Evidence Base

The benefits of Cardiac Resynchronisation Therapy (CRT) in improving the management of heart failure associated with left ventricular dysfunction caused by electrical dyssynchrony are well known. There are now more than 10 studies comparing CRT with optimal pharmacological therapy: five systematic reviews and five randomised controlled trials (RCTs).

The outcomes reported in these studies were the relative effectiveness of CRT-P and/or CRT-D devices compared with optimal pharmacological therapy alone and included all-cause mortality, heart failure deaths, cardiac death and sudden cardiac death, morbidity including rate of hospitalisation and symptoms of worsening heart failure, change in New York Heart Association (NYHA) class, exercise capacity, adverse events and health-related quality of life.

This evidence, supporting the use of cardiac resynchronisation therapy, is reviewed within the NICE Technology Appraisal Guidance for Cardiac Resynchronisation Therapy, TA120. In addition, the role of CRT is also described within the NICE treatment pathway for heart failure within the clinical guidelines Chronic Heart Failure CG108.

This section of the guide provides the supporting evidence/clinical trials that underpin this technology implementation project. In addition, it provides additional evidence on the impact of this therapy on patients services and staff during an implementation project the aim of which was to understand and address the root causes of under-provision of this therapy in the NHS.

The summary impact data is provided from the NTAC implementation sites that participated in this project and are now routinely using this technology as a standard clinical option, together with national standards and guidance and other useful reference papers that may support organisations who would like to develop and enhance their cardiac device services.

Overview of Supporting Evidence/Clinical Trials

CARE-HF

The Effect of Cardiac Resynchronization on Morbidity and Mortality in Heart Failure

 

John G.F. Cleland, M.D., Jean-Claude Daubert, M.D.,

Erland Erdmann, M.D., Nick Freemantle, Ph.D., Daniel Gras, M.D.,

Lukas Kappenberger, M.D., and Luigi Tavazzi, M.D.,

for the Cardiac Resynchronization - Heart Failure (CARE-HF) Study Investigators

COMPANION

Cardiac-Resynchronization Therapy with or without an Implantable Defibrillator in Advanced Chronic Heart Failure

 

Michael R. Bristow, M.D., Leslie A. Saxon, M.D., John Boehmer, M.D., Steven Krueger, M.D., David A. Kass, M.D., Teresa De Marco, M.D., Peter Carson, M.D., Lorenzo DiCarlo, M.D., David DeMets, Ph.D., Bill G. White, Ph.D., Dale W. DeVries, B.A., and Arthur M. Feldman, M.D., Ph.D. for the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators

N Engl J Med 2004; 350:2140-2150May 20, 2004

MIRACLE

Cardiac-Resynchronization Therapy for Heart Failure

Joshua M. Hare, M.D.

N Engl J Med 2002; 346:1902-1905 June 13, 2002

CONTAK-CD

Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias.

 

 

Steven L. Higgins, MD, FACC*,*, John D. Hummel, MD, FACC , Imran K. Niazi, MD, FACC , Michael C. Giudici, MD, FACC , Seth J. Worley, MD, FACC||, Leslie A. Saxon, MD, FACC, John P. Boehmer, MD, FACC#, Michael B. Higginbotham, MD**, Teresa De Marco, MD, FACC, Elyse Foster, MD, FACC and Patrick G. Yong, MSEE.

J Am Coll Cardiol, 2003; 42:1454-1459, doi:10.1016/S0735-1097(03)01042-8
© 2003 by the American College of Cardiology Foundation

ESC GUIDELINES

2010 Focused Update of ESC Guidelines on device therapy in heart failure

An update of the 2008 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure and the 2007 ESC guidelines for cardiac and resynchronization therapy

 

Developed with the special contribution of the Heart Failure

Association and the European Heart Rhythm Association

Authors/Task Force Members, Kenneth Dickstein (Chairperson) (Norway)*,

Panos E. Vardas (Chairperson) (Greece)*, Angelo Auricchio (Switzerland),

Jean-Claude Daubert (France), Cecilia Linde (Sweden), John McMurray (UK),

Piotr Ponikowski (Poland), Silvia Giuliana Priori (Italy), Richard Sutton (UK),

Dirk J. van Veldhuisen (Netherlands)

European Heart Journal (2010) 31, 2677-2687

doi:10.1093/eurheartj/ehq337

Project Summary Data

The implementation section gives detail of all pathway and service improvements implemented during the project with outcomes, challenges and methods of measuring sustainability.

To see an overview of project outcomes, click here to download Powerpoint presentation

National Standards

Heart Rhythm UK; Standards for Implantation and Follow-up of Cardiac Rhythm Management Devices HRUK, September 2010

Click here to download HRUK standards for Implantation and Follow up

National Guidance

NICE Guidance for the management of Chronic Heart Failure;

This NICE guidance was initially developed in 2003 and was updated in 2010.

New diagnosis and treatment recommendations were highlighted and identified as priorities for implementation; however the guidance is extensive and addresses all aspects of the management of chronic heart failure, including invasive procedures with reference to CRT and ICD implantation and their associated technology appraisals. (CRT; NICE technology appraisal guidance 120 (2007) and ICD; NICE technology appraisal guidance 95 (2006)).

 NICE Technology Appraisal Guidance for Cardiac Resynchronisation Therapy

NICE Technology appraisal www.nice.org.uk/TA120guidance assesses the evidence to ensure cost effectiveness of treatments and ensure clinical benefit for patient groups.

Issued in May 2007, this technology appraisal Cardiac Resynchronisation Therapy as a treatment option for people with Heart Failure who fulfil all of the following criteria.

  • They are currently experiencing or have recently experienced New York Heart Association (NYHA) class III-IV symptoms
  • They are in sinus rhythm:
    • either with a QRS duration of 150 ms or longer estimated by standard electrocardiogram (ECG)
    • or with a QRS duration of 120-149 ms estimated by ECG and mechanical dyssynchrony that is confirmed by echocardiography
  • They have a left ventricular ejection fraction of 35% or less
  • They are receiving optimal pharmacological therapy

Cardiac resynchronisation therapy with a defibrillator device (CRT-D) may be considered for people who fulfil the criteria for implantation of a CRT-P device in section 1.1 and who also separately fulfil the criteria for the use of an ICD device as recommended in NICE technology appraisal guidance 95.

This technology appraisal includes the clinical need and practice and also assesses the clinical and cost effectiveness of this therapy.

Whilst implementation of this guidance is a recommendation from NICE and a requirement set out by the Care Quality Commission (CQC) and, although rates of CRT device implementation have been increasing in the United Kingdom, they have continued to remain much lower than comparable health economies in Western Europe. Further, there is evidence of significant variation in the diagnosis and treatment of heart failure and inequity in access to device therapies for suitable patients with heart failure

NICE Technology Appraisal for Implantable Cardioverter Defibrillators

This review guidance was issued in 2006 and recommends implantable cardioverter defibrillators (ICDs) in the following categories:

'Secondary prevention', that is, for patients who present, in the absence of a treatable cause, with one of the following:

Having survived a cardiac arrest due to either ventricular tachycardia (VT) or ventricular fibrillation (VF)

Spontaneous sustained VT causing syncope or significant haemodynamic compromise

Sustained VT without syncope or cardiac arrest, and who have an associated reduction in ejection fraction (LVEF of less than 35%) (no worse than class III of the NYHA functional classification of heart failure).

'Primary prevention' for patients who have:

  • a history of previous (more than four weeks) myocardial infarction (MI) and:
    • either
      • left ventricular dysfunction with an LVEF of less than 35% (no worse than class III of the NYHA functional classification of heart failure), and
      • non-sustained VT on Holter (24-hour electrocardiogram [ECG]) monitoring, and
      • inducible VT on electrophysiological (EP) testing

    • or
      • left ventricular NYHA functional classification of heart failure) and
      • QRS duration of equal to or more than 120 milliseconds
  • a familial cardiac condition with a high risk of sudden death, including long QT syndrome, hypertrophic cardiomyopathy, Brugada Syndrome or arrhythmogenic right ventricular dysplasia (ARVD), or have undergone surgical repair of congenital heart disease.

Click here for NICE Implementation advice for the use of Cardiac Resynchronisation Therapy and Implantable Cardioverter Defibrillators.

Useful Reference Papers

Implementation of device therapy (cardiac resynchronization therapy and implantable cardioverter defibrillator) for patients with heart failure in Europe: changes from 2004 to 2008. European Journal of Heart Failure (2009) 11, 1143-1151

Health Technol Assess. 2007 Nov;11(47):iii-iv, ix-248.

The clinical effectiveness and cost-effectiveness of cardiac resynchronisation (biventricular pacing) for heart failure: systematic review and economic model. Fox M, Mealing S, Anderson R, Dean J, Stein K, Price A, Taylor RS. Peninsula Technology Assessment Group (PenTAG), Peninsula Medical School, Universities of Exeter and Plymouth, UK.

Economic impact of remote patient monitoring: an integrated economic model derived from a meta-analysis of randomized controlled trials in heart failure. Klersey et al. European Journal of Heart Failure. Dec 2010.

A Meta-Analysis of Remote Monitoring of Heart Failure Patients. Klersey et al. Journal of the American College of Cardiology; Vol. 54, No. 18, 2009..18, 2009

The purpose of this study was to assess the effect of remote patient monitoring (RPM) on the outcome of chronic heart failure (HF) patients.

ESC GUIDELINES; 2010 Focused Update of ESC Guidelines on device therapy in heart failure

An update of the 2008 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure and the 2007 ESC guidelines for cardiac and resynchronization therapy

Developed with the special contribution of the Heart Failure Association and the European Heart Rhythm Association

Click here to download ESC 2010 guidelines

 

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