Filip Málek1, Piotr Gajewski2,3, Robert Zymliński2,3, Dariusz Janczak4, Mariusz Chabowski5,6, Marat Fudim7, Tomas Martinca1, Petr Neužil1, Jan Biegus2,3, Martin Mates1, Andreas Krüger1, Ivo Skalský1, Anisha Bapna8, Zoar J Engelman8, Piotr P Ponikowski2,3. 1. Na Homolce Hospital, Cardiovascular Centre, Prague, Czech Republic. 2. Centre for Heart Diseases, University Hospital, Wroclaw, Poland. 3. Department of Heart Diseases, Medical University, Wroclaw, Poland. 4. Department of Vascular, General and Transplant Surgery, Medical University, Wroclaw, Poland. 5. Division of Surgical Specialties, Department of Clinical Nursing, Faculty of Health Science, Medical University, Wroclaw, Poland. 6. Department of Surgery, 4th Military Hospital, Wroclaw, Poland. 7. Duke Clinical Research Institute, Durham, NC, USA. 8. Coridea LLC, New York, NY, USA.
Abstract
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.
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.
Authors: Marat Fudim; David M Kaye; Barry A Borlaug; Sanjiv J Shah; Stuart Rich; Navin K Kapur; Maria Rosa Costanzo; Michael I Brener; Kenji Sunagawa; Daniel Burkhoff Journal: J Am Coll Cardiol Date: 2022-05-10 Impact factor: 27.203
Authors: Piotr Gajewski; Marat Fudim; Veraprapas Kittipibul; Zoar J Engelman; Jan Biegus; Robert Zymliński; Piotr Ponikowski Journal: J Clin Med Date: 2022-02-18 Impact factor: 4.241
Authors: Marat Fudim; Peter S Fail; Sheldon E Litwin; Tamaz Shaburishvili; Parag Goyal; Scott L Hummel; Barry A Borlaug; Rajeev C Mohan; Ravi B Patel; Sumeet S Mitter; Liviu Klein; Krishna Rocha-Singh; Manesh R Patel; Vivek Y Reddy; Daniel Burkhoff; Sanjiv J Shah Journal: Eur J Heart Fail Date: 2022-05-29 Impact factor: 17.349