Minimum Volume Standards for Surgical Care of Early-Stage Lung Cancer: A Cost-Effectiveness Analysis.

BACKGROUND: Multiple stakeholders have advocated for minimum volume standards for complex surgical procedures. The Leapfrog Group recommends that patients with non-small cell lung cancer (NSCLC) receive surgical resection at hospitals that perform at least 40 lung resections annually. However, the cost-effectiveness of this paradigm is unknown. METHODS: A cost-effectiveness analysis was performed on 90-day and 5-year horizons for patients with clinical stage I NSCLC undergoing surgical resection at hospitals stratified by Leapfrog standard. Model inputs were derived from either the literature or a propensity score-matched cohort using the National Cancer Database. For the 5-year horizon, we simulated using a Markov model with 1-year cycle. Incremental cost-effectiveness ratio (ICER) was calculated to evaluate cost-effectiveness. RESULTS: For the 90-day horizon, resection at a Leapfrog hospital was more costly ($25 567 vs $25 530) but had greater utility (0.185 vs 0.181 quality-adjusted life-years), resulting in an ICER of 10 506. Similarly, for the 5-year horizon, resection at a Leapfrog hospital was more costly ($26 600 vs $26 495) but more effective (3.216 vs 3.122 quality-adjusted life-years), resulting in an ICER of 1108. When the costs for long-distance travel, lodging, and loss of productivity for caregivers were factored in, the ICER was 20 499 during the 5-year horizon for resection at Leapfrog hospitals. Using a willingness-to-pay threshold of $50 000, resection at a Leapfrog hospital remained cost-effective. CONCLUSIONS: Receiving surgery for clinical stage I NSCLC at hospitals that meet Leapfrog volume standards is cost-effective. Payers and policymakers should consider supporting patient and caregiver travel to higher volume institutions for lung cancer surgery.

Different-team procurements: A potential solution for the unintended consequences of change in lung allocation policy.

The new lung allocation policy has led to an increase in distant donors and consequently enhanced logistical burden of procuring organs. Though early single-center studies noted similar outcomes between same-team transplantation (ST, procuring team from transplanting center) and different-team transplantation (DT, procuring team from different center), the efficacy of DT in the contemporary era remains unclear. In this study, we evaluated the trend of DT, rate of transplanting both donor lungs, 1-year graft survival, and risk of Grade 3 primary graft dysfunction (PGD) using the Scientific Registry of Transplant Recipient (SRTR) database from 2006 to 2018. A total of 21619 patients (DT 2085, 9.7%) with 19837 donors were included. Utilization of DT decreased from 15.9% in 2006 to 8.5% in 2018. Proportions of two-lung donors were similar between the groups, and DT had similar 1-year graft survival as ST for both double (DT, HR 1.108, 95% CI 0.894-1.374) and single lung transplants (DT, HR 1.094, 95% CI 0.931-1.286). Risk of Grade 3 PGD was also similar between ST and DT. Given our results, expanding DT may be a feasible option for improving lung procurement efficiency in the current era, particularly in light of the COVID-19 pandemic.

Assessment of Preoperative Opioid Use Prevalence and Clinical Outcomes in Pulmonary Resection.

BACKGROUND: Preoperative opioid use is associated with increased health care use after elective abdominal surgery. However, the scope of preoperative opioid use and its association with outcomes have not been described in elective pulmonary resection. This study aimed to characterize prevalent preoperative opioid use in patients undergoing elective pulmonary resection and compare clinical outcomes between patients with and without preoperative opioid exposure. METHODS: The study investigators assembled a retrospective cohort of adult patients undergoing elective pulmonary resection by using the IBM Watson Health MarketScan Database (2007 to 2015). The study compared opioid-naïve patients with patients with a history of preoperative opioid exposure (>0 morphine milligram equivalent prescription filled within 90 days before surgery). Multivariable logistic and linear regressions adjusting for patient sociodemographic, comorbidity, and operative characteristics were used to compare odds of postoperative complication, prolonged length-of-stay (>14 days), 30-day postdischarge emergency department visits, 90-day readmissions, and 90-day costs. RESULTS: The study identified 14,373 patients, 4502 (31.3%) of whom had opioid exposure before pulmonary resection. In multivariable regression, patients with preoperative opioid exposure had significantly higher odds of experiencing a prolonged length of stay (odds ratio [OR], 1.32; 95% confidence interval [CI], 1.11 to 1.58), 30-day emergency department visits (OR, 1.24; 95% CI, 1.01 to 1.41), and 90-day readmissions (OR, 1.41; 95% CI, 1.28 to 1.55). Adjusted 90-day costs were approximately 5% higher for patients with preoperative opioid use (P < .001). CONCLUSIONS: One-third of patients who underwent pulmonary resection used opioids preoperatively and were at risk of experiencing adverse outcomes and having significantly higher health care use. They represent a unique high-risk population that will require novel, targeted interventions.

Local versus distant lung donor procurement does not influence short-term clinical outcomes.

OBJECTIVE: The purpose of this study was to recognize clinically meaningful differences in lung transplant outcomes based on local or distant lung procurement. This could identify if the lung allocation policy change would influence patient outcomes. METHODS: This single-center retrospective cohort study analyzed adult patients who underwent lung transplant from 2006 to 2017. Donor and recipient data were abstracted from a collaborative, prospective registry shared by our local organ procurement organization, and tertiary medical center. Short-term outcomes, 1-year survival, and hospitalization costs were compared between local and distant lung transplants defined by donor service area. RESULTS: Of the 722 lung transplants performed, 392 (54%) had local donors and 330 (46%) had distant donors. Donors were similar in age and cause of death. Recipients were significantly different in diagnosis and local recipients had lower median lung allocation scores (local, 37.3 and distant, 44.9; P < .01). Distant lung transplants had longer total ischemic times (local, 231 ± 52 minutes and distant, 313 ± 48 minutes; P < .01). The rate of major complications, length of hospital stay, and 1-year survival were similar between groups. Distant lung transplants were associated with higher median overall cost (local, $183,542 and distant, $229,871; P < .01). Local lung transplants were more likely to be performed during daytime (local, 333 out of 392 [85%] and distant, 291 out of 330 [61%]; P < .01). CONCLUSIONS: Local lung transplants are associated with shorter ischemic times, lower cost, and greater likelihood of daytime surgery. Short- and intermediate-term outcomes are similar for lung transplants from local and distant donors. The new lung allocation policy, with higher proportion of distant lung transplants, is likely to incur greater costs but provide similar outcomes.

Impact of Nighttime Lung Transplantation on Outcomes and Costs.

BACKGROUND: Previous studies in the field of organ transplantation have shown a possible association between nighttime surgery and adverse outcomes. We aim to determine the impact of nighttime lung transplantation on postoperative outcomes, long-term survival, and overall cost. METHODS: We performed a single-center retrospective cohort analysis of adult lung transplant recipients who underwent transplantation between January 2006 and December 2017. Data were extracted from our institutional Lung Transplant Registry and Mid-America Transplant services database. Patients were classified into 2 strata, daytime (5 AM to 6 PM) and nighttime (6 PM to 5 AM), based on time of incision. Major postoperative adverse events, 5-year overall survival, and 5-year bronchiolitis obliterans syndrome-free survival were examined after propensity score matching. Additionally we compared overall cost of transplantation between nighttime and daytime groups. RESULTS: Of the 740 patients included in this study, 549 (74.2%) underwent daytime transplantation and 191 (25.8%) underwent nighttime transplantation (NT). Propensity score matching yielded 187 matched pairs. NT was associated with a higher risk of having any major postoperative adverse event (adjusted odds ratio, 1.731; 95% confidence interval, 1.093-2.741; P = .019), decreased 5-year overall survival (adjusted hazard ratio, 1.798; 95% confidence interval, 1.079-2.995; P = .024), and decreased 5-year bronchiolitis obliterans syndrome-free survival (adjusted hazard ratio, 1.556; 95% confidence interval, 1.098-2.205; P = .013) in doubly robust multivariable analyses after propensity score matching. Overall cost for NT and daytime transplantation was similar. CONCLUSIONS: NT was associated with a higher risk of major postoperative adverse events, decreased 5-year overall survival, and decreased 5-year bronchiolitis obliterans syndrome-free survival. Our findings suggest potential benefits of delaying NT to daytime transplantation.

Economic evaluation of the specialized donor care facility for thoracic organ donor management.

BACKGROUND: Over the last decade two alternative models of donor care have emerged in the United States: the conventional model, whereby donors are managed at the hospital where brain death occurs, and the specialized donor care facility (SDCF), in which brain dead donors are transferred to a SDCF for medical optimization and organ procurement. Despite increasing use of the SDCF model, its cost-effectiveness in comparison to the conventional model remains unknown. METHODS: We performed an economic evaluation of the SDCF and conventional model of donor care from the perspective of U.S. transplant centers over a 2-year study period. In this analysis, we utilized nationwide data from the Scientific Registry of Transplant Recipients and controlled for donor characteristics and patterns of organ sharing across the nation's organ procurement organizations (OPOs). Subgroup analysis was performed to determine the impact of the SDCF model on thoracic organ transplants. RESULTS: A total of 38,944 organ transplants were performed in the U.S. during the study period from 13,539 donors with an observed total organ cost of $1.36 billion. If every OPO assumed the cost and effectiveness of the SDCF model, a predicted 39,155 organ transplants (+211) would have been performed with a predicted total organ cost of $1.26 billion (-$100 million). Subgroup analysis of thoracic organs revealed that the SDCF model would lead to a predicted 156 additional transplants with a cost saving of $24.6 million. CONCLUSIONS: The U.S. SDCF model may be a less costly and more effective means of multi-organ donor management, particularly for thoracic organ donors, compared to the conventional hospital-based model.

Shipping Lungs Greater Distances Increases Costs Without Cutting Waitlist Mortality.

BACKGROUND: On November 24, 2017, a change in lung allocation policy was initiated to replace the donor service area with a 250-nautical-mile radius circle around the donor hospital. We aim to analyze the consequences of this change, including organ acquisition cost and transplant outcomes, at the national level. METHODS: Data on adult patients undergoing lung transplantation between April 27, 2017, and June 22, 2018 (30 weeks before to 30 weeks after allocation policy change) were extracted from the Scientific Registry of Transplant Recipients database. Patients were classified into pre-change and post-change subgroups. Six-month overall survival was evaluated by Kaplan-Meier analysis. Organ acquisition costs were compared between the pre-change and post-change groups. RESULTS: Of the 3317 adult patients removed from the waiting list during the study period (pre-change 1637 vs post-change 1680), 2734 underwent transplantation (pre-change 1371 of 1637 [83.8%] vs post-change 1363 of 1680 [81.1%]), and 382 died or became too sick to be transplanted (pre-change 168 of 1637 [10.3%] vs post-change 214 of 1680 [12.7%], P = .077). Six-month survival rates of transplanted patients were similar between the two groups. However, average organ acquisition costs increased after policy change (pre-change $50,735 ± $10,858 vs post-change $53,440 ± $10,247, P < .001) with an increase in nonlocal donors (pre-change 44.3% vs post-change 68.9%, P < .001). CONCLUSIONS: Organ acquisition costs and resource utilization increased with the new lung allocation policy, whereas deaths on the waiting list or after transplantation did not decrease. Further optimization of the allocation policy is necessary to balance access to transplant and proper stewardship of human and financial resources.

Chest computed tomography imaging improves potential lung donor assessment.

OBJECTIVE: Chest computed tomography (CT) imaging is being increasingly used for potential lung donor assessment. However, the efficacy of CT imaging in this setting remains unknown. We hypothesize that chest CT imaging independently affects the decision-making process in donor lung utilization. METHODS: We conducted a retrospective cohort study of all adult donation after brain death donors managed through our local organ procurement organization from June 2011 to November 2016. An experienced thoracic radiologist independently reviewed donor chest CT and chest x-ray images in a blinded, standardized manner to determine the presence of structural lung disease (eg, emphysema, interstitial lung disease [ILD]) and acute abnormalities (eg, traumatic lung injury [TLI]). Distinct models of lung utilization were fit to groups with initial partial pressure of oxygen (iPaO2) ≤300 mm Hg (suboptimal) and iPaO2 >300 mm Hg (optimal). RESULTS: The organ procurement organization managed 753 donors during the study period, with a lung utilization rate ([lung donors/all organ donors] × 100) of 36.5% (275 of 753). Four hundred forty-five (59.1%) donors received chest CT imaging, revealing emphysema (13.7%), ILD (2.5%), and TLI (7.2%). In univariate analysis, findings of TLI (odds ratio [OR], 2.23; 95% confidence interval [CI], 1.08-4.61) were positively associated with lung utilization, whereas findings of emphysema (OR, 0.18; CI, 0.08-0.40) were negatively associated with utilization. In multivariate analysis, CT findings of emphysema (OR, 0.21; CI 0.08-0.54) remained negatively associated with utilization. No potential donors with CT findings of ILD became lung donors. After controlling for chest x-ray findings, chest CT imaging findings of structural lung disease remained negatively associated with utilization (P = .0001). Lung utilization rate in the suboptimal and optimal iPaO2 populations was 35.1% and 41.4%, respectively, and CT findings of emphysema had a significant association with nonutilization in both groups. CONCLUSIONS: In the evaluation of potential lung donors, chest CT imaging findings of structural lung disease, such as emphysema and ILD, have a significant negative association with lung utilization. Our findings suggest that chest CT imaging might be an important adjunct to conventional lung donor assessment criteria.

Office-Based Spirometry: A New Model of Care in Preoperative Assessment for Low-Risk Lung Resections.

BACKGROUND: Formal pulmonary function testing with laboratory spirometry (LS) is the standard of care for risk stratification before lung resection. LS and handheld office spirometry (OS) are clinically comparable for forced expiratory volume in 1 second and forced vital capacity. We investigated the safety of preoperative risk stratification based solely on OS. METHODS: Patients at low-risk for cardiopulmonary complications were enrolled in a single-center prospective study and underwent preoperative OS. Formal LS was not performed when forced expiratory volume in 1 second was more than 60% by OS. Propensity score matching was used to compare patients in the OS group to low-risk institutional database patients (2008 to 2015) who underwent LS and lung resection. Standardized mean differences determined model covariate balance. The McNemar test and log-rank test were performed, respectively, for categorical and continuous paired outcome data. RESULTS: There were 66 prospectively enrolled patients who received OS and underwent pulmonary resection, and 1,290 patients received preoperative LS, resulting in 52 propensity score-matched pairs (83%). There were no deaths and two 30-day readmissions per group. The major morbidity risk was similar in each group (7.7%). All analyses of discordant pair morbidity had p exceeding 0.56. There was no association between length of stay and exposure to OS vs LS (p = 0.31). The estimated annual institutional cost savings from performing OS only and avoiding LS was $38,000. CONCLUSIONS: Low-risk patients undergoing lung resection can be adequately and safely assessed using OS without formal LS, with significant cost savings. With upcoming bundled care reimbursement paradigms, such safe and effective strategies are likely to be more widely used.

The Role of Surgical Resection in Stage IIIA Non-Small Cell Lung Cancer: A Decision and Cost-Effectiveness Analysis.

BACKGROUND: This study evaluated the cost-effectiveness of combination chemotherapy, radiotherapy, and surgical intervention (CRS) vs definitive chemotherapy and radiotherapy (CR) in clinical stage IIIA non-small cell lung cancer (NSCLC) patients at academic and nonacademic centers. METHODS: Patients with clinical stage IIIA NSCLC receiving CR or CRS from 1998 to 2010 were identified in the National Cancer Data Base. Propensity score matching on patient, tumor, and treatment characteristics was performed. Medicare allowable charges were used for treatment costs. The incremental cost-effectiveness ratio (ICER) was based on probabilistic 5-year survival and calculated as cost per life-year gained. RESULTS: We identified 5,265 CR and CRS matched patient pairs. Surgical resection imparted an increased effectiveness of 0.83 life-years, with an ICER of $17,618. Among nonacademic centers, 1,634 matched CR and CRS patients demonstrated a benefit with surgical resection of 0.86 life-years gained, for an ICER of $17,124. At academic centers, 3,201 matched CR and CRS patients had increased survival of 0.81 life-years with surgical resection, for an ICER of $18,144. Finally, 3,713 CRS patients were matched between academic and nonacademic centers. Academic center surgical patients had an increased effectiveness of 1.5 months gained and dominated the model with lower surgical cost estimates associated with lower 30-day mortality rates. CONCLUSIONS: In stage IIIA NSCLC, the selective addition of surgical resection to CR is cost-effective compared with definitive chemoradiation therapy at nonacademic and academic centers. These conclusions are valid over a range of clinically meaningful variations in cost and treatment outcomes.

Treatment of malignant pleural effusion: a cost-effectiveness analysis.

BACKGROUND: Patients with malignant pleural effusion (MPE) have varied expected survival and treatment options. We studied the relative cost-effectiveness of various interventions. METHODS: Decision analysis was used to compare repeated thoracentesis (RT), tunneled pleural catheter (TPC), bedside pleurodesis (BP), and thoracoscopic pleurodesis (TP). Outcomes and utility data were obtained from institutional data and review of literature. Medicare allowable charges were used to ensure uniformity. Base case analysis was performed for two scenarios: expected survival of 3 months and expected survival of 12 months. The incremental cost-effectiveness ratio (ICER) was estimated as the cost per quality-adjusted life-year gained over the patient's remaining lifetime. RESULTS: Under base case analysis for 3-month survival, RT was the least expensive treatment ($4,946) and provided the fewest utilities (0.112 quality-adjusted life-years). The cost of therapy for the other options was TPC $6,450, BP $11,224, and TP $18,604. Tunneled pleural catheter dominated both pleurodesis arms, namely, TPC was both less expensive and more effective. The ICER for TPC over RT was $49,978. The ICER was sensitive to complications and ability to achieve pleural sclerosis with TPC. Under base case analysis for 12-month survival, BP was the least expensive treatment ($13,057) and provided 0.59 quality-adjusted life-years. The cost of treatment for the other options was TPC $13,224, TP $19,074, and RT $21,377. Bedside pleurodesis dominated TPC and thoracentesis. Thoracoscopic pleurodesis was more effective than BP but the ICER for TP over BP was greater than $250,000. CONCLUSIONS: Using decision analysis, TPC is the preferred treatment for patients with malignant pleural effusion and limited survival; BP is the most cost-effective treatment for patients with more prolonged expected survival.

A comparison of surgical intervention and stereotactic body radiation therapy for stage I lung cancer in high-risk patients: a decision analysis.

OBJECTIVE: We sought to compare the relative cost-effectiveness of surgical intervention and stereotactic body radiation therapy in high risk patients with clinical stage I lung cancer (non-small cell lung cancer). METHODS: We compared patients chosen for surgical intervention or SBRT for clinical stage I non-small cell lung cancer. Propensity score matching was used to adjust estimated treatment hazard ratios for the confounding effects of age, comorbidity index, and clinical stage. We assumed that Medicare-allowable charges were $15,034 for surgical intervention and $13,964 for stereotactic body radiation therapy. The incremental cost-effectiveness ratio was estimated as the cost per life year gained over the patient's remaining lifetime by using a decision model. RESULTS: Fifty-seven patients in each arm were selected by means of propensity score matching. Median survival with surgical intervention was 4.1 years, and 4-year survival was 51.4%. With stereotactic body radiation therapy, median survival was 2.9 years, and 4-year survival was 30.1%. Cause-specific survival was identical between the 2 groups, and the difference in overall survival was not statistically significant. For decision modeling, stereotactic body radiation therapy was estimated to have a mean expected survival of 2.94 years at a cost of $14,153 and mean expected survival with surgical intervention was 3.39 years at a cost of $17,629, for an incremental cost-effectiveness ratio of $7753. CONCLUSIONS: In our analysis stereotactic body radiation therapy appears to be less costly than surgical intervention in high-risk patients with early stage non-small cell lung cancer. However, surgical intervention appears to meet the standards for cost-effectiveness because of a longer expected overall survival. Should this advantage not be confirmed in other studies, the cost-effectiveness decision would be likely to change. Prospective randomized studies are necessary to strengthen confidence in these results.

A positive return on investment: research funding by the Thoracic Surgery Foundation for Research and Education (TSFRE).

OBJECTIVES: The Thoracic Surgery Foundation for Research and Education (TSFRE) was formed in 1991 with the primary goals of generating new knowledge and nurturing the development of surgeon-scientists. The purpose of this article is to determine how effective the TSFRE has been in achieving these goals. METHODS: A survey instrument was sent electronically to all former and current TSFRE research award recipients. Major themes included the benefits on TSFRE award recipients with respect to career choices of thoracic surgery, progress toward research independence, and the ability to leverage TSFRE funds to more substantive National Institutes of Health (NIH) awards. Success rates for NIH funding were confirmed using NIH Research Portfolio Online Reporting Tools. RESULTS: The total completed survey response rate was 70% (75/107). The response rates for each group were as follows: resident 74% (28/38), faculty 85% (29/34), Braunwald 50% (9/18), and TSFRE/NIH K-award 65% (11/17). The funding rate for all grants was 14% (90/619). For resident research awardees, 81% (34/42) are cardiothoracic surgeons or are thoracic surgery residents. The conversion rate for existing TSFRE/NIH co-sponsored K-awards to R01 grants is 40% at 5 years compared with a 20% K to R conversion rate for all NIH K-award recipients. K to R conversion rates for junior faculty grant awardees without a prior K-award is 44%, which is much higher than NIH rates for all new investigator R01 awards. CONCLUSIONS: The return on investment for TSFRE funding for surgeon-scientists is resoundingly positive with respect to promoting careers in cardiothoracic surgery and to obtaining subsequent NIH funding for thoracic surgeon investigators.

Cost-effectiveness of routine mediastinoscopy in computed tomography- and positron emission tomography-screened patients with stage I lung cancer.

OBJECTIVE: Accurate preoperative staging is essential for the optimal management of patients with lung cancer. An important goal of preoperative staging is to identify mediastinal lymph node metastasis. Computed tomography and positron emission tomography may identify mediastinal lymph node metastasis with sufficient sensitivity to allow omission of mediastinoscopy. This study utilizes our experience with patients with clinical stage I lung cancer to perform a decision analysis addressing whether mediastinoscopy should be performed in clinical stage I lung cancer patients staged by computed tomography and positron emission tomography. METHODS: We retrospectively reviewed our thoracic surgery database for cases between May 1999 and May 2004. Patients deemed clinical stage I by computed tomography and positron emission tomography were chosen for further study. Individual computed tomography, positron emission tomography, and operative and pathology reports were reviewed. The postresection pathologic staging and long-term survival were recorded. A decision model was created using TreeAgePro software and our observed data for the prevalence of mediastinal lymph node metastases and for the rate of benign nodules. Data reported in the literature were also utilized to complete the decision analysis model. A sensitivity analysis of key variables was performed. RESULTS: A total of 248 patients with clinical stage I lung tumors were identified. One hundred seventy-eight patients (72%) underwent mediastinoscopy before resection, and 5/178 (3%) showed N2 disease. An additional 9 patients were found to have N2 metastasis in the final resected specimen, resulting in a total of 14/248 patients (5.6%) with occult mediastinal lymph node metastases. Benign nodules were found in 19/248 (8%) of patients. Decision analysis determined that mediastinoscopy added 0.008 years of life expectancy at a cost of 250,989 dollars per life-year gained. The outcome was sensitive to the prevalence of N2 disease in the population and the benefit of induction versus adjuvant therapy for N2 lung cancer. If the prevalence of N2 disease exceeds 10%, the sensitivity analysis predicts that mediastinoscopy would lengthen life at a cost of less than 100,000 dollars per life-year gained. CONCLUSION: Patients with clinical stage I lung cancer staged by computed tomography and positron emission tomography benefit little from mediastinoscopy. The survival advantage it confers is very small and is dependent on the prevalence of N2 metastasis and the unproven superiority of induction therapy over adjuvant therapy.