LOS ANGELES — The use of electromagnetic navigation bronchoscopy to evaluate lung lesions appears to be safe, according to 1-month interim results from the NAVIGATE trial, presented during a late-breaking session here at CHEST 2016.
The 1289 patients enrolled to date in the NAVIGATE trial come from 15 academic sites, 12 private facilities, and 10 mixed facilities in Europe and North America. This will provide a "generalizable population — of both patients and providers — from different settings that will allow us to draw generalizable conclusions," explained Erik Folch, MD, from Harvard Medical School in Boston.
"This preliminary look allows us to identify clinical use in a large, unrestricted, general population across diverse practices," he reported. "Our continued enrolment and 24-month follow-up will allow us to really draw conclusions about the true negative rate and diagnostic yield."
Previous studies have been criticized for being single-center "or being done by specialists in highly regarded academic centers, so pneumothorax and other complication rates are quite variable — from 0% to 13%," Dr Folch pointed out.
The preliminary analysis at 1-month follow-up involved 455 (91%) of the first 500 patients.
Complementary tools and procedures to confirm location in real time, such as fluoroscopy or radial and bronchial ultrasound, were used at the discretion of the clinician.
Of the 500 procedures, 497 were for lung lesion biopsy, 91 were for fiducial placement, and nine were for dye marking (33% of the patients had more than one indication for the procedure).
"To our surprise," general anesthesia was used in 86.2% of cases, Dr Folch reported. Radial endobronchial ultrasound confirmation was used during 61.0% of cases, and fluoroscopy was used during 92.6% of the cases.
The rate of pneumothorax of grade 2 or higher — the primary outcome — was 2.2%. The rate of any grade was 4.4%.
For other procedure-related adverse events, the rate of bronchopulmonary hemorrhage of grade 2 or higher was 1.0% and of any grade was 2.4%, and the rate of respiratory failure of grade 4 or higher was 0.4%.
One death was associated with the procedure. "The patient had grade 5 hypoxic respiratory failure 9 days after the procedure and, unfortunately, this was deemed to be related to complications of anesthesia," said Dr Folch. "This patient had multiple comorbidities, including cirrhosis, hepatocellular carcinoma, small-cell carcinoma, and ovarian cancer."
Of the 565 lesions investigated, navigation was successful and adequate tissue was obtained in 90.8% of the cases. Overall, the diagnosis was a malignant lesion in 45.2% of the cases, a nonmalignant lesion in 43.3%, and inconclusive in 11.5%.
"I cannot comment on the true yield," Dr Folch explained. One month is not sufficient to make such a determination, which is why these patients are being followed for 24 months.
However, of the 199 lesions diagnosed as primary lung cancer, "70% of the cases were stage I or II. This is one of our targets. If we actually include patients who are undergoing lung cancer screening and we are able to identify them in the early stages, curative intent is a better option."
"The results appear promising, with successful and safe target navigation and potential diagnostic yield," said Nicholas Pastis Jr, MD, from the division of pulmonary and critical care medicine at the Medical University of South Carolina in Charleston.
"Further follow up to at least 1 year will be necessary," he told Medscape Medical News.
The study was funded by Medtronic. Dr Folch and his coauthors serve on the clinical advisory board for Medtronic and have received travel funds and fees from the company. Two of his coauthors are employees of Medtronic. Dr Pastis has participated in research funded by Veran Medical, the makers of navigation systems, and has received teaching honoraria from Olympus.
CHEST 2016: American College of Chest Physicians Annual Meeting. Presented October 25, 2016.
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Cite this: First Glimpse of NAVIGATE Bronchoscopy Results Is Promising - Medscape - Nov 07, 2016.