Selection of electrical algorithms to treat obesity with intermittent vagal block using an implantable medical device

Michael Camilleri, James Toouli, Miguel F. Herrera, Lilian Kow, Juan Pablo Pantoja, Charles J. Billington, Katherine S. Tweden, Richard R. Wilson, Frank G. Moody

Research output: Contribution to journalArticle

37 Citations (Scopus)

Abstract

Background: A laparoscopically implantable electrical device that intermittently blocks both vagi near the esophagogastric junction led to significant excess weight loss (EWL) in an initial clinical trial in obese patients. The study objective was to optimize therapy algorithms and determine the EWL achieved with a second-generation device at university hospitals in Australia, Norway, and Switzerland. Methods: Data acquired during the initial clinical trial were analyzed and subsequently used to select alternative electrical algorithms. In the second trial, vagal blocking using one selected therapy algorithm was initiated 2 weeks after implanting the second-generation device. The patients were followed up for 6 months to assess the EWL and safety, including adverse events. Results: In the initial clinical trial, vagal blocking algorithm durations of 90-150 s were associated with greater EWL compared with either shorter or longer algorithm durations (P 2) to evaluate a 120-s blocking algorithm. At 6 months, greater EWL was achieved (22.7% ± 3.1%, n = 24) compared with the initial study and first-generation device (14.2% ± 2.2%, n = 29, P = .03). In both trials, an association was found between the number of 90-150-s algorithms delivered daily and greater EWL (P = .03). No deaths, unanticipated device-related adverse events, or medically serious adverse events were associated with the device. Conclusion: This second-generation vagal blocking device, using a therapy algorithm of 120-s duration, resulted in a clinically acceptable safety profile and significantly greater EWL compared with the first-generation device delivering a wider range of therapy algorithm durations.

Original languageEnglish (US)
Pages (from-to)224-229
Number of pages6
JournalSurgery for Obesity and Related Diseases
Volume5
Issue number2
DOIs
StatePublished - Mar 2009

Fingerprint

Obesity
Weight Loss
Equipment and Supplies
Clinical Trials
Safety
Esophagogastric Junction
Therapeutics
Norway
Switzerland

Keywords

  • Electrical vagal block
  • Intermittent vagal block
  • Laparoscopic surgery
  • Obesity

ASJC Scopus subject areas

  • Surgery

Cite this

Selection of electrical algorithms to treat obesity with intermittent vagal block using an implantable medical device. / Camilleri, Michael; Toouli, James; Herrera, Miguel F.; Kow, Lilian; Pantoja, Juan Pablo; Billington, Charles J.; Tweden, Katherine S.; Wilson, Richard R.; Moody, Frank G.

In: Surgery for Obesity and Related Diseases, Vol. 5, No. 2, 03.2009, p. 224-229.

Research output: Contribution to journalArticle

Camilleri, Michael ; Toouli, James ; Herrera, Miguel F. ; Kow, Lilian ; Pantoja, Juan Pablo ; Billington, Charles J. ; Tweden, Katherine S. ; Wilson, Richard R. ; Moody, Frank G. / Selection of electrical algorithms to treat obesity with intermittent vagal block using an implantable medical device. In: Surgery for Obesity and Related Diseases. 2009 ; Vol. 5, No. 2. pp. 224-229.
@article{768fd9bd277746c98764383ed8452cde,
title = "Selection of electrical algorithms to treat obesity with intermittent vagal block using an implantable medical device",
abstract = "Background: A laparoscopically implantable electrical device that intermittently blocks both vagi near the esophagogastric junction led to significant excess weight loss (EWL) in an initial clinical trial in obese patients. The study objective was to optimize therapy algorithms and determine the EWL achieved with a second-generation device at university hospitals in Australia, Norway, and Switzerland. Methods: Data acquired during the initial clinical trial were analyzed and subsequently used to select alternative electrical algorithms. In the second trial, vagal blocking using one selected therapy algorithm was initiated 2 weeks after implanting the second-generation device. The patients were followed up for 6 months to assess the EWL and safety, including adverse events. Results: In the initial clinical trial, vagal blocking algorithm durations of 90-150 s were associated with greater EWL compared with either shorter or longer algorithm durations (P 2) to evaluate a 120-s blocking algorithm. At 6 months, greater EWL was achieved (22.7{\%} ± 3.1{\%}, n = 24) compared with the initial study and first-generation device (14.2{\%} ± 2.2{\%}, n = 29, P = .03). In both trials, an association was found between the number of 90-150-s algorithms delivered daily and greater EWL (P = .03). No deaths, unanticipated device-related adverse events, or medically serious adverse events were associated with the device. Conclusion: This second-generation vagal blocking device, using a therapy algorithm of 120-s duration, resulted in a clinically acceptable safety profile and significantly greater EWL compared with the first-generation device delivering a wider range of therapy algorithm durations.",
keywords = "Electrical vagal block, Intermittent vagal block, Laparoscopic surgery, Obesity",
author = "Michael Camilleri and James Toouli and Herrera, {Miguel F.} and Lilian Kow and Pantoja, {Juan Pablo} and Billington, {Charles J.} and Tweden, {Katherine S.} and Wilson, {Richard R.} and Moody, {Frank G.}",
year = "2009",
month = "3",
doi = "10.1016/j.soard.2008.09.006",
language = "English (US)",
volume = "5",
pages = "224--229",
journal = "Surgery for Obesity and Related Diseases",
issn = "1550-7289",
publisher = "Elsevier Inc.",
number = "2",

}

TY - JOUR

T1 - Selection of electrical algorithms to treat obesity with intermittent vagal block using an implantable medical device

AU - Camilleri, Michael

AU - Toouli, James

AU - Herrera, Miguel F.

AU - Kow, Lilian

AU - Pantoja, Juan Pablo

AU - Billington, Charles J.

AU - Tweden, Katherine S.

AU - Wilson, Richard R.

AU - Moody, Frank G.

PY - 2009/3

Y1 - 2009/3

N2 - Background: A laparoscopically implantable electrical device that intermittently blocks both vagi near the esophagogastric junction led to significant excess weight loss (EWL) in an initial clinical trial in obese patients. The study objective was to optimize therapy algorithms and determine the EWL achieved with a second-generation device at university hospitals in Australia, Norway, and Switzerland. Methods: Data acquired during the initial clinical trial were analyzed and subsequently used to select alternative electrical algorithms. In the second trial, vagal blocking using one selected therapy algorithm was initiated 2 weeks after implanting the second-generation device. The patients were followed up for 6 months to assess the EWL and safety, including adverse events. Results: In the initial clinical trial, vagal blocking algorithm durations of 90-150 s were associated with greater EWL compared with either shorter or longer algorithm durations (P 2) to evaluate a 120-s blocking algorithm. At 6 months, greater EWL was achieved (22.7% ± 3.1%, n = 24) compared with the initial study and first-generation device (14.2% ± 2.2%, n = 29, P = .03). In both trials, an association was found between the number of 90-150-s algorithms delivered daily and greater EWL (P = .03). No deaths, unanticipated device-related adverse events, or medically serious adverse events were associated with the device. Conclusion: This second-generation vagal blocking device, using a therapy algorithm of 120-s duration, resulted in a clinically acceptable safety profile and significantly greater EWL compared with the first-generation device delivering a wider range of therapy algorithm durations.

AB - Background: A laparoscopically implantable electrical device that intermittently blocks both vagi near the esophagogastric junction led to significant excess weight loss (EWL) in an initial clinical trial in obese patients. The study objective was to optimize therapy algorithms and determine the EWL achieved with a second-generation device at university hospitals in Australia, Norway, and Switzerland. Methods: Data acquired during the initial clinical trial were analyzed and subsequently used to select alternative electrical algorithms. In the second trial, vagal blocking using one selected therapy algorithm was initiated 2 weeks after implanting the second-generation device. The patients were followed up for 6 months to assess the EWL and safety, including adverse events. Results: In the initial clinical trial, vagal blocking algorithm durations of 90-150 s were associated with greater EWL compared with either shorter or longer algorithm durations (P 2) to evaluate a 120-s blocking algorithm. At 6 months, greater EWL was achieved (22.7% ± 3.1%, n = 24) compared with the initial study and first-generation device (14.2% ± 2.2%, n = 29, P = .03). In both trials, an association was found between the number of 90-150-s algorithms delivered daily and greater EWL (P = .03). No deaths, unanticipated device-related adverse events, or medically serious adverse events were associated with the device. Conclusion: This second-generation vagal blocking device, using a therapy algorithm of 120-s duration, resulted in a clinically acceptable safety profile and significantly greater EWL compared with the first-generation device delivering a wider range of therapy algorithm durations.

KW - Electrical vagal block

KW - Intermittent vagal block

KW - Laparoscopic surgery

KW - Obesity

UR - http://www.scopus.com/inward/record.url?scp=62549163020&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=62549163020&partnerID=8YFLogxK

U2 - 10.1016/j.soard.2008.09.006

DO - 10.1016/j.soard.2008.09.006

M3 - Article

C2 - 18996767

AN - SCOPUS:62549163020

VL - 5

SP - 224

EP - 229

JO - Surgery for Obesity and Related Diseases

JF - Surgery for Obesity and Related Diseases

SN - 1550-7289

IS - 2

ER -