Fiducial marker placement with electromagnetic navigation bronchoscopy: a subgroup analysis of the prospective, multicenter NAVIGATE study

Mark R Bowling, Erik E Folch, Sandeep J Khandhar, Jordan Kazakov, William S Krimsky, Gregory P LeMense, Philip A Linden, Boris A Murillo, Michael A Nead, Michael A Pritchett, Catalina V Teba, Christopher W Towe, Terence Williams, Carlos J Anciano, Mark R Bowling, Erik E Folch, Sandeep J Khandhar, Jordan Kazakov, William S Krimsky, Gregory P LeMense, Philip A Linden, Boris A Murillo, Michael A Nead, Michael A Pritchett, Catalina V Teba, Christopher W Towe, Terence Williams, Carlos J Anciano

Abstract

Background: Fiducial markers (FMs) help direct stereotactic body radiation therapy (SBRT) and localization for surgical resection in lung cancer management. We report the safety, accuracy, and practice patterns of FM placement utilizing electromagnetic navigation bronchoscopy (ENB).

Methods: NAVIGATE is a global, prospective, multicenter, observational cohort study of ENB using the superDimension™ navigation system. This prospectively collected subgroup analysis presents the patient demographics, procedural characteristics, and 1-month outcomes in patients undergoing ENB-guided FM placement. Follow up through 24 months is ongoing.

Results: Two-hundred fifty-eight patients from 21 centers in the United States were included. General anesthesia was used in 68.2%. Lesion location was confirmed by radial endobronchial ultrasound in 34.5% of procedures. The median ENB procedure time was 31.0 min. Concurrent lung lesion biopsy was conducted in 82.6% (213/258) of patients. A mean of 2.2 ± 1.7 FMs (median 1.0 FMs) were placed per patient and 99.2% were accurately positioned based on subjective operator assessment. Follow-up imaging showed that 94.1% (239/254) of markers remained in place. The procedure-related pneumothorax rate was 5.4% (14/258) overall and 3.1% (8/258) grade ⩾ 2 based on the Common Terminology Criteria for Adverse Events scale. The procedure-related grade ⩾ 4 respiratory failure rate was 1.6% (4/258). There were no bronchopulmonary hemorrhages.

Conclusion: ENB is an accurate and versatile tool to place FMs for SBRT and localization for surgical resection with low complication rates. The ability to perform a biopsy safely in the same procedure can also increase efficiency. The impact of practice pattern variations on therapeutic effectiveness requires further study.

Trial registration: ClinicalTrials.gov identifier: NCT02410837.

Keywords: electromagnetic navigation bronchoscopy; fiducial; lung cancer; prospective clinical study; stereotactic body radiation therapy.

Conflict of interest statement

Conflict of interest statement: MRB, EEF, SJK, WSK, GL, MAN, MP, and TW: consultants for Medtronic; WSK: part-time employee of Medtronic (began after enrollment completion) with intellectual property rights; EEF: consultant (Boston Scientific and Olympus); CWT: travel reimbursement (Medtronic). Biostatistical analysis was provided by Haiying Lin of Medtronic. Technical and editorial assistance was provided by Kristin L. Hood PhD, of Medtronic, in accordance with Good Publication Practice (GPP3) guidelines. The first and final drafts were written by the lead author (MRB).

Figures

Figure 1.
Figure 1.
Patients included in the analysis.
Figure 2.
Figure 2.
Number of fiducial markers implanted per patient.

References

    1. Caillet V, Booth JT, Keall P. IGRT and motion management during lung SBRT delivery. Phys Med 2017; 44: 113–22.
    1. Howington JA, Blum MG, Chang AC, et al. Treatment of stage I and II non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2013; 143: e278S–e313S.
    1. Videtic GMM, Donington J, Giuliani M, et al. Stereotactic body radiation therapy for early-stage non-small cell lung cancer: executive summary of an ASTRO evidence-based guideline. Pract Radiat Oncol 2017; 7: 295–301.
    1. Hagmeyer L, Priegnitz C, Kocher M, et al. Fiducial marker placement via conventional or electromagnetic navigation bronchoscopy (ENB): an interdisciplinary approach to the curative management of lung cancer. Clin Respir J 2016; 10: 291–297.
    1. Murphy MJ. Fiducial-based targeting accuracy for external-beam radiotherapy. Med Phys 2002; 29: 334–344.
    1. Van der Voort van Zyp NC, Prevost JB, Hoogeman MS, et al. Stereotactic radiotherapy with real-time tumor tracking for non-small cell lung cancer: clinical outcome. Radiother Oncol 2009; 91: 296–300.
    1. Andrade RS. Electromagnetic navigation bronchoscopy-guided thoracoscopic wedge resection of small pulmonary nodules. Semin Thorac Cardiovasc Surg 2010; 22: 262–265.
    1. Zhao ZR, Lau RW, Ng CS. Hybrid theatre and alternative localization techniques in conventional and single-port video-assisted thoracoscopic surgery. J Thorac Dis 2016; 8: S319-S327.
    1. Abbas A, Kadakia S, Ambur V, et al. Intraoperative electromagnetic navigational bronchoscopic localization of small, deep, or subsolid pulmonary nodules. J Thorac Cardiovasc Surg 2017; 153: 1581–1590.
    1. Ng CSH, Chu CM, Lo CK, et al. Hybrid operating room Dyna-computed tomography combined image-guided electromagnetic navigation bronchoscopy dye marking and hookwire localization video-assisted thoracic surgery metastasectomy. Interact Cardiovasc Thorac Surg 2018; 26: 338–340.
    1. Ohta K, Shimohira M, Murai T, et al. Percutaneous fiducial marker placement prior to stereotactic body radiotherapy for malignant liver tumors: an initial experience. J Radiat Res 2016; 57: 174–177.
    1. Trumm CG, Haussler SM, Muacevic A, et al. CT fluoroscopy-guided percutaneous fiducial marker placement for CyberKnife stereotactic radiosurgery: technical results and complications in 222 consecutive procedures. J Vasc Interv Radiol 2014; 25: 760–768.
    1. Kular H, Mudambi L, Lazarus DR, Cornwell L, et al. Safety and feasibility of prolonged bronchoscopy involving diagnosis of lung cancer, systematic nodal staging, and fiducial marker placement in a high-risk population. J Thorac Dis 2016; 8: 1132–1138.
    1. Harris K, Gomez J, Dhillon SS, et al. Convex probe endobronchial ultrasound placement of fiducial markers for central lung nodule (with video). Endosc Ultrasound 2015; 4: 156–157.
    1. Yousefi S, Collins BT, Reichner CA, et al. Complications of thoracic computed tomography-guided fiducial placement for the purpose of stereotactic body radiation therapy. Clin Lung Cancer 2007; 8: 252–256.
    1. Farkas EA, Stoeckel DA, Nassif AS, et al. Intracoronary fiducial embolization after percutaneous placement for stereotactic radiosurgery. Ann Thorac Surg 2012; 93: 1715-1717.
    1. Hennessey H, Valenti D, Cabrera T, et al. Cardiac embolization of an implanted fiducial marker for hepatic stereotactic body radiotherapy: a case report. J Med Case Rep 2009; 3: 140.
    1. Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2013; 143: e142S–e65S.
    1. Minnich DJ, Bryant AS, Wei B, et al. Retention rate of electromagnetic navigation bronchoscopic placed fiducial markers for lung radiosurgery. Ann Thorac Surg 2015; 100: 1163–1166.
    1. Schroeder C, Hejal R, Linden PA. Coil spring fiducial markers placed safely using navigation bronchoscopy in inoperable patients allows accurate delivery of CyberKnife stereotactic radiosurgery. J Thorac Cardiovasc Surg 2010; 140: 1137–1142.
    1. Belanger AR, Burks AC, Chambers DM, et al. Peripheral lung nodule diagnosis and fiducial marker placement using a novel tip-tracked electromagnetic navigation bronchoscopy system. J Bronchology Interv Pulmonol 2019; 26: 41–48.
    1. Folch EE, Pritchett MA, Nead MA, et al. Electromagnetic navigation bronchoscopy for peripheral pulmonary lesions: one-year results of the prospective, multicenter NAVIGATE study. J Thorac Oncol 2019; 14: 445–458.
    1. Khandhar SJ, Bowling MR, Flandes J, et al. Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study. BMC Pulm Med 2017; 17: 59.
    1. Folch EE, Bowling MR, Gildea TR, et al. Design of a prospective, multicenter, global, cohort study of electromagnetic navigation bronchoscopy. BMC Pulm Med 2016; 16: 60.
    1. Nakamura M, Takamiya M, Akimoto M, et al. Target localization errors from fiducial markers implanted around a lung tumor for dynamic tumor tracking. Phys Med 2015; 31: 934–941.
    1. Pan H, Rose BS, Simpson DR, et al. Clinical practice patterns of lung stereotactic body radiation therapy in the United States: a secondary analysis. Am J Clin Oncol 2013; 36: 269–272.
    1. Rong Y, Bazan JG, Sekhon A, et al. Minimal inter-fractional fiducial migration during image-guided lung stereotactic body radiotherapy using Superlock nitinol coil fiducial markers. PLoS One 2015; 10: e0131945.
    1. Bolton WD, Richey J, Ben-Or S, Hale AL, et al. Electromagnetic navigational bronchoscopy: a safe and effective method for fiducial marker placement in lung cancer patients. Am Surg 2015; 81: 659–662.
    1. Jackson P, Steinfort DP, Kron T, et al. Practical assessment of bronchoscopically inserted fiducial markers for image guidance in stereotactic lung radiotherapy. J Thorac Oncol 2016; 11: 1363–1368.
    1. Bowling MR, Kohan MW, Walker P, Efird J, Ben Or S. The effect of general anesthesia versus intravenous sedation on diagnostic yield and success in electromagnetic navigation bronchoscopy. J Bronchology Interv Pulmonol 2015; 22: 5–13.
    1. Pearlstein DP, Quinn CC, Burtis CC, Ahn KW, Katch AJ. Electromagnetic navigation bronchoscopy performed by thoracic surgeons: one center’s early success. Ann Thorac Surg 2012; 93: 944–949; discussion 9–50.
    1. Ozgul G, Cetinkaya E, Ozgul MA, et al. Efficacy and safety of electromagnetic navigation bronchoscopy with or without radial endobronchial ultrasound for peripheral lung lesions. Endosc Ultrasound 2016; 5: 189–195.
    1. Ng CS, Yu SC, Lau RW, et al. Hybrid DynaCT-guided electromagnetic navigational bronchoscopic biopsy. Eur J Cardiothorac Surg 2016; 49(Suppl 1): i87–i8.
    1. Hsia DW, Jensen KW, Curran-Everett D, et al. Diagnosis of lung nodules with peripheral/radial endobronchial ultrasound-guided transbronchial biopsy. J Bronchology Interv Pulmonol 2012; 19: 5–11.
    1. Eberhardt R, Anantham D, Ernst A, et al. Multimodality bronchoscopic diagnosis of peripheral lung lesions: a randomized controlled trial. Am J Respir Crit Care Med 2007; 176: 36–41.
    1. Finley RJ, Mayo JR, Grant K, et al. Preoperative computed tomography-guided microcoil localization of small peripheral pulmonary nodules: a prospective randomized controlled trial. J Thorac Cardiovasc Surg 2015; 149: 26–31.
    1. Lee NK, Park CM, Kang CH, et al. CT-guided percutaneous transthoracic localization of pulmonary nodules prior to video-assisted thoracoscopic surgery using barium suspension. Korean J Radiol 2012; 13: 694–701.
    1. Su TH, Fan YF, Jin L, et al. CT-guided localization of small pulmonary nodules using adjacent microcoil implantation prior to video-assisted thoracoscopic surgical resection. Eur Radiol 2015; 25: 2627–2633.
    1. Klinkenberg TJ, Dinjens L, Wolf RFE, et al. CT-guided percutaneous hookwire localization increases the efficacy and safety of VATS for pulmonary nodules. J Surg Oncol 2017; 115: 898–904.
    1. Ciriaco P, Negri G, Puglisi A, Nicoletti R, et al. Video-assisted thoracoscopic surgery for pulmonary nodules: rationale for preoperative computed tomography-guided hookwire localization. Eur J Cardiothorac Surg 2004; 25: 429–433.
    1. Chen S, Zhou J, Zhang J, et al. Video-assisted thoracoscopic solitary pulmonary nodule resection after CT-guided hookwire localization: 43 cases report and literature review. Surg Endosc 2011; 25: 1723–1729.
    1. Battisti WP, Wager E, Baltzer L, et al. Good publication practice for communicating company-sponsored medical research: GPP3. Ann Intern Med 2015; 163: 461–464.
    1. Bowling M, Folch E, Khandhar S, et al. Fiducial Marker Placement Using Electromagnetic Navigation Bronchoscopy in the Prospective, Multicenter NAVIGATE Study. J Thorac Oncol. 2017; 12: S1886–S1887.

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren