INFORM-AF II-Phase 1 pilot randomised controlled trial evaluating the effect of an atrial fibrillation digital education programme: study protocol.

AIM: To evaluate the effect of a novel, co-designed, digital AF educational program, 'INFORM-AF', to reduce re-hospitalisation of people with AF. The secondary aims are to examine the effect of the intervention on: (a) reducing cardiovascular-related hospitalisation, (b) increasing medication adherence, AF-related knowledge, and Atrial fibrillation (AF)-related quality of life and (c) determining the cost-effectiveness of the intervention. BACKGROUND: AF is an increasingly prevalent cardiac arrythmia that involves complex clinical management. Comprehensive education is essential for successful self-management of AF and is associated with positive health-related outcomes. There has been an increase in technology-based education for AF. However, its effects on hospitalisation, medication adherence and patient-reported outcomes are unclear. DESIGN: A prospective, randomised (1:1), open-label, blinded-endpoint, multicentre clinical trial. METHODS: Eligible participants are aged 18 years or above, diagnosed with AF, and own a smartphone. The study will be conducted at two metropolitan hospitals. In the intervention group, participants will receive the AF educational program delivered via Qstream®. In the control group, participants will receive the Stroke Foundation 'Living with AF' booklet. The primary outcome is re-hospitalisation within 12 months from an indexed presentation or hospital admission. CONCLUSION: This clinical trial is part of a developing program of work that will examine mHealth educational-behavioural interventions on cardiovascular outcomes. Findings from this pilot study will inform the development of a digital educational framework for patients living with AF. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: There remain many gaps in providing high-quality patient education for patients with AF. This trial will test a new theory-driven, smartphone-based education program on important clinical outcomes, including rehospitalisation. IMPACT: This study evaluates a novel, co-designed, digital AF educational program, 'INFORM-AF', to reduce the re-hospitalisation of people with AF. Study results are expected to be reported in 2025. Findings are expected to inform practice recommendations for AF patient education that may be included in future clinical practice guideline recommendations. REPORTING METHOD: SPIRIT Checklist. PATIENT OR PUBLICATION CONTRIBUTION: JL is a consumer co-researcher on the project and provided critical input into intervention design, and feedback and input across the study duration.

Pharmacological, non-invasive brain stimulation and psychological interventions, and their combination, for treating depression after stroke.

BACKGROUND: Depression is an important morbidity associated with stroke that impacts on recovery, yet is often undetected or inadequately treated. OBJECTIVES: To evaluate the benefits and harms of pharmacological intervention, non-invasive brain stimulation, psychological therapy, or combinations of these to treat depression after stroke. SEARCH METHODS: This is a living systematic review. We search for new evidence every two months and update the review when we identify relevant new evidence. Please refer to the Cochrane Database of Systematic Reviews for the current status of this review. We searched the Specialised Registers of Cochrane Stroke, and Cochrane Depression Anxiety and Neurosis, CENTRAL, MEDLINE, Embase, five other databases, two clinical trials registers, reference lists and conference proceedings (February 2022). We contacted study authors. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing: 1) pharmacological interventions with placebo; 2) non-invasive brain stimulation with sham stimulation or usual care; 3) psychological therapy with usual care or attention control; 4) pharmacological intervention and psychological therapy with pharmacological intervention and usual care or attention control; 5) pharmacological intervention and non-invasive brain stimulation with pharmacological intervention and sham stimulation or usual care; 6) non-invasive brain stimulation and psychological therapy versus sham brain stimulation or usual care and psychological therapy; 7) pharmacological intervention and psychological therapy with placebo and psychological therapy; 8) pharmacological intervention and non-invasive brain stimulation with placebo and non-invasive brain stimulation; and 9) non-invasive brain stimulation and psychological therapy versus non-invasive brain stimulation and usual care or attention control, with the intention of treating depression after stroke. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risk of bias, and extracted data from included studies. We calculated mean difference (MD) or standardised mean difference (SMD) for continuous data, and risk ratio (RR) for dichotomous data, with 95% confidence intervals (CIs). We assessed heterogeneity using the I² statistic and certainty of the evidence according to GRADE. MAIN RESULTS: We included 65 trials (72 comparisons) with 5831 participants. Data were available for: 1) 20 comparisons; 2) nine comparisons; 3) 25 comparisons; 4) three comparisons; 5) 14 comparisons; and 6) one comparison. We found no trials for comparisons 7 to 9. Comparison 1: Pharmacological interventions Very low-certainty evidence from eight trials suggests pharmacological interventions decreased the number of people meeting the study criteria for depression (RR 0.70, 95% CI 0.55 to 0.88; P = 0.002; 8 RCTs; 1025 participants) at end of treatment and very low-certainty evidence from six trials suggests that pharmacological interventions decreased the number of people with inadequate response to treatment (RR 0.47, 95% CI 0.32 to 0.70; P = 0.0002; 6 RCTs; 511 participants) compared to placebo. More adverse events related to the central nervous system (CNS) (RR 1.55, 95% CI 1.12 to 2.15; P = 0.008; 5 RCTs; 488 participants; very low-certainty evidence) and gastrointestinal system (RR 1.62, 95% CI 1.19 to 2.19; P = 0.002; 4 RCTs; 473 participants; very low-certainty evidence) were noted in the pharmacological intervention than in the placebo group. Comparison 2: Non-invasive brain stimulation Very low-certainty evidence from two trials show that non-invasive brain stimulation had little to no effect on the number of people meeting the study criteria for depression (RR 0.67, 95% CI 0.39 to 1.14; P = 0.14; 2 RCTs; 130 participants) and the number of people with inadequate response to treatment (RR 0.84, 95% CI 0.52, 1.37; P = 0.49; 2 RCTs; 130 participants) compared to sham stimulation. Non-invasive brain stimulation resulted in no deaths. Comparison 3: Psychological therapy Very low-certainty evidence from six trials suggests that psychological therapy decreased the number of people meeting the study criteria for depression at end of treatment (RR 0.77, 95% CI 0.62 to 0.95; P = 0.01; 521 participants) compared to usual care/attention control. No trials of psychological therapy reported on the outcome inadequate response to treatment. No differences in the number of deaths or adverse events were found in the psychological therapy group compared to the usual care/attention control group. Comparison 4: Pharmacological interventions with psychological therapy No trials of this combination reported on the primary outcomes. Combination therapy resulted in no deaths. Comparison 5: Pharmacological interventions with non-invasive brain stimulation Non-invasive brain stimulation with pharmacological intervention reduced the number of people meeting study criteria for depression at end of treatment (RR 0.77, 95% CI 0.64 to 0.91; P = 0.002; 3 RCTs; 392 participants; low-certainty evidence) but not the number of people with inadequate response to treatment (RR 0.95, 95% CI 0.69 to 1.30; P = 0.75; 3 RCTs; 392 participants; very low-certainty evidence) compared to pharmacological therapy alone. Very low-certainty evidence from five trials suggest no difference in deaths between this combination therapy (RR 1.06, 95% CI 0.27 to 4.16; P = 0.93; 487 participants) compared to pharmacological therapy intervention and sham stimulation or usual care. Comparison 6: Non-invasive brain stimulation with psychological therapy No trials of this combination reported on the primary outcomes. AUTHORS' CONCLUSIONS: Very low-certainty evidence suggests that pharmacological, psychological and combination therapies can reduce the prevalence of depression while non-invasive brain stimulation had little to no effect on the prevalence of depression. Pharmacological intervention was associated with adverse events related to the CNS and the gastrointestinal tract. More research is required before recommendations can be made about the routine use of such treatments.

ANTECEDENTES: La depresión tiene una morbilidad importante asociada con el accidente cerebrovascular que repercute en la recuperación, pero que a menudo no se detecta o se trata de manera inadecuada. OBJETIVOS: Evaluar los efectos beneficiosos y perjudiciales de las intervenciones farmacológicas, la estimulación cerebral no invasiva, la terapia psicológica o las combinaciones de éstas para tratar la depresión después del accidente cerebrovascular. MÉTODOS DE BÚSQUEDA: Esta es una revisión sistemática continua. Cada dos meses se busca nueva evidencia y la revisión se actualiza cuando se identifica evidencia nueva relevante. Consultar el estado actual de esta revisión en la Base de Datos Cochrane de Revisiones Sistemáticas (Cochrane Database of Systematic Reviews). Se realizaron búsquedas en los Registros especializados del Grupo Cochrane de Accidentes cerebrovasculares (Cochrane Stroke) y del Grupo Cochrane de Depresión, ansiedad y neurosis (Cochrane Depression, Anxiety and Neurosis), en CENTRAL, MEDLINE, Embase, otras cinco bases de datos, dos registros de ensayos clínicos, listas de referencias y resúmenes de congresos (febrero de 2022). Se estableció contacto con autores de estudios. CRITERIOS DE SELECCIÓN: Ensayos controlados aleatorizados (ECA) que compararan: 1) intervenciones farmacológicas con placebo; 2) estimulación cerebral no invasiva con estimulación simulada o atención habitual; 3) terapia psicológica con atención habitual o control de atención; 4) intervención farmacológica y terapia psicológica con intervención farmacológica y atención habitual o control de atención; 5) intervención farmacológica y estimulación cerebral no invasiva con intervención farmacológica y estimulación simulada o atención habitual; 6) estimulación cerebral no invasiva y terapia psicológica versus estimulación cerebral simulada o atención habitual y terapia psicológica; 7) intervención farmacológica y terapia psicológica con placebo y terapia psicológica; 8) intervención farmacológica y estimulación cerebral no invasiva con placebo y estimulación cerebral no invasiva; y 9) estimulación cerebral no invasiva y terapia psicológica versus estimulación cerebral no invasiva y atención habitual o control de atención, con la intención de tratar la depresión después del accidente cerebrovascular. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Dos autores de la revisión, de forma independiente, seleccionaron los estudios, evaluaron el riesgo de sesgo y extrajeron los datos de los estudios incluidos. Se calculó la diferencia de medias (DM) o la diferencia de medias estandarizada (DME) para los datos continuos, y la razón de riesgos (RR) para los datos dicotómicos, con intervalos de confianza (IC) del 95%. La heterogeneidad se evaluó mediante la estadística I² y la certeza de la evidencia según GRADE. RESULTADOS PRINCIPALES: Se incluyeron 65 ensayos (72 comparaciones) con 5831 participantes. Se dispuso de datos para: 1) 20 comparaciones; 2) nueve comparaciones; 3) 25 comparaciones; 4) tres comparaciones; 5) 14 comparaciones; y 6) una comparación. No se encontraron ensayos para las comparaciones 7 a 9. Comparación 1: Intervenciones farmacológicas Evidencia de certeza muy baja de ocho ensayos indica que las intervenciones farmacológicas disminuyeron el número de personas que cumplían los criterios del estudio para la depresión (RR 0,70; IC del 95%: 0,55 a 0,88; p = 0,002; ocho ECA; 1025 participantes) al final del tratamiento y evidencia de certeza muy baja de seis ensayos indica que las intervenciones farmacológicas disminuyeron el número de personas con respuesta inadecuada al tratamiento (RR 0,47; IC del 95%: 0,32 a 0,70; p = 0,0002; seis ECA; 511 participantes) en comparación con placebo. Se observaron más eventos adversos relacionados con el sistema nervioso central (SNC) (RR 1,55; IC del 95%: 1,12 a 2,15; p = 0,008; cinco ECA; 488 participantes; evidencia de certeza muy baja) y el sistema gastrointestinal (RR 1,62; IC del 95%: 1,19 a 2,19; p = 0,002; cuatro ECA; 473 participantes; evidencia de certeza muy baja) en el grupo de intervención farmacológica que en el grupo placebo. Comparación 2: Estimulación cerebral no invasiva Evidencia de certeza muy baja de dos ensayos muestra que la estimulación cerebral no invasiva tuvo poco o ningún efecto sobre el número de personas que cumplían los criterios del estudio para la depresión (RR 0,67; IC del 95%: 0,39 a 1,14; p = 0,14; dos ECA; 130 participantes) y el número de personas con respuesta inadecuada al tratamiento (RR 0,84; IC del 95%: 0,52 a 1,37; p = 0,49; dos ECA; 130 participantes) en comparación con la estimulación simulada. La estimulación cerebral no invasiva no provocó muertes. Comparación 3: Terapia psicológica Evidencia de certeza muy baja de seis ensayos indica que la terapia psicológica disminuyó el número de personas que cumplían los criterios del estudio para la depresión al final del tratamiento (RR 0,77; IC del 95%: 0,62 a 0,95; p = 0,01; 521 participantes) en comparación con atención habitual/control de atención. Ningún ensayo de terapia psicológica informó sobre el desenlace respuesta inadecuada al tratamiento. No se encontraron diferencias en el número de muertes o eventos adversos en el grupo de terapia psicológica en comparación con el grupo de control de atención/atención habitual. Comparación 4: Intervenciones farmacológicas con terapia psicológica Ningún ensayo de esta combinación informó sobre los desenlaces principales. El tratamiento combinado no provocó muertes. Comparación 5: Intervenciones farmacológicas con estimulación cerebral no invasiva La estimulación cerebral no invasiva con intervención farmacológica redujo el número de personas que cumplían los criterios del estudio para la depresión al final del tratamiento (RR 0,77; IC del 95%: 0,64 a 0,91; p = 0,002; tres ECA; 392 participantes; evidencia de certeza baja), pero no el número de personas con respuesta inadecuada al tratamiento (RR 0,95; IC del 95%: 0,69 a 1,30; p = 0,75; tres ECA; 392 participantes; evidencia de certeza muy baja) en comparación con el tratamiento farmacológico solo. Evidencia de certeza muy baja de cinco ensayos no indica diferencias en las muertes entre este tratamiento combinado (RR 1,06; IC del 95%: 0,27 a 4,16; p = 0,93; 487 participantes) en comparación con la intervención de tratamiento farmacológico y la estimulación simulada o la atención habitual. Comparación 6: Estimulación cerebral no invasiva con terapia psicológica Ningún ensayo de esta combinación informó sobre los desenlaces principales. CONCLUSIONES DE LOS AUTORES: Evidencia de certeza muy baja indica que los tratamientos farmacológicos, las terapias psicológicas y los tratamientos combinados pueden reducir la prevalencia de la depresión, mientras que la estimulación cerebral no invasiva tuvo poco o ningún efecto sobre la prevalencia de la depresión. Las intervenciones farmacológicas se asociaron con eventos adversos relacionados con el SNC y el sistema gastrointestinal. Se necesitan más estudios de investigación antes de poder hacer recomendaciones sobre el uso habitual de dichos tratamientos.

Asthma and COVID-19 risk: a systematic review and meta-analysis.

BACKGROUND: Individual case series and cohort studies have reported conflicting results in people with asthma on the vulnerability to and risk of mortality from coronavirus disease 2019 (COVID-19). RESEARCH QUESTION: Are people with asthma at a higher risk of being infected or hospitalised or poorer clinical outcomes from COVID-19? METHODS: A systematic review and meta-analysis based on five main databases including the World Health Organization COVID-19 database between 1 December 2019 and 11 July 2021 on studies with a control (non-asthma) group was conducted. Prevalence and risk ratios were pooled using Sidik-Jonkman random-effects meta-analyses. FINDINGS: 51 studies with an 8.08% (95% CI 6.87-9.30%) pooled prevalence of people with asthma among COVID-19 positive cases. The risk ratios were 0.83 (95% CI 0.73-0.95, p=0.01) for acquiring COVID-19; 1.18 (95% CI 0.98-1.42, p=0.08) for hospitalisation; 1.21 (95% CI 0.97-1.51, p=0.09) for intensive care unit (ICU) admission; 1.06 (95% CI 0.82-1.36, p=0.65) for ventilator use; and 0.94 (95% CI 0.76-1.17, p=0.58) for mortality for people with asthma. Subgroup analyses by continent revealed a significant difference in risk of acquiring COVID-19, ICU admission, ventilator use and death between the continents. INTERPRETATION: The risk of being infected with severe acute respiratory syndrome coronavirus 2 was reduced compared to the non-asthma group. No statistically significant differences in hospitalisation, ICU admission and ventilator use were found between groups. Subgroup analyses showed significant differences in outcomes from COVID-19 between America, Europe and Asia. Additional studies are required to confirm this risk profile, particularly in Africa and South America, where few studies originate.

Asthma and risk of infection, hospitalization, ICU admission and mortality from COVID-19: Systematic review and meta-analysis.

OBJECTIVE: As COVID-19 spreads across the world, there are concerns that people with asthma are at a higher risk of acquiring the disease, or of poorer outcomes. This systematic review aimed to summarize evidence on the risk of infection, severe illness and death from COVID-19 in people with asthma. DATA SOURCES AND STUDY SELECTION: A comprehensive search of electronic databases including preprint repositories and WHO COVID-19 database was conducted (until 26 May 2020). Studies reporting COVID-19 in people with asthma were included. For binary outcomes, we performed Sidik-Jonkman random effects meta-analysis. We explored quantitative heterogeneity by subgroup analyses, meta regression and evaluating the I2 statistic. RESULTS: Fifty-seven studies with an overall sample size of 587 280 were included. The prevalence of asthma among those infected with COVID-19 was 7.46% (95% CI = 6.25-8.67). Non-severe asthma was more common than severe asthma (9.61% vs. 4.13%). Pooled analysis showed a 14% risk ratio reduction in acquiring COVID-19 (95% CI = 0.80-0.94; p < 0.0001) and 13% reduction in hospitalization with COVID-19 (95% CI = 0.77-0.99, p = 0.03) for people with asthma compared with those without. There was no significant difference in the combined risk of requiring admission to ICU and/or receiving mechanical ventilation for people with asthma (RR = 0.87 95% CI = 0.94-1.37; p = 0.19) and risk of death from COVID-19 (RR = 0.87; 95% CI = 0.68-1.10; p = 0.25). CONCLUSION: The findings from this study suggest that the prevalence of people with asthma among COVID-19 patients is similar to the global prevalence of asthma. The overall findings suggest that people with asthma have a lower risk than those without asthma for acquiring COVID-19 and have similar clinical outcomes.

Pharmaceutical interventions for emotionalism after stroke.

BACKGROUND: Antidepressants may be useful in the treatment of abnormal crying associated with stroke. This is an update of a Cochrane Review first published in 2004 and last updated in 2019. OBJECTIVES: To evaluate the benefits and harms of pharmaceutical treatment in people with emotionalism after stroke. SEARCH METHODS: We searched the Cochrane Stroke Group Register, CENTRAL, MEDLINE, Embase, four other databases, and three trials registers (May 2022). SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs comparing psychotropic medication to placebo in people with stroke and emotionalism (also known as emotional lability, pathological crying or laughing, emotional incontinence, involuntary emotional expression disorder, and pseudobulbar affect). DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, assessed risk of bias, extracted data from all included trials, and used GRADE to assess the certainty of the body of evidence. We calculated the mean difference (MD) or standardised mean difference (SMD) for continuous data and the risk ratio (RR) for dichotomous data, with 95% confidence intervals (CIs). We assessed heterogeneity using the I2 statistic. The primary emotionalism measures were the proportion of participants achieving at least a 50% reduction in abnormal emotional behaviour at the end of treatment, improved score on the Center for Neurologic Study - Lability Scale (CNS-LS) or Clinician Interview-Based Impression of Change (CIBIC), or diminished tearfulness. MAIN RESULTS: We did not identify any new trials for this update. We included seven trials with a total of 239 participants. Two trials had a cross-over design, but outcome data were not available from the first phase (precross-over) in an appropriate format for inclusion as a parallel randomised controlled trial (RCT). Thus, the results of the review are based on five trials with a total of 213 participants. It is uncertain whether fluoxetine increases the number of people who have a 50% reduction in emotionalism when compared to placebo (risk ratio (RR) 0.26, 95% CI 0.09 to 0.77; P = 0.02; 1 trial, 19 participants) because the certainty of evidence is very low. Sertraline may lead to little to no difference in Center for Neurologic Study - Lability Scale (CNS-LS) scores and Clinician Interview-Based Impression of Change (CIBIC) scores when compared to placebo (RR 0.20, 95% CI 0.03 to 1.50; P = 0.12; 1 trial, 28 participants; low-certainty evidence). Antidepressants probably increase the number of people who experience a reduction in tearfulness (RR 0.32, 95% CI 0.12 to 0.86; P = 0.02; 3 trials, 164 participants; moderate-certainty evidence). No trials were found that evaluated the impact of other pharmaceutical interventions. Only two trial authors systematically recorded and reported adverse events, resulting in limited data on the potential harms of treatment. Six trials reported death as an adverse event and found no difference between the groups (antidepressants versus placebo) in the number of deaths reported (RR 0.59, 95% CI 0.08 to 4.50; P = 0.61; 172 participants; moderate-certainty evidence). This review provides very low- to moderate-certainty evidence that antidepressants may reduce the frequency and severity of emotionalism. The included trials were small and had some degree of bias. AUTHORS' CONCLUSIONS: Antidepressants may reduce the frequency and severity of crying or laughing episodes when compared to placebo, based on very low-certainty evidence. Our conclusions must be qualified by several methodological deficiencies in the trials and interpreted with caution despite the effect being very large. The effect does not seem specific to one drug or class of drugs. More reliable data are required before appropriate conclusions can be made about the treatment of post-stroke emotionalism. Future trialists investigating the effect of antidepressants in people with emotionalism after stroke should consider developing and using a standardised method to diagnose emotionalism, determine severity, and assess change over time; provide treatment for a sufficient duration and follow-up to better assess rates of relapse or maintenance; and include careful assessment and complete reporting of adverse events.

A RandomisEd ControLled TrIal of ChEwing Gum to RelieVE Thirst in Chronic Heart Failure (RELIEVE-CHF).

BACKGROUND: Thirst is a common and troublesome symptom of patients with chronic heart failure (CHF). To date, there are no interventions to help alleviate thirst in this cohort. Chewing gum is a novel intervention, which has been tested in people undergoing haemodialysis, also prescribed with a fluid restricted therapy. The aim of this study was to determine the effect of chewing gum on the level of thirst in the short-term (average of 24 hours each day for 4 days) and in the longer-term (Days 7, 14 and 28) individuals with CHF. METHODS: Seventy-one (71) individuals with CHF on oral loop diuretics were randomised to chewing gum (n=36) or control (n=35) for 2 weeks. Both groups were assessed for their level of thirst at Days 1-4, 7, 14 and 28. RESULTS: Significant improvements in the level of thirst of those who received chewing gum compared to the control group at Day 4 (p=0.04) and Day 14 (p=0.02) were observed. CONCLUSION: Chewing gum provided relief from thirst in the short-term and in the longer term. This trial provides important information to inform future clinical trials on ways to relieve thirst.

Pharmacological, psychological and non-invasive brain stimulation interventions for preventing depression after stroke.

BACKGROUND: Depression is an important consequence of stroke that influences recovery yet often is not detected, or is inadequately treated. This is an update and expansion of a Cochrane Review first published in 2004 and previously updated in 2008. OBJECTIVES: The primary objective is to test the hypothesis that pharmacological, psychological therapy, non-invasive brain stimulation, or combinations of these interventions reduce the incidence of diagnosable depression after stroke. Secondary objectives are to test the hypothesis that pharmacological, psychological therapy, non-invasive brain stimulation or combinations of these interventions reduce levels of depressive symptoms and dependency, and improve physical functioning after stroke. We also aim to determine the safety of, and adherence to, the interventions. SEARCH METHODS: We searched the Specialised Register of Cochrane Stroke and the Cochrane Depression Anxiety and Neurosis (last searched August 2018). In addition, we searched the following databases; Cochrane Central Register of Controlled Trials, CENTRAL (the Cochrane Library, 2018, Issue 8), MEDLINE (1966 to August 2018), Embase (1980 to August 2018), PsycINFO (1967 to August 2018), CINAHL (1982 to August 2018) and three Web of Science indexes (2002 to August 2018). We also searched reference lists, clinical trial registers (World Health Organization International Clinical Trials Registry Platform (WHO ICTRP); to August 2018 and ClinicalTrials.gov; to August 2018), conference proceedings; we also contacted study authors. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing: 1) pharmacological interventions with placebo; 2) one of various forms of psychological therapy with usual care and/or attention control; 3) one of various forms of non-invasive brain stimulation with sham stimulation or usual care; 4) a pharmacological intervention and one of various forms of psychological therapy with a pharmacological intervention and usual care and/or attention control; 5) non-invasive brain stimulation and pharmacological intervention with a pharmacological intervention and sham stimulation or usual care; 6) pharmacological intervention and one of various forms of psychological therapy with placebo and psychological therapy; 7) pharmacological intervention and non-invasive brain stimulation with placebo plus non-invasive brain stimulation; 8) non-invasive brain stimulation and one of various forms of psychological therapy versus non-invasive brain stimulation plus usual care and/or attention control; and 9) non-invasive brain stimulation and one of various forms of psychological therapy versus sham brain stimulation or usual care plus psychological therapy, with the intention of preventing depression after stroke. DATA COLLECTION AND ANALYSIS: Review authors independently selected studies, assessed risk of bias, and extracted data from all included studies. We calculated mean difference (MD) or standardised mean difference (SMD) for continuous data and risk ratio (RR) for dichotomous data with 95% confidence intervals (CIs). We assessed heterogeneity using the I2 statistic and assessed the certainty of evidence using GRADE. MAIN RESULTS: We included 19 RCTs (21 interventions), with 1771 participants in the review. Data were available for 12 pharmacological trials (14 interventions) and seven psychological trials. There were no trials of non-invasive brain stimulation compared with sham stimulation or usual care, a combination of pharmacological intervention and one of various forms of psychological therapy with placebo and psychological therapy, or a combination of non-invasive brain stimulation and a pharmacological intervention with a pharmacological intervention and sham stimulation or usual care to prevent depression after stroke. Treatment effects were observed on the primary outcome of meeting the study criteria for depression at the end of treatment: there is very low-certainty evidence from eight trials (nine interventions) that pharmacological interventions decrease the number of people meeting the study criteria for depression (RR 0.50, 95% CI 0.37 to 0.68; 734 participants) compared to placebo. There is very low-certainty evidence from two trials that psychological interventions reduce the proportion of people meeting the study criteria for depression (RR 0.68, 95% CI 0.49 to 0.94, 607 participants) compared to usual care and/or attention control. Eight trials (nine interventions) found no difference in death and other adverse events between pharmacological intervention and placebo groups (RR 1.25, 95% CI 0.32 to 4.91; 496 participants) based on very low-certainty evidence. Five trials found no difference in psychological intervention and usual care and/or attention control groups for death and other adverse events (RR 1.18, 95% CI 0.73 to 1.91; 975 participants) based on very low-certainty evidence. AUTHORS' CONCLUSIONS: The available evidence suggests that pharmacological interventions and psychological therapy may prevent depression and improve mood after stroke. However, there is very low certainty in these conclusions because of the very low-certainty evidence. More trials are required before reliable recommendations can be made about the routine use of such treatments after stroke.

Pharmacological, psychological, and non-invasive brain stimulation interventions for treating depression after stroke.

BACKGROUND: Depression is an important morbidity associated with stroke that impacts on recovery yet often undetected or inadequately treated. This is an update and expansion of a Cochrane Review first published in 2004 and updated in 2008. OBJECTIVES: Primary objective • To determine whether pharmacological therapy, non-invasive brain stimulation, psychological therapy, or combinations of these interventions reduce the prevalence of diagnosable depression after stroke Secondary objectives • To determine whether pharmacological therapy, non-invasive brain stimulation, psychological therapy, or combinations of these interventions reduce levels of depressive symptoms, improve physical and neurological function and health-related quality of life, and reduce dependency after stroke • To assess the safety of and adherence to such treatments SEARCH METHODS: We searched the Specialised Registers of Cochrane Stroke and Cochrane Depression Anxiety and Neurosis (last searched August 2018), the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1), in the Cochrane Library, MEDLINE (1966 to August 2018), Embase (1980 to August 2018), the Cumulative Index to Nursing and Alllied Health Literature (CINAHL) (1982 to August 2018), PsycINFO (1967 to August 2018), and Web of Science (2002 to August 2018). We also searched reference lists, clinical trial registers (World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) to August 2018; ClinicalTrials.gov to August 2018), and conference proceedings, and we contacted study authors. SELECTION CRITERIA: Randomised controlled trials comparing (1) pharmacological interventions with placebo; (2) one of various forms of non-invasive brain stimulation with sham stimulation or usual care; (3) one of various forms of psychological therapy with usual care and/or attention control; (4) pharmacological intervention and various forms of psychological therapy with pharmacological intervention and usual care and/or attention control; (5) non-invasive brain stimulation and pharmacological intervention with pharmacological intervention and sham stimulation or usual care; (6) pharmacological intervention and one of various forms of psychological therapy with placebo and psychological therapy; (7) pharmacological intervention and non-invasive brain stimulation with placebo plus non-invasive brain stimulation; (8) non-invasive brain stimulation and one of various forms of psychological therapy versus non-invasive brain stimulation plus usual care and/or attention control; and (9) non-invasive brain stimulation and one of various forms of psychological therapy versus sham brain stimulation or usual care plus psychological therapy, with the intention of treating depression after stroke. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risk of bias, and extracted data from all included studies. We calculated mean difference (MD) or standardised mean difference (SMD) for continuous data, and risk ratio (RR) for dichotomous data, with 95% confidence intervals (CIs). We assessed heterogeneity using the I² statistic and certainty of the evidence according to GRADE. MAIN RESULTS: We included 49 trials (56 comparisons) with 3342 participants. Data were available for: (1) pharmacological interventions with placebo (with 20 pharmacological comparisons); (2) one of various forms of non-invasive brain stimulation with sham stimulation or usual care (with eight non-invasive brain stimulation comparisons); (3) one of various forms of psychological therapy with usual care and/or attention control (with 16 psychological therapy comparisons); (4) pharmacological intervention and various forms of psychological therapy with pharmacological intervention and usual care and/or attention control (with two comparisons); and (5) non-invasive brain stimulation and pharmacological intervention with pharmacological intervention and sham stimulation or usual care (with 10 comparisons). We found no trials for the following comparisons: (6) pharmacological intervention and various forms of psychological therapy interventions versus placebo and psychological therapy; (7) pharmacological intervention and non-invasive brain stimulation versus placebo plus non-invasive brain stimulation; (8) non-invasive brain stimulation and one of various forms of psychological therapy versus non-invasive brain stimulation plus usual care and/or attention control; and (9) non-invasive brain stimulation and one of various forms of psychological therapy versus sham brain stimulation or usual care plus psychological therapy. Treatment effects observed: very low-certainty evidence from eight trials suggests that pharmacological interventions decreased the number of people meeting study criteria for depression (RR 0.70, 95% CI 0.55 to 0.88; 1025 participants) at end of treatment, and very low-certainty evidence from six trials suggests that pharmacological interventions decreased the number of people with less than 50% reduction in depression scale scores at end of treatment (RR 0.47, 95% CI 0.32 to 0.69; 511 participants) compared to placebo. No trials of non-invasive brain stimulation reported on meeting study criteria for depression at end of treatment. Only one trial of non-invasive brain stimulation reported on the outcome <50% reduction in depression scale scores; thus, we were unable to perform a meta-analysis for this outcome. Very low-certainty evidence from six trials suggests that psychological therapy decreased the number of people meeting the study criteria for depression at end of treatment (RR 0.77, 95% CI 0.62 to 0.95; 521 participants) compared to usual care/attention control. No trials of combination therapies reported on the number of people meeting the study criteria for depression at end of treatment. Only one trial of combination (non-invasive brain stimulation and pharmacological intervention) therapy reported <50% reduction in depression scale scores at end of treatment. Thus, we were unable to perform a meta-analysis for this outcome. Five trials reported adverse events related to the central nervous system (CNS) and noted significant harm in the pharmacological interventions group (RR 1.55, 95% CI 1.12 to 2.15; 488 participants; very low-certainty evidence). Four trials found significant gastrointestinal adverse events in the pharmacological interventions group (RR 1.62, 95% CI 1.19 to 2.19; 473 participants; very low-certainty evidence) compared to the placebo group. No significant deaths or adverse events were found in the psychological therapy group compared to the usual care/attention control group. Non-invasive brain stimulation interventions and combination therapies resulted in no deaths. AUTHORS' CONCLUSIONS: Very low-certainty evidence suggests that pharmacological or psychological therapies can reduce the prevalence of depression. This very low-certainty evidence suggests that pharmacological therapy, psychological therapy, non-invasive brain stimulation, and combined interventions can reduce depressive symptoms. Pharmacological intervention was associated with adverse events related to the CNS and the gastrointestinal tract. More research is required before recommendations can be made about the routine use of such treatments.

mHealth education interventions in heart failure.

BACKGROUND: Heart failure (HF) is a chronic disease with significant impact on quality of life and presents many challenges to those diagnosed with the condition, due to a seemingly complex daily regimen of self-care which includes medications, monitoring of weight and symptoms, identification of signs of deterioration and follow-up and interaction with multiple healthcare services. Education is vital for understanding the importance of this regimen, and adhering to it. Traditionally, education has been provided to people with heart failure in a face-to-face manner, either in a community or a hospital setting, using paper-based materials or video/DVD presentations. In an age of rapidly-evolving technology and uptake of smartphones and tablet devices, mHealth-based technology (defined by the World Health Organization as mobile and wireless technologies to achieve health objectives) is an innovative way to provide health education which has the benefit of being able to reach people who are unable or unwilling to access traditional heart failure education programmes and services. OBJECTIVES: To systematically review and quantify the potential benefits and harms of mHealth-delivered education for people with heart failure. SEARCH METHODS: We performed an extensive search of bibliographic databases and registries (CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, IEEE Xplore, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform (ICTRP) Search Portal), using terms to identify HF, education and mHealth. We searched all databases from their inception to October 2019 and imposed no restriction on language of publication. SELECTION CRITERIA: We included studies if they were conducted as a randomised controlled trial (RCT), involving adults (≥ 18 years) with a diagnosis of HF. We included trials comparing mHealth-delivered education such as internet and web-based education programmes for use on smartphones and tablets (including apps) and other mobile devices, SMS messages and social media-delivered education programmes, versus usual HF care. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risks of bias, and extracted data from all included studies. We calculated the mean difference (MD) or standardised mean difference (SMD) for continuous data and the odds ratio (OR) for dichotomous data with a 95% confidence interval (CI). We assessed heterogeneity using the I2 statistic and assessed the quality of evidence using GRADE criteria. MAIN RESULTS: We include five RCTs (971 participants) of mHealth-delivered education interventions for people with HF in this review. The number of trial participants ranged from 28 to 512 participants. Mean age of participants ranged from 60 years to 75 years, and 63% of participants across the studies were men. Studies originated from Australia, China, Iran, Sweden, and The Netherlands. Most studies included participants with symptomatic HF, NYHA Class II - III. Three studies addressed HF knowledge, revealing that the use of mHealth-delivered education programmes showed no evidence of a difference in HF knowledge compared to usual care (MD 0.10, 95% CI -0.2 to 0.40, P = 0.51, I2 = 0%; 3 studies, 411 participants; low-quality evidence). One study assessing self-efficacy reported that both study groups had high levels of self-efficacy at baseline and uncertainty in the evidence for the intervention (MD 0.60, 95% CI -0.57 to 1.77; P = 0.31; 1 study, 29 participants; very low-quality evidence).Three studies evaluated HF self-care using different scales. We did not pool the studies due to the heterogenous nature of the outcome measures, and the evidence is uncertain. None of the studies reported adverse events. Four studies examined health-related quality of life (HRQoL). There was uncertainty in the evidence for the use of mHealth-delivered education on HRQoL (MD -0.10, 95% CI -2.35 to 2.15; P = 0.93, I2 = 61%; 4 studies, 942 participants; very low-quality evidence). Three studies reported on HF-related hospitalisation. The use of mHealth-delivered education may result in little to no difference in HF-related hospitalisation (OR 0.74, 95% CI 0.52 to 1.06; P = 0.10, I2 = 0%; 3 studies, 894 participants; low-quality evidence). We downgraded the quality of the studies due to limitations in study design and execution, heterogeneity, wide confidence intervals and fewer than 500 participants in the analysis. AUTHORS' CONCLUSIONS: We found that the use of mHealth-delivered educational interventions for people with HF shows no evidence of a difference in HF knowledge; uncertainty in the evidence for self-efficacy, self-care and health-related quality of life; and may result in little to no difference in HF-related hospitalisations. The identification of studies currently underway and those awaiting classification indicate that this is an area of research from which further evidence will emerge in the short and longer term.

Pharmaceutical interventions for emotionalism after stroke.

BACKGROUND: Antidepressants may be useful in the treatment of abnormal crying associated with stroke. This is an update of a Cochrane Review first published in 2004 and last updated in 2010. OBJECTIVES: To determine whether pharmaceutical treatment reduces the frequency of emotional displays in people with emotionalism after stroke. SEARCH METHODS: We searched the trial register of Cochrane Stroke (last searched May 2018). In addition, we searched the Cochrane Central Register of Controlled Trials (CENTRAL; to May 2018), MEDLINE (1966 to 14 May 2018), Embase (1980 to 14 May 2018), CINAHL (1982 to 14 May 2018), PsycINFO (1967 to 14 May 2018), BIOSIS Previews (2002 to 14 May 2018), Web of Science (2002 to 14 May 2018), WHO ICTRP (to 14 May 2018), ClinicalTrials.gov (to 14 May 2018), and ProQuest Dissertations and Theses Database (to 14 May 2018). SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs comparing psychotropic medication to placebo in people with stroke and emotionalism (also known as emotional lability, pathological crying or laughing, emotional incontinence, involuntary emotional expression disorder, and pseudobulbar affect). DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risk of bias, extracted data from all included studies, and used GRADE to assess the quality of the body of evidence. We calculated mean difference (MD) or standardised mean difference (SMD) for continuous data and risk ratio (RR) for dichotomous data with 95% confidence intervals (CIs). We assessed heterogeneity using the I2 statistic. The primary emotionalism measures were the proportion of participants achieving at least a 50% reduction in abnormal emotional behaviour at the end of treatment, improved score on Center for Neurologic Study - Lability Scale (CNS-LS), Clinician Interview-Based Impression of Change (CIBIC) or diminished tearfulness. MAIN RESULTS: We included seven trials with a total of 239 participants. Two trials were of cross-over design, and outcome data were not available from the first phase (precross-over) in an appropriate format for inclusion as a parallel randomised controlled trial (RCT). Thus, the results of the review are based on five trials with 213 participants. Treatment effects were observed on the following primary endpoints of emotionalism: There is very low quality of evidence from one small RCT that antidepressants increased the number of people who had 50% reduction in emotionalism (RR 16.50, 95% CI 1.07 to 253.40; 19 participants) and low quality evidence from one RCT of improved scores on Center for Neurologic Study - Lability Scale (CNS-LS) and Clinician Interview-Based Impression of Change (CIBIC) with antidepressants (RR 1.44, 95% CI 0.95 to 2.19; 28 participants). There was moderate quality evidence from three RCTS that they increased the number of people who had a reduction in tearfulness (RR 2.18, 95% CI 1.29 to 3.71; 164 participants); and low quality evidence from one RCT of improved scores on the Pathological Laughter and Crying Scale (PLCS) (MD 8.40, 95% CI 11.56 to 5.24; 28 participants).Six trials reported adverse events (death) and found no difference between the groups in death (RR 0.59, 95% CI 0.08 to 4.50; 6 RCTs, 172 participants, moderate-quality evidence). AUTHORS' CONCLUSIONS: Antidepressants may reduce the frequency and severity of crying or laughing episodes based on very low quality evidence. Our conclusions must be qualified by several methodological deficiencies in the studies and interpreted with caution despite the effect being very large. The effect does not seem specific to one drug or class of drugs. More reliable data are required before appropriate conclusions can be made about the treatment of post-stroke emotionalism. Future trialists investigating the effect of antidepressants in people with emotionalism after stroke should consider developing and using a standardised method to diagnose emotionalism, determine severity and assess change over time; provide treatment for a sufficient duration and follow-up to better assess rates of relapse or maintenance and include careful assessment and complete reporting of adverse events.

Thirst in chronic heart failure: a review.

AIMS AND OBJECTIVES: This review will (1) explore factors related to thirst in chronic heart failure and (2) describe interventions to alleviate thirst in chronic heart failure patients. BACKGROUND: Thirst is a common and troublesome symptom of chronic heart failure. Despite the burden and prevalence of this symptom, there are limited strategies to assist in its management. DESIGN: This is a review of literature on the burden of thirst, contributors to thirst and potential management strategies of thirst in patients with chronic heart failure. METHODS: Medline, Cumulative Index for Nursing and Allied Health, PubMed and Scopus were searched using the key words thirst, chronic heart failure, angiotensin II, fluid restriction and intervention. Of the 165 citations yielded, nine studies (n = 9) were included. The eligibility criteria included participants with confirmed diagnosis of chronic heart failure, randomised controlled studies or any studies with thirst as primary or secondary outcome, in humans and in English. There was no limit to the years searched. RESULTS: Factors related to thirst in chronic heart failure were condition; prolonged neurohormonal activation, treatment; pharmacological interventions and fluid restriction and emotion. No intervention studies were found in chronic heart failure patients. Interventions such as artificial saliva and chewing gum have been investigated for their effectiveness as a thirst reliever in haemodialysis patients. CONCLUSION: Thirst is a frequent and troublesome symptom for individuals with chronic heart failure. It is highly likely that this contributes to poor adherence with fluid restrictions. Chewing gum can help alleviate thirst, but investigation in people with heart failure is needed. RELEVANCE TO CLINICAL PRACTICE: Increasing awareness of thirst and interventions to relieve it in clinical practice is likely to improve the quality of care for people with chronic heart failure.

Measurement of thirst in chronic heart failure - A review.

UNLABELLED: Abstract Background: Thirst is a bothersome symptom of chronic heart failure (CHF) which impacts adversely on quality of life. Despite this, limited work has been done to investigate thirst as a symptom or to develop reliable and valid measures of thirst in CHF. The purpose of this manuscript is to establish which tools have been used in research to measure thirst in CHF. METHODS: Medline, PubMed, Cumulative Index for Nursing and Allied Health, and Scopus were searched using following key words thirst, heart failure, measure, scale, randomised controlled trials and multicentre studies. RESULTS: The search discovered 37 studies of which 6 studies met the inclusion criteria. One study was a research abstract and five were full-text studies. To date, there are only three measurement tools utilised in studies examining thirst in CHF patients [Visual Analogue Scale (VAS), Numeric Rating Scale and Thirst Distress Scale]. CONCLUSION: Thirst in CHF is measured in a non-systematic way. In recent studies, the VAS has been used to measure thirst intensity. While this measurement tool is very easy and quick to administer, using a uni-dimensional tool in conjunction with a multi-dimensional tool may be beneficial to capture all dimensions of thirst. In order to manage thirst efficiently, consistent measurement of thirst in CHF is vital.

A practical guide to living evidence: Reducing the knowledge-to-practice gap.

Living evidence involves continuous evidence surveillance to incorporate new relevant evidence into systematic reviews and clinical practice guideline recommendations as soon as it becomes available. Thus, living evidence may improve the timeliness of recommendation updates and reduce the knowledge-to-practice gap. When considering a living evidence model, several processes and practical aspects need to be explored. Some of these include identifying the need for a living evidence model, funding, governance structure, time, team skills and capabilities, frequency of updates, approval and endorsement and publication and dissemination.

Multifaceted needs of individuals living with peripheral arterial disease: A qualitative study.

OBJECTIVES: To ascertain a comprehensive perspective of the impact of peripheral arterial disease (PAD) on people including needs for access to disease specific information, education, services, and support. METHODS: Participants were recruited from outpatient clinics at a tertiary hospital in metropolitan Australia. Telephone and face-to-face semi-structured interviews were conducted with nine individuals living with PAD and analysed using qualitative content thematic analysis. RESULTS: The nine participants were on average 74.2 (SD 10.9) years and predominantly women (67%). Lack of understanding of PAD and inconsistent information resulted in confusion regarding self-management strategies. Effects of pain and mobility problems were amplified for participants who lived alone and did not have an informal carer. DISCUSSION: Poor quality of life in PAD reflects pain, social isolation and fear of falls. Multidisciplinary teams with case managers should consider older people's living situations and needs for additional support services and education to facilitate integrated care.

Key elements of interventions for heart failure patients with mild cognitive impairment or dementia: A systematic review.

BACKGROUND: The purpose of this systematic review was to (a) examine the effects of interventions delivered by a heart failure professional for mild cognitive impairment and dementia on cognitive function, memory, working memory, instrumental activities of daily living, heart failure knowledge, self-care, quality of life and depression; and (b) identify the successful elements of these strategies for heart failure patients with mild cognitive impairment or dementia. METHODS AND RESULTS: During March 2018, an electronic search of databases including CINAHL, MEDLINE, EMBASE and PsycINFO was conducted. All randomised controlled trials, which examined an intervention strategy to help heart failure patients with mild cognitive impairment or dementia cope with self-care, were included. An initial search yielded 1622 citations, six studies were included (N= 595 participants, mean age 68 years). There were no significant improvements in cognitive function and depression. However, significant improvements were seen in memory (p=0.015), working memory (p=0.029) and instrumental activities of daily living (p=0.006). Nurse led interventions improved the patient's heart failure knowledge (p=0.001), self-care (p<0.05) and quality of life (p=0.029). Key elements of these interventions include brain exercises, for example, syllable stacks, individualised assessment and customised education, personalised self-care schedule development, interactive problem-solving training on scenarios and association techniques to prompt self-care activities. CONCLUSIONS: Modest evidence for nurse led interventions among heart failure patients with mild cognitive impairment or dementia was identified. These results must be interpreted with caution in light of the limited number of available included studies.

Valvular Regurgitation in a Biventricular Mock Circulatory Loop.

Aortic regurgitation (AR), mitral regurgitation (MR), and tricuspid regurgitation (TR) after continuous-flow left ventricular assist device (LVAD) are common and may increase with prolonged LVAD support. The aim of this study was to simulate severe valvular regurgitation (AR, MR, and TR) within a 4-elemental pulsatile mock circulatory loop (MCL) and observe their impact on isolated LVAD and biventricular assist device (BiVAD) with HeartWare HVAD. Aortic regurgitation, MR, and TR were achieved via the removal of one leaflet from bileaflet mechanical valve from the appropriate valves of the left or right ventricles. The impact of alteration of LVAD pump speed (LVAD 2200-4000 RPM, right ventricular assist device [RVAD] 2400 RPM) and altered LVAD preload (10-25 mm Hg) was assessed. With each of the regurgitant valve lesions, there was a decrease in isolated LVAD pump flow pulsatility. Isolated LVAD provided sufficient support in the setting of severe MR or TR compared with control, and flows were enhanced with BiVAD support. In severe AR, there was no benefit of BiVAD support over isolated LVAD, and actual loop flows remained low. High LVAD flows combined with low RVAD flows and dampened aortic pressures are good indicators of AR. The 4-elemental MCL successfully simulated several control and abnormal valvular conditions using various pump speeds. Current findings are consistent with conservative management of MR and TR in the setting of mechanical support, but emphasize the importance of the correction of AR.

Thirst in heart failure: what do we know so far?

PURPOSE OF REVIEW: Thirst is a common and burdensome symptom of heart failure, which impacts adversely on quality of life. To date, there is limited research on the prevalence of thirst, the factors associated with thirst and interventions to help manage thirst in heart failure. This review summarizes key empirical research developments of thirst. RECENT FINDINGS: Recent research shows that the heart failure syndrome, medications, self-care practice such as fluid restriction and anxiety contributes greatly to increased thirst in patients with heart failure. In addition, predictors such as being younger, male patient, with high symptom burden and serum urea is also associated with thirst. There are no intervention studies to manage thirst, only reports of various strategies recommended to heart failure patients in clinical practice. SUMMARY: Despite the burden of thirst in heart failure patients, strategies to relieve thirst remains insufficiently addressed in literature. Further research to improve the understanding of the severity of thirst and its relationship to possible factors associated with thirst is required in order to develop future interventions to either prevent or alleviate troublesome thirst in patients with heart failure.

Right Ventricular Failure Post LVAD Implantation Corrected with Biventricular Support: An In Vitro Model.

Right ventricular failure after left ventricular assist device (LVAD) implantation is associated with high mortality. Management remains limited to pharmacologic therapy and temporary mechanical support. Delayed right ventricular assist device (RVAD) support after LVAD implantation is associated with poorer outcomes. With the advent of miniaturized, durable, continuous flow ventricular assist device systems, chronic RVAD and biventricular assist device (BiVAD) support has been used with some success. The purpose of this study was to assess combined BiVAD and LVAD with delayed RVAD support within a four-elemental mock circulatory loop (MCL) simulating the human cardiovascular system. Our hypothesis was that delayed continuous flow RVAD (RVAD) would produce similar hemodynamic and flow parameters to those of initial BiVAD support. Using the MCL, baseline biventricular heart failure with elevated right and left filling pressures with low cardiac output was simulated. The addition of LVAD within a biventricular configuration improved cardiac output somewhat, but was associated with persistent right heart failure with elevated right-sided filling pressures. The addition of an RVAD significantly improved LVAD outputs and returned filling pressures to normal throughout the circulation. In conclusion, RVAD support successfully restored hemodynamics and flow parameters of biventricular failure supported with isolated LVAD with persistent elevated right atrial pressure.

Biventricular mechanical support devices--clinical perspectives.

Cardiac transplantation remains the optimal treatment for end stage heart failure in selected patients. However, the shortage of donor hearts, rigorous eligibility criteria and long waiting lists have increased the demand for alternative treatment strategies such as mechanical circulatory support. While many patients are adequately supported with left ventricular assist devices, frequently there is right heart failure or involvement of the right ventricle, requiring biventricular support. Pulsatile flow biventricular devices and total artificial hearts approved for temporary biventricular support have limitations including size, high rates of adverse events and restricted mobility which makes them unsuitable for long term support. A number of centres have reported dual continuous flow left ventricular assist devices as a means of supporting the left and right heart. This review will summarise the literature on the outcomes and complications from current biventricular support devices and assess the role of dual continuous flow VAD therapy, and the new continuous flow total heart replacement devices.