A Randomized Controlled Trial of Nonfasting vs Fasting Before Interventional Coronary Procedures: The TONIC Trial.

BACKGROUND: Fasting before coronary procedures is currently recommended to reduce complications despite the lack of scientific evidence. OBJECTIVES: The TONIC (Comparison Between Fasting and No Fasting Before Interventional Coronary Intervention on the Occurrence of Adverse Events) noninferiority trial investigated the safety and comfort of a nonfasting strategy (ad libitum food and drinks) vs traditional fasting (>6 hours for solid food and liquids) before coronary procedures. METHODS: In this monocentric, prospective, single-blind randomized controlled trial, 739 patients undergoing coronary procedures were included and randomized to a fasting or a nonfasting strategy. Emergency procedures were excluded. The primary endpoint was a composite of vasovagal reaction, hypoglycemia (defined by blood sugar ≤0.7 g/L), and isolated nausea and/or vomiting. Noninferiority margin was 4%. Secondary endpoints were contrast-induced nephropathy and patients' satisfaction. RESULTS: Among the 739 procedures (697 elective and 42 semiurgent), 517 angiographies, and 222 angioplasties (including complex and high-risk procedures) were performed. The primary endpoint occurred in 30 of 365 nonfasting patients (8.2%) vs 37 of 374 fasting patients (9.9%), demonstrating noninferiority (absolute between-group difference, -1.7%; 1-sided 95% CI upper limit: 1.8%). No food-related adverse event occurred, and contrast-related acute kidney injuries were similar between groups. Overall, procedure satisfaction and perceived pain were similar in both groups, but nonfasting patients reported less hunger and thirst (P < 0.01). In case of redo coronary procedures, most patients (79%) would choose a nonfasting strategy. CONCLUSIONS: The TONIC randomized trial demonstrates the noninferiority of a nonfasting strategy to the usual fasting strategy for coronary procedures regarding safety, while improving patients' comfort.

Temporal relationship between haemodynamic changes and activation of closed-loop stimulation during a tilt-induced vasovagal syncope.

AIMS: A dual-chamber pacemaker with closed-loop stimulation (CLS) mode is effective in reducing syncopal recurrences in patients with asystolic vasovagal syncope (VVS). In this study, we explored the haemodynamic and temporal relationship of CLS during a tilt-induced vasovagal reflex. METHODS AND RESULTS: Twenty patients underwent a tilt test under video recording 3.9 years after CLS pacemaker implantation. Three patients were excluded from the analysis because of no VVS induced by the tilt test (n = 1) and protocol violation (n = 2). In 14 of the remaining 17 patients, CLS pacing emerged during the pre-syncopal phase of circulatory instability when the mean intrinsic heart rate (HR) was 88 ± 12 b.p.m. and systolic blood pressure (SBP) was 108 ± 19 mmHg. The CLS pacing rate thereafter rapidly increased to 105 ± 14 b.p.m. within a median of 0.1 min [inter-quartile range (IQR), 0.1-0.7 min] when the SBP was 99 ± 21 mmHg. At the time of maximum vasovagal effect (syncope or pre-syncope), SBP was 63 ± 17 mmHg and the CLS rate was 95 ± 13 b.p.m. The onset of CLS pacing was 1.7 min (IQR, 1.5-3.4) before syncope or lowest SBP. The total duration of CLS pacing was 5.0 min (IQR, 3.3-8.3). Closed-loop stimulation pacing was not observed in three patients who had a similar SBP decrease from 142 ± 22 mmHg at baseline to 69 ± 4 mmHg at the time of maximum vasovagal effect, but there was no significant increase in HR (59 ± 1 b.p.m.). CONCLUSION: The reproducibility of a vasovagal reflex was high. High-rate CLS pacing was observed early during the pre-syncopal phase in most patients and persisted, although attenuated, at the time of maximum vasovagal effect. REGISTRATION: ClinicalTrials.gov identifier: NCT06038708.

Prevention strategies for vasovagal reaction in whole blood donors: A quadri-armed randomised control trial.

INTRODUCTION: Vasovagal reaction (VVR) is a frequently encountered generalised donor adverse reaction, associated with donor deterrence towards future donation. Several mitigation strategies for prevention of VVR were tried but still not standardised. This quadri-armed randomised study evaluated the utility of water ingestion, applied muscle tension (AMT) and combination of both in preventing the VVR among blood donors. METHODS: A quadri-armed randomised controlled trial was performed on 4320 whole blood donors. Blood donors of 18-65 years of age were randomised into four groups based on the interventions performed i.e., control with no intervention (Group 1, n = 1081), water ingestion (Group 2, n = 1082), AMT (Group 3, n = 1070) and combined intervention (Group 4, n = 1087). VVR during and immediately after blood donation were observed along with assessment of risk factors in blood donors and the effectiveness of interventions were analysed. RESULTS: The incidence of VVR observed 1.6% in our study, with the highest occurrence in the control group (2.5%) and the lowest in the combined intervention group (0.9%). Multivariable logistic regression revealed that the control group donors faced a 1.38-fold greater risk of VVR compared to those receiving interventions (OR: 1.38, 95% CI: 1.10-1.75). Other risk factors included younger age (OR: 1.5, 95% CI: 1.05-2.17), first-time donation (OR: 5.7, 95% CI: 1.66-5.74), prior history of VVR (OR: 2.5, 95% CI: 10.4-101.52). DISCUSSION/CONCLUSION: The combined approach of water ingestion and AMT proved significantly more effective in VVR prevention compared to individual interventions.

Interventions aimed to increase average 24-h systolic blood pressure reduce blood pressure drops in patients with reflex syncope and orthostatic intolerance.

AIMS: Systolic blood pressure (SBP) drops recorded by 24-h ambulatory blood pressure (BP) monitoring (ABPM) identify patients with susceptibility to reflex syncope and orthostatic intolerance. We tested the hypothesis that treatments aimed to increase BP (reassurance, education, and lifestyle measures plus pharmacological strategies) can reduce SBP drops. METHODS AND RESULTS: This was a multicentre, observational proof-of-concept study performed in patients with reflex syncope and/or orthostatic intolerance and with SBP drops on a screening ABPM. Among 144 eligible patients, 111 underwent a second ABPM on average 2.5 months after start of treatment. Overall, mean 24-h SBP increased from 114.1 ± 12.1 to 121.4 ± 14.5 mmHg (P < 0.0001). The number of SBP drops <90 and <100 mmHg decreased by 61%, 46% during daytime, and by 48% and 37% during 24-h period, respectively (P < 0.0001 for all). The dose-response relationship between difference in 24-h average SBP increase and reduction in number of SBP drops reached a plateau around ∼15 mmHg increase of 24-h SBP. The reduction in SBP drop rate was consistent and significant in patients who underwent deprescription of hypotensive medications (n = 44) and in patients who received BP-rising drugs (n = 67). CONCLUSION: In patients with reflex syncope and/or orthostatic intolerance, an increase in average 24-h SBP, regardless of the implemented strategy, significantly reduced the number of SBP drops and symptom burden. A 13 mmHg increase in 24-h SBP appears to represent the optimal goal for aborting the maximal number of SBP drops, representing a possible target for future interventions. ClincalTrials.gov identifier: NCT05729724.

The efficacy of non-pharmacological and non-pacing therapies in preventing vasovagal syncope: Tilt training, physical counter pressure maneuvers, and yoga - A systematic review and meta-analysis.

BACKGROUND: Vasovagal syncope (VVS) is a prevalent condition characterized by a sudden drop in blood pressure and heart rate, leading to a brief loss of consciousness and postural control. Recurrent episodes of VVS significantly impact the quality of life and are a common reason for emergency department visits. Non-pharmacological interventions, such as tilt training, physical counter pressure maneuvers, and yoga, have been proposed as potential treatments for VVS. However, their efficacy in preventing VVS remains uncertain. METHODS: A systematic review and meta-analysis were conducted following PRISMA guidelines. PubMed, Web of Science, and Embase were searched up to March 2023 for randomized controlled trials comparing non-pharmacological interventions with control in preventing VVS recurrence. The primary outcome was the recurrence rate of VVS episodes. RESULTS: A total of 1130 participants from 18 studies were included in the meta-analysis. The overall mean effect size for non-pharmacological interventions versus control was 0.245 (95 % CI: 0.128-0.471, p-value <0.001). Subgroup analysis showed that yoga had the largest effect size (odds ratio 0.068, 95 % CI: 0.018-0.250), while tilt training had the lowest effect size (odds ratio 0.402, 95 % CI: 0.171-0.946) compared to control. Physical counter pressure maneuvers demonstrated an odds ratio of 0.294 (95 % CI: 0.165-0.524) compared to control. CONCLUSION: Non-pharmacological interventions show promise in preventing recurrent VVS episodes. Yoga, physical counter pressure maneuvers, and tilt training can be considered as viable treatment options. Further research, including randomized studies comparing pharmacological and non-pharmacological approaches, is needed to evaluate the safety and efficacy of these interventions for VVS treatment.

Evaluación de la frecuencia cardiaca durante la bipedestación activa inicial en pacientes que padecen síncope vasovagal / Evaluation of the heart rate during initial active standing in patients with vasovagal syncope

Introducción: El síncope vasovagal es la causa más frecuente de pérdida breve de la conciencia, en su etiopatogenia se reporta una disfunción autonómica que puede ponerse de manifiesto en la bipedestación activa inmediata. Objetivo: Comparar la dinámica de los cambios de la frecuencia cardíaca durante la bipedestación activa inmediata, de pacientes que padecen síncope vasovagal y sujetos controles. Métodos: Se evaluaron 132 sujetos supuestamente sanos (grupo A) entre 18 y 25 años y 156 pacientes con síncopes vasovagales; fueron divididos por su respuesta ante la bipedestación prolongada, negativa 111 (grupo B) y positiva 45 (grupo C). Se registró la actividad electrocardiográfica en decúbito supino y al inicio de la bipedestación activa, se obtuvo las secuencias de intervalos RR. Se comparó la frecuencia cardíaca en los 3 grupos, con 22 indicadores (posicionales, temporales, ordinales y relacionales, promedio y de la velocidad de los cambios). Resultados: No hubo diferencias en los indicadores promedio, sin embargo, algunos que evalúan la velocidad del cambio inicial, fueron significativamente menores en el grupo A comparado con B y C (p < 0,05), mientras que los que evalúan la velocidad de recuperación, fueron significativamente menores en el grupo C comparado con A y B. Conclusión: La dinámica de los cambios de frecuencia, permitió encontrar indicadores que pueden considerarse posibles predictores de una respuesta cardiovascular inadecuada en pacientes con síncope vasovagal(AU)

Introduction: Vasovagal syncope is the most frequent cause of brief loss of consciousness, in its etiopathogenesis an autonomic dysfunction is reported that can be manifested in immediate active standing. Objective: To compare the dynamics of heart rate changes during immediate active standing of patients suffering from vasovagal syncope with control subjects. Methods: 132 supposedly healthy subjects (group A) between 18 and 25 years old and 156 patients with vasovagal syncope were evaluated, which were divided by their response to prolonged standing, negative 111 (group B) and positive 45 (group C). Electrocardiographic activity was recorded in the supine position and at the beginning of active standing, the sequences of RR intervals were obtained. The heart rate was compared in the 3 groups, using 22 indicators (positional, temporal, ordinal and relational, average and of the speed of changes). Results: Differences were not found in the average indicators in the analyzed period, however, some that evaluate the speed of the initial change were significantly lower in group A compared to B and C (p < 0.05), while others that evaluate the speed recovery rates were significantly lower in group C compared to A and B. This allows to characterize, compare and differentiate the groups studied during the complex and rapid interactions that occur in the change of position. Conclusion: The dynamic of frequency changes, allowed to find indicators, which can be considered as possible predictors of an inadequate cardiovascular response in patients with vasovagal syncope(AU)

Qual a contribuição do tilt training (treinamento postural) na prevenção da síncope vasovagal ? / Tilt training: does it have a role in preventing vasovagal syncope? / ¿Cuál es el aporte del tilt training (entrenamiento postural) a la prevención del síncope vasovagal?

Histórico: A síncope vasovagal é um dos quadros clínicos mais comuns em adultos jovens. Estudos anteriores demonstram a eficácia do tilt training (treinamento postural) no tratamento desse transtorno clínico. Realizou-se um estudo prospectivo e randomizado com o objetivo de avaliar a contribuição do tilt training no tratamento de adultos jovens acometidos pela síncope vasovagal. Métodos: Quarenta e seis soldados , 25 dos quais do sexo masculino, média de idade de 19,4 mais ou menos 0,8 anos e diagnóstico clínico de síncope vasovagal pelo tilt teste, foram divididos aleatoriamente em dois grupos: um grupo controle e outro acometido de tilt training diariamente, por três meses. Nos dois grupos, os participantes foram instruídos a aumentar a ingestão de líquidos e sal e evitar situações indutoras de síncope, tais como permanecer em pé por períodos longos. Resultados: A adesão ao programa de treinamento, caracterizada pela realização de 50 por cento ou mais das sessões diárias de tilt training, foi de 91 por cento durante o primeiro mês, caindo para 58 por cento nos três meses. Os que realizaram o treinamento apresentaram uma média (distância interquartilica) e 5,0 episódios de síncope (0,5 a 16,0) durante um ano de acompanhamento, enquanto o grupo controle apresentou média de 2,0 episódios (0 a 6,0, P igual 0,737). Após a randomização não houve diferença significativa no tempo de ocorrência do primeiro episódio entre os dois grupos: média de 1,0 por mês (0,5 a 2,0) no grupo em tratamento...

Background: Vasovagal syncope is one of the most common medical conditions in young adults. Previous trials have shown effectiveness of tilt training in treating this condition. We conducted a prospective, randomized study in order to evaluate the role of tilt-training in young adults with vasovagal syncope. Methods: Forty-six soldiers (mean age 19.4 ± 0.8 years, 25 males), with a clinical diagnosis of vasovagal syncope supported by positive tilt test, were randomized to either three months of daily tilt training (treatment group), or no training (control group). Patients in both groups were instructed to increase fluid and salt intake, and to refrain from syncope-inducing situations, such as prolonged standing. Results: Compliance, defined as performing 50% or more of the tilt training daily sessions, was 91% during the first month, and declined to 58% during three months. Treatment group patients had a median (interquartile range) of 5.0 (0.5–16.0) syncope episodes during one-year follow up, compared to a median of 2.0 (0–6.0) episodes in the control group (P = 0.737). Also, there was no difference in time to first syncope after randomization between groups: a median of 1.0 (0.5–2.0) month in the treatment group, compared to 0.8 (0.5–2.0) month in the control group (P = 0.336). Conclusions: Adding daily three-month tilt training to modifications in lifestyle does not improve treatment results in youngadults with vasovagal syncope. Good compliance is difficult to achieve in a tilt training program.

Historial: El síncope vasovagal es uno de los cuadros clínicos más comunes en adultos jóvenes. Estudios anteriores han demostrado la eficiencia del tilt training (entrenamiento postural) en el tratamiento de ese trastorno clínico. Se llevó a cabo un estudio prospectivo y randomizado con el objetivo de evaluar el aporte del tilt training al tratamiento de adultos jóvenes acometidos por el síncope vasovagal. Métodos: Cuarenta y seis soldados, 25 de ellos del sexo masculino, promedio de edad de 19,4 ± 0,8 años y diagnóstico clínico de síncope vasovagal por el tilt test, fueron divididos aleatoriamente en dos grupos: un grupo control y otro sometido a tilt training diariamente, por tres meses. En ambos grupos, los participantes fueron instruidos a aumentar la ingesta de líquidos y sal y evitar situaciones inductoras del síncope, tales como permanecer en pie por largos períodos. Resultados: La adhesión al programa de entrenamiento, caracterizada por la realización del 50% o más de las sesiones diarias de tilt training, fue del 91% durante el primer mes, bajando al 58% a los tres meses. Quienes llevaron a cabo el entrenamiento presentaron un promedio (distancia intercuartílica) de 5,0 episodios de síncope (0,5 a 16,0) durante un año de acompañamiento, mientras el grupo control presentó un promedio de 2,0 episodios (0 a 6,0; P = 0,737). Tras la randomización, no hubo diferencia significativa en el tiempo de ocurrencia del primer episodio de síncope entre ambos grupos: promedio de 1,0 por mes (0,5 a 2,0) en el grupo en tratamiento y 0,8 (0,5 a 2,0) en el grupo control (P = 0,336). Conclusiones: La realización diaria del tilt training, aliada a los cambios de estilo de vida, no produjo mejora en el resultado del tratamiento de adultos jóvenes con síncope vasovagal. Se verificó asimismo la dificultad de obtener buena adhesión al programa de entrenamiento postural.

Evolução clínica de pacientes com síncope neurocardiogênica (SNC) após suspensão da terapia específica / Clinical outcome of patients with neurocardiogenic syncope (NCS) after therapy interruption

OBJETIVO: Avaliar a evolução clínica de pacientes com SNC após a suspensão do tratamento farmacológico e investigar as possíveis variáveis clínicas preditivas de recidiva. MÉTODOS: Trinta e sete pacientes (média de idade de 31 ± 16 anos) com SNC recidivante refratária, dos quais 19 eram mulheres, foram estudados prospectivamente. Todos os pacientes estavam assintomáticos e apresentaram teste de inclinação ortostática (TI) negativo após a introdução da terapia farmacológica. Um novo TI foi realizado um mês após a suspensão do tratamento. A probabilidade livre de sintomas foi analisada de acordo com sexo, idade, número de síncopes prévias ao tratamento, tempo de história clínica, tempo de tratamento, resultado do TI após interrupção do tratamento e período sem medicação. RESULTADOS: Vinte e dois pacientes (59 por cento) apresentaram recidiva durante um acompanhamento médio de 21 ± 19,7 meses. As variáveis relacionadas com maior recidiva foram número de síncopes anteriores (p = 0,0248), TI positivo após a suspensão da terapia (p = 0,0002) e sexo feminino (p = 0,0131). CONCLUSÕES: A maior parte dos pacientes altamente sintomáticos com SNC apresenta recidiva após a supressão do tratamento. A realização do TI após a suspensão do tratamento pode identificar os pacientes com maior risco de recidiva, sobretudo durante o primeiro ano de acompanhamento.

Marcapasso na prevenção da fibrilação atrial e síncope neurocardiogênica - grandes avanços, novas opções / Pacemaker in atrial fibrillation and neurocardiogenic syncope prevention - new options

A evolução dos marcapassos com a incorporação de mecanismos inteligentes tem permitido novas e brilhantes indicações para essa terapia. Nesse escopo encontram-se as novas possibilidades de tratamento da fibrilação atrial e da síncope neurocardiogênica e das bradiarritmias de origem funcional. Nessas duas áreas, entretanto, os resultados clínicos têm permanecido abaixo das expectativas criadas pelo enorme progresso da tecnologia. Por outro lado, neste artigo apresentamos dois grandes avanços da eletrofisiologia intervencionista, que permitem obter a cura de muitos casos de fibrilação atrial e de bradiarritmias funcionais por meio da ablação por catéter com radiofrequência, ambos contribuições da eletrofisiologia nacional. Apesar de os marcapassos serem próteses muito bem toleradas na maioria dos casos, e não obstante essas novas terapias estarem em fase de investigação clínica, certamente, em auspicioso futuro próximo, poderemos contemplar grande número de nossos pacientes com a opção de evitar o implante de uma prótese

Avaliação do comportamento clínico de pacientes com síncope neurocardiogênica após interrupção da terapêutica farmacológica específica / Assesment of clinical behavior of patients with neurocardiogenic syncope after interruption of specific pharmacological therapy

Não há critérios até o momento para definir o tempo de tratamento da síncope neurocardiogênica e sua interrupção.O estudo se propõe a avaliar a recorrência de síncope neurocardiogênica após interrupção da terapia específica e investigar o valor do resultado do teste de inclinação realizado após a suspensão da medicação como preditor de recorrência. A maioria dos pacientes recorreram após interrupção do tratamento, porém a taxa de recorrência no grupo com teste negativo foi significativamente menor em comparação ao grupo positivo no primeiro ano de seguimento. Concluímos que a resposta ao teste de inclinação pode ser considerado um preditor de recorrência.The are no criteria for treatment time and its interruption in patients with neurocardiogenic syncope up to now.The aims of this study were to evaluate symptoms recurrence after drugs discontinuation and to verify if tilt table test performed after treatment interruption could be a predictor of symptoms recurrence.The majority of patients recurred after therapy interruption, otherwise the group with negative tilt table test had significant lower recurrence rate when to compared to the positive group in the first year of follow-up.We concluded that the response to tilt table teste could be a predictor of recurrence...