First-in-Human Side-to-Side Magnetic Compression Duodeno-ileostomy with the Magnet Anastomosis System
Purposes Classical gastrointestinal anastomoses are formed with sutures and/or metal staples, resulting in significant bleeding and leak rates. This study evaluated the feasibility and safety of the novel magnet anastomosis system (MS) to create a side-to-side duodeno-ileal (DI) diversion for weight...
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| Veröffentlicht in: | Obesity surgery 2023-08, Vol.33 (8), p.2282-2292 |
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| creator | Gagner, Michel Abuladze, David Koiava, Levan Buchwald, J. N. Van Sante, Nathalie Krinke, Todd |
| description | Purposes
Classical gastrointestinal anastomoses are formed with sutures and/or metal staples, resulting in significant bleeding and leak rates. This study evaluated the feasibility and safety of the novel magnet anastomosis system (MS) to create a side-to-side duodeno-ileal (DI) diversion for weight loss and type 2 diabetes (T2D) resolution.
Materials and Methods
Patients with severe obesity (body mass index (BMI) ≥ 35 kg/m
2
with/without T2D (HbA1
C
≥ 6.5%)) underwent the study procedure, a side-to-side MS DI diversion, with a standard sleeve gastrectomy (SG). A linear magnet was delivered by flexible endoscopy to a point 250 cm proximal to the ileocecal valve; a second magnet was positioned in the first part of the duodenum; the bowel segments containing magnets were apposed, initiating gradual anastomosis formation. Laparoscopic assistance was used to obtain bowel measurements, obviate tissue interposition, and close mesenteric defects.
Results
Between November 22 and 26, 2021, 5 female patients (mean weight 117.6 ± 7.1 kg, BMI (kg/m
2
) 44.4 ± 2.2) underwent side-to-side MS DI + SG. All magnets were successfully placed, expelled without re-intervention, and formed patent durable anastomoses. Total weight loss at 12 months was 34.0 ± 1.4% (SEM); excess weight loss, 80.2 ± 6.6%; and BMI reduction, 15.1. Mean HbA1
C
(%) dropped from 6.8 ± 0.8 to 4.8 ± 0.2; and glucose (mg/dL), from 134.3 ± 17.9 to 87.3 ± 6.3 (mean reduction, 47.0 mg/dL). There was no anastomotic bleeding, leakage, obstruction, or infection and no mortality.
Conclusions
Creation of a side-to-side magnetic compression anastomosis to achieve duodeno-ileostomy diversion in adults with severe obesity was feasible and safe, achieved excellent weight loss, and resolved type 2 diabetes at 1-year follow-up.
Trial Registration
Clinicaltrials.gov Identifier: NCT05322122.
Graphical Abstract |
| doi_str_mv | 10.1007/s11695-023-06708-x |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10345004</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2832840863</sourcerecordid><originalsourceid>FETCH-LOGICAL-c475t-764c254d181b867f80de62b65fc3187df02cdb6e841d7e170afe4e253c7cde5d3</originalsourceid><addsrcrecordid>eNp9kUtvEzEUhS0EoqHwB1igkdiwMfhtZ4WqQClSUReFtTWx7ySuZuxge6D598yQvmDR1bV0vnt8jw5Cryl5TwnRHwqlaikxYRwTpYnB10_Qgs4PIph5ihZkqQg2S8aP0ItSrghhVDH2HB1xzZdcKrNAcBpyqThEfDYObWwugwdcE55n863dRKjBNas07DKUElJsPo3JQ0w49JBKTcO--R3qtqnbW745ie0spBJKc7kvFYaX6FnX9gVe3cxj9OP08_fVGT6_-PJ1dXKOndCyYq2EY1J4aujaKN0Z4kGxtZKd49Ro3xHm_FqBEdRrmJK2HQhgkjvtPEjPj9HHg-9uXA_gHcSa297uchjavLepDfZfJYat3aRflhIuJCFicnh345DTzxFKtUMoDvq-jZDGYpnhzAhiFJ_Qt_-hV2nMcco3U0opKYScKHagXE6lZOjurqHEzjXaQ412qtH-rdFeT0tvHua4W7ntbQL4ASiTFDeQ7_9-xPYPrFuqww</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2836665445</pqid></control><display><type>article</type><title>First-in-Human Side-to-Side Magnetic Compression Duodeno-ileostomy with the Magnet Anastomosis System</title><source>MEDLINE</source><source>SpringerNature Journals</source><creator>Gagner, Michel ; Abuladze, David ; Koiava, Levan ; Buchwald, J. N. ; Van Sante, Nathalie ; Krinke, Todd</creator><creatorcontrib>Gagner, Michel ; Abuladze, David ; Koiava, Levan ; Buchwald, J. N. ; Van Sante, Nathalie ; Krinke, Todd</creatorcontrib><description>Purposes
Classical gastrointestinal anastomoses are formed with sutures and/or metal staples, resulting in significant bleeding and leak rates. This study evaluated the feasibility and safety of the novel magnet anastomosis system (MS) to create a side-to-side duodeno-ileal (DI) diversion for weight loss and type 2 diabetes (T2D) resolution.
Materials and Methods
Patients with severe obesity (body mass index (BMI) ≥ 35 kg/m
2
with/without T2D (HbA1
C
≥ 6.5%)) underwent the study procedure, a side-to-side MS DI diversion, with a standard sleeve gastrectomy (SG). A linear magnet was delivered by flexible endoscopy to a point 250 cm proximal to the ileocecal valve; a second magnet was positioned in the first part of the duodenum; the bowel segments containing magnets were apposed, initiating gradual anastomosis formation. Laparoscopic assistance was used to obtain bowel measurements, obviate tissue interposition, and close mesenteric defects.
Results
Between November 22 and 26, 2021, 5 female patients (mean weight 117.6 ± 7.1 kg, BMI (kg/m
2
) 44.4 ± 2.2) underwent side-to-side MS DI + SG. All magnets were successfully placed, expelled without re-intervention, and formed patent durable anastomoses. Total weight loss at 12 months was 34.0 ± 1.4% (SEM); excess weight loss, 80.2 ± 6.6%; and BMI reduction, 15.1. Mean HbA1
C
(%) dropped from 6.8 ± 0.8 to 4.8 ± 0.2; and glucose (mg/dL), from 134.3 ± 17.9 to 87.3 ± 6.3 (mean reduction, 47.0 mg/dL). There was no anastomotic bleeding, leakage, obstruction, or infection and no mortality.
Conclusions
Creation of a side-to-side magnetic compression anastomosis to achieve duodeno-ileostomy diversion in adults with severe obesity was feasible and safe, achieved excellent weight loss, and resolved type 2 diabetes at 1-year follow-up.
Trial Registration
Clinicaltrials.gov Identifier: NCT05322122.
Graphical Abstract</description><identifier>ISSN: 0960-8923</identifier><identifier>ISSN: 1708-0428</identifier><identifier>EISSN: 1708-0428</identifier><identifier>DOI: 10.1007/s11695-023-06708-x</identifier><identifier>PMID: 37393568</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Adult ; Anastomosis, Surgical - methods ; Body mass index ; Diabetes ; Diabetes Mellitus, Type 2 - surgery ; Duodenum - surgery ; Female ; Gastrectomy - methods ; Gastric Bypass - methods ; Gastrointestinal surgery ; Glycated Hemoglobin ; Humans ; Magnetic Phenomena ; Magnets ; Medicine ; Medicine & Public Health ; Obesity - surgery ; Obesity, Morbid - surgery ; Original Contributions ; Ostomy ; Retrospective Studies ; Surgery ; Surgical anastomosis ; Weight control ; Weight Loss</subject><ispartof>Obesity surgery, 2023-08, Vol.33 (8), p.2282-2292</ispartof><rights>The Author(s) 2023</rights><rights>2023. The Author(s).</rights><rights>The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c475t-764c254d181b867f80de62b65fc3187df02cdb6e841d7e170afe4e253c7cde5d3</citedby><cites>FETCH-LOGICAL-c475t-764c254d181b867f80de62b65fc3187df02cdb6e841d7e170afe4e253c7cde5d3</cites><orcidid>0000-0001-6068-0333</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s11695-023-06708-x$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s11695-023-06708-x$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,315,782,786,887,27933,27934,41497,42566,51328</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37393568$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gagner, Michel</creatorcontrib><creatorcontrib>Abuladze, David</creatorcontrib><creatorcontrib>Koiava, Levan</creatorcontrib><creatorcontrib>Buchwald, J. N.</creatorcontrib><creatorcontrib>Van Sante, Nathalie</creatorcontrib><creatorcontrib>Krinke, Todd</creatorcontrib><title>First-in-Human Side-to-Side Magnetic Compression Duodeno-ileostomy with the Magnet Anastomosis System</title><title>Obesity surgery</title><addtitle>OBES SURG</addtitle><addtitle>Obes Surg</addtitle><description>Purposes
Classical gastrointestinal anastomoses are formed with sutures and/or metal staples, resulting in significant bleeding and leak rates. This study evaluated the feasibility and safety of the novel magnet anastomosis system (MS) to create a side-to-side duodeno-ileal (DI) diversion for weight loss and type 2 diabetes (T2D) resolution.
Materials and Methods
Patients with severe obesity (body mass index (BMI) ≥ 35 kg/m
2
with/without T2D (HbA1
C
≥ 6.5%)) underwent the study procedure, a side-to-side MS DI diversion, with a standard sleeve gastrectomy (SG). A linear magnet was delivered by flexible endoscopy to a point 250 cm proximal to the ileocecal valve; a second magnet was positioned in the first part of the duodenum; the bowel segments containing magnets were apposed, initiating gradual anastomosis formation. Laparoscopic assistance was used to obtain bowel measurements, obviate tissue interposition, and close mesenteric defects.
Results
Between November 22 and 26, 2021, 5 female patients (mean weight 117.6 ± 7.1 kg, BMI (kg/m
2
) 44.4 ± 2.2) underwent side-to-side MS DI + SG. All magnets were successfully placed, expelled without re-intervention, and formed patent durable anastomoses. Total weight loss at 12 months was 34.0 ± 1.4% (SEM); excess weight loss, 80.2 ± 6.6%; and BMI reduction, 15.1. Mean HbA1
C
(%) dropped from 6.8 ± 0.8 to 4.8 ± 0.2; and glucose (mg/dL), from 134.3 ± 17.9 to 87.3 ± 6.3 (mean reduction, 47.0 mg/dL). There was no anastomotic bleeding, leakage, obstruction, or infection and no mortality.
Conclusions
Creation of a side-to-side magnetic compression anastomosis to achieve duodeno-ileostomy diversion in adults with severe obesity was feasible and safe, achieved excellent weight loss, and resolved type 2 diabetes at 1-year follow-up.
Trial Registration
Clinicaltrials.gov Identifier: NCT05322122.
Graphical Abstract</description><subject>Adult</subject><subject>Anastomosis, Surgical - methods</subject><subject>Body mass index</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 2 - surgery</subject><subject>Duodenum - surgery</subject><subject>Female</subject><subject>Gastrectomy - methods</subject><subject>Gastric Bypass - methods</subject><subject>Gastrointestinal surgery</subject><subject>Glycated Hemoglobin</subject><subject>Humans</subject><subject>Magnetic Phenomena</subject><subject>Magnets</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Obesity - surgery</subject><subject>Obesity, Morbid - surgery</subject><subject>Original Contributions</subject><subject>Ostomy</subject><subject>Retrospective Studies</subject><subject>Surgery</subject><subject>Surgical anastomosis</subject><subject>Weight control</subject><subject>Weight Loss</subject><issn>0960-8923</issn><issn>1708-0428</issn><issn>1708-0428</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp9kUtvEzEUhS0EoqHwB1igkdiwMfhtZ4WqQClSUReFtTWx7ySuZuxge6D598yQvmDR1bV0vnt8jw5Cryl5TwnRHwqlaikxYRwTpYnB10_Qgs4PIph5ihZkqQg2S8aP0ItSrghhVDH2HB1xzZdcKrNAcBpyqThEfDYObWwugwdcE55n863dRKjBNas07DKUElJsPo3JQ0w49JBKTcO--R3qtqnbW745ie0spBJKc7kvFYaX6FnX9gVe3cxj9OP08_fVGT6_-PJ1dXKOndCyYq2EY1J4aujaKN0Z4kGxtZKd49Ro3xHm_FqBEdRrmJK2HQhgkjvtPEjPj9HHg-9uXA_gHcSa297uchjavLepDfZfJYat3aRflhIuJCFicnh345DTzxFKtUMoDvq-jZDGYpnhzAhiFJ_Qt_-hV2nMcco3U0opKYScKHagXE6lZOjurqHEzjXaQ412qtH-rdFeT0tvHua4W7ntbQL4ASiTFDeQ7_9-xPYPrFuqww</recordid><startdate>20230801</startdate><enddate>20230801</enddate><creator>Gagner, Michel</creator><creator>Abuladze, David</creator><creator>Koiava, Levan</creator><creator>Buchwald, J. N.</creator><creator>Van Sante, Nathalie</creator><creator>Krinke, Todd</creator><general>Springer US</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6068-0333</orcidid></search><sort><creationdate>20230801</creationdate><title>First-in-Human Side-to-Side Magnetic Compression Duodeno-ileostomy with the Magnet Anastomosis System</title><author>Gagner, Michel ; Abuladze, David ; Koiava, Levan ; Buchwald, J. N. ; Van Sante, Nathalie ; Krinke, Todd</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c475t-764c254d181b867f80de62b65fc3187df02cdb6e841d7e170afe4e253c7cde5d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adult</topic><topic>Anastomosis, Surgical - methods</topic><topic>Body mass index</topic><topic>Diabetes</topic><topic>Diabetes Mellitus, Type 2 - surgery</topic><topic>Duodenum - surgery</topic><topic>Female</topic><topic>Gastrectomy - methods</topic><topic>Gastric Bypass - methods</topic><topic>Gastrointestinal surgery</topic><topic>Glycated Hemoglobin</topic><topic>Humans</topic><topic>Magnetic Phenomena</topic><topic>Magnets</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Obesity - surgery</topic><topic>Obesity, Morbid - surgery</topic><topic>Original Contributions</topic><topic>Ostomy</topic><topic>Retrospective Studies</topic><topic>Surgery</topic><topic>Surgical anastomosis</topic><topic>Weight control</topic><topic>Weight Loss</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gagner, Michel</creatorcontrib><creatorcontrib>Abuladze, David</creatorcontrib><creatorcontrib>Koiava, Levan</creatorcontrib><creatorcontrib>Buchwald, J. N.</creatorcontrib><creatorcontrib>Van Sante, Nathalie</creatorcontrib><creatorcontrib>Krinke, Todd</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Obesity surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gagner, Michel</au><au>Abuladze, David</au><au>Koiava, Levan</au><au>Buchwald, J. N.</au><au>Van Sante, Nathalie</au><au>Krinke, Todd</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>First-in-Human Side-to-Side Magnetic Compression Duodeno-ileostomy with the Magnet Anastomosis System</atitle><jtitle>Obesity surgery</jtitle><stitle>OBES SURG</stitle><addtitle>Obes Surg</addtitle><date>2023-08-01</date><risdate>2023</risdate><volume>33</volume><issue>8</issue><spage>2282</spage><epage>2292</epage><pages>2282-2292</pages><issn>0960-8923</issn><issn>1708-0428</issn><eissn>1708-0428</eissn><abstract>Purposes
Classical gastrointestinal anastomoses are formed with sutures and/or metal staples, resulting in significant bleeding and leak rates. This study evaluated the feasibility and safety of the novel magnet anastomosis system (MS) to create a side-to-side duodeno-ileal (DI) diversion for weight loss and type 2 diabetes (T2D) resolution.
Materials and Methods
Patients with severe obesity (body mass index (BMI) ≥ 35 kg/m
2
with/without T2D (HbA1
C
≥ 6.5%)) underwent the study procedure, a side-to-side MS DI diversion, with a standard sleeve gastrectomy (SG). A linear magnet was delivered by flexible endoscopy to a point 250 cm proximal to the ileocecal valve; a second magnet was positioned in the first part of the duodenum; the bowel segments containing magnets were apposed, initiating gradual anastomosis formation. Laparoscopic assistance was used to obtain bowel measurements, obviate tissue interposition, and close mesenteric defects.
Results
Between November 22 and 26, 2021, 5 female patients (mean weight 117.6 ± 7.1 kg, BMI (kg/m
2
) 44.4 ± 2.2) underwent side-to-side MS DI + SG. All magnets were successfully placed, expelled without re-intervention, and formed patent durable anastomoses. Total weight loss at 12 months was 34.0 ± 1.4% (SEM); excess weight loss, 80.2 ± 6.6%; and BMI reduction, 15.1. Mean HbA1
C
(%) dropped from 6.8 ± 0.8 to 4.8 ± 0.2; and glucose (mg/dL), from 134.3 ± 17.9 to 87.3 ± 6.3 (mean reduction, 47.0 mg/dL). There was no anastomotic bleeding, leakage, obstruction, or infection and no mortality.
Conclusions
Creation of a side-to-side magnetic compression anastomosis to achieve duodeno-ileostomy diversion in adults with severe obesity was feasible and safe, achieved excellent weight loss, and resolved type 2 diabetes at 1-year follow-up.
Trial Registration
Clinicaltrials.gov Identifier: NCT05322122.
Graphical Abstract</abstract><cop>New York</cop><pub>Springer US</pub><pmid>37393568</pmid><doi>10.1007/s11695-023-06708-x</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0001-6068-0333</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0960-8923 |
| ispartof | Obesity surgery, 2023-08, Vol.33 (8), p.2282-2292 |
| issn | 0960-8923 1708-0428 1708-0428 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10345004 |
| source | MEDLINE; SpringerNature Journals |
| subjects | Adult Anastomosis, Surgical - methods Body mass index Diabetes Diabetes Mellitus, Type 2 - surgery Duodenum - surgery Female Gastrectomy - methods Gastric Bypass - methods Gastrointestinal surgery Glycated Hemoglobin Humans Magnetic Phenomena Magnets Medicine Medicine & Public Health Obesity - surgery Obesity, Morbid - surgery Original Contributions Ostomy Retrospective Studies Surgery Surgical anastomosis Weight control Weight Loss |
| title | First-in-Human Side-to-Side Magnetic Compression Duodeno-ileostomy with the Magnet Anastomosis System |
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