NEW ORLEANS — New data from a small study showed that patient-specific silicone airway stents made using a 3D printer were associated with fewer adverse events than commercially available stents in patients with underlying complex airway disease, researchers reported at the CHEST Annual Meeting.
Carlos Aravena Leon, MD, a pulmonary disease fellow at Cleveland Clinic, and colleagues conducted a retrospective review of charts of patients who received patient-specific airway stents at their institution under FDA expanded access. The investigators surveyed three bronchoscopists about technical aspects of the procedure, overall clinical change of the patient and stent-related adverse events at 24 hours and 30 days after implantation.
Using information from CT scans, the patient-specific silicone airway stents were created via 3D printing.
“Our goal of this study was to describe our initial clinical outcomes in patients with underlying complex airway diseases who had multiple complications associated with commercially available airway stents,” he said during a presentation of the data.
Four patients received a total of 13 stents. Of these, two patients had Y-stents placed in the mainstream bronchi with short limbs extending into the lobar airways, one had a Y-tracheobronchial stent and one had a combination of both types of stents.
Clinicians reported that the level of difficulty loading 12 of the 13 patient-specific stents into the rigid bronchoscope was on par with (30.8%) or easier than (61.5%) with commercially available stents. Removal was also reported to be easier (22.2%) or the same (77.8%) for all nine stents that had to be removed.
Adverse events occurred in four stent placements at 24 hours and in seven stent placements at 30 days. All events had a Common Terminology Criteria for Adverse Event Severity of three or less, which represented an improvement in these patients compared with prior treatment with commercially available stents, according to the data.
All 13 patient-specific stent placements were associated with positive or no clinical change in patients. Longer time between bronchoscopies was also noted with patient-specific stents vs. commercially available stents (mean, 65.6 vs. 36.3 days; P = .004). Additionally, the incidence and severity of the common adverse events observed with commercially available stents were reduced in these patients, leading to increased lifespan of the patient-specific stents (300.2 vs. 124 days; P < .001).
“Due to the increase in time to subsequent procedures and the increase in stent life, patient-specific silicone airway stents have the potential to decrease the total number of bronchoscopic procedures required for a patient. And overall, bronchoscopists report improved outcomes with patient-specific stents compared to commercially available stents,” Leon said.
He acknowledged that the study was small, with low numbers of patients, stent placements and adverse events, but the findings were interesting and next steps should include a prospective study. – by Melissa Foster
Leon CA, et al. Emerging Techniques for Interventional Pulmonology. Presented at: CHEST Annual Meeting; Oct. 19-23, 2019; New Orleans.
Disclosure: Leon reports no relevant financial disclosures.