Angelchik Antireflux Prosthesis Research Articles

Foregut Erosion Related to Biomedical Implants: A Scoping Review.

Introduction: Biomedical devices implanted transabdominally have gained popularity over the past 50 years in the treatment of gastroesophageal reflux disease, paraesophageal hiatal hernia, and morbid obesity. Device-related foregut erosions (FEs) represent a challenging event that demands special attention owing to the potential of severe postoperative complications and death. Purpose: The aim was to provide an overview of full-thickness foregut injury leading to erosion associated with four types of biomedical devices. Methods: The study was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). PubMed, EMBASE, and Web of Science databases were queried until December 31, 2023. Eligible studies included all articles reporting data, management, and outcomes on device-related FE. Results: Overall, 132 articless were included for a total of 1292 patients suffering from device-related FE. Four different devices were included: the Angelchik antireflux prosthesis (AAP) (n = 25), nonabsorbable mesh for crural repair (n = 60), adjustable gastric banding (n = 1156), and magnetic sphincter augmentation device (n = 51). The elapsed time from device implant to erosion ranged from 1 to 480 months. Most commonly reported symptoms were dysphagia and epigastric pain, while acute presentation was reported rarely and mainly for gastric banding. The technique for device removal evolved from more invasive open approaches toward minimally invasive and endoscopic techniques. Esophagectomy and gastrectomy were mostly reported for nonabsorbable mesh FE. Overall mortality was .17%. Conclusions: Device-related FE is rare but may occur many years after AAP, nonabsorbable mesh, adjustable gastric banding, and magnetic sphincter augmentation implant. FE-related mortality is infrequent, however, increased postoperative morbidity and the need for esophagogastric resection were observed for nonabsorbable mesh-reinforced cruroplasty.

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.

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.

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® anti-reflux prosthesis (AARP) for gastroesophageal reflux disease (GERD): a 10 to 23 years follow up

The Angelchik® anti-reflux prosthesis (AARP) for gastroesophageal reflux disease (GERD): a 10 to 23 years follow up

Reoperation for complications of the Angelchik antireflux prosthesis

The Angelchik antireflux prosthesis is associated with complications that require reoperation in 5% to 15% of patients. To determine the morbidity and success of reoperation for these complications, we conducted a retrospective study of 15 patients. Time to reoperation ranged from 3 weeks to 113 months with a mean of 31 months. Indications for reoperation included dysphagia (8 patients), recurrent reflux (6 patients), and prosthesis migration (1 patient). Ten patients underwent prosthesis removal and fundoplication, 4 had prosthesis removal without fundoplication, and 1 patient had the prosthesis repositioned. latrogenic splenic injury occurred in 2 patients (13%); one splencctomy and one splenic repair were done. Four patients (27%) required intraoperative blood transfusion. There were no operative deaths. Removal of the prosthesis without fundoplication resulted in a significantly higher incidence of recurrent reflux (75%) than prosthesis removal and fundoplication (10%) (p < 0.04). Although reoperation for complications of the Angelchik antireflux prosthesis can be technically difficult, morbidity and mortality are acceptable. An antireflux procedure should be done at the time of prosthesis removal.

Regression of columnar lined (Barrett's) oesophagus with continuous omeprazole therapy.

Twenty-three adult patients with a columnar lined (Barrett's) oesophagus are being treated with long-term omeprazole, 40 mg daily. Twelve had never undergone anti-reflux surgery (Group 1), the other eleven having previously had insertion of an Angelchik anti-reflux prosthesis (Group 2). Endoscopy was carried out six months before, immediately before and six months, one year and two years into treatment. Multiple and standardized biopsies were taken at each endoscopy. Results from the two groups were similar. During the 6-month run-in period there was a statistically non-significant increase in the linear extent of the columnar mucosa, but this showed a progressive, statistically significant decrease during the two years of treatment. Other evidence for regression of the Barrett's mucosa includes the emergence of large numbers of macroscopic squamous islands within the abnormal mucosa, an increase in the number of microscopic squamous islands, and microscopic squamous encroachment of the abnormal mucosa at the squamo-columnar junction. Histological assessment showed a reduction in the proportion of sulphomucin-rich intestinal metaplasia, but this only achieved statistical significance in Group 1. The results substantiate the importance of acid in the pathogenesis of Barrett's oesophagus. Omeprazole may have a therapeutic role in bringing about regression of the metaplastic epithelium.

Minimal access surgery for gastroesophageal reflux: laparoscopic placement of the Angelchik prosthesis in pigs

Conventional surgery for gastroesophageal reflux is effective but requires laparotomy. Minimal access surgery for gastroesophageal reflux could provide a decrease in morbidity. The Angelchik antireflux prosthesis is an alternative to fundoplication for the treatment of this ailment. We evaluated the results of laparoscopic placement of the Angelchik prosthesis in 10 pigs. The duration of the procedure averaged 44 min. The mean lower esophageal sphincter pressure increased from 12.2 +/- 2.8 mmHg at baseline to 45.2 +/- 7.8 (P less than 0.05), 32.1 +/- 3.9 (P less than 0.05), and 25.1 +/- 6.5 mmHg (P greater than 0.05) as measured immediately postoperatively, at 1 week, and at 3 weeks, respectively, following placement of the prosthesis. There was no instance of prosthetic migration or esophageal perforation. One postoperative death due to distention and perforation of the colon occurred. Two animals developed distal esophageal impaction of food. We conclude that the antireflux prosthesis can be safely and effectively placed using laparoscopic methods in a porcine model. Further development of this technique is warranted.

Complications of the Angelchik antireflux prosthesis: endoscopic management

1. Collaborative DHPG Treatment Study Group. Treatment of serious cytomegalovirus infections with 9-{l,3-dihydroxy-2-propoxymethyl) guanine in patients with aids and other immunodeficiencies. N Engl J Med 1986;314:801-5. 2. Ahmed N, Nelson RS, Goldstein HM, Sinkovics JC. Kaposi's sarcoma of the stomach and duodenum: endoscopic and roentgenologic correlations. Gastrointest Endosc 1975.21:149.

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.

Assessment of the Angelchik prosthesis for treatment of symptomatic esophageal reflux.

AbstractDuring a recent 5‐year period, 74 patients were fitted with an Angelchik antireflux prosthesis for symptomatic reflux esophagitis. Seventy‐five percent of 28 patients in the initial series (series 1) have had excellent to very good response to the prosthesis, as indicated by a clinical follow‐up of 36–60 mo. The main cause of failure in this series was prosthesis disruption (4 of 28 patients). Ninety‐two percent of 46 patients in the more recent series (series 2) have had excellent to very good response to prosthesis placement. The new prosthesis design, which includes a circumferential strap, has completely eliminated prosthesis disruption. Of the total series of patients, 19% of patients experienced transient dysphagia. This complication was no longer significant by 6 mo postoperatively, and no prostheses have had to be removed because of this complication. There have been no instances of erosion of the prosthesis. In addition to clinical data, lower esophageal sphincter measurements and recently, 24‐hr ambulatory pH monitoring have demonstrated a physiological effect of reflux protection after prosthesis placement. In our experience, the Angelchik prosthesis has been especially useful in high‐risk patients, patients who have recurrent esophagitis after previous antireflux or foregut surgery, and patients who would probably not have been referred for conventional antireflux surgery. In view of our data, we believe that the Angelchik prosthesis should continue to be commercially available as a surgical option for treating selected patients with medically refractory reflux esophagitis.

Angelchik antireflux device: Computed tomography appearance

The Angelchik antireflux prosthesis is a silicon gel-filled, doughnut-shaped device with a tantalum tie strap that wraps around the gastroesophageal junction after reduction of a hiatal hernia. If dislodged, this prosthesis may produce a confusing picture on computed tomography, as it is of soft tissue density and may mimic a mass lesion. The computed tomography appearance of a normally placed prosthesis is demonstrated, and a case of prosthesis dislodgment diagnosed by computed tomography is reported.

Angelchik antireflux prosthesis associated with pericarditis and complete transmural migration

In 1979 Angelchik and Cohen reported the results ofa series of 46 patients who had surgical implantation of a silicone device around the esophagogastric junction. They reported excellent results in terms of alleviating symptoms of reflux, increasing lower esophageal sphincter pressure, and eliminating radiological findings of reflux and hiatal hernia. Furthermore, they noted that this procedure could be performed concurrently with another procedure such as cholecystectomy without increased morbidity. This report, combined with the facility with which such a prosthesis could be implanted, encouraged widespread utilization of these devices. By June 1984 approximately 18,000 Angelchik prostheses had been implanted. In the absence of a prospective system for reporting results with this new device, reports of complications are described in a few series and case reports. We are presenting a case report involving unusual complications of this device and our experience in managing them. CASE REPORT A 25-year-old male was well until April 1981 when he developed symptoms of pyrosis, epigastric pain, and nausea. Reflux esophagitis with a hiatal hernia was diagnosed in early December 1981. Medical management with cimetidine, antacids, urecholine, and elevation of head of bed was unsuccessful after 4 months. Endoscopy in April 1982 disclosed esophagitis. In mid-April an Angelchik prosthesis was implanted and the diaphragmatic crura were plicated. His postoperative course was complicated by a left lower lobe pneumonitis and complaints of dysphagia and vomiting. One month following surgery, an upper GI series showed delay in the passage of barium from the esophagus into the stomach. By July 1982, a 30-lb weight loss was noted. Thereafter, dysphagia subsided and he felt well until December 1982 when he noted substernal pain with radiation to the left shoulder and fever. Pericarditis was diagnosed with pericardial-window tissue cultures growing Staphylococcus epidermidis, while pericardial fluid cultures grew Staphylococcus aureus. Multiple blood cultures and urine cultures had no growth. Antibiotic

The Angelchik Antireflux Prosthesis

To the Editor.— We read with interest the recent Diagnostic and Therapeutic Technology Assessment (DATTA) report 1 on the Angelchik antireflux prosthesis. As surgeons who implant the prosthesis on a weekly basis, we believe that implantation should not be performed routinely by surgeons unfamiliar with the finer anatomy of the infradiaphragmatic esophagus. However, we do not agree with the panelists' conclusion that concerns about the safety of the device compromise its clinical utility. In our six-year clinical series, 2 which represents the implantation of 410 Angelchik prostheses, there have been no instances of migration while using the improved device with the single circumferential strap (available after the spring of 1982). In addition, the problem of erosion has been eliminated by doing minimal dissection at the level of the lower esophageal sphincter coupled with an anterior fundal gastropexy. Further, the major problem following implantation and one that affects many more patients

The Angelchik Antireflux Prosthesis

To the Editor.— It is my understanding that, of the 24 DATTA panelists who assessed the Angelchik antireflux prosthesis,1few were surgeons and of these even fewer had ever implanted this antireflux device. Eight of the panelists found the device unacceptable. The conclusions of this well-re-searched article are not supported by the data presented therein. It is my belief that if you take the other major procedures for antireflux surgery—like Nissen's fundoplication, Hill's procedure, or the Belsey operation—and present them to a panel of 24 surgeons, one third will probably find any one of these procedures unacceptable simply because these surgeons employ one of the other procedures and find it satisfactory. In the case of 24 physicians who are not specialist surgeons, I cannot begin to imagine what the conclusions would be. The article mentions that of the 7721 protheses with vulcanized straps that were used from 1979 through

The mechanical effect of the angelchik antireflux prosthesis on the lower esophageal sphincter

The mechanical effect of the angelchik antireflux prosthesis on the lower esophageal sphincter

Diagnostic and therapeutic technology assessment. Angelchik antireflux prosthesis

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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.

A Prospective Randomized Double‐Blind Study of Gastroesophageal Reflux Surgery in Pediatric‐Sized Developmentally Disabled Patients

SummaryIn 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 &lt; 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.

Complications of the Angelchik antireflux prosthesis: A community experience

The use of the Angelchik antireflux prosthesis has increased rapidly in our community since its introduction in 1979. Our experience with two patients who had serious complications associated with this prosthesis led us to review all 76 patients in our community who had undergone implantation of the device. Complications developed in 20 patients after placement of the prosthesis, and 12 of them required subsequent laparotomy for removal of the prosthesis. The complications observed were persistent dysphagia, late-onset dysphagia, transient dysphagia, persistent vomiting, esophageal obstruction, early gas bloat syndrome, gastric erosion, slippage of the prosthesis over the gastric fundus, disruption of the prosthesis, and migration of the prosthesis. Because of the frequency of potentially serious complications, we cannot recommend its use in the surgical treatment of esophageal reflux.