A budget impact analysis of a magnetic sphincter augmentation device for the treatment of medication-refractory mechanical gastroesophageal reflux disease: a United States payer perspective.

BACKGROUND: Medication-refractory gastroesophageal reflux disease (GERD) is sometimes treated with laparoscopic Nissen fundoplication (LNF); however, this is a non-reversible procedure associated with important side effects and the need for repeat surgery. Removable magnetic sphincter augmentation (MSA) devices are an alternative, effective, and safe treatment option for such patients who have some lower esophageal sphincter function. The objective of this study was to assess the economic impact of introducing MSA technology (i.e., LINX Reflux Management System) into current practice from a US-payer perspective. METHODS: An economic budget impact model was developed over a 1-year time horizon that compared current treatment of GERD patients who are medically managed (but refractory) or receiving LNF to future treatment of GERD patients that included a mix of patients treated with medical management only, LNF, or MSA. Resources included within the analyses were index procedures (inpatient and outpatient use), reoperations (revisions and removals), readmissions, healthcare visits, diagnostic tests, procedures, and medications. Medicare payment rates were typically used to inform unit costs. RESULTS: Assuming a hypothetical commercial insurance population of 1 million members, the base-case analysis estimated a net cost savings of $111,367 with introduction of the MSA. This translates to a savings of $0.01 per member per month. Results were largely driven by avoided inpatient procedures with use of the MSA device. Alternative analyses exploring the potential impact of increasing surgical volumes predicted that results would remain cost saving if the proportion of MSA market share taken from LNF was ≥ 90%. CONCLUSIONS: This study predicts that the introduction of the MSA device would lead to favorable budget impact results for the treatment of medication-refractory mechanical GERD for commercial payers. Future analyses will benefit from inclusion of middle-ground treatments as well as longer time horizons.

Comparison of surgical payer costs and implication on the healthcare expenses between laparoscopic magnetic sphincter augmentation (MSA) and laparoscopic Nissen fundoplication (LNF) in a large healthcare system.

INTRODUCTION: Magnetic sphincter augmentation (MSA) is a promising antireflux surgical treatment. The cost associated with the device may be perceived as a drawback by payers, which may limit the adoption of this technique. There are limited data regarding the cost of MSA in the management of reflux disease. The aims of the study were to report the clinical outcome and quality of life measures in patients after MSA and to compare the pharmaceutical and procedure payer costs and the disease-related and overall expense of MSA compared to laparoscopic Nissen fundoplication (LNF) from a payer perspective. METHODS AND PROCEDURES: This prospective observational study was performed in conjunction with the region's largest health insurance company. Data were collected on patients who underwent MSA over a 2-year period beginning in September 2015 at the study network hospitals. The LNF comparison group was procured from members' claims data of the payer. Inclusion was predicated by patients having continuous coverage during study period. The total procedural reimbursement and the disease-related and overall medical claims submitted up to 12 months prior to surgery and up to 12 months following surgery were obtained. The payer reimbursement data are presented as allowed cost per member per month (PMPM). These values were then compared between groups. RESULTS: There were 195 patients who underwent MSA and 1131 that had LNF. MSA results in comparable symptom control, PPI elimination rate, and quality of life measures compared to values reported for LNF in the literature. The median (IQR) reimbursement of surgery was $13,522 (13,195-14,439) for those who underwent MSA and $13,388 (9951-16,261) for patients with LNF, p = 0.02. In patients who underwent MSA, the median reimbursement related to the upper gastrointestinal disease was $ 305 PMPM, at 12 months prior to surgery and $ 104 at 12 months after surgery, representing 66% decrease in cost. These values were $ 233 PMPM and $126 PMPM for patients who underwent LNF, representing a 46% decrease (p = 0.0001). At 12 months following surgery, the reimbursement for overall medical expenses had decreased by 10.7% in the MSA group and 1.4% in the LNF group when compared to the preoperative baseline reimbursement. The reimbursement for PPI use after surgery showed a 95% decrease in the MSA group and 90% among LNF group when compared to the preoperative baseline (p = 0.10). CONCLUSION: When compared with LNF, MSA results in a reduction of disease-related expenses for the payer in the year following surgery. While MSA is associated with a higher procedural payer cost compared to LNF, payer costs may offset due to reduction in the expenses after surgery.

The Use of Endoclips in Thoracoscopic Correction of Esophageal Atresia: Advantages or Complications?

Background: Thoracoscopic correction of esophageal atresia (EA) with tracheoesophageal fistula (TEF) has been increasingly widespread, but is still one of the most advanced pediatric surgical skills. This procedure has a challenging learning curve, and usually initially requires a longer operative time than the open approach; furthermore to perform this intervention, the surgeon must be very experienced in endocorporeal knotting. In our opinion, standardization of the technique and the application of "tricks" (including the use of titanium endoclips for TEF closure) to make surgical steps easier, faster, and safe would be useful to the surgeon and to the patient above all. Materials and Methods: We present our experience in thoracoscopic treatment of EA/TEF over the past 12 years; during this period, we have treated 32 neonates. We reviewed all patient clinical records evaluating demographics, surgical technique, postoperative period, and long-term follow-up. Results: Thirty-one patients were affected by type C EA (five presented with a long-gap defect); one by type E EA. Mean gestational age was 36 + 5 weeks (29-41). Mean weight at surgery was 2340 g (990-3715 g). Through a transpleural thoracoscopic approach, after Azygos vein division, TEF was closed by sutures (silk/polydioxanone [PDS]) in 4 patients while in the remaining 28 two 5 mm titanium endoclips were applied. Esophageal anastomosis was then performed with 8-12 interrupted 5/0 absorbable sutures. We had two intraoperative complications in endoclips application (migration and misplacement), which were immediately resolved. After a contrast study on sixth to seventh postoperative day (average eighth), in the absence of leakage, oral feeding was started and chest tube removed. Four to six weeks after surgery, patients underwent endoscopic evaluation. At a follow-up of 9 years, we had no postoperative complications due to endoclips: neither TEF recurrence, nor problems due to clips dislocation. Conclusions: Although the benefits of thoracoscopic correction of EA/TEF are still discussed, we agree with this part of recent literature that considers thoracoscopic approach as a feasible, safe, and advantageous alternative to the traditional open approach. We also want to emphasize that in our experience, TEF closure by titanium endoclips is fast, reducing operative time, and effective, with no reported long-term complications in our case series. Overall success rate after clips application is, in our series, 100%. The only limit we have found, above all for low-weight patients, is the diameter of the clip applier which needs a 5 mm access even if the surgeon uses 3 mm operative instruments.

Gastric tube esophagoplasty for pediatric esophageal replacement.

BACKGROUND: Esophageal replacement in children is indicated in cases of esophageal atresia with or without fistula, in case of long gap esophageal atresia or failed primary repair. Intractable post corrosive esophageal stricture is considered also a major indication for replacement. METHODS: This is a cohort retrospective study of esophageal replacement cases by gastric tube carried out at the pediatric surgery department at Cairo University between 2011 and 2015. We reported 50 patients (30 boys and 20 girls); the ages ranged from 7months to 9years. Esophageal atresia cases were 27 while caustic esophageal stricture cases were 23. Isoperistaltic gastric tube technique was done in 45 patients while antiperistaltic (reversed) gastric tube technique was done in 5 cases. Retrosternal route was chosen in 38 patients while transhiatal route was chosen in 12 patients. RESULTS: Leakage and stricture were the most common complications. We had 5 cases of mortality, which were caused mainly by chest related complications. We had excellent to good results during long term follow up in terms of weight gain, swallowing pattern, quality of life, and overall satisfaction CONCLUSION: Gastric tube is a satisfactory surgical method for esophageal replacement in children. LEVEL OF EVIDENCE: III.

A novel method of esophageal lengthening in a large animal model of long gap esophageal atresia.

PURPOSE: Long gap esophageal atresia remains a significant treatment challenge. We aimed to create the first large animal model of long gap esophageal atresia to test a degradable esophageal lengthening device. METHODS: The distal esophagus was divided 2 cm above the gastroesophageal junction in 6 minipigs. A polycaprolactone (PCL) spring device was secured inside the distal esophageal segment, and the end was oversewn. Nonexpanding PCL tubes served as controls. An esophagogastric anastomosis was created to restore continuity. After 4 weeks, the distal esophageal pouch was analyzed. RESULTS: The distal esophageal pouch of experimental animals increased in length from 1.9 to 4.5 cm. Control animals demonstrated no change. When comparing lengthened to native esophagus, there was no difference in the thickness of muscularis mucosa or muscularis propria. Mechanically lengthened esophagus showed mild to moderate superficial inflammation and fibrosis. There were no differences in the number of myenteric or submucosal ganglia. CONCLUSION: We created the first porcine model of long gap esophageal atresia and lengthened the distal esophagus with an internally placed device. This model may be used to explore novel therapies in the management of long gap esophageal atresia.

[Efficacy of the use of remnant stomach in esophagoplasty].

In the period from 2001 till 2010 there were 117 extirpations of the oesophagus with single-stage plasty of the stomach in 94 patients and plasty of the large intestine--in 23 cases. Gastric resections were performed earlier in 50 (42.7%) patients, though gastrectomy took place in 39 (78%) patients. The accumulated experience allowed making an assessment of immediate and long-term results of esophagoplasty to patients, who had earlier the gastric resection. The incompetence of oesophagogastric anastomosis was noted in 2 times more frequent and the formation of stenosis of given anastomosis in 3 times more often. I order to improve the results of esophagoplasty, the method of serousmyotomy was applied in the cases of remnant stomach.

Robotic esophagectomy: new era of surgery.

Esophagectomy is a surgical operation which requires technical expertise to decrease the morbidity and mortality frequently associated with this advance procedure. Various minimally invasive esophagectomy techniques have been developed to decrease the negative impact of esophageal resection. Recently, robotic assisted esophagectomies have been described with a wide variety in technique and outcome disparity. This article is a summation review of the current literature regarding the various techniques and surgical outcomes of robotic assisted esophagectomies.

Thoracotomy for repair of esophageal atresia: not as bad as they want you to think!

Is it outdated now to do a thoracotomy to repair esophageal atresia (EA)? Our practices and the literature on the subject of thoracoscopic and open thoracotomy repair of EA were reviewed, seeking answers to the following questions: Is it correct to compare the new thoracoscopic approach for the repair of EA against the thoracotomy techniques of 15-30 years ago? Should post-thoracotomy scoliosis/thoracic deformity reported in up to 56% of patients be a significant current concern? Are the clips used to close the fistula in thoracoscopic repairs as safe as open suture closures? Is the leak and stricture rate similar with thoracoscopic surgery? Are the anesthesia, period of ventilation, pain, time to first feeding, and the length of hospital stay significantly different with current thoracotomy techniques compared with thoracoscopic methods? Is the cosmetic result of a thoracoscopic repair significantly better? Is the learning curve for EA thoracoscopic repair harming patients for minimal long-term benefit? These questions were scientifically unanswerable at this time. The limited EA thoracotomies currently performed have a track record of proven safety and minimal morbidity. The results published by surgeons who are pioneers in thoracoscopy may not be generalizable, and the complication rate from teams with less experience is likely underreported. In selected patients and with experienced teams, thoracoscopic EA repair is appropriate. However, EA repair via thoracotomy should, for now, remain as the 'gold standard'. Further registry-based, multicenter, comparative studies on EA repair methodologies and outcomes should provide important answers.

Application of the HyperEye Medical System for esophageal cancer surgery: a preliminary report.

The HyperEye Medical System is a newly developed device that allows for the visualization of the fluorescent image of indocyanine green enhanced by near-infrared light among the surrounding vivid color images. We recently applied this system to confirm the blood flow of an esophageal substitute, and for sentinel node navigation during esophagectomy. Five consecutive patients with thoracic esophageal cancer who underwent a subtotal esophagectomy between June 2010 and May 2011 were enrolled in the study. The esophageal substitute used for reconstruction was the stomach and ileocecum in four and one cases, respectively. In all cases with a reconstructive stomach, fine arterial blood flow and venous perfusion were observed. The blood flow of the reconstructive colon was poor before microvascular anastomosis, however, it dramatically increased after anastomosis. Concerning the sentinel node navigation, the fluorescence of lymph nodes, lymphatic vessels, and the tumor site were detected. The postoperative courses of all cases were uneventful, with no mortalities or anastomotic leakage occurring.

Major complications of pneumatic dilation and Heller myotomy for achalasia: single-center experience and systematic review of the literature.

OBJECTIVES: Pneumatic dilation (PD) and laparoscopic Heller myotomy (LHM) can be definitive therapies for achalasia; recent data suggest comparable efficacy. However, risk must also be considered. We reviewed the major complication rate of PD and LHM in a high-volume center and reviewed the corresponding literature. METHODS: We reviewed 12 years of our institution's achalasia treatment experience. During this interval, a consistent technique of PD was used utilizing Rigiflex dilators. Medical records were reviewed for post-procedure complications. We administered a telephone survey and examined medical records to assess efficacy of treatment. We also performed a systematic review of the literature for comparable clinical data and examined 80 reports encompassing 12,494 LHM and PD procedures. RESULTS: At our center, 463 achalasia patients underwent 567 PD or LHM procedures. In all, 78% of the PDs used a 30-mm Rigiflex dilator. In all, 157/184 (85%) patients underwent 1 or 2 PD without any subsequent treatment. There were seven clinically significant perforations; one from PD and six from LHM. There were no resultant deaths from these perforations; two deaths occurred within 30 days of LHM from unrelated causes. Complications and deaths post-PD were significantly fewer than those post-LHM (P=0.02). CONCLUSIONS: Esophageal perforation from PD at our high-volume center was less common than often reported and lower than that associated with LHM. We conclude that, in the hands of experienced operators using conservative technique, PD has fewer major complications and deaths than LHM.

Pharyngoesophageal junction neoplasia--therapeutic management.

Not only the anatomy but the treatment and the prognosis of these tumors are intermediate between hypopharyngeal and esophageal tumors. After a portion of the esophagus is removed or complete esophagectomy, a conduit must be established. The authors reviewed the experience of Prof. Cristian Popescu in total pharyngo-laryngectomy and his technique of pharyngoesophageal reconstruction with synthetic esophageal prosthesis. We have some 21 patients who underwent an esophageal reconstruction with Montgomery esophageal tube. This is a very important new, modem, interdisciplinary approach bewteen the head and neck surgeon and the general/thoracic surgeon to treat the pharyngo-laryngo-esofageal neoplasia with one stage reconstruction. The follow up for these patients shows that this reconstruction method is a good, reliable choice with low costs and considerable advantages for the quality of life. Surgery for these patients should be considered primarily palliative and the optimal reconstruction should preserve the quality of life for the duration of survival.

In vitro experiments with the triangular flap cutter applied to functional tracheoesophageal shunt for voice rehabilitation after total laryngectomy.

BACKGROUNDS: Since the introduction and practice of functional tracheoesophageal shunt (FTES) for voice rehabilitation after total laryngectomy, patients have often suffered from fistula-related complications such as aspiration, tract stenosis and infection partly as a result of nonstandardized or incorrectly made flap operation. In striving to solve these problems as far as possible, a triangular flap cutter (TFC) was developed to perform the flap operation. METHODS: Flap operations were performed using a TFC on 10 tracheoesophageal models (pigs) and 10 fresh esophageal models (esophageal cancer patients, with their informed consent) and incision parameters and incision effects were detected. RESULTS: Perfect triangular flaps were achieved in 18 out of 20 cases using the TFC with minimal peripheral tissue injury (average time, 2-3 min). Of the 2 unsuccessful cases, 1 case exhibited insertion failure and the other experienced flap creation failure due to clinical contraindication for TFC use and insufficient operational skills, respectively. CONCLUSIONS: The TFC is a new device, which offers the unique advantage of precise incision for the creation of a flap, with the potential to resolve fistula-related problems and improve operation efficiency.

Unsuccessful alloplastic esophageal replacement with porcine small intestinal submucosa.

In general, there is no perfect method for esophageal replacement under consideration of the numerous associated risks and complications. The aim of this study was to examine a new material--small intestinal submucosa (SIS)--in alloplastic esophageal replacement. We implanted tubular SIS prosthesis about 4 cm in length in the cervical esophagus of 14 piglets (weight 9-13 kg). For the first 10 days, the animals were fed parenterally, supplemented by free given water, followed by an oral feeding phase. Four weeks after surgery, the animals were sacrificed. Only 1 of the 14 animals survived the study period of 4 weeks. The other piglets had to be sacrificed prematurely because of severe esophageal stenosis. On postmortem exploration, the prosthesis could not be found either macroscopically or histologically. Sutures between the prosthesis and the cervical muscles did not improve the results. Until now, the use of alloplastic materials in esophageal replacement has failed irrespective of the kind of material. As well as in our experiments, severe stenosis had been reported in several animal studies. The reasons for this unacceptable high rate of stenosis after alloplastic esophageal replacement seem to be multifactorial. Possible solutions could be transanastomotic splints, less inert materials, the decrease of anastomotic tension by stay sutures, the use of adult stem cells, and tissue engineering.

Large paraesophageal hernias in children. Early experience with laparoscopic repair.

BACKGROUND: Large paraesophageal hernias (LPEH) in children are unusual. The aim of this study is to report the management of LPEH and our initial experience with the laparoscopic approach. METHODS: Since September 2005, four children aged 4-17 years underwent laparoscopic repair of LPEH at the Children's Hospital of Eastern Ontario. Three children had previous fundoplications and two of these had a gastrostomy. Closure of the hiatal defect included crural sutures and prosthetic material, either polytetrafluoroethylene-polypropylene mesh or porcine small intestinal submucosal patch. The charts were retrospectively analyzed. RESULTS: The operative time was 300-540 minutes, with one conversion and two mediastinal pleural tears. Postoperative chest X-ray showed neither mediastinal nor intrapleural air. The median hospital stay was 3 days. Contrast X-ray showed no recurrent hernia and an intact fundoplication. CONCLUSION: LPEH in children is usually a complication of previous fundoplication. Laparoscopic repair is technically demanding but feasible. Adequate crural repair using mesh may reduce the incidence of recurrence. In view of the rarity of LPEH in children, a combined multicenter study is needed to evaluate the results of laparoscopic repair.

Hand-assisted laparoscopic esophagojejunostomy using newly developed purse-string suture instrument "Endo-PSI".

Although there are several reports on the esophagojejunostomy during laparoscopy-assisted total gastrectomy, the procedures still remain to be established. We report hand-assisted laparoscopic esophagojejunostomy using circular stapler and newly developed instrument "Endo-PSI." Between April 2005 and April 2006, 13 patients received these products during laparoscopy-assisted total gastrectomy. The Endo-PSI was attached to the abdominal esophagus using hand-assisted laparoscopic surgery. The insertion of the straight needle with 2-0 polypropylene into the device and the cutting of the esophagus were also performed using hand-assisted laparoscopic surgery. The insertion of the anvil head into the esophagus and the ligation of the purse-string suture were performed laparoscopically. After the jejuno-jejunal anastomosis was performed extracorporeally, the combination of the circular stapler for esophagojejunostomy and the closure of the stump of the jejunum were performed laparoscopically. There were no complications attributable to this procedure and there were no cases that required conversion to conventional open procedure or required extension of median incision. This newly developed Endo-PSI was useful for laparoscopic purse-string suture.