Comparison of clinical and economic outcomes among patients undergoing lung resection using ECHELON^TM 3000 Staplers versus ECHELON^TM+ Staplers: a multi-institutional observational study

Introduction

The use of endoscopic staplers in minimally invasive lung resection procedures, including transection and resection of lung parenchyma, lobar or segmental bronchus, and pulmonary vessels, is widespread (1-3). In the past decade, lower rates of combined hemostasis complications, reduced postoperative air leakage, shorter hospital length of stay (LOS), and lower drug and hospital costs have been associated with lung resection procedures performed using powered staplers as compared to manual staplers (1,3-5). For instance, the ECHELON™+ Stapler (ECH+), a powered endoscopic stapler featuring dynamic firing technology and gripping surface technology (GST) reloads, has shown significant benefit in terms of hospital resource use, costs, and clinical outcomes among patients undergoing video-assisted thoracic surgery (VATS) lobectomy as compared to manual endoscopic staplers (3,6).

Nevertheless, current powered endoscopic staplers are still not optimized to meet the unique challenges encountered in difficult-to-access locations within the pleural cavity (7). Pulmonary vessels are relatively immobile in the chest and their thin wall makes them particularly delicate and easily damaged (7). Furthermore, vessel transection under stressful condition such as twisting and lifting could easily lead to avulsion (8). Transection of airways or lung parenchyma under similar stressful condition could lead to staple line deformation and breakdown. In a recent Delphi survey, consensus among thoracic surgeons revealed that greater jaw aperture and articulation are expected to improve surgical access with endoscopic staplers (9).

The ECHELON™ 3000 Stapler (ECH3000), approved in April of 2022 in the United States, innovates on key features of ECH+ to improve surgical access. Featuring a wider jaw aperture, greater articulation span (>110°) and shorter articulation joint, and powered articulation with automatic articulation speed adjustment, ECH3000 provides surgeons better access and control, even in tight spaces and on challenging tissues (10). In benchtop testing, ECH3000 has shown improved access capability, stronger seals, fewer malformed staples, greater grasping force and end effector stability on vascular and thick tissue (11).

However, there are no clinical data on the performance of ECH3000. As such, the purpose of this study was to compare clinical and economic outcomes among patients undergoing lung resection using ECH3000 vs. ECH+ in the course of routine clinical practice. We present this article in accordance with the STROBE reporting checklist (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-153/rc).

Methods

Study design and data source

We conducted a retrospective, active comparator, observational study using hospital billing records contained in the Premier Healthcare Database (PHD). Representing 1 in 4 annual inpatient hospital stays in the United States, Premier collects data from approximately 1,190 hospitals participating in the Premier Healthcare Alliance. The PHD contains hospital administrative and billing discharge data, including discharge-level information on all International Classification of Diseases, Tenth Revision, Clinical Modification and Procedure Code System (ICD-10-CM/PCS), Current Procedural Terminology (CPT), and Healthcare Common Procedure Coding System (HCPCS) diagnosis and procedure codes recorded during each admission. Detailed service-level information for each hospital day is recorded, including details on devices received. Although the PHD excludes federally funded hospitals (e.g., Veterans Affairs), the hospitals included are nationally representative based on bed size, geographic region, and teaching hospital status (12).

The PHD consists of de-identified healthcare records. In the United States, retrospective analyses performed in the PHD are considered exempt from informed consent and institutional review board approval as dictated by Title 45 Code of Federal Regulations [45 CFR 46, 101(b)(4)]. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments.

Study population

We identified inpatient healthcare encounters between April 1, 2022 and September 30, 2023 with a principal ICD-10-PCS or CPT procedure code for lung resection and billing charges for either ECH3000 or ECH+ recorded on the procedure day (see Table S1 for a list of codes used to query the database). For each patient, the index procedure was defined as the first lung resection meeting these criteria. We included patients aged 18 years or older with an index procedure at a hospital contributing data to the PHD for at least 6 months prior to and 30 days post-index procedure. To prevent potential confounding, patients with billing charges for both ECH3000 and ECH+ on the index procedure day, a route of admission from a different facility, or an unknown admission type were excluded.

Study covariates

Patient demographics included age, sex, race, and payor type. Patient clinical characteristics were measured using the Elixhauser comorbidity index, a risk-adjustment score comprised of 31 comorbid conditions derived from ICD-10-CM diagnosis codes; comorbid conditions were measured based on ICD-10-CM codes present on admission at index or recorded within 365 days prior to index. The Elixhauser comorbidity index was stratified into the following categories based on its empiric distribution: 0–1, 2–4, and ≥5. The following procedural characteristics were measured at index: procedure type [i.e., anatomic (lobectomy or segmentectomy) or non-anatomic (wedge resection)], surgical approach (i.e., open or minimally invasive), and admission type. Hospital and provider characteristics included hospital bed size (<500 or ≥500), geographic location and teaching status, and procedural physician specialty.

Study outcomes

The primary endpoint of the study was prolonged air leak (PAL) within 30 days post-index procedure. PAL, defined as an air leak lasting more than 5 days (13), was identified based on the presence of a principal or secondary ICD-10-CM diagnosis code for air leak at index, and at least one of the following: discharge from the index healthcare encounter more than 5 days post-index procedure; or an ICD-10-PCS procedure code for chest drain removal between 6 to 30 days post-index procedure.

Secondary endpoints included bleeding-related complications within 30 days post-index procedure, and index admission total hospital costs from the hospital perspective, LOS, discharge status, mortality, and 30-day all-cause inpatient readmission to the same hospital where the index procedure was performed. Bleeding-related complications were defined by the presence of either a principal or secondary ICD-10-CM diagnosis code for bleeding or an ICD-10-PCS, CPT, or HCPCS procedure code for transfusion recorded within 30 days post-index procedure. Analyses of total hospital costs included only patients where information on total hospital costs was available. A complete list of diagnosis and procedure codes used to identify study outcomes is available in Table S2.

Covariate balancing propensity score (CBPS) weighting

During routine clinical practice, treatment and device selection may be influenced by patient characteristics. As such, differences in baseline characteristics between study groups may exist, which may lead to potential confounding in the evaluation of study outcomes between comparison groups.

To address potential confounding, we used the CBPS weighting method to balance baseline covariates between comparison groups. The CBPS was measured by modeling treatment assignment through multivariable logistic regression incorporating all aforementioned study covariates as potential confounders while optimizing covariate balance (14). Patients in the ECH3000 group were assigned a weight of 1, and patients in the ECH+ group received a weight (w_i) based on the odds of treatment assignment to the ECH3000 group such that wi=CBPSi1−CBPSi. As such, the ECH+ group was weighted to resemble the ECH3000 group with respect to all study covariates, and, therefore, effect estimation reflected the average treatment effect among the ECH3000 group. Covariate balancing was performed by a statistician blinded to study outcomes using a two-stage outcome free design similar to that described by FDA CDRH statisticians (15).

Descriptive analyses were used to describe all aforementioned patient demographic and clinical characteristics, procedural characteristics, and hospital and provider characteristics. Covariate balance between study comparison groups at baseline and after CBPS weighting was assessed using absolute standardized differences (ASDs) where adequate balance was defined as an ASD ≤0.20 across all covariate categories (16). As a post-hoc analysis, we assessed the covariate balance of respiratory comorbidities, including chronic obstructive pulmonary disease (COPD) and interstitial pneumonia, after CBPS weighting. Respiratory comorbidities were measured based on ICD-10-CM codes present on admission at index or recorded within 365 days prior to index, where COPD was previously measured as a component of the Elixhauser comorbidity index and interstitial pneumonia was identified using ICD-10-CM codes J84.11X, except J84.114, and J84.2.

Statistical analyses

The difference in the incidence, measured as a proportion, of binary study outcomes and mean of continuous study outcomes among patients undergoing lung resection using ECH3000 vs. ECH+ after covariate balancing was calculated. Estimation of variance was based on a non-parametric bootstrap using a complex bootstrap approach where 500 bootstrap replicates were drawn from the original sample with replacement and, for each bootstrap sample, covariate balancing was performed using CBPS weighting. The standard-normal theory approach was used to estimate standard error and construct two-sided 95% Wald confidence intervals for both the primary and secondary endpoints (17).

For the primary endpoint, we evaluated the non-inferiority in the difference in the cumulative incidence of PAL among patients undergoing lung resection using ECH3000 vs. ECH+ using a prespecified non-inferiority margin of 10% using a one-sided 2.5% significance level. The non-inferiority margin of 10% was set by comparing the expected cumulative incidence of PAL overall (15%) and among patients with the highest risk of PAL in class D of the Brunelli or ESTS scoring system (≥25%) (18-20).

Results

Patient and hospital/provider characteristics

A total of 910 (ECH3000: 277; ECH+: 633) patients meeting the study eligibility criteria were included in the study (see Table 1 for patient attrition). Patient demographic and clinical characteristics, procedural characteristics, and provider and hospital characteristics at baseline and after covariate balancing are shown in Table 2 and Table 3. At baseline, the average patient age was 65 years, 49.5% of patients were female, 56.4% of procedures were anatomic, and 70.0% of procedures were performed via minimally invasive surgery. Prior to covariate balancing, as indicated by an ASD >0.20, ECH3000, as compared to ECH+, had a higher proportion of patients with an elective admission type (90.3% vs. 75.7%); and lung resection at a hospital with 500 or more beds (56.3% vs. 36.3%) and geographically located in the South (91.0% vs. 57.7%).

To address potential confounding, ECH+ was weighted to resemble ECH3000 using CBPS weighting. After covariate balancing, adequate balance, defined as an ASD ≤0.20, was achieved across all covariate categories (maximum ASD =0.001). Overall, after covariate balancing, the average patient age was 65.37 years, and 52.3% of patients were female. A similar proportion of patients in the ECH3000 vs. ECH+ groups had an elective admission type (90.3% vs. 90.2%); and lung resection at a hospital with 500 or more beds (56.3% vs. 56.3%) and geographically located in the South (91.0% vs. 91.0%). As a post-hoc analysis, we assessed the balance of COPD and interstitial pneumonia between study groups after CBPS weighting. Adequate balance was observed for each respiratory comorbidity; a similar proportion of patients in the ECH3000 vs. ECH+ groups had COPD (50.9% vs. 51.5%; ASD =0.012) and interstitial pneumonia (11.6% vs. 8.1%; ASD =0.118).

Analyses of primary outcome

A summary of analyses of the primary outcome, including both covariate-balanced and unadjusted estimates, is available in Table 4. For the primary endpoint, the covariate-balanced cumulative incidences of 30-day PAL in the ECH3000 and ECH+ groups were 13.7% and 13.0%, respectively. The difference in the cumulative incidence of 30-day PAL was 0.7% [95% confidence interval (CI): −4.6%, 5.9%]. The upper bound of the two-sided 95% CI for the difference in the cumulative incidence (5.9%) was significantly lower than the prespecified non-inferiority margin of 10% (P value compared to the non-inferiority margin of 10%: <0.001) indicating ECH3000 was non-inferior to ECH+ in terms of 30-day PAL.

Analyses of secondary outcomes

Findings from analyses of secondary outcomes, including both covariate-balanced and unadjusted estimates, are shown in Table 4 and Table 5. The covariate-balanced cumulative incidences of 30-day bleeding-related complications in the ECH3000 vs. ECH+ groups were 9.4% vs. 16.4% corresponding to a difference in the cumulative incidence of −7.0% (95% CI: −12.2%, −1.8%). No significant differences were observed in healthcare resource utilization between the ECH3000 vs. ECH+ groups: discharge to home [83.4% vs. 79.4%; difference =4.0% (95% CI: −1.6%, 9.6%)], 30-day all-cause inpatient readmission [5.8% vs. 6.0%; difference =−0.2% (95% CI: −4.1%, 3.6%)], hospital LOS [5.0 vs. 5.0 days; difference =0 (95% CI: −0.5, 0.7)], and in-hospital mortality [0% vs. 0.9%; difference =−0.9% (95% CI: −2.0%, 0.1%)]. Information on total hospital costs was available for a total of 845 (ECH3000: 266; ECH+: 579) patients. Among these patients, index admission total hospital costs were lower in the ECH3000 group ($24,904) as compared to the ECH+ group ($25,855), albeit not significantly [difference = −$951 (95% CI: −$3,987, $2,085)].

Discussion

This was the first study to evaluate clinical and economic outcomes (e.g., healthcare resource utilization and total costs) among patients undergoing lung resection using ECH3000, a new generation endoscopic stapler designed for improved surgical access. As compared to ECH+, ECH3000 was associated with a comparable cumulative incidence of 30-day PAL, a lower cumulative incidence of 30-day bleeding-related complications, and comparable healthcare resource utilization and total costs.

PAL, one of the most frequent complications of lung resection, is associated with delayed chest tube removal and discharge thereby leading to increased costs and decreased patient satisfaction. In a recent meta-analysis including 39 studies with 89,006 patients, Zheng et al. found the pooled incidence of PAL among patients undergoing pulmonary surgery to be 15% (95% CI: 13%, 17%) (18). The current study found the cumulative incidences of 30-day PAL (ECH3000: 13.7%; ECH+: 13.0%) to be similar, albeit approaching the lower boundary of the confidence interval reported in Zheng et al. These findings may be attributable to the properties of GST reloads compatible with both ECH3000 and ECH+. GST reloads minimize tissue movement while firing leading to significantly less malformed staples and the more consistent formation of stable, secure staple lines (6,11). An ex vivo study on porcine bronchus (thickness 3.0–3.3 mm after applying an 8 g/mm² pressure for 15 seconds) showed significantly higher air leak pressure associated with ECH+ with GST reloads as compared to staplers without GST reloads (21).

Bleeding-related complications are common and potentially fatal causes of conversion to open thoracotomy in lung resection procedures (22). In the current study, the covariate-balanced cumulative incidence of 30-day bleeding-related complications in the ECH3000 group was significantly lower as compared to the ECH+ group [9.4% vs. 16.4%; difference −7.0% (95% CI: −12.2%, −1.8%)]. International expert consensus has summarized 7 surgical situations of intraoperative bleeding in VATS (22). Findings from the current study most likely reflect the impact of innovative design features of ECH3000 on 2 surgical situations of intraoperative bleeding: bleeding from the pulmonary vessels and bleeding from the lung parenchyma.

First, consensus among subject matter experts has been reached that unclear plane and inadequate dissection of the pulmonary artery (PA) branches and improper endo-stapler angulation adjustments may lead to PA lacerations (22). To increase vessel stump integrity and, therefore, reduce bleeding, the stapler should not apply tension on the vessel during closure and firing (8). The most important innovation of ECH3000 as compared to predicate staplers is its control mechanisms, realized by embedding software (23). Control features include powered articulation with the ability to make articulation adjustments by 1° (10). Indeed, in benchtop testing, the distal tip movement of ECH3000 was controlled up to 0.35° offering significantly more stability compared to standard powered staplers (5.15°, P<0.001) (11). Greater end effector stability of ECH3000 on fragile vascular tissue and wider articulation span (>110°) may contribute to precise placement and tension-free firing on pulmonary vessels, thus resulting in lower incidence of bleeding-related complications.

Second, another key technical difference of ECH3000 realized by embedded software is its dynamic firing motor, which optimizes firing speed based on tissue thickness (23). An ex vivo study showed that ECH3000, as compared to standard powered staplers, was associated with significantly fewer malformed staplers on porcine stomach of target thickness of 3.3 mm (thick; 0.10% vs. 2.06%; P<0.001) and 4.0 mm (extra thick; 0.40% vs. 1.41%; P<0.001) (11). Improved staple formation on thick tissue through optimized stapler firing speed may also contribute to decreasing the risk of bleeding-related complications from staple lines in the lung parenchyma.

Third, the joint length of ECH3000 (28.4 mm) is 10.3 mm less than that of ECH+ (38.7 mm) (10). In the limited space setting of the thoracic cavity, especially the upper thoracic cavity, the shorter joint length of ECH3000 may increase access and maneuverability thereby reducing the likelihood of potential bleeding due to firing on pulmonary vessels under tension. Under the framework outlining seven surgical situations of intraoperative bleeding in VATS, the two surgical situations described above represent the most probable mechanisms by which the innovative design of the ECH3000 may reduce bleeding-related complications. To better understand the performance of ECH3000 based on the type and location of bleeding, further investigation is needed.

Although no significant differences in the magnitude of healthcare resource utilization and total costs were observed between ECH3000 and ECH+, the direction of findings for 30-day all-cause inpatient readmission, non-home discharge status, in-hospital mortality, and index admission total hospital costs were lower in the ECH3000 group. This consistent trend in the direction of favorable economic and utilization outcomes may reflect the lower cumulative incidence of bleeding-related complications among patients undergoing lung resection with ECH3000 as compared to ECH+. Further investigation is needed to better understand the role of ECH3000 in reducing bleeding-related complications and related health expenditures.

Strengths and limitations

The current study possessed several strengths. First, a large, nationally representative sample of 910 patients undergoing lung resection using ECH3000 and ECH+ in the United States was included in this study. Second, covariate balancing was performed on patient-level data to reduce bias from potential confounders using appropriate statistical methods. Third, to ensure study objectivity, a two-stage outcome free design was used in which covariate balancing was performed by a statistician blinded to study outcomes, and outcome analyses was conducted by a separate statistician.

There were limitations to the current study. First, given ECH3000 was recently launched in April of 2022 in the United States, the time period of the study was limited. Although the study included 910 patients, a greater sample size may have enabled better evaluation of potential differences in economic outcomes associated with the use of ECH3000 vs. ECH+ among patients undergoing lung resection. Second, bleeding-related complications were assessed based on the presence of ICD-10-CM, ICD-10-PCS, CPT, or HCPCS codes. Information on the type and location of intraoperative and/or postoperative bleeding-related complications was not available. To better understand the performance of ECH3000 on vessel transection and lung parenchyma resection, further investigation is needed. Third, study results may not necessarily be generalizable to all hospitals in the United States. However, the hospitals included in the PHD are nationally representative based on bed size, geographic region, location (i.e., urban or rural), and teaching hospital status (12); and, as patients receiving these devices should not differ across populations, the study is generalizable to patients meeting the study inclusion and exclusion criteria. Finally, as with any observational study, potential residual confounding may exist due to unobserved or otherwise unadjusted covariates due to limitations of the data. For instance, clinical outcomes may be impacted by surgeon experience, technique, or use of concomitant devices. An implicit assumption is made that the distribution of potential confounders is similar between study groups.

Conclusions

ECH3000 represents an important innovation in surgical stapling technology. Among patients undergoing lung resection, ECH3000 was comparable to ECH+ in terms of 30-day PAL and had a lower cumulative incidence of 30-day bleeding-related complications. Although economic outcomes trended favorably to the ECH3000 group, no significant differences were observed between study devices; additional research is necessary to evaluate potential differences in economic outcomes between study groups. It is hoped that these findings will be used to inform surgeon decision-making to the benefit of patients.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-153/rc

Data Sharing Statement: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-153/dss

Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-153/prf

Funding: This work was supported by Johnson & Johnson.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-153/coif). S.F., J.H., M.P., G.C., P.C. and S.Z. are employees of Johnson & Johnson, or a subsidiary of Johnson & Johnson, and may own stock or stock options in Johnson & Johnson. G.C. is an employee of Ethicon, a subsidiary of Johnson & Johnson, and may own stock or stock options in Johnson & Johnson. 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. The PHD consists of de-identified healthcare records. In the United States, retrospective analyses performed in the PHD are considered exempt from informed consent and institutional review board approval as dictated by Title 45 Code of Federal Regulations [45 CFR 46, 101(b)(4)]. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments.

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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