A word of caution: never use tacks for mesh fixation to the diaphragm!

A word of caution: never use tacks for mesh fixation to the diaphragm! Background The mesh fixation technique used in repair of hiatal hernias and subxiphoid ventral and incisional hernias must meet strenuous requirements. In the literature, there are reports of life-threatening complications with cardiac tamponade and a high mortality rate on using tacks. The continuing practice of tack deployment for mesh fixation to the diaphragm and esophageal hiatus should be critically reviewed. Methods In a systematic search of the available literature in May 2017, 23 cases of severe penetrating cardiac complica- tions were identified. The authors became aware of two other cases in which they acted as medical experts. Furthermore, the instructions for use issued by the manufacturers of the tacks were reviewed with regard to their deployment in the diaphragm. Results Twenty-three of 25 cases (92%) with severe cardiac injuries and subsequent cardiac tamponade were triggered by the use of tacks in the diaphragm. In six cases (24%), these related to ventral and incisional hernias with extension to the subxi- phoid area, and in 19 cases (76%) to mesh-augmented hiatoplasty. Twelve of 25 (48%) patients died as a result of pericardial and/or heart muscle injury with cardiac tamponade despite heart surgery intervention. In the tack manufacturers’ instructions for use, their deployment in the diaphragm, in particular in the vicinity of the heart, is contraindicated. Likewise, the existing guidelines urgently advise against the use of tacks in the diaphragm, recommending instead alternative fixation techniques. Conclusions Tacks should not be used for mesh fixation in the diaphragm above the costal arch. Keywords Mesh fixation · Tacks · Cardiac tamponade · Hiatal hernia · Laparoscopic IPOM Background of cardiac tamponade due to tack fixation of the mesh to the diaphragm in incisional hernia repair was published [5]. Compared to the open approach, laparoscopic intraperitoneal In hiatal hernia repair, the use of a mesh for reinforce- onlay mesh (IPOM) repair of ventral and incisional hernias ment of large hiatal hernias leads to decreased short-term has a lower rate of wound infections and similar recurrence recurrence rates [6]. In a survey of the Society of American and postoperative pain rates [1–4]. For fixation of the mesh Gastrointestinal Endoscopic Surgeons (SAGES) members, in laparoscopic IPOM, the use of sutures alone or a combi- 261 surgeons reported a total of 5486 hiatal hernia repairs nation with tacks is recommended [1]. In addition to other with mesh [7]. factors reported in the literature, larger defects greater than The Society of American Gastrointestinal Endoscopic 10 cm in diameter and subxiphoid location are identified as Surgeons (SAGES) guidelines for the management of hiatal increasing the complexity of laparoscopic IPOM in ventral hernia state that there exists inadequate evidence for a rec- and incisional hernia repair [1, 4]. In 2010, the first report ommendation to be made regarding optimal fixation tech- niques [6]. In 2000, Kemppainen et al. [8] reported the first case of fatal cardiac tamponade after emergency tension-free mesh * F. Köckerling ferdinand.koeckerling@vivantes.de repair of a large paraesophageal hernia. The mesh was fixed with tacks. Department of Surgery and Center for Minimally In 2012, Frantzides et al. [9] presented a review of the Invasive Surgery, Academic Teaching Hospital of Charité literature and search of the US Food and Drug Administra- Medical School, Vivantes Hospital, Neue Bergstrasse 6, 13585 Berlin, Germany tion’s Manufacturer and User Device Experience (MAUDE) database. They reported a total of 10 cases of cardiac Hernia Center, Winghofer Medicum, Winghofer Strasse 42, 72108 Rottenburg am Neckar, Germany Vol.:(0123456789) 1 3 3296 Surgical Endoscopy (2018) 32:3295–3302 tamponade in hiatal hernia repair, of which six resulted in with temporary improvement. On returning to the operat- patient mortality, and five cases of ventral hernia repair, of ing room, he coded and died on the operating table. The which four had a fatal outcome. Ten cases were caused by autopsy findings showed laceration of a coronary vessel. the helical tacker, two by sutures, one by the straight stapler, and in one case the cause was not identified [9 ]. All cases of severe penetrating cardiac complications Case 3 [8] known to be triggered by surgery are now described in detail below. In addition to the cases presented in the review by A patient with thoracic herniation and incarceration of Frantzides et al. [9], ten further cases are included. As a the stomach underwent laparoscopic operation, including consequence of these cases, numerous statements and rec- reduction of an intrathoracic stomach, hernia sac removal, ommendations have in the meantime been incorporated into and tension-free repair of the hiatus with polytetrafluoro- guidelines and publications for avoidance of this severe com- ethylene mesh. The mesh was fixed with a straight hernia plication. These are presented in Discussion section as a stapler. Postoperatively, the patient developed fatal cardiac management recommendation for surgeons. The instructions tamponade secondary to coronary vein laceration due to for use given by the manufacturers of the mesh fixation sys- fixation of the mesh with a stapler. tems are also reviewed in that context. Case 4 [12] Methods An 84-year-old woman suffered from a type IV diaphrag- In May 2017, a systematic search of the available litera- matic hernia with a tortuous intrathoracic stomach and ture was performed using Medline, PubMed, the Cochrane grade II esophagitis. The stomach was reduced into the Library, as well as a search of relevant journals and reference abdominal cavity and the hernia sac resected. A coated lists. The following search terms were used: mesh fixation polyester mesh was attached to the crura with 5-mm AND diaphragm, mesh fixation AN D hiatal hernia, mesh titanium helical tacks. After an uneventful recovery, the fixation AN D subxiphoid hernia, mesh fixation AN D cardiac patient suddenly developed cardiogenic shock on post- complications, mesh fixation AN D cardiac tamponade, mesh operative day 14. A left thoracotomy was subsequently fixation AN D hemopericardium, tacks AND cardiac com- performed. There was active bleeding of the epicardium plications, and mesh AND cardiac tamponade. The search from a number of pointed lesions, just opposite the tackers identified 19 relevant articles. which had penetrated the pericardium. The offending tacks were removed and the defects in the epicardium sutured. The patient was discharged 18 days after thoracotomy. Results (Table 1) Case 1 [10] Case 5 [13] A 66-year-old female patient underwent surgery because of A 74-year-old woman presented with a request for a sec- a large paraesophageal hiatal hernia. Just prior to the fun- ond antireflux surgery seven years after the primary sur - dal wrap of the Nissen fundoplication, the patient suddenly gery. Because of the previous surgical intervention, an became tachycardic and profoundly hypotensive. Emergency upper median laparotomy was used. Mesh-reinforced hia- sternotomy revealed hemopericardium and a 2-cm laceration toplasty with anterior fundophrenicopexy was performed of the diaphragmatic surface of the right ventricle, which as an antireflux procedure. A 6 × 6 cm prolene mesh was was controlled by placement of several sutures. The authors applied and fixed to the diaphragm with 10 helical staples. believed that the injury to the heart was secondary to a per- A few hours postoperatively, a decrease in blood pres- forating needle on the contracting ventricle. The patient sure occurred and the subsequent computed tomography could be discharged from hospital on postoperative day 21. (CT) scan confirmed suspected cardiac tamponade. An emergency relaparotomy with pericardial fenestration was Case 2 [11] performed. Venous bleeding from the myocardium of the right ventricle, probably caused by a fundophrenicopexy A 40-year-old man underwent Collis-Nissen repair of gas- suture, was stopped by resuturing, the pericardium was troesophageal reflux disease. The night of the operation left open, and the left hemithorax was drained. The patient he became hypotensive and was believed to have cardiac could be discharged on postoperative day 24. tamponade. Bedside pericardiocentesis was performed 1 3 Surgical Endoscopy (2018) 32:3295–3302 3297 Table 1 Overview of all cases with cardiac tamponade/injuries caused by hernia surgery Case Author Access Indication Procedure Cause Outcome 1 Farlo et al. [10] Laparoscopic Large paraesophageal Nissen fundoplication Suture Recovery hernia 2 Trastek et al. [11] Thoracotomy Gastroesophageal reflux Collis-Nissen fundoplica- Suture Death disease tion 3 Kemppainen et al. [8] Laparoscopic Large paraesophageal Mesh-augmented hiato- Straight hernia stapler Death hernia with gastric incar- plasty ceration 4 Thijssens et al. 2002 [12] Laparoscopic Upside-down stomach Mesh-augmented hiato- Helical tacker Recovery plasty 5 Müller-Stich et al. [13] Open Recurrent reflux disease Mesh-reinforced hiato- Suture Recovery after fundoplication plasty and fundophren- icopexy 6 Müller-Stich et al. [13] Laparoscopic Gastroesophageal reflux Mesh-augmented hiato- Helical tacker Death disease plasty and fundophren- icopexy 7 Dapri et al. 2007 [14] Laparoscopic Congenital diaphragmatic Mesh-augmented defect Helical tacker Recovery hernia closure 8 Malmstrom et al. [5] Laparoscopic Incisional hernia Intraperitoneal onlay mesh Helical tacker Recovery repair 9 Frantzides et al. [9] Laparoscopic Incisional hernia Intraperitoneal onlay mesh Helical tacker Death repair 10 Frantzides et al. [9] Laparoscopic Unknown Mesh-augmented hiato- Helical tacker Death plasty 11 Frantzides et al. [9] Unknown Ventral hernia Ventral hernia repair Helical tacker Death 12 Frantzides et al. [9] Unknown Ventral hernia Ventral hernia repair Helical tacker Death 13 Frantzides et al. [9] Unknown Ventral hernia Ventral hernia repair Helical tacker Death 14 Frantzides et al. [9] Unknown Hiatal hernia Hiatal hernia repair Helical tacker Death 15 Frantzides et al. [9] Unknown Hiatal hernia Hiatal hernia repair Helical tacker Death 16 Frantzides et al. [9] Unknown Hiatal hernia Hiatal hernia repair Helical tacker Recovery 17 Paz et al. [15] Laparoscopic Gastroesophageal reflux Mesh-augmented hia- Tacker Recovery disease toplasty and Toupet fundoplication 18 Makarewicz et al. [16] Laparoscopic Gastroesophageal reflux Mesh-augmented hia- Helical tacker Recovery disease toplasty and Nissen fundoplication 19 Jorgensen et al. [17] Laparoscopic Unknown Mesh-augmented hiato- Tacker Death plasty 20 del Carmen Fernandez Laparoscopic Gastroesophageal reflux Mesh-augmented hia- Absorbable tacker Recovery et al. [18] disease toplasty and Nissen fundoplication 21 del Carmen Fernandez Laparoscopic Gastroesophageal reflux Mesh-augmented hia- Absorbable tacker Recovery et al. [18] disease toplasty and Nissen fundoplication 22 del Carmen Fernandez Laparoscopic Upside-down stomach Mesh-augmented hiato- Absorbable tacker Recovery et al. [18] plasty and Nissen fundoplication 23 McClellan et al. (19) Laparoscopic Bariatric redo-procedure Mesh closure of a large Absorbable tacker Recovery with large hiatal defect hiatal hernia defect 24 We are aware of an addi- Open Incisional hernia extend- Intraperitoneal onlay mesh Absorbable tacker Death tional unreported, unpub- ing from suprapubic to repair lished case, in which one subxiphoid the authors (F. K.) acted as medical expert 1 3 3298 Surgical Endoscopy (2018) 32:3295–3302 Table 1 (continued) Case Author Access Indication Procedure Cause Outcome 25 We are aware of an addi- Laparoscopic Upside-down stomach Mesh-augmented hiato- EMS Stapler Death tional unreported, unpub- plasty lished case, in which one of the authors (R. B.) acted as medical expert Extensive pericardial tamponade diagnosed on echocar- Case 6 [13] diography was treated by percutaneous drainage, evacuat- ing 500 ml of blood. Sternotomy showed a spiral tacker An 82-year-old man presented with an 8-cm mixed hiatal protruding through the pericardium, resulting in a lesion of hernia with grade IV esophagitis. Surgical treatment con- 2 × 2 mm in the right ventricle. Furthermore, five spiral tack - sisted of laparoscopically mesh-augmented hiatoplasty with ers were visible from the inside of the pericardium and two anterior fundophrenicopexy. Because of accidental rupture had gone through the diaphragm and into the pleural cavity. of the right crus of the diaphragm, a 15 × 15 cm prolene The patient was discharged a week later in good health. mesh was necessary to reconstruct the hiatus. The mesh was fixed by 16 helical tacks. During the first 24 postoperative hours, deteriorating oxygen saturation with increasing dysp- Cases 9 and 10 [9] nea was most notable. After 48 h, the patient experienced severe retrosternal pressure with simultaneous tachyarrhyth- The authors were aware of two additional unreported, mia and consecutive circulatory failure. The patient died unpublished cases with cardiac injury, of which one was despite resuscitation attempts. The autopsy revealed cardiac sustained during ventral herniorrhaphy and one during hiatal tamponade originating from an epicardial vascular erosion hernia repair. The senior author acted as a medical expert caused by one of the helical tacks. in these cases. Both heart injuries were the result of helical tacks being Case 7 [14] used for fixation of the mesh to the central tendon of the dia- phragm. Both patients died as a result of hemopericardium A 57-year-old woman presented with right, medial, and left tamponade. In each of these cases, the diagnosis of cardiac congenital diaphragmatic hernia defect. The hernia defect tamponade was established only at autopsy. was closed laparoscopically by a running suture and then a mesh placed as an onlay fixed with helical hernia tacks. Cases 11 to 16 [9] The patient developed cardiac tamponade on the second day due to tack-induced bleeding of an epicardial artery of The MAUDE database (US Food and Drug Administration’s the inferior surface of the heart, which required emergency Manufacturer and User Facility Device Experience) search pericardial drainage. The outcome was good, and discharge revealed a total of six cases of cardiac tamponade associ- home was allowed after 1 month. ated with the helical tacker during mesh fixation to the dia- phragm. Three of these cases occurred during ventral hernia Case 8 [5] repair and all were fatal. The other three cases occurred dur- ing hiatal hernia repair and two were fatal. A 25-year-old obese patient developed a large incisional hernia after gallbladder removal with lesion of the common Case 17 [15] bile duct and open transverse revision. This was repaired laparoscopically using two meshes measuring 30 × 30 and A 61-year-old female with a history of gastroesophageal 20 × 30 cm, respectively, sewn together. The facial defect was in a transverse incision under both rib curvatures, meas- reflux disease and hiatal hernia developed hemopericar - dium and tamponade one day after laparoscopic hiatal her- uring 35 × 15 cm. The mesh was positioned ensuring an overlap of about 8 cm. The mesh was fixed using titanium nia repair and Toupet fundoplication. The patient underwent emergency pericardiocentesis and subsequent surgical peri- spiral tackers along the margin of the mesh, with a distance of 1 cm between each tacker. On postoperative day 9, the cardial window. During surgery, a tack that had been used to secure the mesh to the inferior aspect of the diaphragm was patient exhibited a decreased state of consciousness, blood pressure of 80/50 mmHg, a heart rate of 70 beats/min, and found to have penetrated the pericardium near the right ven- tricle. The patient recovered without further complications. spontaneous breathing with 40 respirations/min. 1 3 Surgical Endoscopy (2018) 32:3295–3302 3299 laparoscopic Nissen fundoplication with hiatal mesh rein- Case 18 [16] forcement using absorbable tacks. On postoperative day 2, the patient developed hypotension, tachycardia, and irregular A 69-year-old patient presented with gastroesophageal reflux disease and a stage III paraesophageal hernia. Nis- pulse. A CT scan revealed an extrapericardial hematoma in the sen fundoplication was performed. For hiatoplasty a mesh was used, which was fixed to the diaphragm with six helical hernia sac with mild left atrium compromise. Conservative treatment was decided and the patient discharged on post- tackers. On postoperative day 3, the patient collapsed with signs of acute heart failure and low output syndrome sec- operative day 15. ondary to cardiac tamponade. On emergency sternotomy, approximately 1500 mm of hemolyzed blood with clots was Case 23 [19] retrieved from pericardial sac. Two tacks (3 cm medially to the inferior vena cava) penetrating into the pericardial sac During a redo bariatric procedure, a hiatal defect of 10 cm were noted. The patient survived this severe complication. could not be initially repaired due to its significant size, rigidity of the lateral edges, and the anterior location, and Case 19 [17] thus mesh repair was performed. Due to a difficult sutur - ing angle of the most posterior area of the defect, the mesh A 79-year-old woman underwent laparoscopic hiatal hernia was secured to the anterior portion of the right and left crus repair with mesh implantation. Tacks were used to secure the with several absorbable tacks. On postoperative day 1, the mesh to the diaphragm. Nine hours after surgery the patient patient became tachycardic and the echocardiogram revealed died from circulatory collapse. Autopsy showed perforation a moderate-sized pericardial effusion with a partially filled of the pericardium and the right coronary artery by a tacker. right atrium and partially collapsed right ventricle consistent with early tamponade. During percutaneous pericardiocen- tesis, 370 ml of bloody fluid was aspirated with subsequent Case 20 [18] immediate normalization of vital signs and relief of symp- toms. The patient was discharged home two days later. A 46-year-old man with gastroesophageal reflux disease underwent Nissen fundoplication with hiatal mesh reinforce- ment using absorbable tacks. Forty-eight hours after surgery, Case 24 the patient developed hypotension and sweating. Cardiac magnetic resonance imaging showed a large pericardial The authors are aware of an additional unreported, unpub- effusion. Pericardiocentesis was performed with removal lished case with cardiac injury during open incisional hernia of 650 cc of bloody fluid. The pericardial drain could be repair in IPOM technique. The first author (F. K.) acted as removed two days later. The patient’s further course was medical expert in that case. This related to a 52-year-old uneventful. male patient with a large incisional hernia and status post multiple laparotomies following emergency left hemicolec- Case 21 [18] tomy, Hartmann’s operation, and Hartmann’s reversal opera- tion. Open IPOM operation with placement of a 50 × 30 cm A 62-year-old woman with gastroesophageal reflux disease polypropylene mesh was performed. Since the incisional and a large hiatal hernia underwent Nissen fundoplication hernia extended from the lower abdomen to the subxiphoid with mesh hiatoplasty using absorbable tacks. On postopera- area, the mesh was positioned from the symphysis to the tive day 5, the patient developed acute respiratory distress subdiaphragmatic area. The mesh was fixed with sutures and syndrome with hypotension and oliguria. A thoracic CT scan reinforced with absorbable tackers between the sutures. Post- showed a bilateral pleural effusion and a large pericardial operatively, the patient experienced increasing thoracic pain. effusion that caused the collapse of the right atrium and ven- On postoperative day 1, a suspected heart attack was diag- tricle. She was taken back to the operating room for urgent nosed and treatment initiated with platelet aggregation inhib- surgical pericardial drainage. After that, the postoperative itors. Due to increasing circulatory instability, the patient course was uneventful. was transferred to the cardiac surgery clinic for treatment on postoperative day 2. Cardiac tamponade was diagnosed in the cardiac surgery clinic and initially treated by means Case 22 [18] of emergency pericardial drainage. Despite that, emergency sternotomy had to be performed and the patient died on the A 70-year-old woman presented with a giant hiatal her- operating table. Autopsy revealed four tacks in the vicinity nia with intrathoracic stomach. The patient underwent of the diaphragm which had penetrated the pericardium. One 1 3 3300 Surgical Endoscopy (2018) 32:3295–3302 tack had perforated the right ventricle causing bleeding into Discussion the pericardium and cardiac tamponade. Twenty-five cases of life-threatening complications due to Case 25 mechanical injuries to the pericardium and heart during her- nia surgery are known from the literature and expert witness The authors are aware of an additional unreported, unpub- processes. In three cases (12%), the pericardium or heart lished case with cardiac injury during mesh-augmented hia- injury was caused by sutures and in 22 cases (88%) by the toplasty of an upside-down stomach. The senior author (R. use of tacks. The clinical implications of such injuries were B.) acted as medical expert in this case. In the 65-years-old generally cardiac tamponade necessitating pericardial drain- female patient the mesh was partially fixed with sutures and age and/or open heart surgery with sternotomy. The mor- EMS staples. A branch of a single EMS staple did not close, tality rate associated with this severe complication is 48%. perforated the pericardium and injured a vene at the anterior The underlying indications for surgery were ventral and inci- part of the heart. Subsequently, a cardiac tamponade devel- sional hernia repair in six cases (24%) and mesh-augmented oped, which was not diagnosed in time. The patient died on hiatoplasty in 19 cases (76%). The tacks used included both postoperative day 3. non-absorbable titanium and absorbable types. The major- ity of tack-mediated injuries were caused by mesh fixation Instructions for use by the manufacturers to the diaphragm or diaphragmatic crura. Mesh fixation in of the tacks this critical anatomic region is needed in a variety of situ- ations ranging from mesh-augmented hiatoplasty for treat- The instructions for use for the most commonly employed ment of gastroesophageal reflux disease (GERD) through tacks contain the following contraindications: paraesophageal hernias to upside-down stomach and ventral and incisional hernias with extension to the subxiphoid area. ProTack (Medtronic—Covidien) The severe complications described here in associa- tion with the use of tacks in the vicinity of the diaphragm This device should not be used in tissues that have direct and esophageal hiatus naturally raise the question as to anatomical relationship to major vascular structures. This whether tacks should at all be used in this region. The would include the deployment of helical fasteners in the dia- thickness of the diaphragm muscle ranges from 1.5 to phragm in the vicinity of the pericardium, aorta, or inferior 5.4 mm [9]. The central tendon of the diaphragm averages vena cava during diaphragmatic hernia repair. only 2.9–3.00 mm in thickness [9]. The depth of penetra- tion, not including the thickness of the mesh, of the vari- AbsorbaTack (Medtronic—Covidien) ous tacks on the market ranges between 3.7 and 5.9 mm. The tack manufacturers’ instructions for use contraindicate This device should not be used in tissues that have a direct the deployment of tacks in the vicinity of the heart, major anatomic relationship to major vascular structures. This vascular structures, and diaphragm. would include deployment of tacks in the diaphragm in the The SAGES guidelines for laparoscopic ventral hernia vicinity of the pericardium, aorta, and inferior vena cava repair state that fixation of meshes above the costal mar - during diaphragmatic hernia repair. gins should not be performed with sutures placed between the ribs [4]. Furthermore, while fixation with tacks may SecureStrap (Ethicon) by feasible, it should generally be avoided to prevent lung or cardiac injury or injuries to the neurovascular bundles This device should not be used in tissues that have a direct running along the inferior surface of each rib [4]. anatomic relationship to major vascular structures. This The guidelines for laparoscopic treatment of ventral would include the deployment of fasteners in the diaphragm and incisional abdominal wall hernias of the International in the vicinity of the pericardium, aorta, or inferior vena cava Endohernia Society (IEHS) recommend not to fix the prox- during diaphragmatic hernia repair. imal part of the mesh for subxiphoid hernia repair [1]. The SAGES guidelines for management of hiatal hernia SorbaFix (Bard) state that care should be taken about the mesh fixation technique. Particularly tacks can breach the aorta or peri- Carefully inspect the area in the vicinity of the tissue being cardium when applied low on the left crus or anteriorly fastened to avoid inadvertent penetration of underlying struc- near the apex of the crura. tures such as nerves, vessels, viscera, or bone. Use of the As an alternative, Rodriguez et al. [20] advocate for SorbaFix in the close vicinity of such underlying structures extreme care when suturing mesh in hiatal hernia repair at is contraindicated. 1 3 Surgical Endoscopy (2018) 32:3295–3302 3301 the diaphragm, taking very superficial bites just to encour - References age scarring to the diaphragm and avoiding fixation by 1. Bittner R, Bingener-Casey J, Dietz U, Fabian M, Ferzli GS, tacks at all costs. Fortelny R, Köckerling F, Kukleta J, LeBlanc K, Lomanto Poris et al. [21] reported on laparoscopic repair of a sub- D, Misra MC, Bansal VK, Morales-Conde S, Ramshaw B, xiphoid hernia. 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Kemppainen E, Kiviluoto T (2000) Fatal cardiac tamponade after often and as such should be published. emergency tension-free repair of a large paraesophageal hernia. Surg Endosc. https://doi.org/10.1007/s004640000138 Acknowledgements Ferdinand Köckerling—Personal fees for the 9. Frantzides CT, Welle SN (2012) Cardiac tamponade as a life- performance of workshops from Bard, Karlsruhe and Tutogen, threatening complication in hernia repair. Surgery 152:133–135 Neunkirchen. 10. Farlo J, Thawgathurai D, Mikhail M, Yaker K, Sullivan J, Morgan E (1998) Cardiac tamponade during laparoscopic Nissen fundopli- cation. Eur J Anaesthesiol 15:246–247 Compliance with ethical standards 11. Trastek VF, Deschamps C, Allen MS, Miller DL, Pairolero PC, Thompson AM (1998) Uncut Collis-Nissen fundoplication: learn- Disclosures C. Schug-Pass and R. Bittner have no conflicts of interest ing curve and long-term results. Ann Thorac Surg 66:1739–1744 or financial ties to disclose. 12. Thijssens K, Hoff C, Meyerink J (2002) Tackers on the diaphragm. Lancet 360:1586. https://doi.org/10.1016/S0140-6736(02)11530-3 13. Müller-Stich BP, Linke G, Leemann B, Lange J, Zerz A (2006) Open Access This article is distributed under the terms of the Creative Cardiac tamponade as a life-threatening complication in antireflux Commons Attribution 4.0 International License (http://creativecom- surgery. Am J Surg 191:139–141 mons.org/licenses/by/4.0/), which permits unrestricted use, distribu- 14. Dapri G, Himpens J, Hainaux B, Roman A, Stevens E, Capelluto tion, and reproduction in any medium, provided you give appropriate E, Germay O, Cadière GB (2007) Surgical technique and com- credit to the original author(s) and the source, provide a link to the plications during laparoscopic repair of diaphragmatic hernias. Creative Commons license, and indicate if changes were made. Hernia 11:179–183. https://doi.org/10.1007/s10029-006-0161-8 1 3 3302 Surgical Endoscopy (2018) 32:3295–3302 15. Paz YE, Vasquez J, Bessler M (2011) Cardiac tamponade as a 19. McClellan JM, Nelson D, Martin M (2016) Hemopericardium complication of laparoscopic hiatal hernia repair: case report and after laparoscopic perihiatal procedures: high index of suspicion literature review. Catheter Cardovasc Interv 78:819–821 facilitates early diagnosis and successful nonoperative manage- 16. Makarewicz W, Jaworski L, Bobowicz M, Roszak K, Jaroszewicz ment. Surg Obes Relat Dis 12: e27–e32. https://doi.org/10.1016/j. K, Rogowski J, Jastrzebski T, Jaskiéwicz J (2012) Paraesophageal soard.2015.12.020 hernia repair followed by cardiac tamponade caused by ProTacks. 20. Rodriguez HA, Oelschlager BK (2017) Secrets for successful Ann Thorac Surg 94:e87–e89 laparoscopic antireflux surgery: mesh hiatoplasty. Ann Laparosc 17. Jørgensen JB, Lundbech PE, Rask P, Jensen L (2014) Cardiac Endosc Surg 2:50. https://doi.org/10.21037/ales.2017.02.16 tamponade after laparoscopic operation for a traumatic. Ugeskr 21. Poris S, Goldberg L, Miner J (2015) Laparoscopic repair of a sub- Laeger 15:176 xiphoid hernia after omental flap reconstruction. CRSLS. https:// 18. del Carmen Fernandez M, Diaz M, Lopez F, Marti-Obiol R, doi.org/10.4293/CRSLS.2015.00061 Ortega J (2015) Cardiac complications after laparoscopic large 22. von Rahden B, Spor L, Germer CT, Dietz U (2012) Three-com- hiatal hernia repair. Is it related with staple fixation of the ponent intraperitoneal mesh fixation for laparoscopic repair of mesh?—Report of three cases. Ann Med Surg 4:395–398, https:// anterior parasternal costodiaphragmatic hernias. J Am Coll Surg doi.org/10.1016/j.amsu.2015.09.008 214:e1–e6 https://doi.org/10.1016/j.jamcollsurg.2011.10.001 1 3 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Surgical Endoscopy Springer Journals

A word of caution: never use tacks for mesh fixation to the diaphragm!

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Medicine & Public Health; Surgery; Gynecology; Gastroenterology; Hepatology; Proctology; Abdominal Surgery
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10.1007/s00464-018-6050-2
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Abstract

Background The mesh fixation technique used in repair of hiatal hernias and subxiphoid ventral and incisional hernias must meet strenuous requirements. In the literature, there are reports of life-threatening complications with cardiac tamponade and a high mortality rate on using tacks. The continuing practice of tack deployment for mesh fixation to the diaphragm and esophageal hiatus should be critically reviewed. Methods In a systematic search of the available literature in May 2017, 23 cases of severe penetrating cardiac complica- tions were identified. The authors became aware of two other cases in which they acted as medical experts. Furthermore, the instructions for use issued by the manufacturers of the tacks were reviewed with regard to their deployment in the diaphragm. Results Twenty-three of 25 cases (92%) with severe cardiac injuries and subsequent cardiac tamponade were triggered by the use of tacks in the diaphragm. In six cases (24%), these related to ventral and incisional hernias with extension to the subxi- phoid area, and in 19 cases (76%) to mesh-augmented hiatoplasty. Twelve of 25 (48%) patients died as a result of pericardial and/or heart muscle injury with cardiac tamponade despite heart surgery intervention. In the tack manufacturers’ instructions for use, their deployment in the diaphragm, in particular in the vicinity of the heart, is contraindicated. Likewise, the existing guidelines urgently advise against the use of tacks in the diaphragm, recommending instead alternative fixation techniques. Conclusions Tacks should not be used for mesh fixation in the diaphragm above the costal arch. Keywords Mesh fixation · Tacks · Cardiac tamponade · Hiatal hernia · Laparoscopic IPOM Background of cardiac tamponade due to tack fixation of the mesh to the diaphragm in incisional hernia repair was published [5]. Compared to the open approach, laparoscopic intraperitoneal In hiatal hernia repair, the use of a mesh for reinforce- onlay mesh (IPOM) repair of ventral and incisional hernias ment of large hiatal hernias leads to decreased short-term has a lower rate of wound infections and similar recurrence recurrence rates [6]. In a survey of the Society of American and postoperative pain rates [1–4]. For fixation of the mesh Gastrointestinal Endoscopic Surgeons (SAGES) members, in laparoscopic IPOM, the use of sutures alone or a combi- 261 surgeons reported a total of 5486 hiatal hernia repairs nation with tacks is recommended [1]. In addition to other with mesh [7]. factors reported in the literature, larger defects greater than The Society of American Gastrointestinal Endoscopic 10 cm in diameter and subxiphoid location are identified as Surgeons (SAGES) guidelines for the management of hiatal increasing the complexity of laparoscopic IPOM in ventral hernia state that there exists inadequate evidence for a rec- and incisional hernia repair [1, 4]. In 2010, the first report ommendation to be made regarding optimal fixation tech- niques [6]. In 2000, Kemppainen et al. [8] reported the first case of fatal cardiac tamponade after emergency tension-free mesh * F. Köckerling ferdinand.koeckerling@vivantes.de repair of a large paraesophageal hernia. The mesh was fixed with tacks. Department of Surgery and Center for Minimally In 2012, Frantzides et al. [9] presented a review of the Invasive Surgery, Academic Teaching Hospital of Charité literature and search of the US Food and Drug Administra- Medical School, Vivantes Hospital, Neue Bergstrasse 6, 13585 Berlin, Germany tion’s Manufacturer and User Device Experience (MAUDE) database. They reported a total of 10 cases of cardiac Hernia Center, Winghofer Medicum, Winghofer Strasse 42, 72108 Rottenburg am Neckar, Germany Vol.:(0123456789) 1 3 3296 Surgical Endoscopy (2018) 32:3295–3302 tamponade in hiatal hernia repair, of which six resulted in with temporary improvement. On returning to the operat- patient mortality, and five cases of ventral hernia repair, of ing room, he coded and died on the operating table. The which four had a fatal outcome. Ten cases were caused by autopsy findings showed laceration of a coronary vessel. the helical tacker, two by sutures, one by the straight stapler, and in one case the cause was not identified [9 ]. All cases of severe penetrating cardiac complications Case 3 [8] known to be triggered by surgery are now described in detail below. In addition to the cases presented in the review by A patient with thoracic herniation and incarceration of Frantzides et al. [9], ten further cases are included. As a the stomach underwent laparoscopic operation, including consequence of these cases, numerous statements and rec- reduction of an intrathoracic stomach, hernia sac removal, ommendations have in the meantime been incorporated into and tension-free repair of the hiatus with polytetrafluoro- guidelines and publications for avoidance of this severe com- ethylene mesh. The mesh was fixed with a straight hernia plication. These are presented in Discussion section as a stapler. Postoperatively, the patient developed fatal cardiac management recommendation for surgeons. The instructions tamponade secondary to coronary vein laceration due to for use given by the manufacturers of the mesh fixation sys- fixation of the mesh with a stapler. tems are also reviewed in that context. Case 4 [12] Methods An 84-year-old woman suffered from a type IV diaphrag- In May 2017, a systematic search of the available litera- matic hernia with a tortuous intrathoracic stomach and ture was performed using Medline, PubMed, the Cochrane grade II esophagitis. The stomach was reduced into the Library, as well as a search of relevant journals and reference abdominal cavity and the hernia sac resected. A coated lists. The following search terms were used: mesh fixation polyester mesh was attached to the crura with 5-mm AND diaphragm, mesh fixation AN D hiatal hernia, mesh titanium helical tacks. After an uneventful recovery, the fixation AN D subxiphoid hernia, mesh fixation AN D cardiac patient suddenly developed cardiogenic shock on post- complications, mesh fixation AN D cardiac tamponade, mesh operative day 14. A left thoracotomy was subsequently fixation AN D hemopericardium, tacks AND cardiac com- performed. There was active bleeding of the epicardium plications, and mesh AND cardiac tamponade. The search from a number of pointed lesions, just opposite the tackers identified 19 relevant articles. which had penetrated the pericardium. The offending tacks were removed and the defects in the epicardium sutured. The patient was discharged 18 days after thoracotomy. Results (Table 1) Case 1 [10] Case 5 [13] A 66-year-old female patient underwent surgery because of A 74-year-old woman presented with a request for a sec- a large paraesophageal hiatal hernia. Just prior to the fun- ond antireflux surgery seven years after the primary sur - dal wrap of the Nissen fundoplication, the patient suddenly gery. Because of the previous surgical intervention, an became tachycardic and profoundly hypotensive. Emergency upper median laparotomy was used. Mesh-reinforced hia- sternotomy revealed hemopericardium and a 2-cm laceration toplasty with anterior fundophrenicopexy was performed of the diaphragmatic surface of the right ventricle, which as an antireflux procedure. A 6 × 6 cm prolene mesh was was controlled by placement of several sutures. The authors applied and fixed to the diaphragm with 10 helical staples. believed that the injury to the heart was secondary to a per- A few hours postoperatively, a decrease in blood pres- forating needle on the contracting ventricle. The patient sure occurred and the subsequent computed tomography could be discharged from hospital on postoperative day 21. (CT) scan confirmed suspected cardiac tamponade. An emergency relaparotomy with pericardial fenestration was Case 2 [11] performed. Venous bleeding from the myocardium of the right ventricle, probably caused by a fundophrenicopexy A 40-year-old man underwent Collis-Nissen repair of gas- suture, was stopped by resuturing, the pericardium was troesophageal reflux disease. The night of the operation left open, and the left hemithorax was drained. The patient he became hypotensive and was believed to have cardiac could be discharged on postoperative day 24. tamponade. Bedside pericardiocentesis was performed 1 3 Surgical Endoscopy (2018) 32:3295–3302 3297 Table 1 Overview of all cases with cardiac tamponade/injuries caused by hernia surgery Case Author Access Indication Procedure Cause Outcome 1 Farlo et al. [10] Laparoscopic Large paraesophageal Nissen fundoplication Suture Recovery hernia 2 Trastek et al. [11] Thoracotomy Gastroesophageal reflux Collis-Nissen fundoplica- Suture Death disease tion 3 Kemppainen et al. [8] Laparoscopic Large paraesophageal Mesh-augmented hiato- Straight hernia stapler Death hernia with gastric incar- plasty ceration 4 Thijssens et al. 2002 [12] Laparoscopic Upside-down stomach Mesh-augmented hiato- Helical tacker Recovery plasty 5 Müller-Stich et al. [13] Open Recurrent reflux disease Mesh-reinforced hiato- Suture Recovery after fundoplication plasty and fundophren- icopexy 6 Müller-Stich et al. [13] Laparoscopic Gastroesophageal reflux Mesh-augmented hiato- Helical tacker Death disease plasty and fundophren- icopexy 7 Dapri et al. 2007 [14] Laparoscopic Congenital diaphragmatic Mesh-augmented defect Helical tacker Recovery hernia closure 8 Malmstrom et al. [5] Laparoscopic Incisional hernia Intraperitoneal onlay mesh Helical tacker Recovery repair 9 Frantzides et al. [9] Laparoscopic Incisional hernia Intraperitoneal onlay mesh Helical tacker Death repair 10 Frantzides et al. [9] Laparoscopic Unknown Mesh-augmented hiato- Helical tacker Death plasty 11 Frantzides et al. [9] Unknown Ventral hernia Ventral hernia repair Helical tacker Death 12 Frantzides et al. [9] Unknown Ventral hernia Ventral hernia repair Helical tacker Death 13 Frantzides et al. [9] Unknown Ventral hernia Ventral hernia repair Helical tacker Death 14 Frantzides et al. [9] Unknown Hiatal hernia Hiatal hernia repair Helical tacker Death 15 Frantzides et al. [9] Unknown Hiatal hernia Hiatal hernia repair Helical tacker Death 16 Frantzides et al. [9] Unknown Hiatal hernia Hiatal hernia repair Helical tacker Recovery 17 Paz et al. [15] Laparoscopic Gastroesophageal reflux Mesh-augmented hia- Tacker Recovery disease toplasty and Toupet fundoplication 18 Makarewicz et al. [16] Laparoscopic Gastroesophageal reflux Mesh-augmented hia- Helical tacker Recovery disease toplasty and Nissen fundoplication 19 Jorgensen et al. [17] Laparoscopic Unknown Mesh-augmented hiato- Tacker Death plasty 20 del Carmen Fernandez Laparoscopic Gastroesophageal reflux Mesh-augmented hia- Absorbable tacker Recovery et al. [18] disease toplasty and Nissen fundoplication 21 del Carmen Fernandez Laparoscopic Gastroesophageal reflux Mesh-augmented hia- Absorbable tacker Recovery et al. [18] disease toplasty and Nissen fundoplication 22 del Carmen Fernandez Laparoscopic Upside-down stomach Mesh-augmented hiato- Absorbable tacker Recovery et al. [18] plasty and Nissen fundoplication 23 McClellan et al. (19) Laparoscopic Bariatric redo-procedure Mesh closure of a large Absorbable tacker Recovery with large hiatal defect hiatal hernia defect 24 We are aware of an addi- Open Incisional hernia extend- Intraperitoneal onlay mesh Absorbable tacker Death tional unreported, unpub- ing from suprapubic to repair lished case, in which one subxiphoid the authors (F. K.) acted as medical expert 1 3 3298 Surgical Endoscopy (2018) 32:3295–3302 Table 1 (continued) Case Author Access Indication Procedure Cause Outcome 25 We are aware of an addi- Laparoscopic Upside-down stomach Mesh-augmented hiato- EMS Stapler Death tional unreported, unpub- plasty lished case, in which one of the authors (R. B.) acted as medical expert Extensive pericardial tamponade diagnosed on echocar- Case 6 [13] diography was treated by percutaneous drainage, evacuat- ing 500 ml of blood. Sternotomy showed a spiral tacker An 82-year-old man presented with an 8-cm mixed hiatal protruding through the pericardium, resulting in a lesion of hernia with grade IV esophagitis. Surgical treatment con- 2 × 2 mm in the right ventricle. Furthermore, five spiral tack - sisted of laparoscopically mesh-augmented hiatoplasty with ers were visible from the inside of the pericardium and two anterior fundophrenicopexy. Because of accidental rupture had gone through the diaphragm and into the pleural cavity. of the right crus of the diaphragm, a 15 × 15 cm prolene The patient was discharged a week later in good health. mesh was necessary to reconstruct the hiatus. The mesh was fixed by 16 helical tacks. During the first 24 postoperative hours, deteriorating oxygen saturation with increasing dysp- Cases 9 and 10 [9] nea was most notable. After 48 h, the patient experienced severe retrosternal pressure with simultaneous tachyarrhyth- The authors were aware of two additional unreported, mia and consecutive circulatory failure. The patient died unpublished cases with cardiac injury, of which one was despite resuscitation attempts. The autopsy revealed cardiac sustained during ventral herniorrhaphy and one during hiatal tamponade originating from an epicardial vascular erosion hernia repair. The senior author acted as a medical expert caused by one of the helical tacks. in these cases. Both heart injuries were the result of helical tacks being Case 7 [14] used for fixation of the mesh to the central tendon of the dia- phragm. Both patients died as a result of hemopericardium A 57-year-old woman presented with right, medial, and left tamponade. In each of these cases, the diagnosis of cardiac congenital diaphragmatic hernia defect. The hernia defect tamponade was established only at autopsy. was closed laparoscopically by a running suture and then a mesh placed as an onlay fixed with helical hernia tacks. Cases 11 to 16 [9] The patient developed cardiac tamponade on the second day due to tack-induced bleeding of an epicardial artery of The MAUDE database (US Food and Drug Administration’s the inferior surface of the heart, which required emergency Manufacturer and User Facility Device Experience) search pericardial drainage. The outcome was good, and discharge revealed a total of six cases of cardiac tamponade associ- home was allowed after 1 month. ated with the helical tacker during mesh fixation to the dia- phragm. Three of these cases occurred during ventral hernia Case 8 [5] repair and all were fatal. The other three cases occurred dur- ing hiatal hernia repair and two were fatal. A 25-year-old obese patient developed a large incisional hernia after gallbladder removal with lesion of the common Case 17 [15] bile duct and open transverse revision. This was repaired laparoscopically using two meshes measuring 30 × 30 and A 61-year-old female with a history of gastroesophageal 20 × 30 cm, respectively, sewn together. The facial defect was in a transverse incision under both rib curvatures, meas- reflux disease and hiatal hernia developed hemopericar - dium and tamponade one day after laparoscopic hiatal her- uring 35 × 15 cm. The mesh was positioned ensuring an overlap of about 8 cm. The mesh was fixed using titanium nia repair and Toupet fundoplication. The patient underwent emergency pericardiocentesis and subsequent surgical peri- spiral tackers along the margin of the mesh, with a distance of 1 cm between each tacker. On postoperative day 9, the cardial window. During surgery, a tack that had been used to secure the mesh to the inferior aspect of the diaphragm was patient exhibited a decreased state of consciousness, blood pressure of 80/50 mmHg, a heart rate of 70 beats/min, and found to have penetrated the pericardium near the right ven- tricle. The patient recovered without further complications. spontaneous breathing with 40 respirations/min. 1 3 Surgical Endoscopy (2018) 32:3295–3302 3299 laparoscopic Nissen fundoplication with hiatal mesh rein- Case 18 [16] forcement using absorbable tacks. On postoperative day 2, the patient developed hypotension, tachycardia, and irregular A 69-year-old patient presented with gastroesophageal reflux disease and a stage III paraesophageal hernia. Nis- pulse. A CT scan revealed an extrapericardial hematoma in the sen fundoplication was performed. For hiatoplasty a mesh was used, which was fixed to the diaphragm with six helical hernia sac with mild left atrium compromise. Conservative treatment was decided and the patient discharged on post- tackers. On postoperative day 3, the patient collapsed with signs of acute heart failure and low output syndrome sec- operative day 15. ondary to cardiac tamponade. On emergency sternotomy, approximately 1500 mm of hemolyzed blood with clots was Case 23 [19] retrieved from pericardial sac. Two tacks (3 cm medially to the inferior vena cava) penetrating into the pericardial sac During a redo bariatric procedure, a hiatal defect of 10 cm were noted. The patient survived this severe complication. could not be initially repaired due to its significant size, rigidity of the lateral edges, and the anterior location, and Case 19 [17] thus mesh repair was performed. Due to a difficult sutur - ing angle of the most posterior area of the defect, the mesh A 79-year-old woman underwent laparoscopic hiatal hernia was secured to the anterior portion of the right and left crus repair with mesh implantation. Tacks were used to secure the with several absorbable tacks. On postoperative day 1, the mesh to the diaphragm. Nine hours after surgery the patient patient became tachycardic and the echocardiogram revealed died from circulatory collapse. Autopsy showed perforation a moderate-sized pericardial effusion with a partially filled of the pericardium and the right coronary artery by a tacker. right atrium and partially collapsed right ventricle consistent with early tamponade. During percutaneous pericardiocen- tesis, 370 ml of bloody fluid was aspirated with subsequent Case 20 [18] immediate normalization of vital signs and relief of symp- toms. The patient was discharged home two days later. A 46-year-old man with gastroesophageal reflux disease underwent Nissen fundoplication with hiatal mesh reinforce- ment using absorbable tacks. Forty-eight hours after surgery, Case 24 the patient developed hypotension and sweating. Cardiac magnetic resonance imaging showed a large pericardial The authors are aware of an additional unreported, unpub- effusion. Pericardiocentesis was performed with removal lished case with cardiac injury during open incisional hernia of 650 cc of bloody fluid. The pericardial drain could be repair in IPOM technique. The first author (F. K.) acted as removed two days later. The patient’s further course was medical expert in that case. This related to a 52-year-old uneventful. male patient with a large incisional hernia and status post multiple laparotomies following emergency left hemicolec- Case 21 [18] tomy, Hartmann’s operation, and Hartmann’s reversal opera- tion. Open IPOM operation with placement of a 50 × 30 cm A 62-year-old woman with gastroesophageal reflux disease polypropylene mesh was performed. Since the incisional and a large hiatal hernia underwent Nissen fundoplication hernia extended from the lower abdomen to the subxiphoid with mesh hiatoplasty using absorbable tacks. On postopera- area, the mesh was positioned from the symphysis to the tive day 5, the patient developed acute respiratory distress subdiaphragmatic area. The mesh was fixed with sutures and syndrome with hypotension and oliguria. A thoracic CT scan reinforced with absorbable tackers between the sutures. Post- showed a bilateral pleural effusion and a large pericardial operatively, the patient experienced increasing thoracic pain. effusion that caused the collapse of the right atrium and ven- On postoperative day 1, a suspected heart attack was diag- tricle. She was taken back to the operating room for urgent nosed and treatment initiated with platelet aggregation inhib- surgical pericardial drainage. After that, the postoperative itors. Due to increasing circulatory instability, the patient course was uneventful. was transferred to the cardiac surgery clinic for treatment on postoperative day 2. Cardiac tamponade was diagnosed in the cardiac surgery clinic and initially treated by means Case 22 [18] of emergency pericardial drainage. Despite that, emergency sternotomy had to be performed and the patient died on the A 70-year-old woman presented with a giant hiatal her- operating table. Autopsy revealed four tacks in the vicinity nia with intrathoracic stomach. The patient underwent of the diaphragm which had penetrated the pericardium. One 1 3 3300 Surgical Endoscopy (2018) 32:3295–3302 tack had perforated the right ventricle causing bleeding into Discussion the pericardium and cardiac tamponade. Twenty-five cases of life-threatening complications due to Case 25 mechanical injuries to the pericardium and heart during her- nia surgery are known from the literature and expert witness The authors are aware of an additional unreported, unpub- processes. In three cases (12%), the pericardium or heart lished case with cardiac injury during mesh-augmented hia- injury was caused by sutures and in 22 cases (88%) by the toplasty of an upside-down stomach. The senior author (R. use of tacks. The clinical implications of such injuries were B.) acted as medical expert in this case. In the 65-years-old generally cardiac tamponade necessitating pericardial drain- female patient the mesh was partially fixed with sutures and age and/or open heart surgery with sternotomy. The mor- EMS staples. A branch of a single EMS staple did not close, tality rate associated with this severe complication is 48%. perforated the pericardium and injured a vene at the anterior The underlying indications for surgery were ventral and inci- part of the heart. Subsequently, a cardiac tamponade devel- sional hernia repair in six cases (24%) and mesh-augmented oped, which was not diagnosed in time. The patient died on hiatoplasty in 19 cases (76%). The tacks used included both postoperative day 3. non-absorbable titanium and absorbable types. The major- ity of tack-mediated injuries were caused by mesh fixation Instructions for use by the manufacturers to the diaphragm or diaphragmatic crura. Mesh fixation in of the tacks this critical anatomic region is needed in a variety of situ- ations ranging from mesh-augmented hiatoplasty for treat- The instructions for use for the most commonly employed ment of gastroesophageal reflux disease (GERD) through tacks contain the following contraindications: paraesophageal hernias to upside-down stomach and ventral and incisional hernias with extension to the subxiphoid area. ProTack (Medtronic—Covidien) The severe complications described here in associa- tion with the use of tacks in the vicinity of the diaphragm This device should not be used in tissues that have direct and esophageal hiatus naturally raise the question as to anatomical relationship to major vascular structures. This whether tacks should at all be used in this region. The would include the deployment of helical fasteners in the dia- thickness of the diaphragm muscle ranges from 1.5 to phragm in the vicinity of the pericardium, aorta, or inferior 5.4 mm [9]. The central tendon of the diaphragm averages vena cava during diaphragmatic hernia repair. only 2.9–3.00 mm in thickness [9]. The depth of penetra- tion, not including the thickness of the mesh, of the vari- AbsorbaTack (Medtronic—Covidien) ous tacks on the market ranges between 3.7 and 5.9 mm. The tack manufacturers’ instructions for use contraindicate This device should not be used in tissues that have a direct the deployment of tacks in the vicinity of the heart, major anatomic relationship to major vascular structures. This vascular structures, and diaphragm. would include deployment of tacks in the diaphragm in the The SAGES guidelines for laparoscopic ventral hernia vicinity of the pericardium, aorta, and inferior vena cava repair state that fixation of meshes above the costal mar - during diaphragmatic hernia repair. gins should not be performed with sutures placed between the ribs [4]. Furthermore, while fixation with tacks may SecureStrap (Ethicon) by feasible, it should generally be avoided to prevent lung or cardiac injury or injuries to the neurovascular bundles This device should not be used in tissues that have a direct running along the inferior surface of each rib [4]. anatomic relationship to major vascular structures. This The guidelines for laparoscopic treatment of ventral would include the deployment of fasteners in the diaphragm and incisional abdominal wall hernias of the International in the vicinity of the pericardium, aorta, or inferior vena cava Endohernia Society (IEHS) recommend not to fix the prox- during diaphragmatic hernia repair. imal part of the mesh for subxiphoid hernia repair [1]. The SAGES guidelines for management of hiatal hernia SorbaFix (Bard) state that care should be taken about the mesh fixation technique. Particularly tacks can breach the aorta or peri- Carefully inspect the area in the vicinity of the tissue being cardium when applied low on the left crus or anteriorly fastened to avoid inadvertent penetration of underlying struc- near the apex of the crura. tures such as nerves, vessels, viscera, or bone. Use of the As an alternative, Rodriguez et al. [20] advocate for SorbaFix in the close vicinity of such underlying structures extreme care when suturing mesh in hiatal hernia repair at is contraindicated. 1 3 Surgical Endoscopy (2018) 32:3295–3302 3301 the diaphragm, taking very superficial bites just to encour - References age scarring to the diaphragm and avoiding fixation by 1. Bittner R, Bingener-Casey J, Dietz U, Fabian M, Ferzli GS, tacks at all costs. Fortelny R, Köckerling F, Kukleta J, LeBlanc K, Lomanto Poris et al. [21] reported on laparoscopic repair of a sub- D, Misra MC, Bansal VK, Morales-Conde S, Ramshaw B, xiphoid hernia. Because of the location of the defect and the Reinpold W, Rim S, Rohr M, Schrittwieser R, Simon T, Smi- proximity to the patient’s heart and diaphragm, they believed etanski M, Stechemesser B, Timoney M, Chowbey P (2014) Guidelines for laparoscopic treatment of ventral and incisional that tacks and transfascial sutures could not be safely placed abdominal wall hernias (International Endohernia Scoiety and they therefore allowed for additional overlap of 8 cm [IEHS]—Part 1. Surg Endosc 28:2–29. https://doi.org/10.1007/ superior to the uppermost aspect of the defect. Upon desuf- s00464-013-3170-6 flation of the abdomen, the liver was noted to buttress the 2. Bittner R, Bingener-Casey J, Dietz U, Fabian M, Ferzli GS, Forstelny R, Köckerling F, Kukleta J, LeBlanc K, Lomanto mesh, holding it in place. D, Misra MC, Morales-Conde S, Ramshaw B, Reinpold W, The IEHS guidelines also recommend that mesh overlap Rim S, Rohr M, Schrittwieser R, Simon T, Smietanski M, should be sufficient, especially in the proximal retro-xiphoid Stechemesser B, Timoney M, Chowbey P (2014) Guidelines space [1]. Von Rahden et al. [22] recommended for mesh for laparoscopic treatment of ventral and incisional abdomi- nal wall hernias (International Endohernia Society [IEHS])— fixation to the diaphragm in subxiphoid hernia repair the use Part 2. Surg Endosc 28:353–379. https://doi.org/10.1007/ of fibrin glue in the proximal third. s00464-013-3171-5 The SAGES guidelines propose, as an alternative and 3. Bittner R, Bingener-Casey J, Dietz U, Fabian G, Fortelny R, Köck- safer option to prosthetic fixation, above the costal margin erling F, Kukleta J, LeBlanc K, Lomanto D, Misra M, Morales- Conde S, Ramshaw B, Reinpold W, Rim S, Rohr M, Schrittwieser in subxiphoid hernia repair, allowing the mesh to drape over R, Simon T, Smietanski M, Stechemesser B, Timoney M, Chow- the diaphragm superiorly without x fi ation, and full-thickness bey P (2014) Guidelines for laparoscopic treatment of ventral fixation to the edge of the costal margin and xiphoid process and incisional abdominal wall hernias (international Endohernia away from the edge of the prosthetic [4]. Society [IEHS])—Part III. Surg Endosc 28:380–404. https://doi. org/10.1007/s00464-013-3172-4 In conclusion, no tacks should be used for mesh fixa- 4. Earle D, Roth JS, Saber A, Haggerty S, Bradley JF III, Fanelli R, tion in surgical repair of hiatal hernias and of ventral and Price R, Richardson WS, Stefanidis D (2016) SAGES guidelines incisional hernias with extension to the subxiphoid area. In for laparoscopic ventral hernia repair. Surg Endosc 30:3163–3183. the tack manufacturers’ instructions for use, the deployment https://doi.org/10.1007/s00464-016-5072-x 5. Malmstrøm ML, Thorlacius-Ussing O (2010) Cardiac tamponade of tacks for mesh fixation in the vicinity of the diaphragm as a rare complication in laparoscopic incisional hernia repair. is contraindicated. Likewise, the guidelines of the surgical Hernia 14:421–422. https://doi.org/10.1007/s10029-009-0557-3 societies advise against the use of tacks in this critical ana- 6. Kohn GP, Price RR, DeMeester SR, Zehetner J, Muensterer OJ, tomic region. The cases of severe complications and very Awad Z, Mittal SK, Richardson WS, Stefanidis D, Fanelli RD (2013) For the SAGES Guidelines committee guidelines for the high mortality rate presented here more than adequately management of hiatal hernia. Surg Endosc 27:4409–4428. https:// prove that the use of tacks in the diaphragm is too danger- doi.org/10.1007/s00464-013-3173-3 ous and should therefore be absolutely avoided. Alternative 7. Frantzides CT, Carlson MA, Loizides S, Papfili A, Luu M, Roberts approaches that present no risk to patients are shown to be J, Zeni T, Frantzides A (2010) Hiatal hernia repair with mesh: a survey of SAGES members. Surg Endosc 24:1017–1024. https:// sufficiently effective. One could argue this is just case report doi.org/10.1007/s00464-009-0718-6 series, but an important message unlikely to be reported 8. Kemppainen E, Kiviluoto T (2000) Fatal cardiac tamponade after often and as such should be published. emergency tension-free repair of a large paraesophageal hernia. Surg Endosc. https://doi.org/10.1007/s004640000138 Acknowledgements Ferdinand Köckerling—Personal fees for the 9. Frantzides CT, Welle SN (2012) Cardiac tamponade as a life- performance of workshops from Bard, Karlsruhe and Tutogen, threatening complication in hernia repair. Surgery 152:133–135 Neunkirchen. 10. Farlo J, Thawgathurai D, Mikhail M, Yaker K, Sullivan J, Morgan E (1998) Cardiac tamponade during laparoscopic Nissen fundopli- cation. Eur J Anaesthesiol 15:246–247 Compliance with ethical standards 11. Trastek VF, Deschamps C, Allen MS, Miller DL, Pairolero PC, Thompson AM (1998) Uncut Collis-Nissen fundoplication: learn- Disclosures C. Schug-Pass and R. Bittner have no conflicts of interest ing curve and long-term results. Ann Thorac Surg 66:1739–1744 or financial ties to disclose. 12. Thijssens K, Hoff C, Meyerink J (2002) Tackers on the diaphragm. Lancet 360:1586. https://doi.org/10.1016/S0140-6736(02)11530-3 13. Müller-Stich BP, Linke G, Leemann B, Lange J, Zerz A (2006) Open Access This article is distributed under the terms of the Creative Cardiac tamponade as a life-threatening complication in antireflux Commons Attribution 4.0 International License (http://creativecom- surgery. Am J Surg 191:139–141 mons.org/licenses/by/4.0/), which permits unrestricted use, distribu- 14. Dapri G, Himpens J, Hainaux B, Roman A, Stevens E, Capelluto tion, and reproduction in any medium, provided you give appropriate E, Germay O, Cadière GB (2007) Surgical technique and com- credit to the original author(s) and the source, provide a link to the plications during laparoscopic repair of diaphragmatic hernias. Creative Commons license, and indicate if changes were made. Hernia 11:179–183. https://doi.org/10.1007/s10029-006-0161-8 1 3 3302 Surgical Endoscopy (2018) 32:3295–3302 15. Paz YE, Vasquez J, Bessler M (2011) Cardiac tamponade as a 19. McClellan JM, Nelson D, Martin M (2016) Hemopericardium complication of laparoscopic hiatal hernia repair: case report and after laparoscopic perihiatal procedures: high index of suspicion literature review. Catheter Cardovasc Interv 78:819–821 facilitates early diagnosis and successful nonoperative manage- 16. Makarewicz W, Jaworski L, Bobowicz M, Roszak K, Jaroszewicz ment. Surg Obes Relat Dis 12: e27–e32. https://doi.org/10.1016/j. K, Rogowski J, Jastrzebski T, Jaskiéwicz J (2012) Paraesophageal soard.2015.12.020 hernia repair followed by cardiac tamponade caused by ProTacks. 20. Rodriguez HA, Oelschlager BK (2017) Secrets for successful Ann Thorac Surg 94:e87–e89 laparoscopic antireflux surgery: mesh hiatoplasty. Ann Laparosc 17. Jørgensen JB, Lundbech PE, Rask P, Jensen L (2014) Cardiac Endosc Surg 2:50. https://doi.org/10.21037/ales.2017.02.16 tamponade after laparoscopic operation for a traumatic. Ugeskr 21. Poris S, Goldberg L, Miner J (2015) Laparoscopic repair of a sub- Laeger 15:176 xiphoid hernia after omental flap reconstruction. CRSLS. https:// 18. del Carmen Fernandez M, Diaz M, Lopez F, Marti-Obiol R, doi.org/10.4293/CRSLS.2015.00061 Ortega J (2015) Cardiac complications after laparoscopic large 22. von Rahden B, Spor L, Germer CT, Dietz U (2012) Three-com- hiatal hernia repair. Is it related with staple fixation of the ponent intraperitoneal mesh fixation for laparoscopic repair of mesh?—Report of three cases. Ann Med Surg 4:395–398, https:// anterior parasternal costodiaphragmatic hernias. J Am Coll Surg doi.org/10.1016/j.amsu.2015.09.008 214:e1–e6 https://doi.org/10.1016/j.jamcollsurg.2011.10.001 1 3

Journal

Surgical EndoscopySpringer Journals

Published: Jan 16, 2018

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