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Staple Line Reinforcement

Are all Staple Line Reinforcement materials equal?

There may be precipitating factors, factors that stress the gastric staple line such as a tight passage or angulation at the incisura angularis
There are several different products on the market and the danger of grouping them all together is that they came to several conclusions which were counterintuitive

The causes of staple line leaks and how they can be remedied, remain one of the controversies of laparoscopic sleeve gastrectomy. At this year’s XXII IFSO World Congress, WL Gore & Associates will be host two symposia that will examine the latest evidence supporting staple line reinforcement. Bariatric News talked to Mr Ahmed R. Ahmed (Consultant Bariatric Surgeon, St Mary’s Hospital, Imperial College NHS Trust, UK) about the primary causes of staple line leaks and how they can be prevented, the different buttress materials available and the supporting evidence.

If we consider early post-operative leaks, we must think of issues with the endostapler, especially a disparity between staple height and tissue thickness” he stated. “There is increasing data that supports the notion that different parts of the stomach varies in thickness and if surgeons do not switch their cartridge selection going up the stomach then there may be problems – either the staples are going to be too short and the staple will not form correctly, or conversely, if the staples are too long the staple again may not form correctly leading to oozing. So, for early leaks, optimising staple line integrity and staple cartridge selection are key in the prevention of leaks.” Mr Ahmed said that with immediate or intra operative staple line problems, a surgeon may see an ooze from the staple line or notice an air or dye leak when they perform a leak test.

Mr Ahmed Ahmed

There can be instances of stapler malfunction – but these are increasingly rare with the new range of endostaplers available on the market. There may also be precipitating factors, factors that stress the gastric staple line such as a tight passage or angulation at the incisura angularis, a kink in the intestine or a bolus obstruction that increase a back pressure in the stomach tube and thereby triggering a leak in the setting of a poorly formed gastric staple line.

“All surgeons perform a visual examination of the staple line and many a leak test of some sort to give some degree of confidence that the staple line is secure and the operation – at a technical level – has been a success,” he added. “Of course, leaks will still occur despite apparent technical integrity from, for example, tissue ischaemia or injury say from an undetected instrument burn injury. But, in my opinion, a majority of early leaks can be prevented by a visual survey of the staple line and a leak test. In my opinion, staple line integrity may be improved with the usage of adjuncts such as staple line reinforcement.”

Evidence

Mr Ahmed explained that the problem with the literature regarding staple line reinforcement is that it changes from one year to the next. There can be one group of authors that claim staple line reinforcement works, it prevents bleeds and leaks, and saves money and then 12 months later another paper will be published claiming that staple line reinforcement shows no benefit, costs more etc.

“It is very difficult for surgeons to interpret the data to get a definite answer. My own personal experience and my interpretation of the literature is one that favours the use of staple line reinforcement. Unfortunately, we must rely on systematic reviews and meta-analyses – as leaks are so rare in incidence that performing a randomised clinical trial, the gold standard of scientific evidence, to address this issue would require enrolling tens of thousands of patients to power such a study – which is not feasible in the real world.”

Reinforce or not reinforce?

The first study by Dr Michel Gagner (Meta-analysis of leaks following laparoscopic sleeve gastrectomy, presented at the IFSO XVI World Congress; Aug 31- Sep 3, 2011; Hamburg, Germany. Obesity Surgery 2011;21 (8): 958. Abstract PL 02-05), showed that reinforcement reduces the leak risk by three-fold, compared with not using reinforcement. The second paper, a systematic review, again by Dr Michel Gagner (Comparison of laparoscopic sleeve gastrectomy leak rates in four staple-line reinforcement options: a systematic review. SOARD 2014: Jul-Aug;10(4):713-23) showed that the leak rate without using reinforcement was 2.6%, but with reinforcement the leak rate was reduced to 1.09%. Moreover, in his third and most recent paper, Gagner et al (Update on Sleeve Gastrectomy Leak Rate with the Use of Reinforcement. Obesity Surgery. January 2016, Volume 26, Issue 1, pp 146–150), reported a leak rate with Seamguard of 0.67%.

However, Mr Ahmed commented that there is some incongruity in the literature, as last year’s MBSAQIP paper (Berger et al. The Impact of Different Surgical Techniques on Outcomes in Laparoscopic Sleeve Gastrectomies: The First Report from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). Annals of Surgery. 2016 Sep;264(3):464-73)’ highlighted. This was a large study that included more than 189,000 sleeve gastrectomy procedures by over 1,630 surgeons at 720 different centres in the US.

“They came to the conclusion that using staple line reinforcement actually increased the leak rate (0.96%), compared to no reinforcement (0.65%) – which is the opposite of what previous papers have concluded. They also found that if reinforcement was used the staple line bleed rate was reduced to 0.75%, compared to no reinforcement (1.00%). Somewhat paradoxically, the authors noted that reinforcement with oversewing of the staple line increased the leak rate to 1.22%. Furthermore, those patients who had oversewing of the staple line lost more weight than those patients who had staple line reinforcement – and this was a statistically significant finding. I cannot understand how staple line reinforcement or lack thereof, influences weight loss.”

Other unexpected findings from the same paper were that a larger the bougie size (>38) was associated with an increased reduction in BMI at one year. He added that the authors also found that the further away the initial stapling was away from the pylorus, the greater the weight loss.

He said one of the limitations of this paper was that the authors grouped all of the different staple line reinforcement materials together. There are several different products on the market and the danger of grouping them all together is that they came to several conclusions which were counterintuitive.

“I think there really must be an attempt to perform a sub-analysis of the different staple line reinforcement materials from the MBSAQIP database, if possible, and to determine the outcomes of each individual material on leak rates and bleeding etc. The paper did not identify which staples and cartridges were used, how the oversewing was performed, if the fundus was removed, and distance from the gastro-oesophageal junction with the final staple firing – we know all these elements do have an influence on leak rates. So, in many ways this paper raised more questions than answers and I look at some of the conclusions with some trepidation.”

Buttress materials

Another important consideration when assessing leaks are the type of buttress material used. There currently are several staple line reinforcement materials on the market. Medtronic has recently introduced a new product to the market, Neoveil, and Cook Medical has the Surgisis Biodesign Staple Line Reinforcement material. However, most popular products are WL Gore & Associates’ biocompatible glycolide copolymer buttress material, Seamguard, and Baxter Healthcare’s bovine pericardium material, Peristrips Dry/Peristrips Dry with Veritas.

Again, Mr Ahmed said there was limited data in the literature that directly compares staple line reinforcement materials. Gagner and Buckwald’s 2014 paper (Comparison of laparoscopic sleeve gastrectomy leak rates in four staple-line reinforcement options: a systematic review. SOARD 2014: Jul-Aug;10(4):713-23), reported that bovine pericardium had a leak rate of 3.30%, compared to a leak rate of 1.09% for the biocompatible glycolide copolymer, so Peri-Strips had a three-times-higher leak rate than Seamguard. In fact, the paper also found that the leak rate for Peri-Strips was actually higher than oversewing using sutures (2.04%) and no-reinforcement (2.60%).

However, a paper by Dr Scott Shikora et al (Clinical Benefit of Gastric Staple Line Reinforcement (SLR) in Gastrointestinal Surgery: a Meta-analysis. Obesity Surgery. 2015; 25(7): 1133–1141), reported the opposite and found that staple line reinforcement provided superior results for patients, compared to no reinforcement, and that buttressing with bovine pericardium resulted in a leak rate of 1.28%, compared to buttressing with a biocompatible glycolide copolymer that had a leak rate of 2.61%.

Cost-benefit?

Despite the debate raging over which buttress material to use, there is little debate that the costs of treating leaks following laparoscopic sleeve gastrectomy is considerable. For example, Bransen et al (Costs of Leaks and Bleeding After Sleeve Gastrectomies. Obesity Surgery. 2015 Oct;25(10):1767-71) reported that prolonged hospitalisation in the ward and ICU accounted for the majority of additional costs for leaks (median €9,284, range €1,748-€125,684) at 50.3% and 31.4%, respectively.

Mr Ahmed also cited research by Nedelcu el al (Cost analysis of leak after sleeve gastrectomy. Surgical Endoscopy. 2017 April 4) that evaluated the costs of leaks after a laparoscopic sleeve gastrectomy. This retrospective analysis of 2,012 found 20 cases (0.99%) of gastric leak (only one gastric leak was recorded for the last 800 cases in which absorbable staple line reinforcement was used). The authors reported that the mean intra-hospital cost was €34,398 (range €7543–€91,632 with prolonged hospitalisation in ICU accounting for the majority of hospital costs (58.9%).

Mr Ahmed and colleagues also conducted their own economic analysis, which was presented at the 2015 IFSO World Congress, in Vienna, Austria (‘The Real Costs Of Treating Early Post-Operative Leaks Following Sleeve Gastrectomy Procedures’ (20th World Congress of the International-Federation-for-the-Surgery-of-Obesity-and-Metabolic-Disorders (IFSO), Springer, Pages: S45-S45). The paper, which was based on modelling theory as opposed to retrospective data analysis, looked at three different leaks scenarios: 1) An early leak with sepsis leading to a four-week hospital stay; 2) A leak with sepsis leading to a six-week hospital stay; and 3) A leak with complications need further interventions leading to a 12 week hospital stay. Using economic modelling theory, they then estimated the costs for each scenario. They based their model on Michel Gagner’s data (Meta-analysis of leaks following laparoscopic sleeve gastrectomy, presented at the IFSO XVI World Congress; Aug 31- Sep 3, 2011; Hamburg, Germany. Obesity Surgery 2011;21 (8): 958. Abstract PL 02-05) showing that staple line reinforcement reduces the leaks by three-fold. According to their modelling, a hospital would save approximately £41,000 for every 100 laparoscopic sleeve gastrectomies performed in the UK, if each patient received the Seamguard buttress material, as the number of leaks would be drastically reduced (the costings included the cost of the Seamguard). The assumption is that if one does not use staple line reinforcement there will be three leaks for every 100 laparoscopic sleeve gastrectomies, as opposed to a single leak by using the Seamguard buttress material (the modelling showed the extra costs for treating 2 additional leaks was approximately £83,000).

“At this year’s WL Gore symposium at IFSO, I have been invited to review the latest data and literature, and will be presenting some of the more controversial papers concerning staple line reinforcement,” concluded Mr Ahmed. “As we have discussed, there is lots of contradicting data, so I hope there will be some lively and healthy discussions with the audience about the use of staple line reinforcement, the supporting clinical evidence and how we can use the information to improve patient outcomes.”

There will be a limited number of spaces at the Gore Symposia at IFSO. To register your interest in attending this event, please click here

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