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24 Advancements in Transoral Robotic Surgery and the Treatment of Oropharyngeal…
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looking at PFS and disease-free survival (DFS). The results of this trial are not yet
available.
The PATHOS trial looks at T1-T3, N0-N2b tumors treated by TORS with neck
dissection and straties them based on histopathologic features [31]. The low-risk
arm is observed without any adjuvant therapy. The high-risk group (positive margins and/or extracapsular spread) is randomized to either radiation (60Gy) alone or
chemoradiation (60Gy+cisplatin). The intermediate group (PNI, LVI, close margins) is randomized among two radiation-only dosing paradigms of 50Gy versus
60Gy. The question being asked in the PATHOS trial is whether long-term dysphagia (measured by the MDADI) can be reduced through less intense adjuvant radiation treatment without an adverse clinical outcome. The results of this trial are not
yet available.
A clinical trial known as DART-HPV or MC-1675 (NCT02908477) looks at a
signicantly de-escalated adjuvant radiation therapy (DART) protocol of hyperfractionated 30–36Gy [32]. The signicant decrease in radiotherapy dose compared
to other trials draws from successful treatment of HPV-related anorectal cancers
with a similar dosing regimen. Inclusion criteria for the trial include having undergone TORS and having one of the following risk factors indicating adjuvant treatment: lymph node >3cm, two or more positive lymph nodes, perineural invasion,
lymphovascular invasion, T3 or T4 primary disease (with gross total resection
within two attempts), or extranodal extension (ENE). 194 patients were recruited
into the study. Intermediate-risk patients were randomized 2:1 to DART
(30 Gy/1.5 Gy BID + docetaxel 15 mg/m2 on day 1 and 8) or standard of care
(60Gy +/− weekly cisplatin 40mg/m2). Risk stratication was based on the presence of extranodal extension and smoking history. The high-risk group received
36Gy/1.8Gy BID or standard of care. The endpoints of the trial are treatment toxicity, overall survival, and quality of life. The study is still ongoing, currently with a
median follow-up of just over 2years as of July 2021. Compared to the standard-ofcare arm, the DART arm has demonstrated less toxicity, less need for feeding tubes,
improved swallowing function, and better quality-of-life indices. Regarding survival, 2-year follow-up statistics show similar PFS in DART versus standard of care,
except in the subset of the high-risk ENE+ DART group where their N-stage was
pN2. Otherwise, DART compared to standard-of-care adjuvant chemoradiation, the
data is promising for de-escalation.
427
Conclusion
Progress in the treatment of oropharyngeal cancer continues to improve as we rene
our understanding of the disease, introduce new technologies, and rigorously question the dogma that drives our practices. As oncologists, we are tasked to nd the
best treatment plan for our patients—one that maximizes survival and minimizes
long-term undesired secondary effects. In the epidemic of HPV-related oropharyngeal cancer, transoral robotic surgery has undoubtedly become a powerful weapon.
As a technology, it has opened opportunities to advance its own agenda. From the
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G. M. I. Low and J. M. Bigcas
rst iterations of the da Vinci Si, the need for more access, applications, and safety
has not only driven its own evolution, but it has also created industries to support it.
This is seen in innovations in retractor systems, endoscopes, camera technologies,
and the development of augmented reality tools. As the indications for robotic head
and neck surgery continue to expand so will the need for more solutions.
Robotic surgery has given head and neck surgeons a powerful weapon that not
only de-escalates traditional approaches to the oropharynx but may also empower
radiation oncologists and medical oncologists to de-escalate their therapies. In some
patients, TORS provides a minimally invasive means for achieving the same end
results as primary radiation, with less radiation-driven toxicity. This is not to say
that surgery is without risk; it certainly carries its own set of risks, complications,
and morbidity. Surgery does, however, provide invaluable histopathologic information, which may indicate the need for postoperative chemoradiation. As we continue
to investigate what is the appropriate amount of treatment, TORS has made it possible to pursue multimodal paradigms of de-escalation.
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14. Liu WP, Richmon JD, Sorger JM, Azizian M, Taylor RH.Augmented reality and cone beam
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26. Mahmoud O, Sung K, Civantos FJ, Thomas GR, Samuels MA.Transoral robotic surgery for
oropharyngeal squamous cell carcinoma in the era of human papillomavirus. Head Neck.
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27. Cracchiolo JR, Baxi SS, Morris LG, Ganly I, Patel SG, Cohen MA, etal. Increase in primary
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28. Nichols AC, Theurer J, Prisman E, Read N, Berthelet E, Tran E, etal. Radiotherapy versus transoral robotic surgery and neck dissection for oropharyngeal squamous cell carcinoma
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29. Weinstein GS, Quon H, O'Malley BW Jr, Kim GG, Cohen MA.Selective neck dissection
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30. Ferris RL, Flamand Y, Weinstein GS, Li S, Quon H, Mehra R, etal. Phase II randomized trial
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31. Owadally W, Hurt C, Timmins H, Parsons E, Townsend S, Patterson J, etal. PATHOS: a phase
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32. Ma DM, Price K, Moore EJ, Patel SH, Hinni ML, Fruth B, etal. MC1675, a phase III evaluation of De-escalated adjuvant radiation therapy (DART) vs. standard adjuvant treatment for
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Chapter 25
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Cold Ablation Robot-Guided Laser
Osteotome (CARLO®): Technology
andClinical Application inMaxillofacial
Surgery andReconstruction
TobiasEttl, MartaMorawska, andPhilippJürgens
Introduction
Bone osteotomy is a major component of many cranio- and maxillofacial (CMF)
interventions for corrective or reconstructive intent.
For decades, osteotomies were performed by mechanical instruments as saws
and drills with well-known collateral effects. The vibrations and heat generated by
those mechanical tools provoke damage of soft tissue and delayed healing process
for the cut area. During the last two decades, the piezoelectric surgery has gained
great popularity for its ability to precisely cut bone structures without causing injuries to soft tissue and providing accelerated bone healing [1, 2].
Laser radiation can be used to cut, shape, treat, and remove soft tissues. A variety
of laser wavelengths have been analyzed and suggested for cutting cortical bone [3].
This thermal mechanism of bone ablation results in coagulation, carbonization, and
vaporization of living tissues. Laser osteotomy offers the potential advantage of
high precision and reduced collateral damage to surrounding tissues. Other advantages include high productivity, narrow kerf (kerf is the gap between the cut
T. Ettl (*)
Department of Oral and Maxillofacial Surgery, University Medical Centre Regensburg,
Regensburg, Germany
e-mail: tobias.ettl@ukr.de
M. Morawska
Department of Cranio-Maxillofacial Surgery, Advanced Osteotomy Tools (AOT) AG,
Basel, Switzerland
e-mail: marta.morawska@aot.swiss
P. Jürgens
Department of Cranio-Maxillofacial Surgery, Leading Medical Center (LMC) Munich,
Munich, Germany
e-mail: pj@mkg-arabellapark.de
© The Author(s), under exclusive license to Springer Nature
Switzerland AG 2023
J. C. Melville et al. (eds.), Advancements and Innovations in OMFS, ENT, and
Facial Plastic Surgery, https://doi.org/10.1007/978-3-031-32099-6_25
431
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surfaces) width, low roughness of cut surfaces, and minimum distortion. The two
main obstacles faced with laser osteotomy are thermal damage and residual char
formation of adjacent tissues and its potential impact on healing [4, 5]. Thermal
damage greatly depends on the laser settings, such as wavelength, power, and pulse
duration [4, 6, 7]. The selection of appropriate settings has proven to lead to clean,
non- carbonized cuts with similar bone-healing proles compared to ones obtained
using piezoelectric device [8]. However, despite the promising outcomes of studies,
the majority of research in laser surgery relies on handheld lasers, which outcomes
depend on the manual skills of the surgeon and cannot fully utilize digitalized workows for preoperative planning.
T. Ettl et al.
Cold Ablation Robot-Guided Laser Osteotomy
CARLO® (Cold Ablation Robot-guided Laser Osteotome) (Fig.25.1a, b) represents
a surgical robotic platform, which uses cold laser ablation for bone cutting. An
erbium-doped yttrium aluminum garnet (Er:YAG) laser emits radiation at 2.94μm,
and so it can be used for thermal bone ablation due to water exhibiting a strong
absorption coefcient at this wavelength. The water molecules selectively absorb
the energy, thereby increasing the internal pressure in the form of steam, which
causes the explosive destruction of inorganic substances [7]. Potential thermal damage to the surrounding tissues is eliminated by spraying water into the surgical eld
[3]. In contrast to conventional rotating instruments and piezoelectric surgery, laserinduced thermal bone ablation does not create a smear layer on the osteotomy edges.
This results in a channeled scaffold that preserves the trabecular ridges, which
allows the passage of cells to the site of injury, therefore potentially beneting bone
healing [8] (Fig.25.1c, d).
Several preclinical and clinical studies have shown that the healing outcome
when using an Er:YAG laser with water cooling is comparable to that of conventional mechanical osteotomy and piezoelectric surgery [8–10]. The described technique is currently available by the start-up company Advanced Osteotomy Tools
(AOT AG, Basel, Switzerland) as miniaturized ablation laser with an optical system
in a compact casing and mounted on a tactile surgical robot (KUKA Light Weight
medical grade Robot, Augsburg, Germany), which is controlled by a navigation system.
The laser head of the system hosts the ablation laser and, additionally, a visualization laser for enhanced safety, which is coaxially bundled. The low-power
continuous- wave Class I green visualization laser indicates the osteotomy path at all
times. The so-called CARLO® enables exact contact- and debris-free osteotomies
according to a preoperative virtual planning without the need for cutting guides and
independent of surgeon’s individual maneuvers. This device offers the possibility of
a total digital workow that allows the direct transfer of the virtual planning into the
operating room. The potential of the CARLO® device has been conrmed
25 Cold Ablation Robot-Guided Laser Osteotome (CARLO®): Technology…
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433
ab
cd
Fig. 25.1 The Cold Ablation Robot-guided Laser Osteotome (CARLO primo). (a, b) CARLO®
trolley with navigation camera. (c) Bone surface cut with piezoelectric device. (d) Bone surface cut
with CARLO primo at x1000 magnication. Note the preserved bone structure after CARLO cut
resembling natural bone ((c–d) adapted from Baek etal., 2015) [9]
previously in invivo animal studies that compared piezoelectric surgery and the
CARLO® device in minipig mandibles and sheep skulls. The results showed that the
osteotomies had similar durations but higher accuracies and a tendency of faster
bone healing when the CARLO® device was employed [8–10].
Applications inCraniomaxillofacial Surgery
The feasibility of the CARLO® device for craniomaxillofacial interventions has
been demonstrated in a rst-in-man (FiM) study [9, 10], in daily clinical use for
midface osteotomies and on human cadavers by successfully performing mandible
split osteotomies and bula osteotomies with various designs [10].
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T. Ettl et al.
Orthognathic Surgery
In 2019 the rst-in-man clinical multicenter study to evaluate the safety and accuracy of linear midface osteotomies performed with the CARLO® device was started
(ClinialTrials.gov Identier: NCT03901209). 28 patients were enrolled across multiple sites (Allgemeines Krankenhaus der Stadt Wien (AKH Wien), Austria;
Universitätsklinikum Hamburg-Eppendorf, Germany; Kantonsspital Aarau AG,
Switzerland; Universitätsspital Basel, Switzerland). It was shown that cold ablation
robot-guided laser osteotomy could successfully be performed with no intraoperative complications or technical failure [11, 12]. In addition, these publications men-
tion CARLO® as a promising technical innovation with the potential to set new
standards for accuracy and safety in craniomaxillofacial interventions. CARLO®
device was granted CE-1250 certication for midface osteotomies in January 2021.
Since the certication, the CARLO® system is routinely used in ParacelsusKlinik in Munich, Germany (Fig.25.2). First 50 patients were operated using the
system and will be included in the Post Market Clinical Follow-up (PMCF) study to
conrm that CARLO® can be used safely and efciently in routine clinical setting.
The study so far revealed no safety issues or side effects associated with the use of
CARLO®, conrming the ndings from FiM study.
Although the current CE certication includes only upper jaw, recent studies aim
at extending the indication to full orthognathic surgery. In 2021, a study using
human cadavers aimed at assessing safety and efcacy of CARLO® for performing
Bilateral Sagittal Split Osteotomy (BSSO) [13]. The study utilized the possibility of
Fig. 25.2 CARLO being used in daily clinical practice in Paracelsus-Klinik in Munich, Germany
25 Cold Ablation Robot-Guided Laser Osteotome (CARLO®): Technology…
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435
ab c
Fig. 25.3 Cadaver study bilateral sagittal split osteotomy (BSSO). (a) Initial cut with CARLO®
prior to fracturing. Note the cortex is still intact after application of ve pulses. (b) Osteotomy site
after successful fracturing with intact nerve. (c) 20x magnication of the intact nerve following the
fracturing
protecting vulnerable structures, such as nerves, by creating “risk zones” over the
inferior alveolar nerve (IAN). During CARLO® surgery, these risk zones translate
into risk segments, where a limited number of laser pulses is used, to cut through the
cortex without compromising the IAN canal walls. During the study, 30 osteotomies
were performed with 100% success rate for primary end point (no damage to IAN),
verifying the safety of the device (Fig.25.3). The secondary end point (no malfracture) was achieved with 97% success rate, which is consistent with the rate reported
in clinical practice [14]. What is more, CARLO® cut was associated with high accuracy (dened as max. 2mm discrepancy between planned and executed cut) and no
observed carbonization. However, the duration of surgery was slightly longer then
when using piezoelectric tool, but comparable to standard techniques [15].
In addition to BSSO, a pilot study with three cadavers was conducted to assess
CARLO® use for surgically assisted rapid palatal expansion (SARPE). Following
the use of CARLO, there was no visible damage of the soft tissue on the hard palate
in any of the studied cephali. In addition, no damage was observed to teeth roots and
upper alveolar ridge. The average accuracy was kept within the required 2mm from
the planned cut. Overall, the studies showed that CARLO® is ready to perform the
full workow of orthognathic surgery safely and efciently, possibly offering a
safer and more precise alternative to standard surgical techniques.
Mandibular Reconstruction
The initial feasibility of free bula ap reconstruction of the mandible using
CARLO was successfully proven in a pilot study using human cadaver (Fig.25.4a–d).
There are several clinical patient benets in using CARLO® for mandibular
reconstruction with free bula graft, such as high accuracy of the osteotomies and
hence, high tting of the graft, and higher primary stability than conventional tools
would allow. When functional geometries are performed with CARLO®, the contact
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T. Ettl et al.
ab
c
d
ef g
Fig. 25.4 Pilot cadaver study. Mandible reconstruction with free bula graft using CARLO®. (a)
®
CARLO
tration. (b) Clean straight cut of the mandible using CARLO
using CARLO
with sinusoidal geometry. (f) CARLO
bula. (g) Functional cut in the bula with sinusoidal geometry
performing mandibular defect. The marker is xed to the mandible for permanent regis-
®
. (d) Reconstructed mandible with skin paddle. (e) Functional mandible defect
®
laser osteotome performing functional cut in a cadaver
®
. (c) Clean straight cut in the bula
area between bone segments is increased which will imply accelerated bony ossication and a reduction of load-bearing osteosynthesis material (Fig.25.4e–g).
Another big advantage would be the omission of cutting guides, resulting in
time-saving, cost-saving, and removing of fabrication errors and mispositioning of
the template during the surgery. The time needed for performing full surgical workow for CARLO® device, including planning and execution, would be substantially
less than in computer-assisted template-guided reconstruction, allowing fast treatment, which would be especially benecial for cancer patients. At best, adaption of
25 Cold Ablation Robot-Guided Laser Osteotome (CARLO®): Technology…
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osteotomy planning and CARLO® execution according to the extent of cancer
resection will be possible within surgery. Overall, the combination of high precision, advantages of functional cuts, and time-saving in comparison to conventional
state-of-the-art techniques could prove highly benecial to patients.
437
Further CMF Indications
Several other promising CMF indications for CARLO® use are currently under
investigation. Of course, orthognathic CARLO® surgery could be extended to Le
Fort II and III osteotomies in patients with midfacial hypoplasia, and also frontoorbital advancements in craniosynostosis seem to be a good indication for safe
CARLO® performance. Besides, osteonecrosis of the jaw is a fairly common problem among oncology patient population, being as high as 18.6% [16]. A number of
studies explored the use of laser surgery in the treatment of osteonecrosis of the jaw,
with a great success [17]. CARLO® could offer advancements in the treatment of
osteonecrosis not only for a precise resection of the lesion, based on presurgical
planning, but also for ad hoc surface ablation, which is currently performed with a
bur [18]. It is conceivable that resulting preservation of the cancellous bone structure with CARLO® ablation, in contrast to more closed structure when using
mechanical instruments, could result in better healing outcomes in the treatment of
osteonecrosis.
On the other hand, the possibility of resecting free-form shapes could be a promising approach in resection of craniofacial tumors and deformities, particularly bone
tumors. The tumor shape can be segmented and mapped preoperatively, resulting in
a very precise resection. Additionally, the use of CARLO® allows for very precise
reconstruction of missing bone fragments using autograft approaches, such as calvarial or iliac crest bone [19]. This may be interesting for preimplant augmentation
using autogeneous bone in contrast to the increasing use of freeze-dried bone
allografts. In a pilot study, the zygomatic bone was traced in a virtual model, and its
shape was precisely resected from the cranium. This free-shape approach could be
used not only for a precise t of the graft to the resection site but possibly also for
increased stability of the construct and lower use of osteosynthesis material, when
specic cutting geometries are used. The custom cut could be particularly useful for
stock temporomandibular joint (TMJ) prosthesis preparation to adapt cranial fossa
and the ramus for better t and load-bearing.
Overall, clinical practice and recent studies highlight the promising features of
CARLO® system, including preservation of natural bone surface while cutting, precision independent from individual surgeon’s skill, the possibility of geometric cuts,
and the potential to utilize digital presurgical planning strategies, which could revolutionize the future of CMF surgery.
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