10.14639/0392-100X-N2549
text/xml
1827-675X
2549
en
Pasquale Marra
http://creativecommons.org/licenses/by-nc-nd/4.0
ACTA Otorhinolaryngologica Italica
anaesthesia
Stapedoplasty without sedation in an office-based setting
Text.Serial.Journal
https://www.actaitalica.it/
43
Letters to the Editor-in-Chief
2023-07-24
2023-03-13
2023-07-25
2023-07-25
294-296
1
Pasquale Marra
2023/07/24
10.14639/0392-100X-N2549
294
Department of Otolaryngology, AORN San Giuseppe Moscati, Avellino, Italy
1827-675X
anaesthesia
en
296
Stapedoplasty without sedation in an office-based setting
https://www.actaitalica.it/article/download/2549/1022
43
ACTA OTORHINOLARYNGOLOGICA ITALICA 2023;43:294-296; doi: 10.14639/0392-100X-N2549




Letter to the Editor


Stapedoplasty without sedation
in an office-based setting
Stapedoplastica senza sedazione effettuata in regime ambulatoriale
Giuseppe Malafronte, Barbara Filosa, Antonio Trusio, Generoso De Cristofaro, Vito Colacurcio, Pasquale Marra
Department of Otolaryngology, AORN San Giuseppe Moscati, Avellino, Italy


KEY WORDS: office-based, stapedotomy, stapes surgery, sedation, anaesthesia
PAROLE CHIAVE: ambulatoriale, stapedotomia, chirurgia della staffa, sedazione,
anestesia

Dear Editor,
We greatly appreciated the recently published article comparing local anes-
thesia (LA) and general anaesthesia (GA) during stapes surgery, by Giannoni
et al. 1. The authors evaluated the hearing outcomes and patient satisfaction of
two cohorts, showing that there are no significant differences between LA and
GA. The choice of type of anaesthesia should be tailored to different situa-
tions, particular needs, and the specific patient, the authors concluded. We can
only agree on this perspective, yet we believe that another possibility should
be kept in mind in the near future.
Slow but steady advancements in surgical techniques have allowed the ex-
pansion of otolaryngological practice toward minimally invasive approaches,
where the effectiveness of the intervention is associated with the rapidity and
safety of the execution. In this context, risks should be minimised as much as
possible. This includes an aspect of great importance: sedation.
                                                                                       Received: March 13, 2023
Procedural sedation, defined as the use of sedative drugs to provide anxiolysis
                                                                                       Accepted: April 10, 2023
and analgesia during painful or unpleasant diagnostic and therapeutic proce-
dures 2, is ubiquitously used in otolaryngology. It is, however, not a trivial prac-   Correspondence
tice: individual patient response is often difficult to predict, and hypotension,      Pasquale Marra
                                                                                       ENT Department AORN, “San Giuseppe Moscati”,
apnea, hypoxia, pulmonary aspiration, and anaphylactic reaction are report-            via Melito, 83029 Solofra (AV), Italy
ed. Different options exist for sedation, including benzodiazepines, opioids,          Tel. +39 0824.203171
propofol, and dexmedetomidine 3. All these options have their technicalities           E-mail: pasquale.marra.m178@gmail.com
and usually require the presence of trained personnel and careful monitoring to
be safely carried out. Otolaryngologists are not routinely involved in training          How to cite this article: Malafronte G, Filosa
programs regarding sedation management, and therefore the help of an anaes-              B, Trusio A, et al. Stapedoplasty without seda-
                                                                                         tion in an office-based setting. Acta Otorhi-
thesia provider (e.g. an aneasthesiologist or trained nurse) is recommended 4.           nolaryngol Ital 2023;43:294-296. https://doi.
If no sedation is administered, there is no need for pre-operative fasting, and          org/10.14639/0392-100X-N2549
the peri-procedural monitoring is less demanding, and the patient can benefit
                                                                                       © Società Italiana di Otorinolaringoiatria
from a shorter recovery period. A re-evaluation closely after the procedure is         e Chirurgia Cervico-Facciale
nonetheless indicated to ensure that there are no signs or symptoms of com-
plications and the patient can safely return home. Avoiding sedation allows                           OPEN ACCESS
the procedure to be more easily managed by the ENT surgeon alone. This also            This is an open access article distributed in accordance with
                                                                                       the CC-BY-NC-ND (Creative Commons Attribution-Non-
means the possibility of translating it into a less controlled environment, such       Commercial-NoDerivatives 4.0 International) license. The
as an office-based setting (OBS).                                                      article can be used by giving appropriate credit and mentio-
                                                                                       ning the license, but only for non-commercial purposes and
Nowadays, there is an increased interest in OBS procedures, which are entirely         only in the original version. For further information: https://
conducted within the specialist’s office. The shift toward OBS is animated by          creativecommons.org/licenses/by-nc-nd/4.0/deed.en




294
                                                                                                         Office-based stapedoplasty




the necessity of reducing healthcare costs and reallocating      the entire superstructure, reducing the possibility of luxa-
resources and facilities 5. Such a need has been remarked        tion or fracture of the footplate. Given the effectiveness in
on by the Italian health legislation in 2017, when a min-        terms of hearing results, low level of discomfort, and prac-
isterial decree was issued, urging the local health authori-     ticality experienced, we started collecting data for future
ties to avoid inappropriate hospitalisation 6. More and more     publications.
otolaryngological procedures are now recommended to be           Performing stapedoplasty without sedation in OBS means
carried out on an outpatient basis and several of them, in-      a significant reduction in pre- and post-operative times. On
cluding laryngeal surgery, nasal endoscopy with polypec-         the other hand, the OBS approach could also be profitable
tomy, and ventilation tube placement, are already routinely      for the surgeon, who can benefit from greater autonomy and
performed in OBS. Streamlining these procedures can also         control, decentralisation of care, optimising efficiency and
be advantageous in the post-pandemic era, where the wait-        flexibility, reducing costs (no anaesthesiologist needed, no
ing list for otolaryngological surgery has increased dra-        storing of sedative drugs), and increasing reimbursement.
matically.                                                       However, such an approach could prove to be a double
Among middle ear surgeries, stapedoplasty is a technically       edge sword. Caution is necessary, considering the limited
demanding procedure, requiring experience to achieve con-        resources immediately available in this setting. The sur-
fidence and proficiency in its execution; yet it is also quick   geon must be proficient in the procedure to be carried out
and minimally invasive, with few well-thought steps and          and prepared to deal with complications. Utilising mini-
not many instruments needed. Considering this, we believe        invasive techniques 9 could help in this regard. A crucial
that stapedoplasty could be successfully done in an OBS          point to evaluate is ensuring the safety of the patient in a
without sedation.                                                less protected environment, while also preserving the ef-
Articles exploring this alternative are now available in the     fectiveness of the procedure. Strict protocols in instrument
literature: Voizard et al. recently conducted a proof-of-        disinfection have to be employed and choosing one instru-
concept study evaluating stapes surgery in OBS without           ment over another (e.g. manual perforator over skeeter-drill
sedation vs a standard procedure in the operating room,          or carbon dioxide laser, endoscopy over microscopy, and so
showing comparable results 7; the OBS cohort had the ad-         on) must be weighed on a logistical and patient-wise basis.
vantage of reducing the post-operative observation, while        Advanced obliterative otosclerosis with a thick footplate
all patients tolerated the procedure well, the authors con-      could represent an infrequent but not negligible limit for
cluded. Shoman et al. assessed the feasibility and safety of     OBS stapedoplasty with a manual perforator. A large air-
ossiculoplasty in OBS without sedation and found potential       bone gap could be indicative of this condition. However,
benefits for the patient and the healthcare system 8. This       several studies have highlighted that the size of the air-bone
conclusion could be extended to stapes surgery.                  gap does not reliably predict otosclerosis type (marginal,
Regarding our experience, we started to perform OBS sta-         biscuit, obliterative) 10. Intra-operative evaluation remains
pedoplasty out of necessity during the early pandemic; this      the gold standard for the diagnosis. When obliterative oto-
allowed us to work around the reduction in operating room        sclerosis is found during OBS stapedoplasty, it is advisable
availability. We chose a dedicated room equipped with an         to switch to electric microdrill.
examination table, inside our institution. The procedures        Intra-operative and immediate post-operative vertigo could
are conducted with the help of only one assistant nurse.         represent a complication that prevents the discharge and in-
Pulse oximetry, blood pressure, and heart frequency are          validate an OBS approach. Removing only the stapes head
monitored. Before surgery, the patient is carefully instruct-    could, as previously highlighted, minimise the risk of foot-
ed on the necessity of laying still and reporting any change     plate luxation or fracture. Incus luxation and perilymphatic
in hearing or balance. No sedation is administered. We           gusher are fearmongering possibilities that could discour-
slowly inject the ear canal with local anaesthesia and per-      age the inexperienced surgeon from engaging in OBS sta-
form a trans-canal minimally-invasive stapedotomy using          pedoplasty. Adequate preparation and a safety net should
manual perforators under microscopic visualisation 9. After      be predisposed (e.g. the possibility of hospitalising the pa-
the stapedotomy is performed with an increasing diameter         tient or consulting a senior surgeon).
perforator and the prosthesis is crimped to the incus, we        The patient must be carefully selected: good cooperation,
proceed to only remove the stapes head and not the en-           no anxiety disorders or other psychiatric illness, no tremor,
tire superstructure. This allows us to avoid intra-operative     and the ability to follow instructions are paramount. Clini-
bleeding which is often determined by the fracture of the        cal conditions must be evaluated and the American Society
anterior crus and can impair the surgical view. During sta-      of Anesthesiologists (ASA) Physical Status Classification
pes head removal, the force applied is equally distributed to    System can be used for risk stratification. We prefer to treat



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G. Malafronte et al.




only ASA class I and II patients in an OBS, although this         actual results are discussed here, therefore no ethical com-
aspect remains debatable. Also, the risk related to local         mittee approval was necessary.
anaesthesia (e.g. anaphylaxis) remains; some patients can
experience discomfort despite adequate local anaesthesia,         References
and a sympathetic response can be elicited. It is important
                                                                  1
                                                                       Giannoni B, Pollastri F, Adembri C, et al. Hearing outcomes and
to thoroughly explain this matter to the patient and let him/
                                                                       patient satisfaction after stapes surgery: local versus general an-
her participate in the decision. Many subjects, motivated by           aesthesia. Acta Otorhinolaryngol Ital 2022;42:471-480. https://doi.
fear of pain, are uncomfortable with even minor discomfort             org/10.14639/0392-100X-N2033
and directly demand sedation. Others will prefer the OBS          2
                                                                       Krauss B, Green SM. Procedural sedation and analgesia in
option because it is less demanding in terms of time spent             children. Lancet 2006;367:766-780. https://doi.org/10.1016/
                                                                       S0140-6736(06)68230-5
in the hospital. Appropriate counseling is essential.
In conclusion, OBS stapedoplasty without sedation may be
                                                                  3
                                                                       Chari D, McKenna MJ. Awake stapedectomy. Oper Tech Otolaryn-
                                                                       gol Head Neck Surg 2021;32:130-135. https://doi.org/10.1016/j.
a viable alternative to be explored in the future, considering         otot.2021.05.012
its pros and cons.                                                4
                                                                       Metzner J, Domino KB. Risks of anesthesia or sedation outside
                                                                       the operating room: the role of the anesthesia care provider. Curr
Conflicts of interest statement                                        Opin Anaesthesiol 2010;23:523-531. https://doi.org/10.1097/
The authors declare no conflict of interest.                           ACO.0b013e32833b7d7c
                                                                  5
                                                                       Prickett KK, Wise SK, DelGaudio JM. Cost analysis of office-based
                                                                       and operating room procedures in rhinology. Int Forum Allergy Rhi-
Funding                                                                nol 2012;2:207-211. https://doi.org/10.1002/alr.21020
This research did not receive any specific grant from fund-       6
                                                                       Definizione e aggiornamento dei livelli essenziali di assistenza, di
ing agencies in the public, commercial, or not-for-profit              cui all’articolo 1, comma 7, del decreto legislativo 30 dicembre 1992,
sectors.                                                               n. 502. (17A02015) (https://www.trovanorme.salute.gov.it/norme/
                                                                       dettaglioAtto?id=58669, accessed on 25/2/2023).
Author contributions
                                                                  7
                                                                       Voizard B, Maniakas A, Saliba I. Office-based stapes surgery.
                                                                       Otolaryngol Head Neck Surg 2019;161:1018-1026. https://doi.
GM: conception, drafting, editing and final approval of the            org/10.1177/0194599819877652
manuscript; BF, AT: editing of the manuscript; GDC: draft-        8
                                                                       Shoman N. Pilot study assessing the feasibility and clinical out-
ing of the manuscript; VC: drafting and editing of the man-            comes of office-based ossiculoplasty. Ann Otol Rhinol Laryngol
uscript; PM: conception and drafting of the manuscript. All            2019;128:50-55. https://doi.org/10.1177/0003489418806922
Authors contributed to the article and approved the submit-       9
                                                                       Malafronte G, Trusio A, Motta G, et al. Stapedotomy removing only
ted version.                                                           the stapes head and not the entire stapes superstructure: long-term
                                                                       results. Otol Neurotol 2021;42:E844-E848. https://doi.org/10.1097/
                                                                       MAO.0000000000003163
Ethical consideration                                             10
                                                                       Samimi-Ardestani H, Khorsandi-Ashtiani M, Ghoujeghi E, et al. Pre-
This is a letter to the editor containing a preliminary discus-        diction of stapes footplate thickness based on the level of hearing loss
sion on a new approach to stapedoplasty; no research and               in otosclerosis. Ear Nose Throat J 2012;91:328-334.




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