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J Robotic Surg

DOI 10.1007/s11701-016-0662-0

ORIGINAL ARTICLE

Early clinical experience with the da Vinci Xi Surgical System


in general surgery
Monika E. Hagen1 • Minoa K. Jung1 • Frederic Ris1 • Jassim Fakhro1 •

Nicolas C. Buchs1 • Leo Buehler1 • Philippe Morel1

Received: 19 August 2016 / Accepted: 4 December 2016


 Springer-Verlag London 2016

Abstract The da Vinci Xi Surgical System (Intuitive docking. No intraoperative and two postoperative compli-
Surgical Inc., Sunnyvale, CA, USA) has been released in cations occurred. The da Vinci Xi might facilitate single-
2014 to facilitate minimally invasive surgery. Novel fea- setups of totally robotic gastric bypass and colorectal
tures are targeted towards facilitating complex multi- surgeries. However, further comparable research is needed
quadrant procedures, but data is scarce so far. Perioperative to clearly determine the significance of this latest version of
data of patients who underwent robotic general surgery the da Vinci Surgical System.
with the da Vinci Xi system within the first 6 month after
installation were collected and analyzed. The gastric Keywords Robotic  Robotic surgery  Da Vinci  Xi 
bypass procedures performed with the da Vinci Xi Surgical Minimally invasive surgery  Digestive surgery
System were compared to an equal amount of the last
procedures with the da Vinci Si Surgical System. Thirty-
one foregut (28 Roux-en-Y gastric bypasses), 6 colorectal Introduction
procedures and 1 revisional biliary procedure were per-
formed. The mean operating room (OR) time was 221.8 With improved vision and dexterity, robotic technology for
(±69.0) minutes for gastric bypasses and 306.5 (±48.8) for minimally invasive surgery has been developed to over-
colorectal procedures with mean docking time of 9.4 come technical limitations of conventional laparoscopy
(±3.8) minutes. The gastric bypass procedure was transi- [1–3]. Since its introduction to the market, the da Vinci
tioned from a hybrid to a fully robotic approach. In com- Surgical System (Intuitive Surgical, Sunnyvale, CA, USA)
parison to the last 28 gastric bypass procedures performed remains the most widely used system for robotic-assisted
with the da Vinci Si Surgical System, the OR time was laparoscopic surgery and is currently available in its 4th
comparable (226.9 versus 230.6 min, p = 0.8094), but the generation with the da Vinci Xi Surgical System [4].
docking time significantly longer with the da Vinci Xi All da Vinci generations that include the da Vinci
Surgical System (8.5 versus 6.1 min, p = 0.0415). All Standard (sales and support discontinued by Intuitive), the
colorectal procedures were performed with a single robotic da Vinci S, the da Vinci Si and the da Vinci Xi Surgical
System share common core technical features that differ-
entiate them from conventional laparoscopy. All systems
This work was presented at the 7th worldwide meeting of the Clinical contain three components with a surgical console, a sur-
Robotic Surgery Association on October 3rd 2015. gical cart and a vision tower with the following specifica-
M. E. Hagen and M. K. Jung contributed equally.
tions [4]:
• Surgical console allowing comfortable seating position
& Monika E. Hagen
monikahagen@aol.com of the surgeon with physical separation from the
patient, tools to interact with environment, and a
1
Division of Digestive and Transplant Surgery, Department of natural hand-eye alignment
Surgery, University Hospital Geneva, 4 Rue Gabrielle-Perret-
Gentil, 1211 Geneva, Switzerland

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J Robotic Surg

• 3D HD Vision with up to tenfold magnification and an After 8 years of clinical experience with all other da
immersive surgical field-of-view Vinci models (Standard, S and Si) mainly for gastric
• Wristed instrumentation with 7 degrees of freedom bypass surgery (Over 650 cases performed) but also many
• Software features including motion scaling and tremor other procedures of digestive surgery [5–9], we have
filtration. installed two da Vinci Xi Surgical Systems in late March
2015. One of the systems offers a dual console and the
In addition to more gradual enhancements of the Stan-
other one has a single console setup.
dard over the S to the Si Surgical System, the latest version
Prior to the installation of the Xi Surgical Systems, we
(da Vinci Xi Surgical System; released to the market in
have performed a hybrid procedure for Roux-en-Y gastric
2014) has more fundamental design changes including
bypass (RYGB) with laparoscopic cholecystectomy for
changes to the surgical cart including [4]:
most patients, laparoscopic formation of gastric pouch and
• Torpedo-shaped robotic arms that are mounted on a laparoscopic measurement of the biliary loop [6]. Both
rotating beam (Fig. 1) gastro-jejunal, as well as jejuno-jejunal anastomoses and
• Universal arms where camera can be docked onto any the measurement of the alimentary loop were performed
arm robotically. The gastro-jejunal, as well as the jejuno-jejunal
• Longer instruments, but currently only available at a anastomoses were fully ‘‘hand-sutured’’. The left-sided
reduced variety colorectal procedures were performed with either a hybrid
• A new vision architecture with chip-at-the tip technol- approach (laparoscopic mobilization of splenic flexure) or
ogy and camera, endoscope and cable integrated into with a re-arrangement of robotic arms with or without
one handheld design repositioning of the surgical cart. This manuscript reports
• Adapted user interface offering more assistance with our initial (first six month) experience with the novel da
robotic setup and installation Vinci Xi Surgical System in digestive surgery.
• Integrated energy with a single device for mono- and
bipolar energy
• Standard integration of Firefly Fluorescence Imaging. Materials and methods
These design changes are targeted towards a facilitated
Data on all patients undergoing robotic surgery had been
robotic setup and more streamlined user experience with
entered into a prospective database since 2006. All rel-
the possibility to access a greater field of surgery without
evant technical aspects during the procedure were col-
the need to re-install the robotic system. As such, the
lected including operating room time, docking time,
system appears to be specifically capable of abdominal
intraoperative complications and other various other data
procedures that take place in several quadrants of the
points.
abdominal cavity such as colorectal and gastric bypass
A basic dataset of all patients who underwent robotic
procedures and thus appeared very appealing to us for our
digestive surgery in the first months after the Xi imple-
robotic digestive surgery program.
mentation was derived. Patients who underwent gastric
bypass surgery were compared to the equal amount of
gastric bypass patients who were operated with the da
Vinci Si Surgical System just before transitioning to the Xi
Surgical System. Data was presented using descriptive
statistics, and cohorts were compared. A p value of B0.05
was considered as statistically significant.
All members of the team were trained before the 1st Xi
procedure including online and live training with mock-up
of docking procedure according to Intuitive’s training
pathway. All team members involved in the early cases had
significant experience with the former versions of the da
Vinci Surgical System.
Robotic docking and port positioning was performed
after careful review of the targeted procedures and Intu-
itive’s recommendations according to their informational
product brochure. An Intuitive representative was present
Fig. 1 The da Vinci Xi arms mounted onto the rotating beam during the initial cases and continuous support was pro-
(Provided by courtesy of Intuitive Surgical Inc.) vided as needed by Intuitive.

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Results right colectomy developed anastomotical leakage with


required surgical treatment.
Thirty-eight patients underwent Xi surgery from the end of For detailed general results, please refer to Table 2.
March to July 2015. The procedures included 28 RYGB, 3
low anterior resections, 2 right colectomies, 1 revisional
bariatric procedure, 1 sigmoid resection, 1 Nissen fundo- Discussion
plication, 1 atypical gastrectomy and 1 revisional biliary
procedure. While robotic radical prostatectomy is an established pro-
The overall docking time was 9.4 (±3.8) minutes and cedure confirmed by large clinical data analyses [10, 11],
overall operating room (OR) time was 229.5 (±70.4) systematic meta-analyses and reviews [12–14], clinical
minutes. No conversions to open, laparoscopic or da Vinci guidelines [15] and several Health Technology Assess-
Si surgery occurred. ments (Ireland: HIQA HITA 2012; UK: NHS NIHR HTA
The gastric bypass procedures using the da Vinci Xi 2012), quality data with high level of evidence is still
Surgical System were either performed as hybrid, near- missing for the field of digestive surgery [16]. Besides this
total robotic single console or dual console near-total currently limited availability of high quality data, technical
robotic with laparoscopic stapling procedures. The near- specifications of the former versions of the da Vinci Sys-
total robotic procedure resulted in very similar docking tem pose several challenges to abdominal procedures that
times (11.1 versus 8.7 min, p = 0.) and OR times (218.2 might be a contributing factor for a limited use in this
versus 223.7 min, p = 0.9616) when compared to the surgical field. In that regards, robotic surgery has repeat-
hybrid procedure. Besides a higher percentage of male edly been criticized for a complicated setup, a limited
patients, demographic parameters including rate of con- ability to reach multiple abdominal quadrants without re-
comitant cholecystectomy was similar when comparing arrangement of robotic arms, and re-docking and/or repo-
the last 28 Si gastric bypass patients to the first 28 Xi sitioning of the surgical cart resulting in longer OR times
cases. Significantly more Xi patients underwent a total and less (cost-) efficient procedures versus alternative
robotic procedure (p = 0.007). With similar OR times methods [16]. However, numerous design changes to the da
(230.6 ± 38.5 min for Si and 226.9 ± 71.0 for Xi, Vinci family leading to the market release of the da Vinci
p = 0.8094) and no intraoperative complication due to Xi Surgical System in 2014 address some of the major
the robotic system occurred in both groups. Docking challenges of robotic digestive surgery: Longer instruments
times were significantly longer for the da Vinci Xi Sur- allow to retract the trocar location from the targeted anat-
gical System (6.1 ± 4.3 versus 8.5 ± 4.3 min, omy, torpedo-shaped robotic arms result in a greater range
p = 0.0415). Costs of a basic set of robotic instruments of motion without outside collision, and changeability of
including one harmonic instrument and accessories (Si) or camera position offers a more versatile view of the surgical
vessel sealer (Xi), one needles driver, one long tip for- field. These qualities in combination allow access to a
ceps, two Cadiere forceps, one cautery hook, one fenes- greater surgical field without re-docking, re-arranging arms
trated bipolar forceps, necessary accessories (drapes, and/or surgical cart—at least in theory.
cannula seals, etc.) was 25527.7 United States Dollars In our early clinical experience with the Xi Surgical
(USD) for the da Vinci Si Surgical System and USD System, we were able to use the above-described technical
2296.4 for the Xi da Vinci System. Details in regards to advances to shift all of our low anterior resections and our
the comparison of Si and Xi gastric bypasses are listed in gastric bypasses from hybrid approaches or procedures
Table 1. with re-arrangement of robotic arms to total robotic pro-
All colorectal procedures were performed as total cedures within the first cases after clinical implementation
robotic single docking procedures without re-arrangement of the new system. As for all other procedures including
of robotic arms. The OR time was 283.3 (±9.5) minutes for atypical gastric resection, Nissen fundoplication, hepatic
low anterior resections and 285 (7.1) minutes for right and revisional biliary surgery, we have not achieved a
colectomies. change in surgical approach with the introduction of the
Two patients required re-intervention due to a surgical novel system and no distinct advantages of the Xi Surgical
complication: One gastric bypass patient was diagnosed System were observed. Perhaps streamlined docking and
with a biliary leak due to an insufficiently sealed cystic setup might have a positive impact on these procedures
duct (One of two intraoperatively placed Hem-o-lock clips mid- and long-term, but other significant advantages over
(Teleflex, Morrisville, NC, USA) in insufficient location at previous da Vinci models are not obvious at this point.
revision, second clip was not found in place). One patient As mentioned, all Xi low anterior resections were per-
with a hand-sutures extra-corporeal anastomosis during a formed with a single docking approach without re-

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Table 1 Comparative data da Vinci Si versus da Vinci Xi surgical system for gastric bypass surgery
Cases da Vinci Si surgical system da Vinci Xi surgical system p value
(n = 28) (n = 28)

Age, years
Mean (standard deviation) 44.0 (11.8) 46.1 (8.1) 0.4409
Gender, n (%)
Female 16 24 0.0366
Male 12 4
Body mass index, kg/m2
Mean (standard deviation) 43.3 (6.6) 42.2 (5.8) 0.5105
Rate of cholecystectomy, n (%) 21 (75.0) 17 (60.7) 0.5544
Surgical procedure methods, n (%)
Hybrid procedure 28 18 0.0007
Near total robotic 0 10
Operating room time, minutes
Mean (standard deviation) 230.6 (38.5) 226.9 (71.0) 0.8094
Docking time, minutes
Mean (standard deviation) 6.1 (4.3) 8.5 (4.3) 0.0415
Intraoperative complications due to surgical system, n (%) 0 (0) 0 (0) 1
Material costs of standard set of robotic instruments* in 2552.7 2296.4 NA
USD
* Set includes: One da Vinci Harmonic ACE (Si) or vessel sealer instrument (Xi–Harmonic Ace not available at that point) instrument and
accessories, one needles driver, one long tip forceps, two Cadiere forceps, one cautery hook, one fenestrated bipolar forceps, necessary
accessories (drapes, cannula seals, etc.)—All by Intuitive Surgical Inc., Sunnyvale, CA, USA

arrangement of robotic arms (Fig. 2). Surprisingly, all procedures to a more robotically involved approach. How-
anatomical areas of a classical LAR (splenic flexure to pelvic ever, this transition has not been ‘‘enabled’’ but rather ‘‘in-
floor) were accessible with the recommended docking strat- spired’’ by the da Vinci Xi Surgical System. As a matter of
egy by the manufacturer. Even though the upper left fact, several other groups routinely perform total or ‘‘near
hypochondrial robotic arm is very cranial and is arranged in a total’’ robotic gastric bypasses using the da Vinci Si Surgical
very flat angle to the pelvis, we were sufficiently satisfied with System and as such the Xi features are not necessary for the
the range of motion during the pelvic dissection and all other implementation of this technique. Still, the transition to a
parts of the procedure. While there was no fundamental shift in new version of the da Vinci has been an occasion to revise the
technique for the right colectomy cases, the retracted trocar robotic use for our dominant robotic procedure. Most of the
position (again allowed by the new design of the Xi arms and initial Xi gastric bypass cases were performed as ‘‘near total
the additional length of the robotic instruments) led to a larger robotic’’ cases using laparoscopic staplers as the Xi staplers
surgical field with improved macro-view of the anatomy. were not available during this early Xi experience.
Generally, this should help with orientation and handling of When analyzing the comparative data of our last twenty-
tissue particularly in large and obese patients. Remarkably, the eight da Vinci Si patients to the first twenty-eight da Vinci
Xi trocar setups for left- and right-sided colorectal procedures Xi cases, two items are most noteworthy: docking times
are extremely similar (only mirrored—Fig. 3). This reduces were 2.4 min longer when compared to our Si dockings.
the complexity of the robotic docking for colorectal teams that While this number reached statistical significance, the
should result in improved OR workflow. Again, this early clinical impact might be of less importance considering the
colorectal experience is biased by the limited number of overall OR times of these procedures. However, the da
patients included in the analysis with a limited variability in Vinci Xi Surgical System with an adapted user interface
body sizes and shapes. We will further drive our colorectal Xi offering more assistance with robotic setup and installation
experience with addition of robotic staplers and report larger as a distinct feature-has specifically been designed to
and more systematic data sets in the future. facilitate this part of the procedure. Indeed, the system
Since the introduction of the da Vinci Xi Surgical System, offers a variety of anatomical setups that are chosen before
we significantly shifted our robotic gastric bypass docking, has a laser targeting system (Fig. 4), which helps

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Table 2 Patient data


Cases N Technique Innovation Mean docking Mean OR-time
time (standard (standard
deviation), deviation),
minutes minutes

Roux-en-Y 28 All RYGB – 9.6 (3.8) 221.8 (69.0)


gastric bypass 18 Hybrid procedure None 8.7 (3.5) 223.7 (79.7)
10 Near total robotic, dual console Shift from hybrid procedure to the 11.1 (3.9) 218.2 (46.7)
procedure with laparoscopic maximum amount of robotic use at time
stapling (robotic stapler not yet available at site)
Revisional 1 Hybrid procedure None, but if conversion to gastric bypass all 7 (NA) 217 (NA)
bariatric of the above innovations possible
surgery
Nissen 1 4-arm total robotic procedure None 9 (NA) 131 (NA)
fundoplication
Atypical 1 4-arm total robotic procedure None 4 (NA) 175 (NA)
gastrectomy
Revisional 1 4-arm total robotic procedure None 17 (NA) 225 (NA)
biliary
surgery
Sigmoid 1 4-arm total robotic (transanal Shift from either hybrid or multiple robotic 5 (NA) 379 (NA)
resection circularly stapled anastomosis) arm position procedure
single docking procedure
Low anterior 3 4-arm total robotic (transanal Shift from either hybrid or multiple robotic 10.3 (2.5) 283.3 (9.5)
resection circularly stapled anastomosis) arm position procedure
single docking procedure
Right 2 4-arm total robotic single None 6 (1.4) 285 (7.1)
colectomy docking procedure
Overall 38 9.4 (3.8) 229.5 (70.4)

Fig. 2 Xi trocar positioning for low anterior resection Fig. 3 Xi trocar positioning for right colectomy

to position the arm beam in the optimal location and allows and the da Vinci Si Single Site platform [17, 18]. Despite
to automatically arranging the robotic arms in relation to the technology-enhanced user interface, the larger dimen-
the targeted anatomy. While all this should facilitate a sions of the Xi surgical cart pose a challenge in our ORs.
robotic setup and faster system docking, we have observed Because, we have firmly installed frames for airflow
the contrary when compared to the last Si procedures, as (Fig. 5), we have limited space for the robotic system in
well as reported times for the da Vinci Standard System close proximity to the patient. As such, we have to position

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efficiency of the docking with the previous da Vinci


models. Although these prolonged docking times might
also be a result of learning curve effects, we are certain that
challenges to docking increased with the implementation of
the Xi Surgical System in our setting. Still, we believe that
the innovations of the da Vinci Xi facilitate robotic setup
and docking for robotically inexperienced teams with ORs
without space constraints.
Another interesting finding is a cost difference in favor
of the da Vinci Xi Surgical System for a basic set of robotic
instruments that are necessary to perform a gastric bypass
in our setting. Certainly, a per-procedure advantage of
USD 256.3 is meaningful. Still, the increased capital
investment and yearly maintenance for the Xi in compar-
ison to the Si System impact the overall per procedure
costs. As such, the da Vinci Xi Surgical System appears
financially most attractive at high volume site where the
positive impact of lower instrument costs and wide distri-
bution of other posts potentially have a meaningful impact.
Besides some positive developments of the da Vinci
Fig. 4 Xi laser targeting system
family, the current version of the Xi system also poses
challenges particularly in regards to yet missing instru-
the Xi system within the frame before we can deploy the ments and equipment that forces us to adapt our surgical
arms. The system is too high to enter with deployed arms. technique: Currently, a variety of instruments are not yet
The deployment of the arms and final positioning is then available for the Xi system including the Harmonic scalpel.
complicated due to space restrictions within the frame. We routinely used this instrument during gastric bypasses
This complexity of our specific setup results in a certain as well as colorectal procedures. Thus far, we were able to
variety of docking times and has so far not yet reached the compensate by replacing with mono-polar energy devices

Fig. 5 OR installation with airflow frame off ceiling

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or the da Vinci vessel sealer. In addition, as no other trocar Ethical approval All procedures performed in studies involving
is needed for the camera (robotic 8 mm trocar used as all human participants were in accordance with the ethical standards of
the institutional and/or national research committee and with the 1964
arms are able to host instruments and camera), we miss the Helsinki declaration and its later amendments or comparable ethical
option to introduce the first trocar under direct camera standards.
control within the trocar (Optiview). This option is par-
ticularly useful during our bariatric cases because an open
incision would need to be relatively large. To this point, we References
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