The Smart Panther Automatic Stapler (Panther Healthcare) is safe and effective with very low rates of bleeding and zero complications in the immediate post-operative period, such as bleeding or fistula, according to a study by researchers from the Clinica Michel Menezes, Rio de Janeiro, Brazil. Led by Dr Michel Menezes, the investigators highlighted that the ability of the Smart Stapler to read the thickness of the tissue and indicate to the surgeon possible adjustments to the chosen load, prior to firing, is a particular important feature of the device that helps to deliver such low complication rates.
The choice of the correct staple size by surgeons is extremely important - staples that are too wide can cause improper apposition, leakage and bleeding, while staples that are too tight can cause excessive tissue compression and ischemia. In addition, several studies have previously demonstrated that there is significant variation in gastric tissue thickness (TT) not only between individuals, but also between sites along the stomach itself (1-2). For example, several studies have found that the stomach is thickest at the antrum, thinnest in the middle of the body and even thinner at the fundus (3-5).
For optimal tissue apposition that prevents bleeding and leakage, the height of the closed staple (CSH) must be appropriate for the TT. A higher CSH can result in inadequate tissue apposition. Conversely, a shorter CSH can result in excessive compressive pressure on the tissue, resulting in ischemia or mechanical tissue damage. In either case, staple line leakage or bleeding may occur.
Consequently, to accommodate different TT, staples with different CSHs are available and surgeons usually choose the distribution of loads according to their preference, personal experience and also depending on the intraoperative visual inspection and tactile feedback.
The solution was to develop a stapler that signals whether the CSH is suitable for the tissue to be stapled, even blocking the firing in the case of thicker tissue than the chosen load can handle. According to Panther Healthcare, the Smart Stapler provides a slower firing speed over thicker tissue automatically, which produces improved staple formation and patient outcomes.
“The stapler previously reads the thickness of the tissue to be stapled, which brings more security to the surgeon when choosing the most appropriate load, eliminating the risk of fistulas, bleeding and stapler failure,” explained Dr Menezes. “The objective of this study was to assess the stapler’s impact on fistulas and bleeding, and to note stapler failure in the immediate post-operative period.”
In total, the study looked at the results from 300 patients (male n=96, female n=204) who underwent either Roux-en-Y gastric bypass (RYGB, n=239 patients, 79%) or laparoscopic sleeve gastrectomy (LSG, n=61 patients, 21%). All the procedures were by video laparoscopy and were performed by the same surgeon.
In the LSG technique, 60mm purple loads were used, and for the RYGB, 45mm purple loads (clamps from 1.25-1.7mm) were used for gastric time, and 45mm brown loads (clamps from 0.75-1.25mm) were used for intestinal time and gastroenteroanastomosis. Firing was performed only after the Smart Stapler signaled to the surgeon that the chosen load was suitable for the tissue to be stapled.
The researchers highlighted that in all the procedures over suture of staple lines or reinforcement of loads for hemostasis were not utilised to prevent bleeding or fistulas. In this way, there was no factor that could distort the objective of the study to evaluate bleeding or fistula.
The method used for hemostasis were polydioxanone stiches (PDS) 3.0 thread only in the case of punctual bleeding from the staple line that required hemostasis during surgery.
They recorded all procedural data regarding stapling failures and the need for hemostasis of staple lines through the use of sutures. Patients were followed for 30 days to assess the occurrence of early complications associated with the stapler, more specifically, bleeding and fistula related to the staple line.
Outcomes
At baseline (Table 1), the mean age was 39 years (19-63), mean weight 262lbs (200-445, 119kgs) and mean body mass index was 44.5kg/m2 (36-66). The most common comorbidity was hepatic steatosis (77%), followed by arterial hypertension (41%), dyslipidemia (40%), type II diabetes mellitus (32%) and arthropathies (14%), mainly of the lumbar spine and knees.
During surgery, there was bleeding from the staple line in 11 procedures that required hemostasis with PDS 3.0 thread sutures. There were no instances of staple failure. There were no cases of bleeding or fistula was observed in the first 30 post-operative days.
“If we consider an average of 6 shots per surgery, approximately 1,800 shots were performed. Correcting the numbers, we would arrive at a bleeding rate immediately after the trigger of 0.6% requiring hemostasis compared to other similar products available, based on the our observations and experience,” he added.
Despite the positive outcomes from this study, the researchers caution that these findings are from an initial 300 patients and will increase the number of cases to provide more robust results, and possibly, confirm these outcomes in a greater number of patients.
Nevertheless, they concluded that this study demonstrates very low rates of bleeding after stapling, confirming the ability of the Smart Stapler technology to deliver safe and effective results in both the peri- and post-operative period.
“Our all surgical team was really surprised by the results of this trial. The new Smart Stapler Panther is comfortable and easy to handle, increased the safety of surgery, saved surgery time by dispensing oversutures and hemostasis stitches, reduced costs by dispensing the use of reinforcement materials and extra use of suture thread,” Dr Menezes concluded. “Finally, and most importantly, it improves patient outcomes.”
References
Elariny H, Gonzalez H, Wang B. Tissue thickness of human stomach measured on excised gastric specimens from obese patients. Surg Technol Int. 2005;14: 119e124.
Huang R, Gagner M. A thickness calibration device is needed to determine staple height and avoid leaks in laparoscopic sleeve gastrectomy. Obes Surg. 2015;25:2360e2637.
Eujin Yeo, Jonathan Thompson, Dennis Hanseman, Adam Dunki-Jacobs, Ben Thompson, Michael Goodman & Tayyab Diwan. Increased staple loading pressures and reduced staple heights in laparoscopic sleeve gastrectomy reduce intraoperative bleeding. Surgery 169 (2021) 1110-1115
Emma Lundvall, Johan Ottosson & Erick Stenberg. The influence of staple height on postoperative complocation rates after laparoscopic gastric by-pass surgery using linear staplers. Surgery for obesity and related disease (2109) 15: 404-408
Yasmin Abu-Ghanem, Chanan Meydan, Lior Segev, Moshe Rubin, Orit Blumenfeld & Hadar Spivak. Gastric Wall Thickness and the choice of linear Staples in laparoscopic Sleeve gastrectomy: Challenging convencional concepts. Obesity Surgery (2017) 27: 837-843.
This article is sponsored by Panther Healthcare. The products featured here are available in Europe, the Middle East, Africa, Asia and Latin America. For more information, please visit: www.pantherhealthcare.com
Comments