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Robotic bronchoscopy improves diagnostic yield for peripheral pulmonary nodules

NEW ORLEANS — When compared with existing technologies, robotic bronchoscopy increased the ability to localize and successfully puncture small peripheral pulmonary nodules, researchers reported.

More than 1 million of the approximately 1.5 million pulmonary nodules identified per year are benign, according to Lonny Yarmus, DO, MBA, from the division of pulmonary and critical care at Johns Hopkins University School of Medicine.

“We need to better differentiate how to perform or how not to perform unnecessary procedures and surgeries,” he said during a presentation at the CHEST Annual Meeting. “Part of the issue is that there is wide variation and controversy in reporting yields within the existing literature. ... We’ve really tried in an aggressive way to move away from case series and registry data, which do not answer questions. What we need are comparative trials in advanced bronchoscopic techniques.”

With this in mind, Yarmus and colleagues conducted the prospective, single-blind, randomized, controlled PRECISION-1 study, which was designed to compare success in localization and puncture of peripheral pulmonary nodules with an ultrathin bronchoscope with radial endobronchial ultrasound, electromagnetic navigation and robotic bronchoscopy in a cadaveric model of peripheral pulmonary nodules smaller than 2 cm.

The study involved 60 nodules, all placed percutaneously in separate distinct lobes of human cadavers using a transthoracic needle under fluoroscopic guidance, and eight bronchoscopists who attempted localization and puncture of nodules using three technologies: an ultrathin bronchoscope with radial ultrasound, an electromagnetic system and a robotic system. All bronchoscopists used the ultrathin bronchoscope with radial ultrasound first and were then randomly assigned to use one of the other systems next. Using each technology, bronchoscopists could perform up to three separate and consecutive attempts to reach and puncture each nodule via needle advancement.

The primary endpoint was the ability to successfully localize and puncture the target nodule, defined as an assessment of needle to nodule localization (center, peripheral or distal), which was verified using cone-beam CT.

Results showed that the ultrathin bronchoscope with radial ultrasound was able to localize and puncture 25% of nodules. Compared with electromagnetic navigation, robotic bronchoscopy appeared to be superior for localization and puncture of nodules (45% vs. 80%; P = .02).

Regarding localization and puncture for secondary outcomes, which included a pass in which the needle was adjacent to the nodule, the percentages increased to 35% for the ultrathin bronchoscope with radial ultrasound, 65% for the electromagnetic navigation system and 90% for the robotic bronchoscopy system. Further, with successful navigation –defined as the provider localizing using software or radial ultrasound and then passing a needle to make a biopsy attempt – the percentages increased to 65% with the ultrathin bronchoscope with radial ultrasound, 85% with electromagnetic navigation and 100% with robotic bronchoscopy.

The researchers also evaluated needle-to-target “miss” distance. They found a much wider interval of miss for radial ultrasound, a smaller miss distance for electromagnetic navigation and a very tight interval for robotic bronchoscopy (P = .0014), according to Yarmus.

“This is really the first study to randomize, blind and compare procedural outcomes between existing technologies in advanced bronchoscopy,” Yarmus said. “We see that utilization of robotic bronchoscopy with shape-sensing technology significantly increased the ability to localize and puncture lesions when compared with standard existing technologies and this study demonstrates its potential to reach, localize and puncture small nodules that are deep in the periphery of the lung.”

Yarmus added that based on these findings, future studies are warranted. – by Melissa Foster

Reference:

Yarmus L. Late Breaking Bronchoscopy. Presented at: CHEST Annual Meeting; Oct. 19-23, 2019; New Orleans.

Yarmus L, et al. Chest. 2019;doi:10.1016/j.chest.2019.10.016.

Disclosures: This study was funded by the Association of Interventional Pulmonary Program Directors. Yarmus reports he has received educational grants and consulting fees from Boston Scientific, Inspire Medical Consulting, Olympus, SuperDimension and Veran Medical. Please see the study for all other authors’ relevant financial disclosures.

NEW ORLEANS — When compared with existing technologies, robotic bronchoscopy increased the ability to localize and successfully puncture small peripheral pulmonary nodules, researchers reported.

More than 1 million of the approximately 1.5 million pulmonary nodules identified per year are benign, according to Lonny Yarmus, DO, MBA, from the division of pulmonary and critical care at Johns Hopkins University School of Medicine.

“We need to better differentiate how to perform or how not to perform unnecessary procedures and surgeries,” he said during a presentation at the CHEST Annual Meeting. “Part of the issue is that there is wide variation and controversy in reporting yields within the existing literature. ... We’ve really tried in an aggressive way to move away from case series and registry data, which do not answer questions. What we need are comparative trials in advanced bronchoscopic techniques.”

With this in mind, Yarmus and colleagues conducted the prospective, single-blind, randomized, controlled PRECISION-1 study, which was designed to compare success in localization and puncture of peripheral pulmonary nodules with an ultrathin bronchoscope with radial endobronchial ultrasound, electromagnetic navigation and robotic bronchoscopy in a cadaveric model of peripheral pulmonary nodules smaller than 2 cm.

The study involved 60 nodules, all placed percutaneously in separate distinct lobes of human cadavers using a transthoracic needle under fluoroscopic guidance, and eight bronchoscopists who attempted localization and puncture of nodules using three technologies: an ultrathin bronchoscope with radial ultrasound, an electromagnetic system and a robotic system. All bronchoscopists used the ultrathin bronchoscope with radial ultrasound first and were then randomly assigned to use one of the other systems next. Using each technology, bronchoscopists could perform up to three separate and consecutive attempts to reach and puncture each nodule via needle advancement.

The primary endpoint was the ability to successfully localize and puncture the target nodule, defined as an assessment of needle to nodule localization (center, peripheral or distal), which was verified using cone-beam CT.

Results showed that the ultrathin bronchoscope with radial ultrasound was able to localize and puncture 25% of nodules. Compared with electromagnetic navigation, robotic bronchoscopy appeared to be superior for localization and puncture of nodules (45% vs. 80%; P = .02).

Regarding localization and puncture for secondary outcomes, which included a pass in which the needle was adjacent to the nodule, the percentages increased to 35% for the ultrathin bronchoscope with radial ultrasound, 65% for the electromagnetic navigation system and 90% for the robotic bronchoscopy system. Further, with successful navigation –defined as the provider localizing using software or radial ultrasound and then passing a needle to make a biopsy attempt – the percentages increased to 65% with the ultrathin bronchoscope with radial ultrasound, 85% with electromagnetic navigation and 100% with robotic bronchoscopy.

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The researchers also evaluated needle-to-target “miss” distance. They found a much wider interval of miss for radial ultrasound, a smaller miss distance for electromagnetic navigation and a very tight interval for robotic bronchoscopy (P = .0014), according to Yarmus.

“This is really the first study to randomize, blind and compare procedural outcomes between existing technologies in advanced bronchoscopy,” Yarmus said. “We see that utilization of robotic bronchoscopy with shape-sensing technology significantly increased the ability to localize and puncture lesions when compared with standard existing technologies and this study demonstrates its potential to reach, localize and puncture small nodules that are deep in the periphery of the lung.”

Yarmus added that based on these findings, future studies are warranted. – by Melissa Foster

Reference:

Yarmus L. Late Breaking Bronchoscopy. Presented at: CHEST Annual Meeting; Oct. 19-23, 2019; New Orleans.

Yarmus L, et al. Chest. 2019;doi:10.1016/j.chest.2019.10.016.

Disclosures: This study was funded by the Association of Interventional Pulmonary Program Directors. Yarmus reports he has received educational grants and consulting fees from Boston Scientific, Inspire Medical Consulting, Olympus, SuperDimension and Veran Medical. Please see the study for all other authors’ relevant financial disclosures.

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