Piezoelectric Osteotomy versus Conventional Osteotomy in Rhinoplasty: A Systematic Review and Meta-analysis : Plastic and Reconstructive Surgery – Global Open

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Cosmetic: Original Article

Piezoelectric Osteotomy versus Conventional Osteotomy in Rhinoplasty: A Systematic Review and Meta-analysis

Khajuria, Ankur MBBS (Hons), BSc (Hons), FHEA, FRSPH, MRCS (Eng), MAcadMEd, MFSTEd, MSc, PhD*,†; Krzak, Ada M. MB BChir, MA (Cantab); Reddy, Rohin K MBBS*; Lai, Kenneth MBBS§; Wignakumar, Thirushan BA (Oxon); Rohrich, Rod J. MD

Author Information
Plastic and Reconstructive Surgery - Global Open: November 2022 - Volume 10 - Issue 11 - p e4673
doi: 10.1097/GOX.0000000000004673
  • Open
  • SDC
  • UNITED KINGDOM

Abstract

Takeaways

Question: What are the clinical and patient-reported outcomes of piezoelectric versus conventional osteotomy in rhinoplasty?

Findings: Piezoelectric osteotomy was associated with significantly reduced edema, ecchymosis, mucosal injury, and pain in postoperative week 1 with no difference in osteotomy duration or total procedural time.

Meaning: The review provides support for piezoelectric over conventional osteotomy, for reducing morbidity in the early postoperative period.

INTRODUCTION

Osteotomy is a key step in rhinoplasty surgery used to reshape the nasal bones. However, osteotomies contribute to procedural morbidity secondary to soft tissue damage,1 with resultant postoperative edema, ecchymosis, and pain.2 Traditionally, osteotomy is performed with hammer and chisel, but piezoelectric devices using ultrasonic microvibrations to cut bones with precision offer promise by theoretically minimizing damage to soft-tissue structures.3

Several studies, including randomized controlled trials (RCTs), have shown piezoelectric osteotomy to be associated with fewer postoperative morbidities.4–9 However, four previously published systematic reviews comparing piezoelectric osteotomy to conventional technique contain inconsistencies2,3,10,11 and are low or critically low quality, as judged by the AMSTAR-2 (a measurement tool to assess systematic reviews) criteria12 for systematic reviews. (See table, Supplemental Digital Content 1, which displays key findings of previous reviews assessing the effect of piezoelectric osteotomy in rhinoplasty on various clinical outcomes, https://links.lww.com/PRSGO/C271; see table, Supplemental Digital Content 2, which displays quality of reviews according to AMSTAR-2 criteria, https://links.lww.com/PRSGO/C272.)

This precludes reliable conclusions being drawn regarding relative merits of piezoelectric devices for osteotomies. Previous reviews also excluded observational studies, despite low patient enrollment and lack of long-term follow-up in RCTs. Additionally, none investigated patient-reported outcomes (PROs), which should be considered paramount in the field of cosmetic surgery, given patient satisfaction is the bedrock of procedural success.13,14 Obtaining precise answers about the impact of piezoelectric osteotomy will assist shared decision-making between patients and surgeons when discussing best treatment options in rhinoplasty, and allow accurate characterization of postsurgical morbidity, facilitating better informed consent processes.

This systematic review and meta-analysis aimed to clarify methodologic concerns of past reviews and evaluate the effect of piezoelectric osteotomy in patients undergoing rhinoplasty compared with conventional technique on short- and long-term clinical outcomes including PROs, using a robust prespecified methodology.

METHODS

The study protocol was registered and published a priori with the international prospective register for systematic reviews, PROSPERO (CRD42021287877).15 The AMSTAR-2 criteria were used to assess the quality of previously published systematic reviews in relation to this review.

Search Strategy and Selection Criteria

This systematic review and meta-analysis adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines16 and was AMSTAR-2 compliant.12 Two authors independently searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Web of Science for studies published before April 16, 2022. (See appendix, Supplemental Digital Content 3, which displays the search strategies, https://links.lww.com/PRSGO/C273.) The search strategies were devised in consultation with a literature search expert from the University of Cambridge, UK. No language restrictions were applied to the search.

To identify the totality of relevant literature, randomized and observational studies enrolling human participants comparing the use of piezoelectric osteotomy and conventional osteotomy in rhinoplasty including at least one clinical outcome of interest were included. We included observational studies to increase statistical power for clinical outcomes, increase follow-up length, and identify rare adverse effects. Outcomes of interest included eyelid edema, periorbital ecchymosis, postoperative pain‚ duration of surgery, mucosal injury, and PROs. Case series, review articles, conference abstracts, opinion pieces, basic science research, studies with no outcome data, and studies in non-English languages without translation were excluded. The PRSIMA flow diagram of selection of included studies is depicted in Figure 1. The characteristics of the included studies are shown in Table 1.

F1
Fig. 1.:
Flow diagram of selection of included studies.
Table 1. - Characteristics of Included Studies
First Author Journal Year Country Design Type No. Centers Ethics Fun-ding Size Age ± SD Male (%) Inclusion/Exclusion Criteria Rhinoplasty Approach Osteo-tomy Ap-proach Piezoelectric Osteo-tome Conventional Osteo-tome Duration of Follow- up
Aydogdu et al The Journal of Craniofacial Surgery 2020 Turkey RCT Single-blinded (blinded outcome assessment) 1 Bakirkoy Sadi Konuk Training and Research Hospital Ethics Committee U 72 28.1 ± 6.5 42 Exclusion: nasal surgery, patients with anticoagulant drug use, patients with bleeding diathesis, patients with chronic liver and kidney disease, patients with hypertension, patients with active rhinitis, and smokers Open External lateral Woodpecker piezosurgery unit SDT-E702, Guangxi, China 2-mm-wide chisel 8 wk
Demirbilek et al The Journal of Craniofacial Surgery 2019 Turkey RCT Single-blinded (blinded outcome assessment) 1 Ethics and research committee of local institution U 30 29.16 ± 8.17 30 Exclusion: previous nasal surgery, use of anticoagulant drugs, hypertension, bleeding diathesis with chronic disease, chronic skin allergy, or inflammatory skin disease Open Endonasal median and lateral 20 mL/min irrigation under the Woodpecker Piezosurgery unit SDT-E702, (Guangxi, China) 4-mm sharp osteomes, endonasal NA
Fallahi et al Journal of Oral and Maxillofacial Surgery 2019 Iran RCT Double-blinded 1 Ethics committee of the Jundishapour University of Medical Sciences U 20 24.00 ± 1.63 y in group A and 24.90 ± 2.38 y in group B 40% Inclusion: indication for an internal lateral osteotomy, no anesthesia contraindication (American Society of Anesthesiologists physical status I and II), and no serious airway malformation (septal deviation, breathing dysfunction).
Exclusion: pregnancy, used antidepressants, appeared noncompliant, or were unwilling to participate in the study.
Open Internal lateral Micro-saw OT7 tip (Mectron, Carasco, Italy) Double-guarded straight osteotome 1 wk
Ghavimi et al Journal of Advanced Pharmaceutical Technology & Research 2018 Iran RCT Double-blinded 1 Ethics committee of Tabriz NF 66 NR 50 Inclusion: satisfaction of the patients and the absence of contraindication for rhinoplasty surgery.
Exclusion: current smokers, patients with chronic rhinosinusitis, chronic diseases of the skin or rheumatology, nasal polyps, asthma, allergic rhinitis, patients with prior septoplasty or nasal beautification surgeries, ecchymosis or edema before surgery for any reason, and the patients who did not come back for postoperative examinations
Open External lateral Variosurg3 piezosurgery unit (Nakanishi Inc, Tochigi, Japan) with a lateral osteotomy pen 2-mm osteotome 1 wk
Ilhan et al Aesthetic Surgery Journal 2016 Turkey RCT Double-blinded 1 Ethics committee of Medipol University NF 56 NR 14.00 Exclusion: current smokers; patients with chronic rhinosinusitis, chronic dermatologic or rheumatologic diseases, nasal polyposis, asthma, or allergic rhinitis; and patients who had previously undergone septoplasty or rhinoplasty. Open Internal medial Variosurg3 piezosurgery unit (Nakanishi Inc, Tochigi, Japan) 4-mm straight osteotome and 4-mm guarded curved right and left osteotomes (Aesculap AG, Tuttlingen, Germany) 1 wk
Koc et al Ear, Nose & Throat Journal 2017 Turkey RCT Single-blinded (blinded outcome assessment) 1 Baskent University institutional review board U 65 23.6 ± 5.71 45 Exclusion: history of smoking, presence of systemic diseases (such as cardiac disease, diabetes mellitus, hypertension, bronchial asthma, and neurologic diseases), and use of any medications. Open External lateral Piezosurgery Flex medical device ([PMD] (Mectron Medical Technology; Carasco, Italy) 2-mm osteotome 1 wk
Kocak et al European Archives of Oto-Rhino-Laryngology 2017 Turkey RCT Double-blinded 1 Local ethics committee (Bezmialem Foundation University) NF 49 25.7 ± 5.4 in group 1, 28.5 ± 3.1 in group 2 35 Exclusion: history of rhinoplasty, an extremely wide nasal roof, a need for double lateral osteotomy, a narrow nasal roof and coagulopathy, smoking, and systemic diseases. Open Internal. Low-to-low lateral with transverse, or low to high lateral Transverse with low-to-low lateral in 13, low-to-high lateral in 11, with NSK VarioSurg 3 device tips Transverse with low-to-low lateral in 9, low-to-high lateral in 16, using 3-mm guided curved osteotome 1 wk
Taskin et al European Archives of Oto-Rhino-Laryngology 2016 Turkey RCT Double-blinded 1 Ethics committee of Bagcilar Education and Research Hospital NF 90 25.6 ± 5.6 38 Exclusion: previous nasal surgery, use of anticoagulant drugs, hypertension, bleeding diathesis with chronic disease, chronic skin allergy, or inflammatory skin disease. Open Median oblique and lateral Variosurg3 piezosurgery unit (Nakanishi Inc, Tochigi, Japan) 2-mm guarded, straight osteotome 1 wk
Tirelli et al American Journal of Otolaryngology 2015 Italy RCT Single-blinded (blinded outcome assessment) 1 Institutional review board of the University of Trieste U 22 NR 45 Inclusion: history of maxillofacial trauma with specific nasal involvement, consensual deviation of both the nasal septum and pyramid, presence of a wide nasal dorsum and prominent hump and associated nasal respiratory dysfunction.
Exclusion: previous rhinoplasty procedure, or who presented a narrow nasal dorsum and a minimal hump.
Closed External lateral Curved, narrow, and unguarded MT1S-10 tip of the Mectron Piezosurgery Medical Device Traditional 2-mm-wide osteotome 1 wk
Troedhan Journal of Oral and Maxillofacial Surgery 2016 Austria Observational Prospective cohort 3 Hospital institutional review boards for all three centers U 84 44 ± 11 20 Exclusion: demand for rhinoplasty was associated with a major functional impairment of nasal breathing, resulting from significant deviation of the nasal septum and/or hypertrophic turbinates. Open NR (Piezotome I or II; Acteon, Bordeaux- Merignac, France) Traditional instruments (chisels and rasps) 6 mo
U, undisclosed; NA, not applicable; NF, no funding received; NR, not reported.

Two authors independently performed title and abstract screening of retrieved studies, with full texts of all potentially eligible papers subsequently assessed for inclusion. Any discrepancy was resolved by consensus discussion with a senior author.

Data Analysis

Data from studies that fulfilled our inclusion criteria were extracted independently by two authors. In the event of missing or incomplete data, we planned to contact corresponding authors of relevant studies to share study-level anonymized data. Study demographics (author, journal, date, country, design, ethical approval, and funding), total numbers of patients, patient demographics, and clinical outcomes stratified by osteotomy technique were extracted.

Two authors independently assessed the quality of included studies using the ROBINS-I tool17 for observational studies and Cochrane risk-of-bias tool for randomized trials (RoB2).18 Any discrepancies in quality assessment were resolved in consultation with a senior author.

As per the prespecified analysis plan and in anticipation of moderate-to-high heterogeneity given the differing clinical settings and piezoelectric devices used, a random effects meta-analysis of pooled raw data was employed using the DerSimonian and Laird method for each outcome with adequate data for quantitative synthesis. Rhinoplasty patients undergoing piezoelectric osteotomy were compared with patients who underwent conventional osteotomy. Where available, adjusted effect estimates were combined, and in the absence of adjustment for confounders, raw effect estimates were combined. The results are presented in forest plots as standardized mean differences (SMDs) for continuous outcomes and odds ratios for dichotomous outcomes. Corresponding 95% confidence intervals (CIs) were generated for each outcome. I2 estimates of heterogeneity, representing the variability across studies, are classified as low (<30%), moderate (30%–60%), or high (>60%). Sensitivity analyses were planned to investigate how inclusion of low risk-of-bias studies and only RCTs would affect the observed results. Tests for publication bias were only planned in the event of 10 or more studies being included in meta-analyses, because when there are fewer studies, the power of the tests is too low to distinguish chance from real asymmetry.19P values less than 0.05 were considered statistically significant.

Data were analyzed using Review Manager (RevMan) Version 5.4, The Cochrane Collaboration, 2020.

RESULTS

Search and Included Studies

The literature search identified 347 studies. Following title and abstract screening, 10 studies were deemed eligible for inclusion following full-text screening.1,4–9,20–22 No additional studies were identified via hand search/snowballing of references of included full texts. The 10 included studies enrolled 554 participants who underwent a rhinoplasty procedure, either with a piezoelectric or conventional osteotomy. Of these participants, 260 underwent rhinoplasty with a piezoelectric osteotomy, with 239 of these randomized to this intervention, and the remaining participants underwent rhinoplasty with a conventional osteotomy. Nine included studies were RCTs, and the other remaining study was a prospective cohort design.20 Nine studies were performed at a single center, and one study was performed across three centers. Most studies were performed in Turkey (6 of 10, 60%), with two performed in Iran, one performed in Austria, and one performed in Italy. Less than half (4 of 10, 40%) of studies disclosed funding status. All studies that disclosed funding status were unfunded.

The open rhinoplasty approach was used in the majority (9 of 10, 90%) of studies, with the remaining opting for the closed approach. The piezoelectric device of choice varied between studies and included Woodpecker piezosurgery unit SDT-E702 (Woodpecker, Guangxi, China), Piezosurgery flex device (Mectron, Carasco, Italy), VarioSurg device (NSK Ltd., Tokyo, Japan), and the Piezotome I or II (Acteon, Bordeaux-Merignac, France).

The present review was deemed to be high quality as per the AMSTAR-2 criteria. (See table, Supplemental Digital Content 2, https://links.lww.com/PRSGO/C272.)

Clinical Outcomes

Postoperatieve Edema

Postoperative edema was reported as an outcome in four studies using a standardized grading scale5,6,8,9 first proposed by Kara and Gökalan23 in 1999. Three additional studies reported P values for difference in edema between piezoelectric and conventional osteotomy,1,4,20 but no measures of effect or raw data were reported, precluding their involvement in quantitative meta-analysis.4 The corresponding authors of these studies were contacted via email to obtain study-level data on two separate occasions, but no response was received. Studies reported early edema (postoperative days 2–4) and late edema (postoperative day 7). Only one study reported edema on postoperative day 4,6 so this study was not meta-analyzed at this time point but was included in the overall meta-analysis across the first postoperative week.

Piezoelectric osteotomy, compared with conventional osteotomy, was associated with significantly reduced edema on postoperative day 2 (SMD, −0.90; 95% CI, −1.40 to −0.40; P = 0.0004; I2 = 0%), on postoperative day 3 (SMD, −1.01; 95% CI, −1.39 to −0.62; P < 0.00001; I2 = 0%), and on postoperative day 7 (SMD, −0.67; 95% CI, −1.04 to −0.29; P = 0.0005; I2 = 34%). Combining all recorded edema across the first postoperative week, edema was significantly reduced by use of piezoelectric osteotomy when compared with conventional osteotomy (SMD, −0.67; 95% CI, −1.03 to −0.30; P < 0.0004; I2 = 70%). These results are depicted graphically in Supplemental Digital Content 4. (See figure, Supplemental Digital Content 4, which displays (a) forest plot showing the effect of piezoelectric osteotomy on postoperative edema following rhinoplasty compared with conventional osteotomy, (b) forest plot showing the effect of piezoelectric osteotomy on postoperative ecchymosis following rhinoplasty compared with conventional osteotomy, and (c) forest plot showing the effect of piezoelectric osteotomy on postoperative pain following rhinoplasty compared with conventional osteotomy, https://links.lww.com/PRSGO/C274.)

Postoperative Ecchymosis

Postoperative ecchymosis was reported as an outcome in four studies using a standardized grading scale5,6,8,9 first proposed by Kara and Gökalan23 in 1999. Three additional studies1,4,20 reported P values for difference in ecchymosis between piezoelectric and conventional osteotomy, but no measures of effect or raw data were reported, precluding their involvement in quantitative meta-analysis. The corresponding authors of these studies were contacted via email to obtain study-level data on two separate occasions, but no response was received. Studies reported early ecchymosis (postoperative days 2–4) and late edema (postoperative day 7). Only one study reported ecchymosis on postoperative day 4, so this study was not meta-analyzed at this time point but was included in the overall meta-analysis across the first postoperative week.

Use of piezoelectric osteotomy when compared with conventional osteotomy significantly reduced ecchymosis on postoperative day 2 (SMD, −1.19; 95% CI, −1.71 to −0.67; P < 0.00001; I2 = 0%), day 3 (SMD, −1.06; 95% CI, −1.44 to −0.68; P < 0.00001; I2 = 0%), and day 7 (SMD, −0.73; 95% CI, −1.06 to −0.40; P < 0.0001; I2 = 17%). Combining all recorded ecchymosis across the first postoperative week, ecchymosis was significantly reduced by use of piezoelectric osteotomy when compared with conventional osteotomy (SMD, −0.93; 95% CI, −1.13 to −0.73; P < 0.00001; I2 = 0%). These results are depicted graphically in Supplemental Digital Content 4. (https://links.lww.com/PRSGO/C274.)

Postoperative Pain

Postoperative pain was reported as an outcome in three studies5,6,20 using a visual analogue scale. Two additional studies reported P values for difference in postoperative pain between piezoelectric and conventional osteotomy,4,21 but no measures of effect or raw data were reported, precluding their involvement in quantitative meta-analysis. The corresponding authors of these studies were contacted via email to obtain study-level data on two separate occasions, but no response was received. Studies reported early ecchymosis (postoperative days 2–4) and late edema (postoperative day 7). Pain was reported at differing time points along the first postoperative week, so an overall meta-analysis was performed combining scores across the first postoperative week.

Combining all recorded pain across the first postoperative week, pain was significantly reduced by use of piezoelectric osteotomy when compared with conventional osteotomy (SMD, −1.48; 95% CI, −2.07 to −0.88; P < 0.00001; I2 = 59%). These results are depicted graphically in Supplemental Digital Content 4. (See figure, Supplemental Digital Content 4, https://links.lww.com/PRSGO/C274.)

Mucosal Injury

Mucosal injury was reported as an outcome in two studies.6,21 Odds of mucosal injury was significantly lower following piezoelectric osteotomy compared with conventional osteotomy (odds ratio, 0.06; 95% CI, 0.01 to 0.52; P = 0.01; I2 = 0%). These results are depicted graphically in Supplemental Digital Content 5. (See figure, Supplemental Digital Content 5, which displays (a) forest plot showing the effect of piezoelectric osteotomy on postoperative mucosal injury following rhinoplasty compared with conventional osteotomy and (b) forest plot showing the effect of piezoelectric osteotomy on postoperative duration of surgery following rhinoplasty compared with conventional osteotomy, https://links.lww.com/PRSGO/C275.)

Duration of Surgery

Total duration of osteotomy was reported in two studies,6,21 and total duration of procedure was reported in one study.6 One additional study7 reported total duration of procedure, but no measures of data spread were reported, precluding its inclusion in a quantitative meta-analysis. There was no significant difference in the duration of osteotomy (SMD, 3.15; 95% CI, −1.82 to 8.12; P = 0.22; I2 = 94%) or total duration of procedure (SMD, 0.46, 95% CI, −0.43 to 1.36; P = 0.31; I2 = NA) when performing piezoelectric osteotomy versus conventional osteotomy, though a nonsignificant trend toward increasing procedural duration (length of osteotomy + total length of surgery) was identified with use of piezoelectric technology (SMD, 2.01; 95% CI, −0.10 to 4.13; P = 0.06; I2 = 90%). These results are depicted graphically in Supplemental Digital Content 5 (https://links.lww.com/PRSGO/C275).

Risk of Bias, Heterogeneity, and Publication Bias

Risk of bias assessment identified five included studies that were at high/serious risk of bias,4,7,9,20,21 four with some concerns1,6,8,22 and only one with low risk of bias.5 Full risk of bias assessment is presented in Supplemental Digital Content 6. (See figure, Supplemental Digital Content 6, which displays risk of bias. (A) Summary of risk of bias assessment as per RoB 2 for randomized trials. (B) Summary of risk of bias assessment as per ROBINS-I for nonrandomized studies. (C) Graphical representation of risk of bias across all included studies displayed as percentages, https://links.lww.com/PRSGO/C276.)

Heterogeneity did not exist for edema on postoperative days 2 and 3 (I2 = 0% for both), and was moderate for day 7 (I2 = 34%). It was high when combining all edema grades in the first postoperative week (I2 = 70%). Heterogeneity did not exist for periorbital ecchymosis on postoperative days 2 and 3 (I2 = 0% for both), and was low for day 7 (I2 = 17%). There was no heterogeneity when combining all ecchymosis grades in the first postoperative week (I2 = 0%). Heterogeneity was moderate for pain in the first postoperative week (I2 = 59%). There was no heterogeneity for mucosal injury postoperatively (I2 = 0%). Heterogeneity was high for duration of surgery (I2 = 90%).

As recommended by the Cochrane Collaboration,19 statistical or graphical tests for publication bias were not performed due to no outcome being reported by ten or more studies. This is because the power of the tests is too low to distinguish chance from real asymmetry.

DISCUSSION

To our knowledge, this is the largest systematic review and meta-analysis comparing outcomes with piezoelectric and conventional osteotomy techniques following rhinoplasty procedures.2,3,10,11 It is also the first high-quality systematic review and meta-analysis, as judged by the AMSTAR-2 criteria. (See table, Supplemental Digital Content 2, https://links.lww.com/PRSGO/C272.)12 It demonstrates that use of piezoelectric osteotomy is associated with reduced postoperative edema, periorbital ecchymosis, and pain scores in the first postoperative week compared with conventional osteotomes. Furthermore, mucosal injury was reduced with use of piezoelectric technology, while duration of surgery was not prolonged despite use of novel technology.

Application of electric charge to piezoelectric crystals results in rapid expansion and contraction with subsequent high-frequency vibration of the instrument tip allowing denaturation of proteins and emulsification of bone.24 Piezoelectric osteotomy was first applied to rhinoplasty in lateral osteotomies, but has since expanded to medial osteotomy and dorsal hump reduction.24 It offers increased precision when cutting and sculpting bone compared with conventional osteotomy techniques, minimizing damage to surrounding tissue.25 This was demonstrated in our review by reduction in mucosal injuries when compared with conventional techniques. Additional reported advantages include increasingly stable osteotomies and avoidance of radial and asymmetric fracture lines, and damage to underlying periosteum and mucosa. The ability to maintain periosteal and mucosal integrity while reducing bony damage is likely one mechanism by which piezoelectric osteotomy reduces severity of postoperative complications such as eyelid edema, periorbital ecchymosis, and pain throughout the early postoperative period.

Previously reported limitations of piezoelectric technology include prolonged procedure time,26 potential for increased tissue damage if used inappropriately, increased cost, and learning curve inherent with new surgical techniques.24 Although one included study did report significantly longer procedure duration with piezoelectric osteotomy,6 meta-analysis revealed no significant difference, in duration of the overall procedure or of osteotomy specifically. Thus, it appears that while piezoelectric technology comes with an inconvenience of a learning curve, once proficiency is achieved, the surgeon and patient may be rewarded with superior clinical outcomes.

Extent of tissue damage is difficult to evaluate in vivo, but our search identified a cadaveric study performed by Demirbilek and Evren,22 reporting increased levels of soft-tissue necrosis with use of piezoelectric technology following histopathological evaluation. The authors postulate that long-term tissue damage caused by ultrasonic vibrations may cause problems later in follow-up, particularly in those with thin skin, representing another reason studies with longer follow-up durations are required. We also identified an RCT evaluating the impact of piezoelectric technology on short-term auditory outcomes27 that found no difference between piezoelectric and conventional osteotomy technology. This was not included in our meta-analysis as no other primary outcomes of interest identified in our prespecified protocol were reported.15

Piezoelectric technology is more expensive than conventional osteotomy techniques, with the cost of a piezoelectric osteotome unit previously reported at between 5000 and 7000‚ euros and the cost of a replacement tip ranging between 150 and 200 euros per tip. The cost of the technology may be offset by the observed reductions in postoperative complications; however, no conclusions about this can be drawn from our study as no included studies included economic analyses.3 Clinical investigators enrolling participants into future RCTs using piezoelectric osteotomy in rhinoplasty should endeavor to incorporate cost-utility analysis into their statistical plans and report incremental cost-effectiveness ratios to facilitate economic evaluation.

Our results confirm findings previously reported in smaller systematic reviews and meta-analyses. To our knowledge, three systematic reviews and meta-analyses comparing use of new piezoelectric technology and conventional osteotomy techniques in rhinoplasty have been published to date. All three studies were critically low2,3,10 when assessed using the AMSTAR-2 criteria.12 (See table, Supplemental Digital Content 2, https://links.lww.com/PRSGO/C272.) The main weaknesses were lack of explicit use of PICO framework,28 lack of transparency about literature screening process and data extraction, and omission of risk of bias assessment. Tsikopoulos et al10 also omitted the clinical trial conducted by Ghavimi et al8 despite it being published within the time window of the search and fulfilling the inclusion criteria. A recently published systematic review by McGuire et al11 compared the use of piezoelectric technology and conventional techniques in craniofacial surgery more broadly. This study was also deemed to be critically low in quality as per AMSTAR-2 criteria. (See table, Supplemental Digital Content 2, https://links.lww.com/PRSGO/C272.) This was due to their use of the methodological index for non-randomized studies (MINORS) criteria for assessing risk of bias, which does not consider bias in selection of reported results.11,29

There were several inconsistencies between the three currently published systematic reviews evaluating use of piezoelectric technology in rhinoplasty. All three studies included the study by Taskin et al,1 which failed to report which groups received which interventions. Mirza et al2 interpreted “group 1” as having undergone conventional osteotomy, while Tsikopoulos et al10 assigned the same group to have undergone piezoelectric osteotomy. Kim et al3 also included this RCT in their analysis; however, they did not report individual values and, therefore, it remains unclear how they interpreted the assignment of interventions. Ilhan et al9 reported in their RCT individual scores for postoperative edema and ecchymosis assigned by each of the two examiners; however, Tsikopoulos et al10 included only one of the two reported scores in their meta-analysis.

Rhinoplasty is an aesthetic procedure. As such, overall patient satisfaction should feature among primary outcome measures of a clinical trial assessing its use. Indeed, it has even been argued that PROs should be the raison d’etre for cosmetic surgery, with simple clinical outcome measures alone being inadequate.30 It was, therefore, surprising to find that only one study included in our analysis assessed overall patient satisfaction with the final outcome with use of a PRO. Troedhan20 used the validated and simple Rhinoplasty Outcome Evaluation (ROE) questionnaire, which addresses both aesthetic and functional deficiencies that may encourage patients to pursue rhinoplasty.31 They also correlated ROE scores with severity of postsurgical morbidity, suggesting an association between reduced morbidity in the immediate postoperative period and increased overall patient satisfaction.20 However, while the author should be commended for using PROs, it should also be noted that ROE did not undergo robust psychometric assessment during its development, and Rasch measurement theory methods were not used. Rasch analysis is increasingly used in outcomes research and highlights to what extent rigorous measurement is achieved by examining fit between observed scores (participant responses) and expected values predicted from the data by the Rasch mathematical model.32 There is an abundance of PROs available assessing functional and cosmetic aspects of rhinoplasty, with a systematic review identifying ten validated, rhinoplasty-specific PROs.14 Furthermore, the American Society of Plastic Surgeons and Royal College of Surgeons in England have reinforced the importance of including PROs in studies evaluating new cosmetic modalities.33,34 Future trials assessing any aspect of rhinoplasty should include PROs that have used modern psychometric methods in their development as key gold-standard outcome measures to ensure that patient experience remains at the forefront of surgical intervention.

Research should be transparent, reproducible, and allow readers to interpret the results independently of the author. Only four of ten included studies1,6,8,9 reported funding status, which is crucial when evaluating novel technology that carries commercial interest for device manufacturers. No studies reported comorbidities or demographic characteristics other than age and sex, which precludes analysis of specific subgroups that may benefit more from piezoelectric osteotomy. Although our study confirmed the superiority of piezoelectric osteotomy to traditional osteotomy techniques, the overall quality and internal validity of the data supporting this conclusion are low. All but one5 study included in the meta-analysis were deemed to be at moderate to high risk of bias using the RoB 2 or ROBINS-I tool. Therefore, we were unable to perform sensitivity analyses including only studies with low risk of bias, as only one study fulfilled this criterion. The key limitations were lack of clarity about randomization processes, single or unclear blinding protocols, and lack of transparency in reported results. These concerns have been raised previously about the plastic surgery literature.35 One study displayed a high attrition rate with 16 patients lost to follow-up and a further four patients dismissed from the study, with no mention of how these four patients were chosen for exclusion, which may have had important implications for interpretations of the results.9 No mention was made of whether the final study population was analyzed via the intention-to-treat principle or whether attempts to address missing data using methods such as imputation or last-observation-carried-forward were used. (See table, Supplemental Digital Content 7, which displays the PRISMA checklist, https://links.lww.com/PRSGO/C277.)

To facilitate informative comparison and meta-analysis of RCTs, authors must report findings in a standardized format including exact values for any data collected, effect sizes, standard deviations, and sample size for all subgroups as well as P values for differences and associated 95% CIs. We excluded data from multiple relevant studies because of insufficient or inadequate data reporting.1,4,6,7,21,22 Two of these excluded studies could have contributed valuable study-level data on edema, ecchymosis, and pain outcomes but the authors did not report raw data or effect sizes, only P values for differences.4,7 We were, therefore, unable to incorporate these data into meta-analyses. Another study was excluded as, while reporting data correctly, the authors failed to make explicit which groups had been assigned to which intervention, instead calling them group 1 and group 2, with no way to differentiate the groups in terms of allocation.1 Corresponding authors of these studies were contacted via email to obtain study-level data on two separate occasions, but unfortunately, no response was received. We also only included RCTs that graded edema and ecchymosis using a scale described by Kara and Gökalan23 in 1999 to ensure validity of our meta-analysis. This meant correctly reported but incompatible data from several studies were excluded.7,20,21 Future studies should focus on using standardized scales to grade postrhinoplasty outcomes to facilitate sound comparison and meta-analysis.

Heterogeneity was generally low or moderate when considering periorbital ecchymosis, pain, and mucosal injury. When combining all edema grades in the first postoperative week, heterogeneity was noted to be high. As the number of included studies in meta-analysis was small, we investigated individual study heterogeneity qualitatively rather than quantitatively. Although statistical causes of heterogeneity are likely present, clinical causes were also considered. Troedhan20 has previously noted that environmental and patient-specific factors such as ambient temperature, patient positioning, and ice-pack usage can greatly affect postoperative edema. Heterogeneity was also high for duration of surgery, which may represent differences in theater protocols or surgeon preferences and styles between different study centers. Furthermore, studies took place in disparate clinical settings, and used different brands of piezoelectric devices, which likely further contribute to an element of overall heterogeneity between included studies.

There are a few limitations of our work. Despite our study being the first high-quality systematic review and meta-analysis comparing piezoelectric with conventional osteotomy in rhinoplasty, we had to exclude three studies7,20,21 from meta-analyses because of the aforementioned issues with reporting of results. This resulted in a third of the totality of RCT evidence evaluating piezoelectric osteotomy in rhinoplasty being unavailable for comparison. As the results were in favor of piezoelectric osteotomy, they would be unlikely to change the direction of the results, but more precise effect estimates, and corresponding CIs would be obtained. If any responses from the corresponding authors who were contacted are received in the future, we will update our meta-analysis and disseminate our results. Another limitation is that the results of this meta-analysis may not be generalizable globally, as six of 10 studies were performed in Turkey,1,4,6,7,9,22 and a further two performed in Iran.5,8 Only two were performed in Western Europe,20,21 and none in the United States of America or other geographical regions undertaking a major volume of global plastic surgery procedures. The possibility of ethnic, cultural, and healthcare system-specific differences should prompt exercising caution when extrapolating these results to patient populations not enrolled in the included studies. Finally, included studies tended to only have follow-up in the immediate postoperative period‚ and as such, we cannot comment on whether the observed superiority of piezoelectric osteotomy remains robust in the medium to long term.

In conclusion, this first methodologically robust systematic review and meta-analysis provides support (albeit weak) for piezoelectric osteotomy for reducing morbidity in the immediate postoperative period, in light of the low-quality evidence that underpins these results. There is a paucity of data on medium and long-term outcomes as well as lack of PRO measurement, which must be prioritized in future research evaluating piezoelectric osteotomy. It is crucial that further RCTs adhere to Consolidated Standards of Reporting Trials36 guidelines to increase confidence in the use of piezoelectric osteotomy and provide a robust evidence base to support adoption of this promising technology.

ACKNOWLEDGMENT

We thank literature search expert Veronica Phillips at Cambridge University Medical Library, UK, for help with optimizing the search strategy applied in this study.

REFERENCES

1. Taskin U, Batmaz T, Erdil M, et al. The comparison of edema and ecchymosis after piezoelectric and conventional osteotomy in rhinoplasty. Eur Arch Otorhinolaryngol. 2017;274:861–865.
2. Mirza AA, Alandejani TA, Al-Sayed AA. Piezosurgery versus conventional osteotomy in rhinoplasty: a systematic review and meta-analysis. Laryngoscope. 2020;130:1158–1165.
3. Kim DH, Kang H, Jin HJ, et al. Effect of piezoelectric osteotomy on postoperative oedema and ecchymosis after rhinoplasty. Clin Otolaryngol. 2019;44:968–974.
4. Aydoğdu I, Bayram AA. Comparison of early and long-term effects of piezosurgery with conventional techniques for osteotomies in rhinoplasty. J Craniofac Surg. 2020;31:1539–1543.
5. Fallahi HR, Keyhan SO, Fattahi T, et al. Comparison of piezosurgery and conventional osteotomy post rhinoplasty morbidities: a double-blind randomized controlled trial. J Oral Maxillofac Surg. 2019;77:1050–1055.
6. Kocak I, Dogan R, Gokler O. A comparison of piezosurgery with conventional techniques for internal osteotomy. Eur Arch Otorhinolaryngol. 2017;274:2483–2491.
7. Koc B, Koc EA, Erbek S. Comparison of clinical outcomes using a piezosurgery device vs. a conventional osteotome for lateral osteotomy in rhinoplasty. Ear Nose Throat J. 2017;96:318–326.
8. Ghavimi MA, Nezafati S, Yazdani J, et al. Comparison of edema and ecchymosis in rhinoplasty candidates after lateral nasal osteotomy using piezosurgery and external osteotomy. J Adv Pharm Technol Res. 2018;9:73–79.
9. Ilhan AE, Cengiz B, Caypinar Eser B. Double-blind comparison of ultrasonic and conventional osteotomy in terms of early postoperative edema and ecchymosis. Aesthetic Surg J. 2016;36:390–401.
10. Tsikopoulos A, Tsikopoulos K, Doxani C, et al. Piezoelectric or conventional osteotomy in rhinoplasty? A systematic review and meta-analysis of clinical outcomes. ORL J Otorhinolaryngol Relat Spec. 2020;82:216–234.
11. McGuire C, Boudreau C, Prabhu N, et al. Piezosurgery versus conventional cutting techniques in craniofacial surgery: a systematic review and meta-analysis. Plast Reconstr Surg. 2022;149:183–195.
12. Shea BJ, Reeves BC, Wells G, et al. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both. BMJ. 2017;358:4008.
13. Kosowski TR, McCarthy C, Reavey PL, et al. A systematic review of patient-reported outcome measures after facial cosmetic surgery and/or nonsurgical facial rejuvenation. Plast Reconstr Surg. 2009;123:1819–1827.
14. Barone M, Cogliandro A, Di Stefano N, et al. A systematic review of patient-reported outcome measures after rhinoplasty. Eur Arch Otorhinolaryngol. 2017;274:1807–1811.
15. Wignakumar T, Krzak AM, Reddy R, et al. PROSPERO. Available at https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=287877. Accessed April 19, 2022.
16. Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535332–b25b2535.
17. Sterne JA, Hernán MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016;355:i4919.
18. Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898.
19. Higgins J, Green S, eds. Recommendations on testing for funnel plot asymmetry. In: Cochrane Handbook for Systematic Reviews of Interventions. Updated March 2011. Available at https://handbook-5-1.cochrane.org/chapter_10/10_4_3_1 recommendations_on_testing_for_funnel_plot_asymmetry.htm. Accessed April 19, 2022.
20. Troedhan A. Piezotome rhinoplasty reduces postsurgical morbidity and enhances patient satisfaction: a multidisciplinary clinical study. J Oral Maxillofac Surg. 2016;74:e1–1659.
21. Tirelli G, Tofanelli M, Bullo F, et al. External osteotomy in rhinoplasty: piezosurgery vs osteotome. Am J Otolaryngol. 2015;36:666–671.
22. Demirbilek N, Evren C. Is piezoelectric surgery really harmless to soft tissue? J Craniofac Surg. 2019;30:1966–1969.
23. Kara CO, Gökalan I. Effects of single-dose steroid usage on edema, ecchymosis, and intraoperative bleeding in rhinoplasty. Plast Reconstr Surg. 1999;104:2213–2218.
24. Meller C, Havas TE. Piezoelectric technology in otolaryngology, and head and neck surgery: a review. J Laryngol Otol. 2017;131:S12–S18.
25. Robiony M, Toro C, Costa F, et al. Piezosurgery: a new method for osteotomies in rhinoplasty. J Craniofac Surg. 2007;18:1098–1100.
26. Jiang Q, Qiu Y, Yang C, et al. Piezoelectric versus conventional rotary techniques for impacted third molar extraction: a meta-analysis of randomized controlled trials. Medicine (Baltim). 2015;94:e1685.
27. Ilhan AE, Durna YM, Tekin AM, et al. Effect of piezoelectric technique on auditory function on postoperative day one in septorhinoplasty surgery. J Craniofac Surg. 2018;29:E750–E753.
28. Miller SA, Forrest JL. Enhancing your practice through evidence-based decision making: PICO, learning how to ask good questions. J Evid Based Dent Pract. 2001;1:136–141.
29. Slim K, Nini E, Forestier D, et al. Methodological index for non-randomized studies (minors): development and validation of a new instrument. ANZ J Surg. 2003;73:712–716.
30. PRSonally Speaking. PROMs—King of outcome assessment tools: understanding how patients feel about their cosmetic surgery. Available at https://prsonallyspeaking.wordpress.com/2015/02/11/proms-king-of-outcome-assessment-tools-understanding-how-patients-feel-about-their-cosmetic-surgery/. Accessed April 19, 2022.
31. Alsarraf R, Larrabee WF, Anderson S, et al. Measuring cosmetic facial plastic surgery outcomes: a pilot study. Arch Facial Plast Surg. 2001;3:198–201.
32. Pusic AL, Klassen AF, Scott AM, et al. Development and psychometric evaluation of the FACE-Q satisfaction with appearance scale: a new patient-reported outcome instrument for facial aesthetics patients. Clin Plast Surg. 2013;40:249–260.
33. ASPS. ASPS Recommends the Use of Plastic Surgery Specific Patient-Reported Outcome Measures. Available at https://www.plasticsurgery.org/news/press-releases/asps-recommends-the-use-of-plastic-surgery-specific-patient-reported-outcome-measures. Accessed April 19, 2022.
34. RCSEngland. Patient Reported Outcome Measures—Royal College of Surgeons. Available at https://www.rcseng.ac.uk/standards-and-research/standards-and-guidance/service-standards/cosmetic-surgery/clinical-quality-and-outcomes/patient-reported-outcome-measures/. Accessed April 19, 2022.
35. Reddy RK, Dutt A, Charles WN, et al. The 100 most-cited articles in liposuction: a bibliometric analysis. Ann Plast Surg. 2021;87:615–622.
36. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:869.

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