Renal denervation prevents subclinical atrial fibrillation in patients with hypertensive heart disease: Randomized, sham-controlled trial.


Journal

Heart rhythm
ISSN: 1556-3871
Titre abrégé: Heart Rhythm
Pays: United States
ID NLM: 101200317

Informations de publication

Date de publication:
11 2022
Historique:
received: 25 01 2022
revised: 09 06 2022
accepted: 26 06 2022
medline: 23 10 2023
pubmed: 6 7 2022
entrez: 5 7 2022
Statut: ppublish

Résumé

Catheter-based renal denervation (RD), in addition to pulmonary vein isolation (PVI), reduces atrial fibrillation (AF) recurrence in hypertensive patients. Whether RD, without additional PVI, can prevent subclinical atrial fibrillation (SAF) in patients with hypertensive heart disease (HHD) is unknown. The purpose of this study was to assess the efficacy of RD in preventing SAF in patients with HHD. A single-center, randomized, sham-controlled pilot trial, including patients >55 years in sinus rhythm, but with a high risk of developing SAF was conducted. Patients had uncontrolled hypertension despite taking 3 antihypertensive drugs, including a diuretic. The primary endpoint was the first SAF episode lasting ≥6 minutes recorded via an implantable cardiac monitor scanned every 6 months for 24 months. A blinded independent monitoring committee assessed electrocardiographic rhythm recordings. Change in SAF burden (SAFB), and office and 24-hour ambulatory blood pressure (BP) at 6-month follow-up were secondary endpoints. Eighty patients were randomly assigned to RD (n = 42) or sham groups (n = 38). After 24 months of follow-up, SAF occurred in 8 RD patients (19%) and 15 sham patients (39.5%) (hazard ratio 0.40; 95% confidence interval 0.17-0.96; P = .031). Median [interquartile range] SAFB was low in both groups but was significantly lower in the RD vs sham group (0% [0-0] vs 0% [0-0.3]; P = .043). Fast AF (>100 bpm) occurred less frequently in the RD than sham group (2% vs 26%; P = .002). After adjusting for baseline values, there were no significant differences in office or 24-hour BP changes between treatment groups. RD reduced incident SAF events, SAFB, and fast AF in patients with HHD. The observed effects may occur independent of BP lowering.

Sections du résumé

BACKGROUND
Catheter-based renal denervation (RD), in addition to pulmonary vein isolation (PVI), reduces atrial fibrillation (AF) recurrence in hypertensive patients. Whether RD, without additional PVI, can prevent subclinical atrial fibrillation (SAF) in patients with hypertensive heart disease (HHD) is unknown.
OBJECTIVE
The purpose of this study was to assess the efficacy of RD in preventing SAF in patients with HHD.
METHODS
A single-center, randomized, sham-controlled pilot trial, including patients >55 years in sinus rhythm, but with a high risk of developing SAF was conducted. Patients had uncontrolled hypertension despite taking 3 antihypertensive drugs, including a diuretic. The primary endpoint was the first SAF episode lasting ≥6 minutes recorded via an implantable cardiac monitor scanned every 6 months for 24 months. A blinded independent monitoring committee assessed electrocardiographic rhythm recordings. Change in SAF burden (SAFB), and office and 24-hour ambulatory blood pressure (BP) at 6-month follow-up were secondary endpoints.
RESULTS
Eighty patients were randomly assigned to RD (n = 42) or sham groups (n = 38). After 24 months of follow-up, SAF occurred in 8 RD patients (19%) and 15 sham patients (39.5%) (hazard ratio 0.40; 95% confidence interval 0.17-0.96; P = .031). Median [interquartile range] SAFB was low in both groups but was significantly lower in the RD vs sham group (0% [0-0] vs 0% [0-0.3]; P = .043). Fast AF (>100 bpm) occurred less frequently in the RD than sham group (2% vs 26%; P = .002). After adjusting for baseline values, there were no significant differences in office or 24-hour BP changes between treatment groups.
CONCLUSION
RD reduced incident SAF events, SAFB, and fast AF in patients with HHD. The observed effects may occur independent of BP lowering.

Identifiants

pubmed: 35781044
pii: S1547-5271(22)02160-9
doi: 10.1016/j.hrthm.2022.06.031
pii:
doi:

Types de publication

Randomized Controlled Trial Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1765-1773

Informations de copyright

Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Auteurs

Marshall Heradien (M)

Department of Medicine, Stellenbosch University, Tygerberg, South Africa; SA Endovascular, Netcare Kuils River Hospital, Cape Town, South Africa. Electronic address: hartspesialis@gmail.com.

Felix Mahfoud (F)

Department of Internal Medicine III, Cardiology, Angiology, Intensive Care Medicine, Saarland University Hospital, Homburg/Saar, Germany.

Christeman Greyling (C)

Department of Medicine, Stellenbosch University, Tygerberg, South Africa.

Lucas Lauder (L)

Department of Internal Medicine III, Cardiology, Angiology, Intensive Care Medicine, Saarland University Hospital, Homburg/Saar, Germany.

Pieter van der Bijl (P)

SA Endovascular, Netcare Kuils River Hospital, Cape Town, South Africa.

Douglas A Hettrick (DA)

Renal Denervation Unit. Medtronic, Inc., Santa Rosa, California.

Warren Stilwaney (W)

Department of Medicine, Stellenbosch University, Tygerberg, South Africa.

Siyolise Sibeko (S)

Department of Medicine, Stellenbosch University, Tygerberg, South Africa.

Rene Jansen van Rensburg (R)

Department of Medicine, Stellenbosch University, Tygerberg, South Africa.

Dale Peterson (D)

Department of Medicine, Stellenbosch University, Tygerberg, South Africa.

Bonke Khwinani (B)

SA Endovascular, Netcare Kuils River Hospital, Cape Town, South Africa.

Althea Goosen (A)

Department of Medicine, Stellenbosch University, Tygerberg, South Africa; SA Endovascular, Netcare Kuils River Hospital, Cape Town, South Africa.

Jan A Saaiman (JA)

SA Endovascular, Netcare Kuils River Hospital, Cape Town, South Africa.

Christian Ukena (C)

Department of Internal Medicine III, Cardiology, Angiology, Intensive Care Medicine, Saarland University Hospital, Homburg/Saar, Germany.

Michael Böhm (M)

Department of Internal Medicine III, Cardiology, Angiology, Intensive Care Medicine, Saarland University Hospital, Homburg/Saar, Germany.

Paul A Brink (PA)

Department of Medicine, Stellenbosch University, Tygerberg, South Africa; SA Endovascular, Netcare Kuils River Hospital, Cape Town, South Africa.

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Classifications MeSH