scholarly journals Comparison of efficacy and safety of His-Purkinje system pacing versus cardiac resynchronisation therapy in patients with pacing-induced cardiomyopathy: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e045302
Author(s):  
Junjun Chen ◽  
Liting Cheng ◽  
Zefeng Wang ◽  
Zhuo Liang ◽  
Ruiqing Dong ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cardiac Resynchronisation Therapy ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Efficacy And Safety ◽  
Purkinje System ◽  
Cardiac Resynchronisation ◽  
Resynchronisation Therapy ◽  
Randomised Controlled

IntroductionRecent studies have shown that the His-Purkinje system pacing (HPSP) can achieve electrocardiomechanical synchronisation, and thus improve cardiac function. For patients with pacing-induced cardiomyopathy (PICM) who should be treated with pacemaker upgrade, the HPSP is a viable alternative to cardiac resynchronisation therapy (CRT). However, no randomised controlled trial has been performed to evaluate the efficacy and safety of HPSP in patients with PICM. The present study compared the efficacy and safety of HPSP with that of traditional CRT in the treatment of patients with PICM.Methods and analysisThis study is a single-centre, randomised controlled non-inferiority trial. This trial was carried out at the cardiac centre of Beijing Anzhen Hospital. A total of 46 patients with PICM who needed pacemaker upgrade treatment between January 2022 and December 2023 will be enrolled in this study. Patients will be randomised into an investigational group (HPSP) and a control group (CRT) at a 1:1 ratio. The primary outcome is the duration of QRS complex (QRS width), and the secondary outcomes are NT-proBNP (N terminal pro B type natriuretic peptide), C reactive protein, the number of antibiotics used, left ventricular ejection fraction, end systolic volume, end diastolic volume, the hospitalisation duration, the incidence of postoperative infection, pacemaker parameters (threshold, sensing and impedance), the 6-minute walking test, and quality of life (36-Item Short Form Survey scale), all-cause mortality, cardiovascular death, heart failure-related rehospitalisation rate, other rehospitalisation rates, major complication rates and procedure costs.Ethics and disseminationThis study has been approved by the Beijing Anzhen Hospital Medical Ethics Committee (No. 2020043X).Trial registration numberChinese Clinical Trial Registry (ChiCTR2000034265).

scholarly journals Response to cardiac resynchronisation therapy in men and women: a secondary analysis of the SMART-AV randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e049017
Author(s):  
Stacey Howell ◽  
Timothy M Stivland ◽  
Kenneth Stein ◽  
Kenneth Ellenbogen ◽  
Larisa G Tereshchenko
Keyword(s):  
Logistic Regression ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Cardiac Resynchronisation Therapy ◽  
Left Ventricular ◽  
Cardiac Resynchronisation ◽  
Resynchronisation Therapy ◽  
Randomised Controlled ◽  
Crt Response

ObjectivesThere is a controversy about whether both sexes’ response to cardiac resynchronisation therapy (CRT) is similar. We aimed to assess a causal effect of sex on CRT response.DesignSecondary analysis of a randomised controlled trial (RCT) data. Doubly robust augmented-inverse-probability-weighted (AIPW) estimation of sex effect on CRT response.SettingThe SmartDelay Determined Atrioventricular (AV) Optimisation (SMART-AV) RCT.ParticipantsThe SMART-AV RCT enrolled New York Heart Association class III-IV patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≤35% despite optimal medical therapy and QRS duration ≥120 ms, in sinus rhythm. After exclusion of those with missing outcome or covariates, 741 participants (age 66±11 years; 33% female; 78% white; LVEF 28%±9%; 58% ischaemic cardiomyopathy; 75% left bundle branch block; left ventricular end-systolic volume index (LVESVI) 65±30 mL/m2) were included.InterventionsImplanted CRT defibrillator with randomly assigned AV delay as either (1) fixed at 120 ms, or (2) echocardiography-determined, or (3) SmartDelay algorithm-programmed.OutcomeA composite of freedom from death and HF hospitalisation and a >15% reduction in LVESVI at 6 month post-CRT was the endpoint.ResultsThe primary endpoint was met by 337 patients (45.5%); 134 were women (55.6% response) and 203 were men (40.6% response); p<0.0001. After conditioning for 33 covariates that included baseline demographic, clinical, ECG, echocardiographic and biomarker characteristics, known predictors of CRT response, logistic regression showed a higher probability for composite CRT response for women versus men (OR 1.79; 95% CI 1.08 to 2.98; p<0.0001), whereas AIPW estimation showed no difference in CRT response (average treatment effect 0.88; 95% CI 0.41 to 1.89; p=0.739). After removing colliders from the model, both logistic regression (OR 1.00; 95% CI 0.69 to 1.44) and AIPW (ATE 1.06; 95% CI 0.96 to 1.16) reported similar results.ConclusionsBoth sexes’ response to CRT is similar. Sex differences in HF substrate, treatment and comorbidities explain sex disparities in CRT outcomes.Trial registration numberClinicalTrials.gov Identifier; NCT00677014.

scholarly journals Advanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled ADVISE trial and early economic evaluation

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e054115
Author(s):  
Philippe C Wouters ◽  
Chris van Lieshout ◽  
Vincent F van Dijk ◽  
Peter-Paul HM Delnoy ◽  
Pieter AFM Doevendans ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cardiac Resynchronisation Therapy ◽  
Analytic Model ◽  
Image Guided ◽  
Lead Placement ◽  
Cardiac Resynchronisation ◽  
Resynchronisation Therapy ◽  
Randomised Controlled ◽  
Lead Location

IntroductionAchieving optimal placement of the left ventricular (LV) lead in cardiac resynchronisation therapy (CRT) is a prerequisite in order to achieve maximum clinical benefit, and is likely to help avoid non-response. Pacing outside scar tissue and targeting late activated segments may improve outcome. The present study will be the first randomised controlled trial to compare the efficacy of real-time image-guided LV lead delivery to conventional CRT implantation. In addition, to estimate the cost-effectiveness of targeted lead implantation, an early decision analytic model was developed, and described here.Methods and analysisA multicentre, interventional, randomised, controlled trial will be conducted in a total of 130 patients with a class I or IIa indication for CRT implantation. Patients will be stratified to ischaemic heart failure aetiology and 1:1 randomised to either empirical lead placement or live image-guided lead placement. Ultimate lead location and echocardiographic assessment will be performed by core laboratories, blinded to treatment allocation and patient information. Late gadolinium enhancement cardiac magnetic resonance imaging (CMR) and CINE-CMR with feature-tracking postprocessing software will be used to semi-automatically determine myocardial scar and late mechanical activation. The subsequent treatment file with optimal LV-lead positions will be fused with the fluoroscopy, resulting in live target-visualisation during the procedure. The primary endpoint is the difference in percentage of successfully targeted LV-lead location. Secondary endpoints are relative percentage reduction in indexed LV end-systolic volume, a hierarchical clinical endpoint, and quality of life. The early analytic model was developed using a Markov-model, consisting of seven mutually exclusive health states.Ethics and disseminationThe protocol was approved by the Medical Research Ethics Committee Utrecht (NL73416.041.20). All participants are required to provide written informed consent. Results will be submitted to peer-reviewed journals.Trial registration numberNCT05053568; Trial NL8666.

Emerging Cardiac Resynchronisation Therapy Indications

2011 ◽  
Vol 7 (1) ◽  
pp. 29
Author(s):  
Charlotte Eitel ◽  
Gerhard Hindricks ◽  
Christopher Piorkowski ◽  
◽  
◽  
...  
Keyword(s):  
Heart Failure ◽  
Systolic Heart Failure ◽  
Cardiac Resynchronisation Therapy ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Current Evidence ◽  
Class Iii ◽  
Ventricular Ejection Fraction ◽  
Cardiac Resynchronisation ◽  
Resynchronisation Therapy

Cardiac resynchronisation therapy (CRT) is an efficacious and cost-effective therapy in patients with highly symptomatic systolic heart failure and delayed ventricular conduction. Current guidelines recommend CRT as a class I indication for patients with sinus rhythm, New York Heart Association (NYHA) functional class III or ambulatory class IV, a QRS duration ≥120ms, and left ventricular ejection fraction (LVEF) ≤35%, despite optimal pharmacological therapy. Recent trials resulted in an extension of current recommendations to patients with mild heart failure, patients with atrial fibrillation, and patients with an indication for permanent right ventricular pacing with the aim of morbidity reduction. The effectiveness of CRT in patients with narrow QRS, patients with end-stage heart failure and cardiogenic shock, and patients with an LVEF >35% still needs to be proved. This article reviews current evidence and clinical applications of CRT in heart failure and provides an outlook on future developments.

scholarly journals Use of Cardiac Resynchronisation Therapy – Change of Clinical Settings

2014 ◽  
Vol 3 (1) ◽  
pp. 20-24 ◽  
Author(s):  
Khang-Li Looi ◽  
Anthony SL Tang ◽  
Sharad Agarwal
Keyword(s):  
Left Ventricular Dysfunction ◽  
Ventricular Dysfunction ◽  
Cardiac Resynchronisation Therapy ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Severe Left Ventricular Dysfunction ◽  
Surface Ecg ◽  
Cardiac Resynchronisation ◽  
Resynchronisation Therapy ◽  
Qrs Duration

Current guidelines recommend cardiac resynchronisation therapy (CRT) for patients with severe left ventricular dysfunction (left ventricular ejection fraction [LVEF] ≤35 %), QRS duration of ≥120–150 ms (Class IA and IB indications) on surface electrocardiogram (ECG) and New York Heart Association (NYHA) class III or IV heart failure (HF) symptoms. Ongoing studies aim to expand the use of CRT in patients with asymptomatic or minimal symptoms left ventricular dysfunction. There have been studies that have shown benefit of CRT extended to this group of patients. There have also been different implications of the role of CRT in patients with atrial fibrillation (AF), patients with narrow QRS duration or with right bundle branch block (RBBB) on surface ECG, as well as patients with end-stage renal failure on dialysis therapy. This article aims to review the current body of evidence of expanding use of CRT in these populations.

scholarly journals Cardiac Resynchronisation Therapy and Heart Failure: Persepctive from 5P Medicine

2015 ◽  
Vol 1 (1) ◽  
pp. 35 ◽  
Author(s):  
Fang Fang ◽  
Zhou Yu Jie ◽  
Luo Xiu Xia ◽  
Liu Ming ◽  
Ma Zhan ◽  
...  
Keyword(s):  
Heart Failure ◽  
Cardiac Resynchronisation Therapy ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Patients With Heart Failure ◽  
Cardiac Resynchronisation ◽  
Resynchronisation Therapy ◽  
Qrs Duration

Chronic heart failure is still a major challenge for healthcare. Currently, cardiac resynchronisation therapy (CRT) has been incorporated into the updated guideline for patients with heart failure, left ventricular ejection fraction ≤35 % and prolonged QRS duration. With 20 years of development, the concept of ‘from bench to bedside’ has been illustrated in the field of CRT. Given the fact that the indications of CRT keep evolving, the role of CRT is not limited to the curative method for heart failure. We therefore summarise with the perspective of 5P medicine – preventive, personalised, predictive, participatory, promotive, to review the benefit of CRT in the prevention of heart failure in those with conventional pacemaker indications, the individualised assessment of patient’s selection, the predictor of responders of CRT, and the obstacles hindering the more application of CRT and the future development of this device therapy.

scholarly journals Characterisation of circulating biomarkers before and after cardiac resynchronisation therapy and their role in predicting CRT response: the COVERT-HF study

Open Heart ◽  
2018 ◽  
Vol 5 (2) ◽  
pp. e000899 ◽  
Author(s):  
Christopher J McAloon ◽  
Temo Barwari ◽  
Jimiao Hu ◽  
Thomas Hamborg ◽  
Alan Nevill ◽  
...  
Keyword(s):  
Heart Failure ◽  
Functional Response ◽  
Cardiac Resynchronisation Therapy ◽  
Left Ventricular ◽  
Collagen I ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Cardiac Resynchronisation ◽  
Before And After ◽  
Resynchronisation Therapy

AimsCardiac resynchronisation therapy (CRT) is effective treatment for selected patients with heart failure (HF) but has ~30% non-response rate. We evaluated whether specific biomarkers can predict outcome.MethodsA prospective single-centre pilot study of consecutive unselected patients undergoing CRT for HF between November 2013 and December 2015 evaluating cardiac extracellular matrix biomarkers and micro-ribonucleic acid (miRNA) expression before and after CRT assessing ability to predict functional response and survival. Each underwent three assessments (pre-implant, 6  weeks and 6  months postimplant) including: New York Heart Association (NYHA) class, echocardiography, electrocardiography, 6  min walk test (6MWT), Minnesota Living with Heart Failure Questionnaire (MLHFQ) and N-terminal pro-brain natriuretic peptide (NT-pro-BNP). Plasma markers of cardiac fibrosis assessed were: N-terminal pro-peptides of collagen I and III, collagen I C-terminal telopeptides (CTx) and matrix metalloproteinases (MMP-2 and MMP-9) as well as a panel of miRNAs (miRNA-21, miRNA-30d, miRNA-122, miRNA-133a, miRNA-210 and miRNA-486).ResultsA total of 52 patients were recruited; mean age (±SD) was 72.4±9.4 years; male=43 (82.7%), ischaemic aetiology=30 (57.7%), mean QRS duration=166.4±23.5  ms, left bundle branch block (LBBB) morphology = 39 (75.0%), mean NYHA=2.7±0.6, 6MWT=238.8±130.6  m, MLHFQ=46.4±21.3  and left ventricular ejection fraction (LVEF)=24.3%±8.0%. Mean follow-up=1.7±0.3  and 5.8±0.7 months. There were 27 (55.1%) functional responders (3 no definable 6-month response; 2 missed assessments and 1 long-term lead displacement). No marker predicted response, however, CTx and LBBB trended most towards predicting functional response.ConclusionNo specific biomarkers reached significance for predicting functional response to CRT. CTx showed a trend towards predicting response and warrants further study.Trial registration numberNCT02541773.

scholarly journals Left ventricular ejection fraction as an imaging biomarker to guide cardiac resynchronisation therapy in heart failure patients: a multimodal comparison of 2D and 3D echocardiography and CMR

2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
S Lam ◽  
MS Nazir ◽  
B Campbell ◽  
M Yazdani ◽  
G Carr-White ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Cardiac Resynchronisation Therapy ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
King's College ◽  
Cardiac Resynchronisation ◽  
Resynchronisation Therapy ◽  
2D And 3D

Abstract Funding Acknowledgements Type of funding sources: Public Institution(s). Main funding source(s): The authors acknowledge financial support from the Department of Health through the National Institute for Health Research (NIHR) comprehensive Biomedical Research Centre award to Guy’s & St Thomas’ NHS Foundation Trust in partnership with King’s College London and King’s College Hospital NHS Foundation Trust and by the NIHR MedTech Co-operative for Cardiovascular Disease at Guy’s and St Thomas’ NHS Foundation Trust. This work was supported by the Wellcome/EPSRC Centre for Medical Engineering [WT 203148/Z/16/Z]. MSN was funded by a clinical lectureship awarded by the NIHR. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, the DoH, EPSRC, MRC or the Wellcome Trust. Introduction – Imaging derived left ventricular ejection fraction (LVEF) has an important role to guide initiation of medical therapy and device insertion in patients with heart failure and reduced ejection fraction (HFrEF). Previous studies have reported the correlation and agreement of LVEF in various patient populations, but sparse evidence exists on patients with heart failure referred for Cardiac Resynchronisation Therapy (CRT) using 2D and 3D echocardiography (2DE & 3DE) and cardiovascular magnetic resonance (CMR). Objectives – To determine the correlation and agreement of LVEF as determined by 2DE, 3DE and CMR in a cohort of HF patients referred for assessment of CRT. Methods – Patients with suspected HFrEF referred for assessment for CRT therapy were included in this single centre study. Patients underwent 2DE, 3DE and CMR to derive LVEF, LVESV and LVEDV. Correlation was determined with Pearson’s correlation, agreement with Bland-Altman analysis and Cohen’s kappa analysis for agreement using a dichotomous cut off of LVEF ≤35% as a threshold for CRT insertion (Ponikowski, 2016). Results - 55 patients (mean age 71 ± 9.2, 76% male) were included. The mean LVEF for 2DE, 3DE, CMR and were 32.4 ± 8.6, 32.1 ± 9.6 and 30.3 ± 9.5 respectively. CMR had a significantly lower LVEF compared to 2DE (p = 0.03). There was good correlation between 3DE & CMR and 2DE & CMR, and excellent correlation between 3DE and 2DE for LVEF (Table 1). There was for trend for CMR to underestimate LVEF compared to 2DE and 3DE, with small biases although wide limits of agreement (Figure 1). There was excellent correlation of LVEDV and LVESV across all 3 techniques. CMR underestimated volumes compared to 2DE and 3DE with large biases and wide LOA. The kappa coefficient agreement at threshold level for CRT insertion (LVEF ≤35%) was fair for 3DE and CMR (0.379, p = 0.004) and 2DE and CMR (0.462, p = 0.001), and moderate for 3DE and 2DE (0.575, p ≤ 0.001). Conclusion – Whilst LVEF is not the only indicator to guide CRT insertion, it remains an important imaging parameter for clinical decision making. We observed large biases in left ventricular volumes between 2D, 3D and CMR. However, whilst the overall bias in LVEF is small, the wide limits of agreement (LOA) observed may represent an area of clinical uncertainty, which may impact on the dichotomous imaging threshold for CRT insertion. Comparison of indices between modalities LVEF Correlation (r) LVEF Bias & LOA (%±SD) EDV Correlation (r) EDV Bias & LOA (mL ± SD) ESV Correlation (r) ESV Bias & LOA (mL ± SD) 3DE vs CMR 0.676 (p &lt; 0.001) +1.75 ± 15.4 0.896 (p &lt; 0.001) -82.16 ± 42.8 0.937 (p &lt; 0.001) -61.3 ± 34.9 3DE vs 2DE 0.872 (p &lt; 0.001) +0.48 ± 4.5 0.909 (p &lt; 0.001) -10.31 ± 28.3 0.936 (p &lt; 0.001) -8.42 ± 20.5 2DE vs CMR 0.675 (p &lt; 0.001) +2.35 ± 14.6 0.876 (p &lt; 0.001) -67.35 ± 36.3 0.898 (p &lt; 0.001) -51.42 ± 30.1 Abstract Figure. Bland-Altman Plot LVEF by 3DE & CMR

scholarly journals Efficacy and safety of left bundle branch area pacing versus biventricular pacing in heart failure patients with left bundle branch block: study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e036972
Author(s):  
Liting Cheng ◽  
Junmeng Zhang ◽  
Zefeng Wang ◽  
Mengge Zhou ◽  
Zhuo Liang ◽  
...  
Keyword(s):  
Heart Failure ◽  
Randomised Controlled Trial ◽  
Left Bundle Branch Block ◽  
Controlled Trial ◽  
Biventricular Pacing ◽  
Left Ventricular Ejection ◽  
Efficacy And Safety ◽  
Bundle Branch Block ◽  
Heart Failure Patients ◽  
Randomised Controlled

IntroductionLeft bundle branch area pacing (LBBaP) has been accepted as a physiological pacing method that can yield narrow paced QRS waves. For patients with failed biventricular pacing (Bi-V), LBBaP is another feasible option. However, no randomised controlled study has evaluated the efficacy and safety of LBBaP in heart failure patients with left bundle branch block (LBBB). Therefore, we aimed to conduct this type of randomised controlled trial.Methods and analysisThis study is a single-centre, randomised controlled non-inferiority trial. This study will be conducted at the cardiac centre of Beijing Anzhen Hospital. From January 2020 to December 2022, 180 heart failure patients with reduced left ventricular ejection fraction (LVEF ≤35%) and LBBB undergoing Bi-V implantation will be consecutively enrolled in this study. Participants will be randomised at a 1:1 ratio into an experimental group (LBBaP) and a control group (Bi-V). The primary outcome is LVEF. The secondary outcomes are NT-proBNP, duration of the QRS complex, end systolic volume, end diastolic volume, the 6-minute walking test and quality of life (SF-36 scale), all causes of mortality, cardiovascular death, rehospitalisation rate of heart failure, other rehospitalisation rates, major complication rates, procedure costs and hospitalised dates.Ethics and disseminationThis study has been approved by the Beijing Anzhen Hospital Medical Ethics Committee (No. ks201932). The results of this study will be presented at domestic and international conferences. We hypothesise that LBBaP is non-inferior compared with Bi-V for treating patients with heart failure and LBBB. This trial will provide evidence-based recommendations for electrophysiologists.Trial registration numberChinese Clinical Trial Registry (ChiCTR2000028726).

scholarly journals Possible genetic implications in the response to cardiac resynchronisation therapy in a patient affected by heart failure

2011 ◽  
Vol 5 (2) ◽  
pp. 61-68
Author(s):  
Natalia Pezzali ◽  
Marco Metra ◽  
Livio Dei Cas
Keyword(s):  
Heart Failure ◽  
Left Ventricular Systolic Dysfunction ◽  
Cardiac Resynchronisation Therapy ◽  
Left Ventricular ◽  
Idiopathic Dilated Cardiomyopathy ◽  
Left Ventricular Ejection ◽  
Ventricular Ejection Fraction ◽  
Cardiac Resynchronisation ◽  
Resynchronisation Therapy

This report presents a case of a patient with idiopathic dilated cardiomyopathy and severe left ventricular systolic dysfunction who underwent cardiac resynchronisation therapy (CRT). During the follow-up a progressive increase in left ventricular ejection fraction was observed, as well as clinical improvement. No cardiovascular events occurred during the follow-up, except for appropriate Implantable Cardioverter Defibrillator (ICD) bursts for fast ventricular tachycardia. Genotyping for adrenoceptor gene polymorphisms detected that the patient was Glu27Glu homozygous carrier. There’s a large interindividual variability in response to CRT. Despite attempts to identify factors having an impact on this therapy, only QRS duration is accepted according to guidelines. Beta-adrenoceptors polymorphisms, modulating sympathetic drive in heart failure and left ventricular remodelling, may have a role in identifying patients with a better response to CRT, in order to target and individualise the patients’ treatment.

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