Mechanical dyssynchrony as a selection criterion for cardiac resynchronization therapy: Design of the AMEND‐CRT trial

Author:

Puvrez Alexis12ORCID,Duchenne Jürgen12,Donal Erwan34,Gorcsan John5,Patel Hitesh C.678,Marwick Thomas H.8,Smiseth Otto A.9,Søgaard Peter1011,Stankovic Ivan1213,Diogo Pedro G.12,Vörös Gábor12,Voigt Jens‐Uwe12ORCID

Affiliation:

1. Department of Cardiovascular Diseases University Hospitals Leuven Leuven Belgium

2. Department of Cardiovascular Sciences KU Leuven Leuven Belgium

3. LTSI, Inserm 1099, LTSI University of Rennes Rennes France

4. Department of Cardiology CHU Rennes Rennes France

5. Heart and Vascular Institute Penn State University College of Medicine Hershey Pennsylvania USA

6. Department of Cardiology Alfred Hospital Melbourne Victoria Australia

7. Central Clinical School Monash University Melbourne Victoria Australia

8. Baker Heart and Diabetes Institute Melbourne Australia

9. Institute for Surgical Research Oslo University Hospital and University of Oslo Oslo Norway

10. Department of Cardiology Aalborg University Hospital and University of Aalborg Aalborg Denmark

11. Department of Cardiology Rigshospitalet Copenhagen Denmark

12. Faculty of Medicine University of Belgrade Belgrade Serbia

13. Department of Cardiology Clinical Hospital Centre Zemun Belgrade Serbia

Abstract

AbstractAimsOne third of patients do not improve after cardiac resynchronization therapy (CRT). Septal flash (SF) and apical rocking (ApRock) are deformation patterns observed on echocardiography in most patients eligible for CRT. These markers of mechanical dyssynchrony have been associated to improved outcome after CRT in observational studies and may be useful to better select patients. The aim of this trial is to investigate whether the current guideline criteria for selecting patients for CRT should be modified and include SF and ApRock to improve therapy success rate, reduce excessive costs and prevent exposure to device‐related complications in patients who would not benefit from CRT.MethodsThe AMEND‐CRT trial is a multicentre, randomized, parallel‐group, double‐blind, sham‐controlled trial with a non‐inferiority design. The trial will include 578 patients scheduled for CRT according to the 2021 ESC guidelines who satisfy all inclusion criteria. The randomization is performed 1:1 to an active control arm (‘guideline arm’) or an experimental arm (‘echo arm’). All participants receive a device, but in the echo arm, CRT is activated only when SF or ApRock or both are present. The outcome of both arms will be compared after 1 year. The primary outcome measures are the average change in left ventricular end‐systolic volume and patient outcome assessed using a modified Packer Clinical Composite Score.ConclusionsThe findings of this trial will redefine the role of echocardiography in CRT and potentially determine which patients with heart failure and a prolonged QRS duration should receive CRT, especially in patients who currently have a class IIa or class IIb recommendation.

Publisher

Wiley

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