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DOI 10.1007/s00405-010-1308-x
OTOLOGY
Received: 1 January 2010 / Accepted: 7 June 2010 / Published online: 25 June 2010
© Springer-Verlag 2010
Abstract Piezosurgery® is a recently developed system Keywords Inner ear function · Mastoidectomy ·
for cutting bone with microvibrations. The objectives of the Otologic surgery · Piezoelectric device · Piezosurgery® ·
present study were to report our experience with the piezo- Vestibular function
electric device in the intact canal mastoidectomy, and to
compare the results with traditional method by means of
microdrill. A non-randomized controlled trial was under- Introduction
taken on 60 intact canal wall mastoidectomy performed
using the piezoelectric device (30 patients) or the microdrill Mastoidectomy is one of the commonly performed proce-
(30 patients). Before 1 month and 1 year after surgery, all dures in the Welds of otology and neurotology. Multiple
the patients underwent the following instrumental examina- diVerent procedures exist, each with their own indications,
tions: otomicroscopic evaluation of the tympanic mem- advantages, and disadvantages [1].
brane and external auditory duct, bone conduction Piezosurgery® (Mectron Medical Technology, Carasco,
threshold audiometry, tympanometry, transient-evoked Genoa, Italy) is a recently developed system for cutting bone
otoacoustic emissions with linear click emission, distortion with microvibrations. The piezoelectric device uses low-
product otoacoustic emissions, auditory brainstem response frequency ultrasonic waves (24.7–29.5 kHz). The applied
(ABR) by MK 12-ABR screener with natus-ALGO2e power can be modulated between 2.8 and 16 W, and the
(Amplifon, Milan, Italy), and electronystamographic machine is programed in accordance with the density of the
recording. The piezoelectric device is proved to be eVective bone. The microvibrations which are created in the piezo-
in sclerotic and pneumatic mastoid, with an excellent con- electric hand-piece cause the inserts to vibrate linearly
trol and without side eVects on the adjacent structures of the between 60 and 210 . The amplitude of the ultrasonic waves
middle and inner ear (lateral sinus, facial nerve, and/or dura allows a clean, precise, and selective cut when the insert
mater). The operation time has been the same as compared works on mineralized tissue; yet, it is ineVective on soft
with microdrill, and the average hospital stay was signiW- tissue (higher frequency waves need to be utilized) [2–7].
cantly (p < 0.05) shorter. Postoperatively, all patients had The equipment consists of two hand-pieces, two inserts,
uneventful recovery with no evidence of audiovestibular and two peristaltic pumps connected to the control unit
deWcit or side eVects. Our experience highlights the safety (Fig. 1); appropriate inserts have been created: the width,
of the piezoelectric device on the anatomic structures of the the thickness, and the angle of the insets vary in relation to
middle and inner ear, and demonstrates its eYciency in the power that is applied, the bone density and the surgical
terms of cutting precision and healing process. techniques that they are used for (some are coated with dia-
mond in various grades) [2–7] (Fig. 2).
The objectives of the present study were to report our
A. Salami · R. Mora (&) · M. Dellepiane · B. Crippa · experience with the piezoelectric device in the intact canal
V. Santomauro · L. Guastini
ENT Department, University of Genoa,
mastoidectomy, to evaluate the eYciency and applicability
Via Dei Mille 11/9, 16147 Genoa, Italy of the piezoelectric device, and to compare the results with
e-mail: renzomora@libero.it traditional method by means of microdrill.
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1706 Eur Arch Otorhinolaryngol (2010) 267:1705–1711
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Eur Arch Otorhinolaryngol (2010) 267:1705–1711 1707
Fig. 3 The mastoid cortex has been removed through three linear
Fig. 5 Final reposition of the cortical bony specimen and the good
osteotomies performed along the linea temporalis, perpendicular to
esthetic result
external ear canal and from mastoid tip to sinodural angle
Fig. 4 The mastoid cortex has been removed through a cortical bony
Results
specimen like a pyramid, with its triangular base in high and the apex
in bass: the arrow highlights the absence of lesions on the lateral sinus In group A, the piezoelectric device is proved to be eVec-
tive in sclerotic and pneumatic mastoid: the device allowed
a rapid and easy intra-operative management and a precise
layers, as traditional methods: the thinning of the bone of and safe cut; the diVerent angles and diameters of the
the external ear canal wall, infero-lateral to the buttress and inserts allowed therapeutic success in all the phases of the
the short process of the incus (the lateral limit of the facial operations. It was possible to preserve the bone of the pos-
recess was exposed by further inferior extension of the terior external ear canal wall without side eVects to the
osteoplasty at the level of the chordal eminence), was done chorda tympani or to the facial nerve. The further use
with OP3 (bone scalpel for osteoplasty) insert, and skelet- toward the hypotympanum along the course of the chorda
onization of the canal facial nerve was allowed with OT4 tympani opened the inferior part of the facial recess: if nec-
(round cylindrical bone scalpel coated with diamond). The essary, complete skeletonization of the facial nerve or even
OP3 and OT4 inserts were linearly moved with a light decompression was performed without damaging the sur-
pressure. rounding structures. The operating Welds were blood-free,
After the intact canal wall mastoidectomy, the piezoelec- with perfect intra-operative visibility without any sign of
tric device was used (with OP3 insert) in atticotomy and surgical damage to soft tissues such as facial nerve, lateral
close tympanoplasty: with a light pressure, OP3 insert was sinus, dura mater, and/or vascular formations. After unin-
linearly moved along the middle ear bone; after inspection tentional contact with the facial nerve, no patient experi-
and removal of any adhesions and bony spicule of the enced side eVects. Lateral sinus, dura mater, and facial
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1708 Eur Arch Otorhinolaryngol (2010) 267:1705–1711
Table 1 Surgical operation time, hospital stay, and number of compli- time range from 3 to 7 weeks (mean 4.9 weeks). Among 30
cations in each patient’s group cases followed for 1 year, 27 (90%) maintained a dry and
Patient’s group p value safe ear. Intermittent otorrhea with perforation of the tym-
panic membrane occurred in three patients (10%) (Table 1).
A (n = 30) B (n = 30)
In group B, the microdrill allowed a rapid and easy intra-
Average operation time 78.4 § 7.41 80.2 § 8.03 >0.05 operative management. Dura mater and facial nerve had
(min) (mean § SD) been exposed in 2/30 (6.6%) and 1/30 (3%) patients,
Average hospital stay 3.1 § 0.31 4.1 § 0.28 <0.05 respectively, without injury. The chronic otitis media
(days) (mean § SD) eroded the middle ear ossicles, causing ossicular chain dis-
No. of complications 1 3 – continuity in 21/30 (70%) patients. Erosion or absence of
malleus was found in 23/30 (76.6%) cases, the incus in 22/30
(73.3%) cases, and the stapes in 6/30 (20%) cases.
nerve had been exposed in 2/30 (6.6%), 1/30 (3.3%), and In the group A, 1 year after surgery, all the patients pre-
3/30 (10%) patients, respectively (Fig. 4). sented no worsening of their mean air and bone audiometric
The chronic otitis media eroded the middle ear ossicles, threshold at 250 dB (27.1 § 2.56, 13.6 § 1.35 vs. 34.5 §
causing ossicular chain discontinuity in 23/30 (76.6%) 3.22, 14.1 § 1.38), 500 dB (26.9 § 2.71, 15.9 § 1.42 vs.
patients. Erosion or absence of malleus was found in 24/30 34.9 § 3.42, 16.1 § 1.44), 1,000 dB (27.7 § 2.89, 19.5 §
(80%) cases, the incus in 25/30 (83.3%) cases, and the sta- 1.81 vs. 34.1 § 3.27, 19.7 § 1.89), 2,000 dB (31.1 § 3.11,
pes in 7/30 (23%) cases. 18.9 § 1.82 vs. 36.5 § 3.44, 21.2 § 2.01), and 4,000 dB
The cortical specimen, suitable to be reinserted in the (30.1 § 3.02, 20.1 § 1.98 vs. 34.6 § 3.39, 20.6 § 1.99). In
mastoid cortex, allowed no obvious retraction or depression all the patients with hearing improvement, the TEOAEs
in the postauricular area. revealed an improvement from “Fail” to “Pass” and otoa-
In the group A, the operation time has been the same as coustic distortion products, which were previously absent,
compared with microdrill (78.4 § 7.41 vs. 80.2 § 8.03); were evoked at frequencies of the tonal Weld normally
the average hospital stay was signiWcantly (p < 0.05) lower examined (Table 2).
(3.1 § 0.31 vs. 4.1 § 0.28); the dry-up time range from 3 to The ABR responses were normal, and ENG recording
6 weeks (mean 4.3 weeks). Among 30 cases followed for revealed a normoreXexia in all the patients (Table 2).
1 year, 29 (97%) maintained a dry and safe ear. Intermittent In the group B, 1 year after surgery, all the patients pre-
otorrhea with perforation of the tympanic membrane sented no worsening of their mean air and bone audiometric
occurred in one patient (3%). In the group B, the dry-up threshold at 250 dB (27.3 § 2.57, 13.8 § 1.37 vs. 34.2 § 3.21,
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Eur Arch Otorhinolaryngol (2010) 267:1705–1711 1709
14.4 § 1.41), 500 dB (26.9 § 2.71, 15.7 § 1.39 vs. 34.5 § exchange function between the mastoid and blood vessels
3.38, 16.4 § 1.51), 1,000 dB (27.5 § 2.81, 19.3 § 1.76 vs. through the middle ear mucosa: this function plays a very
34.2 § 3.28, 19.4 § 1.76), 2,000 dB (30.9 § 3.09, 18.7 § important role in the regulation of middle ear pressure [9].
1.81 vs. 36.8 § 3.47, 21.4 § 2.05), and 4,000 dB (30.3 § The overall complication rate of mastoid surgery is
3.05, 20.3 § 1.99 vs. 34.4 § 3.37, 20.9 § 2.03). In all the around 1–16% [1]. After chronic ear surgery, injuries
patients with hearing improvement, the TEOAEs revealed include: facial nerve and vascular damages, tegmen inju-
an improvement from “Fail” to “Pass” and otoacoustic dis- ries, canal dehiscence, and cholesteatoma recurrence [1].
tortion products, which were previously absent, were Furthermore, after surgery, a Wbrous tissue may partially or
evoked at frequencies of the tonal Weld normally examined completely substitute the mastoid air reserve and results in
(Table 3). retraction of the mastoid skin and/or tympanic membrane
The ABR responses were normal, and ENG recording into the cavity [1, 9].
revealed a normoreXexia in all the patients (Table 3). Comparative histologic studies between the piezoelectric
At the endpoint, with regard to the bone conduction devices, saw and bur, highlighted the superiority of the pie-
threshold audiometry, comparison between the two groups zoelectric device in terms of safety, cutting precision, and
showed no signiWcant (p > 0.05) best results in group A at protection of anatomic structures and, consequently, a bet-
the 250, 500, 1,000, 2,000, and 4,000 Hz frequencies ter healing process [2]. After Piezosurgery® the new bone
(Table 4). formation was better and more rapid than with saw and bur:
the new tissue was primarily composed by bone, while after
osteotomies with bur and saw the new tissue presented less
Discussion advanced stages of healing with the central areas of the
osteotomies Wlled with non-mineralized Wbrovascular tissue
In the surgical treatment of chronic otitis media with [2]. The less invasive action of the piezoelectric device and
cholesteatoma, the main goals for surgery are to eliminate the better new bone formation allow the preservation of the
cholesteatoma and bone disease in order to produce a dry mastoid mucosa and its function in regulating middle ear
and safe ear, to prevent recurrent disease, and to restore pressure by transmucosal exchange function: for these rea-
serviceable hearing [8]. sons, postoperatively, all patients had uneventful recovery.
Among the pathogenic factors that are responsible for a Instead, traditional motorized instruments generate a sig-
surgical failure, a bad mastoid and tympanic cavity aeration is niWcant increase of heat with an alteration of the healing
very important; recent studies have shown that there is a gas bony response [10].
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1710 Eur Arch Otorhinolaryngol (2010) 267:1705–1711
Table 4 Liminal tonal audiometry results (mean § SD) in the patients underwent intact canal wall mastoidectomy with the piezoelectric device (group A) and with microdrill (group B), before
30.1 § 3.02
20.1 § 1.98
30.3 § 3.05
20.3 § 1.99
used in the recent past and conventional devices (saw, bur),
microscopic examination of an anatomic specimen of the
>0.05
t=2
operative site showed no signs of coagulative necrosis after
the piezoelectric cut [2, 9]. The presence of live osteocytes
34.6 § 3.39
20.6 § 1.99
34.4 § 3.37
20.9 § 2.03
of normal dimension and morphology on the cut surfaces
highlighted the reduced trauma of the piezoelectric cut,
>0.05
4,000
t=1
with a complete absence of harmful eVects [2]. In the group
A, the lower dry-up time range highlights the absence of a
31.1 § 3.11
thermal eVect on the surface cut and shows a better healing
18.9 § 1.82
30.9 § 3.09
18.7 § 1.81
process.
>0.05
The main advantage of the piezoelectric device is the
t=2
36.8 § 3.47
21.4 § 2.05
Therefore, it was possible to make the cortical bony speci-
men, as the following surgical steps, without injuries to the
>0.05
2,000
t=1
27.5 § 2.81
19.3 § 1.76
34.2 § 3.28
19.4 § 1.76
t=1
26.9 § 2.71
15.7 § 1.39
34.5 § 3.38
16.4 § 1.51
27.3 § 2.57
13.8 § 1.37
34.2 § 3.21
14.4 § 1.41
Group B
p value
Group
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Eur Arch Otorhinolaryngol (2010) 267:1705–1711 1711
Because we have experienced a longer operative time by 3. Vercellotti T, Dellepiane M, Mora R, Salami A (2007)
performing mastoidectomy with the piezoelectric device in Piezoelectric bone surgery in otosclerosis. Acta Otolaryngol
127:932–937
the traditional method (removing bone in layers), we have 4. Salami A, Verecellotti T, Mora R, Dellepiane M (2007) Piezoelec-
decided to remove the mastoid cortex through a bony spec- tric bone surgery in otologic surgery. Otolaryngol Head Neck Surg
imen. After having removed the bony specimen, the other 136:484–485
surgical steps have been done by removing bone in layers, 5. Salami A, Dellepiane M, Mora R (2008) A novel approach to the
facial nerve decompression: use of Piezosurgery®. Acta Otolaryn-
as traditional methods: for this reason, only four patients, gol 128:530–533
with an anterior sigmoid sinus (n = 2) or a low hanging 6. Salami A, Mora R, Dellepiane M (2008) Piezosurgery in the exer-
dura (n = 1), presented areas of the lateral sinus and of the esis of glomus tympanicum tumours. Eur Arch Otorhinolaringol
dura uncovered. 265:1035–1038
7. Salami A, Dellepiane M, Proto E, Mora R (2009) Piezosurgery in
otologic surgery: four years of experience. Otolaryngol Head Neck
Surg 140:412–418
Conclusion 8. Cho Y-S, Hong DS, Chung KW, Hong SH, Chung W-H, Shin HP
(2010) Revision surgery for chronic otitis media: characteristics
and outcomes in comparison with primary surgery. Auris Nasus
Our experience and the postoperative audiologic data show Larynx 37:18–22
the eYciency of the piezoelectric device in terms of safety, 9. Kanemaru S, Nakamura T, Omori K (2004) Regeneration of mas-
cutting precision, and protection of anatomic structures of toid air cells: clinical applications. Acta Otolaryngol Suppl
the middle and inner ear, and conWrm its applicability in the 551:80–84
10. Chapple IL, Walmsley AD, Saxby MS, Moscrop H (1995) EVect
intact canal wall mastoidectomy. of instrument power setting during ultrasonic scaling upon treat-
ment outcome. J Periodontol 66:756–760
ConXict of interest statement None of the authors have a Wnancial 11. Lazo-Sáenz JG, Galván-Aguilera AA, Martínez-Ordaz VA,
relationship with any organization that sponsored the research. Velasco-Rodriguez VM, Nieves-Renteria A, Rincon-Castaneda C
(2005) Eustachian tube dysfunction in allergic rhinitis. Otolaryn-
gol Head Neck Surg 132:626–629
12. Salami A, Dellepiane M, Crippa B, Ralli G, Mora R (2009) The
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