Rate or Rhythm Control in CRT (RHYTHMIC): Study rationale and protocol

Mark K. Elliott; Felicity de Vere; Vishal S. Mehta; Nadeev Wijesuriya; Marina Strocchi; Ronak Rajani; Steven Niederer; Christopher A. Rinaldi

doi:10.1016/j.hroo.2022.09.001

Rate or Rhythm Control in CRT (RHYTHMIC): Study rationale and protocol

Mark K. Elliott^*, Felicity de Vere, Vishal S. Mehta, Nadeev Wijesuriya, Marina Strocchi, Ronak Rajani, Steven Niederer, Christopher A. Rinaldi

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

2 Citations (Scopus)

Abstract

Background: Atrial fibrillation (AF) has several detrimental effects on heart failure patients treated with cardiac resynchronization therapy (CRT). These include suboptimal biventricular pacing and the loss of atrioventricular (AV) synchrony. AV node ablation improves biventricular pacing and clinical outcomes in large observational studies. However, restoration of sinus rhythm with AF ablation may have additional benefits. Objectives: To compare the effects of AV node ablation and AF ablation on echocardiographic and symptomatic outcomes in patients with CRT and suboptimal biventricular pacing. Methods: RHYTHMIC is a multicenter prospective randomized controlled trial. Seventy patients will be recruited and randomized to each ablation strategy in a 1:1 ratio. Key inclusion criteria include a previous CRT implant (with atrial lead) for dyssynchronous heart failure, and biventricular pacing <95% secondary to AF. Patients with permanent AF will be excluded. Results: Patients will undergo baseline assessment including transthoracic echocardiography (TTE), device check, blood tests, electrocardiogram (ECG), 6-minute walk test, and symptom questionnaire. They will then undergo either AV node ablation or AF ablation according to their allocated group. Follow-up will occur at 1 week (TTE and ECG) and at 6 months (repeat of baseline investigations). The primary endpoint will be change in left ventricular ejection fraction on TTE. Conclusion: This is the first randomized controlled trial comparing AV node ablation and AF ablation in patients with CRT. We anticipate it will provide valuable insight into the management of this frequently encountered clinical scenario in a challenging patient cohort.

Original language	English
Pages (from-to)	681-687
Number of pages	7
Journal	Heart Rhythm O2
Volume	3
Issue number	6
DOIs	https://doi.org/10.1016/j.hroo.2022.09.001
Publication status	Published - Dec 2022

Keywords

Atrial fibrillation
Atrial fibrillation ablation
Atrioventricular node ablation
Atrioventricular synchrony
Biventricular pacing percentage
Cardiac resynchronization therapy

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10.1016/j.hroo.2022.09.001

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title = "Rate or Rhythm Control in CRT (RHYTHMIC): Study rationale and protocol",

abstract = "Background: Atrial fibrillation (AF) has several detrimental effects on heart failure patients treated with cardiac resynchronization therapy (CRT). These include suboptimal biventricular pacing and the loss of atrioventricular (AV) synchrony. AV node ablation improves biventricular pacing and clinical outcomes in large observational studies. However, restoration of sinus rhythm with AF ablation may have additional benefits. Objectives: To compare the effects of AV node ablation and AF ablation on echocardiographic and symptomatic outcomes in patients with CRT and suboptimal biventricular pacing. Methods: RHYTHMIC is a multicenter prospective randomized controlled trial. Seventy patients will be recruited and randomized to each ablation strategy in a 1:1 ratio. Key inclusion criteria include a previous CRT implant (with atrial lead) for dyssynchronous heart failure, and biventricular pacing <95% secondary to AF. Patients with permanent AF will be excluded. Results: Patients will undergo baseline assessment including transthoracic echocardiography (TTE), device check, blood tests, electrocardiogram (ECG), 6-minute walk test, and symptom questionnaire. They will then undergo either AV node ablation or AF ablation according to their allocated group. Follow-up will occur at 1 week (TTE and ECG) and at 6 months (repeat of baseline investigations). The primary endpoint will be change in left ventricular ejection fraction on TTE. Conclusion: This is the first randomized controlled trial comparing AV node ablation and AF ablation in patients with CRT. We anticipate it will provide valuable insight into the management of this frequently encountered clinical scenario in a challenging patient cohort.",

keywords = "Atrial fibrillation, Atrial fibrillation ablation, Atrioventricular node ablation, Atrioventricular synchrony, Biventricular pacing percentage, Cardiac resynchronization therapy",

author = "Elliott, {Mark K.} and {de Vere}, Felicity and Mehta, {Vishal S.} and Nadeev Wijesuriya and Marina Strocchi and Ronak Rajani and Steven Niederer and Rinaldi, {Christopher A.}",

note = "Publisher Copyright: {\textcopyright} 2022 Heart Rhythm Society",

year = "2022",

month = dec,

doi = "10.1016/j.hroo.2022.09.001",

language = "English",

volume = "3",

pages = "681--687",

journal = "Heart Rhythm O2",

issn = "2666-5018",

publisher = "Elsevier Inc.",

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TY - JOUR

T1 - Rate or Rhythm Control in CRT (RHYTHMIC)

T2 - Study rationale and protocol

AU - Elliott, Mark K.

AU - de Vere, Felicity

AU - Mehta, Vishal S.

AU - Wijesuriya, Nadeev

AU - Strocchi, Marina

AU - Rajani, Ronak

AU - Niederer, Steven

AU - Rinaldi, Christopher A.

PY - 2022/12

Y1 - 2022/12

N2 - Background: Atrial fibrillation (AF) has several detrimental effects on heart failure patients treated with cardiac resynchronization therapy (CRT). These include suboptimal biventricular pacing and the loss of atrioventricular (AV) synchrony. AV node ablation improves biventricular pacing and clinical outcomes in large observational studies. However, restoration of sinus rhythm with AF ablation may have additional benefits. Objectives: To compare the effects of AV node ablation and AF ablation on echocardiographic and symptomatic outcomes in patients with CRT and suboptimal biventricular pacing. Methods: RHYTHMIC is a multicenter prospective randomized controlled trial. Seventy patients will be recruited and randomized to each ablation strategy in a 1:1 ratio. Key inclusion criteria include a previous CRT implant (with atrial lead) for dyssynchronous heart failure, and biventricular pacing <95% secondary to AF. Patients with permanent AF will be excluded. Results: Patients will undergo baseline assessment including transthoracic echocardiography (TTE), device check, blood tests, electrocardiogram (ECG), 6-minute walk test, and symptom questionnaire. They will then undergo either AV node ablation or AF ablation according to their allocated group. Follow-up will occur at 1 week (TTE and ECG) and at 6 months (repeat of baseline investigations). The primary endpoint will be change in left ventricular ejection fraction on TTE. Conclusion: This is the first randomized controlled trial comparing AV node ablation and AF ablation in patients with CRT. We anticipate it will provide valuable insight into the management of this frequently encountered clinical scenario in a challenging patient cohort.

AB - Background: Atrial fibrillation (AF) has several detrimental effects on heart failure patients treated with cardiac resynchronization therapy (CRT). These include suboptimal biventricular pacing and the loss of atrioventricular (AV) synchrony. AV node ablation improves biventricular pacing and clinical outcomes in large observational studies. However, restoration of sinus rhythm with AF ablation may have additional benefits. Objectives: To compare the effects of AV node ablation and AF ablation on echocardiographic and symptomatic outcomes in patients with CRT and suboptimal biventricular pacing. Methods: RHYTHMIC is a multicenter prospective randomized controlled trial. Seventy patients will be recruited and randomized to each ablation strategy in a 1:1 ratio. Key inclusion criteria include a previous CRT implant (with atrial lead) for dyssynchronous heart failure, and biventricular pacing <95% secondary to AF. Patients with permanent AF will be excluded. Results: Patients will undergo baseline assessment including transthoracic echocardiography (TTE), device check, blood tests, electrocardiogram (ECG), 6-minute walk test, and symptom questionnaire. They will then undergo either AV node ablation or AF ablation according to their allocated group. Follow-up will occur at 1 week (TTE and ECG) and at 6 months (repeat of baseline investigations). The primary endpoint will be change in left ventricular ejection fraction on TTE. Conclusion: This is the first randomized controlled trial comparing AV node ablation and AF ablation in patients with CRT. We anticipate it will provide valuable insight into the management of this frequently encountered clinical scenario in a challenging patient cohort.

KW - Atrial fibrillation

KW - Atrial fibrillation ablation

KW - Atrioventricular node ablation

KW - Atrioventricular synchrony

KW - Biventricular pacing percentage

KW - Cardiac resynchronization therapy

UR - http://www.scopus.com/inward/record.url?scp=85144787440&partnerID=8YFLogxK

U2 - 10.1016/j.hroo.2022.09.001

DO - 10.1016/j.hroo.2022.09.001

M3 - Article

AN - SCOPUS:85144787440

SN - 2666-5018

VL - 3

SP - 681

EP - 687

JO - Heart Rhythm O2

JF - Heart Rhythm O2

IS - 6

ER -

Rate or Rhythm Control in CRT (RHYTHMIC): Study rationale and protocol

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