A retrospective comparison of silicone and hybrid metal tracheobronchial Y stents

Introduction

Symptomatic malignant central airway obstruction (MCAO) is a common consequence of bronchogenic carcinoma and metastatic disease from non-pulmonary cancers. About 17% of new diagnoses of lung cancer had MCAO, with another 8.2% developing MCAO over the next 5 years (1). Frequencies of MCAO from non-pulmonary cancers are less well-defined, although one series demonstrated that 4% of MCAO originated from a non-pulmonary source (2). Regardless of the site of origin, the presence of MCAO portends a worse prognosis (1,3,4). In a retrospective cohort study of patients diagnosed with lung cancer in 2015, MCAO was found on multivariate analysis to have a hazard ratio for mortality of 1.702 [95% confidence interval (CI): 1.365–2.123; P<0.001] when compared with patients with lung cancer but without MCAO (1).

Survival in lung cancer is likely reduced by multiple factors. Airflow limitation affecting one or both lungs increases the work of breathing and impairs oxygenation and ventilation. Additionally, tumor invasion into adjacent critical structures, such as the great vessels or esophagus, can further compromise patient outcomes (5). These factors also impair patients’ functional capacities. The Eastern Cooperative Oncology Group (ECOG) status is a numerical scale from 0 (no functional impairment) to 5 (dead) that directly measures a patient’s functional abilities. Patients with low ECOG status [0–1] demonstrate significantly better survival outcomes compared to those with high status [2–4] in both lung cancer (6) and general cancer populations (7). Poor functional status also directly impairs a patient’s ability to tolerate further cancer-directed treatment. Numerous studies have demonstrated that successful therapeutic bronchoscopy can improve the respiratory status in many critically ill patients with airway obstruction, allowing for ventilation liberation, and a fundamental improvement in functional status (8-13).

A common and challenging location for MCAO is the distal trachea—carinal region where the airway divides into the right and left mainstem bronchi. Tumors that metastasize to the subcarinal lymph nodes often break through the airway, leading to mixed obstruction and life-threatening narrowing or occlusion of two or even all three main airways. Often, these patients are the most impacted by the symptoms of central airway obstruction and are the most tenuous in their functional status. Despite the risk, successful recanalization can effectively palliate symptoms in such patients (14,15) and stents can help to make a sustained symptomatic benefit (14).

Commonly used silicone Y stents have advantages: they are relatively inexpensive; they can be customized to only include areas of malignant stenosis, and fenestrations can be placed to allow for aeration to crucial structures, such as the right upper lobe that might otherwise be occluded. Drawbacks include their requirement for placement using rigid bronchoscopy, as well as risks of airway injury/rupture, stent malposition, and inability to form complete seals in tapered airways/complex stenoses. Hybrid metal Y stents are an emerging alternative, may be easier to place, and due to their self-expanding nature, may allow for better apposition to the airway in complex stenoses or in cases of fistula where a complete seal over a hole is crucial. One study suggested that they exert a more uniform and stronger radial force against the walls of the trachea once placed, and this may have benefits in lesions with excessive collapsing pressure (16). They are, however, substantially more expensive and do not allow for customization. Stents containing metal (hybrid or bare metal) also carry the risk of stent fracture, which appears to increase with a longer duration of insertion.

To our knowledge, there has been only one comparison of hybrid metal and silicone Y stents (17). We performed a retrospective review of all Y stents placed at Roswell Park Comprehensive Cancer Center over the last 10 years. The study population included all patients with primary lung cancer or extrapulmonary malignancies that had metastasized to the lungs, causing MCAO at the main carina that required intervention. The intervention tracked was the placement of a tracheobronchial “Y” stent. We compared patients who had received a silicone Y stent against those receiving hybrid metal Y stents. Primary outcomes were procedural and periprocedural complications, as well as 30-day mortality. Secondary outcomes were procedure duration, repeat bronchoscopies following stent placement, change in level of hospital care before and after stent, and degree of obstruction improvement. We present this article in accordance with the STROBE reporting checklist (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-307/rc).

Methods

This is a retrospective study comparing the outcomes of hybrid metal and silicone Y stent deployment in the airways. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Roswell Park Comprehensive Cancer Center Institutional Review Board (study protocol number 136120) and exemption from informed consent was granted by the Institutional Review Board. We included all patients with MCAO or tracheoesophageal fistulas who underwent bronchoscopic placement of a Y stent at Roswell Park Comprehensive Cancer Center from June 10, 2014 to January 2, 2024. Silicone stents (Bryan or Hood) were placed by four interventional pulmonologists and one thoracic surgeon over the last 10 years. Hybrid metal Y stents became commercially available only recently in the United States. Thus, silicone stents were used exclusively until 2022. Following 2022, both silicone and hybrid metal Y stents were available as treatment options, and the placement decision was up to the discretion of the treating physician. All hybrid metal Y stents (Thoracent) were placed by one interventional pulmonologist (Figure 1). Patients with MCAO from primary or secondary lung cancer who received Y stents in this time interval were included sequentially. Eligible patients were identified using the Current Procedural Terminology (CPT) code 31631. Exclusion criteria were patients receiving a Y stent for non-malignant indications.

Figure 1 Bronchoscopic image with MCAO visualized from trachea into main stem bronchi (on the left), after hybrid metal stent placement (top right), after silicone stent placement (bottom right). MCAO, malignant central airway obstruction.

Patient characteristics were abstracted from the electronic medical record (EMR) and are shown in Table 1. The bronchoscopy indication was categorized as stent placement and treatment or surveillance. Procedure time and procedure type were recorded from the procedure note. In a few cases where procedure time was not separately recorded, it is taken as 80% of the operative time (time under anesthesia). Procedure time was recorded as the time from the rigid or flexible bronchoscope insertion until its removal and case completion. For each case, the stent insertion time represented only a fraction of the total procedure time.

Hybrid metal Y stents were inserted through a rigid tracheoscope under fluoroscopy with the patient under general anesthesia. Stent size was preselected based on the length of the right mainstem bronchus, the desired diameter of all limbs, and the length of the tracheal limb. Once selected, a radio-opaque marker was placed on the chest using fluoroscopy guidance to denote the main carina. A flexible bronchoscope was advanced into the left mainstem, and a radio-opaque guidewire was advanced while simultaneously withdrawing the flexible scope. This wire is used to guide the left mainstem bronchus limb of the stent. The stent is then inserted by threading the left mainstem limb over the wire. As the rigid scope is cleared, the clear plastic collar holding the two bronchial limbs together is withdrawn, allowing the right and left mainstem bronchi to spread and seat in their respective airways. Once in position, the right and left mainstem bronchi strings are deployed, allowing the spread of these parts of the stent. In the final portion, the tracheal limb is deployed by unsheathing the collar holding it collapsed. These stents can also be inserted into the airway through a 9.0 endotracheal tube, but positioning is often more difficult, as is the need to pull the endotracheal tube proximally in the trachea, thus, rigid insertion is preferred.

Procedure types were denoted as therapeutic or diagnostic bronchoscopy. A diagnostic procedure was defined as the utilization of endobronchial ultrasound-guided biopsy or other bronchoscopic-based biopsy modalities in addition to bronchoscopy and stenting, thus both diagnostic and therapeutic in nature. The therapeutic procedure included stenting (and any necessary debulking). The subtypes of airway obstruction on bronchoscopy were recorded based on available bronchoscopy images, categorized as intrinsic (tumor within airway lumen distinct from luminal border), extrinsic (cartilaginous narrowing without tumor in lumen), or mixed. We assessed the degree of airway obstruction before and after the intervention. The performing physician documented this based on visual assessment. For reports lacking this data, we reviewed the bronchoscopy images. Data was collected by a research intern (W.M.) and was confirmed by an interventional pulmonologist (N.I.). The obstruction severity was graded as follows: 0 (0–25%), 1 (26–50%), 2 (51–75%), and 3 (76–100%) luminal obstruction, as previously described (1).

Complications were classified into three categories: procedural complications (including bleeding and reintubation on the same day), early complications (1–7 days), delayed complications (7–30 days), and death within 30 days. We documented the level of care—from outpatient, floor, intensive care unit (ICU), and mechanical ventilation—before and after stenting to assess improvement. Technical success was considered as <50% airway obstruction at completion. During follow-up, we documented patients who underwent repeat bronchoscopy and the indication. Recommendations regarding stent clearance strategies were at the discretion of the attending physician and were not captured. The level of care was categorized into four tiers: outpatient care (level 1), inpatient care on a regular hospital floor (level 2), inpatient care in the ICU without ventilator support (level 3), and ICU care requiring ventilator support (level 4).

Post-stenting repeat bronchoscopy data, including frequency, indications (urgent or planned), findings (e.g., granulation tissue, mucus accumulation), and instances of stent removal or revision, were systematically recorded. There was no standardized follow-up protocol for repeat bronchoscopies; clinical decisions were driven by individualized patient needs, symptom progression (e.g., dyspnea recurrence, radiographic changes, or clinical suspicion of stent dysfunction), and the physician’s judgment. Urgent bronchoscopies were defined as those performed for acute clinical emergencies such as respiratory distress or pneumonia, while planned procedures included scheduled surveillance or evaluation of suspected obstruction in the absence of acute symptoms. Mean repeat bronchoscopy rates per month were calculated for each patient by dividing the total number of procedures by the duration of follow-up in months.

Statistical analysis

Statistical analyses were performed using IBM SPSS statistical software version 28.0.1.0. Patient demographic and disease data were presented as counts (percentages) for categorical variables and median (interquartile range) for continuous variables. Group comparison between the hybrid metal and silicone stents was done using the Chi-squared test and Fisher’s exact test for independent categorical variables. A comparison of continuous variables was done using the Mann-Whitney U non-parametric test. A P value <0.05 was considered statistically significant after assuming all the rules of statistical tests.

Results

A total of 34 patients were included in the study cohort. There were no significant differences in demographic characteristics between groups, as summarized in Table 1. The majority of patients (24, 70.6%) had non-small cell lung cancer, while 5 patients (14.7%) had small cell lung cancer, and another 5 patients had other types of cancer. Most patients presented with advanced disease, with 23 (67.6%) having stage IV disease and 10 (29.4%) having stage III disease. The ECOG performance status was predominantly 1 in 14 patients (41.1%) and 2 in 6 patients (17.6%).

The most common indication for stenting was malignant airway obstruction (MAO), observed in 29 patients (85.2%). Four patients underwent stenting for tracheoesophageal fistula; of these, three received hybrid metal stents, and one received a silicone stent. Therapeutic bronchoscopy alone was performed in 17 patients (50%), while the remaining 17 patients (50%) underwent both diagnostic and therapeutic procedures. Mixed airway obstruction was the most frequently observed type, affecting 20 patients (58.8%), followed by extrinsic obstruction in 7 patients (20.6%) and intrinsic obstruction in another 7 patients (20.6%). Overall, 14 patients (41.2%) received hybrid metal stents, while 20 patients (58.8%) received silicone stents. Subsequent therapy with chemotherapy, radiotherapy, or both was administered to 9 patients (64.3%) in the hybrid metal stent group and to 17 patients (85%) in the silicone stent group, as detailed in Table 1.

Bronchoscopic procedures involving hybrid metal Y stent placement were significantly shorter than those involving silicone stent placement, with median procedure times of 56 vs. 91 minutes, respectively (P=0.001). This time difference remained significant when procedures were stratified into therapeutic-only or combined diagnostic and therapeutic categories. Although stent insertion itself accounted for only a fraction of the total procedure time, direct timing of this step was not performed; however, anecdotal observations suggest that hybrid metal Y stent insertion typically lasted between 3 and 10 minutes. No significant differences were observed between the two groups regarding the degree of improvement following intervention, as shown in Table 2.

Procedure-related complications occurred more frequently in the silicone stent group compared to the hybrid metal stent group (6/20 vs. 2/14; P=0.43), with bleeding and traumatic injuries being the most common events. In a chart review of these complications, several features likely complicated some of the silicone Y stent placements. In some instances, there is a mention of a more oblique angle to the left mainstem due to left lobar resection or widened carina. In our experience, this can increase difficulty in stent deployment. In certain cases, patient selection also likely increased the complication rate. Patients with more respiratory and hemodynamic instability are challenging to treat in any situation but are made additionally more challenging by the need to quickly insert a radio-opaque and occlusive stent quickly enough to maintain oxygenation. Attempts at rapid insertion may have increased trauma in some of these instances.

Rates of early complications (21.4% vs. 30%; P=0.70) and delayed complications (35.7% vs. 25%; P=0.70) were comparable between the two groups. Death within 30 days of intervention was seen in 3 (21.4%) patients in the hybrid metal stent group and 3 (15%) patients in the silicone stent group, as detailed in Table 2.

The proportion of patients requiring repeat bronchoscopies after stenting was significantly higher in the silicone stent group compared to the hybrid metal group (65% vs. 21.4%; P=0.005). Both urgent and planned bronchoscopies were higher in the silicone stent group. Upon repeat bronchoscopy, granulation and mucus were the most frequently noted findings. Stent revision due to misplacement, failure, or granulation tissue formation was more common in the silicone stent group, affecting two patients (10%), compared to none in the hybrid metal group. Similarly, stent removal due to complications such as infection, mucus plugging, or granulation tissue overgrowth occurred more frequently in the silicone stent group (3/20; 15%) than in the hybrid metal stent group (1/14; 7.1%). Stents were removed following the resolution of MCAO in four silicone stent cases and one hybrid metal stent case, as summarized in Table 3.

Discussion

In this retrospective, single-center study of silicone Y stents versus hybrid metal Y stents, we found no significant differences in our primary outcomes of procedural and periprocedural complications, as well as 30-day mortality. There was a trend toward more periprocedural complications with the silicone Y stent placement (6/20 in silicone vs. 2/14 with hybrid metal), but this did not reach statistical significance (P=0.43). Our secondary outcomes found that hybrid metal Y stents are associated with reduced procedure times. We also found that the hybrid metal Y stent group may require fewer follow-up bronchoscopies, however, this may reflect practice differences between bronchoscopists.

We found a significantly reduced procedure time when placing hybrid metal Y stents, whether therapeutic or for combined diagnostic and therapeutic when the hybrid stent was placed. Increased procedure time for bronchoscopy has been correlated to increased intraprocedural complications (18), such as respiratory complications. Shorter procedure times may also reflect the technical ease of stent placement, whereas longer durations of placement reflect greater challenges to satisfactory stent deployment. Our findings are very similar to those demonstrated by Lachkar et al. in their comparison of self-expanding metallic Y and silicone stents, where the silicone Y stent procedure duration was significantly longer (17). The study also reported greater feasibility with hybrid metal Y stents where stent placement failed in 7 patients of the silicone Y stent group, while all hybrid metal Y stents were successfully placed. Since CPT codes are billed for the successful use of stents, we were not able to track instances of failed Y stent placement in the current study and cannot comment on silicone Y stent failures. Second, reduced procedure time leads to cost savings and the opportunity for greater patient throughput. At our institution, a reduction of endoscopy procedure time of 30–40 minutes equates to a greater than $700 difference in cost to the hospital. This cost savings would be further magnified in an operating room, where room time costs nearly double that of endoscopy. This increased cost does not consider the additional medication used or other supplies and likely underestimates true cost savings and warrants further study. Differences in stent costs are also important to consider. An average silicone Y stent costs around $500, while a hybrid metal Y stent costs over 10 times as much. If all other things are equal, the much cheaper option for a proceduralist is to choose the silicone Y stent.

Regarding the relative learning curve of the two insertion techniques, insertion of silicone Y stent has been argued to have a very steep learning curve. Proceduralists are hindered by the need to deploy only minimally collapsed silicone stent into a diseased airway that is nearly the same size as the silicone stent. They are limited by the lack of radio-opaque features in the stent to help guide the deployment of limbs and by the occlusive nature of an incompletely deployed stent, which can further exacerbate respiratory compromise. In contrast, the authors feel the hybrid metal stents can be learned with comparative ease. As with any stent, determination of stent size is crucial, as well as confirmation that one can avoid jailing the right upper lobe takeoff (unless that is the intent). Otherwise, the greatest challenge was in ensuring that the mainstem limbs went to the appropriate sides. To accomplish this, we quickly switched from deploying two wires (one for each bronchial limb) to only deploying a left mainstem wire. This allowed greater ease of insertion because there was then no question of wire and bronchial limb deployment. These stents can be deployed through a rigid bronchoscope (ideally with an inner diameter of 10–11 mm) or a 9.0 endotracheal tube. The authors prefer a rigid bronchoscope for greater control of deployment. The stent in its nonexpanded form is significantly smaller than its deployed size, allowing for adjustment as well as ventilation before deployment. As the device is radio-opaque, using fluoroscopy, it is clear where the deployment will occur. It should also be noted that at Roswell Park, since the hybrid metal Y stent has become available, we have not felt the need to place any silicone stents. This is also in part because we do not treat as many benign airway obstructions as other institutions.

The two stent groups have clinical situations where they each exhibit superior properties, and these should be considered. We feel that silicone stents are favored in benign disease or in instances where anatomic deviations require the ability to modify to stent. Examples might include tracheal bronchus or abnormally short right mainstem bronchus. We feel that a hybrid metal Y stent is favored in several situations. First, if the underlying tissue is badly diseased such that the concern for airway puncture is heightened, a self-expanding stent will likely cause less trauma on insertion. Second, in cases of airway/esophageal fistula, a self-expanding stent is favored because it is much more likely to provide a seal over the fistula and a relative seal of the tracheal and bronchial limbs. Thus, if positive pressure is necessary after the procedure, there is less chance of continued air leakage. A final situation is in critically ill patients with the need for further mechanical ventilation. The hybrid metal Y Stent can be intentionally oversized, thus allowing apposition against an airway wall, in contrast to the silicone Y, which in its upper tracheal reaches often does not contact the tracheal wall as closely (particularly if the lower stenosis was severe and the bronchial limb size limited the tracheal size options). In those instances, an endotracheal tube could end up parallel to the stent, effectively limiting ventilation and requiring emergency repositioning of the endotracheal tube. We have seen this happen several times with silicone stent patients but have not observed this risk in patients with hybrid metal Y stents.

Our comparative analysis showed a significant difference in reintervention rates between stent types: 65% for silicone stents versus 14.3% for hybrid metal stents. Silicone stents frequently developed granulation tissue and mucus accumulation, consistent with previous studies (19,20). These findings suggest hybrid metal stents may require less maintenance. Two factors complicate the comparison: operator variability due to non-standardized protocols and temporal confounding from longer follow-up periods for silicone stents. When normalized to procedures per patient-month, the trend favoring hybrid metal stents persisted but lost statistical significance (P=0.28). This underscores the need for standardized protocols and matched follow-up durations in future studies to accurately compare long-term maintenance needs between stent types.

Our study did not identify significant differences between groups in early or late complication rates, change in level of care, or improvement in the degree of airway obstruction, suggesting the stents may be relatively equivalent in these aspects.

This study suggests that silicone and hybrid metal Y stents are relatively equivalent in their function, complication rate, and degree of airway improvement, which is consistent with prior studies (14,21,22).

There are several important implications of these findings. Greater speed of placement might suggest that such stents can be used to palliate sick patients who could not tolerate more aggressive endobronchial therapy. We have found the hybrid metal Y stents to be beneficial in certain clinical situations involving young and critically ill patients who would have otherwise succumbed immediately to their disease (23). This faster stent placement may allow for other critically ill patients who are ventilator-dependent to experience airway palliation and perhaps make them candidates for palliative radiation therapy.

This study is subject to several limitations. First, the small cohort size restricts the statistical power of our analysis. Second, all hybrid metal Y stents were placed by a single interventional pulmonologist, whereas silicone stents were placed by a total of five different physicians. This variation introduces a potential source of bias, and our findings should be interpreted with this consideration in mind. Third, the retrospective and single-center design of this study, conducted at a comprehensive cancer center, may limit the generalizability of our results to broader populations. Because patient identification partially relied on billing codes, cases involving failed Y stents could not be captured. The inclusion of such cases might alter the perceived benefits of Y stents in either direction. Lastly, due to the relatively small sample size, we were unable to assess the impact of concomitant treatments, such as radiation or chemotherapy, on post-stenting efficacy. This represents an important area for further investigation in future studies.

Conclusions

Hybrid metal Y stents are safe to use and require less procedure time than silicone Y stents. Additionally, hybrid metal Y stents may also have less need for subsequent bronchoscopies. We detected no significant difference in early or late complications, change in post-procedure level of care, or 30-day mortality.

Acknowledgments

Clinical data delivery and Honest Broker services for this study were provided by the Biomedical Research Informatics Shared Resource, and editorial assistance for this publication was provided by the Scientific Editing and Research Communications Core (SERCC) Resource.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-307/rc

Data Sharing Statement: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-307/dss

Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-307/prf

Funding: This study was supported in part by an award through the Roswell Park Alliance Foundation (startup funds to N.I.). This work was also supported by the Roswell Park Comprehensive Cancer Center and a National Cancer Institute (NCI) Cancer Center Support Grant (No. P30CA016056) in regard to shared resource use. The content is solely the responsibility of the authors and does not necessarily represent the official views of Roswell Park Comprehensive Cancer Center.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-307/coif). The authors have no 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. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Roswell Park Comprehensive Cancer Center Institutional Review Board (study protocol number 136120). Exemption from informed consent was granted by the Roswell Park Comprehensive Cancer Center Institutional Review Board.

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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