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BACKGROUND: Physiological activation of the heart using algorithms to minimize right ventricular pacing (RVPm) may be an effective strategy to reduce adverse events in patients requiring anti-bradycardia therapies. This systematic review and meta-analysis aimed to evaluate current evidence on clinical outcomes for patients treated with RVPm algorithms compared to dual chamber pacing (DDD). METHODS AND RESULTS: We conducted a systematic search of the PubMed database. The predefined endpoints were the occurrence of persistent/permanent atrial fibrillation (PerAF), cardiovascular (CV) hospitalization, all-cause death, and adverse symptoms. We also aimed to explore the differential effects of algorithms in studies enrolling a high percentage of atrioventricular block (AVB) patients. Eight studies (7229 patients) were included in the analysis. Compared to DDD-pacing, patients using RVPm algorithms showed a lower risk of PerAF (Odds Ratio [OR] 0.74, 95% confidence interval [CI] 0.57-0.97) and CV hospitalization (OR 0.77, 95% CI 0.61-0.97). No significant difference was found for all-cause death (OR 1.01, 95% CI 0.78-1.30) or adverse symptoms (OR 1.03, 95% CI 0.81-1.29). No significant interaction was found between the use of the RVPm strategy and studies enrolling a high percentage of AVB patients. The pooled mean RVP percentage for RVPm algorithms was 7.96% (95% CI 3.13-20.25), as compared with 45.11% (95% CI 26.64-76.38) of DDD-pacing. CONCLUSION: Algorithms for RVPm may be effective in reducing the risk of PerAF and CV hospitalization in patients requiring anti-bradycardia therapies, without an increased risk of adverse symptoms. These results are also consistent for studies enrolling a high percentage of AVB patients.
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BACKGROUND: Clinical complexity is increasingly prevalent among patients with atrial fibrillation (AF). The 'Atrial fibrillation Better Care' (ABC) pathway approach has been proposed to streamline a more holistic and integrated approach to AF care; however, there are limited data on its usefulness among clinically complex patients. We aim to determine the impact of ABC pathway in a contemporary cohort of clinically complex AF patients. METHODS: From the ESC-EHRA EORP-AF General Long-Term Registry, we analysed clinically complex AF patients, defined as the presence of frailty, multimorbidity and/or polypharmacy. A K-medoids cluster analysis was performed to identify different groups of clinical complexity. The impact of an ABC-adherent approach on major outcomes was analysed through Cox-regression analyses and delay of event (DoE) analyses. RESULTS: Among 9966 AF patients included, 8289 (83.1%) were clinically complex. Adherence to the ABC pathway in the clinically complex group reduced the risk of all-cause death (adjusted HR [aHR]: 0.72, 95%CI 0.58-0.91), major adverse cardiovascular events (MACEs; aHR: 0.68, 95%CI 0.52-0.87) and composite outcome (aHR: 0.70, 95%CI: 0.58-0.85). Adherence to the ABC pathway was associated with a significant reduction in the risk of death (aHR: 0.74, 95%CI 0.56-0.98) and composite outcome (aHR: 0.76, 95%CI 0.60-0.96) also in the high-complexity cluster; similar trends were observed for MACEs. In DoE analyses, an ABC-adherent approach resulted in significant gains in event-free survival for all the outcomes investigated in clinically complex patients. Based on absolute risk reduction at 1 year of follow-up, the number needed to treat for ABC pathway adherence was 24 for all-cause death, 31 for MACEs and 20 for the composite outcome. CONCLUSIONS: An ABC-adherent approach reduces the risk of major outcomes in clinically complex AF patients. Ensuring adherence to the ABC pathway is essential to improve clinical outcomes among clinically complex AF patients.
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Fibrilación Atrial , Accidente Cerebrovascular , Anticoagulantes/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/epidemiología , Humanos , Sistema de Registros , Factores de Riesgo , Accidente Cerebrovascular/complicacionesRESUMEN
Atrial fibrillation (AF) is the most common arrhythmia in the setting of critically ill patients. Pneumonia, and in particular community-acquired pneumonia, is one of the most common causes of illness and hospital admission worldwide. This article aims to review the association between AF and acute diseases, with specific attention to pneumonia, from the pathophysiology to its clinical significance. Even though the relationship between pneumonia and AF has been known for years, it was once considered a transient bystander. In recent years there has been growing knowledge on the clinical significance of this arrhythmia in acute clinical settings, in which it holds a prognostic role which is not so different as compared to that of the so-called "primary" AF. AF is a distinct entity even in the setting of pneumonia, and acute critical illnesses in general, and it should therefore be managed with a guidelines-oriented approach, including prescription of anticoagulants in patients at thromboembolic risk, always considering patients' individuality. More data on the significance of the arrhythmia in this setting will help clinicians to give patients the best possible care.
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BACKGROUND: The Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF (mAFA-II) randomised trial demonstrated the efficacy of a mobile health (mHealth) technology-implemented 'Atrial fibrillation Better Care' (ABC) pathway-approach (mAFA intervention) in reducing the risk of adverse events in patients with atrial fibrillation (AF). Whether these benefits also apply to older patients is unclear. In this ancillary analysis, we evaluated the effect of mAFA intervention among older AF patients. METHODS: The mAFA-II trial enrolled adult AF patients across 40 centres in China. For this analysis, we defined older patients as those aged ≥75 years. Primary outcome was the composite of ischemic stroke or thromboembolism, all-cause death and rehospitalisation. The effect of mAFA intervention was assessed through multivariable Cox-regression models. We also evaluated the interaction between age and effect of the mAFA intervention in the main trial population. RESULTS: In this analysis, we included 1,163 AF patients ≥75 years (mean age: 82.6 ± 5.3 years, 43.1% females); 520 were allocated to mAFA intervention, 643 to usual care. mAFA intervention was associated with a significant reduction of the primary composite outcome (adjusted hazard ratio [aHR]: 0.58, 95% confidence interval [CI]: 0.35-0.97) and rehospitalisations alone (aHR: 0.47, 95%CI: 0.24-0.91). Significant interaction between age and mAFA intervention effect was observed for both the composite outcome (P = 0.002) and rehospitalisation alone (P = 0.015), with the effect decreasing as age increased, particularly among patients ≥80 years old. CONCLUSIONS: A mHealth technology-implemented ABC pathway is effective in reducing adverse clinical outcomes in older AF patients. The benefits obtained with mAFA intervention were attenuated at extreme ages.
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Fibrilación Atrial , Prestación Integrada de Atención de Salud , Accidente Cerebrovascular , Telemedicina , Femenino , Humanos , Anciano , Anciano de 80 o más Años , Masculino , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/terapia , Tecnología Biomédica , Tecnología , Accidente Cerebrovascular/complicaciones , Anticoagulantes/efectos adversosRESUMEN
Atrial fibrillation (AF) may be asymptomatic and the extensive monitoring capabilities of cardiac implantable electronic devices (CIEDs) revealed asymptomatic atrial tachi-arrhythmias of short duration (minutes-hours) occurring in patients with no prior history of AF and without AF detection at a conventional surface ECG. Both the terms "AHRE" (Atrial High-Rate Episodes) and subclinical AF were used in a series of prior studies, that evidenced the association with an increased risk of stroke. Two randomized controlled studies were planned in order to assess the risk-benefit profile of anticoagulation in patients with AHRE/subclinical AF: the NOAH and ARTESiA trials. The results of these two trials (6548 patients enrolled, overall) show that the risk of stroke/systemic embolism associated with AHRE/subclinical AF is in the range of 1-1.2 % per patient-year, but with an important proportion of severe/fatal strokes occurring in non-anticoagulated patients. The apparent discordance between ARTESiA and NOAH results may be approached by considering the related study-level meta-analysis, which highlights a consistent reduction of ischemic stroke with oral anticoagulants vs. aspirin/placebo (relative risk [RR] 0.68, 95 % CI 0.50-0.92). Oral anticoagulation was found to increase major bleeding (RR 1.62, 95 % CI 1.05-2.5), but no difference was found in fatal bleeding (RR 0.79, 95 % CI 0.37-1.69). Additionally, no difference was found in cardiovascular death or all-cause mortality. Taking into account these results, clinical decision-making for patients with AHRE/subclinical AF at risk of stroke, according to CHA2DS2-VASc, can now be evidence-based, considering the benefits and related risks of oral anticoagulants, to be shared with appropriately informed patients.
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Anticoagulantes , Fibrilación Atrial , Desfibriladores Implantables , Ensayos Clínicos Controlados Aleatorios como Asunto , Accidente Cerebrovascular , Humanos , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/complicaciones , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificación , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/etiología , Marcapaso Artificial/efectos adversos , Toma de Decisiones Clínicas , Medición de RiesgoRESUMEN
In the 2000s, cardiac resynchronization therapy (CRT) became a revolutionary treatment for heart failure with reduced left ventricular ejection fraction (HFrEF) and wide QRS. However, about one-third of CRT recipients do not show a favorable response. This review of the current literature aims to better define the concept of CRT response/nonresponse. The diagnosis of CRT nonresponder should be viewed as a continuum, and it cannot rely solely on a single parameter. Moreover, baseline features of some patients might predict an unfavorable response. A strong collaboration between heart failure specialists and electrophysiologists is key to overcoming this challenge with multiple strategies. In the contemporary era, new pacing modalities, such as His-bundle pacing and left bundle branch area pacing, represent a promising alternative to CRT. Observational studies have demonstrated their potential; however, several limitations should be addressed. Large randomized controlled trials are needed to prove their efficacy in HFrEF with electromechanical dyssynchrony.
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BACKGROUND: The DOAC score has been recently proposed for bleeding risk stratification of patients with atrial fibrillation treated with direct oral anticoagulants (DOAC). OBJECTIVE: To compare the performance of HAS-BLED and DOAC score in predicting major bleeding events in a contemporary cohort of European AF patients treated with DOAC. METHODS: We included patients derived from a prospective observational registry of European AF patients. HAS-BLED and DOAC scores were calculated as per the original schemes. Our primary endpoint was major bleeding events. Receiver operating characteristic (ROC) curves were used to compare the predictive ability of the scores. RESULTS: A total of 2834 AF patients (median age [IQR] 69 [62-77] years; 39.6 % female) treated with DOAC were included in the analysis. According to the HAS-BLED score, 577 patients (20.4 %) were categorized as very low risk of bleeding, as compared to 1276 (45.0 %) according to DOAC score. A total of 55 major bleeding events occurred with an overall incidence of 1.04 per 100 patient-years. Both scores showed only a modest ability for the prediction of bleeding events (HAS-BLED area under the curve [AUC], 0.65, 95 % confidence interval [CI] 0.55-0.70; DOAC score AUC 0.62, 95 % CI 0.59-0.71, p for difference = 0.332]. At calibration analysis, the DOAC score showed modest calibration, especially for patients at high risk, when compared to HAS-BLED. CONCLUSION: In a contemporary cohort of DOAC-treated AF patients, both HAS-BLED and DOAC scores only modestly predicted the occurrence of major bleeding events. Our results do not support the preferential use of DOAC score over HAS-BLED.
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The management of patients with atrial fibrillation (AF) requires intricate clinical decision-making to optimize outcomes. In everyday clinical practice, physicians undergo difficult choices to better manage patients with AF. They need to balance thromboembolic and bleeding risk to focus on patients' symptoms and to manage a variety of multiple comorbidities. In this review, we aimed to explore the multifaceted dimensions of clinical decision-making in AF patients, encompassing the definition and diagnosis of clinical AF, stroke risk stratification, oral anticoagulant therapy selection, consideration of bleeding risk, and the ongoing debate between rhythm and rate control strategies. We will also focus on possible grey zones for the management of AF patients. In navigating this intricate landscape, clinicians must reconcile the dynamic interplay of patient-specific factors, evolving guidelines, and emerging therapies. The review underscores the need for personalized, evidence-based clinical decision-making to tailor interventions for optimal outcomes according to specific AF patient profiles.
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BACKGROUND: The outcome implications of asymptomatic vs. symptomatic atrial fibrillation (AF) in specific groups of patients according to clinical heart failure (HF) and left ventricular ejection fraction (LVEF) need to be clarified. METHODS: In a prospective observational study, patients were categorized according to overt HF with LVEF≤40 %, or with LVEF>40 %, or without overt HF with LVEF40 %≤ or > 40 %, as well as according to the presence of asymptomatic or symptomatic AF. RESULTS: A total of 8096 patients, divided into 8 groups according to HF and LVEF, were included with similar proportions of asymptomatic AF (ranging from 43 to 48 %). After a median follow-up of 730 [699 -748] days, the composite outcome (all-cause death and MACE) was significantly worse for patients with asymptomatic AF associated with HF and reduced LVEF vs. symptomatic AF patients of the same group (p = 0.004). On adjusted Cox regression analysis, asymptomatic AF patients with HF and reduced LVEF were independently associated with a higher risk for the composite outcome (aHR 1.32, 95 % CI 1.04-1.69) and all-cause death (aHR 1.33, 95 % CI 1.02-1.73) compared to symptomatic AF patients with HF and reduced LVEF. Kaplan-Meier curves showed that HF-LVEF≤40 % asymptomatic patients had the highest cumulative incidence of all-cause death and MACE (p < 0.001 for both). CONCLUSIONS: In a large European cohort of AF patients, the risk of the composite outcome at 2 years was not different between asymptomatic and symptomatic AF in the whole cohort but adverse implications for poor outcomes were found for asymptomatic AF in HF with LVEF≤40 %.
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Fibrilación Atrial , Insuficiencia Cardíaca , Humanos , Fibrilación Atrial/complicaciones , Fibrilación Atrial/epidemiología , Volumen Sistólico , Función Ventricular Izquierda , Factores de Riesgo , Insuficiencia Cardíaca/complicacionesRESUMEN
The medical approach to atrial fibrillation (AF) underwent a paradigm shift over time, evolving from considering AF as a simple arrhythmic phenomenon to a complex nosological entity [...].
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BACKGROUND: To assess the effect of mobile health (mHealth) technology-implemented 'Atrial fibrillation Better Care' (ABC) pathway-approach (mAFA intervention) in AF patients with Heart Failure (HF). METHODS: From the Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF (mAFA-II) cluster randomized trial, we evaluated the effect of mAFA intervention on the risk of major outcomes in patients with HF using Inverse Probability of Treatment Weighting. Primary outcome was the composite outcome of stroke/thromboembolism, all-cause death, and rehospitalization. The effect of mAFA and the interaction with HF at baseline was assessed through Cox-regressions. RESULTS: Among the 3,324 patients originally enrolled in the trial, 714 (21.5%; mean age: 72.7±13.1 years; 39.9% females) had HF. The effect of mAFA intervention on the primary outcome was consistent in patients with and without HF (Hazard Ratio, (HR): 0.59, 95% Confidence Interval (CI): 0.29-1.22 vs. HR: 0.40, 95%CI: 0.21-0.76, p for interaction=0.438); similar findings were found for rehospitalisations and bleeding events. A trend towards lower efficacy of mAFA in HF patients was observed for all-cause death, while the risk of the composite outcome of 'recurrent AF, HF and acute coronary syndrome' was higher among AF-HF patients allocated to mAFA (p for interaction: <0.001). CONCLUSION: A mHealth-technology implemented ABC pathway provides consistent effects on the risks of primary outcome, rehospitalisation and bleeding, in AF patients both with and without HF. However, AF-HF patients may need tailored approaches to improve their overall prognosis, specifically to reduce the risk of recurrent AF, HF and acute coronary syndrome.
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Síndrome Coronario Agudo , Fibrilación Atrial , Prestación Integrada de Atención de Salud , Insuficiencia Cardíaca , Telemedicina , Femenino , Humanos , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Masculino , Fibrilación Atrial/complicaciones , Fibrilación Atrial/terapia , Fibrilación Atrial/diagnóstico , Hemorragia , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/terapiaRESUMEN
BACKGROUND: The European Society of Cardiology (ESC) clinical practice guidelines are essential tools for decision-making. AIM: To analyze the level of evidence (LOE) and the class of recommendations in the ESC guidelines released in the last 12 years. METHODS: We evaluated 50 ESC guidelines released from 2011 to 2022, related to 27 topics and categorized them into seven macro-groups. We analyzed every recommendation in terms of LOE and class of recommendation, calculating their relative proportions and changes over time in consecutive editions of the same guideline. RESULTS: A total of 6972 recommendations were found, with an increase in number per year over time. Among the 50 ESC guidelines, the proportional distribution of classes of recommendations was 49% for Class I, 29% for Class IIa, 15% for Class IIb, and 8% for Class III. Overall, 16% of the recommendations were classified as LOE A, 31% LOE B and 53% LOE C. The field of preventive cardiology had the largest proportion of LOE A, while the lowest was in the field of valvular, myocardial, pericardial and pulmonary diseases. The overall proportion of LOE A recommendations in the most recent guidelines compared to their prior versions increased from 17% to 20%. CONCLUSIONS: The recommendations included in the ESC guidelines widely differ in terms of quality of evidence, with only 16% supported by the highest quality of evidence. Although a slight global increase in LOE A recommendations was observed in recent years, further scientific research efforts are needed to increase the quality of evidence.
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Cardiología , Sociedades Médicas , HumanosRESUMEN
Background: The 'Atrial fibrillation Better Care' (ABC) pathway has been proposed to streamline a more holistic or integrated care approach to atrial fibrillation (AF) management. We aimed to analyse the impact of adherence to the ABC pathway on the risk of major adverse outcomes in a contemporary prospective global cohort of patients with AF. Methods: Patients enrolled Phase II and III of the GLORIA-AF Registry with complete data on ABC pathway adherence and follow-up were included in this post-hoc analysis between November 2011 and December 2014 for Phase II, and between January 2014 and December 2016 for Phase III. The primary outcome was the composite of all-cause death and major adverse cardiovascular events (MACEs). Multivariable Cox-regression and delay of event (DoE) analyses were used to evaluate the association between adherence to the ABC pathway and the risk of outcomes. Findings: We included 24,608 patients in this analysis (mean age: 70.2 (10.3) years, 10,938 (44.4%) females). Adherence to the ABC pathway was associated with a significant risk reduction for the primary outcome, with greatest magnitude observed for full ABC pathway adherence (adjusted Hazard Ratio [aHR] 0.54, 95% Confidence Interval [CI]: 0.44-0.67, p < 0.0001). ABC pathway adherence was also associated with reduced risk of mortality (aHR: 0.89, 95% CI: 0.79-1.00, p = 0.048), thromboembolism (aHR: 0.78, 95% CI: 0.65-0.94, p = 0.0078), and MACE (aHR: 0.82, 95% CI: 0.71-0.95, p = 0.0071). An increasing number of ABC criteria attained was associated with longer event-free survival in the DoE analysis. Interpretation: Adherence to the ABC pathway in patients with AF was associated with a reduced risk of major adverse events, including mortality, thromboembolism and MACE. This underlines the importance of using the ABC pathway in the clinical care of patients with AF. Funding: This study was funded by Boehringer Ingelheim.
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Cardiac surgery in Jehovah's Witnesses (JW) patients who refuse blood transfusion is challenging requiring dedicated strategies. We aimed to analyze non-selected JW patients undergoing cardiac surgery and to compare with matched controls both perioperative outcomes and long-term survival. We retrospectively analyzed JW patients undergoing cardiac surgery from January 2016 to March 2021 and compared them with matched controls. The primary outcome was a composite of in-hospital perioperative adverse events and in-hospital mortality. The secondary outcome was all-cause mortality at long-term follow-up. A total of 113 JW patients and 113 controls were included. Baseline clinical characteristics, including laboratory parameters were comparable. Overall, there were no statistical differences between JW vs controls in terms of in-hospital mortality (2.7% vs 1.8%, p = 1.00) but mortality was remarkably high (40%) in JW patients with post-op hemoglobin < 8 g/dl. Logistic regression analysis found that the JW group was not associated with a higher occurrence of the composite outcome (adjusted odds ratio 0.91, 95% confidence interval [CI] 0.54-1.57). After a median follow-up of 1397 [IQR 922.7-1723.5] days, JW patients were not associated with a significantly higher all-cause mortality (adjusted hazard ratio 0.77, 95% CI 0.24-2.42). Cardiac surgery can be safely performed in non-anemic JW patients despite the refusal of blood transfusions. Favorable clinical outcomes can be achieved by the use of specific perioperative strategies for bloodless surgery with no differences as compared to control patients except in JW patients with a very low level of post-operative hemoglobin not supported by immediate transfusions.
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Procedimientos Quirúrgicos Cardíacos , Testigos de Jehová , Humanos , Estudios de Casos y Controles , Estudios Retrospectivos , Resultado del Tratamiento , Procedimientos Quirúrgicos Cardíacos/efectos adversos , HemoglobinasRESUMEN
BACKGROUND: The incidence of infections and death in patients implanted with cardiac implantable electronic devices (CIEDs) is not fully known yet. AIM: To describe the incidence of CIED-related infection and death, and their potential predictors in a contemporary cohort of CIED patients. METHODS: All consecutive patients implanted with a CIED at our institution were prospectively enrolled. Follow-up visits were performed 2 weeks after CIED implantation for all patients, and then every 6 months for implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy (CRT) patients and every 12 months for pacemaker (PM) patients. The adjudication of CIED-related infections was performed by two independent investigators and potential disagreement was resolved by a senior investigator. RESULTS: Between September 2016 and August 2020, a total of 838 patients were enrolled (34.6% female; median age 77 (69.6-83.6); median PADIT score 2 (2-4)). PMs were implanted in 569 (68%) patients and ICD/CRT in 269 (32%) patients. All patients had pre-implant antibiotic prophylaxis and 5.5% had an antibiotic-eluting envelope. Follow-up data were available for 832 (99.2%) patients. After a median follow-up of 42.3 (30.2-56.4) months, five (0.6%) patients had a CIED-related infection and 212 (25.5%) patients died. Using multivariate Cox regression analysis, end-stage chronic kidney disease (CKD) requiring dialysis and therapy with corticosteroids was independently associated with a higher risk of infection (hazard ratio (HR): 14.20; 95% confidence interval (CI) 1.48-136.62 and HR: 14.71; 95% CI 1.53-141.53, respectively). Age (HR: 1.07; 95% CI 1.05-1.09), end-stage CKD requiring dialysis (HR: 6.13; 95% CI 3.38-11.13) and history of atrial fibrillation (HR: 1.47; 95% CI 1.12-1.94) were independently associated with all-cause death. CONCLUSIONS: In a contemporary cohort of CIED patients, mortality was substantially high and associated with clinical factors depicting a population at risk. On the other hand, the incidence of CIED-related infections was low.
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INTRODUCTION: VDD pacing system was introduced more than 30 years ago. Its use is considered by the 2021 European Society of Cardiology guidelines on cardiac pacing as a potential alternative to dual chambers system for patients with atrioventricular block and normal sinus node function. AREAS COVERED: In this article, we performed a narrative review of current literature in order to identify the strengths and weaknesses of this pacing system. VDD system allows the maintenance of AV synchronous pacing and its hemodynamic advantages. Some disadvantages may be related to the non-negligible incidence of atrial undersensing and the possible subsequent need for upgrade to DDD system. On the other hand, shorter implantation time and lower complications rate may be advantages. EXPERT OPINION: In the modern pacing era, VDD pacing system struggles to find its own space. However, it may still be considered as a valuable alternative to a dual-chamber pacemaker for selected patients, in specific clinical scenarios.
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Estimulación Cardíaca Artificial , Marcapaso Artificial , Humanos , Atrios CardíacosRESUMEN
AF patients with history of thromboembolic events are at higher risk of thromboembolic recurrences, despite appropriate antithrombotic treatment. We aimed to evaluate the effect of mobile health (mHealth) technology-implemented 'Atrial fibrillation Better Care' (ABC) pathway approach (mAFA intervention) in secondary prevention AF patients. The Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF (mAFA-II) cluster randomized trial enrolled adult AF patients across 40 centers in China. The main outcome was the composite outcome of stroke or thromboembolism, all-cause death, and rehospitalization. Using Inverse Probability of Treatment Weighting (IPTW), we evaluated the effect of the mAFA intervention in patients with and without prior history of thromboembolic events (i.e., ischemic stroke or thromboembolism). Among the 3324 patients enrolled in the trial, 496 (14.9%, mean age: 75.1 ± 11.4 years, 35.9% females) had a previous episode of thromboembolic event. No significant interaction was observed for the effect of mAFA intervention in patients with vs. without history of thromboembolic events [Hazard ratio, (HR): 0.38, 95% confidence interval (CI):0.18-0.80 vs. HR 0.55, 95% CI 0.17-1.76, p for interaction = 0.587); however, a trend towards lower efficacy of mAFA intervention among AF patients in secondary prevention was observed for secondary outcomes, with significant interaction for bleeding events (p = 0.034) and the composite of cardiovascular events (p = 0.015). A mHealth-technology-implemented ABC pathway provided generally consistent reduction of the risk of primary outcome in both primary and secondary prevention AF patients. Secondary prevention patients may require further specific approaches to improve clinical outcomes such as bleeding and cardiovascular events.Trial registration: WHO International Clinical Trials Registry Platform (ICTRP) Registration number ChiCTR-OOC-17014138.
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Fibrilación Atrial , Prestación Integrada de Atención de Salud , Accidente Cerebrovascular , Telemedicina , Tromboembolia , Adulto , Femenino , Humanos , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Masculino , Fibrilación Atrial/tratamiento farmacológico , Prevención Secundaria , Anticoagulantes/uso terapéutico , Accidente Cerebrovascular/etiología , Hemorragia/inducido químicamente , Tromboembolia/etiología , Tromboembolia/prevención & control , Tromboembolia/diagnósticoRESUMEN
In this review we focus on heart failure (HF) which, as known, is associated with a substantial risk of hospitalizations and adverse cardiovascular outcomes, including death. In recent years, systems to monitor cardiac function and patient parameters have been developed with the aim to detect subclinical pathophysiological changes that precede worsening HF. Several patient-specific parameters can be remotely monitored through cardiac implantable electronic devices (CIED) and can be combined in multiparametric scores predicting patients' risk of worsening HF with good sensitivity and moderate specificity. Early patient management at the time of pre-clinical alerts remotely transmitted by CIEDs to physicians might prevent hospitalizations. However, it is not clear yet which is the best diagnostic pathway for HF patients after a CIED alert, which kind of medications should be changed or escalated, and in which case in-hospital visits or in-hospital admissions are required. Finally, the specific role of healthcare professionals involved in HF patient management under remote monitoring is still matter of definition. We analyzed recent data on multiparametric monitoring of patients with HF through CIEDs. We provided practical insights on how to timely manage CIED alarms with the aim to prevent worsening HF. We also discussed the role of biomarkers and thoracic echo in this context, and potential organizational models including multidisciplinary teams for remote care of HF patients with CIEDs.
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Desfibriladores Implantables , Insuficiencia Cardíaca , Humanos , Insuficiencia Cardíaca/terapiaRESUMEN
Background Clinical risk factors are common among patients with atrial fibrillation (AF), but there are still limited data on their association with oral anticoagulant (OAC) treatment patterns and major outcomes. We aim to analyze the association between clinical risk phenotypes on AF treatment patterns and the risk of major outcomes. Methods and Results The GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation) phase 2 and 3 registries enrolled patients with a recent diagnosis of AF between 2011 and 2016. We defined 4 features of clinical risk among patients with CHA2DS2-VASc ≥2: elderly individuals (aged ≥80 years), chronic kidney disease (estimated glomerular filtration rate <45 mL/min), history of stroke, and history of bleeding. We analyzed the odds of receiving OAC and the risk of OAC discontinuation and adverse events at follow-up according to specific combinations and cumulative burden of these features. Primary outcome was the composite of all-cause death, thromboembolism, and major bleeding. Among 28 891 (mean±SD age, 70.1±10.5 years; 45.5% women) patients included, 10 797 (37.3%) had at least 1 clinical risk feature. OAC use was lower among patients in the elderly group (odds ratio [OR], 0.85 [95% CI, 0.75-0.96]), those with history of both stroke and bleeding (OR, 0.45 [95% CI, 0.35-0.56]), and those with multiple features (OR, 0.71 [95% CI, 0.62-0.82]). Increasing burden of clinical risk features was associated with OAC discontinuation, with highest magnitude in those with ≥3 features (hazard ratio [HR], 1.68 [95% CI, 1.31-2.15]). Groups with increasingly complex clinical risk phenotypes were associated with the occurrence of the primary composite outcome, with the highest figures observed for groups with a history of both stroke and bleeding (adjusted HR, 2.36 [95% CI, 1.83-3.04]) and multiple features (adjusted HR, 2.86 [95% CI, 2.52-3.25]). Conclusions In patients with AF, clinical risk phenotypes are multifaceted and heterogenous, and they are associated with differences in stroke prevention and worse prognosis.
Asunto(s)
Fibrilación Atrial , Accidente Cerebrovascular , Anciano , Humanos , Femenino , Persona de Mediana Edad , Anciano de 80 o más Años , Masculino , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/tratamiento farmacológico , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Anticoagulantes/efectos adversos , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Factores de Riesgo , Sistema de Registros , Administración Oral , Medición de RiesgoRESUMEN
BACKGROUND: Strategies for blood conservation, coupled with a careful preoperative assessment, may be applied to Jehovah's Witnesses (JW) patients who are candidates for cardiac surgery interventions. There is a need to assess clinical outcomes and safety of bloodless surgery in JW patients undergoing cardiac surgery. METHODS: We performed a systematic review and meta-analysis of studies comparing JW patients with controls undergoing cardiac surgery. The primary endpoint was short-term mortality (in-hospital or 30-day mortality). Peri-procedural myocardial infarction, re-exploration for bleeding, pre-and postoperative Hb levels and cardiopulmonary bypass (CPB) time were also analyzed. RESULTS: A total of 10 studies including 2,302 patients were included. The pooled analysis showed no substantial differences in terms of short-term mortality among the two groups (OR 1.13, 95% CI 0.74-1.73, I2=0%). There were no differences in peri-operative outcomes among JW patients and controls (OR 0.97, 95% CI 0.39-2.41, I2=18% for myocardial infarction; OR 0.80, 95% CI 0.51-1.25, I2=0% for re-exploration for bleeding). JW patients had a higher level of preoperative Hb (Standardized Mean Difference [SMD] 0.32, 95% CI 0.06-0.57) and a trend toward a higher level of postoperative Hb (SMD 0.44, 95% CI -0.01-0.90). A slightly lower CPB time emerged in JWs compared with controls (SMD -0.11, 95% CI -0.30-0.07). CONCLUSIONS: JW patients undergoing cardiac surgery, with avoidance of blood transfusions, did not have substantially different peri-operative outcomes compared with controls, with specific reference to mortality, myocardial infarction, and re-exploration for bleeding. Our results support the safety and feasibility of bloodless cardiac surgery, applying patient blood management strategies.