Effect of a home-based inspiratory muscle training programme on functional capacity in postdischarged patients with long COVID: the InsCOVID trial.

BACKGROUND: Fatigue and exercise intolerance are the most common symptoms in patients with long COVID. AIMS: This study aimed to evaluate whether a home-based inspiratory muscle training (IMT) programme improves maximal functional capacity in patients' long COVID after a previous admission due to SARS-CoV-2 pneumonia. METHODS: This study was a single-centre, blinded assessor, randomised controlled trial. Twenty-six patients with long COVID and a previous admission due to SARS-CoV-2 pneumonia were randomly assigned to receive either a 12-week IMT or usual care alone (NCT05279430). The physiotherapist and participants were not blinded. Patients allocated to the IMT arm were instructed to train at home twice daily using a threshold inspiratory muscle trainer and to maintain diaphragmatic breathing during the training session. The usual care arm received no intervention.The primary endpoint was the change in peak oxygen consumption (peakVO2). Secondary endpoints were changes in quality of life (QoL), ventilatory efficiency and chronotropic response during exercise (evaluated by chronotropic index-CIx- formula). We used linear mixed regression analysis for evaluating changes in primary and secondary endpoints. RESULTS: The mean age of the sample and time to first visit after discharge were 50.4±12.2 years and 362±105 days, respectively. A total of 11 (42.3%) were female. At baseline, the mean of peakVO2, ventilatory efficiency and CIx were 18.9±5 mL/kg/min, 29.4±5.2 and 0.64±0.19, respectively. The IMT arm improved their peakVO2 significantly compared with usual care (+Δ 4.46 mL/kg/min, 95% CI 3.10 to 5.81; p<0.001). Similar positive findings were found when evaluating changes for CIx and some QoL dimensions. We did not find significant changes in ventilatory efficiency. CONCLUSION: In long COVID patients with a previous admission due to SARS-CoV-2 pneumonia, IMT was associated with marked improvement in exercise capacity and QoL. TRIAL REGISTRATION NUMBER: NCT05279430.

Home-based inspiratory muscle training for management of older patients with heart failure with preserved ejection fraction: does baseline inspiratory muscle pressure matter?

BACKGROUND: Heart failure with preserved ejection fraction is a clinical syndrome characterised by reduced exercise capacity. Some evidence has shown that a simple and home-based programme of inspiratory muscle training offers promising results in terms of aerobic capacity improvement in patients with heart failure with preserved ejection fraction. This study aimed to investigate whether the baseline inspiratory muscle function predicts the changes in aerobic capacity (measured as peak oxygen uptake; peak VO2) after a 12-week home-based programme of inspiratory muscle training in patients with heart failure with preserved ejection fraction. METHODS: A total of 45 stable symptomatic patients with heart failure with preserved ejection fraction and New York Heart Association II-III received a 12-week home-based programme of inspiratory muscle training between June 2015 and December 2016. They underwent cardiopulmonary exercise testing and measurements of maximum inspiratory pressure pre and post-inspiratory muscle training. Maximum inspiratory pressure and peak VO2 were registered in both visits. Multivariate linear regression analysis was used to assess the association between changes in peak VO2 (Δ-peakVO2) and baseline predicted maximum inspiratory pressure (pp-MIP). RESULTS: The median (interquartile range) age was 73 (68-77) years, 47% were women and 35.6% displayed New York Heart Association III. The mean peak VO2 at baseline and Δ-peakVO2 post-training were 10.4±2.8 ml/min/kg and +2.2±1.3 ml/min/kg (+21.3%), respectively. The median (interquartile range) of pp-MIP and Δ-MIP were 71% (64-92) and 39.2 (26.7-80.4) cmH2O, respectively. After a multivariate analysis, baseline pp-MIP was not associated with Δ-peakVO2 (ß coefficient 0.005, 95% confidence interval -0.009-0.019, P=0.452). CONCLUSIONS: In symptomatic and deconditioned older patients with heart failure with preserved ejection fraction, a home-based inspiratory muscle training programme improves aerobic capacity regardless of the baseline maximum inspiratory pressure.

Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction: The TRAINING-HF Trial.

INTRODUCTION AND OBJECTIVES: Despite the prevalence of heart failure with preserved ejection fraction (HFpEF), there is currently no evidence-based effective therapy for this disease. This study sought to evaluate whether inspiratory muscle training (IMT), functional electrical stimulation (FES), or a combination of both (IMT + FES) improves 12- and 24-week exercise capacity as well as left ventricular diastolic function, biomarker profile, and quality of life in HFpEF. METHODS: A total of 61 stable symptomatic patients (New York Heart Association II-III) with HFpEF were randomized (1:1:1:1) to receive a 12-week program of IMT, FES, or IMT + FES vs usual care. The primary endpoint of the study was to evaluate change in peak exercise oxygen uptake at 12 and 24 weeks. Secondary endpoints were changes in quality of life, echocardiogram parameters, and prognostic biomarkers. We used a mixed-effects model for repeated-measures to compare endpoints changes. RESULTS: Mean age and peak exercise oxygen uptake were 74 ± 9 years and 9.9 ± 2.5mL/min/kg, respectively. The proportion of women was 58%. At 12 weeks, the mean increase in peak exercise oxygen uptake (mL/kg/min) compared with usual care was 2.98, 2.93, and 2.47 for IMT, FES, and IMT + FES, respectively (P < .001) and this beneficial effect persisted after 6 months (1.95, 2.08, and 1.56; P < .001). Significant increases in quality of life scores were found at 12 weeks (P < .001). No other changes were found. CONCLUSIONS: In HFpEF patients with low aerobic capacity, IMT and FES were associated with a significant improvement in exercise capacity and quality of life. This trial was registered at ClinicalTrials.gov (Identifier: NCT02638961)..

Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction: Rationale and Study Design of a Prospective Randomized Controlled Trial.

Heart failure with preserved ejection fraction (HFpEF) has become the most prevalent form of heart failure in developed countries. Regrettably, there is no evidence-based effective therapy for HFpEF. We seek to evaluate whether inspiratory muscle training, functional electrical stimulation, or a combination of both can improve exercise capacity as well as left ventricular diastolic function, biomarker profile, quality of life (QoL), and prognosis in patients with HFpEF. A total of 60 stable symptomatic patients with HFpEF (New York Heart Association class II-III/IV) will be randomized (1:1:1:1) to receive a 12-week program of inspiratory muscle training, functional electrical stimulation, a combination of both, or standard care alone. The primary endpoint of the study is change in peak exercise oxygen uptake; secondary endpoints are changes in QoL, echocardiogram parameters, and prognostic biomarkers. As of March 21, 2016, thirty patients have been enrolled. Searching for novel therapies that improve QoL and autonomy in the elderly with HFpEF has become a health care priority. We believe that this study will add important knowledge about the potential utility of 2 simple and feasible physical interventions for the treatment of advanced HFpEF.

Effects of inspiratory muscle training in patients with heart failure with preserved ejection fraction.

BACKGROUND: Heart failure with preserved ejection fraction (HFpEF) is remarkably common in elderly people with highly prevalent comorbid conditions. Despite its increasing in prevalence, there is no evidence-based effective therapy for HFpEF. We sought to evaluate whether inspiratory muscle training (IMT) improves exercise capacity, as well as left ventricular diastolic function, biomarker profile and quality of life (QoL) in patients with advanced HFpEF and nonreduced maximal inspiratory pressure (MIP). DESIGN AND METHODS: A total of 26 patients with HFpEF (median (interquartile range) age, peak exercise oxygen uptake (peak VO2) and left ventricular ejection fraction of 73 years (66-76), 10 ml/min/kg (7.6-10.5) and 72% (65-77), respectively) were randomized to receive a 12-week programme of IMT plus standard care vs. standard care alone. The primary endpoint of the study was evaluated by positive changes in cardiopulmonary exercise parameters and distance walked in 6 minutes (6MWT). Secondary endpoints were changes in QoL, echocardiogram parameters of diastolic function, and prognostic biomarkers. RESULTS: The IMT group improved significantly their MIP (p < 0.001), peak VO2 (p < 0.001), exercise oxygen uptake at anaerobic threshold (p = 0.001), ventilatory efficiency (p = 0.007), metabolic equivalents (p < 0,001), 6MWT (p < 0.001), and QoL (p = 0.037) as compared to the control group. No changes on diastolic function parameters or biomarkers levels were observed between both groups. CONCLUSIONS: In HFpEF patients with low aerobic capacity and non-reduced MIP, IMT was associated with marked improvement in exercise capacity and QoL.

Differential mortality association of loop diuretic dosage according to blood urea nitrogen and carbohydrate antigen 125 following a hospitalization for acute heart failure.

AIMS: Recent observations in chronic stable heart failure suggest that high-dose loop diuretics (HDLDs) have detrimental prognostic effects in patients with high blood urea nitrogen (BUN), but recent findings have also indicated that diuretics may improve renal function. Carbohydrate antigen 125 (CA125) has been shown to be a surrogate of systemic congestion. We sought to explore whether BUN and CA125 modulate the mortality risk associated with HDLDs following a hospitalization for acute heart failure (AHF). METHODS AND RESULTS: We analysed 1389 consecutive patients discharged for AHF. CA125 and BUN were measured at a mean of 72 ± 12 h after admission. HDLDs (≥120 mg/day in furosemide equivalent dose) were interacted to a four-level variable according to CA125 (>35 U/mL) and BUN (above the median), and related to all-cause mortality. At a median follow-up of 21 months, 561 (40.4%) patients died. The use of HDLDs was independently associated with increased mortality [hazard ratio (HR) 1.23, 95% confidence interval (CI) 1.01-1.50], but this association was not homogeneous across CA125-BUN categories (P for interaction <0.001). In patients with normal CA125, use of HDLDs was associated with high mortality if BUN was above the median (HR 2.29, 95% 1.51-3.46), but not in those with BUN below the median (HR 1.22, 95% CI 0.73-2.04). Conversely, in patients with high CA125, HDLDs showed an association with increased survival if BUN was above the median (HR 0.73, 95% CI 0.55-0.98) but was associated with increased mortality in those with BUN below the median (HR 1.94, 95% CI 1.36-2.76). CONCLUSION: The risk associated with HDLDs in patients after hospitalization for AHF was dependent on the levels of BUN and CA125. The information provided by these two biomarkers may be helpful in tailoring the dose of loop diuretics at discharge for AHF.

Syncope and bundle branch block. Diagnostic yield of a stepped use of electrophysiology study and implantable loop recorders.

INTRODUCTION AND OBJECTIVES: The objective of this study was to determine the diagnostic yield of a stepped protocol involving an electrophysiologic study (EPS) and implantable loop recorders (ILR) in patients with syncope and bundle branch block (BBB). METHODS: Eighty-five consecutive patients referred for syncope and BBB after initial non-diagnostic assessment underwent EPS including a pharmacological challenge with procainamide. Those patients without indication for defibrillator implantation received ILRs. Follow-up continued until diagnosis or end of battery life. RESULTS: The EPS was diagnostic in 36 patients (42%). The most frequent diagnoses were paroxysmal atrioventricular block (AVB) (n=27), followed by ventricular tachycardia (VT) (n=6). All patients with VT had structural heart disease; left BBB was more prevalent in this group. Thirty-eight patients received ILRs and diagnosis was achieved in 13 (34%) of them; paroxysmal AVB (n=10) was the most frequent diagnosis. Median follow-up to diagnosis of paroxysmal AVB was 97 days (interquartile range 60-117 days). Paroxysmal AVB was more frequent in patients with right BBB and prolonged PR interval and/or axis deviation. We found no occurrence of VT or arrhythmic death during follow-up. CONCLUSIONS: The most common etiology of syncope in patients with BBB was paroxysmal AVB, followed by VT. The stepped use of EPS and ILR in negative patients enables us to safely achieve a high diagnostic yield, given that VT is usually diagnosed during EPS.

Impacto pronóstico de una estrategia invasiva en el síndrome coronario agudo sin elevación del segmento ST según la presencia o no de disfunción sistólica / Effect of invasive treatment on prognosis in non-ST-segment elevation acute coronary syndrome with or without systolic dysfunction

Introducción y objetivos. Escasa evidencia respalda la implantación de una estrategia invasiva (EI) en pacientes con síndrome coronario agudo sin elevación del segmento ST (SCASEST) y disfunción sistólica (DS). El objetivo de este trabajo es evaluar el impacto pronóstico atribuible a una EI en sujetos con SCASEST según tengan DS o no. Métodos. Se incluyó a 972 pacientes consecutivos ingresados por SCASEST (descenso del segmento ST y/o elevación de troponina I). Se definió la DS como fracción de eyección < 50% mediante ecocardiografía transtorácica. El objetivo principal fue la muerte o infarto a largo plazo. Se analizó el impacto pronóstico atribuible a una EI mediante regresión de Cox. Resultados. El 23,4% presentó DS. Un total de 303 (31%) pacientes alcanzaron el objetivo primario, hecho que fue más frecuente en los pacientes con DS (el 49,8 frente al 25,5%; p < 0,001). La realización de coronariografías y procedimientos de revascularización fue similar entre pacientes con DS y pacientes con fracción de eyección ≥ 50% (el 59 frente al 63,4%; p = 0,239 y el 38,3 frente al 38,8%; p = 0,9). Tras un minucioso ajuste multivariable que incluyó un índice de propensión, se observó un impacto pronóstico diferencial atribuible a la realización de una coronariografía según hubiera DS o no (interacción, p = 0,01). Así, el beneficio del cateterismo fue evidente en los pacientes con DS ( hazard ratio [HR] = 0,47; intervalo de confianza [IC] del 95%, 0,3-0,75; p = 0,001), pero no en aquellos con fracción de eyección ≥ 50% (HR = 0,9; IC del 95%, 0,63-1,29; p = 0,567). Conclusiones. La presencia de DS permite la identificación de los SCASEST que más se benefician de aplicar una EI (AU)

Introduction and objectives. Few data are available on the use of invasive treatment in patients with non-ST-segment elevation acute coronary syndrome (NSTEACS) and systolic dysfunction. The aim of this study was to determine the effect of invasive treatment on the prognosis of patients with NSTEACS, with or without systolic dysfunction. Methods. The study included 972 consecutive patients admitted for NSTEACS (i.e. ST-segment depression or an elevated troponin-I level). Systolic dysfunction was defined as an ejection fraction <50 on transthoracic echocardiography the primary long-term endpoint was death or myocardial infarction effect of invasive treatment prognosis evaluated by cox regression analysis results overall 23 4 patients had systolic dysfunction and 303 31 2 reached which more frequent in those with 49 8 vs 25 5 p <.001). Usage of coronary angiography and revascularization procedures were similar in patients with systolic dysfunction and those with an ejection fraction ≥50% (59% vs. 63.4%; P=.239; and 38.3% vs. 38.8%; P=.9; respectively). Detailed adjusted multivariate analysis, including the use of a propensity score, demonstrated that coronary angiography had a differential effect on prognosis depending on the presence or absence of systolic dysfunction (interaction, P=.01). Catheterization was clearly beneficial in patients with systolic dysfunction (hazard ratio [HR]=0.47; 95% confidence interval [CI], 0.3-0.75; P=.001) but not in those with an ejection fraction ≥50% (HR=0.9; 95% CI, 0.63-1.29; P=.567). Conclusions. The presence of systolic dysfunction identifies those patients with NSTEACS who will benefit most from invasive treatment (AU)