PMID- 33932262
OWN - NLM
STAT- MEDLINE
DCOM- 20210810
LR  - 20220531
IS  - 1879-0844 (Electronic)
IS  - 1388-9842 (Linking)
VI  - 23
IP  - 7
DP  - 2021 Jul
TI  - Surgical ablation of the right greater splanchnic nerve for the treatment of 
      heart failure with preserved ejection fraction: first-in-human clinical trial.
PG  - 1134-1143
LID - 10.1002/ejhf.2209 [doi]
AB  - AIMS: 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). METHODS AND 
      RESULTS: 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]. CONCLUSION: 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.
CI  - (c) 2021 European Society of Cardiology.
FAU - Malek, Filip
AU  - Malek F
AD  - Na Homolce Hospital, Cardiovascular Centre, Prague, Czech Republic.
FAU - Gajewski, Piotr
AU  - Gajewski P
AD  - Centre for Heart Diseases, University Hospital, Wroclaw, Poland.
AD  - Department of Heart Diseases, Medical University, Wroclaw, Poland.
FAU - Zymlinski, Robert
AU  - Zymlinski R
AD  - Centre for Heart Diseases, University Hospital, Wroclaw, Poland.
AD  - Department of Heart Diseases, Medical University, Wroclaw, Poland.
FAU - Janczak, Dariusz
AU  - Janczak D
AD  - Department of Vascular, General and Transplant Surgery, Medical University, 
      Wroclaw, Poland.
FAU - Chabowski, Mariusz
AU  - Chabowski M
AD  - Division of Surgical Specialties, Department of Clinical Nursing, Faculty of 
      Health Science, Medical University, Wroclaw, Poland.
AD  - Department of Surgery, 4th Military Hospital, Wroclaw, Poland.
FAU - Fudim, Marat
AU  - Fudim M
AD  - Duke Clinical Research Institute, Durham, NC, USA.
FAU - Martinca, Tomas
AU  - Martinca T
AD  - Na Homolce Hospital, Cardiovascular Centre, Prague, Czech Republic.
FAU - Neuzil, Petr
AU  - Neuzil P
AD  - Na Homolce Hospital, Cardiovascular Centre, Prague, Czech Republic.
FAU - Biegus, Jan
AU  - Biegus J
AD  - Centre for Heart Diseases, University Hospital, Wroclaw, Poland.
AD  - Department of Heart Diseases, Medical University, Wroclaw, Poland.
FAU - Mates, Martin
AU  - Mates M
AD  - Na Homolce Hospital, Cardiovascular Centre, Prague, Czech Republic.
FAU - Kruger, Andreas
AU  - Kruger A
AD  - Na Homolce Hospital, Cardiovascular Centre, Prague, Czech Republic.
FAU - Skalsky, Ivo
AU  - Skalsky I
AD  - Na Homolce Hospital, Cardiovascular Centre, Prague, Czech Republic.
FAU - Bapna, Anisha
AU  - Bapna A
AD  - Coridea LLC, New York, NY, USA.
FAU - Engelman, Zoar J
AU  - Engelman ZJ
AD  - Coridea LLC, New York, NY, USA.
FAU - Ponikowski, Piotr P
AU  - Ponikowski PP
AD  - Centre for Heart Diseases, University Hospital, Wroclaw, Poland.
AD  - Department of Heart Diseases, Medical University, Wroclaw, Poland.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210716
PL  - England
TA  - Eur J Heart Fail
JT  - European journal of heart failure
JID - 100887595
SB  - IM
CIN - Eur J Heart Fail. 2021 Jul;23(7):1144-1146. PMID: 34118181
MH  - Aged
MH  - Cardiac Catheterization
MH  - Female
MH  - *Heart Failure/surgery
MH  - Humans
MH  - Male
MH  - Prospective Studies
MH  - Quality of Life
MH  - Splanchnic Nerves/surgery
MH  - Stroke Volume
MH  - Ventricular Function, Left
OTO - NOTNLM
OT  - Greater splanchnic nerve ablation
OT  - Heart failure
OT  - Heart failure with preserved ejection fraction
EDAT- 2021/05/02 06:00
MHDA- 2021/08/11 06:00
CRDT- 2021/05/01 12:07
PHST- 2021/04/26 00:00 [revised]
PHST- 2020/10/17 00:00 [received]
PHST- 2021/04/29 00:00 [accepted]
PHST- 2021/05/02 06:00 [pubmed]
PHST- 2021/08/11 06:00 [medline]
PHST- 2021/05/01 12:07 [entrez]
AID - 10.1002/ejhf.2209 [doi]
PST - ppublish
SO  - Eur J Heart Fail. 2021 Jul;23(7):1134-1143. doi: 10.1002/ejhf.2209. Epub 2021 Jul 
      16.