Article 1 Compressed
Article 1 Compressed
https://doi.org/10.1007/s00405-020-06511-9
REVIEW ARTICLE
Received: 14 September 2020 / Accepted: 19 November 2020 / Published online: 2 January 2021
© Springer-Verlag GmbH Germany, part of Springer Nature 2021
Abstract
Purpose Several authors have reported their experience with the punch technique as compared to open surgical methods
for bone-anchored hearing implants (BAHI). However, no study has attempted to aggregate current evidence. We aimed to
compare post-operative skin complications and operating time between punch and open surgical techniques of BAHI via a
systematic review and meta-analysis.
Methods Databases of PubMed, Embase, Scopus, BioMed Central, Ovoid, and CENTRAL were screened up to 15th Febru-
ary 2020 to include studies comparing punch and open surgical technique for BAHI.
Results Eight studies were included. Punch technique was compared with dermatome and linear incision techniques with
and without soft tissue reduction. There was no difference in normal-to-moderate skin reaction between the punch and open
surgical techniques (OR: 0.86 95% CI 0.23, 3.28 I2 = 0%). The incidence of adverse skin reactions were also not different
between the two groups. Meta-regression for different follow-up periods did not demonstrate any statistically significant
results. Our results also indicated that punch technique requires less operating time, however, the inter-study heterogeneity
in the analysis was very high. Similar results were seen on sub-group analysis based on the type of open surgical technique.
Conclusion There may be no difference in skin tolerance between the punch technique and open surgical techniques. Oper-
ating time may be significantly reduced with the punch technique. Strong conclusions cannot be drawn owing to a limited
number of studies. Further large-scale randomized trials are required.
Keywords Minimally invasive surgery · Complications · Punch technique · Hearing implants · Operating time
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technique or the linear incision techniques traumatize the search strategy along with the results of the PubMed data-
skin around the implant and less invasive methods may base are presented in Supplementary Table 1. The review-
improve outcomes [8, 9]. In an attempt to reduce soft-tissue ers screened the search results initially by their titles and
complications, a minimally invasive punch technique has abstracts for every database. After identifying potentially
been developed in recent years. In the ’punch-only’ tech- pertinent articles, full texts of the articles were sourced.
nique, the implant is placed through a key-hole thereby lim- Both the reviewers assessed individual articles based on the
iting soft-tissue damage. The procedure is thought to reduce inclusion and exclusion criteria. Any disagreements were
operating time, improve soft tissue healing, and lead to bet- resolved by discussion. Post-screening, the bibliography of
ter postoperative outcomes [10, 11]. On the downside, the included studies, as well as review articles on the subject,
technique offers limited intraoperative visibility which may were hand searched for any additional references.
lead to damage to subcutaneous tissues.
Over the years, several authors have reported their experi- Data extraction and risk of bias assessment
ence with the punch technique in reducing soft-tissue com-
plications and operating time for BAHI [12–14]. However, Two reviewers independently extracted data from the
to date, no study has attempted to systematically review the included studies. Data regarding authors, publication year,
available evidence. Therefore, this purpose of this study was study type, sample size, demographic details, surgical
to conduct a systematic review and meta-analysis evaluat- details, abutment length, implant system, outcomes, and fol-
ing the role of punch technique in reducing post-operative low-up were extracted. The primary outcome of our analysis
skin complications and operating time as compared to open was skin tolerance assessed using Holger’s classification [6].
surgical techniques for placement of BAHI. Scores of 0–1 were classified as normal-to-moderate skin
reaction whereas scores of ≥ 2 were classified as an adverse
skin reaction. The secondary outcomes of interest were oper-
Materials and methods ating time, the incidence of intra-operative complications,
and revision surgeries.
Inclusion criteria For RCTs, the Cochrane Collaboration risk assessment
tool was used to assess the quality of included studies [16].
This systematic review and meta-analysis were conducted Studies were assessed for: random sequence generation,
as per the PRISMA statement (Preferred Reporting Items allocation concealment, blinding of participants and person-
for Systematic Reviews and Meta-analyses) [15] and guide- nel, blinding of outcome assessment, incomplete outcome
lines of the Cochrane collaboration [16]. We used the PICOS data, selective reporting, and other bias. For non-RCTs, the
(Population, Intervention, Comparison, Outcome, and Study risk of a bias assessment tool for non-randomized studies
design) model to select studies for inclusion in the review. (RoBANS) was used [17]. Studies were assessed for: selec-
All types of studies conducted on patients undergoing BAHI tion of participants, confounding variables, intervention
surgery (Population) were considered for inclusion. Studies measurements, blinding of outcome assessment, incomplete
were to compare the minimally invasive punch technique outcome data, and selective outcome reporting.
without any additional skin incision or soft tissue reduction
(Intervention) with any other incision or flap technique with Statistical analysis
or without soft tissue reduction (Comparison) and measur-
ing operating time, skin tolerance, or other complications as The software “Open MetaAnalyst” was used for the meta-
Outcomes. Studies were included irrespective of sample size analysis [18]. Predicting heterogeneity in the included stud-
and language of publication. Studies not reporting relevant ies, we used a random-effects model to calculate the pooled
data, single-arm studies, review articles, and case reports effect size for all analyses. We assessed heterogeneity using
were excluded. In the case of duplication of data, the most the I2 statistic. I 2 values of 25–50% represented low, values
updated version of the study was to be included. of 50–75% medium, and more than 75% represented sub-
stantial heterogeneity. Continuous data were summarized
Search strategy using the mean difference (MD) with 95% confidence inter-
vals (CI) and categorical data using Mantel–Haenszel Odds
An electronic search was performed independently by two Ratio (OR) with 95% CI. Sub-group analysis was performed
reviewers. Databases of PubMed, Embase, Scopus, BioMed for the type of comparative technique. We also assessed the
Central, Ovoid, and CENTRAL (Cochrane Central Regis- influence of final follow-up time on the effect size of the
ter of Controlled Trials) were screened up to 15th Febru- primary outcome using random-effects meta-regression
ary 2020. Both MeSH terms and free-text keywords were analysis. For studies not reporting mean and standard devia-
utilized for searching relevant articles. Search terms and tion scores of operating time, the same was calculated from
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available data using methods reported by Wan et al. [19]. In Details of the included studies are presented in Table 1.
case, data were represented only graphically, the software Only one study [23] was an RCT while remaining were
Engauge Digitizer was used to extract numerical data. Due retrospective or prospective studies. All studies were con-
to the inclusion of fewer than ten studies in the review, fun- ducted in North America or European nations. The sam-
nel plots were not used to assess publication bias. ple size of the punch technique group varied from 10 to
65 in the included studies, while that of the open surgical
group varied from 8 to 155. In three studies, pediatric
Results patients were also included [11, 22, 25]. Four studies [11,
20–22] used a ‘skin punch’ for the punch technique while
The study flowchart is presented in Fig. 1. Fourteen studies the remaining four studies used the ‘Minimally Invasive
were analyzed by their full-texts of which six were excluded Ponto Surgery’ (MIPS) system for the same [23–26]. The
as they did not fulfill the inclusion criteria. A total of eight open surgical technique varied amongst included studies.
studies were included in this systematic review and meta- The dermatome technique was used in two studies [20,
analysis [11, 20–26]. 21] while the remaining used the linear incision technique
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Author/year Study type Country Sample size Mean Age Abutment length Punch technique Comparative tech- Implant system Follow-up
nique
PT CT PT CT PT CT
Wilson et al. Retro-spective USA 29 11 61.9 70.5 NA NA Using a 4 mm Using a dermatome NA At least 12 m
[20]/2013 diameter biopsy with soft tissue
punch with a reduction
blade length of
6 mm
Gordon et al. Retro-spective USA 17 34 52.2 49.1 9 mm 6 mm Using a 6 mm skin Linear incision BAHA® and PT: mean 10 m
[11]/2015 biopsy punch with soft tissue PONTO® CT: mean 22 m
reduction
Dumon et al. Prospective France 65 155 58a 57a 9 mm 6 mm Using a soft tissue Using a dermatome 150 BAHA® and PT: median 8 m
[21]/2017 (6–12)a punch with soft tissue 70 PONTO® CT: median 21 m
reduction
Bonilla et al. Retro-spective Spain 18 16 52a 58a 10 mm 6 mm Using a 6 mm skin Linear incision BAHA® in all Mean 24 m
[22]/2017 (8–12) (6–12) punch with soft tissue patients
reduction
Calon et al. RCT Netherlands 33 30 50.3 51.9 9 mm: 21 9 mm: Using the Mini- Linear incision PONTO® in all 12 weeks
[23]/2018 12 mm: 13 mally Invasive without soft tis- patients
10 12 mm: Ponto Surgery sue reduction
14 mm: 2 16 system
14 mm:
1
Giustino et al. Retro-spective Italy 10 G1: 12 60.41 NA NA Using the Mini- G1: Linear incision PT and G1: 12 months
[24]/2018 G2: 8 mally Invasive with soft tissue BAHA®
Ponto Surgery reduction G2: PONTO®
system G2: Linear incision
without soft tis-
sue reduction
Bezdijian et al. Retro-spective Canada 21 38 40.43 16 NA NA Using the Mini- Linear incision PONTO® in all Up to 15 weeks
[25]/2020 mally Invasive without soft tis- patients
Ponto Surgery sue reduction
system
Caspers et al. Prospective Netherlands 25 25 60 52 6 mm: 1 6 mm: 0 Using the Mini- Linear incision PONTO® in all 6 months
[26]/2020 with historical 9 mm: 14 9 mm: mally Invasive without soft tis- patients
control 12 mm: 17 Ponto Surgery sue reduction
10 12 mm: system
8
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Fig. 2 Meta-analysis of normal-to-moderate skin reaction between punch vs open surgical techniques with sub-group analysis based on type of open surgical technique
technique used, we conducted a sub-group analysis for skin
tolerance and operating time. For normal-to-moderate skin
reactions (Holger’s score 0–1), our meta-analysis indicated
no significant difference between punch technique vs der-
matome technique with soft tissue reduction (OR:0.86 95%
CI 0.23, 3.28 I2 = 0%), punch technique vs linear incision
technique with soft tissue reduction (OR:1.49 95% CI 0.38,
5.80 I2 = 0%) and punch technique vs linear incision tech-
nique without soft tissue reduction (OR:3.22 95% CI 0.86,
11.97 I2 = 0%) (Fig. 2). In the overall analysis, there was no
statistically significant difference in the incidence of normal-
to-moderate skin reactions between the punch technique and
the open surgical techniques (OR: 1.62 95% CI 0.75, 3.50
I2 = 0%).
Similarly, for adverse skin reactions (Holger’s score ≥ 2),
our analysis indicated no statistically significant difference
between punch technique vs dermatome technique with
soft tissue reduction (OR: 1.16 95% CI 0.30, 4.41 I2 = 0%),
punch technique vs linear incision technique with soft tissue
reduction (OR: 0.90 95% CI 0.21, 3.74 I2 = 0%) and punch
technique vs linear incision technique without soft tissue
reduction (OR: 0.31 95% CI 0.08, 1.16 I2 = 0%) (Fig. 3).
In the overall analysis, there was no statistically significant
difference in the incidence of adverse skin reactions between
the punch technique and the open surgical techniques (OR:
0.67 95% CI 0.31, 1.47 I2 = 0%).
As the skin tolerance scores were recorded at different
follow-up time points amongst the included studies, we con-
ducted a meta-regression analysis to assess any influence
of this moderator on the overall effect size. Our analysis
demonstrated no statistical significant influence of follow-up
time on normal-to-moderate skin reactions (ß: -0.050 95%
CI -0.281, 0.180 p = 0.669) (Supplemental Fig. 1) as well as
on adverse skin reactions (ß: -0.076 95% CI -0.157, 0.309
p = 0.523) (Supplemental Fig. 2).
Limited data were available for secondary outcomes,
intra-operative complications, revision surgery, implant loss,
skin numbness, and dehiscence. Therefore, a meta-analysis
was not conducted. Details of these complications are pre-
sented in Table 2. Data on operating time were reported
by all eight studies. Pooled analysis indicated significantly
reduced operating time with punch technique as compared
to dermatome technique with soft tissue reduction (MD:
− 21.41 95% CI − 23.55, − 19.28 I2 = 0%), compared to
linear incision technique with soft tissue reduction (MD:
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Fig. 3 Meta-analysis of adverse skin reaction between punch vs open surgical techniques with sub-group analysis based on type of open surgical technique
is presented in Supplemental Table 2. Owing to the study
design blinding was not possible in the RCT [23]. The RCT
was sponsored by the manufacturer of the MIPS system. For
non-RCTs, the overall quality was not high.
Discussion
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Fig. 4 Meta-analysis of operating time between punch vs open surgical techniques with sub-group analysis based on type of open surgical tech-
nique
This has been challenged by Van De Berg et al. [9] who skin reactions are due to the implanted foreign body and the
have suggested that less invasive the surgery, better are the length of the surgical incision and the associated surgical
outcomes. Following this principle and aided with the avail- trauma may have little role in the inflammatory reaction. It
ability of longer implant abutments, the linear incision tech- is also important to note that the outcomes were reported at
nique without soft tissue reduction has gained popularity different follow-up times in the included studies. Therefore,
[30]. Hogsbro et al. [31] in an RCT have shown that the lin- a meta-regression analysis was performed which, however,
ear incision technique without soft tissue reduction results in did not demonstrate any statistical significance.
faster healing, less post-operative pain, and sensibility loss Skin reactions after BAHI surgery can be influenced by
as compared to the dermatome technique. However, long- the post-operative protocol which includes use of antibiotics,
term skin tolerance was similar in the two groups. Despite appropriate wound care and regular follow-up. Although,
being less invasive than the dermatome technique, this linear in a recent retrospective case–controlled study, Kazi et al.
incision technique still requires elevation of the skin flap [32] have reported that the use of post-operative antibiotics
with soft-tissue dissection and suturing at the end of the may not reduce the incidence of skin reactivity in patients
procedure. To further minimize soft tissue injury, the punch undergoing MIPS surgery. The authors suggested that skin
technique was described by Goldman et al. in 2013 [10]. reactions, when occur, are not mediated by infection and
Since the implant is placed through a key-hole without any are directed towards the foreign body. Furthermore, studies
soft tissue reflection and tissue reduction, skin complications have also stressed on the importance of patient education
were thought to reduce with this method. to maintain implant hygiene especially in the early post-
On analysis of skin tolerance scores using the Holger’s operative period and the need of regular follow-up appoint-
classification, we found that there was no significant dif- ments to reduce skin complications [33]. However, due to
ference between the punch technique and either of the unavailability of data, we could not assess the impact of such
three open surgical techniques. The incidence of adverse variables on the outcomes of this review.
skin reactions in 149 cases implanted with the punch tech- Other important adverse skin complications with BAHI
nique was 8.7%. On the other hand, adverse skin reactions surgery include skin numbness and dehiscence. Due to the
were seen in 12.9% cases in the dermatome group, 8.06% key-hole incision of punch technique, less neural damage
cases in the linear incision with soft tissue reduction group, may be expected and therefore reduced skin numbness
and 14.28% cases in the linear incision without soft tissue [26]. However, we could not find strong evidence on the
reduction group. In the absence of an incision in the punch influence of the punch technique on these complications.
group, the risk of adverse skin reactions is expected to be Only two studies [23, 26] compared skin numbness and
low. Lack of statistical significance in our results can be dehiscence between the punch group and linear incision
attributed to two reasons. First, in view of the small sample with the soft tissue reduction group. On long-term follow-
size and a limited number of studies in the review, the meta- up, both did not report any significant difference in the
analysis may not have been adequately powered to detect rates of skin dehiscence around the implant sites. In the
significant differences. Second, it may be argued that the RCT of Calon et al. [23], skin sensibility was significantly
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European Archives of Oto-Rhino-Laryngology (2021) 278:3171–3180 3179
better in the punch group but in the study of Casper et al. Nevertheless, this study is the first review to systemati-
[26], no difference was detected in the two cohorts after a cally synthesize evidence on the outcomes of the punch tech-
follow-up of 6 months. nique as compared to open surgical techniques. We pooled
Our analysis did demonstrate a statistically significant together the dermatome and linear incision techniques
reduction of operating time with the use of the punch tech- against the punch technique as they all invasive surgical pro-
nique. The reduced surgical time may be beneficial in terms cedures as compared to the punch technique where no inci-
of reducing hospital costs of BAHI surgery. Sardiwalla et al. sion is involved. Appropriate sub-group analysis was carried
[34] in their comparison of punch technique vs open surgi- out for the different comparative open surgical techniques
cal techniques have shown that the use of punch technique in our analysis to provide clarity on the current evidence.
reduces hospital costs by a mean of 456.83 Canadian Dol- We also performed a meta-regression analysis to factor in
lars. The procedure may be performed in an office setting the difference of follow-up periods in the included studies.
under local anesthesia thereby eliminating anesthesia and To conclude, our review indicates that there may be no
admission costs [35]. It is important to note that the overall difference in skin tolerance between the punch technique
pooled analysis for operating time had high inter-study het- and open surgical techniques. Operating time is significantly
erogeneity. This may be due to the different open techniques reduced with the punch technique as compared to all open
pooled together for comparison with the punch technique. surgical methods. However, strong conclusions cannot be
Disadvantages of the punch technique include the limited drawn owing to a limited number of studies in this review.
visibility of the surgical field which may lead to damage to Also, data regarding intra-operative and other skin complica-
soft tissues, difficulty in managing intra-operative complica- tions are, at present, limited. Further large-scale RCTs are
tions like bleeding, and non-perpendicular insertion of the needed to strengthen the evidence on this subject.
implant in the bone [25]. The absence of adequate irrigation
may also lead to high bone temperatures causing thermal
osteonecrosis thereby affecting implant stability [25, 26]. On Authors’ contributions QX conceived and designed the study. FG, NW
and WH collected the data and performed the literature search. QX was
descriptive analysis of data, the incidence of intra-operative involved in the writing of the manuscript. All authors have read and
complications and implant loss was low in all included stud- approved the final manuscript.
ies with no statistically significant difference between punch
technique and other open surgical techniques. Furthermore, Funding None.
not all studies reported data on these outcomes, which fur-
ther limits our ability to draw conclusions. Availability of data and materials The datasets used and/or analyzed
during the current study are available from the corresponding author
The limitations of our review need to be specified. First, on reasonable request.
only eight studies were available for inclusion in the review.
Also, the punch technique was compared with different open Compliance with ethical standards
surgical techniques in the included studies. The number of
studies in each comparative sub-group was not more than Conflicts of interest None to declare.
three. The sample size of the included studies was small
and despite pooling results, our analysis may not have been
adequately powered. Also, not all outcome variables were
studied by all included studies. Second, only one study was References
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