Magnetic Gastrointestinal Anastomosis in Pediatric Patients Mario Zaritzky, Ricardo Ben, Krystal Johnston PII: DOI: Reference:

S0022-3468(13)00852-X doi: 10.1016/j.jpedsurg.2013.11.002 YJPSU 56558

To appear in:

Journal of Pediatric Surgery

Received date: Revised date: Accepted date:

11 July 2013 29 October 2013 2 November 2013

Please cite this article as: Zaritzky Mario, Ben Ricardo, Johnston Krystal, Magnetic Gastrointestinal Anastomosis in Pediatric Patients, Journal of Pediatric Surgery (2013), doi: 10.1016/j.jpedsurg.2013.11.002

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Magnetic Gastrointestinal Anastomosis in Pediatric Patients Mario Zaritzky, MD1, Ricardo Ben, MD2, Krystal Johnston, MD3

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Correspondence to: Mario Zaritzky, MD Assistant Professor of Radiology Department of Radiology The University of Chicago Medicine Comer Children’s Hospital 5721 S. Maryland Avenue Chicago, IL 60637 Phone: 773-702-2075 Fax: 773-834-7452 E-mail: [email protected]

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1. Department of Radiology, The University of Chicago Medicine, Comer Children’s Hospital, 5721 S. Maryland Avenue, Chicago, IL 60637. 2. Department of Gastroenterology, Hospital de Niños de La Plata, Calle 14 Nro 1631, La Plata, Buenos Aires, Argentina. 3. MED Institute, Inc., 1 Geddes Way, West Lafayette, IN 47906.

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Running title – Magnetic anastomosis in pediatrics Acknowledgments: The authors thank Andres Aguirre, Michael Brecht, and Aerie Thuo for serving as study engineers and thank Tim Anderson for his artistic expertise.

INTRODUCTION Compression devices to facilitate intestinal anastomoses have achieved intermittent popularity in the medical literature. The first description of compression anastomosis in an animal model was put forth by Denans in 1826; his device was composed of metal rings. The Murphy button, introduced in 1892, also consisted of metal rings held in place by a purse-string suture [1-3]. In the mid-1980s, additional compression devices were introduced, which were composed of

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biodegradable rings and non-biodegradable rings with or without magnets included in the design [1,2]. These devices were primarily used to create small or large bowel anastomoses.

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In the 1970s, Hendren and Hale published clinical outcomes of magnet-induced growth in the treatment of esophageal atresia and high-pouch imperforate anus; magnetic bougienage allowed

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primary esophageal or rectal anastomosis without interposition of additional tissue [4-6]. From 1995 to 2001, Cope published four papers describing gastroenteric and cholecystogastric/jejunal

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anastomoses in animals [7-10]. In 2005, Chopita et al. published results of 15 patients who had

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malignant upper GI obstruction and who underwent successful magnetic compression gastroenteric anastomosis [11]. Additionally, Takao et al. published a case report of a patient

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with benign common bile duct obstruction who underwent choledochoduodenostomy by magnetic compression anastomosis.[12] More recently, magnetic compression anastomosis

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treatment for biliary obstruction has been reported in case reports and small case series [13-16].

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Gastrointestinal (GI) anastomoses are traditionally created by suture or staple methods. The goal

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of any anastomosis is to connect the two structures and allow sufficient healing to discourage anastomotic leak. If a safe, minimally invasive treatment technique were developed, it could become the preferred anastomotic treatment method. Therefore, creation of a functional magnetic compression anastomosis through minimally invasive techniques warrants appropriate investigation. The purpose of this analysis is to describe patients with GI obstruction, stenosis, or atresia who underwent magnetic, non-surgical GI anastomoses. MATERIALS AND METHODS Between June 2001 and December 2012, 17 pediatric patients were treated by magnetic compression anastomosis at a single center in Argentina (Table 1). Approval was obtained from

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the site’s Ethics Committee and informed consent was obtained from the parents or legal guardians.

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Discoid magnet pairs

A circular discoid magnet pair (Cook Medical, Winston-Salem, NC; device not currently

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marketed) was used to treat GI obstruction in 8 patients. One patient had gastric outlet

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obstruction due to metastatic colon adenocarcinoma, 2 patients had rectocolonic stenosis after surgical repair of Hirschprung’s disease, and 5 patients had severe esophageal stenosis after

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primary surgical repair of esophageal atresia. The discoid magnets (neodymium, iron, and boron, or NdFeB) were 12 mm and 14 mm in diameter and had a magnetic power of 12,550 G

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(Figure 1). The distal 12 mm magnet was placed under fluoroscopic guidance via a catheter

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advanced over a wire guide. The proximal 14 mm magnet was placed with the same technique, using endoscopic forceps to move the magnet into position, if necessary. Magnetic attraction was

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monitored by repeat radiographs. Upon successful anastomosis, the coupled magnet pair was

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removed by endoscopic introduction of a third magnet held by forceps. Once attracted, all three magnets were removed under endoscopic and fluoroscopic guidance. Catheter-based bullet-shaped magnet pairs Nine patients with previously untreated esophageal atresia underwent placement of catheterbased bullet-shaped magnet pairs (Cook Medical, Winston-Salem, NC; device not currently marketed). Mid-term outcomes for 5 of these patients have been previously reported [17]. Six patients had Type A esophageal atresia (an esophageal pouch and a gastric pouch with no tracheoesophageal fistula, or TEF) and 3 patients had Type C esophageal atresia (an esophageal pouch and a gastric pouch with a TEF). Patients with Type C atresia underwent surgical repair of

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the TEF prior to magnetic compression anastomosis treatment. The gap between the upper and lower pouches was evaluated by placement of metal probes viewed on anterioposterior (AP) and

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lateral chest x-rays. Only children with a gap of 4 cm or less between the esophageal and gastric

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pouches were treated with the catheter-based device. Additionally, all 9 patients previously underwent surgical gastrostomy and had a mature gastrostomy tract at the time of catheter-based

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treatment.

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The esophageal catheter used for anastomosis of primary esophageal atresia contained 2 lumens.

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One lumen had a 5 mm bullet-shaped NdFeB magnet at the tip and the second lumen facilitated suction of excess saliva from the upper pouch. The gastric catheter contained 3 lumens. One

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lumen had a 5 mm bullet-shaped NdFeB magnet at the tip, another lumen had a retention balloon to keep the device in place within the stomach, and one lumen permitted gastric feeding. Each

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catheter-based magnet contained a central opening for passage of a 0.038 inch wire guide and

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had a magnetic power of 12,800 G (Figures 2A, 2B, and 2C).

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AP and lateral chest radiographs were obtained immediately after placement of the catheterbased magnets to verify appropriate catheter position and magnet alignment. Radiographs were obtained daily thereafter until magnetic coupling was demonstrated. When anastomosis was achieved, the proximal end of the inner esophageal guiding catheter was cut, the retention balloon of the gastric catheter was deflated, and a wire guide was introduced and passed through the esophageal catheter, through the anastomosis, and through the gastrostomy port. The esophageal catheter was pushed distally toward the stomach while the gastric catheter was pulled away from the patient, thus removing the esophageal catheter, coupled magnets, and gastric catheter as a unit. The outer esophageal catheter was left in place for use as an orogastric tube.

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RESULTS

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Discoid magnet pairs

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Gastroenteric anastomosis was achieved in 7 days in an 11-year-old patient with gastric outlet obstruction due to metastatic colon cancer (Figures 3A to 3F). Immediately, a 25 mm diameter

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partially covered duodenal stent was placed. One week after magnet removal, the patient

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required balloon dilatation for recurrent anastomotic obstruction caused by tumor ingrowth at an uncovered end of the stent. Importantly, the patient was able to ingest a normal diet until his

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death, which occurred 6 months after placement of the discoid magnets.

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Colorectal anastomosis was achieved in 8 and 10 days in 2 patients who developed rectocolonic stenosis after surgical correction of Hirschprung’s disease. These patients were 2 years old and

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3.4 years old, respectively, at the time of magnet therapy. In both patients, magnets were

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introduced through the existing colostomy. Both patients required anastomotic balloon dilatation 15 days after magnet removal and 1 patient also underwent prophylactic placement of a 28 mm

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diameter fully covered colonic stent. The colostomies were eventually taken down in both patients and neither patient experienced difficulty passing stool. Esophageal re-anastomosis was achieved in an average of 6 days (range 3 days to 7 days) in 5 patients who previously underwent surgical correction of esophageal atresia but experienced severe recurrent postsurgical esophageal stenoses that were refractory to dilatation. These patients were aged 6 months to 5.9 years. Representative images from one of these patients are shown in Figures 4A to 4E. Three of these patients also underwent prophylactic covered stent placement 2 weeks after placement of the discoid magnets. Stents were removed 2 months after placement.

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Catheter-based bullet-shaped magnet pairs Primary esophageal anastomosis was achieved in an average of 4.2 days (range 3 to 6 days) in

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9 patients with previously unrepaired esophageal atresia. The average patient age in this group was 3 months (range 23 days to 5 months). Representative images from one of these patients are

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shown in Figures 5A to 5D. No patient experienced an anastomotic leak. One patient developed sepsis (defined as fever and elevated white blood cell count) 48 hours after magnet placement. In

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this case, the catheter-based magnets were removed, the patient was successfully treated with

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antibiotics, and the catheter-based magnets were replaced to complete the magnetic treatment. Eight patients developed anastomotic strictures that required dilatation and 2 of these patients

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with intractable esophageal stenosis also underwent placement of 10 mm diameter fully covered biliary stents after dilatation. One patient (who underwent several dilatations and stent

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placement) ultimately required surgical re-anastomosis.

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Three esophageal atresia patients were lost to long-term follow-up. All 6 patients with long-term

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follow-up data are ingesting normal residue diets for their age. At the time of this writing, the oldest patient is over 12 years old. Several patients in this group demonstrate common comorbidities associated with esophageal atresia. Two patients have gastroesophageal reflux disease (GERD) and tracheomalacia. Three patients have esophageal dysmotility requiring treatment and 3 patients have asthma or recurrent pulmonary infections. None of the patients have scoliosis or rib deformities. Of note, 1 patient (17 months old at the time of writing) carries concurrent diagnoses of GERD, tracheomalacia, esophageal dysmotility, and asthma/recurrent pulmonary infection. This patient is at the 15th growth percentile for age at the time of publication.

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DISCUSSION Temporary, minimally invasive magnet placement achieved GI anastomosis in all 17 patients in

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this series. Discoid magnet pairs were placed under fluoroscopic and endoscopic guidance. Catheter-based bullet-shaped magnet pairs were placed and monitored under radiographic

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guidance. Anastomoses were created in the esophagus, the gastric outlet, and the colon/rectum

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and all were accomplished between 3 and 10 days after magnet placement. In animals, the integrity of small intestinal or gastroenteric magnetic anastomoses have been

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shown to be equivalent to or better than sutured [18] and stapled [18,19] anastomoses. An animal study demonstrated a slightly higher average burst pressure for magnetic compression

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duodenocolonic anastomoses when compared to stapled anastomoses [20], while another animal

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study demonstrated a significantly higher burst pressure for magnetic compression jejunojejunal anastomoses compared to sutured anastomoses [21]. It is unlikely that a randomized controlled

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trial will be devised in humans to compare magnetic and sutured or stapled anastomoses, but it is

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important to recognize that the suture and staple techniques most commonly used in GI surgeries may not be the optimal choice. Further, magnetic compression anastomoses do not leave behind permanent foreign bodies like sutured and stapled anastomoses. An animal study of magnetic colorectal anastomoses described magnet placement through a hybrid natural orifice translumenal endoscopic surgery (NOTES) procedure [22]. Both side-toside and end-to-side anastomoses were created in these animals. Two animals developed asymptomatic anastomotic stenosis, but without further intervention, at 30-day follow-up, both anastomoses were easily crossed with the endoscope.

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Eleven patients in this series required anastomotic dilatation, including eight patients who had esophageal atresia and were treated with catheter-based magnets. However, stenosis following

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magnetic compression anastomosis is not necessarily related to the catheter-based device. For

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example, Takamizawa et al. described a patient who underwent surgical repair of esophageal atresia, had recurrent postsurgical esophageal stenosis refractory to dilatation, and was treated

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with one magnet suspended on a nylon thread and one magnet introduced through the mouth

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[23]. Because these magnets did not attract, larger magnets were introduced in the same fashion two months later; reanastomosis was achieved but the patient still required several balloon

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dilatations over the subsequent three months. In contrast, the catheter-based magnets in the

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present study all functioned appropriately and achieved magnetic coupling in all patients. Postoperative esophageal stenosis is also common after surgical intervention. Outcomes of

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surgical esophageal atresia repair can vary by center (i.e., surgeon experience with the chosen

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surgical technique) and can be influenced by the presence and degree of underlying comorbidities. Postoperative esophageal stenoses occur in 27% to 44% of patients who undergo

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Type A esophageal atresia repair [24-26]. Nevertheless, the overall rate of anastomotic stenosis in the present study was particularly high (64.7%, 11/17); this rate can be addressed by revision of magnet design and/or magnet power. Further investigations are needed to refine the technique and to develop a suitable alternative to open surgical or laparoscopic repair. Seven patients in this series underwent stent placement after magnetic compression anastomosis, including five patients who had stents placed in the esophagus. Since there are no currently approved pediatric esophageal stents, tracheobronchial and fully covered biliary stents have been used in the treatment of pediatric esophageal stenosis. One group recommends consideration of tracheobronchial stent placement in the treatment of all recurrent severe pediatric esophageal

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strictures [27]. In adults, a study investigating magnetic gastroenteric anastomosis followed by routine stent placement was terminated prematurely due to a serious adverse event (i.e., stent-

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related perforation and sepsis leading to death) [28]. These investigators noted that magnetic

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compression itself was feasible and safe, but concluded that the requirement for subsequent stent placement caused unnecessary risk. However, the adult patients in that study had a primary

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malignant diagnosis, and thus, represent a different patient population than the pediatric patients

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with benign pathology who are described in the present study. Even so, it would be most beneficial if magnetic compression anastomoses did not require stent placement to maintain the

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anastomotic tract; however, since a stent is often necessary, the best type of stent (e.g., biodegradable, self-expanding, covered, or uncovered) and the appropriate duration of stent

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placement, two currently unknown factors, require further investigation.

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In conclusion, minimally invasive magnet placement was feasible using either discoid or

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catheter-based bullet-shaped magnet pairs. GI anastomosis was achieved in all patients. Further design refinements are necessary to reduce the rate of post-anastomotic stenosis, but magnetic

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compression anastomosis appears to be a promising new therapeutic option. REFERENCES

1. Aggarwal R, Darzi A: Compression anastomoses revisited. J Am Coll Surg 2005;201:965-971. 2. Kopelman D, Hatoum OA, Kimmel B, et al: Compression gastrointestinal anastomosis. Expert Rev Med Devices 2007;4:821-828. 3. Kaidar-Person O, Rosenthal RJ, Wexner SD, et al: Compression anastomosis: history and clinical considerations. Am J Surg 2008;195:818-826. 4. Hendren WH, Hale JR: Electromagnetic bougienage to lengthen esophageal segments in congenital esophageal atresia. N Engl J Med 1975;293:428-432. 5. Hendren WH, Hale JR: Esophageal atresia treated by electromagnetic bougienage and subsequent repair. J Pediatr Surg 1976;11:713-722.

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6. Hendren WH, Hale JR: High-pouch imperforate anus treated by electromagnetic bougienage and subsequent perineal repair. J Pediatr Surg 1976;11:723-733. 7. Cope C: Creation of compression gastroenterostomy by means of the oral, percutaneous, or

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surgical introduction of magnets: feasibility study in swine. J Vasc Interv Radiol 1995;6:539-

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8. Cope C: Evaluation of compression cholecystogastric and cholecystojejunal anastomoses in

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swine after peroral and surgical introduction of magnets. J Vasc Interv Radiol 1995;6:546-552. 9. Cope C, Clark TW, Ginsberg G, et al: Stent placement of gastroenteric anastomoses formed

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by magnetic compression. J Vasc Interv Radiol 1999;10:1379-1386. 10. Cope C, Ginsberg GG: Long-term patency of experimental magnetic compression

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gastroenteric anastomoses achieved with covered stents. Gastrointest Endosc

11. Chopita N, Vaillaverde A, Cope C, et al: Endoscopic gastroenteric anastomosis using

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magnets. Endoscopy 2005;37:313-317.

12. Takao S, Matsuo Y, Shinchi H, et al: Magnetic compression anastomosis for benign

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obstruction of the common bile duct. Endoscopy 2001;33:988-90. 13. Jang SI, Kim JH, Won JY, et al: Magnetic compression anastomosis is useful in biliary

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anastomotic strictures after living donor liver transplantation. Gastrointest Endosc 2011;74:10401048.

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14. Itoi T, Kasuya K, Sofuni A, et al: Magnetic compression anastomosis for biliary obstruction: review and experience at Tokyo Medical University Hospital. J Hepatobiliary Pancreat Sci 2011;18:357-365.

15. Itoi T, Yamanouchi E, Ikeuchi N, et al: Magnetic compression duct-to-duct anastomosis for biliary obstruction in a patient with living donor liver transplantation. Gut Liver 2010;4 (suppl 1):S96-98. 16. Avaliani M, Chigogidze N, Nechipai A, et al: Magnetic compression biliary-enteric anastomosis for palliation of obstructive jaundice: initial clinical results. J Vasc Interv Radiol 2009;20:614-623. 17. Zaritzky M, Ben R, Zylberg GI, et al: Magnetic compression anastomosis as a nonsurgical treatment for esophageal atresia. Pediatr Radiol 2009;39:945-949.

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18. Jamshidi R, Stephenson JT, Clay JG, et al: Magnamosis: magnetic compression anastomosis with comparison to suture and staple techniques. J Pediatr Surg 2009;44:222-228. 19. Pichakron KO, Jelin EB, Hirose S, et al: Magnamosis II: magnetic compression anastomosis

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for minimally invasive gastrojejunostomy and jejunojejunostomy. J Am Coll Surg 2011;212:42-

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20. Gonzales KD, Douglas G, Pichakron KO, et al: Magnamosis III: delivery of a magnetic

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compression anastomosis device using minimally invasive endoscopic techniques. J Pediatr Surg 2012;47:1291-1295.

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21. Fan C, Ma J, Zhang HK, et al: Sutureless intestinal anastomosis with a novel device of magnetic compression anastomosis. Chin Med Sci J 2011;26:182-189.

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22. Wall J, Diana M, Leroy J, et al: MAGNAMOSIS IV: magnetic compression anastomosis for minimally invasive colorectal surgery. Endoscopy 2013; Jun 27 [Epub ahead of print]. 23. Takamizawa S, Yamanouchi E, Muraji T, et al: MCRA of an anastomotic stenosis after

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esophagoesophagostomy for long gap esophageal atresia: a case report. J Pediatr Surg 2007;42:769-772.

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24. Burjonrappa S, Thiboutot E, Castilloux J, et al: Type A esophageal atresia: a critical review of management strategies at a single center. J Pediatr Surg 2010;45:865-871.

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25. Holland AJ, Ron O, Pierro A, et al: Surgical outcomes of esophageal atresia without fistula for 24 years at a single institution. J Pediatr Surg 2009;44:1928-1932.

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26. Antoniou D, Soutis M, Christopoulos-Geroulanos G: Anastomotic strictures following esophageal atresia repair: a 20-year experience with endoscopic balloon dilatation. J Pediatr Gastroenterol Nutr 2010;51:464-467. 27. Best C, Sudel B, Foker JE, et al: Esophageal stenting in children: indications, application, effectiveness, and complications. Gastrointest Endosc 2009;70:1248-1253. 28. van Hooft JE, Vleggaar FP, Le Moine O, et al: Endoscopic magnetic gastroenteric anastomosis for palliation of malignant gastric outlet obstruction: a prospective multicenter study. Gastrointest Endosc 2010;72:530-535.

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FIGURE LEGENDS Figure 1. A circular discoid magnet pair (12 mm and 14 mm diameter, respectively). Magnets are composed of neodymium, iron, and boron. The discoid magnets have a magnetic power of

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12,550 G.

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Figure 2. A. Catheter-based bullet-shaped magnet pair (2-lumen esophageal catheter at top, 3lumen gastric catheter at bottom). Magnets are composed of neodymium, iron, and boron. The

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catheter-based magnets have a magnetic power of 12,800 G. B. AP representation of the catheter-based magnets in situ. C. Lateral representation of the catheter-based magnets in situ.

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Figure 3. An 11-year-old patient with gastric outlet obstruction due to metastatic colon cancer. A. Pyloric obstruction is demonstrated endoscopically. B. Endoscopic placement of the first

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discoid magnet distal to the pylorus. C. Second discoid magnet in position in the stomach. D. Initial radiologic image after magnets placed. E. Radiologic image showing coupling of the magnets. F. Radiologic image after prophylactic stent placement.

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Figure 4. A patient with recurrent postsurgical esophageal stenosis refractory to dilatation. A. Endoscopic view of the distal discoid magnet placed through the gastrostomy. B. Radiographic

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image of the distal discoid magnet in position. C. Addition of the proximal discoid magnet placed via the mouth. D. Radiologic image showing coupling of the magnets. E. Endoscopic

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image showing the final anastomosis.

Figure 5. Radiologic images from a patient with esophageal atresia (Type A or Type C converted

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to Type A) and a gap length of 4 cm or less. A. AP image demonstrating measurement of the esophageal gap. B. Image verifying initial catheter-based magnet placement. C. Image showing coupling of the magnets. D. First esophagram after anastomosis.

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Table 1. Underlying conditions and magnets used for each patient. Patient Indication for magnetic compression anastomosis Type of number magnet used 1 Gastric outlet obstruction Discoid pair* (metastatic colon adenocarcinoma) 2 Rectocolonic stenosis Discoid pair (post-Hirschprung’s repair) 3 Rectocolonic stenosis Discoid pair (post-Hirschprung’s repair) 4 Esophageal stenosis Discoid pair (post-surgical repair of esophageal atresia) 5 Esophageal stenosis Discoid pair (post-surgical repair of esophageal atresia) 6 Esophageal stenosis Discoid pair (post-surgical repair of esophageal atresia) 7 Esophageal stenosis Discoid pair (post-surgical repair of esophageal atresia) 8 Esophageal stenosis Discoid pair (post-surgical repair of esophageal atresia) 9 Type A Esophageal atresia, unrepaired Catheter-based pair† Type A Esophageal atresia, unrepaired

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Type A Esophageal atresia, unrepaired

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Type A Esophageal atresia, unrepaired

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Catheter-based pair Catheter-based pair

Type C Esophageal atresia, esophagus unrepaired Catheter-based pair (tracheoesophageal fistula had been repaired) 16 Type C Esophageal atresia, esophagus unrepaired Catheter-based pair (tracheoesophageal fistula had been repaired) 17 Type C Esophageal atresia, esophagus unrepaired Catheter-based pair (tracheoesophageal fistula had been repaired) * Discoid magnet pairs contained a 12 mm and a 14 mm diameter magnet with a magnetic power of 12,550 G † Bullet-shaped catheter-based magnets were 5 mm in diameter with a magnetic power of 12,800G

Magnetic gastrointestinal anastomosis in pediatric patients.

To describe 17 patients who underwent magnetic, non-surgical gastrointestinal (GI) anastomoses...
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