A prospective, non-randomized evaluation of a novel low energy radiofrequency treatment for nasal obstruction and snoring

Abstract

Background
Weak or inward-bent cartilage of the nasal sidewall at the level of the internal nasal valve (INV) can produce narrowness or collapse of the nasal valve. This is a common cause of impaired nasal breathing during daily activities and there is also an established connection between nasal obstruction and snoring. The condition is often difficult to treat, although even a small enlargement of the lumen at the nasal valve can lead to a significant improvement in the ease of nasal breathing.

Methods
The primary objective of this prospective study was to evaluate the safety and efficacy of the Vivaer system for the treatment of narrowed nasal valves and to measure changes in the symptoms of nasal obstruction and snoring. The Vivaer system uses low energy radiofrequency to remodel the nasal sidewall in order to improve airflow.

Results
The study involved 31 patients presenting from 1st September 2017 to 1st May 2018 with symptoms of nasal obstruction and snoring. In all patients, an improvement was observed in nasal breathing measured by NOSE score, sleep quality by SOS questionnaire and quality of life as measured by EQ-5D and SNOT-22.

Conclusion
Vivaer intranasal remodeling can provide a durable and well-tolerated non-invasive treatment for those patients who are suffering congestion due to narrowness or collapse of the INV.

Full text

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European Archives of Oto-Rhino-Laryngology (2019) 276:1039–1047
https://doi.org/10.1007/s00405-018-05270-y
RHINOLOGY
A prospective, non-randomized evaluation ofanovel low energy
radiofrequency treatment fornasal obstruction andsnoring
DetlefBrehmer1,2,3 · RobertBodlaj4· FriedemannGerhards5
Received: 14 October 2018 / Accepted: 24 December 2018 / Published online: 3 January 2019
© The Author(s) 2019
Abstract
Background Weak or inward-bent cartilage of the nasal sidewall at the level of the internal nasal valve (INV) can produce
narrowness or collapse of the nasal valve. This is a common cause of impaired nasal breathing during daily activities and
there is also an established connection between nasal obstruction and snoring. The condition is often difficult to treat, although
even a small enlargement of the lumen at the nasal valve can lead to a significant improvement in the ease of nasal breathing.
Methods The primary objective of this prospective study was to evaluate the safety and efficacy of the Vivaer system for the
treatment of narrowed nasal valves and to measure changes in the symptoms of nasal obstruction and snoring. The Vivaer
system uses low energy radiofrequency to remodel the nasal sidewall in order to improve airflow.
Results The study involved 31 patients presenting from 1st September 2017 to 1st May 2018 with symptoms of nasal obstruc-
tion and snoring. In all patients, an improvement was observed in nasal breathing measured by NOSE score, sleep quality
by SOS questionnaire and quality of life as measured by EQ-5D and SNOT-22.
Conclusion Vivaer intranasal remodeling can provide a durable and well-tolerated non-invasive treatment for those patients
who are suffering congestion due to narrowness or collapse of the INV.
Keywords Nasal valve· Radiofrequency therapy· Snoring· Nose score
Introduction
Impaired nasal breathing is a common reason for patients’
consultations to the ENT physician and is considered by
those affected to cause significant reduction in their quality
of life [1]. Habitual snoring can have an incidence of up
to 50% and can be a serious social problem for the patient
and the bed partner [2]. Amongst anatomical causes, septal
deviation plays an important role in many patients. Even
so, a combined septoplasty with turbinate reduction does
not always provide a complete solution to the problem. The
most frequent cause of septoplasty failure is closely related
to the nasal valve [3].
The Vivaer intranasal remodeling treatment is a mini-
mally invasive procedure and uses a stylus to deliver con-
trolled and targeted low energy radiofrequency heating
to the nasal sidewall to gently reshape the tissues. Unlike
most established treatments, it is an outpatient intervention
administered under local anesthesia.
In this study, we aim to investigate the effect of using
isolated intranasal remodeling of the INV on measures of
nasal breathing and snoring.
Materials andmethods
Participants andsetting
This study was a prospective, uncontrolled open-label
bicenter trial which was conducted from September, 2017
* Detlef Brehmer
dr.d.brehmer@t-online.de
1 Faculty ofMedicine, University Witten / Herdecke,
Alfred-Herrhausen-Straße 50, 58455Witten, Germany
2 Department ofElectrical Engineering andApplied Natural
Sciences, Westphalian University ofApplied Sciences,
Neidenburger Str. 43, 45897Gelsenkirchen, Germany
3 Department ofOtorhinolaryngology, Private ENT Practice,
Friedrichstr. 3/4, 37073Goettingen, Germany
4 ENT Practice Lichtenfels, Bamberger Straße 7,
96215Lichtenfels, Germany
5 Center forPsychobiological andPsychosomatic Research,
Trier University, Johanniterufer 15, 54290Trier, Germany
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1040 European Archives of Oto-Rhino-Laryngology (2019) 276:1039–1047
1 3
to June, 2018 in ENT practice Göttingen and ENT practice
Lichtenfels. The flowchart diagram demonstrates the study
design (Fig.1).
Thirty-four patients reporting snoring during sleep due
to nasal obstruction or problems breathing through the nose
were prospectively recruited for low energy radiofrequency
remodeling treatment of the nasal valve.
The assessments by means of the questionnaires listed
below and the WatchPAT200 device were conducted at study
enrollment (measurement time point t1) as well as 90 days
after the radiofrequency treatment (measurement time point
t3). Thirty days after the treatment (measurement time point
t2) patients filled in the two questionnaires measuring nasal
obstruction and snoring (NOSE, SOS). The treatment was
conducted within 30 days after the study enrollment. The
patients´ satisfaction with the treatment was assessed 90
days after the intervention by means of a 10-point Likert
scale (1 = completely dissatisfied; 10 = very satisfied).
At study enrollment, several inclusion and exclusion
criteria were used. The inclusion criteria for a patient to
participate were: (a) age, 18–60 years; (b) a chronically per-
sistent nasal obstruction documented in the patient record;
(c) a positive reaction to a minimum of two of four diagnos-
tic tests for nasal obstruction at the INV (1. application of
Fig. 1 Schematic diagram
summarizing the study design.
WatchPAT200: wrist-worn
device measuring peripheral
arterial tone. NOSE nasal
obstruction symptom evaluation
scale, LOCF last observation
carried forward
Assessed for degree of sleep disordered
breathing, snoring, nasal on, sinonasal
health problems, generic health related quality
of life (by means of WatchPAT 200 as well as
• Age 18-60
• Chro
(documented in the pa )
• NOSE score >30
l on
Excluded (n=3)
cipate (n=2)
• Not ion
criteria (n=1)
Treated with radiofrequency remodeling of the
nasal airway in twoENT es within 30 days
ment (n=31)
Assessed for degree of sleep disordered
breathing, snoring, nasal on, sinonasal
health problems, generic health related quality
of life (by means of WatchPAT 200 and
Dropped out po atment
assessment A, but kept for
analysis applying the LOCF
method (n=1)
Assessed for degree of sleep disordered
breathing, snoring, nasal on, sinonasal
health problems, generic health related quality
of life (by means of WatchPAT 200 and
Analysed nonparametrically with respect to a
pre-post change concerning sleep
disordered breathing, snoring, nasal
on, sinonasal health problems, and
generic health related quality of life only in case
the individual database was valid (n=25 to n=31)
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1041European Archives of Oto-Rhino-Laryngology (2019) 276:1039–1047
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dilatative nasal strips like breathe right; 2. modified Cottle
test using a Q-tip; 3. use of nasal stents; 4. Cottle test); (d)
a minimum score of 30 in the Nasal Obstruction Symptom
Evaluation (NOSE) Scale. The NOSE survey consists of five
items assessing problems associated with or resulting from
nasal obstruction [4]. A NOSE score of 30 is most appropri-
ate to differentiate patients with and without nasal obstruc-
tion and is indicative of at least a moderate (instead of only
mild) severity of nasal obstruction according to findings of
Lipan and Most [5].
Patients were excluded if they (a) had a prior surgery
of the nasal valve; (b) snored due to an abnormal anatomy
of the palate, uvula or tonsil function; (c) had a body mass
index, ≥ 40kg/m2.
N = 3 patients were excluded due to ‘Not meeting inclu-
sion criteria’ or ‘Declined to participate’. Therefore, 31 par-
ticipants (17 females, 14 males) were included in the study.
Their mean age was 42.84years (SD = 11.27; range 24–64)
and their mean BMI was 26.18 (SD = 4.30; range 20–38).
The study was carried out according to the principles
stated in the 1964 Declaration of Helsinki and its later
amendments. The study was approved by the Ethics Com-
mission at the University of Witten/Herdecke, Germany.
Once written patient consent was obtained patients received
a standardized nasal examination (see above) and endoscopy
and paper preoperative questionnaires. In each study center,
a study nurse was in charge of the data collection.
Evaluation oftreatment success bymeans ofdata
fromquestionnaires andsleep studies
For an evaluation of treatment success, we used question-
naires as well as data from sleep studies (see below). Assess-
ments for the evaluation were conducted at study enrollment
(measurement time point t1) as well as 30 and 90 days after
the radiofrequency treatment (post-treatment time points t2
and t3). Patients were discharged from the study after they
had participated in the last posttreatment assessments (t3).
The questionnaires used assess problems associated with
or resulting from nasal obstruction and snoring, sinonasal
health problems, and generic health-related quality of life.
To incorporate only valid information, a sum or mean ques-
tionnaire score was calculated only if at least 75% of the
items of a questionnaire had been answered.
For the assessment of subjective nasal airway obstruction,
we used the NOSE which has been shown to be a valid and
reliable instrument [4]. The NOSE survey has been con-
structed especially for the use in outcome studies in adults
with nasal obstruction [4]. Each of the NOSE items is scored
using a 5-point Likert scale to make a total score range of 0
through 100. Higher scores indicate worse obstruction. Stud-
ies reporting outcomes using the NOSE scale often demon-
strate improvement after surgical treatment [6].
To assess subjective snoring severity, we selected four
items (#1, #3, #7, #8) from the Snore Outcomes Survey
(SOS) developed by Gliklich and Wang [7] with the inten-
tion to measure snoring and sleep-disordered breathing. The
selected items focus on (a) the amount of sleeping time spent
snoring; (b) the extent of awakening due to snoring and/or
sleepiness due to poor sleep; and (c) the sound intensity of
snoring. In case a patient answered a question with “I don’t
know” the answer was rated as “missing”. Answers were
coded from 0 (lowest degree of severity) to 3 or 4 (highest
degree of severity) depending on the number of response
levels per item. By dividing the achieved severity score by
the maximal score and by multiplying this division by 100,
all answers were transformed into a uniform response format
with scores ranging from 0 to 100. We checked the reliability
of our instrument on the basis of the data from this study
(see Data Analyses and Results).
As a measure of health-related quality of life that was
constructed specifically for patients with sinonasal health
problems, we used the SNOT-20-GAV [8–10]. This instru-
ment is a further German development (GAV = German
Adapted Version) of the Sino-Nasal Outcome Test 20 con-
structed by Piccirilo etal. [11]. The SNOT-20-GAV proved
to be valid and reliable, it allows for the calculation of a total
score (TS) as well as of subscale scores representing pri-
mary nasal symptoms (PNS), secondary rhinogenic symp-
toms (SRS) and quality of life in general (QLG). Each score
ranges from 0 to 100, higher scores indicate worse health or
quality of health.
Generic quality of life was furthermore assessed by
means of the EQ-5D. This instrument was designed by the
EuroQoL group [12], it consists of a visual analog scale and
five items (concerning mobility, self-care, usual activities,
pain/discomfort and anxiety/depression) with five response
levels each. With regard to the evaluation of the five items,
we applied a method presented by Hinz etal. who calculated
an individual crude sum score that was transformed into a
score ranging from 0 to 100 indicating low-to-high quality of
life [12]. Hinz etal. showed that this simple form of evalu-
ation yielded values that were highly correlated (r = 0.93)
with those of the far more complex conventional measure-
ment [13].
The NOSE and the selected SOS items were administered
at all three assessment time points, the remaining question-
naires were filled in by the patients at time points t1and t3
(see Fig.1).
At study enrollment (time point t1) as well as 90 days
after the treatment (time point t3), every patient participated
in a home sleep study making use of the portable wrist-
worn diagnostic device WatchPat200 (Itamar Medical Ltd,
3579 Caesarea, Israel). This device measures pulse oxime-
try and peripheral arterial tone (PAT) and allows for a reli-
able assessment of relevant indicators of sleep-disordered
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1042 European Archives of Oto-Rhino-Laryngology (2019) 276:1039–1047
1 3
breathing. Different studies show a high correlation of
results from simultaneous recordings of WatchPAT200
and polysomnography [14, 15]. The WatchPat 200 is FDA-
approved and has a Conformitè Europeene (CE) mark. As a
central parameter of sleep-disordered breathing, we deter-
mined the Apnea–Hypopnoea Index (AHI). We furthermore
used the WatchPAT to assess the snoring volume by means
of its integrated acoustic decibel detector and determined the
mean snoring volume during sleep as well as the percent-
age of sleeping time spent snoring with an intensity above
45dB.
One patient dropped out after the assessment at time point
t2. For the purpose of our data analyses, the missing data
of this patient concerning the measurement 90 days after
treatment (t3) were filled in according to the LOCF-method
(LOCF: last observation carried forward).
Procedural technique
The treatment was conducted within 30 days after the study
enrollment. All procedures were performed by two of the
three authors (DB and RB), one surgeon per patient was
involved. And neither of them participated in the collection
of the questionnaires.
The nasal valve regions of all patients were treated bilat-
erally on an outpatient basis under local anesthesia using
a handheld single-use device, the Vivaer™ stylus (Aerin
Medical Inc. Sunnyvale, CA 94089 USA). The device con-
sists of a handle, shaft and treatment tip and is designed
to be used with the Aerin console to deliver temperature
controlled, low energy radiofrequency to the target tissue
(Fig.2). An array of bipolar electrodes at the treatment tip
is designed to deform the nasal valve into a curve whilst
delivering bipolar energy into the tissue (Fig.3). A tempera-
ture sensor at the tip ensures a constant, low temperature
is maintained through the treatment. The device has been
awarded a Conformité Européene (CE) mark and thus meets
the requirements of the EU guidelines on health and safety.
The treatment criteria used were: temperature 60°C,
maximum power 4W, treatment duration 18s, and cooling
time 12s. After the application of a submucosal local anes-
thetic along the scrolling edge of the upper lateral cartilage
of both nasal valve regions, the treatment tip of the stylus
was inserted into the nostril and pressed against the mucosa
of the caudal region of the ULC. The surgeon administered
the 30s treatment, whilst deflecting the nasal wall later-
ally. This procedure was carried out 3 (maximum 4) times
Fig. 2 The RF remodeling platform
Fig. 3 Handpiece treatment device
Fig. 4 Treatment points
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1043European Archives of Oto-Rhino-Laryngology (2019) 276:1039–1047
1 3
per nostril on adjacent areas of tissue at the ULC (Fig.4).
No special post-treatment actions were performed although
patients were instructed to refrain from any manipulation of
the treatment area.
The follow-up phase began after the procedure. Patients
underwent post treatment visits with completion of the ques-
tionnaires after 30 and 90 days (as usual for this procedure).
Requirements for each follow-up visit are listed in Table1.
Patients were discharged from the study on the 90day fol-
low-up visit.
Each patient´s satisfaction with the treatment was
assessed 90 days after the radiofrequency treatment by
means of a 10-point Likert scale (1 = completely dissatis-
fied; 10 = very satisfied).
Data analyses andresults
Data were analyzed using IBM SPSS Statistics, Version 23.0
(IBM SPSS Inc., Chicago, USA). The analysis of patients’
ratings of satisfaction with the treatment showed that nearly
76% of the sample submitted satisfaction ratings located in
the upper half of the Likert scale (range 6–10); the modal
value was 8 (median = 7). These results indicate a high level
of contentment with the radiofrequency treatment in ¾ of
the patients.
Because Shapiro–Wilk tests of normality showed that not
all dependent variables regarded as indicators of treatment
success were normally distributed at each measurement time
point we decided to analyze all data uniformly by Wilcoxon
signed-rank tests. This non-parametric way of data analysis
is recommended as the better choice in non-normal situa-
tions compared to Student’s t test, the power advantages of
which are small even under normal theory [16, 17].
First of all, we checked the reliability of our questionnaire
assessing snoring severity (selected SOS items) by the calcu-
lation of Cronbach’s alpha for each of the three measurement
time points. The α coefficients ranged from 0.81 to 0.90,
indicating a good internal consistency of our instrument.
We secondly analyzed whether patients’ answers to the
NOSE items and the selected SOS items at study enrollment
(t1) were different from their answers 30 days after radiofre-
quency treatment (t2). Our analyses revealed (see Table1)
that 1month after treatment there was a highly significant
(p < 0.000) reduction of problems associated with or result-
ing from nasal obstruction (NOSE) as well as of snoring and
problems due to snoring/poor sleep (SOS).
The comparison of the NOSE and SOS data collected at
study enrollment (t1) and 90 days after treatment (t3) showed
that 3months after surgery there was still a highly significant
reduction (p < 0.000; see Table2) of problems concerning
nasal obstruction and snoring. Figure5 shows the change
over time for both variables.
In addition to analyzing treatment success of the total
patient group, we determined the magnitude of long-term
nasal obstruction change in terms of percentage improve-
ment for patient subgroups with distinct pre-treatment nasal
obstruction severity levels. Lipan and Most [4] proposed
a severity classification system for nasal obstruction that
comprises four classes of severity: the obstruction severity
in patients who achieve a NOSE score of 5–25 is graded
“mild”, the grades above are labeled “moderate” (30–50),
“Severe” (55–75), and “extreme” (80–100). In our study, the
patients with an initial “moderate” nasal obstruction (n = 7)
showed a medium percentage of the NOSE score reduction
of 37.50% 3months after treatment (t3), those with an ini-
tial “severe” obstruction (n = 18) had a reduction of 37.86%.
Patients whose initial obstruction was graded “extreme”
(n = 6) presented with an improvement of 69.30%. We also
looked at improvement in terms of a patient´s potential
down-stepping to a lower nasal obstruction severity level.
Our cross-tabulation of severity classes at study enrollment
(t1) and 90 days after treatment (t3) did not show any class-
change over time in the negative direction. A continuance in
the same severity class was observed in n = 6 cases, whereas
a positive change of one grade was seen in n = 15 cases. The
remaining cases presented with a positive change of two
(n = 7) or even three (n = 3) grades. In 25 of 31 patients, i.e.,
in > 80%, there was an improvement.
Further Wilcoxon signed-rank tests of the patients’
answers at study enrollment (t1) and 90 days after treatment
(t3) concerning generic and sinonasal specific quality of life
(EQ-5D-5L, SNOT-20-GV) showed an at least significant
improvement for both dimensions (Table2). In contrast to
Table 1 Medium score (and interquartile range) for the Nasal
Obstruction Symptom Evaluation Scale (NOSE) and the Snore Out-
comes Survey (SOS; selected items) at study enrollment (t1) and 30
days after radiofrequency treatment (t2); sample size and significance
level of the Wilcoxon signed-rank test
Bold—Significance level p: probability that the difference between
the data collected at the measurement time points mentioned occured
randomly or by chance, but is instead attributed to the low energy
radiofrequency remodeling treatment (probabilty of error α)
Statistical comparisons by Wilcoxon signed-rank test; p significance
level (one-tailed) concerning the difference of scores at time points
t1 and t2
Mdn median, IQR interquartile range, N number of participants
t1t2N p (one-tailed)
Mdn (IQR) Mdn (IQR)
Nasal Obstruc-
tion Symtom
Evaluation Scale
(NOSE)
65.00 (21.25) 30.00 (35.00) 30 0.000
Snore Outcomes
Survey (SOS;
selected items)
66.67 (32.29) 47.92 (40.63) 25 0.000
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1044 European Archives of Oto-Rhino-Laryngology (2019) 276:1039–1047
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this there was no significant change over time for any of
those dependent variables that were assessed by means of
the WatchPAT200 (AHI, average snoring intensity, percent
of sleeping time with a snoring intensity > 45dB).
Additional analyses conducted separately for patients who
at study enrollment did not show any problems regarding
apneas or hypopneas during sleep (AHI < 5; n = 11) and
those showing at least a mild sleep-related breathing disor-
der (AHI ≥ 5; n = 20) did not result in findings different from
those reported for the total sample.
Table 2 Medium score (and interquartile range) for the Nasal
Obstruction Symptom Evaluation Scale (NOSE), the Snore Outcomes
Survey (SOS; selected items), the 20-Item Sino-Nasal Outcome Test,
German Adapted Version (SNOT-20 GAV), the EQ-5D-5L ques-
tionnaire and parameters of disordered breathing and snoring during
sleep assessed by the WatchPAT200 at study enrollment (t1) and 90
days after radiofrequency treatment (t3); sample size and significance
level of the Wilcoxon signed-rank test
Bold—Significance level p: probability that the difference between the data collected at the measurement time points mentioned occured ran-
domly or by chance, but is instead attributed to the low energy radiofrequency remodeling treatment (probabilty of error α)
Statistical comparisons by Wilcoxon signed-rank test; p significance level (one-tailed) concerning the difference of scores at time points t1 and t3
Mdn median, IQR interquartile range, N number of participants
t1t3N p (one-tailed)
Mdn (IQR) Mdn (IQR)
Nasal Obstruction Symtom Evaluation Scale (NOSE) 65.00 (20.00) 30.00 (25.00) 31 0.000
Snore Outcomes Survey (SOS; selected items) 66.67 (31.25) 41.67 (29.17) 27 0.000
20-Item Sino-Nasal Outcome Test, German Adapted Version (SNOT-20 GAV)
Total Score (TS) 30.00 (26.00) 19.00 (16.00) 31 0.000
Primary Nasal Symptoms (PNS) 32.00 (28.00) 20.00 (16.00) 31 0.000
Secondary Rhinogenic Symptoms (SRS) 20.00 (20.00) 10.00 (10.00) 31 0.000
Generic Quality of Life (GQL) 28.89 (28.89) 20.00 (24.44) 31 0.003
EuroQoL group questionnaire for generic quality of life (EQ-5D-5L)
Visual Analog Scale (VAS) 80.00 (22.50) 80.00 (21.00) 29 0.030
Sum Score (SS) 95.00 (20.00) 95.00 (10.00) 31 0.033
WatchPAT200
Apnea–Hypopnea Index (AHI) 8.21 (10.39) 8.15 (16.96) 31 0.197
Mean snoring intensity (dB) 41.00 (1.00) 41.00 (1.00) 30 0.497
Percent of sleeping time spent with a snoring intensity > 45 dB 2.25 (5.18) 2.45 (5.13) 30 0.237
Fig. 5 Development of nasal
obstruction and snoring: mean
(± SEM) of the NOSE and SOS
score at pre- and post-treatment
assessment time points. NOSE
Nasal Obstruction Symptom
Evaluation Scale, SOS Snore
Outcomes Survey (selected
items), RF radiofrequency
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1045European Archives of Oto-Rhino-Laryngology (2019) 276:1039–1047
1 3
Discussion
In this discussion, we will address several points, namely
• Defining the anatomy of the nasal valve.
• Interventions that address congestion at the nasal valve
and their relative efficacy.
• Whether snoring be reduced by nasal valve surgery.
• Using objective versus subjective measures of effect for
nasal congestion.
The inner nasal valve is bounded by the angle between
the caudal border of the upper lateral cartilages (ULC) and
dorsal septum. The external nasal valve extends from the
nasal entrance to the INV and is bounded by the alar rim,
the lower lateral cartilages (LLC), alar lobule and nasal sill
inferiorly [18, 19].
Physiologically, the INV is the narrowest part of the nose
and thus the location of the maximum air flow resistance.
According to Hagen–Poiseuille’s law, the volume of air-
flow is directly proportional to the pressure difference and
to the 4th power of the inner radius. This means that even
the smallest increase in the area of the INV results in large
reduction in the resistance of the nasal cavity and a notice-
able improvement in the nasal airflow.
When air flows through a narrowed region it accelerates
with a resulting reduction in pressure as described by the
Bernoulli principle. In an unstable nasal valve, this has the
effect of reducing or even closing the opening. Stabilizing
this region can reduce the Bernoulli effect and improve nasal
breathing.
Anomalies within the NVA are often responsible for
nasal obstructions. The importance of the angle between
the caudal boundary of the ULC and the nasal septum as a
fundamental feature of the INV is immortalized in the lit-
erature and remains a key concept in the planning of surgical
intervention. In fact, the NVA has a complex geometry and
needs to be examined thoroughly and objectively before any
INV surgery is proposed [20].
However, the fact that well-chosen surgical interventions
such as septoplasty, turbinate reduction and spreader grafts,
or combinations thereof, can improve nasal breathing is well
established. Rhee etal. [5] in a literature review of 20 het-
erogeneous publications involving 643 patients undergoing
various types of nasal surgery who were evaluated using
NOSE score showed that average improvements of − 42
points were achieved post surgery.
The Vivaer system works via the principle of using tar-
geted low-energy radiofrequency to heat and reshape the tis-
sues of INV to create more space in the nose. Wong etal.
were able to show in an experimental setting that it is pos-
sible to reshape cartilage with electrical energy and that this
treated cartilage also retains its new shape with no significant
weakening [21]. In a further study, they showed that it is
possible to achieve the same effect using electromagnetic
radiation without causing excessive heating of the tissues
[22]. Keefe at al. used RF-generated heat to reform porcine
nasal septal cartilage which retained its shape after 14 days
[23]. In addition, this group showed that chondrocytes in the
cartilage survive this form of RF reshaping. The prerequisites
for efficacy at tissue shaping with the preservation of cellu-
lar and structural integrity are the optimization of electrode
geometry, generator frequency, power and heating time.
The use of RF energy to stabilize the cartilage of the
INV is not without precedent: Seren successfully used low-
energy RF introduced to the ULC to stabilize the nasal valve
(Celon-ProBreath; Celon AG Medical Instruments, Berlin,
Germany) [24]. However, this procedure was more invasive
as the access to the cartilage was created by an incision and
the RF introduced via inserted probes with the incision closed
with a suture after the intervention. The improvement in
symptoms of nasal obstruction after treatment compared with
before treatment was evaluated using the visual analog scale
(VAS). Each of the 29 patients in this study showed a signifi-
cant improvement in the severity of obstruction scores in the
VAS 4 months after treatment. In another study, RF stabiliza-
tion therapy (n = 7) was compared with the Bone-Anchored
Suspension technique (BAST) (n = 6) for lateral nasal wall
collapse [25]. Both groups benefited from the treatment and
improved in NOSE score post-treatment compared pre-treat-
ment with no significant difference between the two groups.
The results of the present study also showed a significant
improvement in the NOSE score post-treatment vs. pre-treat-
ment in 80% of patients. In slightly more than one-third of
the cases, there was even an improvement of 2° or 3° of
severity in the NOSE score. The improvement in the NOSE
score by − 35 in median shown here is comparable to the
results generally achieved by more invasive surgical inter-
ventions as shown by Rhee even given the exacting nature
of the ITT analysis applied in this study [6].
A subanalysis of the improvement in the NOSE score indi-
cates that in general the Vivaer procedure showed the greatest
benefit to the more congested individuals. This is not unex-
pected given Hagen–Poiseuille’s law: those patients with the
narrowest INV will receive a proportionally greater benefit
with the addition of just a little extra space in the lumen.
The significant improvement in the snoring and sleep-
related SOS questionnaire is also reflected elsewhere in the
literature albeit that the evidence is less clear cut. Although
Virkkula etal. showed no effect of nose surgery on snoring
[26], other observational studies have shown that nasal con-
gestion has a considerable impact on snoring and daytime
sleepiness [27]. Similarly, Leitzen found no significant cor-
relation between anatomical nasal obstruction and the severity
of obstructive sleep apnoea in their study [28]. In contrast, a
recently published meta-analysis on the efficacy of isolated
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1046 European Archives of Oto-Rhino-Laryngology (2019) 276:1039–1047
1 3
nasal surgery in OSA patients showed a significant improve-
ment in both the Epworth Sleepiness Scale and RDI [29]. In
the present study, the SOS score shows a 90-day improvement
over baseline of 27 points (from 66.6 to 41.6). This marked
improvement of the subjective SOS scores in this study is
in stark contrast to the lack of improvement in the objective
WatchPAT200 data and this will be discussed shortly.
The significant improvement of patients’ Quality of
Life as show for both the SNOT-20-GAV and EQ-5D
questionnaires is not unexpected for an effective tech-
nique to improve nasal breathing. Patients with problems
with nasal breathing have numerous other problems such
as the need to blow the nose, sneezing, facial pain, loss
of productivity, sleep disturbance, snoring, restlessness
and other issues which lead to a decreased quality of life
[3, 30]. Improvement in one or more of these areas can be
expected to be reflected in a QoL questionnaire.
The procedure was shown to be well tolerated with all
patients treated under only local anesthetic. No complica-
tions occurred with any patient and with no change in the
external appearance of the nose. There was no incapacity
to work caused by the treatment and all patients were
able to return to their daily activities. Other observations
from the study showed that the total procedure time was
generally under 15min.
From the literature, it is apparent that there is, as yet,
no objective measuring instrument which provides repro-
ducible results regarding the degree and nature of nasal
obstruction or which closely correlated with both patient
sensations of breathing and the results of macroscopic
and endoscopic examinations [31]. In the literature, large
differences are reported between objective and subjec-
tive measurements of nasal obstruction [32–34]. Even the
application of reformatted computer tomography to assess
the INV proves inferior to the combination of physical
examination of the nose and patient symptoms [35].
This trend of objective instrumentation being unable to
measure subjective improvement reported by the patient
or their bedpartners is reflected in this study with the
measurements recorded using the WatchPAT200 system.
In this case, one speculates as to whether the variability
of sleep quality that people experience on a night-to-night
basis generates too much noise in the data for any under-
lying trend to be statistically isolated without a very large
increase in the quantity of data collected. This remains a
subject for further investigation.
Computational fluid dynamics on digital nasal models
could possibly provide objective data in the future. Until
then the physical examination with a Cottle maneuver,
the use of a validated questionnaire such as the NOSE
Score and, last but not least, the experience of the nasal
surgeon remains the gold standard for the positioning of
surgical intervention.
The intervention performed in this study targets the
upper anatomical structures of the INV which leads to
the conclusion that most widening occurs near the inter-
section of the ULC with the nasal septum. This approach
appears to represent the greatest improvement in obstruc-
tion with minimal surgical effort [36].
Strengths andlimitations ofthestudy
The inherent limitation of this study is certainly the absence
of a placebo group (non-treatment group) and the short fol-
low-up period (average of 3 months). A further improvement
to the study would be the substitution of the Epworth Sleepi-
ness Scale for the SOS questionnaire which suffers some
difficulties in administration and interpretation.
A strength of the study lies in the prospective study
design since many studies investigating the effectiveness in
the improvement of nasal breathing are retrospective stud-
ies (16–20). A further strength of the study is the use of
validated questionnaires such as NOSE and SNOT 20; other
studies only have a VAS as the measuring instrument. Worth
mentioning is the statistical evaluation of the measurement
results with ITT analysis. It is certainly no disadvantage that
only two surgeons performed all assessments.
Conclusions
In summary, the results of this study collected with validated
measuring instruments show that low energy radiofrequency
intranasal remodeling treatment to enlarge collapsing or nar-
row nasal valve areas is significantly effective. The patients
with the most severe complaints benefitted most from the
treatment. The therapy is also safe and well tolerated and
as an outpatient procedure offers a benefit to the healthcare
system.
Funding This study was funded by Aerin Medical Inc. Sunnyvale,
CA 94089 USA They provided the SPT devices. They did not, how-
ever, have any role in the study design, data analysis, interpretation, or
reporting of results. In the past, Detlef Brehmer has received research
funding from Aerin Medical Inc. Sunnyvale, CA 94089 USA.
Compliance with ethical standards
Conflict of interest The authors declare that they have no conflict of
interest.
Ethics approval The study was approved by the Ethics Commission at
the University of Witten/Herdecke, Germany.
Informed consent The study was conducted in accordance with the
principles of Goof Clinical Practices and Declaration of Helsinki (1964
and its revisions). Patients who provided written informed consent,
were enrolled in the study.
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1047European Archives of Oto-Rhino-Laryngology (2019) 276:1039–1047
1 3
OpenAccess This article is distributed under the terms of the Crea-
tive Commons Attribution 4.0 International License (http://creat iveco
mmons .org/licen ses/by/4.0/), which permits unrestricted use, distribu-
tion, and reproduction in any medium, provided you give appropriate
credit to the original author(s) and the source, provide a link to the
Creative Commons license, and indicate if changes were made.
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