Page 69 - World Journal of Laparoscopic Surgery

Medtronic I-Drive vs Ethicon Echelon
intraoperative complications. There were three stapler misfires dIscussIon
in the GIA-R arm—a malfunctioning reload requiring physician
assist to reload, stapler stuck on staple line, and improper loading The laparoscopic sleeve gastrectomy is now the most commonly
resulting in stapler jam. There was one stapler misfire in the performed bariatric surgery in the world, owing to its low rates of
ESG arm due to a misfire caused by the Seamguard string not morbidity and effectiveness in reducing comorbidities in both the
22–24
being pulled. All operations had a negative leak test in both the adult and pediatric populations. However, complication rates
perioperative and postoperative periods. of perioperative bleeding and leakage are still suboptimal, though
The primary endpoints are summarized in Table 2. In respect to the use of staple line reinforcement as a mitigation strategy for these
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total time for sleeve creation, 15.63% of sleeve creations using the morbidities is established. Our institution aimed to perform a
GIA-R system required a hemostatic intervention compared to 34.38% head-to-head analysis of the time and cost to reload two commonly
in the Echelon arm (p = 0.44). Half of all staple line bleeds across used powered linear staplers with staple line reinforcement in
both arms resolved spontaneously—the remaining half-achieved laparoscopic sleeve gastrectomies.
hemostasis using a surgical clip with one exception requiring a In respect of time analysis, there are also significant differences
hemostatic agent. All operations did not require blood transfusion between the reloading mechanism of each platform. The Echelon
and were without serious complications as defined by the American device has a reloadable, staple containing plastic cartridge that is
College of Surgeons National Surgical Quality Improvement Program mechanically secured to the powered unit via a snap-in system.
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(ACS NSQIP). There was no mortality in either group. The absorbable polymer reinforcement is subsequently attached.
There was a mean of 5.38 stapler loads used per sleeve In comparison, the entire shaft of the I-Drive platform is exchanged
gastrectomy in the ESG group and a mean of 4.92 stapler loads with each staple reload and each reload cartridge contains the
used per sleeve gastrectomy in the GIA-R arm (p = 0.052). There staple line reinforcement already attached. However, the powered
were 140 stapler loads used in the ESG arm and 123 used in the unit of the I-Drive platform requires a diagnostic systems check
GIA-R arm. The median reload time was 41.77 seconds in the ESG with each cartridge reload whereas the Echelon is ready to fire.
group 39.78 seconds in the GIA-R group (p = 0.4242). The total In our study, each arm did not have a statistically significant
time for sleeve creation was 12.14 minutes in the ESG arm and difference in the number of staple reloads required to conduct
14.26 minutes in the GIA-R arm (p = 0.04). the operation (p = 0.052). Moreover, the time required to reload
The total cost for the stapler supplies used in each arm was the staple cartridge and add the staple line reinforcement in the
calculated at both the government rate and the commercial Echelon arm was equivalent to the time needed to change the shaft
rate listed on the government-ordering website. The mean total with the pre-attached staple line reinforcement and perform the
government cost for the ESG was $2,449.44 and $2,097.66 for the diagnostic system check in the I-Drive arm (p = 0.4242). However,
GIA-R (p = 0.0002). The mean total commercial cost for the ESG was there was a statistically significant faster time to sleeve creation
$1,982.17 and $2,037.25 for the GIA-R (p = 0.4774). using the Echelon platform at 12.14 minutes vs the Covidien I-Drive
platform at 14.26 minutes (p = 0.04). Though the difference in time
to sleeve creation was statistically significant, we feel that the mean
Table 1: Summary of baseline demographics for study participants
difference of 2.08 minutes is not clinically significant.
Ethicon Echelon with Covidien I-Drive with GIA In respect of cost analysis, there are differences between
Seamguard (ESG) (n = 26) reinforcement (GIA-R) (n = 25) the two powered staplers due to the ancillary purchase required
Age 36.4 33.2 to conduct the operation. While the I-Drive is re-usable after
Gender re-processing, the Echelon stapling device is disposable and thus,
Male 5 (20.0%) 1 (3.8%) requires purchase with each operation. The cost of the staple
Female 20 (80.0%) 25 (96.2%) reloads with staple line reinforcement in the I-Drive platform range
Race from $413.94 to $472.36. In comparison, the staple reloads for the
White 12 (48.0%) 15 (57.7%) Echelon range from $156.60 to $178.26. However, the absorbable
polymer reinforcement is purchased separately and costs an
Black 5 (20.0%) 1 (3.8%) additional $164.54 for commercial use and $224.03 for government
Other 8 (32.0%) 10 (38.5%) use. Thus, the mean total cost for conducting a sleeve gastrectomy

Table 2: Table of primary end points for the Ethicon Echelon with Seamguard vs Covidien I-Drive with GIA reinforcement
Ethicon Echelon with Seamguard (ESG) Covidien I-Drive with GIA reinforcement
(n = 26) (GIA-R) (n = 25) p value
Sleeve creation time (minutes) 12.14 14.26 0.04
Time to reload (seconds) 41.77 39.78 0.42
Hemostatic intervention 34.38% 15.63% 0.44
Transfusion None None n/a
Perioperative leak rate None None n/a
Postoperative leak rate None None n/a
Serious complication None None n/a
Mortality rate None None n/a
Stapler cost (Government rate) $2,449.44 $2,097.66 0.0002
Stapler cost (Commercial rate) $1,982.17 $2,037.25 0.48

World Journal of Laparoscopic Surgery, Volume 15 Issue 1 (January–April 2022) 67