Innovative Technologies for Staple Line Reinforcement
O.R. Insights Blog
Staple line complications, including bleeding and leaks, can have catastrophic results, especially in the morbidly obese.1 Moreover, staple line complications can increase costs with prolonged hospitalization and resource utilization.2 Staple line reinforcement is a popular tool used by a majority (70%) of surgeons to increase staple line strength and reduce staple line complications.3 However, some buttress materials require special attention during attachment that may require additional operating room time.4 Here, Natalia Peres Martinez, MD, MSc, PhD, a Senior Medical Science Liaison at Baxter Healthcare Corporation, explains the importance of staple line reinforcement and the benefits of a new innovation that is faster and easier to use in the operating room.4
Innovative Technologies for Staple Line Reinforcement
Stapling devices are commonly used in open and laparoscopic surgery as they allow for quick tissue division and closure.5 Despite the sophistication of modern stapling technology, staple line complications that could result in high morbidity and mortality persist.1,6 Complications, such as leakage, may occur after bariatric surgery due to mechanical or ischemic causes.7,8 Mechanical factors related to complications include tissue stress, the long staple line in sleeve gastrectomy and lack of discretion in choosing the appropriate stapler cartridge.7,9 In addition, patient-related factors may reduce tissue strength and promote tissue friability, tissue ischemia, and infection.10 Decreased tissue strength combined with manipulations may result in the staples tearing through the tissues, culminating in leaks, making up one of the two most common staple line complications, the other one being bleeding.10-12
7% of the time
Leaks occur following bariatric procedures.2
1.1% to 8.7%
of the time significant hemorrhage from the staple line, requiring blood transfusion or reoperation, is reported.14
Staple line buttressing was developed to improve staple line strength.6 Application of buttress material in the staple line is thought to distribute tension throughout the staple line, seal off the staple holes and narrow the spaces between each staple, thus reducing tearing at the staple line.5,6 Thus, leakage, bleeding and tearing at the staple line can be reduced, especially in fragile tissue.5,6
PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix (PSDV) is derived from bovine pericardium and processed during manufacturing to produce a biocompatible, acellular, non-crosslinked collagen matrix that is immunologically inert.15,16 PSDV has been shown to reduce the risk of staple line bleeding and leaks, and remodels in conjunction with natural healing processes.1,6,14,17-19 Tissue integration through remodeling following the use of PSDV entails two simultaneous processes: degradation of the PSDV scaffold and deposition of new tissue and blood vessels.19-21
The PSDV product that was originally approved for use by the Food and Drug Administration (FDA) in 2004, is applied to a surgical stapler using an adhesive gel.15 PSDV now comes with Secure Grip Technology (PSDV-SG).22 The PSDV-SG product is made from the same biologic material as PSDV, but is applied to the surgical stapler via a pressure-sensitive adhesive strip that provides strong adherence between the strips and the stapler facilitating easy manipulation of tissue.22,23 This new product allows for greater ease of use and reduced stapler preparation time.4 Thus, buttressing the staple line with PSDV-SG may result in improved, cost-effective outcomes.6,24
In a staple line reinforcement comparison study, 30 registered nurses and surgical technicians evaluated stapler preparation time, ease of use and learnability of three (3) staple line reinforcement products: PSDV-SG, PSDV Gel, and SEAMGUARD®.4
1/2 the Preparation Time
PSDV-SG resulted in a 54.55% reduction in preparation time when compared to SEAMGUARD.4
30 of 30
registered nurses and surgical technicians ranked PSDV-SG the #1 preferred staple line reinforcement.4
Staple line reinforcement provides superior results for patients compared to no reinforcement for reducing staple line complications.6 When choosing a staple line reinforcement product, ease of use, as well as proven efficacy, are important considerations. Products that are easy to use not only better aid dedicated surgical teams, but allow for more efficient training and adoption for new team members.4 As the complexity of surgical procedures increase, it’s important to provide time-saving innovations that promote positive patient outcomes.
See the Simplicity of Application of PSDV Secure Grip
Watch PSDV Secure Grip Product Preparation on the Medtronic Auto Secure GIA Universal Stapler.
Important Risk Information
PSDV Instructions for Use
PERI-STRIPS DRY with VERITAS Collagen Matrix (PSDV) Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
(Circular reinforcement only) PSDV reinforcement can be used for reinforcement of staple lines during gastric, bariatric, and small bowel procedures.
(Linear reinforcement only) PSDV Reinforcement can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical
procedures, and during gastric, small bowel, mesentery, colon, and colorectal procedures.
PSDV Secure Grip Instructions for Use
PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP
PSDV-SG is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
PSDV-SG can be used for reinforcement of staple lines during bariatric, gastric, small bowel, colon, and colorectal procedures.
PSDV Important Risk Information
The use of PSDV Reinforcement is contraindicated in patients with known sensitivity to bovine or acrylic material.
Do not re-sterilize. Resterilization may cause changes to the tissue and negatively impact functionality of the device.
Discard all open unused components. Do not use product if there is damage to the pouch or seals.
Ensure the staple line is completely covered with the buttress or inadequate coverage after firing may result.
Do not use PSDV Reinforcement if the product has been exposed (1) to solutions above room temperature, (2) to chemicals, antibiotics, or other substances other than
specifically addressed in the instructions, (3) or if heat indicator has been activated.
Use care when removing loading unit components from the stapler to prevent buttress dislodgement.
Do not get the buttress wet before applying Gel, or the buttress may not adhere to the stapler properly.
Ensure the anvil and cartridge sides of the loading unit are on the corresponding stapler jaws or the buttress may not adhere to the stapler properly. The cartridge and
anvil sides of the PSDV Reinforcement loading unit differ; substitution of one side for the other may interfere with alignment and adherence of the buttress strips.
Final tissue compression, including PSDV Reinforcement, must meet the range specified by the stapler manufacturer; this is especially important if staple firings are
overlapped. PSDV Reinforcement increases the total thickness of the area stapled by 0.4 mm – 1.2 mm (0.016” – 0.048”).
(Circular reinforcement only) Cartridge cones may be used for entry into the surgical site on the cartridge side of the stapler during endoscopic surgery. Before
completion of surgery be sure to remove the cartridge cone from the surgical site.
Rx Only. For safe and proper use of this device, refer to the Instructions for Use.
PSDV Secure Grip Important Risk Information
Do not re-sterilize. Resterilization may cause changes to the tissue and negatively impact functionality of the device.
Discard all open, used, or unused components as sterility is no longer assured.
Do not use product if there is damage to the pouch or seals as sterility may be compromised.
Ensure the staple line is completely covered with the buttress, or it may result in inadequate coverage after firing.
PSDV-SG is not designed, sold, or intended for use except as indicated; doing so may result in surgical complications.
PSDV-SG configurations differ; substitution of one product for another product may reduce product performance.
Do not use PSDV-SG if the product has been submerged in liquids or if heat indicator has been activated.
Use care when removing loading unit components from the stapler to prevent buttress dislodgement.
Do not get the anvil or cartridge buttress wet before applying, or the buttress may not adhere to the stapler properly.
Ensure the anvil and cartridge side of the loading unit are on the corresponding stapler jaws or the buttress may not adhere to the stapler properly.
Final tissue compression, including PSDV-SG, must meet the range specified by the stapler manufacturer; this is especially important if staple firings are overlapped.
PSDV-SG increases the total thickness of the area stapled by 0.45 mm–1.26 mm (0.018”–0.049”).
Follow Instructions for Use supplied by the stapler manufacturer.
Do not use PSDV-SG contrary to the stapler manufacturer’s instructions.
The cartridge and anvil sides of the PSDV-SG loading unit differ; substitution of one side for the other may interfere with alignment and adherence of the buttress strips.
The use of PSDV-SG has not been studied in lung or bronchus resection.