PMID- 36471179
OWN - NLM
STAT- MEDLINE
DCOM- 20230113
LR  - 20230201
IS  - 1708-0428 (Electronic)
IS  - 0960-8923 (Print)
IS  - 0960-8923 (Linking)
VI  - 33
IP  - 1
DP  - 2023 Jan
TI  - Feasibility and Efficacy of Magnetic Sphincter Augmentation for the Management of 
      Gastroesophageal Reflux Disease Post-Sleeve Gastrectomy for Obesity.
PG  - 387-396
LID - 10.1007/s11695-022-06381-6 [doi]
AB  - BACKGROUND: Patients with medically intractable GERD after laparoscopic sleeve 
      gastrectomy (LSG) have limited surgical options. Fundoplication is difficult 
      post-LSG. Roux-en-Y gastric bypass may be used as a conversion procedure but is 
      more invasive with potential for serious complications. Magnetic sphincter 
      augmentation (MSA) is a less invasive GERD treatment alternative. The objective 
      of this study was to assess safety and efficacy outcomes of MSA after LSG. 
      METHODS: The primary outcome of this observational, multicenter, single-arm 
      prospective study was the rate of serious device and/or procedure-related adverse 
      events (AEs). The efficacy of the LINX device was measured comparing baseline to 
      12-month post-implant reductions in distal acid exposure, GERD-HRQL score, and 
      average daily PPI usage. RESULTS: Thirty subjects who underwent MSA implantation 
      were followed 12 months post-implant. No unanticipated adverse device effects 
      were observed. There were two adverse events deemed serious (dysphagia, pain, 
      6.7%) which resolved without sequelae. GERD-HRQL scores showed significant 
      improvement (80.8%, P < 0.001), and reduction in daily PPI usage was seen (95.8%, 
      P < 0.001). Forty-four percent of subjects demonstrated normalization or >  = 50% 
      reduction of total distal acid exposure time (baseline 16.2%, 12 months 11%; 
      P = 0.038). CONCLUSIONS: Post-LSG, MSA showed an overall improvement of GERD 
      symptoms, and reduction in PPI use with explants within anticipated range along 
      with improvement in distal esophageal acid exposure time.
CI  - (c) 2022. The Author(s).
FAU - Khaitan, Leena
AU  - Khaitan L
AD  - Division of Thoracic & Foregut Surgery, Department of Cardiovascular Sciences, 
      University Hospitals Cleveland Medical Center, Cleveland, OH, 44106, USA.
FAU - Hill, Michael
AU  - Hill M
AD  - Adirondack Surgical Group, Saranac Lake, NY, 12983, USA.
FAU - Michel, Michael
AU  - Michel M
AD  - Coastal Carolina Bariatric & Surgical Center, Summerville, SC, 29485, USA.
FAU - Chiasson, Patrick
AU  - Chiasson P
AD  - Northwest Allied Bariatric & Foregut Surgery, Tucson, AZ, 85741, USA.
FAU - Woodworth, Philip
AU  - Woodworth P
AD  - Institute of Esophageal & Reflux Surgery, Englewood, CO, 80113, USA.
FAU - Bell, Reginald
AU  - Bell R
AD  - Institute of Esophageal & Reflux Surgery, Englewood, CO, 80113, USA.
FAU - Sadek, Ragui
AU  - Sadek R
AD  - Advanced Surgical and Bariatrics of New Jersey & Pennsylvania, Somerset, NJ, 
      08873, USA.
FAU - Hoffman, Aaron
AU  - Hoffman A
AD  - Kaleida Health, Buffalo, NY, 14203, USA.
FAU - Loing, Kari
AU  - Loing K
AD  - Medical Affairs, Ethicon Inc, 4545 Creek Rd, Cincinnati, OH, 45242, USA.
FAU - Veldhuis, Paula
AU  - Veldhuis P
AUID- ORCID: 0000-0002-2657-9773
AD  - Medical Affairs, Ethicon Inc, 4545 Creek Rd, Cincinnati, OH, 45242, USA. 
      PVeldhui@its.jnj.com.
FAU - Petraiuolo, William
AU  - Petraiuolo W
AD  - Medical Affairs, Ethicon Inc, 4545 Creek Rd, Cincinnati, OH, 45242, USA.
FAU - Anciano, Carlos
AU  - Anciano C
AD  - Division of Thoracic & Foregut Surgery, Department of Cardiovascular Sciences, 
      East Carolina University, Greenville, NC, 27834, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20221206
PL  - United States
TA  - Obes Surg
JT  - Obesity surgery
JID - 9106714
SB  - IM
MH  - Humans
MH  - Esophageal Sphincter, Lower/surgery
MH  - Prospective Studies
MH  - Feasibility Studies
MH  - *Obesity, Morbid/surgery
MH  - *Laparoscopy/methods
MH  - *Gastroesophageal Reflux/surgery/etiology
MH  - Gastrectomy/methods
MH  - Obesity/surgery
MH  - Magnetic Phenomena
MH  - Treatment Outcome
PMC - PMC9834340
OTO - NOTNLM
OT  - GERD
OT  - Gastroesophageal reflex disease
OT  - LINX(R)
OT  - Laparoscopic sleeve gastrectomy
OT  - MSA
OT  - Magnetic augmented sphincter
OT  - Weight loss surgery
COIS- Study was funded by Ethicon, Inc. KL, PV, and WP are employees of Ethicon, Inc. 
      LK, CA, RB, PC, RS, PW, AH, MM, and MM are clinical consultants for Ethicon, Inc. 
      RB is a consultant for Ambu, Intuitive, Medtronic, and Beckton Dickinson.
EDAT- 2022/12/06 06:00
MHDA- 2023/01/14 06:00
PMCR- 2022/12/06
CRDT- 2022/12/05 23:42
PHST- 2022/08/18 00:00 [received]
PHST- 2022/11/27 00:00 [accepted]
PHST- 2022/11/18 00:00 [revised]
PHST- 2022/12/06 06:00 [pubmed]
PHST- 2023/01/14 06:00 [medline]
PHST- 2022/12/05 23:42 [entrez]
PHST- 2022/12/06 00:00 [pmc-release]
AID - 10.1007/s11695-022-06381-6 [pii]
AID - 6381 [pii]
AID - 10.1007/s11695-022-06381-6 [doi]
PST - ppublish
SO  - Obes Surg. 2023 Jan;33(1):387-396. doi: 10.1007/s11695-022-06381-6. Epub 2022 Dec 
      6.