ILD diagnosis step-up strategy can ‘mitigate patient and health care system burdens’
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Key takeaways:
- Unexpected/prolonged chest tube drainage was less frequent with use of a step-up strategy vs. immediate surgical lung biopsy for diagnosing ILD.
- Fewer serious adverse events occurred with the step-up strategy.
The diagnostic yield for interstitial lung disease was comparable between immediate surgical lung biopsy and a strategy that began with transbronchial cryobiopsy, according to results published in The Lancet Respiratory Medicine.
Further, patients assigned to receive transbronchial cryobiopsy then surgical lung biopsy (SLB) if the results are inconclusive vs. patients assigned to immediate SLB spent fewer days in the hospital and did not experience as many serious adverse events, according to researchers.
“This is the first randomized study to support the strategy recommended in the transbronchial cryobiopsy guideline by Daniël A. Korevaar et al, focusing on patient-centered outcomes,” Kirsten A. Kalverda, MD, PhD, pulmonology medical specialist at Amsterdam University Medical Centers, told Healio. “These results offer tangible evidence for clinicians during patient consultations regarding diagnostic procedures for ILD.”
In a multicenter, randomized controlled trial (COLD study), Kalverda and colleagues evaluated 52 patients (median age, 66 years; 81% men) with ILD and an indication for lung biopsy to determine if a step-up strategy involving initial transbronchial cryobiopsy followed by SLB if cryobiopsy is inconclusive is better than immediate SLB for ILD diagnosis.
Researchers specifically compared the proportion of patients with unexpected chest tube drainage (chest tube requirement following transbronchial cryobiopsy) or chest tube drainage longer than 24 hours after SLB between the two groups.
“In the last decade, widespread adoption and integration of transbronchial cryobiopsy in clinical practice has occurred despite a notable absence of randomized trials, leaving a void in high-confidence evidence for its efficacy,” Kalverda said. “Previous work revealed a diagnostic yield for transbronchial cryobiopsies that was inferior to that of surgical biopsies.”
Of the total cohort, 28 patients (median age, 68 years; 79% men) received the step-up strategy, and 24 patients (median age, 65 years; 83% men) received immediate SLB.
More patients who received immediate SLB had prolonged chest tube drainage than the patients who received the step-up strategy and had unexpected chest tube drainage (n = 11; 46% vs. n = 3; 11%). This corresponded with a 35% absolute risk reduction with use of the step-up strategy vs. immediate SLB (95% CI, 11-56%; P = .0058).
Further, median in situ chest tube duration was longer among those who received immediate SLB (30 hours vs. 25 hours).
In addition to unexpected/prolonged chest tube drainage, researchers assessed diagnostic yield, in-hospital stay, pain and serious adverse events.
Multidisciplinary team diagnostic yield was comparable between the immediate SLB group and the step-up group when considering the yield that included SLB due to inconclusive transbronchial cryobiopsy (88% vs. 89%). With transbronchial cryobiopsy alone, the diagnostic yield was 82%.
The rest of the evaluated outcomes showed favor for the step-up strategy.
According to researchers, patients who received the step-up strategy had shorter hospital stays than those who received immediate SLB (median, 1 day vs. 5 days), as well as fewer serious adverse events (one patient vs. 11 patients) and less pain on the first day after transbronchial cryobiopsy/SLB (visual analogue scale pain score > 30, 28% vs. 70%; P = .0072).
By day 4 and month 3, pain scores reported by patients from each group did not significantly differ.
“Our findings indicate that a diagnostic pathway commencing with cryobiopsy can achieve a diagnostic yield similar to that of immediate surgical intervention, with significantly reduced hospital admissions,” Kalverda said. “Indeed, 82% of cryobiopsies were executed on an outpatient basis.”
Lastly, a pathologist reviewed the biopsies so that the researchers could assess if diagnostic confidence differed based on the assigned strategy. A greater percentage of patients in the immediate SLB group vs. the step-up group had a high-confidence histopathological diagnosis (74% vs. 46%).
“In line with previous research, the histological confidence for ILD diagnosis via cryobiopsy is lower compared to surgical methods, partly due to the reliance of existing guidelines and literature on surgical biopsy interpretations,” Kalverda said. “We advocate for future studies aimed at refining the guidelines for ILD histopathological assessments based on cryobiopsies, particularly as interobserver variability was comparable between the two biopsy modalities despite lower confidence with cryobiopsy.”
Based on the study findings, Kalverda suggests adopting the step-up strategy.
“In anticipation of long-term follow-up data addressing diagnostic precision and survival outcomes, we propose the adoption of the step-up strategy for tissue sampling in ILD diagnoses to mitigate patient and health care system burdens while preserving comparable diagnostic accuracy."