Overall survival in lung cancer patients remains limited.1 However, survivorship varies greatly from the diagnosed stage, ranging from 55% in those presenting with localized disease to 4% in those with metastases.2 The National Lung Screening Trial has demonstrated the utility of low-dose computed tomography (CT) scans in reduction of lung cancer–related mortality in those who meet high-risk criteria. This information combined with recent findings that delayed treatment can lead to decreased survival and increased mortality has led to a widespread search for more efficient and stream-lined tracks from cancer detection to surgical treatment.
The conventional workup consists of nodule detection leading to bronchoscopic navigational biopsy and/or CT-guided biopsy, followed by referral to thoracic surgeon with potential surgical resection. The current model is often convoluted and complicated with the involvement of multiple disciplines, clinic visits, untimely scheduling of diagnostic procedures and reporting of results, as well as potential complications and hospitalizations. This drawn-out process can, at times, takes months and often requires seeing a pulmonologist and interventional radiologist before finally arriving at a thoracic surgeon's office. With the advent of the hybrid operating room (OR) equipped with a flat-panel detector angiographic system, this conventional workup can now be consolidated into a single-stage procedure by a single provider. This represents a paradigm shift in the approach to lung nodule management and should be added to the armamentarium of the modern thoracic surgeon.
We believe a stream-lined approach to obtaining the biopsy, pathology, and treatment in one setting not only avoids the upstaging and worse prognosis associated with delayed treatment but also is a cost-effective paradigm for the institution.
Hybrid OR Layout
The hybrid OR is an integrative theater created to combine the capabilities of a catheterization suite with a traditional OR. The hybrid OR described in our study consists of fully equipped angiography facilities with a ceiling mounted C-arm (Allura Xper FD20, Philips). This C-arm can also be used to perform a high-quality on-table cone-beam CT scan. Approximate cost of the hybrid OR complex was US $2.6 million. Figure 1D displays the typical thoracic surgery set-up in a commercially available unit.
Computed Tomography and Thoracic Procedures
To generate a cone-beam CT scan in the hybrid OR system the C-arm is used to perform a rotational tomography (Figs. 1A–C) and 3D processing is performed.3 To fully incorporate the hybrid OR into one's practice, there are three major clinical applications that should be considered.
First, we will address the use of cone-beam CT in navigational bronchoscopy. Traditionally, navigational bronchoscopy has been performed as a separate procedure from video-assisted thoracic surgery (VATS), typically by a pulmonologist. Navigational bronchoscopy is now an accepted standard of care when approaching a tumor endobronchially with typical biopsy accuracy approximately 70%.4,5 Cone-beam CT in a hybrid OR can be used during navigational bronchoscopy and offers intraoperative 3D confirmation and real-time fluoroscopy augmentation with 3D digital overlay of the targeted tumor.6,7 The availability of cone-beam CT allows for increased accuracy of endobronchial biopsy to more than 85%.8 Mediastinal lymph node staging is usually integrated at this step using navigational and endobronchial ultrasound (EBUS) techniques.
The second skill set to be incorporated is cone-beam CT-guided percutaneous biopsy. Rather than an interventional radiology referral, percutaneous biopsy can be performed in the hybrid suite using the cone-beam CT scan and a dedicated fluoroscopic guidance technique that visualizes procedure planning overlay with live fluoroscopy (Fig. 2).9 Using the cone-beam CT data, the lung nodule is segmented (i.e., to be digitally partitioned to allow the images to be analyzed and boundaries determined) and used to further augment on overlay with live fluoroscopy. Patients are exposed to less radiation with preserved accuracy of the biopsy when compared with conventional CT guidance.10,11
Rapid on-site evaluation is critical to the algorithm of proceeding with a surgical resection. A team of on-call pathologists must be available to come into the OR and provide immediate diagnosis using the standard techniques.
The final element is the percutaneous intraoperative placement of fiducial markers.12 Using a cone-beam CT-guided percutaneous technique, radio-opaque markers are placed in and around the tumor to allow for localization. Image-guided VATS (iVATS) can be performed in the same setting, using the hybrid-suite fluoroscopy to localize these markers and guide a wedge resection (Fig. 3).13 Intraoperative cone-beam CT associated with augmented reality during pulmonary resection has additionally shown to be useful for confirming appropriate resection margins.14
A total of 25 patients underwent our paradigm of navigation bronchoscopy, CT-guided lung biopsy and/or marker placement, pathology, and subsequent surgical treatment in an individualized approach for 11 months. Average age was 59 years with 52% female and 48% male. The mean lesion size was 25 mm. 32% of the lesions were in the right upper lobe, followed by 28% in the right lower lobe and 20% in the left upper lobe. Average pack years was 36 with 5 patients identified as never smokers. Final pathology returned 13 patients (52%) with malignancy on their biopsies (Table 1).
Of the 25 patients, 7 (28%) went onto a same-day surgical procedure after on-site pathology results; 6 received a wedge resection and 1 received a lobectomy. Eight patients who underwent hybrid OR bronchoscopy and biopsy did not receive a same-day surgical resection but went on to receive a resection at a later date, and half were due to patients' choice to not pursue surgery and half due to inconclusive pathology results. Average OR time used was 167 minutes; if no surgical resection was performed, the average time was 136 minutes compared with surgical resection times totaling 232 minutes. Results are summarized in Table 1.
The combination of these techniques (cone-beam CT scan augmented navigational bronchoscopy, cone-beam CT-guided percutaneous biopsy, and fiducial-guided VATS resection) into a single-stage, single-provider procedure allows for more efficient and stream-lined patient management. As data have shown that delayed treatment greater than 8 weeks in stage I lung cancers results in increased mortality, the use of the hybrid OR for same-day diagnosis and resection promotes better healthcare.15 Our current multi-institutional clinical trial aims to determine the accuracy and feasibility of a single-stage procedure for lung nodules. All patients are entered into a quality improvement database, and all cases are reviewed by a multi-institutional tumor board. Since the opening of our hybrid suite, we have performed 25 cases using the integrated cone-beam CT scan and 3D overlay, with several patients undergoing navigational bronchoscopy, percutaneous biopsy (lung and bone), and iVATS resection in a single operation (Fig. 3). Thirty-two percent of our patients underwent this hybrid procedure with initial on-site pathology concerning for malignancy and subsequently received a surgical resection. Although total OR utilization time was increased by proceeding with surgery after biopsy (232 minutes compared with 136 minutes), we believe that overall the time saved by avoiding another preoperative visit, holding time, and set-up helps off-set the opportunity cost.
Although there is a learning curve associated with maneuvering controls in the hybrid OR, our experience shows the user-friendly software and use of the hybrid OR team smooths the transition. As our cases were only scheduled during times where the theater was not in use by the surgery teams, we were able to bring the dedicated hybrid OR team who were able to perform the techniques necessary for our procedures. The lack of scheduling conflicts also contributes to avoiding a loss of revenue as the room would otherwise not be in use.
The financial aspects must also be considered before this paradigm can feasibly be modeled at other institutions. The capital investment required to build a hybrid OR complex is not insignificant, with ours approximately costing US $2.6 million. However, our particular institution, as with other level 1 tertiary centers, already had an existing hybrid OR mainly for the vascular surgery service, and therefore, our discussion relies more on the repurposing of the hybrid OR in times when it was not being used to its full imaging capabilities using 3D CT scan interventions. Instead of using it as a regular OR when not in use, we were able to schedule cases to implement our stream-lined paradigm. In addition, the same team of OR nurses, staff, and technicians was available to assist with the procedure during the regular working hours and did not increase any indirect costs. Total charges were nearly US $400,000 for the 11-month period with an average of US $28,553 per case in 14 same-day surgery cases. However, although combining diagnosis and treatment in one visit is beneficial to the patient, more research needs to be conducted to compare the revenue generated compared with different-day procedures. This will be even more important in the near future when fee-for-service reimbursement will change to a quality driven patient care system. Here, shorter diagnosis to treatment time will lead to improved cancer outcomes.15 The proposed hybrid OR techniques can achieve diagnosis and treatment in the same day.
As thoracic surgery stakes its claim in the hybrid OR, these skills should be incorporated into not only the armamentarium of any thoracic surgeon but also into the standard curriculum of Thoracic Surgery Residency.
3. Orth RC, Wallace MJ, Kuo MD. Technology Assessment Committee of the Society of Interventional Radiology. C-arm cone-beam CT: general principles and technical considerations for use in interventional radiology. J Vasc Interv Radiol
4. Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest
5. Gex G, Pralong JA, Combescure C, et al. Diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules: a systematic review and meta-analysis. Respiration
6. Hohenforst-Schmidt W, Zarogoulidis P, Vogl T, et al. Cone beam computertomography (CBCT) in interventional chest medicine - high feasibility for endobronchial realtime navigation. J Cancer
7. Park SC, Kim CJ, Han CH, et al. Factors associated with the diagnostic yield of computed tomography-guided transbronchial lung biopsy. Thorac Cancer
8. Pritchett M, Radaelli A, Schampaert S, et al. Cone beam CT-guided endobronchial biopsy assisted by augmented fluoroscopy. Chest
9. Abi-Jaoudeh N, Mielekamp P, Noordhoek N, et al. Cone-beam computed tomography fusion and navigation for real-time positron emission tomography-guided biopsies and ablations: a feasibility study. J Vasc Interv Radiol
10. Abi-Jaoudeh N, Fisher T, Jacobus J, et al. Prospective randomized trial for image-guided biopsy using cone-beam CT navigation compared with conventional CT. J Vasc Interv Radiol
11. Braak SJ, Van Strijen MJ, Van Es HW, et al. Effective dose during needle interventions: cone-beam CT guidance compared with conventional CT guidance. J Vasc Interv Radiol
12. Abu Saleh WK, Jabbari OA, Lumsden A, et al. Simultaneous localization and removal of lung nodules through extended use of the hybrid suite. Methodist DeBakey Cardiovasc J
13. Gill RR, Zheng Y, Barlow JS, et al. Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial. J Surg Oncol
14. Rouze S, de Latour B, Flecher E, et al. Small pulmonary nodule localization with cone beam computed tomography during video-assisted thoracic surgery: a feasibility study. Interact Cardiovasc Thorac Surg
15. Samson P, Patel A, Garrett T, et al. Effects of delayed surgical resection on short-term and long-term outcomes in clinical stage I non-small cell lung cancer. Ann Thorac Surg