Shape-Sensing Robotic-Assisted Bronchoscopy May Improve Diagnostic Efficiency, Shorten Time to Treatment for Patients with Malignant Lung Lesions

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Shape-sensing robotic-assisted bronchoscopy (ssRAB) may improve the diagnostic yield of suspicious pulmonary lesions while providing an excellent safety profile, according to a study by Memorial Sloan Kettering Cancer Center (MSK) investigators published recently in Chest. (1)

The study was the first to report substantial clinical evidence on the performance of this recently introduced technology within a multidisciplinary, high-volume institution. It also represented the first collaboration between thoracic surgeons and interventional pulmonologists in the field of diagnostic bronchoscopy.

Matthew Bott, MD, thoracic surgeon, specializing in treating cancers of the chest, including lung cancer, esophageal cancer, thymic tumors, and neuroendocrine tumors

Matthew Bott, MD, thoracic surgeon, specializing in treating cancers of the chest, including lung cancer, esophageal cancer, thymic tumors, and neuroendocrine tumors

“Shape-sensing robotic-assisted bronchoscopy allows for more precise navigation further out into narrow airways of the lung, resulting in higher diagnostic yield from suspicious lung nodules compared with traditional guided bronchoscopy,” says interventional pulmonologist and study author Bryan Husta, MD, FCCP.

“Our evidence shows that the ssRAB platform improves our ability to sample challenging lesions significantly while delivering similar or lower complication rates than traditional guided bronchoscopy,” says thoracic surgeon Matthew Bott, MD, co-senior study author. “Greater efficiencies are translating to faster diagnoses and shorter times to treatment for patients with malignant lesions.”

Shape-Sensing Robotic-Assisted Bronchoscopy: How It Works

Dr. Husta and Dr. Bott in surgery

Members of MSK’s interventional pulmonology and thoracic surgery teams prepare to perform a bronchoscopy using ssRAB technology, which allows for navigation into further reaches of the lung periphery while retaining stability and shape for maximizing sampling precision.

Traditional guided bronchoscopy uses a catheter with a stiff curvature and relies on electromagnetic navigation to locate and sample lesions. By contrast, ssRAB technology uses an articulating robotic catheter that allows for navigation into further reaches of the lung periphery while retaining stability and shape for maximizing sampling precision. (2)

A pre-procedural CT scan identifies the target nodule location and creates a roadmap of the best path for access with the ssRAB’s robotic catheter. During navigation, the ssRAB provides real-time 3-D imaging and information on the angle of approach and distance to target as the robotic catheter travels to the lesion. The ssRAB platform allows for consecutive sampling of multiple lesions and performing endobronchial ultrasound (EBUS) for mediastinal staging of lung cancer in the same procedure, saving time compared with performing separate diagnostic procedures.

MSK thoracic specialists have been pioneering the use of the Ion Robotic-Assisted Endoluminal Platform (Intuitive Surgical, Inc., Sunnyvale, California) since the US Food and Drug Administration (FDA) cleared the device in the fall of 2019. (3)

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Key Study Findings and Implications

Patients with pulmonary lesions were referred to MSK’s interventional pulmonology or thoracic surgery services. MSK physicians performed diagnostic sampling and captured prospective data for 159 pulmonary lesions targeted during 131 consecutive ssRAB procedures between October 2019 and July 2020. (1)

The median lesion size was 1.8 cm, with 59.1 percent located in the upper lobe and 66.7 percent found beyond a sixth-generation airway. (1)

The navigational success rate of the ssRAB was 98.7 percent. (1) Diagnostic yield was 81.7 percent, much higher than historical rates of 44 percent to 74 percent with guided bronchoscopy.(4),(5),(6),(7),(8),(9),(10),(11),(12)

Remarkably, the diagnostic yield for typically problematic lesions 2 cm or less was 69.9 percent, (1) higher than the previously reported range of 43 percent to 59 percent for guided bronchoscopy.(8),(9),(12)

Lesions 1.8 cm or larger were significantly more likely to be diagnostic compared with those smaller than 1.8 cm, with an odds ratio of 12.22, according to multivariate analysis. The sensitivity and negative predictive value of ssRAB for identifying primary thoracic malignancies were 79.8 percent and 72.4 percent, respectively. (1)

The overall complication rate was 3.0 percent with a pneumothorax rate of 1.5 percent, in line with(8),(9),(13),(14) or improved, compared with previously published guided bronchoscopy studies.(6),(15),(16)

MSK has nine ssRAB-certified physicians on staff. Collectively, they perform a high volume of procedures, more than 200 annually.

Shape-sensing robotic-assisted bronchoscopy has become an essential component of standard practice at MSK for diagnosing lung nodules. MSK thoracic specialists look forward to results of the manufacturer-sponsored PRECiSE trial (NCT03893539) in progress, a prospective, clinical study that is assessing the clinical utility and performance of the device in 360 patients.

“Our study reported on our experience with the first iteration of this technology,” Dr. Bott says. “We expect this field will continue to evolve and improve over time and will continue pioneering advancements that improve our diagnostic capabilities.”

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Learn More About MSK’s Multidisciplinary Thoracic Service

At MSK, thoracic surgeons and pulmonologists share different areas of expertise and collaborate on diagnosis and treatment procedures to improve patient outcomes. As a result, our patients receive collaborative, seamless care from an integrated team of specialists.

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Dr. Husta and Dr. Bott receive speaker fees from Intuitive Surgical, Inc. Please refer to the paper for disclosures from other MSK study authors.

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  1. Kalchiem-Dekel O, Connolly JG, Lin IH, et al. Shape-Sensing Robotic-Assisted Bronchoscopy in the Diagnosis of Pulmonary Parenchymal Lesions [published online ahead of print, 2021 Aug 9]. Chest. 2021;S0012-3692(21)03625-4.
  2. Galloway KC, Chen Y, Templeton E, et al. Fiber optic shape sensing for soft robotics. Soft Robot. 2019;6(5):671-684.
  3. United States Food and Drug Administration. 510(k) Premarket notification—Ion Endoluminal System. November 26, 2019. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192367. Accessed Oct. 22, 2021.
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  13. 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.
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