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Robotic Bronchoscopy Safe, Effective in Post-Marketing Study

Robotic bronchoscopy was found to have a low complication rate, with navigation success of 88.6% and an initial diagnostic yield of 69.1% to 77% among patients with lung lesions in the first multicenter, post-marketing study of the technology.

The FDA cleared Auris Health’s Monarch robotic endoscopy platform in the spring of 2018 for diagnostic and therapeutic bronchoscopic procedures.

The new retrospective analysis, published online in BMC Pulmonary Medicine by a team led by Udit Chaddha, MD, of Icahn School of Medicine at Mount Sinai in New York City, and Stephen Kovacs, DO, of UPMC Hamot in Pittsburgh, included 165 patients with lung lesions who underwent robot-assisted bronchoscopy at four treatment centers from mid-June to mid-December 2018.

Another member of the research team, Christopher Manley, MD, director of Interventional Pulmonary at Fox Chase Cancer Center in Philadelphia (one of the first three U.S. hospitals to have access to the technology), told MedPage Today that it’s too soon to establish the system’s diagnostic accuracy in real-world clinical practice for detecting lung cancer. Still, he said, the early findings show the technology to be safe and feasible.

“There were very few pneumothorax and airway bleeding complications, and good navigation success,” he said.

The 165 participants (167 lung lesions) were followed for 185 ± 55 days. Seventy-five (46%) were female, 77% were smokers, and the average age at the time of the procedure was 66.5 ± 10.9. None of the study participants were on dual anti-platelet therapy or anti-coagulants at the time of their biopsy.

Tissue samples were successfully obtained in 97.6% of cases, the researchers reported. Target lung lesion size averaged 25 ± 15 mm, 71% of lesions were in the peripheral third of the lung, and 71.3% were 30 mm or smaller. Navigation was successful in 88.6% of patients.

Diagnostic yield was 81.5%, 71.7%, and 26.9% for concentric, eccentric, and absent radial endobronchial ultrasound (r-views), respectively (P<0.001), and the diagnostic yield was higher for lesions with a "bronchus sign" (78.3% vs 54.1%, P=0.001), the team noted.

“Yield was not different for solid versus ground glass nodules (68.8% vs 70.6%, P=0.74), central versus peripheral location (73.5% vs 67.8%, P=0.47) and did not depend upon lesion size (45.5% for <1 cm vs 68.5% for 1–3 cm vs 77.1% for ≥3 cm, P=0.11),” the researchers wrote.

Pneumothorax occurred in six cases (3.6%), and four patients required chest tube placement as a result (2.4%). Significant bleeding following biopsy was also reported in four patients (2.4%).

There were no reported respiratory failures, deaths, or other procedure-related complications, and no blood transfusions, open thoracotomy, or use of endobronchial blockers.

A study limitation cited by the researchers included the short (6-month) average follow-up, which Manley noted was not long enough to establish a true diagnostic yield.

He said a larger retrospective review is now underway and a prospective study evaluating robotic bronchoscopy is in the planning stages.

The as yet unrealized promise of robot bronchoscopy is the ability to deliver treatments, such as targeted drug therapy or tumor ablation at the lung nodule, Manley said.”We are not there yet, but I think there is the potential to do a biopsy of a nodule, look at the lymph nodes and, if negative, deliver therapy to the nodule to destroy the tumor in one anesthetic period.”

The researchers noted that longer-term follow-up is needed, “to better establish the true diagnostic yield and delineate the factors affecting it.”

“As of now, in our opinion, when available, robotic bronchoscopy should be offered to all patients with suspicious peripheral lung lesions that also require concurrent guidelines-recommended endobronchial ultrasound-transbronchial needle aspiration lymph node staging for [computerized tomography-positron emission tomography] normal mediastinum or prior to [stereotactic body radiation therapy]; or preoperative tissue diagnosis based on questionable operability or patient or surgeon’s preference,” the researchers wrote.

Chaddha reported having no disclosures. Manley and Kovacs, along with several other co-authors reported various financial relationships with Auris Health, which markets the robotic endoscopic system used in the study.