The primary endpoint of the ERASe trial is to investigate the impact of ertugliflozin on total burden of ventricular arrhythmias. Further objectives will include number of therapeutic interventions of implanted devices, atrial fibrillation and heart failure biomarkers. CONCLUSION: The ERASe trial will be the first trial to test ertugliflozin in heart failure patients with nonpreserved ejection fraction and ongoing ICD ± CRT therapy regardless of their diabetic status. The ERASe trial may therefore extend the concept of SGLT2 inhibition to improve cardiac remodelling, including reduced arrhythmic burden. Trial registration Identifier EudraCT Nr. 2020-002581-14 / ClinicalTrials.gov Identifier: NCT04600921.
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Desfibriladores Implantables , Insuficiencia Cardíaca , Compuestos Bicíclicos Heterocíclicos con Puentes/uso terapéutico , Método Doble Ciego , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/terapia , Humanos , Volumen Sistólico/fisiología , Resultado del Tratamiento , Función Ventricular Izquierda/fisiologíaRESUMEN
AIMS: Catheter ablation (CA) is recommended for patients with atrial fibrillation (AF) after failure of antiarrhythmic drugs (AADs). The role of CA as 'initial therapy' for AF is to be determined. METHODS AND RESULTS: Following PRISMA guideline an up-to-date pooled analysis of randomized data comparing ablation vs. AADs as first-line therapy for symptomatic AF was performed. The primary outcome was recurrence of atrial tachyarrhythmia. The secondary outcomes were improvement in quality-of-life (QoL) and major adverse events. A total of 997 patients from five randomized trials were enrolled (mean age 57.4 years, 68.6% male patients, 98% paroxysmal AF, mean follow-up 1.4 years). The baseline characteristics were similar between the ablation and AADs group. Overall pooled analysis showed that, as compared with AADs, CA as first-line therapy was associated with significantly higher freedom from arrhythmia recurrence (69% vs. 48%, odds ratio: 0.36, 95% confidence interval: 0.27-0.48, P < 0.001). This significance was maintained in subgroup analyses of 1- and 2-year follow-up (P < 0.001). Catheter ablation was associated with significantly greater improvement in QoL regarding AFEQT score and 36-Item Short-Form Health Survey score. The incidence of serious adverse events between ablation and AADs group (5.6% vs. 4.9%, P = 0.62) was similar. CONCLUSIONS: Catheter ablation as 'initial therapy' was superior to AADs in maintenance of sinus rhythm and improving QoL for patients with symptomatic paroxysmal AF, without increasing risk of serious adverse events.
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Fibrilación Atrial , Ablación por Catéter , Antiarrítmicos/efectos adversos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/cirugía , Ablación por Catéter/efectos adversos , Ablación por Catéter/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Calidad de Vida , Recurrencia , Taquicardia/etiología , Resultado del TratamientoRESUMEN
AIMS: The optimal treatment for patients with atrial fibrillation (AF) and heart failure (HF) has been a subject of debate for years. We aimed to evaluate the efficacy and safety of rhythm control strategy in patients with AF complicated with HF regarding hard clinical endpoints. METHODS AND RESULTS: Up-to-date randomized data comparing rhythm control using antiarrhythmic drugs (AADs) vs. rate control (Subset A) or rhythm control using catheter ablation vs. medical therapy (Subset B) in AF and HF patients were pooled. The primary outcomes were all-cause mortality, re-hospitalization, stroke, and thromboembolic events. A total of 11 studies involving 3598 patients were enrolled (Subset A: 2486; Subset B: 1112). As compared with medical rate control, the AADs rhythm control was associated with similar all-cause mortality [odds ratio (OR): 0.96, P = 0.65], significantly higher rate of re-hospitalization (OR: 1.25, P = 0.01), and similar rate of stroke and thromboembolic events (OR: 0.91, P = 0.76,); however, as compared with medical therapy, catheter ablation rhythm control was associated with significantly lower all-cause mortality (OR: 0.51, P = 0.0003), reduced re-hospitalization rate (OR: 0.44, P = 0.003), similar rate of stroke events (OR: 0.59, P = 0.27), greater improvement in left ventricular ejection fraction [weighted mean difference (WMD): 6.8%, P = 0.0004], lower arrhythmia recurrence (29.6% vs. 80.1%, OR: 0.04, P < 0.00001), and greater improvement in quality of life (Minnesota Living with Heart Failure Questionnaire score) (WMD: -9.1, P = 0.007). CONCLUSION: Catheter ablation as rhythm control strategy substantially improves survival rate, reduces re-hospitalization, increases the maintenance rate of sinus rhythm, contributes to preserve cardiac function, and improves quality of life for AF patients complicated with HF.
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Fibrilación Atrial , Ablación por Catéter , Insuficiencia Cardíaca , Antiarrítmicos/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/terapia , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/terapia , Humanos , Minnesota , Calidad de Vida , Volumen Sistólico , Resultado del Tratamiento , Función Ventricular IzquierdaRESUMEN
AIMS: Atrial fibrillation (AF) is the most prevalent arrhythmia in western countries. It is associated with increased mortality and morbidity and responsible for hospitalization rates of 10-40% per patient per year. Studies from the UK and the USA have shown that AF is responsible for â¼1% of the total healthcare expenditures in these countries. The only potentially curative treatment is pulmonary vein isolation (PVI). Published health economic data on the impact of PVI mainly consist of simulations of expenditures with assumed efficacy taken from ablation studies. Real expenditure data are missing as well as pre-ablation period data and long-term data. METHODS AND RESULTS: We analyse true healthcare expenditures based on inpatient and outpatient data from the Upper Austrian Health Insurance Fund social security system of patients undergoing PVI during 2005 to 2015. We identified 1135 patients undergoing PVI with 268 having multiple procedures. Days of hospitalization and days of sick leave started to rise in the year before ablation. PVI was able to lower both parameters to the level of 1 year before ablation. Comparing four quarters before and after a single-index ablation, a highly significant reduction in inpatient healthcare expenditures was documented. There was a significant, but numerically small increase in outpatient expenditures, resulting in a significant reduction in overall healthcare expenditures. CONCLUSION: Analysing a cohort of the Upper Austrian Health Insurance Fund undergoing PVI, we found significant cost-saving effects on post-interventional healthcare expenditures and a reduction in days of sick leave.
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Fibrilación Atrial , Ablación por Catéter , Gastos en Salud , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/economía , Fibrilación Atrial/cirugía , Austria , Humanos , Venas Pulmonares/cirugía , Recurrencia , Resultado del TratamientoRESUMEN
BACKGROUND: Atrial fibrillation (AF) without other stroke risk factors is assumed to have a low annual stroke risk comparable to patients without AF. Therefore, current clinical guidelines do not recommend oral anticoagulation for stroke prevention of AF in patients without stroke risk factors. We analyzed brain magnetic resonance imaging (MRI) imaging to estimate the rate of clinically inapparent ("silent") ischemic brain lesions in these patients. METHODS: We pooled individual patient-level data from three prospective studies comprising stroke-free patients with symptomatic AF. All study patients underwent brain MRI within 24-48 h before planned left atrial catheter ablation. MRIs were analyzed by a neuroradiologist blinded to clinical data. RESULTS: In total, 175 patients (median age 60 (IQR 54-67) years, 32% female, median CHA2DS2-VASc = 1 (IQR 0-2), 33% persistent AF) were included. In AF patients without or with at least one stroke risk factor, at least one silent ischemic brain lesion was observed in 4 (8%) out of 48 and 10 (8%) out of 127 patients, respectively (p > 0.99). Presence of silent ischemic brain lesions was related to age (p = 0.03) but not to AF pattern (p = 0.77). At least one cerebral microbleed was detected in 5 (13%) out of 30 AF patients without stroke risk factors and 25 (25%) out of 108 AF patients with stroke risk factors (p = 0.2). Presence of cerebral microbleeds was related to male sex (p = 0.04) or peripheral artery occlusive disease (p = 0.03). CONCLUSION: In patients with symptomatic AF scheduled for ablation, brain MRI detected silent ischemic brain lesions in approximately one in 12 patients, and microbleeds in one in 5 patients. The prevalence of silent ischemic brain lesions did not differ in AF patients with or without further stroke risk factors.
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Fibrilación Atrial/cirugía , Isquemia Encefálica/diagnóstico por imagen , Ablación por Catéter , Imagen de Difusión por Resonancia Magnética , Accidente Cerebrovascular/diagnóstico por imagen , Anciano , Enfermedades Asintomáticas , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Isquemia Encefálica/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Arterial Periférica/epidemiología , Valor Predictivo de las Pruebas , Prevalencia , Estudios Retrospectivos , Factores de Riesgo , Factores Sexuales , Accidente Cerebrovascular/epidemiología , Factores de Tiempo , Resultado del TratamientoRESUMEN
Aims: Cardiac arrhythmias following acute myocardial infarction (AMI) can be associated with major adverse cardiovascular events. Data on the "real incidence" of post-MI arrhythmias are limited. We aimed to determine the rate and burden of cardiac arrhythmias by the use of insertable cardiac monitors (ICM) in patients with preserved left ventricular ejection fraction (LVEF) after AMI. Methods and results: In this prospective observational study, patients with LVEF ≥40% who underwent PCI within 7 days following AMI were enrolled to receive an ICM. Primary outcome was the incidence of new-onset atrial fibrillation (AF) measured by the ICM during a follow-up of 2 years; results: Of 165 consecutive patients with AMI, 50 (30.3%) eligible patients were recruited (mean age 57.8 ± 8.3, 88% male). During follow-up, AF was the most frequently detected arrhythmia. Twenty-nine (58%, 95% CI: 42-70%) patients developed new-onset AF, with a cumulative rate of all detected arrhythmias of 65%. Median time to the first detected AF episode was 4.8 months and the peak cumulative AF burden was detected between 3 and 6 months. Twenty-seven (93%) out of 29 patients with AF were asymptomatic. Cox regression analysis found that baseline troponin level (hazard ratio [HR] for 1 ng/mL increment: 1.03, 95% CI: 1.01-1.06, P = 0.01) and CHA2DS2-VASc score of 4 (HR: 11.42, 95% CI: 1.01-129.06, P = 0.04) were independent risk factors of new-onset AF post-AMI. Conclusion: AF is a frequent but largely underestimated cardiac arrhythmia after AMI. More rigorous monitoring strategies resulting in crucial medical interventions (e.g. implementation of oral anti-coagulation) are needed. Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT02492243.
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Fibrilación Atrial/diagnóstico , Electrocardiografía Ambulatoria , Infarto del Miocardio con Elevación del ST/diagnóstico , Volumen Sistólico , Función Ventricular Izquierda , Anciano , Fibrilación Atrial/epidemiología , Fibrilación Atrial/fisiopatología , Electrocardiografía Ambulatoria/instrumentación , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Países Bajos/epidemiología , Valor Predictivo de las Pruebas , Pronóstico , Estudios Prospectivos , Factores de Riesgo , Infarto del Miocardio con Elevación del ST/complicaciones , Infarto del Miocardio con Elevación del ST/epidemiología , Infarto del Miocardio con Elevación del ST/fisiopatología , Factores de TiempoRESUMEN
BACKGROUND: Sufficient electrode-tissue contact is crucial for adequate lesion formation in radiofrequency catheter ablation (RFCA). OBJECTIVE: We assessed the impact of direct catheter force measurement on acute procedural parameters and outcome of RFCA for paroxysmal and persistent atrial fibrillation (AF). METHODS: Ninety-nine consecutive patients (70% men) with paroxysmal (63.6%) or persistent AF underwent left atrial RFCA using a 3.5-mm open-irrigated-tip (OIT) catheter with contact force measurement capabilities (group 1). For comparison a case-matched cohort with standard OIT catheters was used (99 patients; group 2). Case matching included gender, type of AF, number or RFCA procedures, and type of procedure. RESULTS: Procedural data showed a significant decline in radiofrequency ablation time from 52 ± 20 to 44 ± 16 minutes (P = 0.003) with a remarkable mean reduction in overall procedure time of 34 minutes (P = 0.0001; 225.8 ± 53.1 vs 191.9 ± 53.3 minutes). In parallel, the total fluoroscopy time could be significantly reduced from 28.5 ± 11.0 to 19.9 ± 9.3 minutes (P = 0.0001) as well as fluoroscopy dose from 74.1 ± 58.0 to 56.7 ± 38.9 Gy/cm(2) (P = 0.016). Periprocedural complications were similar in both groups. CONCLUSIONS: The use of contact force sensing technology is able to significantly reduce ablation, procedure, and fluoroscopy times as well as dose in RFCA of AF in a mixed case-matched group of paroxysmal and persistent AF. Energy delivery is substantially reduced by avoiding radiofrequency ablation in positions with insufficient surface contact. Additionally 12-month outcome data showed increased efficacy. Such time saving and equally safe technology may have a relevant impact on laboratory management and increased cost effectiveness.
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Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/cirugía , Ablación por Catéter/instrumentación , Tempo Operativo , Cirugía Asistida por Computador/instrumentación , Ablación por Catéter/métodos , Diseño de Equipo , Análisis de Falla de Equipo , Retroalimentación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Radiografía , Estrés Mecánico , Cirugía Asistida por Computador/métodos , Tacto , Resultado del TratamientoAsunto(s)
Ablación por Catéter/métodos , Válvula Pulmonar/fisiopatología , Complejos Prematuros Ventriculares , Adulto , Técnicas Electrofisiológicas Cardíacas/métodos , Femenino , Sistema de Conducción Cardíaco/fisiopatología , Sistema de Conducción Cardíaco/trasplante , Ventrículos Cardíacos/fisiopatología , Humanos , Resultado del Tratamiento , Complejos Prematuros Ventriculares/diagnóstico , Complejos Prematuros Ventriculares/fisiopatología , Complejos Prematuros Ventriculares/cirugíaRESUMEN
The current gold standard in device therapy for advanced heart failure (HF), which has been firmly established in HF management for more than 25 years, is classical biventricular pacing (BiV-CRT). In the last decade, a new pacing modality called conduction system pacing (CSP) has emerged as a variant for advanced cardiac device therapy. It provides pacing with preserved intrinsic cardiac activation by direct stimulation of the specific cardiac conduction system. The term CSP integrates the modalities of HIS bundle pacing (HBP) and left bundle branch area pacing (LBBAP), both of which have provided convincing data in smaller randomized and big non-randomized studies for the prevention of pacemaker-induced cardiomyopathy and for providing effective cardiac resynchronization therapy in patients with classical CRT-indication (primary approach or after failed CRT). Recent American guidelines proposed the term "cardiac physiological pacing" (CPP), which summarizes CSP including left ventricular septal pacing (LVSP), a technical variant of LBBAP together with classical BiV-CRT. The terms HOT-CRT (HIS-optimized CRT) and LOT-CRT (LBBP-optimized CRT) describe hybrid technologies that combine CSP with an additional coronary-sinus electrode, which is sometimes useful in patients with advanced HF and diffuse interventricular conduction delay. If CSP continues providing promising data that can be confirmed in big, randomized trials, it is likely to become the new gold standard for patients with an expected high percentage of pacing (>20%), possibly also for cardiac resynchronization therapy. CSP is a sophisticated new treatment option that has the potential to raise the term "cardiac resynchronization therapy" to a new level. The aim of this review is to provide basic technical, anatomical, and functional knowledge of these new pacemaker techniques in order to facilitate the understanding of the different modalities, as well as to provide an up-to-date overview of the existing randomized and non-randomized evidence, particularly in direct comparison to right ventricular and classical biventricular pacing.
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Background: Pulmonary vein isolation (PVI) using radiofrequency ablation (RFA) is a standard-of-care treatment in the rhythm control strategy of symptomatic atrial fibrillation (AF). Ablation protocols, varying in the power and duration of energy delivery, have changed rapidly in recent years. Very high-power very short-duration ablation (vHPvSD) is expected to shorten procedural times compared to conventional ablation approaches. However, the existing data suggest that this might come at the cost of lower first-pass isolation rates, a predictor of poor ablation long-term outcomes. This study aims to compare a vHPvSD protocol to a hybrid strategy, in which the power and duration of the energy transfer are adapted depending on the anatomical location. Methods: We retrospectively analyzed procedural and outcome data from 93 patients (55 vHPvSD vs. 38 hybrid) scheduled for de novo pulmonary vein isolation. A vHPvSD ablation protocol (90 Watt (W), 4 s) was compared to a hybrid protocol using vHPvSD on the posterior wall and 50 W HPSD (high-power short-duration) ablation guided by the Ablation Index along the remaining spots. Results: Ablation times were significantly shorter in the vHPvSD cohort (5.4 min. vs. 14.2 min, p < 0.001), thus resulting in a significant reduction in the overall procedural duration (91 min vs. 106 min, p = 0.003). The non-significant slightly higher first-pass isolation rates in the vHPvSD cohort (85% vs. 76%, p = 0.262) did not affect freedom from AF 6 months after the procedure (83% vs. 87%, p = 0.622). Conclusions: vHPvSD helps in shortening the PVI procedural duration, thus neither affecting first-pass isolation rates nor freedom from atrial tachyarrhythmia recurrence at 6 months after the index procedure.
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Background: Cardiac radioablation is a new treatment for patients with refractory ventricular tachycardia (VT). The target for cardiac radioablation is subject to cardiorespiratory motion (CRM), the heart's movement with breathing and cardiac contraction. Data regarding the magnitude of target CRM are limited but are highly important for treatment planning. Objectives: The study sought to assess CRM amplitude by using ablation catheter geometrical data. Methods: Electroanatomic mapping data of patients undergoing catheter ablation for VT at 3 academic centers were exported. The spatial position of the ablation catheter as a function of time while in contact with endocardium was analyzed and used to quantify CRM. Results: Forty-four patients with ischemic and nonischemic cardiomyopathy and VT contributed 1364 ablation lesions to the analysis. Average cardiac and respiratory excursion were 1.62 ± 1.21 mm and 12.12 ± 4.10 mm, respectively. The average ratio of respiratory to cardiac motion was approximately 11:1. CRM was greatest along the craniocaudal axis (9.66 ± 4.00 mm). Regional variations with respect to respiratory and cardiac motion were observed: basal segments had smaller displacements vs midventricular and apical segments. Patient characteristics (previous cardiac surgery, height, weight, body mass index, and left ventricular ejection fraction) had a statistically significant, albeit clinically moderate, impact on CRM. Conclusion: CRM is primarily determined by respiratory displacement and is modulated by the location of the target and the patient's biometric characteristics. The patient-specific quantification of CRM may allow to decrease treatment volume and reduce radiation exposure of surrounding organs at risk while delivering the therapeutic dose to the target.
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BACKGROUND: Outcome comparisons among subcutaneous implantable cardioverter-defibrillator (S-ICD) recipients with nonischemic cardiomyopathies are scarce. OBJECTIVE: The aim of this study was to evaluate differences in device-related outcomes among S-ICD recipients with different structural substrates. METHODS: Patients enrolled in the i-SUSI (International SUbcutaneouS Implantable cardioverter defibrillator registry) project were grouped according to the underlying substrate (ischemic vs nonischemic) and subgrouped into dilated cardiomyopathy, hypertrophic cardiomyopathy, Brugada syndrome (BrS), arrhythmogenic right ventricular cardiomyopathy (ARVC). The main outcome of our study was to compare the rates of appropriate and inappropriate shocks and device-related complications. RESULTS: Among 1698 patients, the most common underlying substrate was ischemic (31.7%), followed by dilated cardiomyopathy (20.5%), BrS (10.8%), hypertrophic cardiomyopathy (8.5%), and ARVC (4.4%). S-ICD for primary prevention was more common in the nonischemic cohort (70.9% vs 65.4%; P = .037). Over a median (interquartile range) follow-up of 26.5 (12.6-42.8) months, no differences were observed in appropriate shocks between ischemic and nonischemic patients (4.8%/y vs 3.9%/y; log-rank, P = .282). ARVC (9.0%/y; hazard ratio [HR] 2.492; P = .001) and BrS (1.8%/y; HR 0.396; P = .008) constituted the groups with the highest and lowest rates of appropriate shocks, respectively. Device-related complications did not differ between groups (ischemic: 6.4%/y vs nonischemic: 6.1%/y; log-rank, P = .666), nor among underlying substrates (log-rank, P = .089). Nonischemic patients experienced higher rates of inappropriate shocks than did ischemic S-ICD recipients (4.4%/y vs 3.0%/y; log-rank, P = .043), with patients with ARVC (9.9%/y; P = .001) having the highest risk, even after controlling for confounders (adjusted HR 2.243; confidence interval 1.338-4.267; P = .002). CONCLUSION: Most S-ICD recipients were primary prevention nonischemic cardiomyopathy patients. Among those, patients with ARVC tend to receive the most frequent appropriate and inappropriate shocks and patients with BrS the least frequent appropriate shocks.
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Displasia Ventricular Derecha Arritmogénica , Cardiomiopatías , Cardiomiopatía Dilatada , Desfibriladores Implantables , Humanos , Desfibriladores Implantables/efectos adversos , Muerte Súbita Cardíaca/epidemiología , Muerte Súbita Cardíaca/etiología , Muerte Súbita Cardíaca/prevención & control , Cardioversión Eléctrica/efectos adversos , Displasia Ventricular Derecha Arritmogénica/complicaciones , Cardiomiopatía Dilatada/complicaciones , Cardiomiopatía Dilatada/terapia , Sistema de Registros , Resultado del TratamientoRESUMEN
AIMS: Currently, fluoroscopy-based catheter visualization is the standard modality in invasive electrophysiological procedures. Recently a new technology for non-fluoroscopic visualization of diagnostic (since 2010) and ablation catheters (since May 2012) has been introduced. The MediGuide™-Technology (MediGuide) projects catheter tips on prerecorded cine loops in a high time resolution. METHODS AND RESULTS: We report on MediGuide-based supraventricular tachycardia (SVT) cases [atrioventricular nodal reentry tachycardia (AVNRT), atrioventricular reentry tachycardia (AVRT), Wolff-Parkinson-White syndrome (WPW), ectopic atrial tachycardia (EAT) and typical atrial flutter) from two European centres. In all patients, diagnostic and/or ablation catheters with a special sensor were used to perform the ablation procedures. All procedural data such as acute success, duration of the procedure, fluoroscopy time, and dose and patients' characteristics were analyzed and compared with conventionally ablated patients (n = 1865). Procedure-related complications during the hospital stay were recorded. A total of 24 consecutive patients were analyzed: no significant difference to the control group was seen in the baseline characteristics. The MediGuide patients were predominantly male (66%), aged 58 ± 14 years and were ablated for 6 AVNRT (25%), 4 AVRT/WPW (17%), 1 EAT (4%), and 13 typical atrial flutter (54%). The acute success rate was 100% (98% in the control group, n.s.). The median fluoroscopy time was 0.5 ± 1.4 min (10.2 ± 9.6 in the control group, P < 0.001), the median fluoroscopy dose was 187 ± 554 cGy cm(2) (996 ± 2593 cGy cm(2), P < 0.05). Mean procedure time was 70 ± 25 min (60 ± 36 min, n.s.). No complications during the hospital stay were recorded. CONCLUSION: In several different forms of supraventricular tachycardias the MediGuide-Technology contributed to a dramatic reduction in irradiation exposure. With a median fluoroscopy time of 30 s all SVT cases were effectively performed with no complications; the fluoroscopy burden can be significantly reduced not only for the patient but also for the nurses and the physicians performing the case. The overall procedure times are not prolonged due to the use of MediGuide Technology compared with a control group of >1800 patients undergoing conventional ablation procedures.
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Ablación por Catéter/estadística & datos numéricos , Sistema de Registros , Cirugía Asistida por Computador/métodos , Cirugía Asistida por Computador/estadística & datos numéricos , Taquicardia Supraventricular/diagnóstico , Taquicardia Supraventricular/terapia , Austria/epidemiología , Femenino , Alemania/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Prevalencia , Estudios Retrospectivos , Factores de Riesgo , Taquicardia Supraventricular/epidemiología , Resultado del TratamientoRESUMEN
AIMS: Left atrial radiofrequency ablation has been shown to carry a risk of asymptomatic cerebral lesions. No data exist in patients under continued oral anticoagulation during the ablation procedure. The aim of this study was to quantify the amount of silent cerebral lesions assessed by pre-procedural and post-procedural magnetic resonance imaging (MRI) in patients under therapeutic international normalized ratio (INR) and to identify clinical or procedural parameters that correlate with cerebral embolism. METHODS AND RESULTS: A total of 131 consecutive patients undergoing catheter ablation for paroxysmal (n = 80, 61.1%) or persistent (n = 51, 38.9%) atrial fibrillation were included in the study. Pulmonary vein antrum isolation (PVI), roofline, mitral isthmus line, and complex fractionated atrial electrogram (CFAE) ablation using 3.5 mm open-irrigated tip catheters were performed, as needed. All patients underwent pre-procedural and post-procedural cerebral MRI. Post-procedural MRI revealed new embolic lesions in 16 patients (12.2%), all of them asymptomatic. Clinical parameters showing a significant correlation with cerebral embolism in univariate analysis were age (P = 0.027), persistent atrial fibrillation (vs. paroxysmal; P = 0.039), and spontaneous echo contrast in transesophageal echocardiography (P = 0.029). Significant procedural parameters were electric cardioversion (P = 0.041), PVI only (P = 0.008), and ablation of complex atrial electrograms (P = 0.005). Independent risk factors in multivariate analysis were age (P = 0.009), spontaneous echo contrast (P = 0.029) and CFAE ablation (P = 0.006). CONCLUSION: Radiofrequency ablation in patients under continued oral therapeutic anticoagulation is associated with a substantial risk of silent embolism detected by cerebral MRI. Therefore, continuation of oral anticoagulation is not able to prevent cerebral embolism. A variety of different clinical and procedural factors seem to contribute to the risk of cerebral lesions.
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Anticoagulantes/administración & dosificación , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/cirugía , Ablación por Catéter/efectos adversos , Embolia Intracraneal/etiología , Venas Pulmonares/cirugía , Administración Oral , Factores de Edad , Anciano , Enfermedades Asintomáticas , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/fisiopatología , Austria , Coagulación Sanguínea/efectos de los fármacos , Distribución de Chi-Cuadrado , Esquema de Medicación , Ecocardiografía Transesofágica , Técnicas Electrofisiológicas Cardíacas , Femenino , Humanos , Relación Normalizada Internacional , Embolia Intracraneal/diagnóstico , Embolia Intracraneal/prevención & control , Modelos Logísticos , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Análisis Multivariante , Valor Predictivo de las Pruebas , Estudios Prospectivos , Venas Pulmonares/fisiopatología , Medición de Riesgo , Factores de Riesgo , Resultado del TratamientoRESUMEN
The management of chronic thromboembolic pulmonary hypertension has significantly changed over the last decade with the availability of both specific therapies and interventional treatments. In parallel, implantable pumps for intravenous administration of treprostinil have broadened the spectrum of continuous prostanoid infusion. We evaluated the course of 17 consecutive patients with inoperable chronic thromboembolic pulmonary hypertension treated with treprostinil by means of an implantable infusion pump between 2011 and 2023 at our center. Complications associated with the infusion system were rare, leading to 0.4 unplanned surgical interventions during 17,160 patient days. No additional safety signals were detected, and clinical benefits achieved with subcutaneous treprostinil before pump implantation could be maintained in all patients. No catheter-related infections or thromboembolic events were observed. Implantable infusion pumps offer an attractive alternative to subcutaneous treprostinil for patients intolerant to the subcutaneous route, including those with chronic thromboembolic pulmonary hypertension.