Robotic Lobectomy Is Cost-effective and Provides Comparable Health Utility Scores to Video-assisted Lobectomy: Early Results of the RAVAL Trial.

OBJECTIVE: The aim of this study was to determine if robotic-assisted lobectomy (RPL-4) is cost-effective and offers improved patient-reported health utility for patients with early-stage non-small cell lung cancer when compared with video-assisted thoracic surgery lobectomy (VATS-lobectomy). BACKGROUND: Barriers against the adoption of RPL-4 in publicly funded health care include the paucity of high-quality prospective trials and the perceived high cost of robotic surgery. METHODS: Patients were enrolled in a blinded, multicentered, randomized controlled trial in Canada, the United States, and France, and were randomized 1:1 to either RPL-4 or VATS-lobectomy. EuroQol 5 Dimension 5 Level (EQ-5D-5L) was administered at baseline and postoperative day 1; weeks 3, 7, 12; and months 6 and 12. Direct and indirect costs were tracked using standard methods. Seemingly Unrelated Regression was applied to estimate the cost effect, adjusting for baseline health utility. The incremental cost-effectiveness ratio was generated by 10,000 bootstrap samples with multivariate imputation by chained equations. RESULTS: Of 406 patients screened, 186 were randomized, and 164 analyzed after the final eligibility review (RPL-4: n=81; VATS-lobectomy: n=83). Twelve-month follow-up was completed by 94.51% (155/164) of participants. The median age was 68 (60-74). There were no significant differences in body mass index, comorbidity, pulmonary function, smoking status, baseline health utility, or tumor characteristics between arms. The mean 12-week health utility score was 0.85 (0.10) for RPL-4 and 0.80 (0.19) for VATS-lobectomy ( P =0.02). Significantly more lymph nodes were sampled [10 (8-13) vs 8 (5-10); P =0.003] in the RPL-4 arm. The incremental cost/quality-adjusted life year of RPL-4 was $14,925.62 (95% CI: $6843.69, $23,007.56) at 12 months. CONCLUSION: Early results of the RAVAL trial suggest that RPL-4 is cost-effective and associated with comparable short-term patient-reported health utility scores when compared with VATS-lobectomy.

Prognostic significance of lymph nodes assessment during pulmonary metastasectomy: a systematic review and meta-analysis.

Background: Lung metastasectomy is an accepted treatment modality worldwide. Whether the addition of lymph node dissection to the procedure is useful remains, however, unknown. Methods: We performed a systematic review of the literature analyzing MEDLINE, Embase, until 31st October 2021. We included all studies which met the inclusion criteria aiming to determine if the addition of lymph node tissue dissection/sampling to lung metastasectomy offers survival benefits when compared to patients who do receive lymph node tissue dissection. Secondary outcomes were 3- and 5-year overall survival (OS) and disease-free survival (DFS). Each study was assessed for risk of bias. The data collected from the included studies were pooled using reconstruction of individual-level patient data and pooling of reported 5-year odds ratios (ORs). Interstudy heterogeneity was estimated with visual inspection of forest plots and calculation of the I2 inconsistency statistic. Results: We found 11 eligible studies that included a total of 3,310 patients. The most common primary tumor type was colorectal cancer (1,740 patients) and the most commonly performed operative procedure was wedge resection (57%) followed by lobectomy (39%). When resection status was reported, R0 resection was achieved in 90% of the cases. Nine studies did not show a statistically significant effect of lymph nodes dissection or sampling on the 5-year OS with a pooled hazard ratio (HR) of 0.94 [95% confidence interval (CI): 0.82, 1.08; I2=26%; 95% prediction interval (PI): 0.70, 1.24]. Regarding DFS, the pooled HR 0.60 (95% CI: 0.44, 0.80; I2=31%; 95% PI: 0.12, 2.09). Conclusions: The addition of lymph node tissue dissection during lung metastasectomy was not associated with a significant benefit in OS and showed a slight tendency towards a better DFS.

Robotic thoracic surgery in Canada: Are patients willing to pay out of pocket?

Robotic-assisted thoracoscopic surgery (RTS) is safe and effective, but is associated with high capital and operating costs that are not reimbursed by the Canadian government. Currently, patients have access to RTS only when it is supported by research or philanthropic funds. In a recent study, we assessed the extent of patient-reported satisfaction with RTS, whether patients would have been willing to pay out of pocket for it, and what factors were associated with patients' willingness to pay. Many patients (290 of 411 [70.56%]) stated that they would have paid the additional $2000 to supplement the government health care coverage to have access to RTS. Factors found to be significantly associated with participants' willingness to pay were an annual income of $60 000 or more (p = 0.034), private insurance coverage (p = 0.007), overall experience with RTS rated as 8 or higher out of 10 (p < 0.001), and overall postoperative postdischarge experience rated as satisfying or very satisfying (p = 0.004).

RAVAL trial: Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancer.

BACKGROUND: Retrospective data demonstrates that robotic-assisted thoracoscopic surgery provides many benefits, such as decreased postoperative pain, lower mortality, shorter length of stay, shorter chest tube duration, and reductions in the incidence of common postoperative pulmonary complications, when compared to video-assisted thoracoscopic surgery. Despite the potential benefits of robotic surgery, there are two major barriers against its widespread adoption in thoracic surgery: lack of high-quality prospective data, and the perceived higher cost of it. Therefore, in the face of these barriers, a prospective randomized controlled trial comparing robotic- to video-assisted thoracoscopic surgery is needed. The RAVAL trial is a two-phase, international, multi-centered, blinded, parallel, randomized controlled trial that is comparing robotic- to video-assisted lobectomy for early-stage non-small cell lung cancer that has been enrolling patients since 2016. METHODS: The RAVAL trial will be conducted in two phases: Phase A will enroll 186 early-stage non-small cell lung cancer patients who are candidates for minimally invasive pulmonary lobectomy; while Phase B will continue to recruit until 592 patients are enrolled. After consent, participants will be randomized in a 1:1 ratio to either robotic- or video-assisted lobectomy, and blinded to the type of surgery they are allocated to. Health-related quality of life questionnaires will be administered at baseline, postoperative day 1, weeks 3, 7, 12, months 6, 12, 18, 24, and years 3, 4, 5. The primary objective of the RAVAL trial is to determine the difference in patient-reported health-related quality of life outcomes between the robotic- and video-assisted lobectomy groups at 12 weeks. Secondary objectives include determining the differences in cost-effectiveness, and in the 5-year survival data between the two arms. The results of the primary objective will be reported once Phase A has completed accrual and the 12-month follow-ups are completed. The results of the secondary objectives will be reported once Phase B has completed accrual and the 5-year follow-ups are completed. DISCUSSION: If successfully completed, the RAVAL Trial will have studied patient-reported outcomes, cost-effectiveness, and survival of robotic- versus video-assisted lobectomy in a prospective, randomized, blinded fashion in an international setting. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02617186. Registered 22-September-2015. https://clinicaltrials.gov/ct2/show/NCT02617186.

Development of a clinical score to distinguish malignant from benign esophageal disease in an undiagnosed patient population referred to an esophageal diagnostic assessment program.

BACKGROUND: Esophageal cancer is associated with poor prognosis. Diagnosis is often delayed, resulting in presentation with advanced disease. We developed a clinical score to predict the risk of a malignant diagnosis in symptomatic patients prior to any diagnostic tests. METHODS: We analyzed data from patients referred to a regional esophageal diagnostic assessment program between May 2013 and August 2016. Logistic regression was performed to identify predictors of malignancy based on patient characteristics and symptoms. Predicted probabilities were used to develop a score from 0 to 10 which was weighted according to beta coefficients for predictors in the model. Score accuracy was evaluated using a receiver operating characteristic (ROC) curve and internally validated using bootstrapping techniques. Patients were classified into low (0-2 points), medium (3-6 points), and high (7-10 points) risk groups based on their scores. Pathologic tissue diagnosis was used to assess the effectiveness of the developed score in predicting the risk of malignancy in each group. RESULTS: Of 530 patients, 363 (68%) were diagnosed with malignancy. Factors predictive of malignancy included male sex, family history of cancer and esophageal cancer, fatigue, chest/throat/back pain, melena and weight loss. These factors were allocated 1-2 points each for a total of 10 points. Low-risk patients had 70% lower chance of malignancy (RR =0.28, 95% CI: 0.21-0.38), medium-risk had 50% higher chance of malignancy (RR =1.5, 95% CI: 1.26-1.77), and high-risk patients were 8 times more likely to be diagnosed with malignancy (RR =8.2, 95% CI: 2.60-25.86). The area under the ROC curve for malignancy was 0.82 (95% CI: 0.77-0.87). CONCLUSIONS: A simple score using patient characteristics and symptoms reliably distinguished malignant from benign diagnoses in a population of patients with upper gastrointestinal symptoms. This score might be useful in expediting investigations, referrals and eventual diagnosis of malignancy.

Robotic Versus Video-Assisted Thoracoscopic Lung Resection During Early Program Development.

BACKGROUND: The objective of this study is to compare robotic portal (RP) to video-assisted thoracoscopic surgery (VATS) pulmonary resections for early stage non-small cell lung cancer with respect to health care resource utilization during the first year of a robotic surgery program in thoracic oncology. METHODS: Patients who underwent anatomic lung resections using RP (n = 42) or VATS (n = 96) for early stage non-small cell lung cancer between April 2014 and March 2015 at a single institution were identified. Patient-level case costing data for hospital and home care-associated resource variables were recorded. We adopted a health care payer perspective and 30-day posthospital discharge/death time horizon. Parametric or nonparametric tests were used as appropriate and incremental cost difference using 10,000 bootstrap samples using bias-corrected and accelerated method to generate 95% confidence intervals for total cost. RESULTS: Baseline demographic and clinical characteristics were comparable between the two groups. The median total hospital cost per patient was $15,247 (95% confidence interval: $15,643 to $18,945) in the RP cohort, compared with $12,131 (95% confidence interval: $13,218 to $15,879) in the VATS cohort (n = 96; p < 0.001). Longer operating times in the RP group were the main driver of higher hospital costs. Post-hoc analysis of mean operating room time for first 20 RP procedures versus remaining 22 RP procedures found a mean difference of 71 minutes (p = 0.004), resulting in an intraoperative cost difference of $883.38 (p = 0.036). CONCLUSIONS: A micro-costing analysis demonstrates that RP pulmonary resection for early stage non-small cell lung cancer utilizes more health care resource dollars when compared with VATS during early program development, but offers similar perioperative outcomes.

The Integrated Comprehensive Care Program: A Novel Home Care Initiative After Major Thoracic Surgery.

The objective of the study was to evaluate the Integrated Comprehensive Care (ICC) program, a novel health system integration initiative that coordinates home care and hospital-based clinical services for patients undergoing major thoracic surgery relative to traditional home care delivery. Methods included a pilot retrospective cohort analysis that compared the intervention cohort (ICC), composed of all patients undergoing major thoracic surgery in the 2012-2013 fiscal year with a control cohort, who underwent surgery in the year before the initiation of ICC. Length of stay, hospital costs, readmission, and emergency room visit data were stratified by degree and approach of resection and compared using univariate logistic regression analysis. A total of 331 patients under ICC and 355 control patients were enrolled. Hospital stay was significantly shorter in patients under video-assisted thoracoscopic surgery (VATS) ICC (sublobar median 3 vs 4 days, P = 0.013; lobar median 4 vs 5 days, P = 0.051) but not for open resections. The frequency of emergency room visits within 60 days of surgery was lower for all stratification groups in the ICC cohort, except for VATS sublobar (25.7% control vs 13.9% ICC, P = 0.097). There were no significant differences in 60-day readmission frequency in any subcohort. The mean inpatient case cost was significantly lower for ICC VATS sublobar resections ($8505.39 vs $11,038.18, P = 0.007), with the other resection types trending lower for ICC but nonsignificant. In conclusion, a hospital-based, postdischarge, patient-centered program could potentially result in shorter hospital stay, fewer readmission and emergency room visits, costsavings, and no increase in adverse postdischarge outcomes after major thoracic surgery.