Published online: 2020-09-30
Original Article
The Evolution of the Free Fibula Flap for Head and Neck Reconstruction: 21 Years of Experience with 128 Flaps Ehud Fliss, MD1 Ravit Yanko, MD1 Gal Bracha, MD1 Roy Teman, MD1 Aharon Amir, MD1 Gilad Horowitz, MD2 Nidal Muhanna, MD2 Dan M. Fliss, MD2 Eyal Gur, MD1 Arik Zaretski, MD1
Medical Center, Sackler Faculty of Medicine, Tel-Aviv University, TelAviv, Israel 2 Department of Otolaryngology, Head and Neck Surgery and Maxillofacial Surgery, Tel-Aviv Sourasky Medical Center, Tel-Aviv University, Tel Aviv, Israel
Address for correspondence Arik Zaretski, MD, Department of Plastic and Reconstructive Surgery, Head of the Microsurgery Unit, Tel-Aviv Sourasky Medical Center, 6 Weizman Street, Tel-Aviv 6423906, Israel (e-mail: [email protected]).
J Reconstr Microsurg
Abstract
Keywords
► ► ► ►
microsurgery head and neck free fibula flap mandibular reconstruction ► maxillary reconstruction
Background The free fibula flap is commonly referred to as a “workhorse” for head and neck reconstruction. During our 21-year experience with this flap, we have performed several changes in preoperative planning, operative technique, and postoperative follow-up. Patients and Methods A retrospective cohort study designed to analyze the cohort of patients who underwent free fibula transfer for head and neck reconstruction. Demographics, medical background, operative data, and postoperative outcome were collected. The changes we performed in preoperative planning, operative technique, and postoperative follow-up were assessed and their impact on outcome discussed. Results During 1998 to 2019 a total of 128 free fibula flaps were transferred for head and neck reconstruction. When comparing the patients treated in the early years to those who were treated in recent years we found no statistically significant difference in minor or major nonmicrosurgical complications in the recipient and donor site and in the rate of take backs due to microsurgical reasons. However total flap failure rate improved from 28% in early years to 8% in recent years (p ¼ 0.012). Conclusion During this 21-year period, we performed several changes in our practice. This included the use of a three-dimensional (3D) prefabricated model of the mandible, a shift toward side-table osteotomies, increasing the rate of osteofascial flaps in contrast to osteocutaneous flaps and the use of an implantable Doppler. These changes, together with a learning curve of the surgical team, significantly improved our overall success rates.
Since described by Hidalgo in 1989, the free fibula flap (FFF) has become the gold standard for reconstruction of composite bony and soft-tissue defects in the head and neck.1–6 Immediate reconstruction of mandibular and maxillary defects has been proven to be safe and efficient and is nowadays routinely performed following ablative surgery of malignant and nonmalignant lesions (e.g., osteoradionec-
rosis). The FFF is a highly diverse flap that may be harvested as an osteocutaneous or osteofascial flap and may be precisely tailored to the defect by using multiple osteotomies, double perforator-based skin flaps, muscle component, etc.3,5,7–11 Preoperative stereolithic models with or without prebent reconstruction plates and osteotomy guides may be used and have shown to decrease ischemia time, operative
received May 9, 2020 accepted August 18, 2020
Copyright © by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA. Tel: +1(212) 760-0888.
DOI https://doi.org/ 10.1055/s-0040-1717101. ISSN 0743-684X.
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1 Department of Plastic and Reconstructive Surgery, Tel-Aviv Sourasky
Fliss et al.
time, and length of stay and in some reports also improve operative outcome.7,12–14 Complication rates vary between reports and include microsurgical complications, recipient site complications (e.g., dehiscence, foreign material extrusion, fistula, and infection) and donor site complications (e.g., skin necrosis, skin graft partial, or nontake). Flap failure rates range between 0 and 13% in the majority of reports.2,7,10,15–18 During our 21-year experience with the FFF for head and neck reconstruction, we have performed several key changes in presurgical planning, surgical technique, and postoperative monitoring. The aim of this study was to describe the demographics, operative, and postoperative course of this cohort of patients, describe the changes we performed in our practice and assess trends in outcome.
Patients and Methods We performed a retrospective cohort study. After obtaining institutional review board approval (No. 0040-20-TLV), we retrieved the medical records of all the patients who underwent free fibula transfer for head and neck reconstruction while conforming to the Declaration of Helsinki. Data were extracted from Tel-Aviv Sourasky Medical Center’s computerized database. We obtained demographic details, ablative operative data, reconstructive operative data, postoperative complications, and data regarding additional surgeries. Patients with incomplete data were excluded. Recipient- and donor-site nonmicrosurgical complications were defined as minor complications if they resolved with conservative measures, and major complications if they required reoperation. Microsurgical outcome assessment included analysis of the rate of unplanned take backs, flap salvage rate, and overall rate of flap loss. Descriptive data were analyzed using Microsoft Excel for Office 365. Statistical analysis was performed using SPSS for Windows, version 22 (SPSS, Inc., Chicago, IL). The cohort was divided into two groups according to the date of surgery. The date separating the two groups was set according to the year in which several changes in patient management were made by the reconstructive team and hence these eras are not of even periods of time. The changes that were assessed included method of osteotomy (in situ vs. side table), the use of osteofascial flaps, introduction of the CAD/CAM (computer aided design and manufacturing) 3D model method, and the use of an implantable Doppler. Pearson’s Chi-square was used to compare categorical variables and two-sample t-test was used to compare means. Results were considered statically significant when p-values were less than 0.05.
Results During the years 1998 to 2019, a total of 128 FFFs were transferred for head and neck reconstruction, 120 for mandibular reconstruction (93%), and 8 for maxillary reconstruction (7%). Following exclusion due to incomplete data, there were a total of 107 patients, mean age at surgery was 53 years (range: 5–78 years), 41% of the patients had cardiovascular comorbidity and 32% were smokers (►Table 1). Mean followup was 44 months (range: 3–144 months). The most comJournal of Reconstructive Microsurgery
Table 1 Patient demographics n
%
Total
107
100
Male
58
54
Age (y) Smoking
34
Range
53
5–78
44
3–144
32
Follow-up (mo) Neoadjuvant radiation (n ¼ 103)
Mean
26
24
Any cardiovascular disease
44
41
HTN
21
20
DL
19
18
Comorbidities
DM
18
17
IHD
7
7
PVD
3
3
CVA
1
1
Squamous cell carcinoma
60
56
Ameloblastoma
15
14
Osteoradionecrosis
9
8
Diagnosis
Previous flap failure
6
5
Sarcoma
5
5
Adenoid cystic carcinoma
3
3
Mucoepidermoid carcinoma
2
2
Osteomyelitis
2
2
Other
5
5
mon indication for the ablative surgery was squamous cell carcinoma of the oral mucosa (n ¼ 60, 56%). The defect resulted from a segmental mandibulectomy in 80% of cases and the resection included skin in 21% (►Table 2). Skin defects in the recipient site were either closed primarily or using manipulation of the flap’s skin paddle. All patients underwent computed tomography angiography (CTA) of the lower limbs as part of the preoperative assessment. Reconstruction was performed with an osteocutaneous flap in 71 cases (66%), with the remainder reconstructed with an osteofascial flaps. A prefabricated 3D model was used in 75 cases (70%) with intraoperative use of balsa wood templates in 32 (30%). The donor site was most commonly closed with a split-thickness skin graft (n ¼ 65, 61%) with the remainder closed primarily. The most common donor artery was the facial artery (n ¼ 50, 50%) and the common recipient vein was the internal jugular vein (n ¼ 41, 37%). Donor and recipient site nonmicrosurgical complications are shown in ►Table 3. In the recipient site, the most common minor complication was dehiscence (n ¼ 5, 5%)
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Evolution of the Free Fibula Flap
Evolution of the Free Fibula Flap Table 2 Operative data
Table 3 Nonmicrosurgical complications %
Segmental mandibulectomy
86
80
Hemimandibulectomy
14
13
Maxillectomy
6
6
Marginal mandibulectomy
1
1
Mean
Resection
%
Dehiscence
5
5
Surgical site infection
4
4
Skin necrosis
1
1
11
10
Recipient site minor complications
Recipient site major complications
Side of resection (n ¼ 105)
Fistula
Left
48
45
Right
46
43
Bilateral
11
10
23
21
Reconstruction Osteocutaneous free fibula flap
71
66
Osteofascial free fibula flap
36
34
Intraoperative shaping
32
Prefabricated 3D model
75
70
Balsa
32
30
30
Number of osseous segments (n ¼ 55)
10
9
Skin necrosis (n ¼ 31)
4
4
Hemorrhage
2
2
Surgical site infection
1
1
Microstomia
1
1
STSG partial take (n ¼ 65)
7
11
Dehiscence
8
7
Surgical site infection
3
3
Hematoma
1
1
STSG partial-/nontake (n ¼ 65)
11
17
Skin necrosis (n ¼ 42)
2
5
Surgical site infection
1
1
Donor site major complications
2 4
Dehiscence/plate extrusion
Donor site minor complications
Reconstruction method
Intraoperative complicationsa
n
Range
1–4
0.5
Abbreviations: 3D, three-dimensional. a Two intraoperative reanastomosis, one hemorrhage, one compartment syndrome upper limb.
and the common major complication was fistula formation (n ¼ 11, 10%). Dehiscence that brought foreign material extrusion appeared in 10 cases (9%). In the donor site, the most common complication was partial or nontake of the skin graft. In 7 cases, this resolved with conservative treatment (11%) and in 11 cases, it required reoperation (17%). Two patients (5%) who underwent primary closure of the donor site suffered from skin necrosis that required reoperation. The cohort was divided into two groups according to the date of operation (►Table 4). There were a total of 25 patients in the early group and 82 patients in the recent-years group. The groups were matched for sex, age, comorbidities, and neoadjuvant irradiation. There was no statistically significant difference in the rate of nonmicrosurgical complications in the recipient or donor site. ►Table 5 summarizes the microsurgical outcome of the entire cohort and of the two subgroups. The overall rate of unplanned take backs due to microsurgical reason was 14% (n ¼ 15), most of which due to
venous congestion of the flap (n ¼ 13, 12%). The overall flap failure rate was 13% (n ¼ 14). Of the patients who were taken back to the operating room, the overall flap salvage rate was 66% (n ¼ 10). There were no statistically significant differences between the two groups in regard to overall rate of take backs; however, there was a statistically significant difference in flap failure rate that decreased from 28% in early years to 8% in recent years (p ¼ 0.012).
Discussion Head and neck and maxillofacial surgery may present great challenges to the reconstructive surgeon. The anatomical defect following composite resection commonly includes bone, skin, oral mucosa, and may include facial organs such as tongue or eye. Patient population is heterogenous in regard to age, comorbidities, and smoking status. Depending on the indication for surgery, some patients may require radiation and/or chemotherapy (neoadjuvant and/or adjuvant). Immediate reconstruction using free tissue transfer is the reconstructive method of choice in most cases. Quality of life (QOL) and functional outcome following ablative head and neck surgery and reconstruction with the FFF has improved over the years; however, objective and Journal of Reconstructive Microsurgery
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n
Resection including skin
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Table 4 Comparison of the patients according to period of surgery 2006–2019 n (%)
Number of patients
25
82
Sex: male
14 (56%)
44 (53.7%)
0.837
Age (y)
54 (13.9)
53.4 (15.9)
0.874
35. 6 (38)
41.3 (41.7)
0.545
8 (32%)
36 (43.9%)
0.290
Neoadjuvant treatment
4 (16%)
22 (26.8%)
0.246
Adjuvant treatment
5 (20%)
33 (40.2%)
0.012
Recipient site minor complications
2 (8%)
8 (9.8%)
0.792
Follow-up (mo) Comorbidities
a
Recipient site major complications
6 (24%)
21 (25.6%)
0.841
Donor site minor complications
5 (20%)
10 (12.2%)
0.471
Donor site major complications
2 (8%)
12 (14.6%)
0.389
Abbreviation: SD, standard deviation. a Ischemic heart disease, hypertension, diabetes mellitus, dyslipidemia, s/p CVA, peripheral vascular disease.
Table 5 Comparison of microsurgical outcome Total
1998–2005 n (%)
2006–2019 n (%)
p-Value
Overall microsurgical take backs
15
4 (16)
11 (13.4)
0.744
Take backs due to venous congestion
13
3 (12)
10 (12.2)
0.979
Take backs due to flap ischemia
2
1 (4)
1 (1.2)
0.369
Flap failure
14
7 (28)
7 (8.5)
0.012
Salvage rate
10
2 (50)
8 (72)
quantitative data in the literature is scarce. A recent study assessed long-term function, QOL, and aesthetics of 25 patients following resection of oral cancer and FFF reconstruction. The study evaluated patient-reported, physicianreported, and lay person-reported outcomes.19 Physicians reported a 64% functionality score in comparison to normal, especially due to absence of teeth, inadequate mastication, oral malocclusion, and incompetency. Patients, however, reported high level of functional scores on the QLQ-C30 scale but lower scores on the H&N35 score. Another study that assessed QOL after FFF reconstruction of segmental mandibulectomy defects showed that patients do experience functional loss in at least one domain but still perceived their general QOL as comparable to normal.20 The FFF is the gold-standard free flap for mandibular and maxillary reconstruction and has several advantages. It is a long bicortical bone that can be harvested up to 25 cm in length. Harvest may be performed simultaneously to the ablative surgery with a two-team approach. Multiple osteotomies can be performed and precise shaping of the flap can be achieved, with up to five bony segments generally used. New studies continue to seek refinements in harvest technique. A recent study used intraoperative indocyanin green (ICG) videoangiography to assess the effect of number of bony segments and segment length on cancellous bone perfusion to the fibula flap.21 The study found additional Journal of Reconstructive Microsurgery
osteotomies and short-segment length to negatively affect bone perfusion to the distal segment of the FFF; however, the impact on bone union and recipient site wound healing is unclear. The fibular bone is relatively uniform in diameter and in many cases allows for dental implants. It may be harvested with a single or double skin island to allow for coverage of mucosal and/or skin defects.1–3,7,10 The necessity of preoperative vascular imaging of the lower limbs is controversial; however, we preformed a preoperative CTA for all patients. A recent meta-analysis on the matter aimed to assess whether lower limb angiography is necessary to detect vascular abnormalities that would alter flap selection and prevent using the fibula flap.22 Following analysis of 16 articles on the subject, the authors conclude that low-quality evidence, suggesting the necessity of routine preoperative angiography, does exist. Furthermore, the meta-analysis found physical examination alone to be insufficient in detecting vascular abnormalities that could lead to pedal perfusion compromise and/or intraoperative change in plan due to inability to use the fibula flap. However, The FFF has several drawbacks to be mentioned. Donor site morbidity may be significant and appears in up to 30% of the patients.6 Delayed wound healing and partial/ nontake of the skin graft are common issues and may require long hospital stay, repeated clinic visits, and in some cases, reoperation.15,23–25 Recipient site morbidity is in part
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p-Value
1998–2005 n (%)
Evolution of the Free Fibula Flap
Flap Harvest We shifted from performing in situ osteotomies to side-table osteotomies. This was performed due to changes in our microsurgery team’s preference as they found side-table osteotomies to be more comfortable for the surgeon. We also found it allowed for more precise osteotomies and decreased the chance of harming the vascular pedicle. This shift most probably increased flap ischemia time; however, we did not have the complete data to assess this.
Flap Design Throughout the study period, we saw a trend toward using more osteofascial flaps in contrast to osteocutaneous flaps. Two cases of osteofascial flaps were performed in the early years and 34 in recent years (8 vs. 42.7%, p ¼ 0.001). Harvesting an osteofascial flap decreases soft tissue bulk of the flap and aids in achieving better and more precise insetting (►Fig. 1). Moreover, it allows tension-free primary closure of the donor site and avoids the need for a skin graft which in cases of partial or nontake may lead to prolonged hospitali-
zation for wound treatment and eventually reoperation. Drawbacks include the need for wide undermining in a suprafascial plane which may compromise cutaneous vascularity and pose a risk for skin necrosis. Smokers and patients with cardiovascular risk factors are at highest risk and may not be good candidates for an osteofascial flap. Previous reports have shown that osteofascial fibula flaps provide a good anatomical solution for intraoral and intramaxillary defects. The need for additional debulking procedures is reduced. The fascia is rapidly covered by mucosa in the recipient site and may allow later dentures. Donor site morbidity may also be reduced due to the decreased rate of skin grafting.4,5,27,28
Flap Design Strategy Since it became available in our institution in 2006, we have been using a prefabricated 3D model of the mandible in every surgery (n ¼ 75, 70%). We use Materialise Mimics Version 22 and Materialise 3-Matic Version 14 for creating our 3D models. We use two methods for modeling the area of the expected defect (►Fig. 2). The first method relies on the contralateral mandible as a template for the area of the defect and the second relies on a negative imprint of the defect. The former allows for a reconstruction plate to be prebent and the fibula tailored to it. The latter allows the bony fibula segments to be placed on the negative imprint and designed precisely to replace the defect. The use of CAD/CAM technology has been shown to shorten operative time, ischemia time, and in some reports improve reconstructive outcome.7,12,29,30 However, we find the main drawback of this method is that any intraoperative deviation from the ablative surgical plan may cause the templates to be less accurate. In addition to the use of a 3D model, we use a novel approach for osteotomy guides using balsa wood templates (►Fig. 3). With this method, segments of balsa wood are shaped according to the 3D model (either conforming to the reconstructive plate or to the negative imprint model). These segments of wood are then transferred to the side table and act as templates for osteotomies. The bony segments are then brought back to the recipient site and insetting is performed. We previously
Fig. 1 Osteofascial fibula flap. (A) Following harvest and osteotomies. (B) Following flap insetting. Forceps showing the thin fascial paddle used for intraoral flap coverage. Journal of Reconstructive Microsurgery
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related to irradiation damage to the head and neck and includes wound dehiscence with extrusion of the reconstruction plate, fistula formation, osteoradionecrosis, and surgical site infection all of which may require unplanned reoperation.18,26 Microsurgical complications may also appear. The rates of reexploration due to venous or arterial insufficiency vary greatly between reports. Salvage rate also varies in various reports between 30 and 70%. Flap failure appears in up to 13% in most reports.2,7,10,15–18 Operative outcome and complications are multifactorial and are patient and surgical team dependent. During the study period, we have found a statistically significant improvement in overall flap success rates with flap failure decreasing from 28% in early years to 8% in the recent decade. This is indeed related to the surgical team’s learning curve; however, other factors most probably takes part. After reviewing the changes we performed in our practice over this period and we defined several key changes that took place during the years that separate the two study groups.
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Fig. 3 Using the balsa wood technique for osteotomy design. (A, B) Segments of balsa wood designed according to the prebent reconstruction plate and fixated together. (C) Osteotomy angles guided by predesigned balsa wood segments. (D) Bony segments inset and fixated to the reconstruction plate.
reported our series that assessed this method and found it not to affect ischemia time; however, the entire cohort gained good function and postoperative imaging revealed excellent positioning and accuracy of flap positioning.12
Flap Monitoring Lastly, during the recent study period, we have introduced the use of an implantable Doppler device. In the current study, we could not compare the timing of reexploration following microsurgical complications due to lack of documentation; however, we did find that the rate of flaps that failed without any revision attempt has decreased from 56% in the early study group to 21% in the recent study group (►Table 6). This may be in part due to earlier detection of flow impairments that drove the surgical team for early reexploration. We have previously published our experience with implantable Doppler for postoperative monitoring of free flaps and found it to increase salvage rate in comparison
Table 6 Revision success rates and nonrevised flap failures 1998–2005 n (% of total)
2006–2019 n (% of total)
Successful revision
2 (22)
8 (53)
Nonsuccessful revision
2 (22)
4 (26)
Flap failure with no revision attempt
5 (56)
3 (21)
Total
9
15
Journal of Reconstructive Microsurgery
to clinical assessment of the flaps alone (96.14 vs. 89.27%, p < 0.005).31 The changes mentioned above appeared in a gradual fashion according to worldwide shifts in common practice and in accordance with updated literature. Moreover, our microsurgical team has gradually changed with younger surgeons being trained in various centers and returning with new insights and experience. These changes in evidence-based data and in surgical experience and exposure led our team to gradually introduce new approaches that later became our common practice.
Conclusion The FFF is a state-of-the-art procedure that allows accurate reconstruction of complex bone and soft-tissue defects in the head and neck (►Fig. 4). Over the years, the flap has been refined and various authors continue to investigate the options for further improvements in flap harvest, insetting, and functional and aesthetic outcome. In this study, we assessed our results with mandibular and maxillary reconstruction using the free fibula flap. We found complications rates and overall success rates to be comparable to those reported in current literature; however, slightly higher than in most recent reports. When assessing the outcome according to date of surgery we found a statistically significant improvement in flap success rates over the years. This in part is related to several key changes we established in our practice. These changes were performed following both world-wide advances in microsurgical methods and
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Fig. 2 Preoperative 3D model of the mandible. (A) The area of the defect designed by comparison to the normal side. (B) The area of the defect underlined by a negative imprint of the defect. 3D, three-dimensional.
Fliss et al.
Fig. 4 5-year-old female with a large ameloblastoma of the left mandible. (A) Preoperative photo. (B) Tumor after resection by ENT team. (C) 3D prefabricated model and reconstruction plate. (D) Balsa wood segments osteotomy guides. (E) Following flap inset. (F) Postoperative photo at 2 years. 3D, three-dimensional; ENT, ear, nose, and tongue.
technique and personal experience and training of the microsurgical team. We conclude that refinements in presurgical planning, operative technique, and postoperative monitoring may continue to improve reconstructive outcome and are therefore encouraged.
4 Mitchell SL, Seth AK, Matros E, Cordeiro PG. Maxillary reconstruc-
5
6
Funding None. Note This study was presented at annual American Society of Reconstructive Surgery (ASRM) meeting, January 13, 2020. Authors’ Contributions All authors have contributed to the study design, drafting and reviewing of the manuscript and have approved it submission.
7
8
9
10
Conflict of Interest None declared.
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Evolution of the Free Fibula Flap
Original Article
The Evolution of the Free Fibula Flap for Head and Neck Reconstruction: 21 Years of Experience with 128 Flaps Ehud Fliss, MD1 Ravit Yanko, MD1 Gal Bracha, MD1 Roy Teman, MD1 Aharon Amir, MD1 Gilad Horowitz, MD2 Nidal Muhanna, MD2 Dan M. Fliss, MD2 Eyal Gur, MD1 Arik Zaretski, MD1
Medical Center, Sackler Faculty of Medicine, Tel-Aviv University, TelAviv, Israel 2 Department of Otolaryngology, Head and Neck Surgery and Maxillofacial Surgery, Tel-Aviv Sourasky Medical Center, Tel-Aviv University, Tel Aviv, Israel
Address for correspondence Arik Zaretski, MD, Department of Plastic and Reconstructive Surgery, Head of the Microsurgery Unit, Tel-Aviv Sourasky Medical Center, 6 Weizman Street, Tel-Aviv 6423906, Israel (e-mail: [email protected]).
J Reconstr Microsurg
Abstract
Keywords
► ► ► ►
microsurgery head and neck free fibula flap mandibular reconstruction ► maxillary reconstruction
Background The free fibula flap is commonly referred to as a “workhorse” for head and neck reconstruction. During our 21-year experience with this flap, we have performed several changes in preoperative planning, operative technique, and postoperative follow-up. Patients and Methods A retrospective cohort study designed to analyze the cohort of patients who underwent free fibula transfer for head and neck reconstruction. Demographics, medical background, operative data, and postoperative outcome were collected. The changes we performed in preoperative planning, operative technique, and postoperative follow-up were assessed and their impact on outcome discussed. Results During 1998 to 2019 a total of 128 free fibula flaps were transferred for head and neck reconstruction. When comparing the patients treated in the early years to those who were treated in recent years we found no statistically significant difference in minor or major nonmicrosurgical complications in the recipient and donor site and in the rate of take backs due to microsurgical reasons. However total flap failure rate improved from 28% in early years to 8% in recent years (p ¼ 0.012). Conclusion During this 21-year period, we performed several changes in our practice. This included the use of a three-dimensional (3D) prefabricated model of the mandible, a shift toward side-table osteotomies, increasing the rate of osteofascial flaps in contrast to osteocutaneous flaps and the use of an implantable Doppler. These changes, together with a learning curve of the surgical team, significantly improved our overall success rates.
Since described by Hidalgo in 1989, the free fibula flap (FFF) has become the gold standard for reconstruction of composite bony and soft-tissue defects in the head and neck.1–6 Immediate reconstruction of mandibular and maxillary defects has been proven to be safe and efficient and is nowadays routinely performed following ablative surgery of malignant and nonmalignant lesions (e.g., osteoradionec-
rosis). The FFF is a highly diverse flap that may be harvested as an osteocutaneous or osteofascial flap and may be precisely tailored to the defect by using multiple osteotomies, double perforator-based skin flaps, muscle component, etc.3,5,7–11 Preoperative stereolithic models with or without prebent reconstruction plates and osteotomy guides may be used and have shown to decrease ischemia time, operative
received May 9, 2020 accepted August 18, 2020
Copyright © by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA. Tel: +1(212) 760-0888.
DOI https://doi.org/ 10.1055/s-0040-1717101. ISSN 0743-684X.
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1 Department of Plastic and Reconstructive Surgery, Tel-Aviv Sourasky
Fliss et al.
time, and length of stay and in some reports also improve operative outcome.7,12–14 Complication rates vary between reports and include microsurgical complications, recipient site complications (e.g., dehiscence, foreign material extrusion, fistula, and infection) and donor site complications (e.g., skin necrosis, skin graft partial, or nontake). Flap failure rates range between 0 and 13% in the majority of reports.2,7,10,15–18 During our 21-year experience with the FFF for head and neck reconstruction, we have performed several key changes in presurgical planning, surgical technique, and postoperative monitoring. The aim of this study was to describe the demographics, operative, and postoperative course of this cohort of patients, describe the changes we performed in our practice and assess trends in outcome.
Patients and Methods We performed a retrospective cohort study. After obtaining institutional review board approval (No. 0040-20-TLV), we retrieved the medical records of all the patients who underwent free fibula transfer for head and neck reconstruction while conforming to the Declaration of Helsinki. Data were extracted from Tel-Aviv Sourasky Medical Center’s computerized database. We obtained demographic details, ablative operative data, reconstructive operative data, postoperative complications, and data regarding additional surgeries. Patients with incomplete data were excluded. Recipient- and donor-site nonmicrosurgical complications were defined as minor complications if they resolved with conservative measures, and major complications if they required reoperation. Microsurgical outcome assessment included analysis of the rate of unplanned take backs, flap salvage rate, and overall rate of flap loss. Descriptive data were analyzed using Microsoft Excel for Office 365. Statistical analysis was performed using SPSS for Windows, version 22 (SPSS, Inc., Chicago, IL). The cohort was divided into two groups according to the date of surgery. The date separating the two groups was set according to the year in which several changes in patient management were made by the reconstructive team and hence these eras are not of even periods of time. The changes that were assessed included method of osteotomy (in situ vs. side table), the use of osteofascial flaps, introduction of the CAD/CAM (computer aided design and manufacturing) 3D model method, and the use of an implantable Doppler. Pearson’s Chi-square was used to compare categorical variables and two-sample t-test was used to compare means. Results were considered statically significant when p-values were less than 0.05.
Results During the years 1998 to 2019, a total of 128 FFFs were transferred for head and neck reconstruction, 120 for mandibular reconstruction (93%), and 8 for maxillary reconstruction (7%). Following exclusion due to incomplete data, there were a total of 107 patients, mean age at surgery was 53 years (range: 5–78 years), 41% of the patients had cardiovascular comorbidity and 32% were smokers (►Table 1). Mean followup was 44 months (range: 3–144 months). The most comJournal of Reconstructive Microsurgery
Table 1 Patient demographics n
%
Total
107
100
Male
58
54
Age (y) Smoking
34
Range
53
5–78
44
3–144
32
Follow-up (mo) Neoadjuvant radiation (n ¼ 103)
Mean
26
24
Any cardiovascular disease
44
41
HTN
21
20
DL
19
18
Comorbidities
DM
18
17
IHD
7
7
PVD
3
3
CVA
1
1
Squamous cell carcinoma
60
56
Ameloblastoma
15
14
Osteoradionecrosis
9
8
Diagnosis
Previous flap failure
6
5
Sarcoma
5
5
Adenoid cystic carcinoma
3
3
Mucoepidermoid carcinoma
2
2
Osteomyelitis
2
2
Other
5
5
mon indication for the ablative surgery was squamous cell carcinoma of the oral mucosa (n ¼ 60, 56%). The defect resulted from a segmental mandibulectomy in 80% of cases and the resection included skin in 21% (►Table 2). Skin defects in the recipient site were either closed primarily or using manipulation of the flap’s skin paddle. All patients underwent computed tomography angiography (CTA) of the lower limbs as part of the preoperative assessment. Reconstruction was performed with an osteocutaneous flap in 71 cases (66%), with the remainder reconstructed with an osteofascial flaps. A prefabricated 3D model was used in 75 cases (70%) with intraoperative use of balsa wood templates in 32 (30%). The donor site was most commonly closed with a split-thickness skin graft (n ¼ 65, 61%) with the remainder closed primarily. The most common donor artery was the facial artery (n ¼ 50, 50%) and the common recipient vein was the internal jugular vein (n ¼ 41, 37%). Donor and recipient site nonmicrosurgical complications are shown in ►Table 3. In the recipient site, the most common minor complication was dehiscence (n ¼ 5, 5%)
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Evolution of the Free Fibula Flap
Evolution of the Free Fibula Flap Table 2 Operative data
Table 3 Nonmicrosurgical complications %
Segmental mandibulectomy
86
80
Hemimandibulectomy
14
13
Maxillectomy
6
6
Marginal mandibulectomy
1
1
Mean
Resection
%
Dehiscence
5
5
Surgical site infection
4
4
Skin necrosis
1
1
11
10
Recipient site minor complications
Recipient site major complications
Side of resection (n ¼ 105)
Fistula
Left
48
45
Right
46
43
Bilateral
11
10
23
21
Reconstruction Osteocutaneous free fibula flap
71
66
Osteofascial free fibula flap
36
34
Intraoperative shaping
32
Prefabricated 3D model
75
70
Balsa
32
30
30
Number of osseous segments (n ¼ 55)
10
9
Skin necrosis (n ¼ 31)
4
4
Hemorrhage
2
2
Surgical site infection
1
1
Microstomia
1
1
STSG partial take (n ¼ 65)
7
11
Dehiscence
8
7
Surgical site infection
3
3
Hematoma
1
1
STSG partial-/nontake (n ¼ 65)
11
17
Skin necrosis (n ¼ 42)
2
5
Surgical site infection
1
1
Donor site major complications
2 4
Dehiscence/plate extrusion
Donor site minor complications
Reconstruction method
Intraoperative complicationsa
n
Range
1–4
0.5
Abbreviations: 3D, three-dimensional. a Two intraoperative reanastomosis, one hemorrhage, one compartment syndrome upper limb.
and the common major complication was fistula formation (n ¼ 11, 10%). Dehiscence that brought foreign material extrusion appeared in 10 cases (9%). In the donor site, the most common complication was partial or nontake of the skin graft. In 7 cases, this resolved with conservative treatment (11%) and in 11 cases, it required reoperation (17%). Two patients (5%) who underwent primary closure of the donor site suffered from skin necrosis that required reoperation. The cohort was divided into two groups according to the date of operation (►Table 4). There were a total of 25 patients in the early group and 82 patients in the recent-years group. The groups were matched for sex, age, comorbidities, and neoadjuvant irradiation. There was no statistically significant difference in the rate of nonmicrosurgical complications in the recipient or donor site. ►Table 5 summarizes the microsurgical outcome of the entire cohort and of the two subgroups. The overall rate of unplanned take backs due to microsurgical reason was 14% (n ¼ 15), most of which due to
venous congestion of the flap (n ¼ 13, 12%). The overall flap failure rate was 13% (n ¼ 14). Of the patients who were taken back to the operating room, the overall flap salvage rate was 66% (n ¼ 10). There were no statistically significant differences between the two groups in regard to overall rate of take backs; however, there was a statistically significant difference in flap failure rate that decreased from 28% in early years to 8% in recent years (p ¼ 0.012).
Discussion Head and neck and maxillofacial surgery may present great challenges to the reconstructive surgeon. The anatomical defect following composite resection commonly includes bone, skin, oral mucosa, and may include facial organs such as tongue or eye. Patient population is heterogenous in regard to age, comorbidities, and smoking status. Depending on the indication for surgery, some patients may require radiation and/or chemotherapy (neoadjuvant and/or adjuvant). Immediate reconstruction using free tissue transfer is the reconstructive method of choice in most cases. Quality of life (QOL) and functional outcome following ablative head and neck surgery and reconstruction with the FFF has improved over the years; however, objective and Journal of Reconstructive Microsurgery
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n
Resection including skin
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Table 4 Comparison of the patients according to period of surgery 2006–2019 n (%)
Number of patients
25
82
Sex: male
14 (56%)
44 (53.7%)
0.837
Age (y)
54 (13.9)
53.4 (15.9)
0.874
35. 6 (38)
41.3 (41.7)
0.545
8 (32%)
36 (43.9%)
0.290
Neoadjuvant treatment
4 (16%)
22 (26.8%)
0.246
Adjuvant treatment
5 (20%)
33 (40.2%)
0.012
Recipient site minor complications
2 (8%)
8 (9.8%)
0.792
Follow-up (mo) Comorbidities
a
Recipient site major complications
6 (24%)
21 (25.6%)
0.841
Donor site minor complications
5 (20%)
10 (12.2%)
0.471
Donor site major complications
2 (8%)
12 (14.6%)
0.389
Abbreviation: SD, standard deviation. a Ischemic heart disease, hypertension, diabetes mellitus, dyslipidemia, s/p CVA, peripheral vascular disease.
Table 5 Comparison of microsurgical outcome Total
1998–2005 n (%)
2006–2019 n (%)
p-Value
Overall microsurgical take backs
15
4 (16)
11 (13.4)
0.744
Take backs due to venous congestion
13
3 (12)
10 (12.2)
0.979
Take backs due to flap ischemia
2
1 (4)
1 (1.2)
0.369
Flap failure
14
7 (28)
7 (8.5)
0.012
Salvage rate
10
2 (50)
8 (72)
quantitative data in the literature is scarce. A recent study assessed long-term function, QOL, and aesthetics of 25 patients following resection of oral cancer and FFF reconstruction. The study evaluated patient-reported, physicianreported, and lay person-reported outcomes.19 Physicians reported a 64% functionality score in comparison to normal, especially due to absence of teeth, inadequate mastication, oral malocclusion, and incompetency. Patients, however, reported high level of functional scores on the QLQ-C30 scale but lower scores on the H&N35 score. Another study that assessed QOL after FFF reconstruction of segmental mandibulectomy defects showed that patients do experience functional loss in at least one domain but still perceived their general QOL as comparable to normal.20 The FFF is the gold-standard free flap for mandibular and maxillary reconstruction and has several advantages. It is a long bicortical bone that can be harvested up to 25 cm in length. Harvest may be performed simultaneously to the ablative surgery with a two-team approach. Multiple osteotomies can be performed and precise shaping of the flap can be achieved, with up to five bony segments generally used. New studies continue to seek refinements in harvest technique. A recent study used intraoperative indocyanin green (ICG) videoangiography to assess the effect of number of bony segments and segment length on cancellous bone perfusion to the fibula flap.21 The study found additional Journal of Reconstructive Microsurgery
osteotomies and short-segment length to negatively affect bone perfusion to the distal segment of the FFF; however, the impact on bone union and recipient site wound healing is unclear. The fibular bone is relatively uniform in diameter and in many cases allows for dental implants. It may be harvested with a single or double skin island to allow for coverage of mucosal and/or skin defects.1–3,7,10 The necessity of preoperative vascular imaging of the lower limbs is controversial; however, we preformed a preoperative CTA for all patients. A recent meta-analysis on the matter aimed to assess whether lower limb angiography is necessary to detect vascular abnormalities that would alter flap selection and prevent using the fibula flap.22 Following analysis of 16 articles on the subject, the authors conclude that low-quality evidence, suggesting the necessity of routine preoperative angiography, does exist. Furthermore, the meta-analysis found physical examination alone to be insufficient in detecting vascular abnormalities that could lead to pedal perfusion compromise and/or intraoperative change in plan due to inability to use the fibula flap. However, The FFF has several drawbacks to be mentioned. Donor site morbidity may be significant and appears in up to 30% of the patients.6 Delayed wound healing and partial/ nontake of the skin graft are common issues and may require long hospital stay, repeated clinic visits, and in some cases, reoperation.15,23–25 Recipient site morbidity is in part
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p-Value
1998–2005 n (%)
Evolution of the Free Fibula Flap
Flap Harvest We shifted from performing in situ osteotomies to side-table osteotomies. This was performed due to changes in our microsurgery team’s preference as they found side-table osteotomies to be more comfortable for the surgeon. We also found it allowed for more precise osteotomies and decreased the chance of harming the vascular pedicle. This shift most probably increased flap ischemia time; however, we did not have the complete data to assess this.
Flap Design Throughout the study period, we saw a trend toward using more osteofascial flaps in contrast to osteocutaneous flaps. Two cases of osteofascial flaps were performed in the early years and 34 in recent years (8 vs. 42.7%, p ¼ 0.001). Harvesting an osteofascial flap decreases soft tissue bulk of the flap and aids in achieving better and more precise insetting (►Fig. 1). Moreover, it allows tension-free primary closure of the donor site and avoids the need for a skin graft which in cases of partial or nontake may lead to prolonged hospitali-
zation for wound treatment and eventually reoperation. Drawbacks include the need for wide undermining in a suprafascial plane which may compromise cutaneous vascularity and pose a risk for skin necrosis. Smokers and patients with cardiovascular risk factors are at highest risk and may not be good candidates for an osteofascial flap. Previous reports have shown that osteofascial fibula flaps provide a good anatomical solution for intraoral and intramaxillary defects. The need for additional debulking procedures is reduced. The fascia is rapidly covered by mucosa in the recipient site and may allow later dentures. Donor site morbidity may also be reduced due to the decreased rate of skin grafting.4,5,27,28
Flap Design Strategy Since it became available in our institution in 2006, we have been using a prefabricated 3D model of the mandible in every surgery (n ¼ 75, 70%). We use Materialise Mimics Version 22 and Materialise 3-Matic Version 14 for creating our 3D models. We use two methods for modeling the area of the expected defect (►Fig. 2). The first method relies on the contralateral mandible as a template for the area of the defect and the second relies on a negative imprint of the defect. The former allows for a reconstruction plate to be prebent and the fibula tailored to it. The latter allows the bony fibula segments to be placed on the negative imprint and designed precisely to replace the defect. The use of CAD/CAM technology has been shown to shorten operative time, ischemia time, and in some reports improve reconstructive outcome.7,12,29,30 However, we find the main drawback of this method is that any intraoperative deviation from the ablative surgical plan may cause the templates to be less accurate. In addition to the use of a 3D model, we use a novel approach for osteotomy guides using balsa wood templates (►Fig. 3). With this method, segments of balsa wood are shaped according to the 3D model (either conforming to the reconstructive plate or to the negative imprint model). These segments of wood are then transferred to the side table and act as templates for osteotomies. The bony segments are then brought back to the recipient site and insetting is performed. We previously
Fig. 1 Osteofascial fibula flap. (A) Following harvest and osteotomies. (B) Following flap insetting. Forceps showing the thin fascial paddle used for intraoral flap coverage. Journal of Reconstructive Microsurgery
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related to irradiation damage to the head and neck and includes wound dehiscence with extrusion of the reconstruction plate, fistula formation, osteoradionecrosis, and surgical site infection all of which may require unplanned reoperation.18,26 Microsurgical complications may also appear. The rates of reexploration due to venous or arterial insufficiency vary greatly between reports. Salvage rate also varies in various reports between 30 and 70%. Flap failure appears in up to 13% in most reports.2,7,10,15–18 Operative outcome and complications are multifactorial and are patient and surgical team dependent. During the study period, we have found a statistically significant improvement in overall flap success rates with flap failure decreasing from 28% in early years to 8% in the recent decade. This is indeed related to the surgical team’s learning curve; however, other factors most probably takes part. After reviewing the changes we performed in our practice over this period and we defined several key changes that took place during the years that separate the two study groups.
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Evolution of the Free Fibula Flap
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Fig. 3 Using the balsa wood technique for osteotomy design. (A, B) Segments of balsa wood designed according to the prebent reconstruction plate and fixated together. (C) Osteotomy angles guided by predesigned balsa wood segments. (D) Bony segments inset and fixated to the reconstruction plate.
reported our series that assessed this method and found it not to affect ischemia time; however, the entire cohort gained good function and postoperative imaging revealed excellent positioning and accuracy of flap positioning.12
Flap Monitoring Lastly, during the recent study period, we have introduced the use of an implantable Doppler device. In the current study, we could not compare the timing of reexploration following microsurgical complications due to lack of documentation; however, we did find that the rate of flaps that failed without any revision attempt has decreased from 56% in the early study group to 21% in the recent study group (►Table 6). This may be in part due to earlier detection of flow impairments that drove the surgical team for early reexploration. We have previously published our experience with implantable Doppler for postoperative monitoring of free flaps and found it to increase salvage rate in comparison
Table 6 Revision success rates and nonrevised flap failures 1998–2005 n (% of total)
2006–2019 n (% of total)
Successful revision
2 (22)
8 (53)
Nonsuccessful revision
2 (22)
4 (26)
Flap failure with no revision attempt
5 (56)
3 (21)
Total
9
15
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to clinical assessment of the flaps alone (96.14 vs. 89.27%, p < 0.005).31 The changes mentioned above appeared in a gradual fashion according to worldwide shifts in common practice and in accordance with updated literature. Moreover, our microsurgical team has gradually changed with younger surgeons being trained in various centers and returning with new insights and experience. These changes in evidence-based data and in surgical experience and exposure led our team to gradually introduce new approaches that later became our common practice.
Conclusion The FFF is a state-of-the-art procedure that allows accurate reconstruction of complex bone and soft-tissue defects in the head and neck (►Fig. 4). Over the years, the flap has been refined and various authors continue to investigate the options for further improvements in flap harvest, insetting, and functional and aesthetic outcome. In this study, we assessed our results with mandibular and maxillary reconstruction using the free fibula flap. We found complications rates and overall success rates to be comparable to those reported in current literature; however, slightly higher than in most recent reports. When assessing the outcome according to date of surgery we found a statistically significant improvement in flap success rates over the years. This in part is related to several key changes we established in our practice. These changes were performed following both world-wide advances in microsurgical methods and
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Fig. 2 Preoperative 3D model of the mandible. (A) The area of the defect designed by comparison to the normal side. (B) The area of the defect underlined by a negative imprint of the defect. 3D, three-dimensional.
Fliss et al.
Fig. 4 5-year-old female with a large ameloblastoma of the left mandible. (A) Preoperative photo. (B) Tumor after resection by ENT team. (C) 3D prefabricated model and reconstruction plate. (D) Balsa wood segments osteotomy guides. (E) Following flap inset. (F) Postoperative photo at 2 years. 3D, three-dimensional; ENT, ear, nose, and tongue.
technique and personal experience and training of the microsurgical team. We conclude that refinements in presurgical planning, operative technique, and postoperative monitoring may continue to improve reconstructive outcome and are therefore encouraged.
4 Mitchell SL, Seth AK, Matros E, Cordeiro PG. Maxillary reconstruc-
5
6
Funding None. Note This study was presented at annual American Society of Reconstructive Surgery (ASRM) meeting, January 13, 2020. Authors’ Contributions All authors have contributed to the study design, drafting and reviewing of the manuscript and have approved it submission.
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8
9
10
Conflict of Interest None declared.
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