Long-term outcomes in virtual surgical planning for mandibular reconstruction: A cost-effectiveness analysis.

OBJECTIVE: This study is an economic evaluation comparing virtual surgical planning (VSP) utilization to free hand mandibular reconstruction (FHR) for advanced oral cavity cancer, for which the cost effectiveness remains poorly understood. The proposed clinical benefits of VSP must be weighed against the additional upfront costs. METHODS: A Markov decision analysis model was created for VSP and FHR based on literature review and institutional data over a 35-year time horizon. Model parameters were derived and averaged from systematic review and institutional experience. VSP cost and surgical time saving was incorporated. We accounted for long-term risks including cancer recurrence and hardware failure/exposure. We calculated cost in US dollars and effectiveness in quality-adjusted-life-years (QALYs). A health care perspective was adopted, discounting costs and effectiveness at 3%/year. Deterministic and probabilistic sensitivity analyses tested model robustness. RESULTS: In the base case scenario, total VSP strategy cost was $49,498 with 8.37 QALYs gained while FHR cost was $42,478 with 8.27 QALY gained. An incremental cost-effectiveness ratio (ICER), or the difference in cost/difference in effectiveness, for VSP was calculated at $68,382/QALY gained. VSP strategy favorability was sensitive to variations of patient age at diagnosis and institutional VSP cost with one-way sensitivity analysis. VSP was less economically favorable for patients >75.5 years of age or for institutional VSP costs >$10,745. In a probabilistic sensitivity analysis, 55% of iterations demonstrated an ICER value below a $100,000/QALY threshold. CONCLUSIONS/RELEVANCE: VSP is economically favorable compared to FHR in patients requiring mandibular reconstruction for advanced oral cancer, but these results are sensitive to the patient's age at diagnosis and the institutional VSP cost. Our results do not suggest if one "should or should not" use VSP, rather, emphasizes the need for patient selection regarding which patients would most benefit from VSP when evaluating quality of life and long-term complications. Further studies are necessary to demonstrate improved long-term risk for hardware failure/exposure in VSP compared to FHR.

Time and cost-analysis of virtual surgical planning for head and neck reconstruction: A matched pair analysis.

OBJECTIVES: Virtual surgical planning (VSP) uses patient-specific modelling of the facial skeleton to provide a tailored surgical plan which may increase accuracy and reduce operating time. The aim of this study was to perform a time and cost-analysis comparing patients treated with and without VSP-technology. MATERIAL AND METHODS: A retrospective analysis of 138 patients undergoing microvascular free flap mandible (76.8%) or maxillary (23.2%) reconstruction between 2010 and 2018 was performed. The cohort was divided into two groups according to reconstruction-approach: non-VSP and proprietary-VSP (P-VSP). Cost-analysis was performed comparing non-VSP and P-VSP by matching patients according to site, bone flap, indication, complexity and age. RESULTS: Fibula, scapula and iliac crest free flaps were used in 92 patients (66.7%), 33 patients (23.9%) and 13 patients (9.4%), respectively. Eight patients (5.8%) required revision of the microvascular anastomosis, of which four flaps were salvaged giving a 2.9% flap failure rate. P-VSP was associated with shorter median length of stay (LOS) (10.0 vs 13.0 days, p = 0.009), lower mean procedure time (507.38 vs 561.75 min, p = 0.042), and similar median total cost ($34939.00 vs $34653.00, p = 0.938), despite higher complexity (2.0 vs 1.0, p = 0.09). In the matched-series, P-VSP was associated with a similar median LOS (10.5 vs 11 days), lower mean procedure time (497 vs 555 min, p = 0.231), lower mean total cost ($35,493 v $37,345) but higher median total cost ($35504.50 vs $32391.50, p = 0.607), although not statistically different. CONCLUSION: VSP-technology represents a helpful surgical tool for complex reconstructions, without adversely impacting on the overall-cost of treatment.

Economic analysis of a low-cost virtual surgical planning protocol for mandibular reconstruction: a case series.

The aim of this study was to make an economic analysis and evaluation of a low-cost virtual surgical planning (VSP) protocol that was developed in house, and based on open-source software and a desktop 3-dimensional printer. All eight patients between April 2014 and 2015 who had been treated by mandibular reconstructions with microvascular fibular flaps that had been planned using the protocol were retrospectively analysed for accuracy, time, and cost. Median differences for planned compared with postoperative intercondylar distance, intergonial distance, and gonial angle did not differ significantly. A median (range) labour time of 85 (€57-124) minutes was needed. An evaluation of cost, including labour, showed an additional median (range) cost/patient of € 276 (€257.50-297.25). With the acquisition cost of the 3-dimensional printer omitted, there was a negligible additional cost/patient of €44.75 (€26.25-66). All planning was done by the junior surgeon and there was a steep learning curve. Our new VSP protocol is cost-effective, easy to use, and has an accuracy comparable with that of a standard VSP protocol. To the best of our knowledge this is the first report of an open-source software protocol in which the labour costs of the planning by a surgeon are included.

Cost-Effectiveness Analysis of Virtual Surgical Planning in Mandibular Reconstruction.

BACKGROUND: Because of the complex nature of osteocutaneous free flap mandibular reconstruction, modern technologies such as virtual surgical planning have become popularized to refine the procedure. Compared with usual care, virtual surgical planning has been suggested to reduce operative time and improve accuracy of outcomes. The aim of this study was to examine the cost-effectiveness of virtual surgical planning versus usual care in mandibular reconstruction. METHODS: A decision-analytic model was constructed to comparatively understand cost-effectiveness of virtual surgical planning and usual care treatments based on additional costs of virtual surgical planning, and costs attributed to probabilities of postoperative complications. Model structure was informed through qualitative clinical interviews from the University of North Carolina, and supported through University of North Carolina clinical data and literature. Costs and complication probabilities were estimated from the literature. Sensitivity analyses of all uncertain model parameters were performed, and distributional parameters were selected based on best practices. RESULTS: Results of base-case analysis indicated that virtual surgical planning was more costly by a difference of $7099 per person and did not reduce the risk of complications or flap loss. Virtual surgical planning cases had an increased incidence of flap loss by 0.6 percent and an increased incidence of mandibular infection by 6.5 percent. CONCLUSIONS: Virtual surgical planning has upfront expenses that do not necessarily translate into downstream reduction in complications or improved outcomes. Clinical decision-makers would benefit from future research to identify thresholds whereby virtual surgical planning may result in more cost-savings for particular types of patients.

Maxillofacial reconstruction using in-house virtual surgical planning.

BACKGROUND: Mandibular and maxillary reconstruction using fibula free transfer is common in many tertiary referral centres. Virtual surgical planning (VSP) is a relatively recent adjunct that allows surgeons to plan resection and reconstruction prior to theatre. This has been shown to reduce operative times and decrease surgeon stress intraoperatively. VSP requires technicians with the appropriate skill set and required materials, software and technology, which is accompanied by a cost that may be prohibitive. Usually, this is outsourced to an external company. We present a preliminary case series of VSP in maxillofacial reconstruction done using our own staff without external resources. METHODS: Six patients underwent mandible (n = 5) or maxillary (n = 1) reconstruction with a fibula free flap using in-house VSP. The cases ranged from relatively simple to complex. We present our steps in the planning process and application of this technique. RESULTS AND CONCLUSION: In-house VSP is a feasible process with low cost and turnaround time, making surgery more efficient.

Low-cost, self-made CAD/CAM-guiding system for mandibular reconstruction.

Facial symmetry, as well as function, remains the big challenge for surgeons who attempt mandibular reconstruction. Nowadays several studies recommend the use of computer aided surgery (CAS) and CAD/CAM technology to guide mandibular segmental osteotomies and reconstruction using free fibula flap. Although these systems have radically changed the way of doing mandibular reconstructive surgery, they are expensive and require extended periods of time for prototypation. This may be an important limitation in case of malignant neoplasms which require short-term treatment. The aim of our study is to investigate the reliability and efficiency of a protocol to obtain cutting guides produced in a "homemade" way. This study includes four consecutive patients who underwent a segmental mandibulectomy and fibula osteo-cutaneous free flap reconstruction for oral squamous cell carcinoma between January and September 2016. The CAD/CAM system algorithm proposed was based on the use of free open source software for digital planning and 3D layer plastic deposition printer. A cost of about 3 Euro for each case was estimated. An average mean distance between 3D preoperative and postoperative mesh points of 1.631 mm and a standard deviation of 5.496 mm has been demonstrated by 3D volume overlay analysis. Overlapping results with much shorter prototyping time was required with the in-house procedure described as compared to the available commercial system. In conclusion, we expect that this technique will reduce operative time and cost however further study and large series are needed to confirm our results and better define the applicability in everyday surgical practice.

Mandible reconstruction with free fibula flaps: Outcome of a cost-effective individual planning concept compared with virtual surgical planning.

PURPOSE: The free osteomyocutaneous fibular flap has become one of the primary options for mandibular reconstruction, because of the later introduction and development of virtual surgical planning (VSP). However, VSP is associated with high additional pre-operative effort and costs. Therefore, the purpose of the study was to develop a new individual cost-effective pre-operative planning concept for free fibula mandible reconstruction and to compare it with VSP regarding clinical parameters and post-operative outcome. MATERIALS AND METHODS: 31 patients undergoing mandibular reconstruction with a microvascular free fibular flap were divided into two groups and retrospectively reviewed. For the first group A (18 of 31 patients), an individual method with stererolithographic (STL) models, silicon templates and hand-made cutting guides was used (about 250 € planning costs/patient). For the second group B (13 of 31 patients), VSP including pre-fabricated cutting guides was used (about 2500 € planning costs/patient). RESULTS: We found no statistically significant differences with respect to intra-operative time of mandibular reconstruction, duration of hospitalisation or post-operative complications between the two groups (p ≥ 0.05). CONCLUSION: The surgical outcomes and operative efficiency of this individual and cost-effective planning concept are comparable with the much more expensive complete VSP concept.

Multicenter prospective micro-costing study evaluating mandibular free-flap reconstruction.

Free-flap mandibular reconstruction is a highly specialized procedure associated with severe complications necessitating re-interventions and re-hospitalizations. This surgery is expensive in terms of health workers' time, equipment, medical devices and drugs. Our main objective was to assess the direct hospital cost generated by osseocutaneous free-flap surgery in a multicentric prospective micro-costing study. Direct medical costs evaluated from a hospital perspective were assessed using a micro-costing method from the first consultation with the surgeon until the patient returns home, thus confirming the success or failure of the free-flap procedure. The mean total cost for free-flap intervention was 34,009€ (5151-119,604€), the most expensive item being the duration of hospital bed occupation, representing 30-90% of the total cost. In the event of complications, the mean cost increased by 77.3%, due primarily to hospitalization in ICU and the conventional unit. This surgery is effective and provides good results but remains highly complex and costly.

Is a computer-assisted design and computer-assisted manufacturing method for mandibular reconstruction economically viable?

The design and manufacture of patient-specific mandibular reconstruction plates, particularly in combination with cutting guides, has created many new opportunities for the planning and implementation of mandibular reconstruction. Although this surgical method is being used more widely and the outcomes appear to be improved, the question of the additional cost has to be discussed. To evaluate the cost generated by the management of this technology, we studied a cohort of patients treated for mandibular neoplasms. The population was divided into two groups of 20 patients each who were undergoing a 'traditional' freehand mandibular reconstruction or a computer-aided design/computer-aided manufacturing (CAD-CAM) mandibular reconstruction. Data concerning operation time, complications, and days of hospitalisation were used to evaluate costs related to the management of these patients. The mean operating time for the CAD-CAM group was 435 min, whereas that for the freehand group was 550.5 min. The total difference in terms of average time gain was 115.5 min. No microvascular complication occurred in the CAD-CAM group; two complications (10%) were observed in patients undergoing freehand reconstructions. The mean overall lengths of hospital stay were 13.8 days for the CAD-CAM group and 17 days for the freehand group. Finally, considering that the institutional cost per minute of theatre time is €30, the money saved as a result of the time gained was €3,450. This cost corresponds approximately to the total price of the CAD-CAM surgery. In conclusion, we believe that CAD-CAM technology for mandibular reconstruction will become a widely used reconstructive method and that its cost will be covered by gains in terms of surgical time, quality of reconstruction, and reduced complications.

Segmental Mirroring: Does It Eliminate the Need for Intraoperative Readjustment of the Virtually Pre-Bent Reconstruction Plates and Is It Economically Valuable?

PURPOSE: The aim of this study was to compare segmental mirroring with mirroring of the entire unaffected side to determine which method obviates intraoperative readjustment of virtually planned pre-bent plates and to evaluate the effect on costs. MATERIALS AND METHODS: Patients eligible for inclusion in this prospective study had unilateral mandibular discontinuity defects. Patients were randomly divided into 2 groups. In group I, models were constructed by mirroring the entire unaffected side of the mandible at the midsagittal plane. In group II, only the resected segments were cut and replaced by the corresponding mirrored healthy segments. The lesions were resected, and their sites were reconstructed using pre-bent reconstruction plates. The need for intraoperative plate readjustment, plate placement time, operation time, and operation costs were reviewed. RESULTS: Fifty patients were enrolled in this study. All but 5 plates in group I required readjustment. In group II, plates were placed without intraoperative handling. Average operating times were 4.20 ± 0.56 hours in group I and 3.186 ± 0.28 hours in group II (P = .00002). Mean times for plate placement were 33.36 ± 8.20 and 21.88 ± 5.73 minutes in groups I and II, respectively. The difference resulted in an average time gain of 11.48 minutes. Average personal costs per minute were US$740.77 for group I and US$560.87 for group II. The difference resulted in an average saving of approximately US$179.90. CONCLUSION: Segmental mirroring is superior in reflecting the bone anatomy in 3-dimensional models, thus eliminating intraoperative plate readjustment and providing better plate adaptation with better contour. It decreases operating time and costs and thus can be recommended for lesions that do not cross the midline.

Are virtual planning and guided surgery for head and neck reconstruction economically viable?

PURPOSE: Virtual planning and guided surgery with or without prebent or milled plates are becoming more and more common for mandibular reconstruction with fibular free flaps (FFFs). Although this excellent surgical option is being used more widely, the question of the additional cost of planning and cutting-guide production has to be discussed. In capped payment systems such additional costs have to be offset by other savings if there are no special provisions for extra funding. Our study was designed to determine whether using virtual planning and guided surgery resulted in time saved during surgery and whether this time gain resulted in self-funding of such planning through the time saved. MATERIALS AND METHODS: All consecutive cases of FFF surgery were evaluated during a 2-year period. Institutional data were used to determine the price of 1 minute of operative time. The time for fibula molding, plate adaptation, and insetting was recorded. RESULTS: During the defined period, we performed 20 mandibular reconstructions using FFFs, 9 with virtual planning and guided surgery and 11 freehand cases. One minute of operative time was calculated to cost US $47.50. Multiplying this number by the time saved, we found that the additional cost of virtual planning was reduced from US $5,098 to US $1,231.50 with a prebent plate and from US $6,980 to US $3,113.50 for a milled plate. CONCLUSIONS: Even in capped health care systems, virtual planning and guided surgery including prebent or milled plates are financially viable.

Accuracy of fibular sectioning and insertion into a rapid-prototyped bone plate, for mandibular reconstruction using CAD-CAM technology.

Modern techniques of mandibular reconstruction, such as CAD-CAM technology and rapid prototyping, offer new means by which reconstructive surgery can be planned to optimise aesthetic outcomes and prosthetic rehabilitation. The high degree of accuracy afforded by these approaches is principally attributable to high-precision fibular sectioning and insertion of the bone into a customised bone plate. CAD-CAM mandibular reconstruction procedures using vascularised bone free-flap transfers were performed on 10 patients with benign or malignant neoplasms. Five were not treated with the aid of CAD-CAM technology, and served as the control group. Five were scheduled for maxillofacial surgery using surgical cutting guides and customised bone plates. A generalised linear model for linear measures was used to compare the accuracy of reconstruction between the two groups. A difference, even though not significant, in the lateral shift of the mesial and distal positions of the fibular units was evident between groups. CAD-CAM-generated fibular surgical guides afford improved accuracy when used to restore native anatomy, especially in the context of mandibular arch restoration, and both operating room time and related costs are reduced during fibular sectioning.

Value of preoperative mandibular plating in reconstruction of the mandible.

BACKGROUND: The purpose of this study was to evaluate the efficacy of preoperative versus intraoperative mandibular contouring using rapid prototyping technology. METHODS: Ten patients requiring mandibular reconstruction had a preoperative mandibular plate contoured to a fabricated 3D mandibular model based on preoperative imaging. A traditional intraoperative plate was also contoured. Two surgeons blinded to the study compared the plates with respect to conformance, surface-area contact, and best overall match. A cost-benefit analysis was then performed. RESULTS: The average time to contour was 867 ± 243 seconds and 833 ± 289 seconds for the preoperative and intraoperative plates, respectively (p = .83). Interobserver analysis revealed no statistically significant differences in conformance (p = .38) or surface area contact (p = .14). In 7 of 9 cases, the preoperative plate was selected for the final reconstruction. In 1 case, an intraoperative plate was not contoured because of the lateral extent of the tumor. CONCLUSION: In cases of mandibular distortion secondary to disease, pathologic fracture or defects involving multiple mandibular subsites this method is particularly advantageous.