Prospective study of the Angelchik anti-reflux prosthesis

Fifty patients with medically refractory gastro-oesophageal reflux were treated by the insertion of an Angelchik anti-reflux prosthesis. All patients had a pre-operative upper gastrointestinal endoscopy, 32 were investigated with 15 h overnight oesophageal pH studies combined with oesophageal bile sampling and 20 underwent oesophageal manometric studies. At pre-operative endoscopy 45 patients had evidence of oesophagitis and the 5 who did not had pathological reflux demonstrated on overnight pH testing. Postoperatively the main clinical problem was dysphagia which appeared to settle with time but left one-third of patients with mild dysphagia at the end of 12 months. A further 12 per cent had residual moderate to severe dysphagia which required the removal of the prosthesis in five patients (10 per cent). In only one patient was the dysphagia due to prosthetic migration and this was the first patient in the series. Subsequently, we have had no problems with prosthetic migration, disruption, or erosion into the oesophagus. The overnight pH studies confirmed the efficacy of the prosthesis in preventing reflux which correlated with symptomatic improvement. We conclude that, while the Angelchik anti-reflux prosthesis is an effective device, it has a disturbingly high incidence of postoperative dysphagia though this appears to settle with time, leaving around 10 per cent of patients with severe dysphagia which will necessitate removal of the prosthesis and one-third with mild dysphagia which may settle with the further passage of time.     

Randomized prospective trial of the Angelchik anti-reflux prosthesis

Fifty-two patients with reflux oesophagitis resistant to medical treatment were randomized at operation to receive either the Angelchik prosthesis or a fundoplication. All patients were assessed postoperatively by a physician unaware of the nature of the operation. Forty-two patients have been followed up for 1-2 years; ten patients for 3-9 months. Ninety-six per cent of the Angelchik patients had satisfactory or excellent results compared with 81 per cent with a fundoplication. There were no failures to control reflux with the Angelchik prosthesis whereas 6 patients (23 per cent) of the fundoplication group have persisting reflux. Operating times for insertion of the prosthesis averaged a little over half that recorded for fundoplication. Complication rates were similar. The results of the trial encourage the use of the prosthesis in patients with gastro-oesophageal reflux, where medical treatment has failed. The prosthesis should not be used if the gut is opened during operation either inadvertently or deliberately, as in making a suture line or anastomosis, because of the risk of sepsis.     

The Angelchik anti-reflux prosthesis--some reservations

A prospective study has been made of the use of the Angelchik prosthesis in the treatment of hiatus hernia and gastro-oesophageal reflux. Forty-one patients under the care of one surgeon were studied over a 3-year period. The operation is simple and safe to perform. Twelve patients suffered transient dysphagia which spontaneously resolved within 3 months. Satisfactory results were obtained thereafter in 80.9 per cent. Seven of the prostheses have been removed (17.1 per cent), all within 18 months of performing the operation. Dysphagia and recurrent symptoms were the main reasons for removal and in two of these stricturing was present pre-operatively. We feel the presence of an established stricture is a contraindication to the use of the device. We have, however, been impressed by its use as a second procedure when previous surgery has failed and when revisional surgery for recurrent hiatus hernia is difficult due to dense adhesion formation. While it is still early to assess the legacy that the use of this prosthesis might incur, we would recommend conservatism if not abandonment of its use until longer-term evaluation is available.     

The Angelchik antireflux prosthesis

A silicone collar containing circumferential tape was tied around the cardio-esophageal junction in eight patients with symptomatic, refractory reflux, who were not good candidates for a standard antireflux procedure. A fine polypropylene tie or clip secured the knot. In two patients with large hiatal defects, the crura were approximated loosely. Mean operating time, including one cholecystectomy and one ventral hernia repair, was 51 minutes. Patients who underwent this simple operation had a combination of hypertension, heart disease, obesity and old age, and two had undergone horizontal gastroplasty previously for morbid obesity. The reflux was associated with hiatal hernia in seven of the eight patients. Preoperative studies included barium swallow roentgenography in all eight patients, and endoscopy, manometry and Bernstein test in six. All the studies were repeated postoperatively. Follow-up ranged from 17 to 48 months (mean 37.8 +/- 10.6 months). Postoperatively, there was a significant (p less than 0.01) improvement in symptoms, endoscopic findings and lower esophageal sphincter pressures. No prosthesis has migrated yet.     

Reflux versus dysphagia: an objective evaluation of the Angelchik prosthesis

Twenty-seven patients with proven longstanding gastro-oesophageal reflux underwent insertion of an Angelchik anti-reflux prosthesis. Preoperative studies included oesophageal manometry, endoscopy, acid reflux provocation test (ARPT) and 24 h oesophageal pH recording (24 h pH). Following operation mean lower oesophageal sphincter pressure was increased from 11 to 20 cmH2O. ARPT revealed significant pre-prandial reflux before operation in 16/24 compared with only 1/20 postoperatively; 24 h pH also showed an improvement in that 21/22 patients refluxed before operation compared with no significant reflux after. Dysphagia for solids of some degree was seen postoperatively in 26 patients and this was also demonstrated by delay in transit of a marsh-mallow swallow test. Severe dysphagia was seen in 4 patients and in 3 of these was related to rotation and displacement of the prosthesis necessitating removal.     

Appraisal of the Angelchik anti-reflux prosthesis based on clinical and manometric data and pH monitoring

Data are presented from manometric and prolonged pH monitoring studies in 11 patients in whom the Angelchik anti-reflux prosthesis was inserted for control of symptomatic gastro-oesophageal reflux. Symptomatic and objective improvement was seen in the majority of our patients, although three suffered major side effects (erosion of prosthesis into the stomach in two, severe dysphagia in one). Impaired lower oesophageal sphincter relaxation noted after operation may explain both the transient dysphagia observed in five patients and the reduction in reflux episodes. Improvement in oesophageal acid clearance may result from fixation of the oesophagus within the abdomen by the device. While continued use of the prosthesis should be viewed with caution, it is effective and may have a place in the management of selected patients.     

Identification of risk factors for postoperative dysphagia after primary anti-reflux surgery

Background  

Transient postoperative dysphagia is not uncommon after antireflux surgery and usually runs a self-limiting course. However, a subset of patients report long-term dysphagia. The purpose of this study was to determine the risk factors for persistent postoperative dysphagia at 1 year after surgery.     

The Angelchik prosthesis: results and complications

Fifty-four patients who had the Angelchik antireflux prosthesis inserted during the period March 1981 to May 1985 were sent a questionnaire and their medical records were reviewed. Forty-four patients replied: 68% said that they were cured, 25% said they were improved and two patients (4.5%) said they were worse after the operation. Of those who replied, 93% would recommend the procedure to others with a similar condition, 89% have had no further heartburn, and 72% have had no further regurgitation. However, it would appear from the responses that eight patients (18% of those who replied) have significant dysphagia not present before operation, at times varying from 8 months to 4 years and 10 months from operation (mean 38.5 months). Six additional patients (14%) had temporary dysphagia, now resolved and five patients (11%) have persisting minor dysphagia not present pre-operatively. Five respondents are known to have postoperative heartburn, two of whom are known to have persisting oesophagitis with ulceration. Nine patients (20%) continue to experience regurgitation, related to dysphagia in eight. Three prostheses have been removed without replacement; one after an oesophageal leak (believed to be related to a simultaneous parietal cell vagotomy), one for severe dysphagia and one which was unsuccessfully used to hold reduced a very large hiatus hernia. Two prostheses have been replaced after they slipped down the stomach wall, one with the tapes detached. (This latter prosthesis was one of the original ones with the tapes attached to the ends of the prosthesis only--a problem which has since been rectified by the manufacturer.) General surgical complications are listed for completeness.     

The Angelchik prosthesis behaves as a fundoplication.

It is not known why the Angelchik prosthesis prevents gastro-oesophageal reflux. A review of 53 barium meal examinations in 39 patients with the prosthesis showed that in 43 examinations the prosthesis was below the diaphragm. In 38 of these a small knuckle of stomach had herniated through the prosthetic ring alongside the oesophagus, forming a small intra-abdominal para-oesophageal hernia. Radiological reflux occurred in only one patient with such a hernia. In the remaining five examinations where the prosthesis was correctly situated in the abdomen, there was no hernia within the prosthetic ring and reflux occurred in three. In ten examinations the prosthesis had migrated into the mediastinum. None of these showed a hernia and reflux occurred in eight. It is suggested that the Angelchik prosthesis results in the formation of a small para-oesophageal hernia within a loosely fitting ring within the abdomen and this is a requirement for the success of the Angelchik prosthesis. Radiographically the intra-abdominal para-oesophageal hernia inside the prosthesis results in buttressing of the intra-abdominal oesophagus in a manner similar to a fundoplication.     

Disastrous complication of the Angelchik prosthesis

Since the introduction of the Angelchik prosthesis for the repair of hiatal hernias in 1979, there have been no previous formal reports of major problems with this procedure. The case reported here demonstrates that the device may be associated with disastrous complications and the authors suggest its use be reevaluated.     

Intraluminal erosion and migration of the Angelchik antireflux prosthesis

Despite a paucity of published clinical trials, use of the Angelchik antireflux prosthesis has increased dramatically since its introduction in 1979. Serious complications of this device have begun to appear. We dealt with two cases of erosion of the prosthesis into the gastrointestinal tract, one of which represents, to our knowledge, the first reported case of a gastroenteric fistula secondary to the device. Other complications of the use of this prosthesis have appeared in the literature. Carefully controlled clinical studies with long-term follow-up are needed to assess the overall benefits and safety of this new antireflux prosthesis.     

The effect of the Angelchik prosthesis on esophageal and gastric function.

The effects of the Angelchik prosthesis on esophageal and gastric function were investigated in 17 patients (11 men and six women; median age, 57 years; age range, 36 to 88 years) who underwent surgery for treatment of gastroesophageal reflux disease. All patients demonstrated unequivocal reflux, either at endoscopy or 24-hour pH testing. There was a significant increase in lower esophageal sphincter pressure after surgery, and no patient demonstrated abnormal reflux on pH testing. Gastric emptying of liquids and solids was not altered by surgery. Six months after surgery, all symptoms except dysphagia had significantly improved. Thirty-three months after surgery, six patients described symptoms as severe as or worse than those before surgery. Four patients had the prosthesis removed, two because of dysphagia alone, one because of reflux and dysphagia, and one because of flatulence and bloating. The patients who required removal of the prosthesis because of dysphagia had gross delay of esophageal emptying. We conclude that the Angelchik prosthesis is an effective antireflux device, but it interferes with esophageal function in some patients, requiring removal of the prosthesis. We think the rate of removal of the prosthesis is too high for its routine use in the treatment of gastroesophageal reflux disease.     

Complications after use of the Angelchik antireflux prosthesis

We report two cases of severe complications after insertion of an Angelchik antireflux prosthesis. In one case, the prosthesis migrated into the pelvis. In the other, severe dysphagia resulted from its insertion. In both instances, surgical removal was required. The high incidence of complications following the use of this prosthesis would suggest that other safer antireflux operations should be the preferred form of therapy.     

Endoscopic removal of an intragastric Angelchik antireflux prosthesis

Four months after insertion of an Angelchik esophageal antireflux prosthesis, a 60-year-old man was seen with epigastric pain and vomiting. Upper gastrointestinal studies demonstrated intragastric migration of the prosthesis. The prosthesis was intact and the straps were untied , and gastroscopic removal was accomplished by pulling out the prosthesis. Surgeons using this prosthesis should be aware of this unique potential complication of erosion into a viscus.