Rate of early restenosis after tracheal resection in patients post-COVID-19 infection: a multicenter real-life study

Introduction

Tracheal stenosis (TS) is a life-threatening condition most commonly associated with prolonged invasive mechanical ventilation (IMV), including intubation and tracheostomy. The global severe acute respiratory syndrome coronavirus 2 (SARS‑CoV2) pandemic, which emerged in late 2019, has led to an unprecedented increase in the number of patients requiring prolonged mechanical ventilation due to severe respiratory failure (1). This surge has coincided with a rise in post-intubation and post-tracheostomy TS, posing unique challenges to thoracic surgeons and intensivists worldwide.

Historically, tracheal resection and anastomosis (TRA) has been the gold-standard surgical treatment for severe TS, offering excellent outcomes in highly selected patients (2). Intubation and tracheostomy can cause significant mechanical and ischemic damage to the tracheal wall, a known risk factor for fibrotic scarring. However, the etiology and pathophysiology of the stenosis secondary to SARS-CoV-2 infection may differ from those seen in pre-pandemic cohorts, raising concerns regarding the comparability of surgical outcomes. SARS-CoV-2, in fact, exacerbates this damage by inducing a prothrombotic state, resulting in microvascular injury and often requiring prolonged high-dose steroid therapy. The extended reliance on IMV in coronavirus disease 2019 (COVID-19) patients, combined with the virus’s ability to harm the tracheal and esophageal mucosa, has led to an increased incidence of complications after intubation and tracheostomy (3-5).

Despite the growing recognition of this clinical problem, limited data exist regarding the postoperative outcomes of tracheal or laryngotracheal resection in this unique subset of patients. Furthermore, the recurrence of stenosis and the need for reintervention in this population remain poorly defined. Most of the existing literature consists of case series or single-center experiences, which may lack the generalizability needed to establish robust clinical recommendations.

This study aimed to fill this knowledge gap by evaluating postoperative outcomes, including complication rates, recurrence, and the need for reintervention, in a multicenter cohort of patients who underwent TRA for stenosis following SARS-CoV-2 infection. By analyzing real-world data from high-volume thoracic surgery centers, this study seeks to provide evidence to guide the surgical management and follow-up strategies for this emerging patient population. We present this article in accordance with the STROBE reporting checklist (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-818/rc).

Methods

Study population

This prospective, observational, multicenter study included patients who developed TS after IMV for COVID-19 and underwent tracheal or laryngotracheal resection between June 2020 and December 2023 in five high-volume thoracic surgery centers in Italy. COVID-19 diagnosis was confirmed by reverse transcription polymerase chain reaction (RT-PCR). For the purpose of this study, COVID-19-related TS was defined as a stenosis developing following a documented episode of IMV (endotracheal intubation and/or tracheostomy) administered for acute respiratory failure due to SARS-CoV-2 infection. Patients with TS unrelated to IMV, including idiopathic or presumed inflammatory causes without a history of intubation, were excluded. Additional exclusion criteria included pre-existing airway disease (e.g., subglottic stenosis), history of neck radiation, or prior tracheal surgery, as these factors were considered potential confounders in restenosis risk.

The choice for direct surgery was based on anatomical criteria (e.g., length and severity of stenosis), clinical condition, and multidisciplinary discussion in referral centers. The remaining patients had received at least one previous endoscopic treatment—often performed in non-referral institutions—prior to surgical referral.

A flowchart illustrating patient selection, inclusion criteria, and follow-up schedule is shown in Figure 1.

Figure 1 Flowchart of patient selection, inclusion and exclusion criteria, and postoperative follow-up schedule for the study cohort. Non-COVID-19-related TS, non-coronavirus disease 2019-related tracheal stenosis.

This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The protocol and criteria were clearly defined before study initiation and approved by the Ethical Review Board of Humanitas Research Hospital (Reference number: TS1.1). All participating institutions were also informed and agreed to the study. Informed consents were obtained from all patients before assessment. The data underlying this article will be shared on reasonable request to the corresponding author.

Demographic data

Collected data included demographics [age, sex, body mass index (BMI), smoking status, comorbidities], intubation duration, tracheostomy type (percutaneous vs. surgical), decannulation time, prior endoscopic treatments (dilation, stenting, laser), timing to surgery, and TS characteristics (type, location, extent). For anatomical classification, subglottic stenosis was defined as a lesion confined to the region between the vocal cords and the first tracheal ring, without extension into the cervical trachea. Laryngotracheal stenosis was defined as a combined involvement of the subglottic region and the upper cervical trachea. Preoperative inflammatory markers [neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR)] were also recorded. Information on preoperative steroid use was not uniformly available, as many patients were referred from outside hospitals where complete medication records were not consistently accessible.

Surgical management

Surgery was performed only when SARS-CoV-2 testing was negative. TRA was considered upfront or after failed endoscopic treatment. The number of resected rings and the type of resection (tracheal vs. laryngotracheal) were recorded. Laryngotracheal resection was performed only in cases with significant involvement of the subglottic mucosa or cricoid cartilage, requiring cricotracheal resection. In all other cases with high stenosis but predominantly tracheal involvement, a standard tracheal resection was preferred to preserve laryngeal function and minimize postoperative voice-related morbidity.

All centers followed shared surgical principles, including complete segmental resection with tension-free end-to-end anastomosis using interrupted absorbable sutures. Indications for tracheostomy or stenting were discussed preoperatively in multidisciplinary meetings when feasible. Extubation timing, intensive care unit (ICU) admission, and duration of stay were recorded. Routine bronchoscopies were performed on postoperative days 1 and 7 to assess the anastomosis, in accordance with the agreed protocol.

Follow-up

After discharge, all patients were followed with scheduled bronchoscopies at 1, 3, 6, and 12 months, according to a standardized surveillance protocol shared among all participating centers. At the time of data cut-off, all patients had undergone at least one bronchoscopic evaluation, and 80 out of 90 had completed the 90-day follow-up, which was the timeframe for the primary endpoint. Missed bronchoscopies or dropout beyond this time point were not formally analyzed. Early restenosis was uniformly defined as a symptomatic tracheal narrowing >50%, confirmed endoscopically, occurring within 90 days from surgery. Restenosis occurring beyond this period was considered late. Each center documented endoscopic findings and reinterventions in a harmonized data collection format to ensure consistency in outcome assessment.

Study end-points

The primary endpoint was the incidence of restenosis after surgery. Secondary outcomes included complication rates and in-hospital mortality. Predictive factors for restenosis were also evaluated.

Statistical analysis

Data distribution was assessed using the Shapiro-Wilk and Skewness-Kurtosis tests. Continuous variables were expressed as mean ± standard deviation (SD) or median and interquartile range (IQR), as appropriate. Between-group comparisons were made using Student’s t-test or the Mann-Whitney U-test for continuous variables, and the chi-square or Fisher’s exact test for categorical variables.

Recurrence-free survival was estimated using the Kaplan-Meier method. To identify potential predictors of early restenosis, a univariate Cox proportional hazards regression analysis was performed. Variables with a P value <0.2 in univariate analysis were considered for inclusion in the multivariable Cox regression model. In addition, variables deemed clinically relevant based on existing literature and expert opinion—such as age, diabetes, preoperative endoscopic treatment, sex, tracheostomy, duration of intubation, and surgical approach—were included to avoid underadjustment. The multivariable model was considered exploratory given the small number of restenosis events. Hazard ratios (HRs) with 95% confidence intervals (CIs) were reported. A P value <0.05 was considered statistically significant. Analyses were conducted using Stata 18.0 (StataCorp, College Station, TX, USA).

Results

Demographic and clinical findings

During the study period, a total of 90 patients (Rome: 38, Milan: 27, Pisa: 11, Padua: 7, Bari: 7) underwent tracheal or laryngotracheal resection/anastomosis for TS. The baseline characteristics of the included patients are presented in Table 1. The mean age was 58.5 years and 62% were male. Most were non-smokers with a mean BMI of 28.8. The mean intubation time was 20±29.5 days. Seventeen patients (19%) developed TS post-intubation, while 73 (81%) patients after a percutaneous (26, 29%) or surgical (47, 52%) tracheostomy. Mean IMV time was 34.8±51.8 days.

Preoperative and surgical findings

The mean time from diagnosis of TS to surgery was 144.5±180.3 days. Fifty-eight (65%) patients received upfront surgery. Thirty-two (35%) patients underwent surgery after a single (n=20, 22.2%) or multiple endoscopic procedures (n=12, 13.3%) had failed. Eighty-two (91%) patients underwent tracheal resection/anastomosis and 8 (9%) underwent laryngotracheal resection/anastomosis. Either endoscopic and surgical features of patients’ tracheal/laryngotracheal stenoses are described in Table 2.

Perioperative data

Most patients (52, 57.8%) were immediately extubated after surgery; otherwise, they were transferred to ICU for protected extubation with a mean ICU-stay of 3.1±3.5 days. Major and overall complication rates were 7.8% and 30%, respectively. No 30-day mortality was reported (Table 3). During a mean follow-up of 18.8 months, 8 patients (8.8%) developed restenosis (mean 34.2 days). Four required endoscopic dilation, one needed stenting, and three underwent tracheostomy. One case was managed conservatively.

Potential predictive factors of restenosis

Multivariate Cox regression identified prior endoscopic treatment (HR 12.25; P=0.02) and diabetes (HR 8.64; P=0.03) as significant predictors. Age showed a non-significant protective trend (HR 0.78; P=0.06) (Table 4).

Discussion

The recent SARS-CoV-2 pandemic increased the number of patients requiring invasive ventilation through prolonged intubation or tracheostomy, increasing the risk of TS. While pre-pandemic literature reported TS rates ranging from 6% to 21% following intubation and 0.6% to 21% following tracheostomy (6-8), recent studies have highlighted an even higher prevalence of airway lesions in COVID-19 patients undergoing prolonged invasive ventilation (9). Although various case reports and small case series have described the surgical management of COVID-19-related TS, data on the long-term postoperative course, particularly the risk of restenosis, remain scarce. Early recurrence of stenosis following surgical resection is a critical concern, as previous studies on non-COVID cohorts have reported restenosis rates ranging from 16% to 36.4%, often influenced by factors such as prior endoscopic treatments, comorbidities, and inflammatory responses (10,11). Our group recently conducted two studies. The first was a retrospective analysis that revealed a higher incidence of obesity, prolonged intubation, tracheostomy, re-tracheostomy, and extended decannulation times in patients exhibiting COVID-related TS (12). The second study was a prospective, observational, multicenter study, showing that patients with a history of prolonged intubation would benefit from a strict follow-up for at least 200 days following invasive ventilation for the early detection of TS (13).

However, little is known about the specific early restenosis risk in post-COVID-19 patients undergoing tracheal or laryngotracheal resection and the need for reintervention due to recurrent stenosis. This study aims to address this gap by evaluating postoperative outcomes, focusing on complications, recurrence, and the need for reintervention, to better define optimal management strategies for this unique patient population.

The results from the present study indicate that, in high-volume centers, surgery for COVID-19-related stenosis is associated with a relatively low rate of major complications (7.8%) and restenosis (8.8%) during an average follow-up of approximately 19 months. These results provide valuable insights into the surgical management of a unique subset of patients, considering the large number of cases treated across multiple high-volume centers and the relatively long follow-up period.

Despite the increasing recognition of post-COVID-19 TS, only three recent studies have specifically examined postoperative outcomes following TRA in this population, with a clear follow-up protocol. Piazza et al. (14) reported a series of 14 patients and documented only one case of restenosis (7.1%) without providing details on the mean postoperative follow-up duration. The lack of a defined follow-up timeframe limits the reliability of their findings, particularly given the well-documented risk of late-onset restenosis. Moreover, their study was not primarily designed to assess long-term postoperative outcomes, raising concerns about the completeness of restenosis detection. Similarly, Rorris et al. (10) conducted a retrospective study on a small cohort of 11 patients and reported a markedly higher restenosis rate of 36.4% during a mean follow-up of 6.6±4.8 months. While this study provides valuable insights, its small sample size and retrospective design limit the generalizability of its findings. Menna et al. recently published the largest series to date (n=24), reporting a restenosis rate of 8% with a mean follow-up of 12 months (15). However, the primary objective of that study was to evaluate the impact of COVID-19 on tracheal surgery by comparing postoperative outcomes of tracheal resections performed in the pre- and post-COVID eras. Compared to these findings, our lower restenosis rate over a longer follow-up suggests that patient outcomes may benefit from treatment in high-volume centers with standardized protocols and multidisciplinary expertise.

In contrast, pre-pandemic data from a larger series indicate a restenosis rate of approximately 16%, with clinical comorbidities, previous tracheal resection, and the extent of resection identified as significant risk factors (11). These findings are consistent with those reported by Wright and colleagues in a large pre-COVID cohort, who demonstrated favorable surgical outcomes but also highlighted the role of comorbidities and surgical complexity in influencing restenosis risk (16).

This discrepancy raises critical questions about whether COVID-19-related tracheal pathology may predispose patients to a higher restenosis risk or whether differences in study design, follow-up duration, or patient selection account for these variations. It is well established that restenosis can result from technical imperfections in the anastomosis or an excessive inflammatory response at the margins. Grillo et al. (17) highlighted the importance of delaying surgery in cases of severe tracheal inflammation to reduce postoperative complications and restenosis risk. Given the known pro-inflammatory effects of SARS-CoV-2, further research is needed to determine whether a more cautious surgical timing or tailored postoperative management could mitigate these risks in post-COVID-19 patients.

Our study identifies a mean restenosis occurrence at 34 days post-surgery, underscoring the necessity of early and structured follow-up. Notably, a recent series of 69 patients who underwent tracheal or cricotracheal resection for airway stenosis, tracheal tumors, and tracheoesophageal fistulas reported an average restenosis onset at 42.6 days, with no new cases occurring beyond three months (18). The earlier restenosis timeframe in our cohort raises important concerns about whether COVID-19-related inflammatory alterations contribute to a more aggressive stenotic process. The accelerated restenosis timeline observed in our cohort reinforces the need for earlier and more rigorous postoperative surveillance.

Although the COVID-19 pandemic is officially over, many referral centers are still managing patients with delayed or suboptimal treatment of COVID-19-related TS. This observation is in line with previous early surgical experiences, which reported delayed diagnosis, long-segment involvement, and challenging airway reconstruction in COVID-19-related cases (19).

This subgroup often presents with more complex lesions and a higher risk of early restenosis, especially in the presence of diabetes or repeated endoscopic interventions. These findings support a tailored clinical approach, advocating for earlier surgical referral and structured postoperative surveillance to optimize outcomes in this population.

In our cohort, early restenosis often developed within the first 30–40 days and could remain asymptomatic until advanced. Therefore, we recommend at least one scheduled bronchoscopy within the first 90 days, even in clinically stable patients, as this allows for early detection of subtle anastomotic narrowing and timely intervention before severe symptoms occur. A purely symptom-driven approach may miss subclinical restenosis, particularly in high-risk patients.

It is worth noting that this study focused primarily on early restenosis, defined as occurring within 90 days postoperatively, which was the prespecified primary endpoint. While bronchoscopic surveillance extended beyond this period, data on late restenosis were not uniformly complete across all centers at the time of analysis, and were therefore not included in the primary outcome evaluation. Further studies with longer follow-up are warranted to assess the incidence and predictors of late restenosis.

The inflammatory response triggered by SARS-CoV-2 infection may accelerate the onset of tracheal restenosis by altering local tissue remodeling and impairing normal healing mechanisms. Some reports suggest that COVID-19 can lead to endothelial dysfunction, fibrosis, and prolonged inflammation, which may affect anastomotic healing in tracheal surgery (3-5). A recent report examined histopathological findings from tracheal wall segments resected during surgery. The results showed fibrosis, inflammation, healing of the laryngotracheal mucosa, and degeneration with ischemic necrosis of the cartilaginous tracheal rings. No specific differences were found when compared to specimens from patients with post-intubation TS in the pre-COVID-19 era (20).

While IL-6 and TGF-β have been implicated in fibrotic and pro-inflammatory pathways in post-viral states (21,22), our study did not directly measure these cytokines. Instead, we analyzed systemic inflammatory markers, including neutrophils, lymphocytes, platelets, N/L ratio, and P/L ratio, none of which proved to be significant risk factors for restenosis.

The lack of association may be attributed to the limited number of restenosis events (n=8), which reduces the statistical power to detect small or moderate effect sizes. Nonetheless, the established role of inflammation in airway remodeling—especially in the context of post-viral injury—supports the biological plausibility of systemic markers such as NLR and PLR as potential predictors. Future investigations with larger cohorts and more detailed inflammatory profiling, including local tissue cytokines (e.g., IL-6, TGF-β) and histopathological evaluation of resected tracheal specimens, are warranted to clarify the pathophysiological mechanisms underlying restenosis in post-COVID-19 patients. Such insights may also guide the development of targeted anti-inflammatory strategies to improve postoperative outcomes.

Concerning secondary endpoints, our study shows that surgical outcomes for COVID-19-related TS are comparable to those reported in pre-pandemic cohorts, with a relatively low rate of major complications. The observed major complication rate (7.8%) aligns closely with historical data for TS unrelated to COVID-19. Historically, TRA has been regarded as the gold standard for treating severe TS, with success rates ranging from 85% to 95% in carefully selected patients. Despite the unique challenges posed by SARS-CoV-2—such as systemic inflammation, prolonged critical illness, and tracheal mucosal damage—our findings suggest that TRA remains a safe and effective treatment option in highly specialized centers (23).

Great attention should be given to patients with a history of previous endoscopic treatments and diabetes, as these factors appear to elevate restenosis risk. The impact of repeated endoscopic procedures on tissue healing is particularly concerning, as prior research indicates that patients undergoing multiple endoscopic interventions before definitive tracheal reconstruction often experience poorer vocal outcomes due to compromised tissue integrity (24). Moreover, the use of bronchial stents for complex tracheal stenoses has been associated with a substantial risk of restenosis, particularly in patients with underlying comorbidities (25). Endoscopic management plays a crucial role in the preoperative treatment of TS; however, its effectiveness in COVID-19 patients presents unique challenges. Recent studies have shown that, compared to non-COVID cohorts, COVID-19 patients are more likely to develop complex tracheal stenoses rather than simpler web-like stenoses, likely due to prolonged intubation and the need for multiple tracheotomies. In particular, COVID-19 patients tend to have stenoses involving a greater number of tracheal rings (2.6±0.8 vs. 1.7±1.0, P=0.001) and develop symptoms earlier post-hospitalization (32 vs. 50 days) than non-COVID patients (10). These complex lesions often necessitate multiple interventions, which, while sometimes effective, may also delay or even preclude definitive surgical management. Repeated endoscopic treatments could potentially alter the tracheal microenvironment, promoting fibrosis and increasing restenosis risk. Patients are frequently referred to specialized centers after undergoing multiple endoscopic interventions at peripheral hospitals, where these procedures are commonly employed as a means of postponing complex surgical interventions. While sometimes effective in providing short-term symptom relief, this approach may ultimately lead to substantial delays in definitive surgical management. The findings from our study indicate that a prolonged interval between diagnosis and surgical treatment is significantly associated with an increased risk of restenosis, potentially due to the detrimental effects of repeated endoscopic interventions. This observation underscores the need to carefully evaluate the timing of surgery in patients with COVID-19-related TS. In selected cases, early surgical intervention may be a more effective approach compared to prolonged endoscopic management, reducing the risk of recurrent stenosis and optimizing long-term patient outcomes.

Diabetes is well-known to impair wound healing, which may explain its association with restenosis occurrence in our cohort. Studies have demonstrated that diabetes leads to alterations in mucosal microcirculation, reducing anastomotic perfusion and increasing the risk of anastomotic complications after TRA (26,27). These findings suggest that careful preoperative evaluation and optimization of modifiable risk factors, such as glycemic control, are crucial for improving surgical outcomes.

Our results have several immediate clinical implications. This data highlights the need for close surveillance, including bronchoscopic evaluations, particularly within the first 1–3 months after surgery. Structured follow-up protocols could further optimize outcomes and allow for timely management of restenosis.

This study presents several limitations. The absence of a control group and the lack of standardized restenosis grading may affect the external validity and reproducibility of our findings. Specific details on prior endoscopic techniques were not uniformly available, preventing subgroup analysis by treatment modality. The relatively small sample size may limit the generalizability of the findings, particularly regarding the predictive factors for restenosis. With only 8 failures, the reliability of the model’s estimates might be limited. It is important to carefully interpret the results, especially for individual covariates, as small event counts can lead to overfitting or unstable estimates. Additionally, the observational design and potential variability in preoperative and intraoperative management across centers could introduce bias.

Intraoperative technical variables—such as resection length thresholds, tension management strategies, or use of buttressing materials—were not formally standardized or audited across centers. This may represent a source of performance bias and should be considered in the interpretation of results. Outcome assessment was not blinded, and bronchoscopic findings were evaluated locally. Although all centers followed a standardized surveillance protocol and shared definitions of restenosis, the lack of central review may have introduced observer bias.

Furthermore, another potential bias is related to the inclusion of referral centers, which might select patients with more complex clinical profiles.

Finally, histopathological analysis was not centrally reviewed and may lack standardization across centers. In addition, subgroup analyses by stenosis characteristics or patient comorbidities were not performed due to sample size limitations, and should be explored in future studies.

Conclusions

In conclusion, tracheal or laryngotracheal resection and anastomosis for COVID-19-related stenosis is a safe and effective procedure in high-volume centers. The observed rates of complications and restenosis are comparable to those reported for pre-pandemic stenosis, underscoring the resilience of TRA as a treatment modality even in this unique patient population. However, the prevalence of early restenosis highlights the importance of close endoscopic surveillance and individualized follow-up, particularly for high-risk patients, such as those with comorbidities or prior failed endoscopic treatments.

Most restenosis events occurred within the first 1–2 months postoperatively, supporting the need for early and structured endoscopic surveillance.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-818/rc

Data Sharing Statement: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-818/dss

Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-818/prf

Funding: None.

Conflicts of Interest: All authors except F.R. have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-818/coif). F.R. passed away before the final approval of the manuscript. The other 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. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Humanitas Research Hospital Ethics Committee (Reference number: TS1.1). All participating institutions were also informed and agreed to the study. Informed consents were obtained from all patients before assessment.

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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