Surgical ablation of the right greater splanchnic nerve for the treatment of heart failure with preserved ejection fraction: first-in-human clinical trial.


Journal

European journal of heart failure
ISSN: 1879-0844
Titre abrégé: Eur J Heart Fail
Pays: England
ID NLM: 100887595

Informations de publication

Date de publication:
07 2021
Historique:
revised: 26 04 2021
received: 17 10 2020
accepted: 29 04 2021
pubmed: 2 5 2021
medline: 11 8 2021
entrez: 1 5 2021
Statut: ppublish

Résumé

Inappropriate control of blood volume redistribution may be a mechanism responsible for exercise intolerance in heart failure with preserved ejection fraction (HFpEF). We propose to address this underlying pathophysiology with selective blockade of sympathetic signalling to the splanchnic circulation by surgical ablation of the right greater splanchnic nerve (GSN). In a single-arm, prospective, two-centre trial, 10 patients with HFpEF (50% male, mean age 70 ± 3 years) all with New York Heart Association (NYHA) class III, left ventricular ejection fraction >40%, pulmonary capillary wedge pressure (PCWP) ≥15 mmHg at rest or ≥25 mmHg with supine cycle ergometry, underwent ablation of the right GSN via thoracoscopic surgery. Patients were evaluated at baseline, 1, 3, 6 and 12 months after the procedure. The primary endpoint was a reduction in exercise PCWP at 3 months. There were no adverse events related to the blockade of the nerve during 12-month follow-up but three patients had significant peri-procedural adverse events related to the surgical procedure itself. At 3 months post-GSN ablation, patients demonstrated a reduction in 20 W exercise PCWP when compared to baseline [-4.5 mmHg (95% confidence interval, CI -14 to -2); P = 0.0059], which carried over to peak exercise [-5 mmHg (95% CI -11 to 0; P = 0.016). At 12 months, improvements were seen in NYHA class [3 (3) vs. 2 (1, 2); P = 0.0039] and quality of life assessed with the Minnesota Living with Heart Failure Questionnaire [60 (51, 71) vs. 22 (16, 27); P = 0.0039]. In this first-in-human study, GSN ablation in HFpEF proved to be feasible, with a suggestion of reduced cardiac filling pressure during exercise, improved quality of life and exercise capacity.

Identifiants

pubmed: 33932262
doi: 10.1002/ejhf.2209
doi:

Types de publication

Clinical Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1134-1143

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2021 European Society of Cardiology.

Références

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Auteurs

Filip Málek (F)

Na Homolce Hospital, Cardiovascular Centre, Prague, Czech Republic.

Piotr Gajewski (P)

Centre for Heart Diseases, University Hospital, Wroclaw, Poland.
Department of Heart Diseases, Medical University, Wroclaw, Poland.

Robert Zymliński (R)

Centre for Heart Diseases, University Hospital, Wroclaw, Poland.
Department of Heart Diseases, Medical University, Wroclaw, Poland.

Dariusz Janczak (D)

Department of Vascular, General and Transplant Surgery, Medical University, Wroclaw, Poland.

Mariusz Chabowski (M)

Division of Surgical Specialties, Department of Clinical Nursing, Faculty of Health Science, Medical University, Wroclaw, Poland.
Department of Surgery, 4th Military Hospital, Wroclaw, Poland.

Marat Fudim (M)

Duke Clinical Research Institute, Durham, NC, USA.

Tomas Martinca (T)

Na Homolce Hospital, Cardiovascular Centre, Prague, Czech Republic.

Petr Neužil (P)

Na Homolce Hospital, Cardiovascular Centre, Prague, Czech Republic.

Jan Biegus (J)

Centre for Heart Diseases, University Hospital, Wroclaw, Poland.
Department of Heart Diseases, Medical University, Wroclaw, Poland.

Martin Mates (M)

Na Homolce Hospital, Cardiovascular Centre, Prague, Czech Republic.

Andreas Krüger (A)

Na Homolce Hospital, Cardiovascular Centre, Prague, Czech Republic.

Ivo Skalský (I)

Na Homolce Hospital, Cardiovascular Centre, Prague, Czech Republic.

Anisha Bapna (A)

Coridea LLC, New York, NY, USA.

Zoar J Engelman (ZJ)

Coridea LLC, New York, NY, USA.

Piotr P Ponikowski (PP)

Centre for Heart Diseases, University Hospital, Wroclaw, Poland.
Department of Heart Diseases, Medical University, Wroclaw, Poland.

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