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.     

Surgery for gastro-oesophageal reflux: the Angelchik prosthesis compared to the floppy Nissen fundoplication. Two-year follow-up study and a five-year evaluation of the Angelchik prosthesis.

Twenty-two patients were followed for 5 years after insertion of an Angelchik prosthesis for gastro-oesophageal reflux (GOR) and the 2-year results compared with a subsequent group of 28 patients treated by floppy Nissen fundoplication. The overall clinical results of the two procedures were equivalent at 2 years (Angelchik Visick 1 and 2, 80%; Nissen Visick 1 and 2, 78%) but the reasons for failure were different. In the Angelchik group failures were due to mechanical problems associated with the device, whereas the Nissen failures were mainly due to recurrent GOR. There were no patients in the Angelchik group with recurrent reflux at 5 years, but between 4 and 5 years postoperatively four patients developed mild dysphagia. The Angelchik prosthesis appears to be as effective as the floppy Nissen fundoplication, but further long-term studies are required before its widespread use can be recommended.     

A prospective randomized trial of angelchik prosthesis versus Nissen fundoplication

A total of 61 patients with gastro-oesophageal reflux; resistant to medical therapy, were entered into a prospective randomized trial comparing the Angelchik antireflux prosthesis with Nissen's fundoplication. Both groups had a similar age and sex distribution and their reflux profiles were comparable. An Angelchik prosthesis was inserted in 30 patients and 31 underwent fundoplication. The mean duration of postoperative follow-up was 38 months. At clinical assessment 23 (77 per cent) of the Angelchik group were graded Visick grade I or II, compared with 29 (94 per cent) of the Nissen group. Assessment by 24 h pH monitoring and manometry between 3 and 6 months after operation showed that both procedures were equally effective in reducing reflux and increasing lower oesophageal sphincter pressure. However, long-term endoscopic follow-up revealed grade III oesophagitis in seven patients in the Angelchik group. No patient in the fundoplication group had grade III oesophagitis. Three of eight patients with strictures in the Angelchik group reported persistent dysphagia. All seven patients with strictures in the Nissen group were relieved of their dysphagia. Migration or erosion of the prosthesis did not occur. Three prostheses (10 per cent) were removed, two for dysphagia and one because of sepsis.     

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.     

The Angelchik prosthesis for gastro-oesophageal reflux: symptomatic and objective assessment.

Twenty-three patients with intractable gastro-oesophageal reflux were treated by insertion of the Angelchik antireflux prosthesis. Good symptomatic relief was achieved in over 80% of patients reviewed up to 28 months after operation and there was marked resolution of oesophagitis as seen on endoscopy. Oesophageal manometry and pH studies performed preoperatively and at 3 and 12 months after operation, showed a significant increase in lower oesophageal sphincter pressure with decreased acid reflux. Some technical problems were encountered, but the prosthesis is potentially a simple and effective means of controlling gastro-oesophageal reflux.     

Prospective randomized trial of Nissen fundoplication and Angelchik prosthesis in the surgical treatment of medically refractory gastro-oesophageal reflux disease

Fifty patients with gastro-oesophageal reflux disease refractory to multiple courses of medical therapy were entered into a prospective randomized trial comparing Nissen fundoplication with the Angelchick prosthesis as a primary surgical procedure. The two groups were matched for age, sex, duration of symptoms before surgery, type of medical therapy, pattern of symptom presentation, endoscopic grade of oesophageal inflammation, manometric lower oesophageal pressure and 24-h pH profile. Twenty-five patients were randomized to each of the Nissen fundoplication and Angelchik prosthesis groups. Operation time and hospital stay were similar in both groups. Persistent dysphagia was reported in five of the patients with an Angelchik prosthesis compared with none in the Nissen fundoplication group. Three prostheses were removed because of severe dysphagia while no Nissen fundoplication required revision. No patient with preoperative dysphagia because of stricture reported swallowing difficulties after operation. At clinical assessment at 3, 6, 12 and 24 months after operation, 85-88 per cent of the patients having a Nissen fundoplication were graded Visick 1 or 2 compared with 60-72 per cent of patients in the Angelchik group.     

Oesophageal transit of marshmallow after the Angelchik procedure

The oesophageal transit time of half a marshmallow was measured radiologically in 17 controls, 28 patients with gastro-oesophageal reflux pre-operatively, 36 patients soon after implantation of the Angelchik prosthesis (2-9 weeks) and in 23 patients later postoperatively (9-48 months). Sixteen postoperative patients also underwent oesophageal manometry. All control and pre-operative patients had a marshmallow transit time of less than 1 min; 67 per cent of the early postoperative patients had prolonged transit and 70 per cent of the late tests were similarly abnormal. Prolonged oesophageal transit as measured by marshmallow swallow correlated well with symptoms of solid food dysphagia. Most, but not all, patients with an abnormal marshmallow swallow had abnormal manometric findings. The oesophageal transit of solid food is significantly slowed after the Angelchik procedure and this is not a transient postoperative phenomenon.     

A quantitative assessment of results with the Angelchik prosthesis.

The Angelchik antireflux prosthesis was assessed in 15 unpromising patients, 12 of whom had peptic strictures of the oesophagus. Radiological techniques were used to show the effect of the device on gastro-oesophageal reflux, and on the bore and length of strictures. Twelve months later (range 6-24) most patients were well satisfied with the operation, and all considered it had been worthwhile; there was radiological evidence of reduction in reflux and remission of strictures. The device never surrounded the oesophageal sphincter; in all but 1 case it encircled a tube of stomach.     

Oesophageal erosion of an Angelchik prosthesis: surgical management using fundoplication.

Complications following insertion of the Angelchik prosthesis are becoming increasingly recognised. We report a 35-year-old patient with both mediastinal migration and intraluminal oesophageal erosion of a prosthesis. Successful management included transthoracic removal combined with a modified onlay fundoplication over the oesophageal defect to prevent gastro-oesophageal reflux.     

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.     

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.     

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.     

Complications of the Angelchik prosthesis in the management of gastroesophageal reflux

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.     

The Angelchik anti-reflux prosthesis and postoperative dysphagia

Dysphagia was studied in 29 patients after implantation of an Angelchik prosthesis for persistent reflux oesophagitis. The incidence of postoperative dysphagia occurred after three months (61%), six months (45%), and one year or more (41%). Severe dysphagia necessitated removal of the prosthesis in five patients (17%). The reoperative findings with regard to a possible explanation of dysphagia are discussed, and comparison is made with reports in literature. Implantation of the Angelchik prosthesis seems only indicated for the treatment of intractable reflux oesophagitis in patients where other operative modalities failed and who are at high risk for operation. The Nissen fundoplication remains the operation of choice.     

Evaluation of the Angelchik Antireflux Prosthesis Using a Model for Esophageal Reflux in Rhesus Monkeys

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.     

Endoscopic management of intragastric migration of an Angelchik prosthesis

The Angelchik prosthesis was devised as a simple surgical solution for reflux oesophagitis. Since 1983 there have been increasing reports of complications attributed to the prosthesis, the more serious being transmural erosion through the oesophageal or gastric wall. The majority of these have required repeat surgery, which is not without risks. A case report of an Angelchik prosthesis incompletely eroding into the stomach is presented. The prosthesis was tethered by a 1 cm-thick mucosal bridge which precluded simple extraction. Using an endoscopic sphincterotome, the bridge was divided and the prosthesis removed. Endoscopic methods of extracting intragastric Angelchik prostheses should be considered before surgery is undertaken for this complication.     

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.     

Treatment of symptomatic gastroesophageal reflux using the Angelchik prosthesis.

During the past 20 months, 28 patients with symptomatic gastroesophageal reflux were treated with the Angelchik anti-reflux prosthesis. The patients ranged in age from 12 to 75 years, with symptoms present from one to 24 years. Vigorous medical management had failed with all patients prior to surgery. Before operation, 28 of 28 patients had upper GI x-rays, 27 of 28 fiberoptic esophagogastroscopy, 26 of 27 esophageal biopsy, eight of 28 Bernstein testing, and 24 of 28 lower esophageal sphincter pressure and motility. Eight patients had strictures requiring preoperative or postoperative dilatation. In four of 28 patients, a Nissen procedure had been previously done. In addition, two patients had metaplastic epithelium, and a single patient a previous Heller myotomy. Twenty-five of the 28 patients are completely asymptomatic eight to 20 months after Angelchik insertion. Fifteen patients had surgery more than one year previously. There are no recurrent hiatal hernias. Endoscopy and biopsy reveal resolution or marked improvement in the esophagitis. Seven patients complained of transient dysphagia lasting up to three months. One patient has persistent "gas bloat" syndrome. There were no technical or perioperative complications. Trouble with the prosthesis occurred in two patients; in one, the prosthesis disrupted and fell into the pelvis, and in the other the prosthesis migrated into the mediastinum. LES pressures preoperatively were 6.17 +/- 0.9 and 16.95 +/- 1.76 mmHg for the 19 patients studied after operation. The limited sample of patients who were studied with preoperative and postoperative acid-reflux tests have all shown improvement in their score. The Angelchik prosthesis in this series has been safe, simple, and reproducible, and can eliminate the symptoms and signs of gastroesophageal reflux.     

The Angelchik antireflux device: a 5-year experience.

A total of 44 patients had an Angelchik antireflux prosthesis inserted over a 5-year period. Of these, 41 were available for review and were assessed by interview using a modified Visick grading. Of the 23 patients followed up for a minimum of 3 years 74% had an excellent or satisfactory outcome; 92% of patients with symptoms of reflux obtained relief, but less than 50% of those patients presenting with dysphagia had a satisfactory outcome. The incidence of mild postoperative dysphagia increased the longer the period of follow-up. The main cause of a Visick 3 or 4 result was prosthesis migration. We have modified our technique of insertion to reduce these complications, and in a more recent series have achieved a Visick Grade 1 or 2 in up to 92% of patients. We conclude that dysphagia is a relative contraindication to the insertion of the Angelchik prosthesis. Our recent results encourage the use of the prosthesis provided steps are taken to reduce the incidence of migration and pericapsular fibrous tissue formation.     

Duodenal diversion with vagotomy and antrectomy for severe or recurrent reflux oesophagitis and stricture: an alternative to operation at the hiatus.

In cases of mild symptomatic gastro-oesophageal reflux, standard antireflux surgery, such as fundoplication or the Angelchik prosthesis, produces satisfactory results. Duodenal diversion is recommended for use only in patients with severe oesophageal damage. This situation commonly arises where the gastro-oesophageal junction cannot be reduced into the abdomen, or where previous surgery has made reoperation at the hiatus difficult and hazardous. Fifty-seven patients with severe reflux oesophagitis have been treated by Roux-en-Y duodenal diversion and antrectomy. Thirty three patients had vagotomy in addition. Median follow-up after operation is 6.1 years. In 35 patients (61%), the technique was used as primary surgical treatment. These included 22 patients in a randomized trial of the method. Thirteen (23%) had previously had unsuccessful antireflux surgery. Nine (16%) had undergone previous operations for peptic ulcer or achalasia. There was no operative mortality. No patient in the series required stricture resection. Good or excellent overall results were achieved in 86% of patients. Eighteen of twenty seven patients with severe strictures required an average of three dilatations after operation before dysphagia was completely relieved. Heartburn was dramatically relieved and oesophagitis settled within an average period of 6 months. Poor or unsatisfactory overall results were observed in 8 (14%) patients. These included one tight fibrous stricture which required endoscopic intubation despite resolution of oesophagitis, and four patients who developed a stomal ulcer. No patients suffered from the dumping syndrome. Malignancy must be carefully excluded by biopsy in all cases of stricture.