==================================HSR39==================================
39.  Anti-gastroesophageal reflux implantation.
1
UI  - 86308310
TI  - Diagnostic and therapeutic technology assessment. Angelchik antireflux
      prosthesis.
AB  - In summary, the DATTA panelists felt that the Angelchik prosthesis is
      effective in relieving gastroesophageal reflux and that the device, along
      with other types of surgical procedures, is indicated when medical
      management has failed and when objective evidence of incompetence of the
      lower esophageal sphincter is present. Because the procedure is rapid and
      requires little dissection, it might be most useful in the elderly and
      high-risk patient. Notwithstanding such support from the DATTA panelists
      for the device's efficacy, the majority of DATTA panelists felt that
      concerns about the safety of the device compromise its clinical utility.
      Such concern arose from past reports of complications and the panelists'
      own experience with migration or erosion of the device. Thus, these
      panelists could not recommend the device's routine use. Additionally,
      some DATTA panelists considered the development of the Angelchik
      prosthesis to be unnecessary, as standard surgical techniques, eg,
      fundoplication, give adequate results. The improved safety statistics
      reported since 1982 may remove some of these reservations in the future.
MH  - American Medical Association ; Gastroesophageal Reflux/*SURGERY ; Human ;
      *Prosthesis/ADVERSE EFFECTS ; Technology Assessment, Biomedical ; United
      States
SO  - JAMA 1986 Sep 12;256(10):1358-60
2
UI  - 86157169
AU  - Kauten JR ; Mansour KA
TI  - Complications of the Angelchik prosthesis in the management of
      gastroesophageal reflux.
AB  - There have been a number of reports on the complications of the Angelchik
      silicone prosthesis since Angelchik and Cohen first reported the use of
      the device in 46 patients with gastroesophageal reflux. The exact
      incidence of complications is difficult to estimate; however, the company
      estimates 0.81 per cent for migration and 0.15 per cent for erosion of
      the prosthesis. The purpose of this paper is to review our experience
      with 13 complications related to the Angelchik prosthesis in eight
      patients referred to Emory University Hospital. These complications
      consisted of recurrent reflux esophagitis in six patients, intractable
      dysphagia in two, esophageal stricture in two, displacement of the
      prosthesis in two, disruption of the prosthesis in one patient, and
      gastric erosion in two patients. The management of these complications
      required removal of the prosthesis and performance of a Nissen
      fundoplication in six patients. Distal esophagectomy with
      esophagogastrostomy was performed in one patient, and colon interposition
      was performed in another patient. In summary, serious complications of
      the Angelchik prosthesis implanted for gastroesophageal reflux and their
      management are presented.
MH  - Adult ; Aged ; Case Report ; Deglutition Disorders/ETIOLOGY/SURGERY ;
      Esophagitis, Peptic/ETIOLOGY/SURGERY ; Esophagus/SURGERY ; Female ;
      Gastroesophageal Reflux/RADIOGRAPHY/*SURGERY ; Human ; Male ; Middle Age
      ; Prosthesis/*ADVERSE EFFECTS ; Prosthesis Failure ; Silicones ; Stomach
      Diseases/ETIOLOGY/SURGERY
SO  - Am Surg 1986 Apr;52(4):208-13
3
UI  - 86129640
AU  - Cohen DJ ; Benjamin SB ; Graeber GM ; Castell DO ; Patrick DH ; Cordova C
      ; Dachman A ; Friedman A
TI  - Evaluation of the Angelchik antireflux prosthesis using a model for
      esophageal reflux in rhesus monkeys.
AB  - Minimal data are available about the Angelchik antireflux prosthesis
      although it has been inserted in more than 14,000 patients. The present
      animal study was designed to evaluate the effectiveness and mechanism of
      action of this prosthesis. A reproducible model of esophageal reflux in
      primates was created using a double myotomy. Lower esophageal sphincter
      (LES) pressure and reflux score were improved significantly in animals by
      insertion of an Angelchik antireflux prosthesis, a modified antireflux
      prosthesis, or a Nissen fundoplication. Manometrically determined LES
      length was increased after insertion of an Angelchik antireflux
      prosthesis but not by a Nissen fundoplication or sham operation.
      Complications after insertion of the modified prosthesis included
      intraluminal erosion, fibrous stricture, and slippage of the device over
      the stomach.
MH  - Animal ; Disease Models, Animal ; Evaluation Studies ; Gastroesophageal
      Reflux/PHYSIOPATHOLOGY/*SURGERY ; Macaca mulatta ; Manometry ; Pressure ;
      *Prosthesis/ADVERSE EFFECTS ; Support, U.S. Gov't, Non-P.H.S.
SO  - Ann Thorac Surg 1986 Feb;41(2):135-42
4
UI  - 86114592
AU  - Gourley GR ; Pellett JR ; Li BU ; Adkins WN Jr
TI  - A prospective randomized double-blind study of gastroesophageal reflux
      surgery in pediatric-sized developmentally disabled patients: Nissen
      fundoplication versus Angelchik prosthesis.
AB  - In order to compare the standard Nissen fundoplication with the more
      recent Angelchik antireflux prosthesis, 47 pediatric-sized,
      developmentally disabled patients were prospectively randomized to
      receive either of these gastroesophageal antireflux procedures. The two
      groups were comparable at the time of surgery with regard to age, weight,
      surface area, emesis, number of chest radiographs, medications, lower
      esophageal sphincter pressure, and number and duration of reflux episodes
      during standard acid reflux testing. The Angelchik group required
      significantly less anesthesia time than the Nissen group: 107.4 +/- 22.6
      min (mean +/- SD) versus 156.5 +/- 42.4 min (p less than 0.001). There
      was no difference in length of postsurgical hospital stay. Six months
      after surgery, both groups showed improvement. There was no significant
      difference between the Angelchik and Nissen groups in mean subjective
      assessment score, increased weight gain, decreases in emesis, numbers of
      chest radiographs, hospital days, or medications, increased lower
      esophageal sphincter pressure, or decreased numbers and duration of
      reflux during acid reflux testing. Long-term follow-up of eight Angelchik
      and 10 Nissen patients 12-30 months postsurgery (Angelchik 21.6 +/- 6.0
      months, Nissen 21.9 +/- 5.0 months) demonstrated no significant
      difference in the percent of time the distal esophageal pH was below 4.0.
      Significant complications potentially related to the type of procedure
      developed in 1/21 patients in the Angelchik group and 1/17 patients in
      the Nissen group. We conclude that both procedures are usually effective
      for the surgical treatment of gastroesophageal reflux. Further study is
      indicated in order to establish the long-term superiority of one
      procedure.
MH  - Adolescence ; Adult ; Anesthesia ; Child ; Comparative Study ;
      Double-Blind Method ; Esophagus/SURGERY ; Female ; Follow-Up Studies ;
      Gastroesophageal Reflux/COMPLICATIONS/PREVENTION & CONTROL/*SURGERY ;
      *Handicapped ; Human ; Length of Stay ; Male ; Mental Retardation/
      COMPLICATIONS ; Postoperative Complications/ETIOLOGY ; Prospective
      Studies ; *Prosthesis ; Random Allocation ; Support, Non-U.S. Gov't ;
      Support, U.S. Gov't, P.H.S. ; Time Factors
SO  - J Pediatr Gastroenterol Nutr 1986 Jan;5(1):52-61
5
UI  - 86056797
AU  - Lang IM ; Sarna SK ; Condon RE
TI  - Gastrointestinal motor correlates of vomiting in the dog: quantification
      and characterization as an independent phenomenon.
AB  - The gastrointestinal motor correlates of vomiting were examined in 8
      dogs. Each dog was chronically implanted with extramural strain gage
      force transducers distributed along the gastrointestinal tract. The
      following gastrointestinal motor responses accompanied vomiting activated
      spontaneously or after apomorphine administration (2.5-15 micrograms/kg,
      i.v.): (a) a retrograde peristaltic contraction (RPC), (b) a peri-RPC
      inhibitory period, (c) a post-RPC series of phasic contractions, and (d)
      a post-RPC inhibitory period. These same motor patterns occurred without
      the somatomotor responses associated with vomiting but sometimes with
      regurgitation under the following conditions: (a) spontaneously, (b)
      one-third of the time after low doses of apomorphine (2.5-5.0
      micrograms/kg, i.v.), or (c) after the intragastric administration of
      hypertonic saline or a vinegar solution. We concluded that a set of
      gastrointestinal motor responses accompany vomiting and that this set of
      responses represents an independent phenomenon. This phenomenon was
      vagally mediated but only one phase, the RPC, was cholinergically
      mediated. Our results suggest that the vomiting center may consist of two
      functionally distinct parts that are activated sequentially: one
      controlling the gastrointestinal responses and the other the somatomotor
      responses.
MH  - Animal ; Apomorphine ; Dogs ; Emetics ; Female ; Gastroesophageal Reflux/
      PHYSIOPATHOLOGY ; *Gastrointestinal Motility ; Intestine, Small/
      *INNERVATION ; Male ; Parasympathetic Nervous System/PHYSIOLOGY ;
      Support, U.S. Gov't, Non-P.H.S. ; Vagotomy ; Vagus Nerve/PHYSIOLOGY ;
      Vomiting/CHEMICALLY INDUCED/*PHYSIOPATHOLOGY
SO  - Gastroenterology 1986 Jan;90(1):40-7