scholarly journals Personalised reprogramming to prevent progressive pacemaker-related left ventricular dysfunction: A phase II randomised, controlled clinical trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0259450
Author(s):  
Maria F. Paton ◽  
John Gierula ◽  
Judith E. Lowry ◽  
David A. Cairns ◽  
Kieran Bose Rosling ◽  
...  

Background Pacemakers are widely utilised to treat bradycardia, but right ventricular (RV) pacing is associated with heightened risk of left ventricular (LV) systolic dysfunction and heart failure. We aimed to compare personalised pacemaker reprogramming to avoid RV pacing with usual care on echocardiographic and patient-orientated outcomes. Methods A prospective phase II randomised, double-blind, parallel-group trial in 100 patients with a pacemaker implanted for indications other than third degree heart block for ≥2 years. Personalised pacemaker reprogramming was guided by a published protocol. Primary outcome was change in LV ejection fraction on echocardiography after 6 months. Secondary outcomes included LV remodeling, quality of life, and battery longevity. Results Clinical and pacemaker variables were similar between groups. The mean age (SD) of participants was 76 (+/-9) years and 71% were male. Nine patients withdrew due to concurrent illness, leaving 91 patients in the intention-to-treat analysis. At 6 months, personalised programming compared to usual care, reduced RV pacing (-6.5±1.8% versus -0.21±1.7%; p<0.01), improved LV function (LV ejection fraction +3.09% [95% confidence interval (CI) 0.48 to 5.70%; p = 0.02]) and LV dimensions (LV end systolic volume indexed to body surface area -2.99mL/m2 [95% CI -5.69 to -0.29; p = 0.03]). Intervention also preserved battery longevity by approximately 5 months (+0.38 years [95% CI 0.14 to 0.62; p<0.01)) with no evidence of an effect on quality of life (+0.19, [95% CI -0.25 to 0.62; p = 0.402]). Conclusions Personalised programming in patients with pacemakers for bradycardia can improve LV function and size, extend battery longevity, and is safe and acceptable to patients. Trial registration ClinicalTrials.gov identifier: NCT03627585.

2019 ◽  
Vol 28 (01) ◽  
pp. 044-049
Author(s):  
Sidhi Purwowiyoto ◽  
Budhi Purwowiyoto ◽  
Amiliana Soesanto ◽  
Anwar Santoso

Exercise improves morbidity, fatality rate, and quality of life in heart failure with low ejection fraction, but fewer data available in heart failure with preserved ejection fraction (HFPEF).The purpose of this study is to test the hypothesis that exercise training might improve the longitudinal intrinsic left ventricular (LV) function in HFPEF patients.This quasi-experimental study had recruited 30 patients with HFPEF. Exercise training program had been performed for a month with a total of 20 times exercise sessions and evaluated every 2 weeks. Echocardiography was performed before sessions, second week and fourth week of exercise training. Six-minute walk tests (6MWTs) and quality-of-life variables using Minnesota living with HF scoring and the 5-item World Health Organization Well-Being Index scoring were measured before and after exercise as well.Left ventricular filling pressure, represented by the ratio of early diastolic mitral flow velocity/early diastolic annular velocity and left atrial volume index, improved during exercise. The longitudinal intrinsic LV function, represented by four-chamber longitudinal strain, augmented during exercise (p < 0.001). Aerobic capacity, measured by 6MWT, increased significantly (p = 0.001). Quality of life improved significantly during exercise (p < 0.001).Exercise training was suggested to improve the longitudinal intrinsic LV function and quality of life in HFPEF. Clinical Trial Registration: ACTRN12614001042639.


2020 ◽  
Author(s):  
Runfeng Zhang ◽  
Jiang Yu ◽  
Ningkun Zhang ◽  
Wensong Li ◽  
Jisheng Wang ◽  
...  

Abstract Objective: Our aimed to evaluate efficacy and safety of intracoronary autologous bone morrow mesenchymal stem cells (BM-MSCs) transplantation in patients with ST-segment elevation myocardial infarction(STEMI). Methods: In this randomised, single-blind, controlled trial, patients with STEMI (aged 39-76 years) were enrolled at 6 centers in Beijing (the People's Liberation Army Navy General Hospital, Beijing Armed Police General Hospital, Chinese People's Liberation Army General Hospital, Beijing Huaxin Hospital, Beijing Tongren Hospital, Beijing Chaoyang Hospital West Hospital). Patients underwent optimum medical treatment and percutaneous coronary intervention,and were randomly assigned in a 1:1 ratio to BM-MSCs group or control group. The primary endpoint was change of myocardial viability at 6 months' follow-up and left-ventricular (LV) function at 12 months' follow-up.The secondary endpoints were incidence of cardiovascular event, total mortality and adverse event at 12 months' follow-up. The myocardial viability assessed by single- photon emission tomography (SPECT). The left ventricular ejection fraction was used to assess LV function. All patients underwent dynamic ECG and laboratory evaluations. This trial is registered with ClinicalTrails.gov, number NCT04421274. Results: Between March , 2008, and July , 2010, 43 patients were randomly assigned to BM-MSCs group (n=21)or control group(n=22) and followed up for 12 months. LV ejection fraction increased from baseline to 12 months in the BM-MSCs group and control group ( mean baseline-adjusted BM-MSCs treatment differences in LV ejection fraction 4.8% (SD 9.0) and mean baseline-adjusted control group treatment differences in LV ejection fraction 5.8% (SD 6.04) ). After 6 months of follow-up, there was no significant improvement in myocardial metabolic activity in the BM-MSCs group before and after transplantation. however,there was no statistically significant difference between the two groups in the change of LV ejection fraction (p=0.30) and myocardial metabolic activity(p>0.05). We noticed that ,after 12 months of follow-up, except for 1 death and 1 coronary microvascular embolism in the BM-MSCs group, no other events occurred and Alanine transaminase(ALT) and C-reactive protein(CRP) in BM-MSCs group were significantly lower than that in control group. Conclusions: It is unreasonable to speculate that intracoronary transfer of autologous bone marrow MSCs could augment recovery of LV function and myocardial viability after acute myocardial infarction.Trial registration: clinicaltrials,NCT04421274. Registered 06,08,2020- Retrospectively registered, https://register.clinicaltrials.gov/NCT04421274.


Author(s):  
Savvas Toumanidis ◽  
John Agrios ◽  
Anna Kaladaridou ◽  
Dimitrios Bramos ◽  
Elias Skaltsiotes ◽  
...  

Aim: Early intravenous use of b-blockers within the first hours of STEMI is less firmly established. The aim of this study was to evaluate the effect of esmolol on left ventricular (LV) haemodynamic, rotational and strain parameters in intact myocardium and early post an experimental acute anterior myocardial infarction (MI). Methods: In 20 healthy pigs LV torsional and strain parameters were calculated from basal and apical short axis epicardial planes with speckle tracking technique using EchoPAC platform. LV measurements at baseline and during esmolol infusion (0.5 mg/kg for 1 min, then 0.05 mg/kg/min for 5 min) were compared in intact myocardium and repeated without b-blocker and during esmolol infusion 2 hours post LAD ligation. Results: LV function was highly dependent on the esmolol infusion, in the intact and even more in the infarcted myocardium. LV ejection fraction, LV dP/dtmax and LV end-systolic pressure decreased significantly, a deterioration produced by the administration of esmolol. Torsion-twist and untwisting rate also presented significant reduction in correlation with ejection fraction and cardiac output, appearing to affect especially the apex torsional and strain parameters. Conclusion: Esmolol infusion significantly reduces LV haemodynamic, torsional and strain parameters in intact myocardium and early post MI. These results suggest that early intravenous use of esmolol in patients with STEMI is risky and it is prudent to wait for the patient to stabilize before starting esmolol.


Kardiologiia ◽  
2019 ◽  
Vol 59 (6S) ◽  
pp. 24-32
Author(s):  
D. O. Dragunov ◽  
A. V. Sokolova ◽  
G. P. Arutyunov ◽  
A. D. Gasanova ◽  
T. V. Latyshev

Purpose. The study of quality of life (QOL) in patients with CHF with preserved LVEF (left ventricular ejection fraction) and a symptom of bendopnea with different levels of salt intake. Materials and methods. The study included 66 patients. The main symptoms of CHF were edema in 54.5% of cases, dyspnea in 77% of cases, ascites was detected in only 2 patients, an enlarged liver in 7 patients. Abdominal obesity was detected in 53 patients. Quality of life was assessed by the SF‑36 questionnaire, the level of salt intake was assessed by the Charlton: SaltScreener questionnaire. Results. On average, the time of occurrence of the bendopnea was 22.5±9.3 seconds, the minimum was 5 seconds. The absence of the effect of abdominal obesity on the risk of bendopnea (relative risk 1.18 [0.76; 1.83]) was revealed. According to the SF‑36 questionnaire, a decrease in physical health indicators (median 31.3 points [20.7; 42.3]) and psychological health (average score 43.2±21.7) was found. In patients with bendopnea, QOL was reduced due to both physical and mental health, unlike patients without bendopnea: physical functioning (Physical Functioning – PF) 24.8±16.1 against 47±28.9 points, p=0.001 ; role‑based functioning due to physical condition (Role‑Physical Functioning – RP), 0 [0; 25] vs. 37.5 [0; 100] points, p=0.008; general health (General Health – GH) 29.9±15.8 against 50±14.2 points, p=0.0005, social functioning (Social Functioning – SF) 56 ± 38 against 78.9 ± 17.8 points ; p = 0.004. Multidimensional regression analysis revealed the relationship between the time of occurrence of the symptom bendopnea and the level of salt intake, physical and psychological activity (r2=0.25; p<0.009). The time of onset of the symptom of bendopnea in patients with CHF decompensation was significantly longer (18.9±8.7 vs. 26.2±8.5 seconds, p=0.003). The presence of diseases such as hypertension, COPD, IHD, atrial fibrillation, cerebrovascular disease did not significantly affect QOL (p> 0.05), while the presence of bronchial asthma or chronic kidney disease significantly reduced QOL of patients (p<0.05). Conclusion. The presence of the symptom bendopnea significantly reduces the quality of life of patients with CHF with preserved LVEF (left ventricular ejection fraction).


2021 ◽  
Vol 99 (4) ◽  
pp. 282-287
Author(s):  
V. G. Tregubov ◽  
P. V. Khilkevich ◽  
I. Z. Shubitidze ◽  
V. M. Pokrovskii ◽  
N. V. Yukhnova

Objective. Compare the eff ect of combination therapy with nebivolol or carvedilol on the functional state of patients with chronic heart failure (CHF) and preserved ejection fraction (pEF) of the left ventricle (LV). Material and methods. The study involved 80 patients with diastolic CHF, who were randomized into two groups. In group I was appointed of nebivolol (7.7 ± 2.4 mg/day, n = 40), in group II — carvedilol (30.5 ± 8.7 mg/day, n = 40). As part of the combination therapy, quinapril was prescribed (13.7 ± 2.7 mg/day, n = 40 and 13.5 ± 2.6 mg/day, n = 40), and if indicated — atorvastatin (15.3 ± 4.6 mg/day, n = 17 and 16.2 ± 5.2 mg/day, n = 17) and acetylsalicylic acid in the intestinal soluble shell (96.4 ± 13.4 mg/day, n = 14 and 93.8 ± 13.3 mg/day, n = 13), respectively. Initially and after 6 months of therapy were carried out: quantitative assessment of regulatory-adaptive status (RAS) (by means of a sample of cardiac-respiratory synchronism), echocardioscopy, treadmill test, test with a six-minute walk, subjective assessment of quality of life, determination of the level of the N-terminal fragment of the brain natriuretic peptide in blood plasma, daily monitoring of blood pressure. Results. Both schemes of combined therapy comparably improved the structural and functional state of the heart, controlled arterial hypertension. In comparison with carvedilol, nebivolol diff ered positive eff ect on the RAS, more increased tolerance to physical activity and improved quality of life. Conclusion. In patients with CHF pEF LV in combination therapy, the use of nebivolol, in comparison with carvedilol, may be preferable due to the more pronounced positive eff ect on the functional state.


2021 ◽  
Vol 20 (Supplement_1) ◽  
Author(s):  
BM Delgado ◽  
IVO Lopes ◽  
E Mendes ◽  
MARIA Loureiro ◽  
L Preto ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Heart failure is often characterized by low exercise capacity and great impairment on performance in activities of daily living. The correct management of the disease can prevent the worsening of symptoms and promote a better quality of life. Self-care behaviour plays an important role on patient"s quality of life. Aim The aims of this study are to evaluate the self-care behaviour in a sample of heart failure inpatients, using the Self-Care Heart Failure Index (SCHFI) and to understand whether gender and patophisiologic characteristics does interfere on it. Methods Cross-sectional multicenter study enrolling 225 heart failure inpatients from eight hospitals. At admission, patient’s functional capacity was evaluated as well as their self-care behaviour, using the SCHFI Portuguese v6.2. Comparison between self-care behaviour with gender was performed. Also some correaltions were perfomed with the total sample of patients, aiming to understand which were the variables that may interfere with the socre of each sub-scale of the self-care HF index.  Results Patients’ mean age was 68.4 ± 10.7 years old, 68% were male and 82.3% have reduced ejection fraction. A mean value of 47.9, 35.6 and 38.8 points was found in the SCHFI score of the sections self-care maintenance (SCMt), self-care management (SCMg) and self-care confidence (SCC), respectively. Heart failure inpatients present inadequate levels of self-care behaviour. No difference was found between genders on any section of the SCHFI. Among all variables, only the number of CVRFs and the left ventricular ejection fraction had significant differences. Males had better results, but not with a statistically significant difference. Association tests (ANOVA) between different variables and the score of each section of the SCHFI were perfomred. Only in the NYHA there are variables associated with a better self-care, namely in the SCMg (p = 0.011) and in SCC (p = 0.010). Correlations were made using the numeric variables age, CVRF, BI, LCADL, SCMt, SCMg and SCC, in order to understand the influence of the variables with each other. All the three dimesnions present a positive correlation, at 99% confidence interval between them (SCMt with SCMg: r = 0.365, p &lt; 0.000; SCMt with SCC: r = 0.272, p &lt; 0.000 and SCMg with SCC: r = 0.670, p &lt; 0.000). In addition, SCMt presents a positive correlation with age at a 95% confidence interval (r = 0.158, p = 0.018). Negative correlations were found between 1) BI and age (r=-0.151, p = 0.023), at a 95% confidence interval and 2) BI with LCALD (r=-0.407, p &lt; 0.000), at a 99% confidence interval. Regarding NYHA functional class and left ventricular systolic function, only NYHA class II patients present a statistically significant difference in SCMg and SCC comparing to Class III and IV patients (who do not present differences between them).  Conclusion The results do not suggest a relationship between gender and pathophysiological characteristics with self-care behaviour.


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