effectiveness analysis on a series of 179 cases

effectiveness analysis on a series of 179 cases

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ARTICLE IN PRESS

JID: JINJ

[m5G;November 6, 2019;14:23]

Injury xxx (xxxx) xxx

Contents lists available at ScienceDirect

Injury journal homepage: www.elsevier.com/locate/injury

Free perforator flaps vs propeller flaps in lower limb reconstruction: A cost/effectiveness analysis on a series of 179 cases Marco Innocenti∗, Irene Dell’Acqua, Matteo Famiglietti, Livia Vignini, Giulio Menichini, Serena Ghezzi Department of Plastic and Reconstructive Surgery and Microsurgery, Careggi University Hospital, Largo Palagi 1, 50139 Florence, Italy

a r t i c l e

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Article history: Available online xxx Keywords: Free flap Lower limb reconstruction Microsurgery Perforator flap Reconstructive surgery

a b s t r a c t Purpose: The aim of this report is to compare free perforator flaps and propeller flaps in the coverage of lower limb soft tissue defects. Patients and methods: 179 patients (age between 5 and 92 years old), underwent soft tissue reconstruction of the lower limb between January 2009 and January 2015, either by free flap or propeller flap. The two groups were retrospectively evaluated in order to assess the outcome, complications and potential risk factors. Correlations between risk factors and presence/absence of failure or complications have been evaluated with descriptive statistical analysis and a set of logistic regression models. Finally, an economic analysis was conducted to evaluate the different tecniques. Results: In a simple descriptive statistical analysis, the overall failure rate is 6% for free flaps and 3.7% for propeller flaps; the complication rates are 14% vs 21.5% and it increases as dimension increases. The logistic models relating failure and complications with potential risk factors do not show significant differences, whereas the economic analysis show that the average expense of free flaps is 5077.5€ per patient, 1595.6€ per patient for propeller flaps. Conclusions: Our results do not demonstrate significant differences between the two groups about correlation of risk factors or flap size with complication or failure. The surgical option choice should be taken only after accurate evaluation of the soft tissue surrounding the defect. Propeller flaps should be preferred in case of small/medium size defects in otherwise healthy extremities. Free perforator flaps should be the choice in large defects due to trauma or vascular diseases. The economic analysis suggests that propeller flap should be considered when possible. © 2019 Elsevier Ltd. All rights reserved.

Introduction The reconstruction of lower limb soft tissue defects is still a challenging task for the reconstructive surgeon, mainly due to the limited availability and mobility of soft tissue and skin in this part of the body. For this reason, free flaps have been widely applied and considered as a gold standard in the treatment of lower extremity soft tissue defects [1–3]. Recently, the advent of propeller flaps significantly changed this perspective increasing the number of potential donor sites and providing a “like with like reconstruction” with a less invasive procedure [4–8] if compared to free flaps. Moreover, some anatomical districts are difficult to cover with conventional pedicled flaps, but

they may be repaired with propeller flaps, achieving similar results to those with free flaps, (Fig. 1(a) and (b)). Free flaps have the advantage of being an healthy tissue from a distant donor site, which does not exploit an already damaged area. Authors that prefer propeller flaps emphasize the relatively simple procedure, the low morbidity and the “like with like reconstruction”. Although many papers in literature report the outcomes either in free [9–16] or propeller flaps [5,17–23], only one article reports the results of a review [24] concerning complications and survival rate in the two groups. In our study a sample of 179 patients, who had surgery in a single Institution, is retrospectively analyzed, comparing two procedures in a cost/effectiveness evaluation, including the economical impact of the two option. Patients and statistical methods



Corresponding author. E-mail addresses: [email protected] (M. Innocenti), [email protected] (S. Ghezzi).

Between January 2007 and January 2015, 179 patients underwent lower limb soft tissue defects reconstruction, either using

https://doi.org/10.1016/j.injury.2019.10.039 0020-1383/© 2019 Elsevier Ltd. All rights reserved.

Please cite this article as: M. Innocenti, I. Dell’Acqua and M. Famiglietti et al., Free perforator flaps vs propeller flaps in lower limb reconstruction: A cost/effectiveness analysis on a series of 179 cases, Injury, https://doi.org/10.1016/j.injury.2019.10.039

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Fig. 1. A propeller flap based on a perforator of the posterior tibial artery (a) and an ALT flap (b) used to cover the same anatomical area after sarcoma resection. Similar cosmetic and functional outcome, however the free flap is affected by some color mismatching. Table 1 Populations of studies concerning free and perforator-pedicled propeller flaps.

Population Numbers Mean age Comorbidities High blood pressure Smoker Diabetes Arteriopathy Etiologies Post-traumatic Oncologic resection Infectious Burn injury Pressure sore

Free flap % (n)

Pedicled propeller flap% (n)

n = 100 49 (range 5–89)

n = 79 53 (range 11–92)

15% (15) 15% (15) 4% (4) 2% (2)

29% (23) 25% (20) 6% (5) 0,8% (1)

49% (49) 28% (28) 3% (3) 3% (3) 17% (17)

50,6% (40) 26,6% (21) 5,1% (4) – 17,7% (14)

free flaps (100 patients) or propeller flaps (79 patients) (Table 1). First, we conducted a statistical descriptive analysis. Then, we fitted several logistic regression models. The aim of our study is the assessment of potential correlations between defect etiology, main risk factors (diabetes, hypertension, smoking) and size of the defect with postoperative complications (including total failure of the flap). We used logistic regressions adjusted for gender and age (75) and dimension as a continuous variable. All the analyses were performed using R 3.2.4 (R Development Core Team, Bell Laboratories, NJ, USA). We considered as outcome variables the occurrence of complications as well as failure. Results from the statistical analysis We elaborated all the data using a descriptive statistical analysis. In the first group, who underwent reconstructive surgery with free flap (100 patients), the mean age was 49 years (range 5– 89 years) and the sex ratio was 1.6 (61 male/39 female). The average follow-up was 12 months. There were 49 post-traumatic cases (49%), 28 oncological resections (28%), 17 unspecified sores of various etiology (17%), 3 post-infectious complications (3%) and 3 burns (3%). Most of cases are, therefore, attributable to the first three etiologies (94%). The anterolateral tigh flap (ALT) was used

in 81 cases (81%), a SCIP flap in 7 cases (7%), a radial flap in 7 cases (7%), a medial plantar flap in 4 cases (4%) and one ulnar flap (1%). Myocutaneous and muscle free flaps have been excluded in order to compare two homogeneous groups of flaps with similar anatomy and similar indications. The average flap size used was 135.6 cm² (range 30–400 cm²). The most frequent comorbidities were high blood pressure (15%), smoke (15%), diabetes (4%), and arteriopathy (2%). In the second group, who underwent reconstruction with pedicled propeller flap (79 patients), the mean age was 53 years (range 11–92 years) and the sex ratio was 1.4 (46 male/33 female). The average follow-up was 12 months. There were 40 posttraumatic cases (50.6%), 21 oncological resections (26.6%), 14 unspecified sores of various etiology (17.7%) and 4 post-infectious complications (5.1%). Most of cases are therefore, attributable to the first three etiologies (94.9%). The vascular source of the perforator artery that supplied the flap was the posterior tibial artery in 36 cases (46%), the peroneal artery in 11 cases (14%), the popliteal artery in 8 cases (10%), the deep femoral artery in 8 cases (10%), the anterior tibial artery in 5 cases (6%), the medial plantar artery in 4 cases (5%), the circumflex femoral artery in 4 cases (5%) and the artery saphenous in 3 cases (4%). The average flap size was 68 cm² (range 10–252 cm²). The most frequent comorbidities were high blood pressure (29%), smoke (25%), diabetes (6%), and arteriopathy (0.8%). During the follow-up period, flaps survival rate and incidence of complications were evaluated in the two groups (free flap and propeller) (Table 2). In the Free flaps group, 94 out of 100 free flaps survived (94%), whereas six flaps developed total necrosis (6%). Four of them underwent limb salvage with a new free flap, whereas 2 limbs were amputated. Complications occurred in 14 patients (14%). Major complications were: wound dehiscence with venous congestion in 8 patients (8%), transient ischemia in 5 patients (5%), partial necrosis in one patient (1%). Six patients (6%) underwent secondary surgery (skin graft) because of complications. The donor site was closed primarily in 89 cases (89%) and a skin graft was required in 11 cases (11%). In the Propeller flaps group 76 out of 79 propeller survived (96,3%), only 3 suffered total necrosis (3,7%) which underwent limb salvage with a free flap. Complications occurred in 17 patients

Please cite this article as: M. Innocenti, I. Dell’Acqua and M. Famiglietti et al., Free perforator flaps vs propeller flaps in lower limb reconstruction: A cost/effectiveness analysis on a series of 179 cases, Injury, https://doi.org/10.1016/j.injury.2019.10.039

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M. Innocenti, I. Dell’Acqua and M. Famiglietti et al. / Injury xxx (xxxx) xxx Table 2 Results of studies concerning free and perforator-pedicled propeller flaps.

Population Success Failure rate Complication Wound dehiscence with venous stasis Transient ischemia Distal necrosis Secondary surgery Donor site Closed primarily Split thickness skin graft

Free flap % (n)

Pedicled propeller flap% (n)

80% (80) 6% (6) 14% (14)

74,8% (59) 3,7% (3) 21,5% (17)

8% 5% 1% 6%

(8) (5) (1) (6)

5% (4) – 16,5% (13) 12,7% (10)

89% (89) 11% (11)

69,6% (55) 30,4% (24)

(21.5%). The main complications were distal tip necrosis in 13 patients (16.5%) and wound dehiscence with venous congestion in 4 (5%). 10 patients (12.7%) required secondary surgery. They went through debridement and skin graft. The donor site was closed primarily in 55 cases (69,6%), a split thickness skin graft was necessary in 24 cases (30,4%). The fitted statistical models relate to three logistic regressions. The risk of complications in the group of patients treated with propeller flap is higher than in the group of patients treated with free flap (OR = 2.03; 90% CI: 0.94,4.42; p-value = 0.1337) and the risk increases as dimension increases (p-value = 0.1259). However, because p-values are quite large, both the results are not statistically significant. Overall, the role of etiology of the defect is not significant (p-value = 0.273), even if the risk of complications is higher in case of infections and burns. Risk factors are not relevant in predicting complications. The risk clearly increases with dimension considering failures (p-value = 0.077), but there is not a relevant difference between surgical treatments. Overall the role of the etiology of the loss of substance is not so relevant (p-value = 0.1521), even if the odds ratio of failure for burns compared to trauma is equal to 42. We can conclude that because of the small sample available, the statistical analysis cannot reach significant levels in order to better define the correlation between risk factors and complications. However, it is possible to find a correlation between the size of the defect and the prognosis of the treatment: a larger loss of substance corresponds to a worse prognosis in both surgical techniques. Concerning the etiology of loss of substance, we can state that this variable is not relevant in the development of complication or failures, but there is some evidence that burns are worse than others. Economical analysis The second aim of our study was to compare the duration of surgery, time of hospitalization and costs related to the two surgical techniques. This results cannot be properly achieved considering all the patients because of different variables. The most disturbing variable is probably the influence of concurrent orthopedic procedures, which affects the duration of the surgery and the time of hospitalization. Therefore, the analysis of data was limited to a group of 20 patients of similar age who underwent reconstruction (10 free and 10 propeller flaps) in the past 2 years without concomitant orthopedic surgery and no complications (Table 3). The average duration was 354 min for reconstruction with free flap, versus 117 min for a reconstruction with the propeller flap. The average length of hospitalization of a patient treated with free flap was 8 days, whereas it was 4 days for those treated with propeller flap. In the economical analysis, we considered the following costs: hospitalization, drugs used during hospitalization,

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Table 3 Economical analysis on a group of 20 patients concerning free and perforatorpedicled propeller flaps.

Population Operating room Staff (surgeons, nurses, other operators) Instruments Hospitalization Days of hospitalization Drugs Wound dressing Lab examinations Total amount

Free flap €

Pedicled propeller flap €

4245.3

1160.2

2987.5 1257.8 832.1 528 64.9 23.2 216 5077.4

689.9 470.3 435.4 234 33.4 9.6 158.4 1595.6

medications, surgical procedure (operating room, medical and nursing staff, materials) and exams. Focusing on materials of the operating room, there is a substantial difference between the two surgical procedures. In fact, while the material cost for a free flap amounts to € 4245.30, the cost amounts to € 1160.20 for a propeller, with a difference of € 3085.10. The economical difference between the two surgical procedures remains the same in most of the other points taken into consideration. In the end, the average total cost was € 5077.40 for a free flap, € 1595.60 for a propeller. Discussion The ideal reconstruction of soft tissue defects in the lower extremity should replace “like with like” tissue, it should minimize the morbidity of the donor site, it should preserve the main vascular axis and reduce operating and hospitalization time [4–8]. Conventional pedicled flaps resulted to be effective only in a limited number of recipient sites so far [25–30]. Medial gastro and hemisoleous flaps used to be the best choice for knee coverage, while the sural flap played some role in the soft tissue reconstruction of the distal leg. However, recently free flaps have been addressed as the gold standard of treatments, specially in case of defects located in the distal third of the leg, due to the lack of local options [1–3]. The introduction of the propeller flaps expanded the reconstructive options for lower limb soft tissue. They increase the potential donor sites, including those anatomical districts where conventional pedicled flaps were not available. Actually, a propeller flap may be raised anywhere a sizable perforator is present. Moreover, the color and texture of the skin in the proximity of the defect match the recipient area. Also, the donor site morbidity is minimal since no major vessels are sacrified, and the donor area may be closed primarily in the most part of cases. Operative technique has been gradually refined over the last few years so nowadays propeller flaps are considered to be an effective procedure for reconstruction, in almost all the anatomical districts, of small/medium size defects [31–33]. Free flaps, on the other hand, are still the favourite method of treatment by several surgeons, who advocate the superiority of free tissue transfer. Dimension is probably the leading reason to prefer a free flap. In fact there is no doubt that a free flap may be much larger than a propeller flap. Another reason is to reduce the impact on an already compromised anatomical segment. That can be a valuable reason to move to free tissue transfer from a distant donor site [34–38]. Although several papers reported large experiences with either the two procedures, only one article is available in international literature reporting the comparison between free and propeller flaps in lower extremity reconstruction [24]. Bekara et al. reported a systematic review of 36 studies discussing the results of 1226

Please cite this article as: M. Innocenti, I. Dell’Acqua and M. Famiglietti et al., Free perforator flaps vs propeller flaps in lower limb reconstruction: A cost/effectiveness analysis on a series of 179 cases, Injury, https://doi.org/10.1016/j.injury.2019.10.039

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Fig. 2. A case where the bad microcirculation of the leg drove to failure of the propeller flap, subsequently salvaged with a free flap. (a) A propeller flap designed on a perforator of the posterior tibial artery to cover a vascular sore exposing the Achilles tendon. (b) Identification and dissection of two healthy perforators from the posterior tibial artery.

Fig. 3. (a) Partial necrosis of the flap and of the surrounding skin two days postop. (b) Salvage with ALT and fascia lata to reconstruct the tendon. (c) Wound dehiscence and partial necrosis of the skin of the lateral aspect of the foot 6 days postop.

Fig. 4. Total recovery 2 months postoperatively, without any further surgery, thanks to the trophic enhancement due to free flap.

free flaps, and 19 articles reporting the outcome of 302 propeller flaps. Although this review provides interesting information on a large number of patients, in our opinion it is different from our report for the following reasons: the total number of free flaps is four times the propeller flaps, in free flaps groups are included also muscle and myocutaneous flaps (57,5%), the period of time is not homogeneous, the assessment of the outcome is carried out in different institutions according to different principles. On the contrary, the aim of our study was to compare retrospectively the outcomes of free flaps and propeller flaps in two similar groups of patients, who underwent reconstructive surgery in a single institution over a period of seven years. All the free flaps were perforator flaps, so that no other variable but the donor site (distant/local) and the execution of microvascular anastomosis had to be taken into account. The two groups of patients are similar in number, etiology of the defect and comorbidities, plus they underwent surgery in the same period of time by the senior author (M.I.). Summarizing, the results of our analysis point out a slight superiority of propeller flaps in terms of survival (96.3% propeller vs 94% free flaps) but a higher rate of complications (21.5% propeller vs 14% free flaps), although complications in propeller flaps have been minor complications in the most of cases, with a low rate of secondary surgery. The correlation between risk factors and complications in the two groups of patients did not show any statistically significant difference. Also, the size of the flap does not seem to affect the results in the two groups of patients. Finally, the economical analysis showed that propeller flaps are less expensive, due to shorter operating time (354 min for free flaps versus 117 min for propeller flaps) and shorter time of hospitalization (8 days free flaps versus 4 days propeller). Although this study cannot provide any algorithm of treatment, the reported data show that both the procedures may be safely

Please cite this article as: M. Innocenti, I. Dell’Acqua and M. Famiglietti et al., Free perforator flaps vs propeller flaps in lower limb reconstruction: A cost/effectiveness analysis on a series of 179 cases, Injury, https://doi.org/10.1016/j.injury.2019.10.039

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applied in lower limb reconstruction. An accurate evaluation of local and general conditions should drive the surgeon to the best option, which should be tailored according to the need of every single patient. In our opinion, free flaps still remain the first choice in case of large defects, whenever composite flaps are required. They are also the gold standard in case of reconstruction of the foot sole, because of the quantity and of the quality of the transferred tissues. Propeller flaps are a good alternative, specially in the knee area, the Achilles tendon region and the ankle. The poor quality of the skin near the defect and the presence of edema are the main contraindications for propeller flaps, which should not be attempted in those circumstances (Figs. 2–4). In our opinion, propeller flaps may be the best choice in case of tumor resection because the involved limb is otherwise healthy and the surrounding tissues may be safely dissected, whereas free flaps may be the best in mangled or severely damaged extremities, especially when some time has elapsed from trauma and the bone is involved. In these cases, we think that a healthy tissue transfer from a distant location provides optimal coverage of the defect without jeopardizing a limb that already suffered from a traumatic event. In our experience of the past seven years, the trend shows an increase of propeller flaps up to a plateau which is now stable. At present time, free and propeller flaps are almost equally applied. The most important limitation of our study is the small size of the sample, indeed it is possible that an association between risk factors and complications (including flap failures) might have been missed due to insufficient sample size. However, the other variables considered (age, gender, etiology of loss of substance, comorbidities and type of complications) are homogenous. Our study was underpowered to better compare the data regarding costs, duration of surgery and time of hospitalization. Nevertheless, our data may be considered as useful pilot data for future, larger, multicenter studies on this topic. Conclusions We did not find any objective reason to prefer routinely either one of the two techniques. Nevertheless, there is no doubt that performing a free flap is a longer procedure with a higher biological and economical impact. That should be taken into account in all those clinical situations where a shorter but not necessarily easier procedure, such as a propeller flap, may be safely applied. Declaration of Competing Interest The authors declare that there is no conflict of interest. Acknowledgments We thank Michela Baccini Ph.D. M.D., Emanuela Dreassi Ph.D. M.D. and Andrea Bencini M.D., University of Florence, Department of Statistics, for their contributions to the statistical analysis. References [1] Acland RD. Refinements in lower extremity free flap surgery. Clin Plast Surg 1990;17:733–44. [2] Shipkov H, Traikova N, Voinov P, Boucher F, Braye F, Mojallal A. Vascularloops in reconstructive microsurgery: a review of the literature. Ann Chir Plast Esthet 2014;59:1–8. [3] Godina M. Early microsurgical reconstruction of complex trauma of the extremities. Plast Reconstr Surg 1986;78:285–92. [4] Teo TC. The propeller flap concept. Clin Plast Surg 2010;37:615–26. [5] Tos P, Innocenti M, Artiaco S, Antonini A, Delcroix L, Geuna S, Battiston B. Perforator-based propeller flaps treating loss of sub-stance in the lower limb. J Orthop Traumatol 2011;12:93–9.

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Please cite this article as: M. Innocenti, I. Dell’Acqua and M. Famiglietti et al., Free perforator flaps vs propeller flaps in lower limb reconstruction: A cost/effectiveness analysis on a series of 179 cases, Injury, https://doi.org/10.1016/j.injury.2019.10.039