Stapedoplasty without sedation in an office-based setting| ACTA Otorhinolaryngologica Italica

Article

Dear Editor,

We greatly appreciated the recently published article comparing local anesthesia (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 situations, 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 expansion 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.

Procedural sedation, defined as the use of sedative drugs to provide anxiolysis and analgesia during painful or unpleasant diagnostic and therapeutic procedures ², is ubiquitously used in otolaryngology. It is, however, not a trivial practice: individual patient response is often difficult to predict, and hypotension, apnea, hypoxia, pulmonary aspiration, and anaphylactic reaction are reported. Different options exist for sedation, including benzodiazepines, opioids, propofol, and dexmedetomidine ³. All these options have their technicalities and usually require the presence of trained personnel and careful monitoring to be safely carried out. Otolaryngologists are not routinely involved in training programs regarding sedation management, and therefore the help of an anaesthesia provider (e.g. an aneasthesiologist or trained nurse) is recommended ⁴.

If no sedation is administered, there is no need for pre-operative fasting, and the peri-procedural monitoring is less demanding, and the patient can benefit from a shorter recovery period. A re-evaluation closely after the procedure is nonetheless indicated to ensure that there are no signs or symptoms of complications and the patient can safely return home. Avoiding sedation allows the procedure to be more easily managed by the ENT surgeon alone. This also means the possibility of translating it into a less controlled environment, such as an office-based setting (OBS).

Nowadays, there is an increased interest in OBS procedures, which are entirely conducted within the specialist’s office. The shift toward OBS is animated by the necessity of reducing healthcare costs and reallocating resources and facilities ⁵. Such a need has been remarked on by the Italian health legislation in 2017, when a ministerial decree was issued, urging the local health authorities to avoid inappropriate hospitalisation ⁶. More and more otolaryngological procedures are now recommended to be carried out on an outpatient basis and several of them, including laryngeal surgery, nasal endoscopy with polypectomy, and ventilation tube placement, are already routinely performed in OBS. Streamlining these procedures can also be advantageous in the post-pandemic era, where the waiting list for otolaryngological surgery has increased dramatically.

Among middle ear surgeries, stapedoplasty is a technically demanding procedure, requiring experience to achieve confidence and proficiency in its execution; yet it is also quick and minimally invasive, with few well-thought steps and not many instruments needed. Considering this, we believe that stapedoplasty could be successfully done in an OBS without sedation.

Articles exploring this alternative are now available in the literature: Voizard et al. recently conducted a proof-of-concept study evaluating stapes surgery in OBS without sedation vs a standard procedure in the operating room, showing comparable results ⁷; the OBS cohort had the advantage of reducing the post-operative observation, while all patients tolerated the procedure well, the authors concluded. Shoman et al. assessed the feasibility and safety of ossiculoplasty in OBS without sedation and found potential benefits for the patient and the healthcare system ⁸. This conclusion could be extended to stapes surgery.

Regarding our experience, we started to perform OBS stapedoplasty out of necessity during the early pandemic; this allowed us to work around the reduction in operating room availability. We chose a dedicated room equipped with an examination table, inside our institution. The procedures are conducted with the help of only one assistant nurse. Pulse oximetry, blood pressure, and heart frequency are monitored. Before surgery, the patient is carefully instructed on the necessity of laying still and reporting any change in hearing or balance. No sedation is administered. We slowly inject the ear canal with local anaesthesia and perform a trans-canal minimally-invasive stapedotomy using manual perforators under microscopic visualisation ⁹. After the stapedotomy is performed with an increasing diameter perforator and the prosthesis is crimped to the incus, we proceed to only remove the stapes head and not the entire superstructure. This allows us to avoid intra-operative bleeding which is often determined by the fracture of the anterior crus and can impair the surgical view. During stapes head removal, the force applied is equally distributed to the entire superstructure, reducing the possibility of luxation or fracture of the footplate. Given the effectiveness in terms of hearing results, low level of discomfort, and practicality experienced, we started collecting data for future publications.

Performing stapedoplasty without sedation in OBS means a significant reduction in pre- and post-operative times. On the other hand, the OBS approach could also be profitable for the surgeon, who can benefit from greater autonomy and control, decentralisation of care, optimising efficiency and flexibility, reducing costs (no anaesthesiologist needed, no storing of sedative drugs), and increasing reimbursement.

However, such an approach could prove to be a double edge sword. Caution is necessary, considering the limited resources immediately available in this setting. The surgeon must be proficient in the procedure to be carried out and prepared to deal with complications. Utilising mini-invasive techniques ⁹ could help in this regard. A crucial point to evaluate is ensuring the safety of the patient in a less protected environment, while also preserving the effectiveness of the procedure. Strict protocols in instrument disinfection have to be employed and choosing one instrument over another (e.g. manual perforator over skeeter-drill or carbon dioxide laser, endoscopy over microscopy, and so on) must be weighed on a logistical and patient-wise basis. Advanced obliterative otosclerosis with a thick footplate could represent an infrequent but not negligible limit for OBS stapedoplasty with a manual perforator. A large air-bone gap could be indicative of this condition. However, several studies have highlighted that the size of the air-bone gap does not reliably predict otosclerosis type (marginal, biscuit, obliterative) ¹⁰. Intra-operative evaluation remains the gold standard for the diagnosis. When obliterative otosclerosis is found during OBS stapedoplasty, it is advisable to switch to electric microdrill.

Intra-operative and immediate post-operative vertigo could represent a complication that prevents the discharge and invalidate an OBS approach. Removing only the stapes head could, as previously highlighted, minimise the risk of footplate luxation or fracture. Incus luxation and perilymphatic gusher are fearmongering possibilities that could discourage the inexperienced surgeon from engaging in OBS stapedoplasty. Adequate preparation and a safety net should be predisposed (e.g. the possibility of hospitalising the patient or consulting a senior surgeon).

The patient must be carefully selected: good cooperation, no anxiety disorders or other psychiatric illness, no tremor, and the ability to follow instructions are paramount. Clinical conditions must be evaluated and the American Society of Anesthesiologists (ASA) Physical Status Classification System can be used for risk stratification. We prefer to treat only ASA class I and II patients in an OBS, although this aspect remains debatable. Also, the risk related to local anaesthesia (e.g. anaphylaxis) remains; some patients can experience discomfort despite adequate local anaesthesia, and a sympathetic response can be elicited. It is important to thoroughly explain this matter to the patient and let him/her participate in the decision. Many subjects, motivated by fear of pain, are uncomfortable with even minor discomfort and directly demand sedation. Others will prefer the OBS option because it is less demanding in terms of time spent in the hospital. Appropriate counseling is essential.

In conclusion, OBS stapedoplasty without sedation may be a viable alternative to be explored in the future, considering its pros and cons.

Conflicts of interest statement

The authors declare no conflict of interest.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Author contributions

GM: conception, drafting, editing and final approval of the manuscript; BF, AT: editing of the manuscript; GDC: drafting of the manuscript; VC: drafting and editing of the manuscript; PM: conception and drafting of the manuscript. All Authors contributed to the article and approved the submitted version.

Ethical consideration

This is a letter to the editor containing a preliminary discussion on a new approach to stapedoplasty; no research and actual results are discussed here, therefore no ethical committee approval was necessary.

References

1. Giannoni B, Pollastri F, Adembri C. Hearing outcomes and patient satisfaction after stapes surgery: local versus general anaesthesia. Acta Otorhinolaryngol Ital. 2022; 42:471-480. DOI
2. Krauss B, Green SM. Procedural sedation and analgesia in children. Lancet. 2006; 367:766-780. DOI
3. Chari D, McKenna MJ. Awake stapedectomy. Oper Tech Otolaryngol Head Neck Surg. 2021; 32:130-135. DOI
4. Metzner J, Domino KB. Risks of anesthesia or sedation outside the operating room: the role of the anesthesia care provider. Curr Opin Anaesthesiol. 2010; 23:523-531. DOI
5. Prickett KK, Wise SK, DelGaudio JM. Cost analysis of office-based and operating room procedures in rhinology. Int Forum Allergy Rhinol. 2012; 2:207-211. DOI
6. Definizione e aggiornamento dei livelli essenziali di assistenza di cui all’articolo 1, comma 7, del decreto legislativo 30 dicembre 1992, n. 502. (17A02015).Publisher Full Text
7. Voizard B, Maniakas A, Saliba I. Office-based stapes surgery. Otolaryngol Head Neck Surg. 2019; 161:1018-1026. DOI
8. Shoman N. Pilot study assessing the feasibility and clinical outcomes of office-based ossiculoplasty. Ann Otol Rhinol Laryngol. 2019; 128:50-55. DOI
9. Malafronte G, Trusio A, Motta G. Stapedotomy removing only the stapes head and not the entire stapes superstructure: long-term results. Otol Neurotol. 2021; 42:E844-E848. DOI
10. Samimi-Ardestani H, Khorsandi-Ashtiani M, Ghoujeghi E. Prediction of stapes footplate thickness based on the level of hearing loss in otosclerosis. Ear Nose Throat J. 2012; 91:328-334.