Minimally-Invasive Myotomy: Percutaneous

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General Surgery SURGICAL TECHNOLOGY INTERNATIONAL Volume 31

Minimally-Invasive Myotomy: Percutaneous Laparoscopic Surgical Approach for Achalasia LAVINIA ALESSANDRA BARBIERI, MD GENERAL SURGEON GENERAL SURGERY DEPARTMENT ISTITUTO CLINICO SANT’AMBROGIO MILAN, ITALY

MARTA CAVALLI, MD GENERAL SURGEON DAY AND WEEK SURGERY DIVISION GENERAL SURGERY DEPARTMENT UNIVERSITY OF INSUBRIA VARESE, ITALY

DAVIDE BONA, PHD PROFESSOR GENERAL SURGERY DEPARTMENT UNIVERSITY OF MILAN DIRECTOR MINIMALLY-INVASIVE SURGERY GENERAL SURGERY DEPARTMENT ISTITUTO CLINICO SANT’AMBROGIO MILAN, ITALY

FRANCESCA LOMBARDO, MD GENERAL SURGEON DAY AND WEEK SURGERY DIVISION GENERAL SURGERY DEPARTMENT ISTITUTO CLINICO SANT’AMBROGIO MILAN, ITALY

ALBERTO AIOLFI, MD GENERAL SURGEON GENERAL SURGERY DEPARTMENT IRCCS POLICLINICO SAN DONATO MILAN, ITALY

PIERO GIOVANNI BRUNI, MD GENERAL SURGEON DAY AND WEEK SURGERY DIVISION GENERAL SURGERY DEPARTMENT ISTITUTO CLINICO SANT’AMBROGIO MILAN, ITALY

GIANCARLO MICHELETTO, PHD PROFESSOR GENERAL SURGERY DEPARTMENT UNIVERSITY OF MILAN DIRECTOR GENERAL SURGERY DEPARTMENT ISTITUTO CLINICO SANT’AMBROGIO MILAN, ITALY

GIAMPIERO CAMPANELLI, PHD FULL PROFESSOR/DIRECTOR DAY AND WEEK SURGERY DIVISION GENERAL SURGERY DEPARTMENT ISTITUTO CLINICO SANT’AMBROGIO MILAN, ITALY

ABSTRACT

T

he laparoscopic approach of the upper gastrointestinal tract is considered the gold standard for the treatment of functional benign esophageal disorders since 1990. In recent years, many efforts have been

made to minimize the abdominal wall’s trauma to reduce postoperative pain and to obtain a prompt

return to daily activities, as well as improve cosmetic results of surgery. The progressive development of

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Minimally-Invasive Myotomy: Percutaneous Laparoscopic Surgical Approach for Achalasia BARBIERI/BONA/AIOLFI/MICHELETTO/CAVALLI/LOMBARDO/BRUNI/CAMPANELLI

novel surgical devices has allowed for the introduction of new minimally-invasive surgical techniques. Criticism of the single-incision laparoscopic surgery includes a modification of surgical technique and an increased incidence of wound-related complications, such as infections and incisional hernia.

We present our early experience using the new MiniLap ® Percutaneous Surgical System (Teleflex

Incorporated, Wayne, Pennsylvania) to perform a two-trocars laparoscopic percutaneous-assisted esophageal

Heller myotomy. We demonstrate that the use of percutaneous instruments was not inferior in terms of

clinical outcomes as compared to the standard technique, while improving cosmetic results and reducing

trocar-related abdominal pain.

INTRODUCTION Achalasia is a rare esophageal motility disorder affecting both genders equally. The incidence of the disease increases with age and ranges from 1 to 4.81 cases per 100,000 per year.1,2 The etiology is still unclear, but the pathogenesis includes an immune-mediated selective loss of inhibitory neurons of the myoenteric plexus that results in impaired relaxation of the lower esophageal sphincter (LES) in response to swallowing and a progressive loss of peristalsis of the esophageal body.3 The subsequent clinical presentation results in the typical symptoms of dysphagia, regurgitation of undigested food or saliva, chest pain, and a sudden and unintentional weight loss complete the clinical presentation. Pulmonary complications, such as chronic cough or pneumonia, due to aspiration, are also described in these patients. Once achalasia is suspected, the complete diagnostic work-up includes a bari-

um swallow, an endoscopy, and an esophageal manometry. Not infrequently, a barium swallow is the first study employed in the evaluation of dysphagia and the typical signs shown are the tapering of the distal esophagus and the typical “bird’s beak” appearance at the cardias. Esophageal dilatation is often seen and ranges from mild to sigmoid-shape megaesophagus. Recently, a timed barium swallow with images obtained at 0, 1, 2 and 5 minutes after having the patient drink 200 mL of barium, has gained popularity for diagnosis and follow-up. Manometry and high-resolution manometry (HRM) are the gold standard for the diagnosis of achalasia. While traditional manometry highlights the absence of peristalsis at the level of the esophageal body and the lack of relaxation of the lower esophageal sphincter during swallowing acts, the more recent HRM and high-resolution esophageal pressure topography (EPT) allow for the classification of esophageal achalasia in three different manometrical patterns according to the Chicago classification (Table I).4

Table I Achalasia classification according to the Chicago criteria version 3.0 Type I

Absence of peristalsis, no pressurization within the esophageal body, high integrated relaxation pressure

Type II

Absence of peristalsis, and contractile activity, panesophageal pressurization >30 mmHg, and high integrated relaxation pressure

Type III

Absence of peristalsis, and two or more spastic contractions with or without periods of compartmentalized pressurization and high integrated relaxation pressure

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The therapeutic options aim to reduce the pressure at the LES and allow for esophageal emptying disrupting the muscular fibers at the cardias through endoscopic or surgical approaches. The medical therapy has been progressively abandoned due to marginal efficacy and the side effects of the drugs.5 Four endoscopic approaches are currently available: intrasphinteric botulin toxin injection, pneumatic dilatation of the lower esophageal sphincter (LES), transcardial placement of retrievable self-expanding stents, and peroral esophageal myotomy (POEM). Botulin toxin injection has excellent, and immediate, clinical response (more than 78%), but is associated with shortterm symptom relief and needs to be repeatedly administered.6 For these reasons, this method is indicated for the exclusive treatment of elderly patients with comorbidities. Pneumatic dilatation (PD) is performed using a low compliance dilator, such as Rigiflex over the wire (OTW), and aims to produce an effective mechanical tear in the muscle fibers. PD is an operator dependent procedure and three variables can affect the result: 1) choice of diameter of the balloon (fully inflated dilator ranges between 3 and 4 cm); 2) the number of dilation sessions; and 3) the inflation time needed for an effective dilation. Pneumatic dilatation with 30, 35, and 40 mm Rigiflex Balloons (Cook Medical, Winston-Salem, North Carolina) result in a range from good to excellent with regard to symptom relief in 74%, 86%, and 90% of patients, respectively, at three-year follow-up, but nearly two-thirds of patients have symptom relapse over a six-year period.7-10 Age more than 40

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years, female, and type II pattern by HRM are independent factors for dilation success.11 PD “on demand strategy” consists of the endoscopic treatment of symptom recurrence and can achieve long-term remission.12 The use of selfexpanding metallic stents to induce a gradual and lasting action at the level of LES is feasible and safe. A study of 90 patients treated with placement of selfexpanding 30 mm metallic stents showed a long-term clinical success rate > 80% during a follow-up period of 10–13 years. No perforation and no mortality were reported. Stent migration occurred in 5% of patients. Cheng et al. reported a better long-term clinical efficacy in treatment of achalasia than with PD.13 Peroral Endoscopic Myotomy (POEM) is a novel, endoscopic, minimally-invasive method used to perform a long esophagomyotomy for the treatment of achalasia. The method was first reported by Pasricha in a porcine model and subsequently successfully performed in humans by Inoue.14,15 POEM is performed by dissecting the muscle layer of the esophagus through a submucosal tunnel transorally with flexible endoscopy. This method is still not widespread because of the extensive learning curve. The results show that POEM appears to be a highly effective treatment for achalasia, providing an overall clinical response rate of 98%. Short-term outcomes after POEM were extremely positive, independent of age, type of achalasia, and previous treatment method.16,17 A recent meta-analysis shows similar results comparing

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POEM and laparoscopic Heller’s myotomy (LHM).18 LHM, for the treatment of achalasia, is widely debated throughout the world. This technique was first reported by Ernst Heller in 1913 and has been modified over the years. In fact, presently, the cardiomyotomy is only performed on the anterior side of the esophagus and, to reduce the incidence of postoperative reflux, it is usually associated with a partial anterior Dor fundoplication.19 The laparoscopic approach allows for good access to the gastroesophageal junction area to perform a wide myotomy, extended 6 cm on the esophageal side and 2 cm on the gastric side. A recent multicenter study suggests that the anterior (Dor) and the posterior Toupet fundoplication effectively protects against postoperative reflux. Conversely, a Dor fundoplication requires minor gastric fundus dissection, acts as a protective patch above the mucous membrane, and keeps the edges of the myotomy far apart which prevents early healing of the myotomy.20 Procedure-related mortality is about 0.1%, stating that it is a safe procedure.6 Esophageal perforation is the most feared surgical complication, especially if unrecognized intraoperatively. If recognized early, primary suture with single stitches is effective. To detect even minimal mucosal discontinuities, a great emphasis is placed on the use of routine intraoperative endoscopy that is mandatory in case of difficult myotomy. Adhesions between the submucosal layer and the muscular one, due to previous endoscopic dilatation treatments, can make

Figure 1. MiniLap® devices and trocars position. The use of these devices allows for replication of the classic videopaparoscopic trocar positioning scheme ensuring the maintenance of the triangulation principles.

myotomy more difficult and can result in more perioperative complications.21,22 The overall complication rate of LHM is 6.3% (range, 0 to 35%), but clinical consequences are reported in 0.7% of cases.23 The resting pressure of the lower esophageal sphincter is greater than 30 mmHg. This, combined with the patient’s young age (< 40 years) and the absence of sigmoid dilatation of the distal esophagus, is considered a positive prognostic factor after laparoscopic Heller myotomy dysphagia relapse. After surgery, it is usually associated with an incomplete myotomy on the gastric side or as a result of an antireflux wrap that is too tight.24 In recent years, more and more importance has been given to postoperative outcomes, cosmetic result, and minimally-invasive technique for this kind of

b

Figure 2. a) Percutaneous insertion of the instrument using the integrated needle tip. b) Wide opening up to 12.5 mm of the grasp that allows adequate tissue manipulation.

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Minimally-Invasive Myotomy: Percutaneous Laparoscopic Surgical Approach for Achalasia BARBIERI/BONA/AIOLFI/MICHELETTO/CAVALLI/LOMBARDO/BRUNI/CAMPANELLI

Figure 3. Diameter comparison between MiniLap® devices and laparoscopic 3 mm and 5 mm instrument port.

benign disease. POEM is gaining ground as an incisionless treatment, but longterm results are still not stated. To have the same results in laparoscopic surgery while improving esthetic and functional results, new mini-trocar and percutaneous systems have been developed. The purpose of these instruments is to minimize the abdominal wall trauma and reduce the size of the scar. The counterpart of these instruments could be a limitation of the manipulation of the tissues and the surgical movements. The aim of this study is to describe our preliminary experience with percutaneous instruments for the treatment of achalasia. Materials andAND Methods MATERIALS METHODS In our institution, an LHM is usually performed through a five trocars laparoscopic access and the diameters of the trocars are 10–12 mm (two trocars)

and 5 mm (three trocars). We present our early experience using the new MiniLap® Percutaneous Surgical System (Teleflex Incorporated, Wayne, Pennsylvania). The proposed technique allows the replacement of three 5 mm trocars with three MiniLap® percutaneous instruments (Fig. 1). Because of their slim 2.3 mm shaft diameter, these devices can be percutaneously inserted using an integrated needle tip (Fig. 2a). The grasper jaws can then be deployed to grasp and manipulate tissue. The patented deployment design allows grasper jaws to open up to 12.5 mm and the proprietary steel shaft provides the strength and rigidity needed for secure tissue retraction (Fig. 2b). The sturdy 2.4 mm shaft allows for direct insertion through the skin, leaving nearly unnoticeable scarring (Fig. 3).Between November 2015 and June 2016, five consecutive patients underwent surgery for type II achalasia. All patients were female and the mean age was 48 ± 7 years. A two-trocars percutaneous-

Figure 4. Secure grip of the right edge of the myotomy and good exposure of the submucosal layer.

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assisted LHM was performed combining an anterior Dor fundoplication.

Operative technique As for the routine, LHM myotomy was extended for 6 cm on the esophagus and 2 cm onto the gastric side. In this phase, we usually use the grasp in the left hand to keep the right edge of myotomy to facilitate exposure of the mucosal layer (Fig. 4). Opposite traction on the gastric wall was done for myotomy orientation using the left inferior percutaneous grasper. After an intraoperative endoscopic check for resistance or leaks was made, we added an anterior Dor fundoplication on the myotomy site with the same instruments in the usual position. We routinely refrain from dividing the short gastric vessels and reserve this surgical step for cases of small non-compliant gastric fundus. The 180° anterior gastric anti-reflux valve is constituted by a double suture line, one on the left and one on the right side of the esophagus, composed of three non-absorbable extracorporeal stitches. The cranial stitches, on both sides, involve the gastric wall, the diaphragmatic pillar, and the edge of the myotomy; the second and third stitches take only the stomach and the esophageal muscular layer—we found no difficulties in performing the fundoplication through this percutaneous mini-trocar. The average operative time was 78 ± 12 minutes. No intraoperative and perioperative complications occurred. No intra-abdominal drains were placed at the end of myotomy. A water-soluble contrast swallow was performed on postoperative day one and the patients resumed oral intake with a semi-liquid diet. Postoperative pain was managed with two intravenous pain-killers administered daily until discharge, if required. The patients were discharged

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on the second postoperative day. No skin infections of the percutaneous introduction sites were observed. After a minimum 15 months of follow-up, there was no recurrence of dysphagia in any of the patients treated. All of the patients gained weight and were able to swallow without difficulties. Median Eckardt score was 1 (0–2), which was on par with our routinely performed laparoscopic Heller’s myotomy. The esthetic result was optimal as the 2.4 mm scars were nearly undetectable. DiscussionDISCUSSION Typically, anti-reflux procedures and esophageal myotomy are performed using a five-trocars laparoscopic technique. The size of the trocars is 12 mm in length (two trocars) and 5 mm in diameter (three trocars). The use of new minimally-invasive instruments (MiniLap®) allows for the replacement of the three 5 mm trocars without any change in the surgical technique. Singleincision laparoscopic surgery, has been widely demonstrated as safe and effective, but not all the procedures are suitable due to difficult triangulation and limited working space that requires the surgeon to modify and modulate the surgical technique—even proper angle between the instruments is not always guaranteed. Minimal skin incisions that do not require skin suture and reduced abdominal trauma are common points of strength for this technique. While performing the myotomy, stomach traction is an essential element in avoiding iatrogenic lesions of the mucosal layer. Furthermore, grasping the right edge of the myotomy helps to complete the gastric myotomy. These percutaneous instruments enable a secure, effective, and atraumatic grip of these anatomical structures. The fundoplication was also simple to perform with this instrument in the same position. However, there are still margins for improvement, especially in terms of ergonomics of the handle as well as the closing mechanism that was found to be a little too rigid. Finally, the possibility to replace the same device in other positions to improve ergonomics and triangulation during the same surgery or to do other

General Surgery SURGICAL TECHNOLOGY INTERNATIONAL Volume 31

surgical interventions should not be underestimated. Conclusions CONCLUSION

To conclude, two-trocars myotomy and Dor anterior fundoplication for the treatment of achalasia is a safe procedure that allows the surgeon to proceede with familiar principles of laparoscopic surgery. The method requires no learning cur ve for the laparoscopic surgeon and it could be considered a good alternative to a three, 5 mm trocar technique, particularly with regard to esthetic improvements in young women. STI Authors’ Disclosures AUTHORS’ DISCLOSURES The authors have no conflicts of interest to disclose. ReferencesREFERENCES 1. Sadowski DC, Ackah F, Jiang B, et al. Achalasia: incidence, prevalence and survival. A population-based study. Neurogastroenterol Motil 2010;22:e256–61. 2. Chuah SK, Hsu PI, Wu KL, et al. 2011 update on esophageal achalasia. World J Gastroenterol 2012;18:1573–8. 3. Champion JK, Delise N, Hunt T. Myenteric plexus in spastic motility disorders. J Gastrointest Surg 2001;5:514–6. 4. Kahrilas PJ, Bredenoord AJ, Fox M, et al. The Chicago Classification of esophageal motility disorders, v3.0. Neurogastroenterol Motil 2015;27(2):160–74. 5. Vaezi MF, Richter JE. Current therapies for achalasia: comparison and efficacy. J Clin Gastroenterol 1998;27(1):21–35. 6. Campos GM, Vittinghoff E, Rabl C, et al. Endoscopic and surgical treatments for achalasia: a systematic review and meta-analysis. Ann Surg 2009;249:45–57. 7. Fisichella PM, Raz D, Palazzo F, et al. Clinical, radiological, and manometric profile in 145 patients with untreated achalasia. World J Surg 2008; 32:1974–7. 8. Vela MF, Richter JE, Khandwala F, et al. The long-term efficacy of pneumatic dilatation and Heller myotomy for the treatment of achalasia. Clin Gastroenterol Hepatol 2006;4: 580–7. 9. Zerbib F, Thétiot V, Richy F, et al. Repeated pneumatic dilations as long-term maintenance therapy for esophageal achalasia. Am J

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Gastroenterol 2006;101:692–7. 10.Seng-Kee C, Chien-Hua C, Wei-Chen T. Current status in the treatment options for esophageal achalasia. World J Gastroenterol 2013;19(33):5421–9. 11.Pandolfino JE, Kwiatek MA, Nealis T, et al. Achalasia: a new clinically relevant classification by high-resolution manometry. Gastroenterology 2008;135:1526–33. 12.Katsinelos P, Kountouras J, Paroutoglou G, et al. Long-term results of pneumatic dilation for achalasia: a 15 years’ experience. World J Gastroenterol 2005;11:5701–5. 13.Ying-Sheng Cheng, Fang Ma, Yong-Dong Li, et al. Temporary self-expanding metallic stents for achalasia: A prospective study with a long-term follow-up. World J Gastroenterol 2010;16(40):5111–7. 14.Pasricha PJ, Hawari R, Ahmed I, et al. Submucosal endoscopic esophageal myotomy: a novel experimental approach for the treatment of achalasia. Endoscopy 2007;39:761–4. 15.Inoue H, Minami H, Kobayashi Y, et al. Preoral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy 2010;42: 265–71. 16.Stavropoulos SN, Modayil RJ, Friedel D, et al. The International Per Oral Endoscopic Myotomy Survey (IPOEMS): a snapshot of the global POEM experience. Surg Endosc 2013; 27(9):3322–38. 17.Shiwaku H, Inoue H, Yamashita K, et al. Peroral endoscopic myotomy for esophageal achalasia: outcomes of the first over 100 patients with short-term follow-up. Surg Endosc. 2016 Nov;30(11):4817-4826. 18.Talukdar R, Inoue H, Reddy DN. Efficacy of peroral endoscopic myotomy (POEM) in the treatment of achalasia: a systematic review and meta-analysis. Surg Endosc 2015;29: 3030–46. 19.Heller E. Extramukose kardioplastik beim chronischen kardiospasm mit dilatation des oesophagus. Mitt Greenzgeb Med Chir 1913;27:141–48. 20.Rawlings A, Soper NJ, Oeschlager B, et al. Laparoscopic Dor versus Toupet fundoplication following Heller myotomy for achalasia: results of a multicenter, prospective, randomized-controlled trial. Surg Endosc 2012;26(1):18–26. 21.Smith CD, Stival A, Howell DL, et al. Endoscopic therapy for achalasia before Heller myotomy results in worse outcomes than heller myotomy alone. Ann Surg 2006; 243:579–84. 22.Rosemurgy AS, Morton CA, Rosas M, et al. A single institution's experience with more than 500 laparoscopic Heller myotomies for achalasia. J Am Coll Surg 2010;210(5): 637–47. 23.Schubert MJ, Luketich JD, Landreneau RJ, et al. Minimally-invasive esophagomyotomy in 200 consecutive patients: factors influencing postoperative outcomes. Ann Thorac Surg 2008;248:986–93. 24.Zaninotto G, Costantini M, Portale G, et al. Etiology, diagnosis and treatment of failures after laparoscopic heller myotomy for achalasia. Ann Surg 2002;235:186–92.