Radioguided Surgery, a Cost-Effective Strategy for Treating Solitary Pulmonary Nodules: 20-Year Experience of a Single Center.

INTRODUCTION: Surgical resection with minimally invasive approach is the gold standard for both definitive diagnosis and treatment of solitary pulmonary nodules (SPNs); however, it can be difficult to pinpoint small, deep, or subsolid nodes without palpating lung parenchyma. The primary endpoint of this study is showing that radioguided surgery is a cost-effective strategy to improve the effectiveness of video-thoracoscopic localization/resection of SPNs/ground-glass opacities (GGOs). Secondary endpoints are analyzing the morbidity of this technique and tips and tricks to better manage this method. METHODS: SPN smaller than 20 mm and/or with a distance from the visceral pleura ≥5 mm underwent minimally invasive resection after computed tomography-guided injection of a solution composed of 0.1/0.2 mL of 99Tc-labeled human serum albumin microspheres and 0.1 mL of nonionic contrast. In the operating theater, a collimated probe connected to a gamma ray detector allowed localization of the target area. RESULTS: Between 1997 and 2018, a total of 451 patients with SPN/GGO underwent minimally invasive surgery with a radioguided technique at our hospital. The mean SPN diameter was 13 mm (range, 5-20 mm), and the mean distance from the visceral pleura was 15 mm (range, 6-29 mm). The mean time to a localizing nodule was 3 minutes (range, 1-5 minutes). No significant injection-related complications were reported; only 3.3% of patients (15 of 451) developed pneumothorax. Both 30- to 60-day and 90-day mortality were 0%. The rate of postoperative complications was 2.53% (prolonged air leak). The conversion rate to thoracotomy was 1.55% (7 of 451). CONCLUSIONS: Our 20-year experience shows that radioguided thoracoscopic surgery is a safe and feasible strategy to treat suspicious SPN/GGO, with a success rate of 98%.

Downstream Costs Associated with Incidental Pulmonary Nodules Detected on CT.

RATIONALE AND OBJECTIVES: To explore downstream costs associated with incidental pulmonary nodules detected on CT. MATERIALS AND METHODS: The cohort comprised 200 patients with an incidental pulmonary nodule on chest CT. Downstream events (chest CT, PET/CT, office visits, percutaneous biopsy, and wedge resection) were identified from the electronic medical record. The 2017 Fleischner Society Guidelines were used to classify radiologists' recommendations and ordering physician management for the nodules. Downstream costs for nodule management were estimated from national Medicare rates, and average costs were determined. RESULTS: Average downstream cost per nodule was $393. Costs were greater when ordering physicians over-managed relative to radiologist recommendations ($940) vs. when adherent ($637) or under-managing ($166) relative to radiologists recommendations. Costs were also greater when ordering physicians over-managed relative to Fleischner Society guidelines ($860) vs. when under-managing ($208) or adherent ($292) to guidelines. Costs did not vary significantly based on whether or not radiologists recommended follow-up imaging ($167-$397), nor whether radiologists were adherent or under- or over-recommended relative to Fleischner Society guidelines ($313-$444). Costs were also higher in older patients, patients with a smoking history, and larger nodules. Five nodules underwent wedge resection and diagnosed as malignancies. No patient demonstrated recurrence or metastasis. Average cost per diagnosed malignancy was $3090. CONCLUSION: Downstream costs for incidental pulmonary nodules are highly variable and particularly high when ordering physicians over-manage relative to radiologist recommendations and Fleischner Society guidelines. To reduce unnecessary utilization and cost from over-management, radiologists may need to assume a greater role in partnering with ordering physicians to ensure appropriate, guideline-adherent, and follow-up testing.

Alternative imaging strategy of solitary pulmonary nodule by FDG PET/CT: Can be imagined a tailored PET?

OBJECTIVE: Patients with solitary pulmonary nodule (SPN) are usually sent to total-body positron emission tomography/computed tomography (PET/CT) examination with 18F-fluorodeoxyglucose (FDG). However, a segmental scan strategy may improve cost/effectiveness in this category of patients. CONCLUSION: A segmental PET/CT scan only at the chest level could be performed in patients with indeterminate SPN. Limiting the PET/CT field to the thoracic region would greatly affect on radiobiology, department organization and health-care costs.

Cost-effectiveness of initial diagnostic strategies for pulmonary nodules presenting to thoracic surgeons.

BACKGROUND: Patients presenting to thoracic surgeons with pulmonary nodules suggestive of lung cancer have varied diagnostic options including navigation bronchoscopy (NB), computed tomography-guided fine-needle aspiration (CT-FNA), (18)F-fluoro-deoxyglucose positron emission tomography (FDG-PET) and video-assisted thoracoscopic surgery (VATS). We studied the relative cost-effective initial diagnostic strategy for a 1.5- to 2-cm nodule suggestive of cancer. METHODS: A decision analysis model was developed to assess the costs and outcomes of four initial diagnostic strategies for diagnosis of a 1.5- to 2-cm nodule with either a 50% or 65% pretest probability of cancer. Medicare reimbursement rates were used for costs. Quality-adjusted life years were estimated using patient survival based on pathologic staging and utilities derived from the literature. RESULTS: When cancer prevalence was 65%, tissue acquisition strategies of NB and CT-FNA had higher quality-adjusted life years compared with either FDG-PET or VATS, and VATS was the most costly strategy. In sensitivity analyses, NB and CT-FNA were more cost-effective than FDG-PET when FDG-PET specificity was less than 72%. When cancer prevalence was 50%, NB, CT-FNA, and FDG-PET had similar cost-effectiveness. CONCLUSIONS: Both NB and CT-FNA diagnostic strategies are more cost-effective than either VATS biopsy or FDG-PET scan to diagnose lung cancer in moderate- to high-risk nodules and resulted in fewer nontherapeutic operations when FDG-PET specificity was less than 72%. An FDG-PET scan for diagnosis of lung cancer may not be cost-effective in regions of the country where specificity is low.

Cost-effectiveness of follow-up of pulmonary nodules incidentally detected on cardiac computed tomographic angiography in patients with suspected coronary artery disease.

BACKGROUND: Pulmonary nodules (PNs) are often detected incidentally during coronary computed tomographic (CT) angiography, which is increasingly being used to evaluate patients with chest pain symptoms. However, the efficiency of following up on incidentally detected PN is unknown. METHODS AND RESULTS: We determined demographic and clinical characteristics of stable symptomatic patients referred for coronary CT angiography in whom incidentally detected PNs warranted follow-up. A validated lung cancer simulation model was populated with data from these patients, and clinical and economic consequences of follow-up per Fleischner guidelines versus no follow-up were simulated. Of the 3665 patients referred for coronary CT angiography, 591 (16%) had PNs requiring follow-up. The mean age of patients with PNs was 59±10 years; 66% were male; 67% had ever smoked; and 21% had obstructive coronary artery disease. The projected overall lung cancer incidence was 5.8% in these patients, but the majority died of coronary artery disease (38%) and other causes (57%). Follow-up of PNs was associated with a 4.6% relative reduction in cumulative lung cancer mortality (absolute mortality: follow-up, 4.33% versus non-follow-up, 4.54%), more downstream testing (follow-up, 2.34 CTs per patient versus non-follow-up, 1.01 CTs per patient), and an average increase in quality-adjusted life of 7 days. Costs per quality-adjusted life-year gained were $154 700 to follow up the entire cohort and $129 800 per quality-adjusted life-year when only smokers were included. CONCLUSIONS: Follow-up of PNs incidentally detected in patients undergoing coronary CT angiography for chest pain evaluation is associated with a small reduction in lung cancer mortality. However, significant downstream testing contributes to limited efficiency, as demonstrated by a high cost per quality-adjusted life-year, especially in nonsmokers.

Navigational bronchoscopy with biopsy versus computed tomography-guided biopsy for the diagnosis of a solitary pulmonary nodule: a cost-consequences analysis.

BACKGROUND: Solitary pulmonary nodules (SPNs) are frequent and can be malignant. Both computed tomography-guided biopsy and electromagnetic navigational bronchoscopy (ENB) with biopsy can be used to diagnose a SPN. A nondiagnostic computed tomography (CT)-guided or ENB biopsy is often followed by video-assisted thoracoscopic surgery (VATS) biopsy. The relative costs and consequences of these strategies are not known. METHODS: A decision tree was created with values from the literature to evaluate the clinical consequences and societal costs of a CT-guided biopsy strategy versus an ENB biopsy strategy for the diagnosis of a SPN. The serial use of ENB after nondiagnostic CT-guided biopsy and CT-guided biopsy after nondiagnostic ENB biopsy were tested as alternate strategies. RESULTS: In a hypothetical cohort of 100 patients, use of the ENB biopsy strategy on average results in 13.4 fewer pneumothoraces, 5.9 fewer chest tubes, 0.9 fewer significant hemorrhage episodes, and 0.6 fewer respiratory failure episodes compared with a CT-guided biopsy strategy. ENB biopsy increases average costs by $3719 per case and increases VATS rates by an absolute 20%. The sequential diagnostic strategy that combines CT-guided biopsy after nondiagnostic ENB biopsy and vice versa decreases the rate of VATS procedures to 3%. A sequential approach starting with ENB decreases average per case cost relative to CT-guided biopsy followed by VATS, if needed, by $507; and a sequential approach starting with CT-guided biopsy decreases the cost relative to CT-guided biopsy followed by VATS, if needed, by $979. CONCLUSIONS: An ENB with biopsy strategy is associated with decreased pneumothorax rate but increased costs and increased use of VATS. Combining CT-guided biopsy and ENB with biopsy serially can decrease costs and complications.

Cost and outcomes of patients with solitary pulmonary nodules managed with PET scans.

BACKGROUND: No prior study to our knowledge has observed the cost of managing solitary pulmonary nodules of patient groups defined by PET scan results. METHODS: We combined study and administrative data over 2 years of follow-up. RESULTS: Of 375 individuals with a definitive diagnosis, 54.4% had a malignant nodule and 62.1% had positive PET scan results. Mortality risk was 5.0 times higher (CI, 3.1-8.2) and cost was greater (50,233 dollars vs 22,461 dollars, P<.0001) among patients with malignant nodule. Mortality risk was 4.1 times higher (CI, 2.4-7.0) and cost was greater (47,823 dollars vs 20,744 dollars, P<.0001) among patients with a positive PET scan result. Among patients with a malignant nodule, 4.9% had a false-negative PET scan, but cost and survival were not different from true positives. Among patients with a benign nodule, 22.8% had a false-positive PET scan. These patients had greater cost (33,783 dollars vs 19,115 dollars, P<.01), more surgeries and biopsies, and 3.8 times the mortality risk (CI, 1.6-9.2) of true negatives. Just over one-half (54.5%) of individuals with positive PET scans received surgery. Most individuals with negative PET scans (85.2%) were managed by watchful waiting. They incurred fewer costs than patients with negative PET scans who were managed more aggressively (19,378 dollars vs 28,611 dollars, P<.01). CONCLUSIONS: Management of solitary pulmonary nodules is expensive, especially if the nodule is malignant or if the PET scan result is false positive. Among patients with malignant nodules, 2-year survival is poor. Compared with true-positive PET scan results, false-negative results are not associated with lower costs or better outcomes.

Economic analyses on the use of positron emission tomography for the work-up of solitary pulmonary nodules and for staging patients with non-small-cell-lung-cancer in Italy.

AIM: Increasing ageing of the population and tumor incidence, along with worldwide rationing of the resources for public health systems, spur the use of economic analyses for the choice of strategies and technologies in the assessment and management of cancer patients. Incidence and clinical managing of tumors vary in different countries even if positron emission tomography (PET) with 2-deoxy-2-[18F]-fluoro-D-glucose (FDG) is becoming a routine clinical method for diagnosis, staging, treatment monitoring and follow-up in a variety of tumors. Available data indicate that PET can be considered a superior alternative or complementary tool to other well-established methods. However, in spite of the above and of the rapidly increasing number of PET centers in Europe, USA and Japan, only a few studies have dealt with some of the economic aspects raised by the clinical use of PET because of differences in values of reimbursements and health costs. The main aim of this study is to propose and discuss an economic model of analysis for PET applications in the field of detection and management of pulmonary tumors. METHODS: In this study 2 assessments were performed by decision tree analysis on the economic impact of the availability of PET on decision-making processes for 2 conditions: solitary pulmonary nodules assessment and non-small-cell lung cancer (NSCLC) staging. In order to define a methodology consistent with the system of reimbursement and the prevalent clinical views of the Italian National Health Service, data on costs, death probability, and life expectancy were gathered from the literature and from the Italian system of reimbursement (ROD-DRGs). RESULTS: The results of the cost minimization analysis demonstrate that the use of PET in the diagnostic path for the workup of patients with SPN reduces the overall diagnostic costs, by approximately 50 Euro per patient, by reducing inappropriate invasive diagnostic investigation and their complications. The results of the cost effectiveness analysis demonstrate that the use of PET in the diagnostic path for the staging of patients with NSCLC reduces the overall diagnostic costs by approximately 108 Euro for added year, by reducing inappropriate surgical interventions and their complications. CONCLUSION: Both analyses are based on standard methods used in the literature, so our conclusions can be compared with results and assessments of similar studies in different countries and health care systems. Also in the Italian case, the use of an economic assessment provides relevant information on the efficacy and effectiveness of PET.

[Whether and under what conditions FDG-PET might be cost-effective in evaluating solitary pulmonary nodules depicted on lung cancer screening in Japan].

PURPOSE: To determine whether and under what conditions fluorine-18 fluorodeoxyglucose positron emission tomography (FDG-PET) may be cost-effective in evaluating solitary pulmonary nodules depicted on lung cancer screening in Japan. MATERIALS AND METHODS: Three decision models for differentiating lung cancer from benign nodules were compared: CT alone, PET alone, and CT plus PET. The various paths of each strategy were dependent on variables determined from a review of the medical literature. Costs were based on Japanese health insurance. RESULTS: The prevalence of lung cancer among solitary pulmonary nodules detected on lung cancer screening was less than 10%. For this prevalence, the CT-plus-PET model was the cost-effective alternative to the CT-alone model (cost savings were yen 64,000 per patient) and provided greater accuracy (0.90 vs. 0.84). Both of these effects were the result of reducing the number of candidates who undergo unnecessary CT-guided or bronchofiberscopic biopsies or thoracotomy for a benign pulmonary nodule. CONCLUSION: The CT-plus-PET strategy is accurate and cost-effective for the characterization of solitary pulmonary nodules detected on lung cancer screening in Japan.

Solitary pulmonary nodules: impact of quantitative contrast-enhanced CT on the cost-effectiveness of FDG-PET.

AIM: To determine the impact of quantitative contrast-enhanced computed tomography (QECT) on the cost-effectiveness of diagnostic strategies for the assessment of solitary pulmonary nodules (SPNs). MATERIALS AND METHODS: Four diagnostic strategies were evaluated using decision tree analysis: conventional CT alone; conventional CT followed by QECT; conventional CT followed positron emission tomography (PET); and conventional CT followed by QECT and PET (QECT+PET). The average cost per patient, accuracy of management and incremental cost:accuracy ratio (ICAR) were determined for each strategy. Although baseline assumptions reflected the Australian setting, sensitivity analysis was used to extrapolate the results to the UK. RESULTS: At the baseline prevalence of malignancy (54%) and cost of PET relative to surgery (16%), the QECT strategy incurs the least cost (5560 dollars/patient) but the QECT+PET strategy is the most cost-effective (ICAR 12,059 dollars/patient). At reported levels of disease prevalence (68.5%) and cost of PET relative to surgery (29.9%) in the UK, the QECT strategy is the most cost-effective. CONCLUSION: QECT offers a cost-effective approach to evaluation of SPNs. Whether QECT is used alone or in combination with PET will depend upon local availability and regional values for prior probability of malignancy within SPNs and the cost of PET relative to surgery.

The solitary pulmonary nodule: aggressive excisional strategy.

Treatment of cancer at an early stage leads to enhanced survival. Low-dose spiral computed tomography (CT) scanning is readily available and allows early detection of solitary pulmonary nodules. Thoracic surgeons should embrace a calculated yet aggressive approach to early definitive diagnosis of solitary pulmonary nodules. Sputum cytology, bronchoscopy and biopsy, image-guided fine-needle aspiration cytology, and positron emission tomography with (18)fluorodeoxyglucose (FDG-PET) scanning are useful diagnostic tools, but problems unique to each and the possibility of false-negative examination have relegated their use to selected nodules. Serial radiographic examination remains the main noninvasive test for diagnosis of solitary pulmonary nodules. Video-thoracic surgery allows resection of pulmonary nodules with minimal morbidity and mortality. Today, diagnosis by excisional biopsy is an acceptable management strategy as more and smaller nodules are being detected but not diagnosed. In 2002, when in doubt, we should take out the solitary pulmonary nodule.

Management of solitary pulmonary nodules: how do thoracic computed tomography and guided fine needle biopsy influence clinical decisions?

BACKGROUND: Computed tomography (CT) and fine needle guided biopsy (FNB) are often used in the assessment of patients with lung nodules. The influence of these techniques on clinical decision making has not been quantified, especially for small solitary pulmonary nodules (SPN) where the probability of malignancy is lower. A study was undertaken to determine the effect of CT and FNB derived information on clinical decision making in patients with a solitary pulmonary nodule < or = 3 cm in diameter on initial chest radiography. METHODS: Clinical, physiological, and outcome data on 114 patients with an SPN < or = 3 cm who had subsequent thoracic CT and FNB were extracted from the records of a specialist cardiorespiratory hospital in Auckland, New Zealand. Chest radiographs and CT scans were reported according to specified criteria by a thoracic radiologist. Computer generated summary sheets were used to present cases to each of six clinicians. Each case was presented three times: (1) with clinical data and chest radiograph only; (2) with the addition of the CT report; and (3) with all data including the result of the FNB. Clinicians were asked to specify their management on each occasion and to estimate the probability of the lesion being malignant. Reproducibility was assessed by re-evaluating 24 cases 1 month later. RESULTS: 33 (29%) nodules were benign, 35 (31%) nodules (malignant) were resected with negative node sampling, and 46 (40%) had a non-curative outcome (radiotherapy, incomplete resection, refused therapy). Intra-clinician decision making was consistent for all three levels of clinical data (median kappa values 0.79-0.89). Agreement between clinicians on the need for surgery was lowest with chest radiography alone (kappa=0.33), rose with CT information (kappa=0.44), and increased further with the addition of the FNB data (kappa=0.57). The proportion of successful decisions on surgical intervention (against the known outcome) increased with the addition of CT reports and further with FNB reports (p=0.006, Friedman's test). The major benefit of the information added by CT and FNB reports was a reduction in unnecessary surgery, especially when the clinical perception of pre-test probability of malignancy was intermediate (31-70%). FNB data contributed most to the benefit (p<0.001). The addition of CT and FNB was cost efficient and can be applied specifically to patients with a low or intermediate probability of malignancy. CONCLUSION: Both CT and FNB make cost effective contributions to the clinical management of SPN < or = 3 cm in diameter by reducing unnecessary operations and increasing agreement between physicians on the need for surgery.

Solitary pulmonary nodules: accuracy and cost-effectiveness of sodium iodide FDG-PET using Australian data.

This study uses Australian data to confirm the accuracy of dedicated sodium iodide (NaI) fluorine-18 fluorodeoxyglucose positron emission tomography (FDG-PET) in evaluating indeterminate solitary pulmonary nodules (SPNs) and to determine the conditions under which PET could play a cost-effective role in this evaluation. Ninety-two patients from two Australian hospitals in different states underwent FDG-PET for evaluation of an SPN. Observed values for prior probability of malignancy and diagnostic accuracy of PET were applied to previously published decision tree models using published Australian health care costs. The accuracy of FDG-PET was 93% with a sensitivity of 92% and a specificity of 95%. The prior probability of malignancy (0.54), PET sensitivity and PET specificity indicated cost savings per patient of up to EUR 455 (Adollars 774) based on a PET cost of EUR 706 (Adollars 1,200). PET would remain cost-effective for levels of prior probability up to 0.8-0.9 and a PET cost of EUR 736-1,161 (Adollars 1,252-Adollars 1,974). It is concluded that NaI PET is accurate, cost saving and cost-effective for the characterisation of indeterminate pulmonary nodules in Australia. Comparison with previous reports from the United States confirms that FDG-PET can remain cost-effective despite population differences in medical costs, disease prevalence and PET diagnostic performance.

Cost-effectiveness of FDG-PET for the management of solitary pulmonary nodules: a decision analysis based on cost reimbursement in Germany.

Management of solitary pulmonary nodules (SPNs) of up to 3 cm was modelled on decision analysis comparing "wait and watch", transthoracic needle biopsy (TNB), exploratory surgery and full-ring dedicated positron emission tomography (PET) using fluorine-18 2-fluorodeoxyglucose (FDG). The incremental cost-effectiveness ratios (ICERs) were calculated for the main risk group, a cohort of 62-year-old men, using first "wait and watch" and second exploratory surgery as the baseline strategy. Based on published data, the sensitivity and specificity of FDG-PET were estimated at 0.95 and 0.80 for detecting malignancy in SPNs and at 0.74 and 0.96 for detecting metastasis in normal-sized mediastinal lymph nodes. The costs quoted correspond to reimbursement in 1999 by the public health provider in Germany. Decision analysis modelling indicates the potential cost-effectiveness of the FDG-PET strategy for management of SPNs. Taking watchful waiting as the low-cost baseline strategy, the ICER of PET [3218 euros (EUR) per life year saved] was more favourable than that of exploratory surgery (4210 EUR/year) or that of TNB (6120 EUR/year). Changing the baseline strategy to exploratory surgery, the use of PET led to cost savings and additional life expectancy. This constellation was described by a negative ICER of -6912 EUR/year. The PET algorithm was cost-effective for risk and non-risk patients. However, the ICER of PET as the preferred strategy was sensitive to a hypothetical deterioration of any PET parameters by more than 0.07. To transfer the diagnostic efficacy from controlled studies to the routine user and to maintain the cost-effectiveness of this technology, obligatory protocols for data acquisitions would need to be defined. If the prevalence of SPNs is estimated at the USA level (52 per 100,000 individuals) and assuming that multiple strategies without PET are the norm, the overall costs of a newly implemented PET algorithm would be limited to far less than one EUR per member of the public health provider in Germany.