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An experimental study on long term outcomes after magnetic esophageal compression anastomosis in piglets

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Abstract

Background/Purpose Previous studies have shown that a patent, watertight esophageal anastomosis can be accomplished safely using specially-shaped magnets in piglets. However, it is unclear whether such a magnetic esophageal compression anastomosis (MECA) remains patent in the long-term. The purpose of this study was to evaluate the long-term outcome of MECA in an experimental pig model over an observation period of 2 months. Methods Ten piglets underwent creation of an MECA with custom-made 8mm magnets and a U-shaped esophageal bypass loop to allow peroral nutrition at eight weeks of life. Two weeks later, the bypass loop was closed surgically, requiring the pigs to swallow via the newly created magnetic compression anastomosis. The pigs were fed soft chow for 2 months. They were monitored for weight gain and signs of dysphagia. At the endpoint of two months, esophagoscopy and contrast esophagography was performed. After removal of the esophagus, the tissues were macroscopiocally and histologically assessed. Results Six piglets survived until the endpoint. In two pigs, closure of the bypass loop failed, these demonstrated mean weight gain of 792 grams/day [95% Confidence interval 575 to 1009 grams/day]. Weight gain in four pigs that exclusively fed via the magnetic anastomosis averaged 577 grams/day [95% confidence interval 434 to 719 grams/day (p=0.18)]. There were no signs of dysphagia. All magnets passed with the stool within 16 days. After 2 months, a well-formed magnetic compression anastomosis was visible and easily negotiated with a 6.5mm endoscope. Esophogram and macroscopic findings confirmed patentency of the esophageal anastomoses. Histopathology showed a circular anastomosis lined with contiguous epithelium. Conclusion MECA creates a long-term functional and patent anastomosis in pigs. This concept may facilitate minimally-invasive esophageal atresia repair by obviating a technically challenging and time-consuming hand-sewn anastomosis.

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... Since Obora reported the study of microvascular magnetic anastomosis in 1978, magnetic compression anastomosis (MCA) has attracted the attention of clinicians. The research on MCA and its clinical application in gastroenterology comprises esophageal [1][2][3], gastrointestinal [4][5][6], and small bowel [7][8][9] anastomosis. Other examples include vascular[10-11] and ureterovesical [12] anastomosis. ...
Article
BACKGROUND Despite much work having been conducted on magnetic compression anastomosis (MCA) in the digestive tract, there are no reports on the influence of magnetic force on the anastomosis. AIM To investigate the effect of different magnetic force magnets on the MCA of the digestive tract. METHODS Two groups of magnets of the same sizes but different magnetic forces were designed and produced. A total of 24 Sprague-Dawley rats were randomly assigned into two groups (powerful magnet group and common magnet group), with 12 rats in each group. Two types of magnets were used to complete the colonic side-to-side anastomosis of the rats. The operation time and magnet discharge time were recorded. The anastomotic specimens were obtained 4 wk after the operation and then the burst pressure and diameter of the anastomosis were measured, and the anastomosis was observed via the naked eye and subjected to histological examination. RESULTS The magnetic forces of the powerful and common magnet groups at zero distance were 8.26 N and 4.10 N, respectively. The colonic side-to-side anastomosis was completed in all 24 rats, and the operation success rate and postoperative survival rate were 100%. No significant difference was noted in the operation time between the two groups. The magnet discharge time of the powerful magnet group was slightly longer than that of the common magnet group, but the difference was not statistically significant (P = 0.513). Furthermore, there was no statistical difference in the burst pressure (P = 0.266) or diameter of magnetic anastomosis (P = 0.095) between the two groups. The gross specimens of the two groups showed good anastomotic healing, and histological observation indicated good mucosal continuity without differences on healing. CONCLUSION In the rat colonic side-to-side MCA model, both the powerful magnet with 8.26 N and the common magnet with 4.10 N showed no significant impact on the anastomosis establishment process or its effect.
... Magnetic compression anastomosis (MCA) is a novel technique for the anastomosis of cavity organs through "noncontact" magnetic force. The current basic and clinical studies on MCA cover esophageal anastomosis [7][8][9], gastrointestinal anastomosis [10,11], and colorectal anastomosis [12,13] of the digestive system. MCA can be used for vascular anastomosis [14][15][16] and therapeutic ostomy [17][18][19] for non-gastrointestinal conditions. ...
Article
BACKGROUND Treatment of postoperative anastomotic stenosis for colorectal cancer is often challenging, especially for patients who do not respond well to endoscopy. In cases where patients have undergone an enterostomy, the stenosis can be easily resolved through magnetic compression. However, common magnetic compression techniques cannot be performed on those without enterostomy. We designed a novel Y–Z deformable magnetic ring (Y–Z DMR) and successfully applied it to a patient with a stenosis rectal anastomosis and without enterostomy after rectal cancer surgery. CASE SUMMARY We here report the case of a 57-year-old woman who had undergone a laparoscopic radical rectum resection (Dixon) for rectal cancer. However, she started facing difficulty in defecation 6 months after surgery. Her colonoscopy indicated stenosis of the rectal anastomosis. Endoscopic balloon dilation was performed six times on her. However, the stenosis still showed a trend of gradual aggravation. Because the patient did not undergo an enterostomy, the conventional endoscopic magnetic compression technique could not be performed. Hence, we implemented a Y–Z DMR implemented through the anus under single channel. The magnetic ring fell off nine days after the operation and the rectal stenosis was relieved. The patient was followed up for six months and reported good defecation. CONCLUSION The Y–Z DMR deformable magnetic ring is an excellent treatment strategy for patients with rectal stenosis and without enterostomy.
... This device has a compressive force of F R3 = 2.2 N at a reference 3-mm face separation, corresponding to a spatially averaged pressure on the interposed double-layer of intestinal tissue of P R3 = 14 kPa. Selection of this device's force and pressure ratings was grounded in extensive work in animal models focused around safety and mechanical robustness of GI tract anastomosis creation [20,21]. This magnetic compression device is designed to create an anastomosis over 7-14 days, after which the mated anchor pair subsequently spontaneously detach from the physiologically mature anastomosis to pass in the fecal stream. ...
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Metabolic surgery remains underutilized for treating type 2 diabetes, as less invasive alternative interventions with improved risk profiles are needed. We conducted a pilot study to evaluate the feasibility of a novel magnetic compression device to create a patent limited caliber side-to-side jejunoileal partial diversion in a nonhuman primate model. Using an established nonhuman primate model of diet-induced insulin resistance, a magnetic compression device was used to create a side-to-side jejunoileal anastomosis. Primary outcomes evaluated feasibility (e.g., device mating and anastomosis patency) and safety (e.g., device-related complications). Secondary outcomes evaluated the device’s ability to produce metabolic changes associated with jejunoileal partial diversion (e.g., homeostatic model assessment of insulin resistance [HOMA-IR] and body weight). Device mating, spontaneous detachment, and excretion occurred in all animals (n = 5). There were no device-related adverse events. Upon completion of the study, ex vivo anastomoses were widely patent with healthy mucosa and no evidence of stricture. At 6 weeks post-device placement, HOMA-IR improved to below baseline values (p < 0.05). Total weight also decreased in a linear fashion (R2 = 0.97) with total weight loss at 6 weeks post-device placement of 14.4% (p < 0.05). The use of this novel magnetic compression device to create a limited caliber side-to-side jejunoileal anastomosis is safe and likely feasible in a nonhuman primate model. The observed glucoregulatory and metabolic effects of a partial jejunoileal bypass with this device warrant further investigation to validate the long-term glucometabolic impact of this approach.
... This demonstrates advances in EMCA technology in comparison to early-generation devices that required stenting and/or stricture resection for recalcitrant stricture in 46% of cases [9,10]. The larger anchor mating surface (8 mm), unique anchor geometry, and graduated radial compression with the Connect-EA device are likely contributing factors to these promising outcomes in a population at elevated risk for anastomotic stricture formation [11,15,17]. ...
... Recently, other groups have been reviving MCA for use in various pediatric surgical indications [13], including esophageal atresia repair [11,12,27], rectal atresia [9], duodenal stenosis [10], vascular anastomosis [28], and for re-cannulation of the hypopharynx [29]. Several experimental studies have been conducted in swine [30,31], rabbits, and dogs [32]. The studies confirm the above findings from decades ago and also seem to suggest that magnets can be used for creating the anastomosis, but that simultaneous approximation of pouches or structures under tension will lead to increased rates of anastomotic stricture [12]. ...
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Originating in the 1970s, magnetic compression anastomosis (MCA) has lately been revisited with a focus on minimal invasive surgery (MIS). The aim of this report is to reappraise our earlier experience with MCA with the intention of facilitating future MCA advancement. A retrospective review was conducted regarding preclinical experiments and clinical trials at a single institution from 1980 to 1995. The reviewed information was compiled and appraised to generate proposals for future MCA use. The experimental studies, including 250 MCA cases in gastrointestinal and urinary tract animal models, demonstrated the technical versatility of MCA as well as the superior biomechanical characteristics in comparison to hand-sewn anastomoses. Clinical trials encompassed 87 MCA procedures in 86 children, 2 to 10 years of age, involving the following techniques: non-operative esophageal recanalization (n = 15), non-operative ileostomy undiversion (n = 46), Swenson pull-through (n = 10), non-operative urethral recanalization (n = 5), and extravesical ureterocystoneostomy (n = 11). Clinical MCA was found to be successful in over 87% of cases. MCA limitations concerning anastomotic failure and scarring were thought to be mostly due to inadequate magnetic compression. Based on our historic experience, we propose further research on the technical aspects of MCA, along with the biological aspects of anastomotic tissue remodeling. Magnets should be designed and manufactured for a wide spectrum of pediatric surgical indications, particularly in combination with novel MIS techniques.
... Thus, the MCA devices currently used for EA repair utilize paired magnets that are placed into apposing pouches-one via the mouth and one via the stomach-and mated to create a completely endoscopic anastomosis. While the widespread adoption of this technique has been limited by early experience, observing the prohibitive rates of anastomotic strictures [54], newer devices with wider mating surfaces and unique mating geometries aim to solve this problem [53,55,56,118] (Figure 2). ...
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The novel use of magnetic force to optimize modern surgical techniques originated in the 1970s. Since then, magnets have been utilized as an adjunct or alternative to a wide array of existing surgical procedures, ranging from gastrointestinal to vascular surgery. As the use of magnets in surgery continues to grow, the body of knowledge on magnetic surgical devices from preclinical development to clinical implementation has expanded significantly; however, the current magnetic surgical devices can be organized based on their core function: serving as a guidance system, creating a new connection, recreating a physiologic function, or utilization of an internal–external paired magnet system. The purpose of this article is to discuss the biomedical considerations during magnetic device development and review the current surgical applications of magnetic devices.
... Once the anastomosis is physiologically mature, the mated anchor pair releases spontaneously from surrounding tissue. In pre-clinical porcine studies, a mechanically robust anastomosis formed in 7-10 days with no complications [18,19]. ...
Article
Introduction : Preservation of native esophagus is a tenet of esophageal atresia (EA) repair. However, techniques for delayed primary anastomosis are severely limited for surgically and medically complex patients at high-risk for operative repair. We report our initial experience with the novel application of the Connect-EA, an esophageal magnetic compression anastomosis device, for salvage of primary repair in 2 high-risk complex EA patients. Compassionate use was approved by the FDA and treating institutions. Operative Technique : Two approaches using the Connect-EA are described – a totally endoscopic approach and a novel hybrid operative approach. To our knowledge, this is the first successful use of a hybrid operative approach with an esophageal magnetic compression device. Outcomes : Salvage of delayed primary anastomosis was successful in both patients. The totally endoscopic approach significantly reduced operative time and avoided repeat high-risk operation. The hybrid operative approach salvaged delayed primary anastomosis and avoided cervical esophagostomy. Conclusion : The Connect-EA is a novel intervention to achieve delayed primary esophageal repair in complex EA patients with high-risk tissue characteristics and multi-system comorbidities that limit operative repair. We propose a clinical algorithm for use of the totally endoscopic approach and hybrid operative approach for use of the Connect-EA in high-risk complex EA patients.
... Magnetic compression technique (also known as magnamosis) is the most widely used technique of magnetic surgery. At present, magnamosis has been applied for esophageal anastomosis [3][4][5][6], gastrointestinal anastomosis [7][8][9] and intestinal anastomosis [10][11][12][13]. In addition, it can also be used for vascular anastomosis [14][15][16][17][18], rectovaginal fistula repair [19], and tracheoesophageal fistula model preparation [20]. ...
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Background Being one of the core techniques of magnetic surgery, magnetic compression technique (MCT) has been used for digestive tract anastomosis reconstruction in experimental studies. This study verified the feasibility of gastroenteric anastomosis through natural orifice using MCT in rats. Methods The parent and daughter magnets were designed and manufactured for oral and anal insertion in 20 Sprague‐Dawley rats. After anesthesia, the parent magnet was inserted into the colon spleen area through the anus, and the daughter magnet was inserted into the stomach through the mouth. Then the two magnets were positioned to attract each other and bind together. The position of the two magnets was monitored using X-ray. The time required for the formation of the anastomosis and expulsion of the magnets were recorded. 2 weeks later, the animal was sacrificed and the anastomotic specimen was obtained which was observed under naked eye and microscope. Results The gastroenteric anastomosis was successfully performed via natural orifices in 18 out of 20 rats. The mean time to construct the anastomosis was 3.78 ± 0.88 min. X-ray examination showed that the magnets were in the appropriate position in 17 rats. The magnets were excreted in 9.47 ± 1.62 days after surgery. The gross and microscopic examination of the specimen showed that the anastomoses were patent and the mucosa at the anastomotic was smooth. The mean bursting pressure of the anastomosis was 136.94 ± 6.79 mmHg. Conclusion It is feasible to perform gastroenteric anastomosis through natural orifices by MCT.
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BACKGROUND The treatment of postoperative anastomotic stenosis after excision of rectal cancer is challenging. Endoscopic balloon dilation and radial incision are not effective in all patients. We present a new endoscopy-assisted magnetic compression technique (MCT) for the treatment of rectal anastomotic stenosis. We successfully applied this MCT to a patient who developed an anastomotic stricture after radical resection of rectal cancer. CASE SUMMARY A 50-year-old man had undergone laparoscopic radical rectal cancer surgery at a local hospital 5 months ago. A colonoscopy performed 2 months ago indicated that the rectal anastomosis was narrow due to which ileostomy closure could not be performed. The patient came to the Magnetic Surgery Clinic of the First Affiliated Hospital of Xi'an Jiaotong University after learning that we had successfully treated patients with colorectal stenosis using MCT. We performed endoscopy-assisted magnetic compression surgery for rectal stenosis. The magnets were removed 16 d later. A follow-up colonoscopy performed after 4 months showed good anastomotic patency, following which, ileostomy closure surgery was performed. CONCLUSION MCT is a simple, non-invasive technique for the treatment of anastomotic stricture after radical resection of rectal cancer. The technique can be widely used in clinical settings.
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Esophageal atresia (EA) repair can be complicated by associated malformations such as a tracheobronchial remnant in the distal esophagus. We describe our experience with a patient found to have long-gap EA with a distal cartilaginous ring who was managed using a combination of esophageal lengthening and magnetic compression anastomosis. A 5-month-old girl was referred to us from an outside hospital with type C EA including a very high upper pouch. She had undergone a prior thoracotomy with fistula ligation during which a clip was placed on the lower esophagus, leaving a 2-cm diverticulum on the trachea and a short lower esophageal pouch. Upon endoscopic evaluation at our center, we found a tracheobronchial remnant in the lower esophagus between the clip and the carina. An open thoracotomy was performed to approximate the esophageal pouches and a magnet anchor (Connect EA, Myka Laboratories, San Francisco, California, United States) was placed retrograde through the distal esophageal cartilaginous ring into the lower pouch. On postoperative day 8, after adequate growth and decreased pouch tension, a second magnetic anchor was placed endoscopically to the upper pouch to mate with the previously placed lower pouch anchor. The anastomosis formed within 14 days. Due to the tracheobronchial remnant, the device did not pass distally and was removed endoscopically. On postoperative day 8, balloon dilation of the anastomosis and tracheobronchial remnant was performed. Subsequently, the patient required a total of 6 dilations in an 18-month follow-up. This case report illustrates the utility of using magnets to create an esophageal anastomosis in complex cases of EA with concomitant esophageal malformations. The parents of the patient gave their written consent to publish this technical report.
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Background and objectives Magnetic anchor technique (MAT) is frequently used in laparoscopic cholecystectomy. However, there are few reports on its clinical application in China. In this study, we retrospectively analyzed the clinical application of MAT in laparoscopic cholecystectomy in China. Materials and methods 25 patients (4 males, 21 females) who underwent laparoscopic cholecystectomy assisted by MAT at the First Affiliated Hospital of Xi'an Jiaotong University were enrolled from November 2020 to March 2021. Their records were retrospectively analyzed. The magnetic anchor device was independently designed and developed by the authors and consisted of the anchor magnet and magnetic grasping apparatus. Surgical time, intraoperative blood loss, intraoperative accidents, operator experience, postoperative incision pain score, postoperative complications, and other indicators were evaluated and analyzed. Results All patients successfully underwent laparoscopic cholecystectomy, including 3 cases of MAT-assisted transumbilical single-port LC, 16 cases of MAT-assisted 2-port LC and 6 cases of conventional 3-port LC. The median operation time was 50 min (range 30–95 min); intraoperative bleeding was less than 30 ml. The median score of surgical incision on day 1 and 3 after the operation was 3 (range 1–4) and 1 (range 1–3), respectively. All patients had no intraoperative bile duct injury, vascular injury, postoperative bleeding, bile leakage, biliary stricture and other complications. No adverse events (such as injury to adjacent organs or failure of the magnetic anchor device) occurred either during or after the operation. Conclusions The MAT-assisted laparoscopic cholecystectomy appears to be safe, feasible and effective and exhibits unique assistance in transumbilical single-port laparoscopic cholecystectomy.
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The use of magnet compression to endoscopically create an esophageal anastomosis is an intriguing approach to esophageal atresia repair, but published cases with an existing available device have demonstrated mixed success. One major shortcoming has been the formation of subsequent severe, recalcitrant strictures after primary repair. To address the limitations of the existing device, we recently introduced and reported success with specially designed bi-radial magnets that exhibit a novel geometry and unique tissue compression profile. The aim of this study is to compare the outcomes using our novel device (novel group, NG) with those of previous reports which utilized the historical device (historic group, HG) in a PRISMA-compliant systematic review. Seven studies were eligible for further analysis. Additionally, one of our previously unreported cases was included in the analysis. Esophageal pouch approximation prior to primary repair was performed more frequently in the NG than in the HG (100% NG vs. 21% HG; p = 0.003). There was no difference in the overall postoperative appearance of postoperative stricture (95% HG vs. 100% NG; p = 0.64). The number of postoperative dilatations trended lower in the NG (mean 4.25 NG vs. 9.5 HG; p = 0.051). In summary, magnetic compression anastomosis adds a new promising treatment option for patients with complex esophageal atresia. Prior approximation of pouches and a novel magnet design have the potential to lower the rate of stricture formation.
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A potential indicator of female lifetime productivity in swine is age of puberty, when a gilt achieves her first behavioral estrus. Follicular activity, as determined by tertiary follicle development, in prepubertal gilts begins during postnatal day (PND) 75-115. The central hypothesis of this study is that gilts demonstrating tertiary follicle development earlier in life, assessed using vulva size as a proxy, achieve puberty earlier in life compared to counterparts of a similar age and weight that lack tertiary follicle development. The objectives of this project were to identify a developmental time point when variation in ovarian development exists and to determine if a relationship between the age prepubertal ovarian development and the age at onset of puberty exists. To accomplish this, 155 gilts of similar age (± 2 days) were weighed and vulva size measured on PND 75, 85, 95, 105 and 115. Vulva measures, including vulva width (VW), length (VL) and area (VA) were utilized as developmental proxies for follicular activity. At each time point, gilts (n = 10) were sacrificed and ovarian follicular activity recorded. In a subset of gilts (n = 105), estrus detection was conducted daily on PND days 126 to 200. Mean vulva area (VA) on PND 75, 85, 95, 105 and 115 was 596 ± 206, 683 ± 190, 864 ± 212, 1014 ± 228 and 1265 ± 252 mm2, respectively. Of the gilts demonstrating behavioral estrus, 28 were within PND 140-160, 36 between PND 161-180, 15 between PND 181-200, and 26 did not demonstrate estrus behavior within 200 days of age. All gilts euthanized at PND 75 lacked follicular activity as defined by having a minimum of two antral follicles per ovary, while 60%, 80%, 90% and 100% demonstrated follicular activity on PND 85, 95, 105, and 115, respectively. Body weight at PND 75 and VW at PND 115 were correlated to age at first estrus (P < 0.05). Of the gilts whose VA was less than one standard deviation from the mean on PND 95 (i.e. < 652 mm2), 31% and 50% demonstrated their first behavioral estrus by PND 180 and 200, respectively. However, of gilts whose VA was within or greater than one standard deviation of the mean (i.e. ≥ 652 mm2), 66% and 79% exhibited estrus prior to PND 180 and 200, respectively. These data support utilization of VA changes between 95 and 115 days of age as a useful tool to identify replacement gilts prior to puberty for inclusion into the sow herd.
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Introduction: Magnamosis forms a compression anastomosis using self-aligning magnetic Harrison rings. The device has been approved by the Food and Drug Administration for first-in-human testing and has been applied in adults for intestinal anastomosis during urologic reconstructions. We now report the first cases of magnamosis to functionally undivert the fecal stream from a previously created loop ileostomy in pediatric patients. Materials and methods: Case 1: A 4-year-old male underwent a diverting loop ileostomy for malignant bowel obstruction. The obstruction gradually resolved with chemotherapy, and persistently high stomal output and malnutrition prompted undiversion. Case 2: A 16-year-old female with iloecolonic polyposis underwent ileoproctectomy with J pouch and diverting ileostomy. The magnamosis functional undiversion (FUN) technique involves introducing a Harrison ring through each stomal limb under general anesthesia with X-ray guidance. Magnets are each tied with sutures that exit the stoma and are then tied to each other externally. The device is removed when patency is detected. Results: The introduction procedure took less than 20 minutes and there were no complications. Enteral feeding was initiated 24 and 6 hours postoperatively, and distal passage of stool occurred by the fourth and fifth days, respectively. Magnets were removed 14 and 15 days postoperatively, without evidence of leak. Conclusion: We conclude that the magnamosis undiversion procedure is a safe, minimally invasive way to gradually refunctionalize the excluded distal bowel after previous diverting ostomy.
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Background: Intraoperative hypercapnia and acidosis have been associated with thoracoscopic repair of both congenital diaphragmatic hernia and esophageal atresia/tracheoesophageal fistula. Aim: The aim of the present study was to investigate whether thoracoscopic repair of congenital diaphragmatic hernia or esophageal atresia/tracheoesophageal fistula was associated with acidosis and hypercapnia in a large group of neonates, and to analyze the effects of acidosis and hypercapnia on early postoperative outcomes. Methods: We reviewed the charts of neonates who underwent open or thoracoscopic congenital diaphragmatic hernia or esophageal atresia/tracheoesophageal fistula repair (2004-2014). Patients with available intraoperative arterial gas values were included. Data (PaCO2 : mm Hg) were compared using paired/unpaired tests and are reported as difference [95% confidence interval]. Results: Congenital diaphragmatic hernia: 187 neonates underwent open (n=153) or thoracoscopic (n=34) repair. Intraoperative arterial gas values were recorded in 96 open and in 23 thoracoscopic operations. Both groups had similar preoperative pH and PaCO2 , and developed intraoperative acidosis (open -0.08 [-0.11, -0.05] P<.001, thoracoscopic -0.14 [-0.24, -0.04] P=.01) and hypercapnia (open: 7.8 [3.2, 12.4], P=.002; thoracoscopic: 20.2 [-2.5, 43, P=.07). Intraoperatively, neonates undergoing thoracoscopic repair developed lower pH than those having open surgery (-0.06 [-0.01, -0.10] P=.018), but maintained similar levels of PaCO2 (-4.0 [-9.0, 4.4] P=.39). Esophageal atresia/tracheoesophageal fistula: 205 neonates underwent open (n=180) or thoracoscopic (n=25) repair. Intraoperative arterial gas values were recorded in 62 open and in 14 thoracoscopic operations. Both groups had similar preoperative pH and PaCO2 , and developed intraoperative acidosis (open: -0.09 [-0.14, -0.04], P<.001; thoracoscopic: 0.21 [-0.28, -0.14], P<.001) and hypercapnia (open: 9.2 [2.6, 15.7] P=.008; thoracoscopic: 15.2 [1.6, 28.7], P=.03). Intraoperatively, neonates undergoing thoracoscopic repair developed lower pH than those having open surgery (difference 0.08 [0.01, 0.15], P=.02) but maintained similar levels of PaCO2 (difference -1 [-9, 3], P=.35). Conclusion: Neonates undergoing operative repair of congenital diaphragmatic hernia and esophageal atresia/tracheoesophageal fistula develop intraoperative acidosis and hypercapnia, regardless of the approach used. However, this phenomenon is more severe during thoracoscopic repair. Novel modalities to reduce intraoperative gas derangements, particularly during thoracoscopic repair, need to be established.
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Background A minimally invasive method of entero-enteral bypass may be desirable for treatment of obstruction, obesity, or metabolic syndrome. We have developed a technology based on miniature self-assembling magnets which create large-caliber anastomoses (incisionless anastomosis system or IAS). The aim of this study was to assess (a) procedural characteristics of IAS deployment and (b) long-term integrity and patency of the resulting jejuno-ileal dual-path bypass. Methods Endoscopic jejuno-ileal bypass creation using IAS magnets was performed in 8 Yorkshire pigs survived 3 months. Procedure: The jejunal magnet was endoscopically deployed. However, the ileal magnet required surgical delivery given restraints of porcine anatomy. A 5-mm enterotomy was created through which the ileal magnet was inserted using a modified laparoscopic delivery tool. Magnets were manually coupled. Pigs underwent serial endoscopies for anastomosis assessment. Three-month necropsies were performed, followed by pressure testing of anastomoses and histological analysis. Results Jejuno-ileal bypass creation using self-assembling IAS magnets was successful in all 8 pigs (100 %). Patent, leak-free bypasses formed in all animals by day 10. All IAS magnets were expelled by day 12. Anastomoses were widely patent at 3 months, with mean maximal diameter of 30 mm. At necropsy, adhesions were minimal. Pressure testing confirmed superior integrity of anastomotic tissue. Histology showed full epithelialization across the anastomosis with no evidence of submucosal fibrosis or inflammation. Conclusions Entero-enteral bypass using self-assembling IAS magnets is safe and technically feasible in the porcine model. IAS magnets can be rapidly delivered endoscopically or through a modified laparoscopic device. Expulsion of fused magnets avoids retention of prosthetic material. Anastomoses are widely patent and fully re-epithelialized. Three-month pressure testing reveals anastomotic tissue to be as robust as native tissue, while necropsy and histology suggests minimal/absent tissue inflammation. In human anatomy, a fully endoscopic jejuno-ileal bypass using IAS magnets may be feasible.
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Background/Objective: Thoracoscopic repair of esophageal atresia (EA) is gaining popularity, but it is a highly technically demanding procedure. The aim of our study is to evaluate our outcomes in the management of type C EA comparing the thoracoscopic and the open (thoracotomy) approaches. Methods: This is a retrospective bicentric study of two major pediatric surgery centers, reviewing all the patients operated for EA with distal tracheoesophageal fistula. Only patients who underwent primary anastomosis were included. From 2008 to 2018, 187 patients were included. Results: Forty-seven patients were operated thoracoscopically (TS group) and 140 by the open approach (TT group). Mean gestational age was 38 ± 2.4 weeks in TS group and 36.4 ± 3.3 weeks in TT group (P = .005) with a mean birth weight of 2785 ± 654 g and 2404.9 ± 651 g in TS and TT groups, respectively (P = .003). The mean operative time was 127.6 ± 35 minutes in TS group and 105.7 ± 23 minutes in TT group (P = .0005). The mean postoperative ventilation time and the mean length of stay were significantly shorter in the thoracoscopic group (P = .004 and P < .0001, respectively). The incidence of anastomotic leak was 8.9% in TS group versus 16.4% in TT group (P = .33). Anastomotic stenosis occurred in 33.3% of TS group and in 22.4% of TT group (P = .17). Conclusions: Surgical outcome of thoracoscopic repair of EA is comparable to the open repair with no higher complication rate with the expected skeletal and cosmetic benefits. However, possible bias regarding prematurity, weight at surgery, and associated anomalies must be taken into consideration.
Article
Background/purpose: Magnamosis is a novel technique which utilizes high power magnets to anastomose the esophageal ends in children with esophageal atresia (EA) with or without a tracheoesophageal fistula (TEF), theoretically avoiding the need for thoracotomy. The objective of this study was to compare anastomotic stricture formation requiring dilatation after magnamosis versus after conventional anastomosis. Methods: Our center treated the first 3 cases of EA ± TEF with magnamosis in Canada. One was unsuccessful and excluded from our study. The number of postintervention dilatations was compared to controls from our database, which includes all children with EA ± TEF treated between 1991 and 2015. The controls had EA ± TEF treated with pouch-to-end anastomosis or colonic interposition (n = 65). Mann-Whitney U tests were used with p < 0.05 being significant. Results: The 2 magnamosis cases had a mean of 13.5 dilatations, compared to 2.6 for the controls. Those managed with pouch-to-end anastomosis or colonic interposition had a mean of 2.3 and 2.7 dilatations, respectively. We found that the cases required more dilatations than controls (p = 0.022) and pouch-to-end anastomosis (p = 0.021), but not than colonic interposition (p = 0.106). Conclusion: Our results indicate that magnamosis is associated with more postintervention dilatations than conventional anastomotic techniques, suggesting that magnamosis results in more frequent and/or more resilient anastomotic strictures. Level of evidence: 3.
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Introduction: The majority of esophageal atresia (EA) patients undergo surgical repair soon after birth. However, factors due to patient characteristics, esophageal length, or surgical complications can limit the ability to obtain esophageal continuity. A number of techniques have been described to treat these patients with "long-gap" EA. Magnets are a nonsurgical alternative for esophageal anastomosis. The purpose of this study was to report long-term outcomes for the use of magnets in EA. Materials and Methods: Between July 2001 and December 2017, 13 patients underwent placement of a magnetic catheter-based system under fluoroscopic guidance at six institutions. Daily chest radiographs were obtained until there was union of the magnets. Magnets were then removed and replaced with an oro- or nasogastric tube. Complications and outcomes were recorded. The average length of follow-up was 9.3 years (range 1.42-17.75). Results: A total of 85% of the patients had type A, pure EA, and 15% had type C with previous fistula ligation. The average length of time to achieve anastomosis was 6.3 days (range 3-13). No anastomotic leaks occurred, and all of the patients had an expected esophageal stenosis that required dilation given the 10F coupling surface of the magnets (average 9.8, range 3-22). Six patients (46%) had retrievable esophageal stents, and two underwent surgery; yet all maintained their native esophagus without interposition. A total of 92% were on full oral feeds at the time of follow-up. Conclusion: The use of magnets for treatment of long-gap EA is safe and feasible and accomplished good long-term outcomes. The main complication was esophageal stricture, although all patients maintained their native esophagus. A prospective observational study is currently enrolling patients to evaluate the safety and benefit of a catheter-based magnetic device for EA.
Article
Introduction: Fashioning a patent, watertight anastomosis in patients with esophageal atresia is a challenging task in pediatric surgery, particularly when performed under tension. A reproducible suture-less alternative would decrease operative time. We evaluated magnetic esophageal compression anastomoses in a novel bypass-loop swine model. Methods: Eight-week-old piglets underwent thoracotomy to mobilize the esophagus at the carina to create a U-shaped loop. Custom-made 8 mm diameter Neodymium Magnets were inserted into the esophagus proximal and distal to the loop, then mated side-to-side at the future anastomosis site. Pigs were observed for 8 (n = 4), 10 (n = 6), and 12 (n = 2) days and then sacrificed. The magnetic compression anastomosis was evaluated macroscopically, by radiography, burst pressure testing, and histology. Results: All 12 pigs survived until the endpoint. Separation of the magnets occurred at a median of 9 days. Contrast esophagrams showed patency and no leak. All anastomoses withstood pressures well over 13 kPa without leak. Histopathology showed epithelialized circular scar tissue. Conclusion: Magnetic compression anastomoses of the esophagus using our specially-designed magnets are formed between the 8th and 10th postoperative day, are patent and mechanically resistant to supraphysiologic intraluminal pressures. These data lay the basis for a potential clinical application in patients born with esophageal atresia.
Article
Background Magnetic compression anastomosis (magnamosis) is the process of forming a sutureless anastomosis of the gastrointestinal tract using two magnetic Harrison rings. It has been shown to be effective in stomach, small bowel and colon, but has not been implemented in the esophagus. A pure esophageal atresia porcine model was developed to test the concept. Methods Five pigs weighing between 35 and 65 kg were used. In all pigs, a percutaneous endoscopic gastrostomy (PEG) tube was placed, and a right thoracotomy was performed. Esophageal atresia was simulated by transecting the esophagus with a cutting stapler, and magnets were placed endoscopically to approximate the two ends of the esophagus. In the first pig, the tissue within the magnetic ring was excised endoscopically to achieve immediate patency. In the second pig, approximation of the blind esophageal ends was reinforced with 3–4 externally-placed sutures but immediate patency was not performed. In the last three pigs, both external suture reinforcement and immediate patency were performed. The pigs survived for 10–14 days and received nutrition through PEG tube. At necropsy, an esophagram was performed, the specimen was explanted and a leak test was performed. Results The first pig died in the early postoperative period from a leak owing to separation of the magnets. The second pig died from aspiration before the anastomosis formed. The last three pigs survived until the study endpoint. The third pig had a contained leak owing to the staple line being placed between the magnets; this was not clinically significant. The last two pigs had well-formed anastomoses. Burst tests showed no leak when injecting saline up to 30 mmHg. Conclusion Magnamosis is technically feasible for esophagoesophageal anastomoses. A survival model for pure esophageal atresia was developed and refined in pigs. Further work in this area may lead to clinical use in humans.
Article
Background: Scoliosis has been reported after repair of esophageal atresia with or without tracheoesophageal fistula (EA-TEF). This study aims to investigate the prevalence and natural history of scoliosis and associated congenital vertebral anomalies in patients operated for EATEF. Methods: A retrospective review of patients operated for EA-TEF with radiological examination for the presence of scoliosis or associated spine congenital anomalies was done on 106 patients (ages 5-19 years). Results: Scoliosis was found in 53 patients (49%) for which 46 of these were in the thoracic region and 33 were right-thoracic curves. After a follow-up ranging from 5 to 14 years, four patients (3.7%) out of 106 were operated for scoliosis. Right-sided thoracotomy (RST) was the identifiable risk factor for scoliosis development; all patients with scoliosis had their EA repaired through RST. Congenital vertebral anomalies were found in 8 of those patients (7.5%). After a median follow-up of 6.5 years, no patients progressed enough to require operation. Conclusion: Scoliosis affects one of every two patients operated for EA; it may progress to the indication of surgery. RST was the identifiable risk factor for scoliosis development.
Article
Introduction: We previously developed a porcine model of long gap pure esophageal atresia (EA) to aid in the creation of novel devices and techniques for treatment of EA. Shortcomings of the model included difficulty decompressing the proximal esophageal pouch (leading to recurrent aspiration) and a requirement for gastrostomy tube (G-tube) feeds. Therefore, we sought to create a porcine model with a bifurcated esophagus wherein one portion of the esophageal lumen retained patency and the other part mimicked EA. Methods: After G-tube placement, thoracotomy was performed with subsequent partial stapled transection of the esophagus in a transverse manner, followed by longitudinal, partial stapled transection of the esophagus proximally and distally. Magnets were placed in the esophageal pouches. Results: Proximal and distal esophageal pouches were created while preserving a parallel, narrower segment of continuous esophagus. G-tube feeds were used initially, but the animal ultimately tolerated full nutrition by mouth. The magnets successfully restored esophageal continuity. The animal regained much of the initial weight lost and survived to planned euthanasia. Necropsy revealed anastomosis formation without evidence of leak. Conclusions: A bifurcated porcine esophagus model was successfully devised, simulating EA while allowing the animal to receive oral feeds and clear oral secretions. This model is anticipated to promote animal well-being and ease of care during future investigations, as well as a platform for the safe development of new therapies for EA.
Article
Background: Magnetic compression anastomosis ("magnamosis") uses a pair of self-centering magnetic "Harrison rings" to create an intestinal anastomosis without sutures or staples. We report the first-in-human case series using this unique device. Study design: We conducted a prospective, single center, first-in-human pilot trial to evaluate the feasibility and safety of creating an intestinal anastomosis using the Magnamosis™ device. Adult patients requiring any intestinal anastomosis to restore bowel continuity were eligible for inclusion. For each procedure, one Harrison ring was placed in the lumen of each intestinal segment. The rings were brought together and mated, and left to form a side-to-side, functional end-to-end anastomosis. Device movement was monitored with serial x-rays until it was passed in the stool. Patients were monitored for adverse effects with routine clinic appointments, as well as questionnaires. Results: Five patients have undergone small bowel anastomosis with the Magnamosis device. All five had severe systemic disease and underwent complex open urinary reconstruction procedures, with the device used to restore small bowel continuity after isolation of an ileal segment. All devices passed without obstruction or pain. No patients have had any complications related to their anastomosis, including anastomotic leaks, bleeding, or stricture at median follow-up of 13 months. Conclusion: In this initial case series from the first-in-human trial of the Magnamosis device, the device was successfully placed and effectively formed a side-to-side, functional end-to-end small bowel anastomosis in all five patients. No patients have had any anastomotic complications at intermediate follow-up.
Article
We describe the treatment of a patient with long-gap esophageal atresia with an upper pouch fistula, mircogastria and minimal distal esophageal remnant. After 4.5 months of feeding via gastrostomy, a proximal fistula was identified by bronchoscopy and a thoracoscopic modified Foker procedure was performed reducing the gap from approximately 7-5 cm over 2 weeks of traction. A second stage to ligate the fistula and suture approximate the proximal and distal esophagus resulted in a gap of 1.5 cm. IRB and FDA approval was then obtained for endoscopic placement of 10-French catheter mounted magnets in the proximal and distal pouches promoting a magnetic compression anastomosis (magnamosis). Magnetic coupling occurred at 4 days and after magnet removal at 13 days an esophagram demonstrated a 10 French channel without leak. Serial endoscopic balloon dilation has allowed drainage of swallowed secretions as the baby learns bottling behavior at home.
Article
Introduction: This report evaluates the results of a two-surgeon experience with thoracoscopic repair in patients with long gap esophageal atresia (EA). Materials and methods: From March 2000 to February 2015, 14 consecutive patients with pure EA were repaired thoracoscopically. The gap length was then evaluated by contrast gastrostomy tube study. Patients were operated on between 4 to 8 weeks of age. Patient weights ranged from 2.6 to 3.8 kg. The longest gap was 7½ vertebral bodies. Dissection was carried well up into the thoracic inlet on the upper pouch and down to the esophageal hiatus on the lower pouch. A 15th patient was not referred until 3 months of age. Results: All 15 procedures were completed successfully thoracoscopically. Operative times ranged from 60 to 135 minutes. There were two leaks; both resolved with conservative therapy. Feeds were started on Day 5 in all other patients. Six of 13 patients required dilations (one to nine), and 8 required a Nissen fundoplication for severe reflux. All patients are currently on full oral feeds. No patient has any evidence of chest wall asymmetry, winged scapula, or clinically significant scoliosis. Conclusions: Thoracoscopic repair of long gap EA has proven to be an effective and safe technique when performed in the first 2 months of life. The improved visualization and access to the upper pouch and lower pouches allow for maximal mobilization. The results are superior to those of documented open series and avoid the morbidity of repeated operations in the neonatal period.
Article
The aim of our study was to assess the feasibility of minimally invasive digestive anastomosis using a modular flexible magnetic anastomotic device made up of a set of two flexible chains of magnetic elements. The assembly possesses a non-deployed linear configuration which allows it to be introduced through a dedicated small-sized applicator into the bowel where it takes the deployed form. A centering suture allows the mating between the two parts to be controlled in order to include the viscerotomy between the two magnetic rings and the connected viscera. Eight pigs were involved in a 2-week survival experimental study. In five colorectal anastomoses, the proximal device was inserted by a percutaneous endoscopic technique, and the colon was divided below the magnet. The distal magnet was delivered transanally to connect with the proximal magnet. In three jejunojejunostomies, the first magnetic chain was injected in its linear configuration through a small enterotomy. Once delivered, the device self-assembled into a ring shape. A second magnet was injected more distally through the same port. The centering sutures were tied together extracorporeally and, using a knot pusher, magnets were connected. Ex vivo strain testing to determine the compression force delivered by the magnetic device, burst pressure of the anastomosis, and histology were performed. Mean operative time including endoscopy was 69.2 ± 21.9 min, and average time to full patency was 5 days for colorectal anastomosis. Operative times for jejunojejunostomies were 125, 80, and 35 min, respectively. The postoperative period was uneventful. Burst pressure of all anastomoses was ≥110 mmHg. Mean strain force to detach the devices was 6.1 ± 0.98 and 12.88 ± 1.34 N in colorectal and jejunojejunal connections, respectively. Pathology showed a mild-to-moderate inflammation score. The modular magnetic system showed enormous potential to create minimally invasive digestive anastomoses, and may represent an alternative to stapled anastomoses, being easy to deliver, effective, and low cost.
Article
Background and study aims: MAGNAMOSIS forms a compression anastomosis using self-assembling magnetic rings that can be delivered via flexible endoscopy. The system has proven to be effective in full-thickness porcine small-bowel anastomoses. The aim of this study was to show the feasibility of the MAGNAMOSIS system in hybrid endoscopic colorectal surgery and to compare magnetic and conventional stapled anastomoses. Methods: A total of 16 swine weighing 35 - 50 kg were used following animal ethical committee approval. The first animal was an acute model to establish the feasibility of the procedure. The subsequent 15 animals were survival models, 10 of which underwent side-to-side anastomoses (SSA) and 5 of which underwent end-to-side (ESA) procedures. Time to patency, surveillance endoscopy, burst pressure, compression force, and histology were assessed. Histology was compared with conventional stapled anastomoses. Magnetic compression forces were measured in various anastomosis configurations. Results: Colorectal anastomoses were performed in all cases using a hybrid NOTES technique. The mean operating time was 71 minutes. Mean time to completion of the anastomosis was similar between the SSA and ESA groups. Burst pressure at 10 days was greater than 95 mmHg in both groups. One complication occurred in the ESA group. Compression force among various configurations of the magnetic rings was significantly different (P < 0.05). Inflammation and fibrosis were similar between magnetic SSA and conventional stapled anastomoses. Conclusion: MAGNAMOSIS was feasible in performing a hybrid NOTES colorectal anastomosis. It has the advantage over circular staplers of precise endoscopic delivery throughout the entire colon. SSA was reliable and effective. A minimum initial compression force of 4 N appears to be required for reliable magnetic anastomoses.
Article
To facilitate endolumenal and natural orifice procedures, this study evaluated a novel technique using external and endoscopically placed magnets to create suture-free gastroenteral anastomoses. Seven anesthetized adult swine underwent endoscopic placement of magnets into the small bowel and stomach. Using external magnets, the endoscopically placed internal magnets were brought into opposition under endoscopic view. After 1-2 weeks, the pigs were killed and analyzed. At laparotomy and under sterile conditions, peritoneal cultures were obtained. The anastomoses were evaluated endoscopically and tested using an air insufflation test. Finally, the anastomoses were resected and evaluated microscopically. The average operative time for endoscopic placement of the magnets was 34.3 +/- 14.8 min. Successful placement and creation of anastomoses occurred in six of the pigs. One pig did not form an anastomosis because the magnets were too large to pass through the pylorus at the time of attempted magnet placement. Six swine experienced uncomplicated postoperative courses. One pig's postoperative course involved constipation for several days, requiring additional fluids and fiber supplementation. The findings at endoscopy showed that the magnets were adhered to the anastomosis, which were easily freed, or within the stomach. The air insufflation test results were negative for all the pigs. At laparotomy, there was no evidence of infection, abscess, or leak, but two peritoneal culture results were positive with scant growth of Staphylococcus aureus and coagulase-negative staphylococcus, presumably contaminants. Microscopically, the anastomoses illustrated granulation and fibrous connective tissue without evidence of infection or leak. Endoscopically placed magnets with external magnet guidance is a feasible and novel approach to creating patent gastroenteral anastomoses without abdominal incisions or sutures.
Article
We describe a unique technique to promote a nonsurgical esophageal anastomosis with magnets in children with esophageal atresia. To evaluate the efficacy of magnetic lengthening of atretic esophageal ends to produce an anastomosis and to communicate our results after more than 2 years of follow-up. Between September 2001 and March 2004, five children were selected for treatment. Two of the children had esophageal atresia without fistula (type A) and three had atresia with fistula converted to type A surgically; however, surgeons failed to achieve an anastomosis because of the width of the gap. Neodymium-iron-boron magnets were used. Daily chest radiographs were taken until union of the magnets was observed. They were then replaced with an orogastric tube. Anastomosis was achieved in all patients in an average of 4.8 days. One patient, with signs of early sepsis, was successfully treated with antibiotics. In four of the five patients, esophageal stenosis developed. At the time of this report, two patients were free of treatment and on an oral diet (after 26 months), two patients required periodic balloon dilatation, and one patient had recently undergone surgery due to recurrent esophageal stenosis not amenable to balloon dilatation. Magnetic esophageal anastomosis is a feasible method in selected patients with esophageal atresia. Esophageal anastomosis was achieved in all patients. The only observed complication of significance was esophageal stenosis. One patient needed surgery because of stenosis.
Thoracoscopy Versus Thoracotomy in the Repair of Esophageal Atresia with Distal Tracheoesophageal Fistula
  • A Lhattab
  • L Ali
  • V Rousseau
  • P Clermidi
  • D Michelet
  • C Farnoux
lhattab A, Ali L, Rousseau V, Clermidi P, Michelet D, Farnoux C, et al. Thoracoscopy Versus Thoracotomy in the Repair of Esophageal Atresia with Distal Tracheoesophageal Fistula. J Laparoendosc Adv Surg Tech A 2020;30:1289-94.