Titanium devices for chest wall surgery: a systematic review

Introduction

Background

Nowadays, chest wall surgery (CWS) remains challenging for surgeons, both for treatment of benign chest wall disease and treatment of chest wall cancer (1). Several improvements in surgical devices and techniques allowed the development of CWS over the past decades. However, there are still no clear guidelines available (2). The main factors ensuring the protection of intrathoracic organs and adequate respiratory function are integrity and stability of chest wall (3,4). Surgeon’s challenge therefore lies in being able to reconstruct the chest wall, maintaining its integrity and rigidity, but at the same time the chest mobility. For these reasons, most surgeons agree that anterior chest defect including >3 ribs, measuring >5 cm in diameter or inducing paradoxical chest wall movement must be reconstructed to avoid chest instability, risk of lung herniation and subsequent respiratory failure (5-8). Likewise, in cases of flail chest due to anterior chest trauma, numerous studies, including two clinical trials, have shown substantial benefits of operative treatment, in terms of mortality, hospital length of stay, pain and complications (9-11).

Rationale and knowledge gap

Many devices may be used to repair the chest wall including synthetic prosthesis, metallic bars, cryopreserved homograft, acellular soft tissue patches of bovine or porcine derivation and other materials (12-15). No one of these devices has proven its superiority so far (12,16). For example, biological or synthetic mesh are unable to maintain both rigidity and a normal conformation of the ribcage. Deschamps et al., in one of the largest studies (with 197 patients), did not find any correlation between the complication rate and the type of non-metallic prosthesis used for CWS (4). Titanium based devices were introduced in clinical practice 10 years ago. Titanium is highly biocompatible with low density, resistant to corrosion, ductile, diamagnetic, and compatible with magnetic resonance imaging (14,17). Many surgeons have already tested these anatomical rib plates, as well as other devices in titanium, with satisfactory results (18-23). However, no prospective clinical trials on titanium devices and their application have been realized yet.

Objective

The aim of our study was to describe the main existing titanium devices and report their results in thoracic surgery to improve future practice. We present this article in accordance with the PRISMA reporting checklist (available at https://asj.amegroups.com/article/view/10.21037/asj-23-36/rc) (24).

Methods

Several meetings were needed to create a detailed protocol-determining database to be searched in and all methodological details.

Information sources and search strategy

In March 2023, we conducted an extensive search of the following databases: PubMed, Web of Science, Embase and Scopus. Keywords or MeSH terms searched were: “Titanium”, “Chest wall”, “thoracic wall surgery”, “Titanium/therapeutic use”. We also used the following Boolean string: (Chest wall reconstruction AND Titanium) or (thoracic wall surgery AND titanium) or (Chest wall reconstruction AND titanium devices) or (thoracic surgery AND Titanium devices) or (thoracic wall surgery AND titanium/therapeutic use). See Appendix 1.

Eligibility criteria and exclusion criteria

Our research has considered all case series, case-control, cohort, cross-sectional studies of patients undergoing CWS using titanium devices for all types of diagnosis: trauma, chest malformation, postoperative dehiscence, primitive cancer, or secondary cancer. This database search was focused on original papers in English language. We excluded all case reports or cases series with less than five patients and all studies not using titanium-based devices. Duplicate reports were also excluded. Patients treated by minimally invasive technique were not included to reduce bias in the outcomes of the review (i.e., Nuss technique).

Study selection

Articles were evaluated independently by the two authors, following the quality standards issued by Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group (see Appendix 2) (25). The article full text was screened by title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, discussion, patient perspective, informed consent, follow-up, and outcomes, as recommended by the CARE (Consensus-based Clinical Case Reporting Guidelines Development) recommendations, specially dedicated to case series (26). For our purpose, outcomes of interest were complications linked to the use of titanium devices. The entire process is summarized in Figure 1.

Figure 1 Flowchart of identifications of the studies via databases.

Data collection process

All selected articles have been read by the authors (A.F. and O.M.), in order to extract all data independently and separately (Table 1). Subsequently, extracted data were examined by the two authors to resolve any discrepancies. To minimize the bias in the analysis of the postoperative outcomes the patients were divided into two groups: patients treated for benign disease (group A) and patients treated for malignant disease (group B).

Data items

Collected data included article type and details, number of enrolled patients, number of patients treated by titanium devices, diagnosis, postoperative outcomes, and devices related complications (i.e., failure, infection, dislocation, and breakage). Surgery complications were defined major when causing prolonged hospitalization and requiring an invasive procedure to treat or endanger the patient life, corresponding at Clavien-Dindo (CD) classification of grade 3 and grade 4 (38). Instead, in the minor complications were included CD of grade 1 and 2. Late complications included all complications developed after discharge correlated to the prosthesis. Different types of titanium devices have been used and their outcomes have been analyzed separately, when possible. Missing data have not been considered.

Results

All 18 included studies were observational studies, including one prospective (30) and 17 retrospective studies published between 2002 and 2022, as shown in Table 1 (6,16,17,20-23,27-37). No clinical trials have been made on titanium devices yet. All the included studies are based on a small sample of patients, 658 patients in total. Among of these, 445 were treated with titanium devices, 186 patients for chest wall benign disease (group A) and 259 patients for chest wall cancer (group B). The systems used were Thorib and Tryonix (Neuro France Implants, Boursay, France, Figure 2), Plates Smith (Smith & Nephew, Memphis, TN, USA), MDF Medica (MDF Medica S.r.l., Venice, Italy, Figure 3), the STRATOS system (Strasbourg Thorax Osteosyntheses System, MedXpert GmbH, Heitersheim, Germany; Figure 4), the Synthes system (Synthes MatrixRib Fixation System or Synthes Sternal Fixation System, Solothurn, Switzerland; Figure 5), Matrix Fixation System (MFS, DePuy Synthes, West Chester, PA, USA), Mathys Medical Devices (LTH) (Mathys Medical Ltd., Bettlach, Switzerland), Thimesh (titanium mesh prosthesis, Medtronic Neurologic Technologies, Minneapolis, USA) and SternaLock (Zimmer Biomet CMF & Thoracic, Jacksonville, FL, USA).

Figure 2 Trionyx titanium plate (A,B), Thorib titanium bar (C,D) thanks to Neuro France Implants.

Figure 3 Broken titanium bars in (A) and titanium mesh MDF Medica (B). Permission was obtained from the publisher (34).

Figure 4 Intraoperative photos. (A) STRATOS system used to ribs reconstruction; (B) STRATOS system used to sternal reconstruction; (C) Thorib used to sternal reconstruction.

Figure 5 Intraoperative photos (A) broken ribs, (B) chest wall stabilization with Synthes^® titanium plates and splints for traumatic flail chest. Permission was obtained from the publisher with permission (33).

Benign disease

Group A included all patients treated for chest wall trauma, sternal dehiscence after median sternotomy, sternal infection, chest wall deformity (i.e., pectus excavatum and carinatum), postoperative ribs fractures and syndrome of Polland, as shown in Tables 2,3. In this group, the systems used were the STRATOS (27 patients), the Synthes system (76 patients), Plates Smith (22 patients), MDF (3 patients) and SternaLock (58 patients). In group A, 21 patients (11.3%) developed major complications; eight patients had complications of CD grade IIIb: four reoperations for bleeding and four reoperations for devices correlated complications (i.e., dislocation or rupture); nine patients had complications of CD grade IVa, such as nine bacterial pneumonias with need of invasive mechanical ventilation; 42 patients (22.6%) developed minor surgery complications; 17 patients had complications of CD grade 1 (like increased levels of amylasemia and lipemia, or fever, or urinary retention), while the other 25 patients had complications of CD grade 2 (like atrial fibrillation, anemia). Two postoperative deaths occurred (1.1%), which was defined as death within the 90^th postoperative day or during hospital stay, but in both cases, deaths were not directly related to the titanium devices implantation. One patient died due to septic shock after severe pneumonia (CWS realized for trauma) and the other due to heart failure (CWS realized for sternal dehiscence after cardiac surgery). The mean [± standard deviation (SD)] of hospital stay was 9.4 (±8) days, while in ICU it was 5.8 (±5.7) days. The duration of postoperative ventilation was in mean 3.8 (±2.75) days. The mean follow-up was 11 (±10.6) months. Moreover, device failure, defined as the appearance of postoperative flail chest (or lung hernia), or the need for another surgical reconstruction to stabilize the chest wall, happened in 2 patients (1.1%). Chronic postoperative pain occurred in nine patients (4.8%) and required device removal in two patients after several months.

Malignant diseases

Group B included all patients treated for primitive or secondary chest wall cancer, as shown in Tables 4,5. In this group the devices used were the STRATOS system (107 patients), the Synthes system (21 patients), Thimesh (27 patients), Mathys (18 patients), Thorib (55 patients), Tryonix (17) and MDF (3 patients). In all patients a mean of three ribs were removed, and in a third of them en-bloc with part of sternum. The defect area may vary between a minimum of 32 cm² to a maximum of 198 cm². In group B, 34 patients developed major surgery complications (13.1%); 12 patients had CD grade IVa complications, such as pneumonia (requiring invasive mechanical ventilation), or renal failure (requiring dialysis); 22 patients had CD grade IIIb complications, among them eight reoperations for device complications (i.e., dislocation or rupture), six reoperations for postoperative infection, six redo surgery for hemothorax and two for hardware failure; 53 patients (20.5%) developed minor surgery complications. The 90-day mortality rate was 1.9% (5 patients). The mean (± SD) of hospital stay was 10.8 (±5.7) days, with 2.4 (±1.5) days in ICU. The mean (± SD) follow-up was 24.5 (±9.51) months. Four articles reported the 5-years overall survival (OS) and disease-free survival (DFS), where the OS ranged from 57.3% to 81%, and the DFS from 50% to 72%.

Titanium devices correlated outcomes

In both groups, during follow-up titanium devices removal was required, because of infection, displacement, or rupture of devices. Infection occurred in 7.7% of cases (35 patients), among them 8 patients (1.8%) with surgical site infections were treated conservatively with surgical debridement and antibiotic therapy. Breakage of the devices occurred in 25 patients (5.5%), while dislocation or deformation occurred in 32 cases (7.1%); 45 patients required devices removal (9.9%), but in only 7 patients of were removed for surgical site infection. Hardware failure occurred in 4 patients (0.9%). Devices infection was the most frequent complication, amongst the correlated titanium devices complications, immediately followed by devices dislocation or deformation. No postoperative death was linked to any of these devices’ complications, except for two patients died due to an early onset of surgical site infections and pneumonia with consequently development of septic shock.

Discussion

Which type of material to be used in CWS is still controversial, especially given the lack of clinical trials comparing different available devices (39). In literature, it is only possible to find several case reports and some case series about titanium devices. Moreover, in many case series, patients are treated both for malignant or benignant disease, as well as treated with titanium devices or others, making it more difficult to compare the different outcomes.

Key findings

The 90-day postoperative mortality rate for overall chest wall resection in this review is 1.9%. In this review, after chest wall reconstruction we found the postoperative major complications (CD grade III and IV) ranged from 3.4% to 36%, while postoperative minor complications (CD grade I and II) from 4.6% to 40%. Only four of these articles reported the 5-year OS and DFS in our review, ranging from 59% to 80% (mean 66%), and from 50% to 72% (mean 61%), respectively. Moreover, in this review, the major postoperative complication rate is approximately 10.76% (CD grade III and IV), while the minor complication rate is 18% (CD grade I and II) in patients treated for traumatic reasons. The postoperative mortality rate in this type of patients is approximately 6.5%.

Comparison with similar researches

In the literature, overall postoperative complication rates after chest wall reconstruction ranged from 24% to 61% (40-42). However, postoperative complications rate remained relatively high, particularly in patients treated for trauma or cancer. Moreover, the introduction of titanium devices allowed reconstruction for more extended resection (8), which are required to ensure negative margins and complete resection, and consequently effective oncological treatment (7,23). The 90-day postoperative mortality of overall chest wall resection ranged from 0% to 17%, in patients treated for chest wall cancers (2,39-44), slightly higher than the rate we found in this review. Considering overall CWS literature, 3- and 5-year OS ranged from 66% to 82% and from 0% to 92%, respectively, as well as 3- and 5-year DFS from 41% to 85%, and 0% to 53%, respectively (8,45-48). The ranges were very large as prognosis depends on tumor histology, lymph nodes involvement and the completeness of the surgery (7,49). All these patients have a very diverse tumor histology, as well as different stages of disease, which does not allow us to draw any conclusions about DFS or OS. In addition, Deschamps et al. in their study find a strong association between pulmonary resection and operative deaths (P<0.001) (4). Taken into account, these results suggest that the use of titanium devices in chest wall reconstruction did not increase either postoperative mortality rate or postoperative complication rate but achieved the best possible long-term outcomes.

Much less is known about trauma chest wall osteosynthesis, despite the encouraging results of several retrospective studies and case reports (9,10,50,51). In the future, the situation could change after the results of NCT02635165 (EMVOLS) trial (52). The aim of this trail is to optimize the management of polytraumatized patients with flail chest, determining if the surgical treatment with Stracos (titanium stapples, Strasbourg Costal Osteosynthesis System, MedXpert GmbH, Germany) could decrease the hospital stay and the rate of complications compared to non-operative management. In trauma CWS postoperative complication rate ranged from 20% to 35% (53-55). In addition, the 90-day postoperative mortality ranged from 8% to 38% (9,53-55), which is slightly higher than our review report. It is important to notice that trauma could involve other organs and so trauma patients may have longer hospitalization and ICU stay for these reasons (54,55).

Strengths and limitations

The limitations of this systematic review include the absence of clinical trials concerning titanium devices, and prospective evaluation of titanium devices is scarce in the literature. We still do not have enough data to evaluate long-term outcomes, chronic postoperative pain, and quality of life. Furthermore, the heterogeneity of potential etiologies that can be treated with titanium bars makes the different articles on this topic not comparable. At the same time, this is the only systematic review that covers the topic of titanium in CWS.

Explanations of findings

After CWS using titanium, the most common late complications are infection, hardware failure, breakage, dislocation, and deformation. In case of infection, device removal is not always mandatory, and patients could be successfully managed with antibiotics (6,28,33). Interestingly, two studies demonstrated that in case of proven surgical site infection, titanium devices could stay in place, after operative debridement, with good results (33,36). Specific interface design of titanium is known to make its surface less interactive with bacteria. Implant infection rate is very variable in the literature, probably due to the material diversity usable for CWS and the undefined definition of surgical site infection in thoracic surgery. Nevertheless, it has been described a decrease in the rate of device’s infection to 4% since the introduction of titanium implants (6,16). In our results the titanium prosthesis infection ranges from 2.6% to 18% of patients (mean 7.1%). Instead, hardware failure, defined as the appearance (or not resolution) of flail chest after the chest wall stabilization and consequently respiratory failure, was less common in our cases, equal to 1% (4 patients). In contrast, Arnold et al. reported 4.6% of postoperative respiratory failure incidence in their 500 chest wall reconstructions experience with non-metallic prosthesis (1). Another bi-centric study found a 44% rate of complications with STRATOS™ and MatrixRIB^® Fixation Systems. In a mean follow-up of 20 months 24 titanium implants (22 STRATOS and 2 MatrixRIB) had to be removed. The malfunction was strongly associated with the anterior location and with three or more bars (P=0.01 and P=0.03), but they did not find significant difference between the two devices (16). Considering all their remarks, Berthet et al. suggest the need for improvements in titanium devices design, and early removal of devices whenever possible (16). On the other hand, Bergovec et al. found a significant association in their multivariate analysis between the use of titanium devices (MatrixRIB) and the complications appearance, but in their article, they compared a limited number of patients (13 vs. 13) (35). In addition, they included in their analysis late device related complications, such as plate fractures or dislocation and obviously these kinds of complications could not occur in patients treated without titanium plates. De Palma et al. reported in their long-term results (mean follow-up 20 months) with the Synthes^® system and MatrixRIB^® Fixation System 11% of implant complications (33). In contrast, Clermidy et al. reported in their late study (mean follow-up 34 months) a lower rate of implant complications (6%) but using Thorib^®/Trionyx^® bars and plates (36).

Another titanium correlated outcome is the implant-related discomfort and the onset of postoperative chronic pain, which sometimes required device removal. Only six studies in this review reported the persistent or recurrence of postoperative pain after CWS (16,21,22,29,35,37). Pain or discomfort was attested in 7–29% of patients, considering a mean of 20 months of follow-up. On the other hand, several authors highlighted the benefit of surgical fixation of rib fractures in case of persistent and chronic pain to improve the quality of live (21,29,30).

The last important consideration to consider is the impact of the learning curve on the outcomes of CWS. Only one article in literature, using operative time as a surrogate for performance, found an improvement of learning curve after 15 to 20 operations of chest wall stabilization in trauma (56). This means that most cases included in our studies were always in the learning curve of the individual surgeons and their institutions.

Implications and actions needed

Overall, the review results suggest that the use of titanium devices was as effective as other surgical prosthesis for chest wall reconstruction. Further prospective clinical studies are needed to demonstrate the long-term benefit of titanium devices compared to other kinds of prosthesis.

Conclusions

Titanium based medical devices can be used with efficiency and reliability in CWS, to treat trauma or oncological diseases.

Acknowledgments

The authors would like to thank © Current Challenges in Thoracic Surgery and Journal of Thoracic Disease for the permission to use their images.

Funding: None.

Footnote

Provenance and Peer Review: This article was commissioned by the Guest Editor (Alessandro Gonfiotti) for the series “New Materials for Reconstruction in Thoracic Surgery” published in AME Surgical Journal. The article has undergone external peer review.

Reporting Checklist: The authors have completed the PRISMA reporting checklist. Available at https://asj.amegroups.com/article/view/10.21037/asj-23-36/rc

Peer Review File: Available at https://asj.amegroups.com/article/view/10.21037/asj-23-36/prf

Conflicts of Interest: Both authors have completed the ICMJE uniform disclosure form (available at https://asj.amegroups.com/article/view/10.21037/asj-23-36/coif). The series “New Materials for Reconstruction in Thoracic Surgery” was commissioned by the editorial office without any funding or sponsorship. O.M. received Edwards grant for Paceport study (Sawan Ganz). He has relationships with drug companies, including AstraZeneca and MSD for consultancy services and memberships to scientific advisory boards. He has been involved in Thorib and Trionyx (NeuroFrance, France) patenting. The authors have no other conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All procedures performed in this study were in accordance with the ethical standards of the institutional research committee and with the Helsinki Declaration (as revised in 2013). Informed consent was obtained to use the photographs of the surgical procedures.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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