Splenic arterial neurovascular bundle stimulation in esophagectomy: A feasibility and safety prospective cohort study
IntroductionThe autonomic nervous system is a key regulator of inflammation. Electrical stimulation of the vagus nerve has been shown to have some preclinical efficacy. However, only a few clinical studies have been reported to treat inflammatory diseases. The present study evaluates, for the first...
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| Format: | Article |
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Frontiers Media S.A.
2022-12-01
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| Series: | Frontiers in Neuroscience |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fnins.2022.1088628/full |
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| author | David J. Brinkman David J. Brinkman Isha Gupta Paul B. Matteucci Sebastien Ouchouche Wouter J. de Jonge Robert W. Coatney Tariqus Salam Daniel J. Chew Eric Irwin R. Firat Yazicioglu Grard A. P. Nieuwenhuizen Margriet J. Vervoordeldonk Misha D. P. Luyer |
| author_facet | David J. Brinkman David J. Brinkman Isha Gupta Paul B. Matteucci Sebastien Ouchouche Wouter J. de Jonge Robert W. Coatney Tariqus Salam Daniel J. Chew Eric Irwin R. Firat Yazicioglu Grard A. P. Nieuwenhuizen Margriet J. Vervoordeldonk Misha D. P. Luyer |
| author_sort | David J. Brinkman |
| collection | DOAJ |
| description | IntroductionThe autonomic nervous system is a key regulator of inflammation. Electrical stimulation of the vagus nerve has been shown to have some preclinical efficacy. However, only a few clinical studies have been reported to treat inflammatory diseases. The present study evaluates, for the first time, neuromodulation of the splenic arterial neurovascular bundle (SpA NVB) in patients undergoing minimally invasive esophagectomy (MIE), in which the SpA NVB is exposed as part of the procedure.MethodsThis single-center, single-arm study enrolled 13 patients undergoing MIE. During the abdominal phase of the MIE, a novel cuff was placed around the SpA NVB, and stimulation was applied. The primary endpoint was the feasibility and safety of cuff application and removal. A secondary endpoint included the impact of stimulation on SpA blood flow changes during the stimulation, and an exploratory point was C-reactive protein (CRP) levels on postoperative day (POD) 2 and 3.ResultsAll patients successfully underwent placement, stimulation, and removal of the cuff on the SpA NVB with no adverse events related to the investigational procedure. Stimulation was associated with an overall reduction in splenic arterial blood flow but not with changes in blood pressure or heart rate. When compared to historic Propensity Score Matched (PSM) controls, CRP levels on POD2 (124 vs. 197 mg/ml, p = 0.032) and POD3 (151 vs. 221 mg/ml, p = 0.033) were lower in patients receiving stimulation.ConclusionThis first-in-human study demonstrated for the first time that applying a cuff around the SpA NVB and subsequent stimulation is safe, feasible, and may have an effect on the postoperative inflammatory response following MIE. These findings suggest that SpA NVB stimulation may offer a new method for immunomodulatory therapy in acute or chronic inflammatory conditions. |
| first_indexed | 2024-04-11T05:35:40Z |
| format | Article |
| id | doaj.art-46ffb830c318473e9a85ffb7ff010f4c |
| institution | Directory Open Access Journal |
| issn | 1662-453X |
| language | English |
| last_indexed | 2024-04-11T05:35:40Z |
| publishDate | 2022-12-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Neuroscience |
| spelling | doaj.art-46ffb830c318473e9a85ffb7ff010f4c2022-12-22T12:56:24ZengFrontiers Media S.A.Frontiers in Neuroscience1662-453X2022-12-011610.3389/fnins.2022.10886281088628Splenic arterial neurovascular bundle stimulation in esophagectomy: A feasibility and safety prospective cohort studyDavid J. Brinkman0David J. Brinkman1Isha Gupta2Paul B. Matteucci3Sebastien Ouchouche4Wouter J. de Jonge5Robert W. Coatney6Tariqus Salam7Daniel J. Chew8Eric Irwin9R. Firat Yazicioglu10Grard A. P. Nieuwenhuizen11Margriet J. Vervoordeldonk12Misha D. P. Luyer13Department of Surgery, Catharina Hospital, Eindhoven, NetherlandsTytgat Institute for Liver and Intestinal Research, Amsterdam UMC, University of Amsterdam, Amsterdam, NetherlandsGalvani Bioelectronics, Stevenage, United KingdomGalvani Bioelectronics, Stevenage, United KingdomGalvani Bioelectronics, Stevenage, United KingdomTytgat Institute for Liver and Intestinal Research, Amsterdam UMC, University of Amsterdam, Amsterdam, NetherlandsGalvani Bioelectronics, Stevenage, United KingdomGalvani Bioelectronics, Stevenage, United KingdomGalvani Bioelectronics, Stevenage, United KingdomGalvani Bioelectronics, Stevenage, United KingdomGalvani Bioelectronics, Stevenage, United KingdomDepartment of Surgery, Catharina Hospital, Eindhoven, NetherlandsGalvani Bioelectronics, Stevenage, United KingdomDepartment of Surgery, Catharina Hospital, Eindhoven, NetherlandsIntroductionThe autonomic nervous system is a key regulator of inflammation. Electrical stimulation of the vagus nerve has been shown to have some preclinical efficacy. However, only a few clinical studies have been reported to treat inflammatory diseases. The present study evaluates, for the first time, neuromodulation of the splenic arterial neurovascular bundle (SpA NVB) in patients undergoing minimally invasive esophagectomy (MIE), in which the SpA NVB is exposed as part of the procedure.MethodsThis single-center, single-arm study enrolled 13 patients undergoing MIE. During the abdominal phase of the MIE, a novel cuff was placed around the SpA NVB, and stimulation was applied. The primary endpoint was the feasibility and safety of cuff application and removal. A secondary endpoint included the impact of stimulation on SpA blood flow changes during the stimulation, and an exploratory point was C-reactive protein (CRP) levels on postoperative day (POD) 2 and 3.ResultsAll patients successfully underwent placement, stimulation, and removal of the cuff on the SpA NVB with no adverse events related to the investigational procedure. Stimulation was associated with an overall reduction in splenic arterial blood flow but not with changes in blood pressure or heart rate. When compared to historic Propensity Score Matched (PSM) controls, CRP levels on POD2 (124 vs. 197 mg/ml, p = 0.032) and POD3 (151 vs. 221 mg/ml, p = 0.033) were lower in patients receiving stimulation.ConclusionThis first-in-human study demonstrated for the first time that applying a cuff around the SpA NVB and subsequent stimulation is safe, feasible, and may have an effect on the postoperative inflammatory response following MIE. These findings suggest that SpA NVB stimulation may offer a new method for immunomodulatory therapy in acute or chronic inflammatory conditions.https://www.frontiersin.org/articles/10.3389/fnins.2022.1088628/fullesophagectomystimulationsplenic arteryfeasibilityDoppler |
| spellingShingle | David J. Brinkman David J. Brinkman Isha Gupta Paul B. Matteucci Sebastien Ouchouche Wouter J. de Jonge Robert W. Coatney Tariqus Salam Daniel J. Chew Eric Irwin R. Firat Yazicioglu Grard A. P. Nieuwenhuizen Margriet J. Vervoordeldonk Misha D. P. Luyer Splenic arterial neurovascular bundle stimulation in esophagectomy: A feasibility and safety prospective cohort study Frontiers in Neuroscience esophagectomy stimulation splenic artery feasibility Doppler |
| title | Splenic arterial neurovascular bundle stimulation in esophagectomy: A feasibility and safety prospective cohort study |
| title_full | Splenic arterial neurovascular bundle stimulation in esophagectomy: A feasibility and safety prospective cohort study |
| title_fullStr | Splenic arterial neurovascular bundle stimulation in esophagectomy: A feasibility and safety prospective cohort study |
| title_full_unstemmed | Splenic arterial neurovascular bundle stimulation in esophagectomy: A feasibility and safety prospective cohort study |
| title_short | Splenic arterial neurovascular bundle stimulation in esophagectomy: A feasibility and safety prospective cohort study |
| title_sort | splenic arterial neurovascular bundle stimulation in esophagectomy a feasibility and safety prospective cohort study |
| topic | esophagectomy stimulation splenic artery feasibility Doppler |
| url | https://www.frontiersin.org/articles/10.3389/fnins.2022.1088628/full |
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