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

Introduction Achieving 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...

Full description

Bibliographic Details
Published in:BMJ Open
Main Authors: Wouters, Philippe C, van Lieshout, Chris, van Dijk, Vincent F, Delnoy, Peter-Paul HM, Doevendans, Pieter AFM, Cramer, Maarten J, Frederix, Geert WJ, van Slochteren, Frebus J, Meine, Mathias
Other Authors: ZonMw
Format: Article in Journal/Newspaper
Language:English
Published: BMJ 2021
Subjects:
Online Access:http://dx.doi.org/10.1136/bmjopen-2021-054115
https://syndication.highwire.org/content/doi/10.1136/bmjopen-2021-054115
id crjcrbmj:10.1136/bmjopen-2021-054115
record_format openpolar
spelling crjcrbmj:10.1136/bmjopen-2021-054115 2024-04-28T08:37:27+00:00 Advanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled ADVISE trial and early economic evaluation Wouters, Philippe C van Lieshout, Chris van Dijk, Vincent F Delnoy, Peter-Paul HM Doevendans, Pieter AFM Cramer, Maarten J Frederix, Geert WJ van Slochteren, Frebus J Meine, Mathias ZonMw 2021 http://dx.doi.org/10.1136/bmjopen-2021-054115 https://syndication.highwire.org/content/doi/10.1136/bmjopen-2021-054115 en eng BMJ http://creativecommons.org/licenses/by-nc/4.0/ BMJ Open volume 11, issue 10, page e054115 ISSN 2044-6055 2044-6055 General Medicine journal-article 2021 crjcrbmj https://doi.org/10.1136/bmjopen-2021-054115 2024-04-02T07:56:05Z Introduction Achieving 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 analysis A 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 dissemination The 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 ... Article in Journal/Newspaper SCAR The BMJ BMJ Open 11 10 e054115
institution Open Polar
collection The BMJ
op_collection_id crjcrbmj
language English
topic General Medicine
spellingShingle General Medicine
Wouters, Philippe C
van Lieshout, Chris
van Dijk, Vincent F
Delnoy, Peter-Paul HM
Doevendans, Pieter AFM
Cramer, Maarten J
Frederix, Geert WJ
van Slochteren, Frebus J
Meine, Mathias
Advanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled ADVISE trial and early economic evaluation
topic_facet General Medicine
description Introduction Achieving 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 analysis A 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 dissemination The 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 ...
author2 ZonMw
format Article in Journal/Newspaper
author Wouters, Philippe C
van Lieshout, Chris
van Dijk, Vincent F
Delnoy, Peter-Paul HM
Doevendans, Pieter AFM
Cramer, Maarten J
Frederix, Geert WJ
van Slochteren, Frebus J
Meine, Mathias
author_facet Wouters, Philippe C
van Lieshout, Chris
van Dijk, Vincent F
Delnoy, Peter-Paul HM
Doevendans, Pieter AFM
Cramer, Maarten J
Frederix, Geert WJ
van Slochteren, Frebus J
Meine, Mathias
author_sort Wouters, Philippe C
title Advanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled ADVISE trial and early economic evaluation
title_short Advanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled ADVISE trial and early economic evaluation
title_full Advanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled ADVISE trial and early economic evaluation
title_fullStr Advanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled ADVISE trial and early economic evaluation
title_full_unstemmed Advanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled ADVISE trial and early economic evaluation
title_sort advanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled advise trial and early economic evaluation
publisher BMJ
publishDate 2021
url http://dx.doi.org/10.1136/bmjopen-2021-054115
https://syndication.highwire.org/content/doi/10.1136/bmjopen-2021-054115
genre SCAR
genre_facet SCAR
op_source BMJ Open
volume 11, issue 10, page e054115
ISSN 2044-6055 2044-6055
op_rights http://creativecommons.org/licenses/by-nc/4.0/
op_doi https://doi.org/10.1136/bmjopen-2021-054115
container_title BMJ Open
container_volume 11
container_issue 10
container_start_page e054115
_version_ 1797568861584752640