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.

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 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).

Atrial Fibrillation in Heart Failure Patients

2009 ◽  
Vol 5 (1) ◽  
pp. 41
Author(s):  
Michalis Efremidis ◽  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Rate Control ◽  
Clinical Trial Data ◽  
Cardiac Resynchronisation Therapy ◽  
Controlled Clinical Trial ◽  
Cardiac Resynchronisation ◽  
Resynchronisation Therapy ◽  
Randomised Controlled ◽  
Near Future

There is a sinister synergism between atrial fibrillation (AF) and heart failure (HF). These common cardiovascular conditions often co-exist and result in significant morbidity and mortality. Despite the extensive amount of research and literature about each of these disorders separately, randomised controlled clinical trial data concerning the management of AF in patients with HF are lacking. The recently published Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial elucidated the matter of rhythm versus rate control. In addition, non-pharmacological treatment approaches such as catheter ablation of AF and cardiac resynchronisation therapy are rapidly growing and are likely to alter AF management in HF patients in the near future.

scholarly journals Surgical epicardial left ventricular lead implantation as a troubleshooting step for a left ventricular lead fracture following difficult transvenous implants in cardiac resynchronisation therapy patients: a case report

2021 ◽  
Author(s):  
Toshiharu Koike ◽  
Yoichi Ajiro ◽  
Ken Kobayashi ◽  
Masayuki Sakai ◽  
Kenjiro Oyabu ◽  
...  
Keyword(s):  
Case Report ◽  
Cardiac Resynchronisation Therapy ◽  
Left Ventricular ◽  
Left Ventricular Lead ◽  
Lead Fracture ◽  
Lead Placement ◽  
Ventricular Lead ◽  
Cardiac Resynchronisation ◽  
Resynchronisation Therapy

Troubleshooting of left ventricular (LV) lead fractures in cardiac resynchronisation therapy patients is important, especially for those with limited and problematic transvenous LV lead placement. In this case, surgical epicardial LV lead implantation was employed.

scholarly journals Rate of device-related infections using an antibacterial envelope in patients undergoing cardiac resynchronisation therapy re-operations

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
M Frausing ◽  
JC Nielsen ◽  
JB Johansen ◽  
OD Joergensen ◽  
C Gerdes ◽  
...  
Keyword(s):  
High Risk ◽  
Propensity Score Analysis ◽  
Controlled Trial ◽  
High Risk Patient ◽  
Cardiac Resynchronisation Therapy ◽  
High Risk Patients ◽  
Cardiac Resynchronisation ◽  
Risk Patients ◽  
Resynchronisation Therapy ◽  
Very High

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Karen Elise Jensen Foundation Background Cardiac resynchronisation therapy (CRT) re-operations are associated with a particularly high risk of device-related infection (DRI). An antibacterial envelope has been shown to reduce the occurrence of DRIs in a broad population of moderate-to-high risk patients. Purpose To investigate the efficacy of an antibacterial envelope in a very high-risk patient population undergoing CRT re-operation. Methods In this Danish two-centre, observational cohort study, we included consecutive patients who underwent a CRT pacemaker- or defibrillator re-operation procedure between January 2008 and November 2019. We obtained data from the Danish Pacemaker and ICD Register and through systematic medical chart review. Follow-up was restricted to two years. Results A total of 1943 patients were included in the study; 736 (38%) patients received an antibacterial envelope. Envelope patients had more independent risk factors for infection than non-envelope patients. Sixty-seven (3.4%) patients met the primary end point of DRI requiring device system extraction; 50 in the non-envelope group and 17 in the envelope group (4.1% vs. 2.3%, adjusted hazard ratio [HR] 0.52, 95% confidence interval [CI] 0.30-0.90, p = 0.021). This difference persisted in propensity score analysis (HR 0.51 95% CI 0.29-0.90, p = 0.019). Conclusion Use of an antibacterial envelope was associated with a clinically and statistically significant reduction in DRIs in patients undergoing CRT re-operations. Our results were comparable to those recently reported from a large randomized controlled trial, which suggests a proportional effect of the envelope even in very high risk patients.

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