Hiatal Hernia Repair Surgical Technique Guide 8 Hiatal Hernia Repair Surgical Technique Guide

1. The technique presented herein is for informational purposes only. The decision of which technique(s) to use in a particular surgical application lies with the physician based on patient profile, particular circumstances surrounding the repair and previous surgical experiences. 2. Please refer to the Instructions for Use included with the applicable Gentrix device for indications, contraindications, cautions, warnings, precautions, potential complications, and other important information about the Gentrix device. 3. The Gentrix devices that are indicated for hiatal hernia repair include Gentrix Hiatal, Gentrix Surgical Matrix, and Gentrix Surgical Matrix Plus.

1 1. Normal Anatomy

Normal anatomy of the esophagus passing through the diaphragm and the esophagogastric junction between the esophagus and the stomach located in the abdominal cavity below the thoracic cavity.

2. Hiatal Hernia Defect

A large hiatal hernia is present resulting in the stomach migrating into the thoracic cavity through the hiatus, or opening, in the chest cavity.

2 3. Reduction of the stomach

The stomach is gently reduced into the abdominal Tip: A Penrose drain can be effective for manipulating cavity through the diaphragmatic opening of the the esophagus allowing a posterior view of the confluence of the diaphragmatic crura or for crural hiatus. approximation and further tacking and securing of the graft. A large hiatal hernia sac may be present and should be excised completely during mobilization and reduction of the hiatal hernia.

Achieving adequate intra-abdominal esophageal length is accomplished through adequate mediastinal esophageal mobilization.

3 4. Re-Approximation of the Crura

Once the stomach has been reduced into the abdomen with an adequate intra-abdominal 4a Before esophageal length (5 cm-6 cm), the diaphragmatic crura are re-approximated.

Posterior sutures are preferred and when necessary, anterior sutures may be required.

Note: Stitch the hiatus to create a snug entry at the gastroesophageal junction. Once the repair is complete, Hiatal defect it is important that a blunt probe passes between the Esophagus crural repair and the esophagus to ensure the defect is not repaired too tightly or too loosely.

4b 4c After

Esophagus

4 5. Preparation of the Graft

To reinforce or buttress the crura repair, select a Tip: Using a surgical marker, clearly mark the smooth Gentrix device appropriate for the repair (i.e. Gentrix basement membrane side of the device to allow for intraoperative identification of recommended device Hiatal, Gentrix Surgical Matrix, or Gentrix Surgical orientation. Matrix Plus).

The graft should be hydrated in room temperature sterile saline solution, per the instructions for use, 5b prior to placement in the surgical site.

Properly orient the graft to prepare for placement. When the notched edge is in the upper right, the basement membrane side of the device is facing the user. This smooth, basement membrane side should be placed away from the diaphragm.

5a If not using the pre-cut Gentrix Hiatal device, the graft will need to be cut after hydration. Prepare the Gentrix Surgical Matrix devices by creating a U-shape in the central portion of the device, in order to serve as the esophageal hiatus.

TEXTURED SMOOTH Lamina propria side Basement membrane side BESIDE/TOWARD AWAY from diaphragm diaphragm

5 6. Graft Placement

Avoiding excess tension, suture or staple the graft The graft is passed posterior to the esophagus and into place along the right crus of the diaphragm and secured around the esophagus. The graft may be right diaphragm to reinforce the primary repair. It is used in open or laparoscopic procedures. recommended that the graft be oriented with the Once the graft is positioned, it may be further lamina propria side facing the diaphragm, using the secured along the diaphragm, carefully avoiding markings placed on the device prior to insertion the pericardium region. into the abdomen.

6 7. Fundoplication

Completing this repair may often include a closing function of the esophageal sphincter and fundoplication, either 360° or partial wrap. During is intended to reduce acid-reflux. Selection of the the fundoplication procedure, the upper curve of specific anti-reflux technique is influenced by pre- the stomach (the fundus) is wrapped or plicated operative esophageal function testing and surgeon around the esophagus and lower esophageal preference. sphincter and sewn into place. This reinforces the

360° FUNDOPLICATION

PARTIAL FUNDOPLICATION

7 Gentrix® products are medical devices comprised of ACell’s proprietary MatriStem UBM™ (Urinary Bladder Matrix) technology and are intended for implantation to reinforce soft tissue where weakness exists. The Gentrix extracellular matrix scaffold has been shown to facilitate the body’s ability to remodel site-appropriate, functional tissue where scarring would be expected1-3.

Ordering Information

Product Name Catalog Number Size Quantity

Gentrix Hiatal HIAT0706 6 x 7.5 cm 1/box

Gentrix Surgical Matrix PSMX0505 5 x 5 cm 1/box Gentrix Surgical Matrix PSMX0710 7 x 10 cm 1/box Gentrix Surgical Matrix PSMX1015 10 x 15 cm 1/box

Gentrix Surgical Matrix Plus MSPL0507 5 x 7 cm 1/box Gentrix Surgical Matrix Plus MSPL0710 7 x 10 cm 1/box Gentrix Surgical Matrix Plus MSPL1010 10 x 10 cm 1/box Gentrix Surgical Matrix Plus MSPL1015 10 x 15 cm 1/box

To order Gentrix or for more information: [email protected] 800-826-2926 | Learn more at www.acell.com

All Illustrations © 2016 or © 2017 Mica Duran.

1. Riganti JM, Ciotola F, Amenabar A, Craiem D, Graf S, Badaloni A, Gilbert TW, Nieponice A#. Urinary bladder matrix scaffolds strengthen esophageal hiatus repair. Journal of Surgical Research. 2016; 204:344-50. 2. Brown BN, Londono R, Tottey S, Zhang L, Kukla KA, Wolf MT, Daly KA, Reing JE, Badylak SF. Macrophage phenotype as a predictor of constructive remodeling following the implantation of biologically derived surgical mesh materials. Acta Biomaterialia. 2012 Mar;8(3):978-87. 3. Young DA‡, Jackson N, Ronaghan CA†, Brathwaite CEM†, Gilbert TW. Retrorectus repair of incisional ventral hernia with urinary bladder matrix reinforcement in a long-term porcine model. Regenerative Medicine. 2018; doi:10.2217/rme-2018-0023. † Consultant | ‡ ACell Employee | # ACell Sponsored Research Agreement | Learn more at www.acell.com ACell, Inc. 6640 Eli Whitney Drive Columbia, MD 21046 www.acell.com 800-826-2926 www.acell.com

MK-0261.04 | 2019 1839716-1-EN