AABIP IP Fellows Reading List

NAVIGATIONAL AND ROBOTIC BRONCHOSCOPY

The Evolutional History of Electromagnetic Navigation Bronchoscopy: State of the Art

https://pubmed.ncbi.nlm.nih.gov/29723514/

Review

Reference: Mehta AC, Hood KL, Schwarz Y, Solomon SB. The Evolutional History of Electromagnetic Navigation Bronchoscopy: State of the Art. Chest. 2018;154(4):935-947.

Summary: This article describes the conception and historical development of electromagnetic navigation (EMN) starting from image guided surgery based on mechanical and optical guidance. These applications were previously of limited use with flexible instruments like bronchoscopy. It describes the historical roots of the electromagnetic theory and EMN origins of use in lung after initially being used for sinus and neurosurgeries. The article also gives an overview of the first preclinical studies with the first superDimension system used to map artificial lesions in animals and the progress to the first human studies in 2003. From there, it describes how the technology evolved with the addition of other navigation systems and the future directions with 3D fluoroscopy and robotic endoscopy platforms.

Interventional Bronchoscopy: State-of-the-Art Review

https://pubmed.ncbi.nlm.nih.gov/32023078/

Review

Reference: Criner GJ, Eberhardt R, Fernandez-bussy S, et al. Interventional Bronchoscopy: State-of-the-Art Review. Am J Respir Crit Care Med. 2020;

Summary: This article reviews the major advances in the past 10-15 years in thoracic imaging, navigational platforms, and the ability to directly visualize lesions during biopsy. It summarizes available modalities that enhance imaging and provide navigation to lung lesions including radial EBUS (rEBUS), navigational techniques such as EMN and virtual bronchoscopic navigation (VBN), and transparenchymal nodule access (TPNA). It goes over available imaging for navigation including CT bronchoscopy: Ct-guidance and cone beam CT (CBCT) and new adjuncts to local imaging techniques such as optical coherence tomography, confocal laser endomicroscopy and image enhancement with autofluorescence and narrow band imaging. In addition, new technological changes to the bronchoscope such as ultrathin bronchoscopy and robotic bronchoscopy are reviewed. The article also reviews new advances in therapeutic approaches to solitary pulmonary nodules including utilization of radiofrequency ablation (RFA), microwave ablation (MWA), cryoablation, bronchial thermal vapor ablation (BTVA), brachytherapy (HDRT), and photodynamic therapy (PDT).

NOTE: Article is a full IP state-of-the-art review, additional summaries on topics not related to this summary on navigational bronchoscopy are available.

Electromagnetic navigation bronchoscopy: a comprehensive review

http://amj.amegroups.com/article/view/4758/html

Review

Reference: Pickering, E. M., Kalchiem-Dekel, O., & Sachdeva, A. (2018). Electromagnetic navigation bronchoscopy: a comprehensive review. AME Medical Journal, 3, 117–117.

Summary: This article provides important principles and practical aspects of pre-procedure preparation, assessment of airway-lesion relationships, procedural workflow and performance (Veran™, superDimension™, Archimedes™) and points for consideration when contemplating acquisition of an EMN system. The article also discusses sampling tool selection and factors affecting diagnostic yield. In addition, it discusses EMN use for lesion marking; fiducial marker placement, embolization coils, dye marking/tattooing. It has good images showing airway-lesion relationships, sampling tools deflection and rEBUS lesion relation.

State-of-the-Art Modalities for Peripheral Lung Nodule Biopsy

https://pubmed.ncbi.nlm.nih.gov/29433709/

Review

Reference: Kalanjeri S, Holladay RC, Gildea TR. State-of-the-Art Modalities for Peripheral Lung Nodule Biopsy. Clin Chest Med. 2018;39(1):125-138.

Summary: The article goes over peripheral pulmonary nodules biopsy modalities focusing on image guided bronchoscopy tools including rEBUS, confocal laser endomicroscopy, virtual bronchoscopy, and EMN bronchoscopy. It provides pooled diagnostic yield (table 2 with studies results summary) for each and factors that affect it. It also reviews the relatively new at the time, CBCT. Finally, it gives an overview of modality selection.

Towards an optimization of bronchoscopic approaches to the diagnosis and treatment of the pulmonary nodules: a review

https://pubmed.ncbi.nlm.nih.gov/30034829/

Review

Reference: Krimsky WS, Pritchett MA, Lau KKW. Towards an optimization of bronchoscopic approaches to the diagnosis and treatment of the pulmonary nodules: a review. J Thorac Dis. 2018;10(Suppl 14):S1637-S1644.

Summary: This article reviews recent advances in the domains of advanced imaging, approaches to accessing various parts of the lung, tools designed to acquire tissue, robotic endoscopy platforms and new approaches to tissue ablation. Advanced imaging CBCT, augmented fluoroscopy, and tomosynthesis are reviewed. Advances in access methods include bronchoscopic transparenchymal nodule access (Archimedes system, Broncus Medical), CrossCountry transbronchial access tool (Medtronic), thin convex probe EBUS, and electromagnetic-guided transthoracic needle aspiration (SPiN Perc system (Veran medical). New tools that are reviewed include new flexible needles and core biopsy systems. It concludes with reviews of the 2 available robotic bronchoscopy platforms and latest advances in peripheral tumor ablation.

Bronchoscopic transparenchymal nodule access (BTPNA): first in human trial of a novel procedure for sampling solitary pulmonary nodules

https://pubmed.ncbi.nlm.nih.gov/25746631/

Clinical Trial (Archimedes)

Reference: Herth FJ, Eberhardt R, Sterman D, Silvestri GA, Hoffmann H, Shah PL. Bronchoscopic transparenchymal nodule access (BTPNA): first in human trial of a novel procedure for sampling solitary pulmonary nodules. Thorax. 2015;70(4):326-32.

Background: First in human trial of transparenchymal tunneling in solitary pulmonary nodules (SPN).

PICO:

Populations:

  • 12 patients enrolled with SPN

Intervention:

  • Transparenchymal access of a SPN

Comparison:

  • None

Outcome:

  • 12 patients recruited. Tunneled pathway created in 10 patients. No adverse events reported. Adequate biopsies in 10 patients (83%) which correlated with the histological findings from the surgical resection. No safety concerns upon inspection of the resected lobes.

Take Home: First human study demonstrating feasibility of bronchoscopic transparenchymal access of SPNs.

Community hospital experience using electromagnetic navigation bronchoscopy system integrating tidal volume computed tomography mapping

https://pubmed.ncbi.nlm.nih.gov/30643545/

Retrospective (Veran)

Reference: Raval AA, Amir L. Community hospital experience using electromagnetic navigation bronchoscopy system integrating tidal volume computed tomography mapping. Lung Cancer Manag. 2016;5(1):9-19.

Background: This retrospective study measured the total diagnostic yield relative to location and size of lung lesions when using the TV-EXP-mapped EMN system (Veran) in the absence of rEBUS, fluoroscopic navigation or rapid onsite cytology evaluation.

PICO:

Populations:

  • The first consecutive 50 patients referred with suspected lung cancer after a positive finding on CT from July 2012 to May 2013 were reviewed at a community hospital’s tumor board.

Intervention:

  • Patients were consented for TV-EXP EMN using SPiNDrive System along with linear EBUS. Patients were followed for 24 months after procedure.

Comparison:

  • None

Outcome:

  • 48 patients completed mapping procedure (2 excessive coughing after linear EBUS, therefore EMN canceled)
  • 61 lesions, nodule size varied (15 nodules <10mm, 22nodules 11-20mm, 14 nodules 21-30mm, 10 nodules >31mm)
  • Overall diagnostic yield 83.3%, 39.6% patients were diagnosed with malignancy.
  • Diagnostic yield for the first 20 patients was 80%, for the subsequent 23 patients increased to 87%.

Take Home: Use of this technology appears to be safe and effective with a limited learning curve.

Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study

https://pubmed.ncbi.nlm.nih.gov/28399830/

Clinical Trial

Reference: 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(1):59.

Background: Prospective, multicenter, global, single arm, cohort study of the superDimension navigation system.

PICO:

Populations:

  • Patients with peripheral lung nodules

Intervention:

  • 1000 subjects, 29 sites (27 USA, 2 Europe) from 4/16/15 to 6/27/16, 11 academic centers, 11 private practice, 7 mixed sites. 93.3% completed 1-month follow up.
  • Lung lesion biopsy n=964.
  • Fiducial marker placement n=210.
  • Pleural dye marking n=17.
  • Lymph node biopsy n=334.

Comparison:

  • None

Outcome:

  • General anesthesia in 79.9%, rEBUS 54.3%,and fluoroscopy 90.1%.
  • Pneumothorax CTCAE ≥2 occurred in 3.2%, any grade pneumothorax 4.9%, bronchopulmonary hemorrhage 1% in CTCAE≥2 and 2.3% overall. CTCAE ≥4 respiratory failure 0.6%.
  • 964 subjects, 1129 lesions, median lesion size 20mm, 48.4% had bronchus sign, 62.6% were peripheral, 30.1% were middle lung thirds. Navigation was completed & tissue was obtained in 94.4%. tissue adequacy for genetic testing was 80%.

Take Home: One-month results of the first 1000 patients demonstrated low adverse event rates in a generalizable population across divers practice settings.

Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study

https://pubmed.ncbi.nlm.nih.gov/30476574/

Clinical Trial

Reference: 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(3):445-458.

Background: 1 year follow up to the NAVIGATE study

PICO:

Populations:

  • Patients with peripheral lung nodules

Intervention:

  • US cohort analysis of 1215 subjects at 29 academic & community sites from April 2015 to Aug 2016.
  • System used, procedures included, primary & secondary endpoints are as the previous summary from Khandhar et al.
  • For the purpose of the 12-month analysis, pathology results from ENB-aided biopsy samples that were diagnostic of non-malignant conditions or indeterminate were referred to as negative for malignancy or negative.

Comparison:

  • None

Outcome:

  • Median lesion size 20mm, fluoroscopy was used in 91% of cases, rEBUS was used in 57%. Median ENB planning time 5minutes, ENB-specific procedure time 25minutes, 1157 subjects underwent ENB with 1092 (94%) navigation completed and tissue obtained. Follow up completed in 99% at 1month, 80% at 12months. 12-month diagnostic yield was 73%, sensitivity 69%, specificity 100%, positive predicted value 100%, and negative predictive value 56% for malignancy.

Take Home: ENB aided diagnosis can be obtained in approximately 75% of evaluated patients across a generalizable cohort based on 12-month prospective follow up with low procedural complication rate.

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

https://pubmed.ncbi.nlm.nih.gov/30958102/

Retrospective – subgroup analysis

Reference: Bowling MR, Folch EE, Khandhar SJ, et al. Fiducial marker placement with electromagnetic navigation bronchoscopy: a subgroup analysis of the prospective, multicenter NAVIGATE study. Ther Adv Respir Dis. 2019;13:1753466619841234.

Background: Subgroup analysis of patient demographics, procedural characteristics, and 1-month outcomes in patients undergoing ENB-guided Fiducial marker (FM) placement. Follow up through 24 months is ongoing.

PICO:

Populations:

  • 258 patients from 21 centers in the US were included.

Intervention:

  • ENB-guided FM placement

Comparison:

  • None

Outcome:

  • General anesthesia was used in 68.2%
  • Lesion location was confirmed by rEBUS in 34.5% of procedures.
  • The median ENB procedure time was 31 min and concurrent lung lesion biopsy was conducted in 82.6% of patients.
  • A mean of 1.7 FM (median 1FM) were placed per patient with 99.2% accurately positioned based on subjective operator assessment.
  • Follow up imaging showed 94.1% remained in place.
  • Procedure related pneumothorax rate was 5.4% overall and 3.1% grade ≥2 on CTCAE scale.
  • Procedure related respiratory failure ≥4 grade was 1.6% and there were no bronchopulmonary hemorrhages reported.

Take Home: ENB is an accurate and versatile tool to place FMs for SBRT and localization for surgical resection with low complication rates.

First Human Use of a New Robotic-Assisted Fiber Optic Sensing Navigation System for Small Peripheral Pulmonary Nodules

https://pubmed.ncbi.nlm.nih.gov/31352444/

Clinical Trial (Robot)

Reference: Fielding DIK, Bashirzadeh F, Son JH, et al. First Human Use of a New Robotic-Assisted Fiber Optic Sensing Navigation System for Small Peripheral Pulmonary Nodules. Respiration. 2019;98(2):142-150.

Background: First in human use of robotic bronchoscopy

PICO:

Populations:

  • 29 patients with pulmonary nodules

Intervention:

  • Subjects enrolled according to study eligibility criteria. Navigation pathways were created semi-automatically using pre-procedure CT scans. Simultaneous (real-time) viewing of actual and virtual bronchi used during navigation to the displayed target. Endobronchial mini probe used to confirm lesion location. Flexible 19-23G needles specifically designed for the robot were used for TBNA along with conventional biopsy tools.
  • Subjects enrolled according to study eligibility criteria. Navigation pathways were created semi-automatically using pre-procedure CT scans. Simultaneous (real-time) viewing of actual and virtual bronchi used during navigation to the displayed target. Endobronchial mini probe used to confirm lesion location. Flexible 19-23G needles specifically designed for the robot were used for TBNA along with conventional biopsy tools.
  • 29 patients, mean lesion size 12.2,12.3, 11.7mm in axial, coronal and sagittal planes, respectively. CT bronchus sign was absent in 41.4% of cases. 96.6% of cases the target was reached, and the lesion sampled. No device related adverse events. No pneumothorax or excessive bleeding observed. Overall diagnostic yield 79.3% with diagnostic yield for malignancy 88%.

Comparison:

  • None

Outcome:

  • 29 patients, mean lesion size 12.2, 12.3, 11.7mm in axial, coronal and sagittal planes, respectively.
  • CT bronchus sign was absent in 41.4% of cases.
  • 6% of cases the target was reached, and the lesion sampled.
  • No device related adverse events. No pneumothorax or excessive bleeding observed.
  • Overall diagnostic yield 79.3% with diagnostic yield for malignancy 88%.

Take Home: This system allowed for safe navigation in very small peripheral airways under continuous visualization while maintaining a static position. This provided a unique sampling capability for biopsy of small SPNs.

Electromagnetic navigational bronchoscopy-directed dye marking for locating pulmonary nodules

https://pubmed.ncbi.nlm.nih.gov/32041826/

Case Series

Reference: Wang LL, He BF, Cui JH, et al. Electromagnetic navigational bronchoscopy-directed dye marking for locating pulmonary nodules. Postgrad Med J. 2020;

Summary: Study aimed to evaluate the accuracy & feasibility of ENB with pleural dye to locate small peripheral pulmonary nodules before video-assisted thoracoscopic (VATS).

ENB performed under general anesthesia, locatable guidewire covered with a sheath was advanced to the ideal location, then it was withdrawn and 0.2-1.0ml of methylene blue/indocyanine green was injected through the guide sheath followed by 20-60ml of air to disperse the dye to the pleura near the nodule. VATS was then performed immediately.

n=25 with 28 nodules. Mean pulmonary nodule diameter was 11.8mm. mean distance from nearest pleural surface was 13.4mm. the dye was visualized in 23 (82.1%) nodules using VATS. Average ENB dye marking procedure length was 12.6min. Complications included hemorrhage & bradycardia (1 patient each) not related to ENB.

ENB can be used to safely and accurately locate small peripheral pulmonary nodules and guide surgical resection.

Cone-Beam CT With Augmented Fluoroscopy Combined With Electromagnetic Navigation Bronchoscopy for Biopsy of Pulmonary Nodules

https://pubmed.ncbi.nlm.nih.gov/30179922/

Retrospective

Reference: Pritchett MA, Schampaert S, De groot JAH, Schirmer CC, Van der bom I. Cone-Beam CT With Augmented Fluoroscopy Combined With Electromagnetic Navigation Bronchoscopy for Biopsy of Pulmonary Nodules. J Bronchology Interv Pulmonol. 2018;25(4):274-282.

Background: The aim of this study was to determine the safety and diagnostic yield of image fusion of intraprocedural CBCT data with live fluoroscopy (augmented fluoroscopy) during ENB-guided biopsy of peripheral lung nodules.

PICO:

Populations:

  • Data from 75 consecutive patients who underwent biopsy with ENB was collected retrospectively.

Intervention:

  • Patients underwent CBCT while temporarily suspending mechanical ventilation. CBCT data were acquired and 3D segmentation of nodules was performed using commercially available software. During ENB the segmented lesions were projected and fused with live fluoroscopy enabling real-time 3D guidance.

Comparison:

  • None

Outcome:

  • All procedures performed by a single pulmonologist, under general anesthesia and in a hybrid OR equipped with C-arm and CBCT.
  • A total of 93 lesions were biopsied, mean size 16mm.
  • Overall diagnostic yield by lesion was 83.7% (CI 95%, 74.8%-89.8%).
  • Multivariate regression analysis showed no independent correlation between lesion size, location, visibility under standard fluoroscopy, and presence of bronchus sign with diagnostic yield.
  • Pneumothorax rate 4%.

Take Home: Intraprocedural CBCT imaging with augmented fluoroscopy is feasible and effective. It is associated with high diagnostic yield.

Biopsy of peripheral lung nodules utilizing cone beam computer tomography with and without trans bronchial access tool: a retrospective analysis

https://pubmed.ncbi.nlm.nih.gov/30505506/

Retrospective

Reference: Sobieszczyk MJ, Yuan Z, Li W, Krimsky W. Biopsy of peripheral lung nodules utilizing cone beam computer tomography with and without trans bronchial access tool: a retrospective analysis. J Thorac Dis. 2018;10(10):5953-5959.

Background: This retrospective review sought to determine the safety and diagnostic yield of the combined modalities of CBCT, ENB and rEBUS in the evaluation of peripheral nodules and masses.

PICO:

Populations:

  • This was a retrospective review of 22 cases in which CBCT, ENB, and rEBUS were utilized with or without TBAT (transbronchial access tool) at a single large community teaching facility from April 2016 to Sep 2016.

Intervention:

  • Bronchoscopy for biopsy of peripheral lung nodules using CBCT, ENB and rEBUS

Comparison:

Outcome:

  • All procedures were performed under general anesthesia and ENB was done using: superDimension (Medtronic).
  • 22 patients; 12 (55%) had visible nodules on fluoroscopy with mean nodule size 2.1cm
  • When TBAT was used (7 of 22 patients) mean tunnel length was 1.5cm.
  • 50% of patients had nodules in the LUL with mean nodule size of 1.98cm.
  • Sufficient sampling in 21 of 22 patients. Total diagnostic yield was 77.2%. TBAT diagnostic yield 100%. Diagnostic yield was 100% in lesions >3cm compared to 72.2% in smaller lesions. 50% diagnostic yield in the lesions in the LUL (all other locations had 100% yield).
  • CXR 2-hours post procedure did not reveal any complications. No adverse events noted at 3 and 6 month follow ups.

Take Home: The combination of CBCT, ENB and rEBUS may be beneficial for the diagnosis of peripheral pulmonary nodules or masses in select patients.

Improved diagnostic yield for lung nodules with digital tomosynthesis-corrected navigational bronchoscopy: Initial experience with a novel adjunct

https://pubmed.ncbi.nlm.nih.gov/31265204/

Retrospective

Reference: Aboudara M, Roller L, Rickman O, et al. Improved diagnostic yield for lung nodules with digital tomosynthesis-corrected navigational bronchoscopy: Initial experience with a novel adjunct. Respirology. 2020;25(2):206-213.

Background: Fluoroscopic tomosynthesis is a software upgrade to the most current version of superDimension system (Medtronic), which corrects for nodule divergence. This study evaluated and compared diagnostic yield of peripheral pulmonary nodule (PPN) biopsies in patients who underwent ENB with and without fluoroscopic tomosynthesis.

PICO:

Populations:

  • All consecutive ENB procedures at a single center from 12/25/2017 to 8/25/2018 were reviewed. Fluoroscopic ENB (f-ENB) was introduced on 4/25/2018.

Intervention:

  • ENB procedure with or without fluoroscopic tomosynthesis

Comparison:

  • 2 cohorts were analyzed: standard (s-ENB) (from 12/25/17 to 4/24/18) and the f-ENB (from 4/25/18 to 8/25/18)

Outcome:

  • Diagnostic yield was 54% in s-ENB group and 79% in f-ENB group (p=0.0019).
  • Factors independently associated with a positive diagnosis were f-ENB and a positive rEBUS view.
  • Pneumothorax rate 1.5%.

Take Home: The use of f-ENB may increase the diagnostic yield of ENB and has a low complication rate.

A Prospective Randomized Comparative Study of Three Guided Bronchoscopic Approaches for Investigating Pulmonary Nodules: The PRECISION-1 Study

https://pubmed.ncbi.nlm.nih.gov/31678307/

Clinical Trial

Reference: Yarmus L, Akulian J, Wahidi M, et al. A Prospective Randomized Comparative Study of Three Guided Bronchoscopic Approaches for Investigating Pulmonary Nodules: The PRECISION-1 Study. Chest. 2020;157(3):694-701.

Background: Cadaver model study to assess efficacy of robotic bronchoscopy (RB)

PICO:

Populations:

  • Cadavers with PPNs < 2 cm

Intervention:

  • 60 procedures performed to target 20 PPNs. Implanted PPNs were distributed in all lobes with 80% in lung periphery, mean diameter was 16.5mm, 50% CT bronchus sign.

Comparison:

  • None

Outcome:

  • Nodule localization resulting in at least one needle pass attempt for a single PPN was achieved in 65% of UTB-rEBUS, 85% EMN, 100% in RB cases. Rate of successful PPN localization & puncture was superior when using RB compared to EMN; 80% vs. 45% p=0.02. and with RB compared to UTB-rEBUS: 80% vs. 25% p=<0.001. no significant difference between UTB-rEBUS & EMN. Among the unsuccessful needle passes the median needle to target “miss” distance was significantly different when comparing UTB-rEBUS, EMN, and RB.

Take Home: In a cadaver model, use of RB significantly increased the ability to localize and successfully puncture small PPNs when compared with existing technologies.

Study Design and Rationale: A Multicenter, Prospective Trial of Electromagnetic Bronchoscopic and Electromagnetic Transthoracic Navigational Approaches for the Biopsy of Peripheral Pulmonary Nodules (ALL IN ONE Trial)

https://pubmed.ncbi.nlm.nih.gov/29885373/

Clinical Trial (Veran)

Reference: Thiboutot J, Lee HJ, Silvestri GA, et al. Study Design and Rationale: A Multicenter, Prospective Trial of Electromagnetic Bronchoscopic and Electromagnetic Transthoracic Navigational Approaches for the Biopsy of Peripheral Pulmonary Nodules (ALL IN ONE Trial). Contemp Clin Trials. 2018;71:88-95.

Background: Staged approach to lung nodule diagnosis

PICO:

Populations:

  • Participants with 1-3cm, intermediate to high risk pulmonary nodules

Intervention:

  • Patients undergo a staged approach with EBUS followed by ENB, then EMN-transthoracic biopsy (EMN-TTNA) with the procedure terminated at any stage after the diagnosis is made via rapid on-site cytopathology.

Comparison:

  • None

Take Home: First study designed to evaluate the diagnostic yield of staged procedure using EBUS, ENB, and EMN-TTNA for the diagnosis of pulmonary nodules. If effective, the procedure will increase minimally invasive procedural diagnostic yield for pulmonary nodules.

What is the value of electromagnetic navigation in lung cancer and to what extent does it require improvement?

https://pubmed.ncbi.nlm.nih.gov/32216487/

Review

Reference: Shaller BD, Gildea TR. What is the value of electromagnetic navigation in lung cancer and to what extent does it require improvement?. Expert Rev Respir Med. 2020;:1-15.

Summary: This article presents an in-depth review of ENB, including commercially available electromagnetic navigational platforms, factors influencing diagnostic yield, adjunctive imaging and biopsy tools, potential risks, cost, technical shortcomings, and competing technologies. While ENB is the leading tool in diagnostic evaluation of peripheral lung lesions, the future of it depends on its potential to expand into the therapeutic realm and its ability to keep up with competing diagnostic and therapeutic technologies. This article has good summary figures and images of the different navigational platforms.

Sensitivity and safety of electromagnetic navigation bronchoscopy for lung cancer diagnosis: systematic review and meta-analysis

https://pubmed.ncbi.nlm.nih.gov/32450240/

Review

Reference:  Folch EE, Labarca G, Ospina-Delgado D, et al. Sensitivity and safety of electromagnetic navigation bronchoscopy for lung cancer diagnosis: systematic review and meta-analysis. Chest. 2020;158(4):1753-1769.

Summary: This Systematic review evaluates sensitivity of electromagnetic navigation bronchoscopy in patients with peripheral pulmonary lesions suspected to be lung cancer. The goal was to determine the safety and sensitivity of electromagnetic navigational bronchoscopic guided biopsy compared with a surgical approach. 40 studies with a total of 3342 patients were analyzed. Pooled sensitivity and specificity were 77% and 100% respectively. ENB is overall a safe and effective approach while having a good sensitivity in identifying lung cancer. Many of the analyzed studies were based on the SuperDimension platform.

Robotic bronchoscopy for peripheral pulmonary lesions: a multicenter pilot and feasibility study (Benefit)

https://pubmed.ncbi.nlm.nih.gov/32822675/

Prospective Trial

Reference: Chen AC, Pastis NJ, Mahajan AK, et al. Robotic bronchoscopy for peripheral pulmonary lesions: a multicenter pilot and feasibility study (Benefit). Chest. 2021;159(2):845-852.

Background: The study was to assess safety and performance of robotic assisted bronchoscopy in sampling peripheral pulmonary lesions

PICO:
  • Population
    • Solid peripheral pulmonary lesions 1-5 cm
    • No mediastinal or hilar adenopathy by CT or PET
    • Acceptable candidate for an elective, non-emergent bronchoscopic procedure
    • Lack bleeding disorders
  • Intervention
    • Robotic assisted bronchoscopy procedures performed using the Monarch platform.
  • Comparison
    • None
  • Outcome
    • 55 patients enrolled: 54 patients available for analysis
    • R-EBUS visualization of 51/53 nodules – 31 concentric, 20 eccentric
    • Pneumothorax 2/54, chest tube required 1/2
    • Diagnostic yield
      • Overall, 40/51 (74.1%)
      • Concentric r-EBUS view 80.6%
      • Eccentric r-EBUS view 70%

Take home: First prospective multicenter trial to demonstrate feasibility and safety of robotic assisted bronchoscopy.

Robot-assisted bronchoscopy for pulmonary lesion diagnosis: results from the initial multicenter experience

https://pubmed.ncbi.nlm.nih.gov/31829148/

Retrospective Cohort

Reference: Chaddha U, Kovacs SP, Manley C, et al. Robot-assisted bronchoscopy for pulmonary lesion diagnosis: results from the initial multicenter experience. BMC Pulm Med. 2019;19(1):243.

Background: The study reported outcomes of consecutive patients undergoing robotic assisted bronchoscopy to sample lung lesions.

PICO:
  • Population
    • 18 years or older
    • Candidates for an elective bronchoscopy under general anesthesia
    • Any of the following present
      • Pulmonary lesions suspected to be primary lung cancer
      • New or growing lesions in known lung cancer patient suspected to have recurrence or progression
      • Pulmonary lesion with extra thoracic malignancy
      • Lesions suspected to be from mycobacterial or fungal infection
  • Intervention
    • Robotic assisted bronchoscopy procedures were performed using the Monarch platform.
  • Comparison
    • None
  • Outcome
    • 165 patients with 167 lesions across four centers
    • Average lesion size was 25 mm +/- 15 mm
    • Bronchus sign present in 106/167 (63.5%)
    • Diagnostic yield 69.1-77% based on diagnostic yield definition for benign lesions
    • Diagnostic yield was 81.5, 71.7 and 26.9% for concentric, eccentric and absent r-EBUS views, respectively
    • Diagnostic yield higher for bronchus sign lesions (78.3% vs 54.1%, p=0.001)
    • Pneumothorax rate 3.6%, pneumothorax requiring chest tube 2.4%

Take home: The study provides the first after market data on robotic assisted bronchoscopy performed with Monarch. Overall, it estimates a moderate diagnostic yield with a fair safety profile. There were some limitations regarding the follow up of benign lesions (6 months) but both conservative and best-case diagnostic yields were provided.

Shape-sensing robotic-assisted bronchoscopy in the diagnosis of pulmonary parenchymal lesions

https://pubmed.ncbi.nlm.nih.gov/34384789/

Prospective Cohort

Reference: Kalchiem-Dekel O, Connolly JG, Lin IH, et al. Shape-sensing robotic-assisted bronchoscopy in the diagnosis of pulmonary parenchymal lesions. Chest. 2022;161(2):572-582.

Background: The study evaluated the feasibility, diagnostic yield and safety of shape sensing robotic assisted bronchoscopy (ssRAB).

PICO:
  • Population
    • 130 consecutive patients (159 lesions) undergoing shape sensing robotic assisted bronchoscopy
    • Median age 69
    • 75.4% were ever smokers
    • 63.8% had a known history of malignancy prior to procedure
  • Intervention
    • Shape sensing robotic assisted bronchoscopy procedures performed with Intuitive Ion platform
  • Comparison
    • None
  • Outcome
    • Median lesion size 1.8cm (range 1.3-2.7cm)
    • Bronchus sign in 62.9%
    • Diagnostic yield
      • Overall - 130/159 (81.7%)
      • Malignant 57.3%, non-malignant 26.7%, non-diagnostic 16%
    • Sensitivity for primary thoracic malignancy
      • Sensitivity of 79.8%; NPPV 72.4%
    • Complication rate - 3%
      • Pneumothorax 1.5% (2 patients)
      • No significant bleeding

Take home: This is the largest series to date describing clinical outcomes with ssRAB establishing diagnostic yield and safety in clinical practice.

Robotic bronchoscopy for pulmonary lesions: a review of existing technologies and clinical data

https://pubmed.ncbi.nlm.nih.gov/32642251/

Review

Reference: Agrawal A, Hogarth DK, Murgu S. Robotic bronchoscopy for pulmonary lesions: a review of existing technologies and clinical data. J Thorac Dis. 2020;12(6):3279-3286.

Summary: This review article provides a good overview of current evidence regarding the use and safety of both robotic assisted bronchoscopy platforms. It also provides a good summary for similarities, differences, advantages, and limitations for both platforms.

Management of significant airway bleeding during robotic assisted bronchoscopy: a tailored approach. Respiration

https://pubmed.ncbi.nlm.nih.gov/33774623/

Review

Reference: Fernandez-Bussy S, Abia-Trujillo D, Majid A, et al. Management of significant airway bleeding during robotic assisted bronchoscopy: a tailored approach. Respiration. 2021;100(6):547-550.

Summary: Significant bleeding during robotic assisted bronchoscopy is rare but can be challenging to manage. The article provides a case-based approach and video regarding management of significant bleeding encountered during robotic assisted bronchoscopy with the Ion robotic bronchoscopy platform

Cone-beam computed tomography-guided electromagnetic navigation for peripheral lung nodules

https://pubmed.ncbi.nlm.nih.gov/33401270/

Retrospective

Reference: Kheir F, Thakore SR, Uribe Becerra JP, et al. Cone-beam computed tomography-guided electromagnetic navigation for peripheral lung nodules. Respiration. 2021;100(1):44-51.

Background: This is a retrospective analysis to assess the impact of adding Cone-Beam CT (CBCT) scan to electromagnetic navigation bronchoscopy (ENB) for sampling peripheral pulmonary lesions.

PICO:
  • Population
    • 62 consecutive patients with lesions < 3cm in outer two-thirds of the lung undergoing ENB (31 in each group)
    • Comparison made before and after introduction of CBCT at a single center
  • Intervention
    • ENB with CBCT
  • Comparison
    • ENB without CBCT
  • Outcome
    • Mean age 64.5 years (ENB) vs 67.7 years (ENB + CBCT)
    • Median target size 21.5 mm (ENB) vs 16 mm (ENB + CBCT) (p = 0.2)
    • Higher diagnostic yield with CBCT 74.2% vs 51.6% (p = 0.05)
    • OR of 3.4 (95%CI, 1.03-11.26) in favor of ENB + CBCT
    • Pneumothorax rate 2/31 in each group
    • Median procedure time was also in favor of CBCT 74 min vs 90 min (p = 0.02)

Take home: This study is concordant with previous reported data on the use of intraprocedural CBCT with ENB and study shows improved diagnostic yields. The study is unique in providing a direct comparison of ENB with and without CBCT in clinical practice.

 

Lung navigation ventilation protocol to optimize biopsy of peripheral lung lesions

https://pubmed.ncbi.nlm.nih.gov/33734150/

Retrospective 

Reference: Bhadra K, Setser RM, Condra W, Pritchett MA. Lung navigation ventilation protocol to optimize biopsy of peripheral lung lesions. J Bronchology Interv Pulmonol. 2022;29(1):7-17.

Background: This study evaluates a proposed navigation lung ventilation protocol as compared to conventional ventilation strategy during bronchoscopic biopsy of peripheral lung nodules.

PICO:
  • Population
    • 50 adult patients undergoing biopsy of peripheral lung lesions < 30mm
    • 25 patients in conventional ventilation arm
    • 25 patients in Lung Navigation Ventilation Protocol (LNVP)
  • Intervention
    • LNVP included rapid intubation, 8.5 or larger ETT, paralytics, lowest possible Fio2. Followed by four PEEP recruitment maneuvers, tidal Volume 10-12 mL/Kg IBW, pressure limit set for 45 mmHg
    • PEEP and APL valve set for 10-15 cmH20 for upper lobe lesions and 15-20 mmH20 for lower lobe lesions
  • Comparison
    • Conventional ventilation- no requirements for tidal volume, PEEP or Fio2 (Fio2 was typically 100%, PEEP 0-5 mmH20)
  • Outcome
    • Primary outcome was atelectasis based on CBCT spin during deployment of tool in lesion, compared by two reviewers
    • Comparable demographics and BMI between groups
    • More dependent atelectasis (R1: 64% and R2: 68% vs. R1: 36% and R2: 16%, p = 0.00014) and sub-lobar atelectasis (R1: 48% and R2: 56% vs. R1: 20% and R2: 32%, p = 0.01) in the conventional arm
    • Target lesion was obscured more often in the conventional arm (R1: 36% and R2: 36% vs. R1: 4% and R2: 8%, p = 0.01)
    • Diagnostic yield trended higher for LNVP vs conventional (92% vs 70%, p = 0.08)

Take home: The proposed lung navigation ventilation protocol potentially reduces the risk of dependent atelectasis and associated CT-body divergence during navigation bronchoscopy.