10.14639/0392-100X-N1984
Objective. Our objective was to specify the indications and duration of effectiveness of Awake Patient Polyp Surgery (APPS) in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). Secondary objectives were to evaluate complications and Patient-Reported Experience (PREMs) and Outcome Measures (PROMs). Methods. We collected information regarding sex, age, comorbidities and treatments. Duration of effectiveness was the duration of non-recurrence defined by the time between APPS and a new treatment. Nasal Polyp Score (NPS) and Visual Analogic Scales (VAS, from 0/10 to 10/10) for nasal obstruction and olfactory disorders were assessed preoperatively and one month after surgery. PREMs were evaluated using a new tool: the APPS score.Results. Seventy-five patients were enrolled (SR = 3.1, mean age = 60.9 ± 12.3 years). 60% of patients had a previous history of sinus surgery, 90% had stage 4 NPS and more than 60% had overuse of systemic corticosteroids. Mean time of non-recurrence was 31.3 ± 2.3 months. We found a significant improvement (all p &lt; 0.001) for NPS (3.8 ± 0.4 vs 1.5 ± 0.6), VAS obstruction (9.5 ± 1.6 vs 0.9 ± 1.7) and VAS olfactory disorders (4.9 ± 0.2 vs 3.8 ± 1.7). Mean APPS score was 46.3 ± 5.5/50. Conclusions. APPS is a safe and efficient procedure in the management of CRSwNP.
text/xml
1827-675X
1984
en
Justin Michel
http://creativecommons.org/licenses/by-nc-nd/4.0
ACTA Otorhinolaryngologica Italica
local anesthesia
Surgical management of chronic rhinosinusitis with nasal polyps under local anaesthesia: indications and results
Text.Serial.Journal
https://www.actaitalica.it/
43
Rhinology
2023-02-27
2021-12-24
2023-02-28
2023-02-28
42-48
1
Justin Michel
2023/02/27
10.14639/0392-100X-N1984
42
Aix-Marseille Univ, APHM, IUSTI, CNRS, Department of Oto-Rhino-Laryngology and Head and Neck Surgery, La Conception University Hospital, Marseille Cedex, France
1827-675X
local anesthesia
en
48
Surgical management of chronic rhinosinusitis with nasal polyps under local anaesthesia: indications and results
https://www.actaitalica.it/article/download/1984/917
43
ACTA OTORHINOLARYNGOLOGICA ITALICA 2023;43:42-48; doi: 10.14639/0392-100X-N1984




Rhinology


Surgical management of chronic rhinosinusitis
with nasal polyps under local anaesthesia:
indications and results
Trattamento chirurgico in anestesia locale della rinosinusite cronica
con poliposi nasale: indicazioni e risultati
Clémence Mimari1*, Thomas Radulesco2*, Martin Penicaud1, Patrick Dessi1, Justin Michel2
1
  Aix-Marseille Univ, APHM, Department of Oto-Rhino-Laryngology and Head and Neck Surgery, La Conception University Hospital,
Marseille Cedex, France; 2 Aix-Marseille Univ, APHM, IUSTI, CNRS, Department of Oto-Rhino-Laryngology and Head and Neck
Surgery, La Conception University Hospital, Marseille Cedex, France
*
  C. Mimari and T. Radulesco contributed equally to this work.



SUMMARY
Objective. Our objective was to specify the indications and duration of effectiveness
of Awake Patient Polyp Surgery (APPS) in Chronic Rhinosinusitis with Nasal Polyps
(CRSwNP). Secondary objectives were to evaluate complications and Patient-Reported Ex-
perience (PREMs) and Outcome Measures (PROMs).
Methods. We collected information regarding sex, age, comorbidities and treatments. Dura-
tion of effectiveness was the duration of non-recurrence defined by the time between APPS
and a new treatment. Nasal Polyp Score (NPS) and Visual Analogic Scales (VAS, from 0/10
to 10/10) for nasal obstruction and olfactory disorders were assessed preoperatively and one
month after surgery. PREMs were evaluated using a new tool: the APPS score.
Results. Seventy-five patients were enrolled (SR = 3.1, mean age = 60.9 ± 12.3 years).
60% of patients had a previous history of sinus surgery, 90% had stage 4 NPS and more
than 60% had overuse of systemic corticosteroids. Mean time of non-recurrence was                   Received: January 13, 2022
31.3 ± 2.3 months. We found a significant improvement (all p < 0.001) for NPS (3.8 ± 0.4 vs         Accepted: September 19, 2022
1.5 ± 0.6), VAS obstruction (9.5 ± 1.6 vs 0.9 ± 1.7) and VAS olfactory disorders (4.9 ± 0.2
vs 3.8 ± 1.7). Mean APPS score was 46.3 ± 5.5/50.                                                   Correspondence
Conclusions. APPS is a safe and efficient procedure in the management of CRSwNP.                    Thomas Radulesco
                                                                                                    Department of Oto-Rhino-Laryngology and Head
KEY WORDS: sinusitis, nasal polyps, endoscopic sinus surgery, inflammatory nasal                    and Neck Surgery, La Conception University Ho-
disease, local anesthesia                                                                           spital, 147 Bd Baille, 13005 Marseille, France
                                                                                                    Tel +33 491435858. Fax +33 491435810
RIASSUNTO                                                                                           E-mail: thomas.radulesco@ap-hm.fr
Obiettivo. Descrivere indicazioni e risultati dell’intervento di polipectomia nasosinusale in
anestesia locale (APPS) in pazienti con rinosinutite cronica polipoide (CRSwNP). Obietti-             How to cite this article: Mimari C, Radulesco
vo secondario è la valutazione delle complicanze post-operatorie, dell’esperienza soggetti-           T, Penicaud M, et al. Surgical management of
va del paziente (PREMs) e la misurazione dell’outcome terapeutico (PROMs).                            chronic rhinosinusitis with nasal polyps under
Metodi. L’efficacia del trattamento è stata definita come intervallo di tempo in assenza di           local anaesthesia: indications and results. Acta
recidiva, stimato come il tempo tra due trattamenti successivi. La clinica è stata quantifica-        Otorhinolaryngol Ital 2023;43:42-48. https://
                                                                                                      doi.org/10.14639/0392-100X-N1984
ta applicando il Nasal Polyp Score (NPS) e la Visual Analogic Scales (VAS) per ostruzione
nasale e disturbi olfattivi, valutati prima e un mese dopo la procedura. La PREM è stata
                                                                                                    © Società Italiana di Otorinolaringoiatria
valutata utilizzando un nuovo strumento: l’APPS score.                                              e Chirurgia Cervico-Facciale
Risultati. Sono stati inclusi 75 pazienti. Il tempo medio in assenza di recidiva è stato di
31,3 ± 2,3 mesi. In seguito ad APPS sono stati documentati miglioramenti significativi
                                                                                                                   OPEN ACCESS
(p < 0,001) per NPS (3,8 ± 0,4 vs 1,5 ± 0,6), VAS per ostruzione nasale (9,5 ± 1,6 vs 0,9 ± 1,7),
VAS per disturbi olfattivi (4,9 ± 0,2 vs 3,8 ± 1,7). L’APPS score medio è stato di 46,3 ± 5,5/50.   This is an open access article distributed in accordance with
                                                                                                    the CC-BY-NC-ND (Creative Commons Attribution-Non-
Conclusioni. APPS si è rivelata essere una procedura sicura ed efficace nel trattamento             Commercial-NoDerivatives 4.0 International) license. The
della CRSwNP.                                                                                       article can be used by giving appropriate credit and mentio-
                                                                                                    ning the license, but only for non-commercial purposes and
PAROLE CHIAVE: rinosinusite cronica, poliposi nasale, chirurgia endoscopica naso-                   only in the original version. For further information: https://
sinusale, patologia infiammatoria nasale, anestesia locale                                          creativecommons.org/licenses/by-nc-nd/4.0/deed.en




42
                                                                                                     Awake patient polyp surgery




Introduction                                                   the paranasal sinuses that were not opened during previous
                                                               operations. Posterior nasal packings were used to prevent
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is
                                                               inhalation only in case of significant intraoperative bleed-
a debilitating disease affecting 2.8-5.8% of the European
                                                               ing. Most of the time, posterior nasal packings were not
population and gives rise to significant impairment of pa-
                                                               needed as small amounts of bleeding were easily suctioned
tients’ health-related quality of life (HR-QOL) and inflated
                                                               by the microdebrider. Postoperative treatment included
public health costs 1. The first-line treatment of CRSwNP
                                                               large-volume nasal lavages, corticosteroid nasal sprays
combines local treatment with short courses of systemic
                                                               (400 micrograms a day) and antibiotic therapy (amoxicil-
corticosteroids that should not exceed 500 to 1000 mg per
                                                               lin-clavulanic acid for 7 days). No systemic corticosteroid
year to avoid short- and long-term side effects (osteoporo-
sis, diabetes, etc.) 2.                                        therapy was prescribed in any case.
When medical treatments are insufficient, the practitioner
should consider surgery. Severe CRSwNP may involve             Data collection
repeated endoscopic sinus surgeries (ESS). Usually, such       Data collection was carried out by consulting patients’
surgeries require general anaesthesia (GA), which can be       medical records, during follow-up consultations, or through
unsafe for vulnerable patients and professionally disabling    teleconsultation due to the current SARS-CoV-2 pandemic.
for young and active patients. This has led to the develop-    We collected information regarding sex, age, comorbidities
ment in recent years of ESS performed under local anaes-       [asthma, aspirin-exacerbated respiratory disease (AERD),
thesia, also called Awake Patient Polyp Surgery (APPS) in      diabetes, cardiovascular diseases, chronic obstructive pul-
our centre. Increasingly practiced in Northern America and     monary disease (COPD), etc.], treatments and doses of cor-
the UK, APPS appears to be beneficial from a cost per-         ticoid therapies, history of nasal surgery with type and date
spective, especially for office-based surgeries 3. However,    and eosinophil levels. We also analysed the nasal polyp
to date, few studies have investigated the indications and     score (NPS) (range: 0/4 to 4/4 for each side) preoperatively
duration of effectiveness of APPS in CRSwNP 4.                 and one month after surgery.
The main objective of this study was thus to clarify the in-
dications and duration of effectiveness of APPS in patients    Main outcome measurement
with CRSwNP. Secondary objectives were to evaluate             By studying the population’s characteristics, we were able
Patient-Reported Experience Measures (PREMs), Patient-         to determine APPS indications and factors influencing the
Reported Outcome Measures (PROMs) and APPS compli-             duration of effectiveness. The duration of effectiveness was
cations.                                                       the duration of non-recurrence defined by the time between
                                                               APPS and the need for a new treatment. A new (systemic
Materials and methods                                          corticosteroid therapy or surgery) treatment was proposed
                                                               if patients complained of nasal symptoms in association
                                                               with polyp recurrence observed at endoscopic examination
Inclusion and exclusion criteria                               (NPS > 2 for each side). In patients with no recurrence of
All adult patients operated on in our centre for CRSwNP        nasal symptoms, the duration of effectiveness was, at least,
under local anaesthesia between February 2018 and March        the time between APPS and the date of the last medical
2021 were included. Non-inclusion criterion was age under      consultation.
18 years.
                                                               Secondary outcome measurement
Description of the Awake Patient Polyp Surgery (APPS)
procedure                                                      PREMs and PROMs
Preoperatively, the patient was received at the hospital by    PREMs are measures usually carried out using a self-re-
the nursing team and escorted to the operating room for        ported questionnaire to assess patients’ feelings or experi-
local anaesthesia. Patients received no premedication and      ences related to a treatment. As no specific tool is reported
were placed in a semi-seated position to limit the risk of     in the literature, we evaluated PREMs by means of a new
inhalation. Local anaesthesia was performed by dabbing         questionnaire, the APPS (Awake Patient Sinus Surgery)
the nasal cavities with cotton-wool soaked in naphazoline      score (Tab. I). The questionnaire included 10 questions
with xylocaine for 10 minutes. No infiltration of vasocon-     (Likert scale from 1 to 5) assessing the patients’ experience
strictor was performed. Using a microdebrider (Medtronic®      before, during and after APPS. APPS scores ranged from
2.9 mm blade, Dublin, Ireland) connected to a suction tube,    10 to 50. The higher the score, the better the outcome.
the surgery consisted in polyp removal, without opening        PROMs were analysed preoperatively and at one month



                                                                                                                            43
C. Mimari et al.




Table I. Awake Patient Polyp Surgery (APPS) questionnaire.
                                                                    APPS questionnaire
                           Please indicate your level of agreement with each of the following statements using the following scale:
 •    Strongly disagree
 •    Disagree
 •    Neither disagree nor agree
 •    Agree
 •    Totally agree
 Before APPS                               During APPS                                            After APPS
 1) I was reassured to be operated on      2) I did not feel pain during the procedure            6) I did not feel pain after the procedure
     under local anesthesia                3) I did not feel stress or anxiety during the         7) I feel an improvement in my nasal obstruction
                                               procedure                                          8) I would recommend this procedure rather than
                                           4) I tolerated the procedure well                          procedures under general anesthesia
                                           5) I was able to tolerate the intervention until the   9) If I should undergo another surgery, I would opt for
                                               end                                                    APPS rather than procedures under general anesthesia
                                                                                                  10) I am overall satisfied with my experience of APPS



postoperatively using Visual Analogic Scales (from 0/10 to                       Main outcome measurements
10/10) for nasal obstruction and olfactory disorders. The                        The main characteristics of the population are reported in
higher the score, the lower the outcome.                                         Table II. APPS is mainly indicated in patients with severe
                                                                                 and difficult-to-treat CRSwNP combined with high corti-
Complications
                                                                                 costeroid use. Most patients (92%) used daily nasal lavages
Major complications included nasal bleeding requiring
re-hospitalisation or revision surgery, intraoperative blood                     and corticosteroid nasal sprays, while only 2.7% used nasal
inhalation, orbital breach or haematoma, CSF leak or the                         lavages alone.
need to stop surgery. Minor complications were postopera-
tive nasal bleeding requiring nasal packing, postoperative                       Duration of effectiveness (Fig. 1)
pain and infections requiring prolonged antibiotic therapy.                      Mean time to nonrecurrence was 31.3 ± 2.38 months.
                                                                                 Sixty-six percent of patients were recurrence-free at 36
Statistics                                                                       months after APPS. History of asthma and ESS were asso-
Statistical analyses were performed using SPSS software.                         ciated with a lower duration of effectiveness (26.88 ± 3.37
The paired series involved a comparison test used to assess                      vs 33.38 ± 1.97 and 27.22 ± 3.24 vs 31.84 ± 2.11 months,
duration of effectiveness, pre- and postoperative differences                    p = 0.04 and p = 0.017, respectively).
in nasal obstruction VAS, olfactory disorders VAS and pre-                       We found a significant improvement between pre- and post-
and postoperative differences in NPS. The significance level                     operative NPS (3.87 ± 0.45 vs 1.59 ± 0.66; p < 0.001). The
was set at 0.05 for all analyses. The highest NPS from both                      difference between pre- and postoperative NPS was sig-
the right and left nasal fossae was used for statistical analy-                  nificantly greater in surgery-naïve patients (p < 0.05) and
ses. Student’s mean comparison test was used to evaluate the                     those with more severe polyposis (preoperative NPS = 4/4,
influence of factors potentially affecting our results. Gender,                  p = 0.006).
asthma or AERD, history and number of sinus surgeries, pre-
operative NPS, hypereosinophilia, cardiovascular history and                     Secondary outcome measurements
diabetes were tested. Survival analysis was performed using
the Kaplan-Meier method to determine non-recurrence. The                         PREMs
log-rank test was performed to evaluate the influence of fac-                    The APPS questionnaire was analysed in 59 patients
tors potentially affecting recurrence.                                           (Fig. 2). The mean APPS score was 46.37/50 ± 5.54. 84.7%
                                                                                 of the patients were reassured about being operated on
                                                                                 without GA. The procedure was well tolerated in 88.1%
Results                                                                          of cases. 91.5% of patients did not experience any postop-
Seventy-five patients were included in our study (male to                        erative pain and would prefer APPS if they had to undergo
female ratio = 3.1). Two patients were lost to follow-up.                        another surgery. Two items, intraoperative pain and stress,
The duration of follow-up ranged from 1 to 41 months. The                        showed slightly lower satisfaction rates. The mean score in
percentage of patients with a minimum follow-up of 36                            response to the statement “I did not feel any pain during the
months was 82.2%.                                                                procedure” was 4.27/5 and the mean score regarding the



44
                                                                                                                       Awake patient polyp surgery




                                                                                  statement “I did not feel any stress or anxiety during the
                                                                                  procedure” was 4.32/5, whereas mean scores to other ques-
                                                                                  tions ranged from 4.70 to 4.83/5. No factor studied herein
                                                                                  influenced the APPS score.
                                                                                  PROMs
                                                                                  Nasal obstruction VAS was significantly improved after
                                                                                  APPS (9.51 ± 1.68 vs. 0.97 ± 1.79; p < 0.001). Patients with
                                                                                  a history of polypectomy without previous ethmoidectomy
                                                                                  had significantly better improvement than patients with a
                                                                                  history of ethmoidectomy (-9.09 ± 1.04 vs -7.87 ± 2.96;
                                                                                  p = 0.05).
                                                                                  Olfactory disorders VAS was significantly improved after
                                                                                  APPS (4.96 ± 0.26 vs 3.86 ± 1.76; p < 0.001). AERD, dia-
                                                                                  betes, hypereosinophilia, and high preoperative NPS were
                                                                                  associated with poorer smell recovery (all p < 0.01).
                                                                                  Complications
Figure 1. Kaplan-Meier curve of non-recurrence after APPS. X-axis repre-
sents the number of months of postoperative follow-up. Y-axis represents the
                                                                                  No procedure had to be stopped early. Sixty-two patients
percentage of non-recurrence. Each step corresponds to a recurrence, each         (82.67%) had no complications. Two patients (2.67%) had
vertical line corresponds to a last news date.                                    major complications (one blood inhalation only requir-




Figure 2. Graphical presentation of mean APPS score. Values range from 3.9 to 4.9/5 for better visibility.



                                                                                                                                              45
C. Mimari et al.




ing monitoring (1 night stay and discharge) and one nasal          Table II. Patient characteristics.
bleeding requiring rehospitalisation).                                                                            Number (%)
Eight patients had minor complications (10.6%). Seven               Male/Female                      56 (74.7%)                 19 (25.3%)
(9.3%) had local superinfection requiring bacteriological           Asthma                                         35 (46.7%)
sampling and a new antibiotic therapy. One (1.33%) had a            AERD                                           20 (26.7%)
vagal malaise.                                                      Previous sinus surgery                          45 (60%)
                                                                    Diabetes                                         6 (8%)
Discussion                                                          Cardiovascular                                  27 (36%)
                                                                    diseases
New findings
                                                                    Chronic obstructive                              3 (4%)
The objective of this study was to clarify APPS indications         Pulmonary disease
and duration of effectiveness in CRSwNP. Our study in-              Anti-coagulant therapy                          3 (4%)
cluded 60% of patients with a prior history of surgery and/         Antiplatelet therapy                          10 (13.3%)
or excessive systemic use of corticosteroids (Tab. II). APPS        Hypereosinophilia               18 (24%)      20 (26.7%)      37 (49.3%)
was safe with a mean duration of effectiveness greater than         Y/N/not tested
2 years and a satisfactory patient experience. Recurrence           Preoperative NPS                      1                       1 (1.33%)
rates were comparable to surgeries performed under GA,              (Highest score of both                2                            0
although our population included patients with poor prog-           nasal cavities)
                                                                                                          3                       7 (9.33%)
nosis. These new data argue in favour of full integration of                                              4                     67 (89.33%)
APPS in the management of CRSwNP. As a reliable pro-                Number of previous                    0                       30 (40%)
cedure, APPS could be an alternative to systemic corticos-          ESS                                   1                      17 (22.7%)
teroid therapy, whose overuse can be harmful to patients.
                                                                                                          2                      16 (21.3%)
                                                                                                          3                       4 (5.3%)
Comparison with literature data
                                                                                                          4                        3 (4%)
Like most studies in the literature, we reported a pre-
                                                                                                          5                       4 (5.3%)
dominance of males and a strong association with asthma
(46.7%) 5. However, our population was 10 to 20 years old-                                            6 or more                   1 (1.3%)
er, probably because APPS is usually performed in frail pa-         Yearly SCT (1 mg/kg):            29 (38.7%)                 46 (61.3%)
                                                                    ≤ 2 week/year / > 2
tients for whom GA would be contraindicated (e.g. cystic            week/year
fibrosis). Compared with the literature, our population had        AERD: Aspirin Exacerbated Respiratory Disease; NPS: Nasal Polyp Score; ESS: Endo-
higher rates of ESS (60% vs 30% to 50%) 6 and AERD his-            scopic Sinus Surgery; SCT: Systemic Corticosteroid Therapy.
tory (26.7% vs 10% to 15%) 7,8. In addition, we observed
a very high use of systemic corticosteroids. These points          obtained with the usual procedures under GA (-1.1/10 vs
reflect the severe and difficult-to-treat condition of patients    -3.31/10) 14. AERD, hypereosinophilia, high preoperative
included in this study. Indeed, a history of ESS, asthma and       NPS and diabetes were associated with poorer recovery of
AERD have been shown to be risk factors for earlier recur-
                                                                   smell, in agreement with the literature 15.
rence 9.
                                                                   APPS appeared to be safe since the major complication rate
Despite this, we reported a mean duration of effectiveness
                                                                   (2.67%) was substantially lower than rates reported for sur-
of approximately 2.5 years. This finding could be underes-
                                                                   gery under GA (12.5 to 20%) 9.
timated given the limited follow-up of the study. A prospec-
tive study with a longer follow-up would allow more accu-
rate results. In the literature, recurrence rates one year after   Patient-related experience
ESS under GA range from 20 to 80% 10,11. Hopkins et al.            One of the strengths of our study lies in the analysis of
reported 11% of surgical revisions 36 months after ESS 12.         PREMs 16. Our questionnaire showed a high degree of
Other authors have shown 78.9% of recurrences within 12            satisfaction since more than 90% of patients expressed a
years with 36.8% of patients requiring revision surgery 11,13.     preference for APPS over GA if they had to be re-oper-
The improvement of olfactory disorders could be surpris-           ated on. Anxiety and intraoperative pain were the main
ing because APPS does not always clear ethmoidal cor-              patient concerns. In future, these findings could be further
ridors and olfactory clefts and postoperative treatment in         improved by optimising the logistics of surrounding sur-
our protocol does not include systemic corticosteroids.            gery, especially with the development of an office-surgery
However, this improvement remained inferior to results             department providing relaxing activities (hypnotherapy,



46
                                                                                                                   Awake patient polyp surgery




virtual reality headsets, relaxing music) and analgesic and       Ethical consideration
anxiolytic premedication. Many studies have shown the             This study was approved by the Institutional Ethics Com-
benefits of using such tools during APPS 17. In our ex-           mittee (Assistance Publique des Hôpitaux de Marseille)
perience, it is rare that patients refuse APPS and prefer         (protocol n. 2021-15).
surgery under GA.                                                 The research was conducted ethically, with all study pro-
                                                                  cedures being performed in accordance with the require-
Financial considerations                                          ments of the World Medical Association’s Declaration of
In Europe, the annual cost of managing a patient with severe      Helsinki.
CRSwNP is € 1570 18. The literature has shown the economic        Written informed consent was obtained from each partici-
interest of office-surgery 19. In our department, the estimated   pant/patient for study participation and data publication.
cost of an APPS procedure is €876. Given its long-lasting
effectiveness, APPS is therefore less expensive compared          References
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