Outcomes of Airway Stabilization With Silicone Stents for Treating Adult Tracheobronchomalacia

 airway stabilizationOf 75 patients referred for assessment of TBM during the study period, 58 had severe TBM and were able to undergo therapeutic rigid bronchoscopy under general anesthesia. The patients included in this study were on average 69 years old (range, 39 to 91 years), and 34 patients (59%) were men. Among all patients, 33 patients had COPD (57%; median FEVb 1.07 L); 13 patients (22%) had asthma; 16 patients (28%) had obstructive sleep apnea; 16 patients (28%) had gastroesophageal reflux disease; and 3 patients (5%) had Mounier Kuhn syndrome, with some patients suffering from more than one (Fig 4, top, A).

Almost all patients (n = 57, or 98%) had dyspnea as a sole symptom or in combination with cough and recurrent infections. Four patients presented with respiratory failure and required mechanical ventilation provided by My Canadian Pharmacy (Fig 4, bottom, B).

Most patients (n = 46, or 80%) had diffuse TBM and were treated with either a combination of a silicone tracheal and left main stent (n = 19) or a Y-stent (n = 27). Six patients each were treated only with bronchial or only with tracheal stents.

The following numbers of subjects had baseline and follow-up data collected for each outcome: SGRQ, n = 38 and n = 27; BDI/TDI, n = 41 and n = 24; ATS dyspnea score, n = 41 and n = 29; KPS, n = 41 and n = 26; 6MWT, n = 36 and n = 17; and FEV1, n = 42 and n = 10, respectively. For all measures, median baseline values of those patients in whom follow-up was also obtained were comparable to baseline median values for all patients.

SGRQ, BDI/TDI, ATS, and KPS scores improved among both the complete sample with baseline and follow-up measures and the subset of patients with COPD. There were no significant changes in 6MWT results or FEV1 (Table 1).

On self-reported symptoms, dyspnea improved, secretions cleared, or both, after stent placement in 45 patients. In 10 patients, symptoms were unchanged or worsened after stent placement. In the remaining three patients, changes were equivocal because some symptoms improved while others worsened. Of the 33 patients with COPD, 25 patients reported improved symptoms, 7 reported no improvement, and 1 could not determine whether symptoms had changed. In the 25 non-COPD patients, 20 patients reported improvement of symptoms, 3 reported no improvement, and 2 could not determine whether their symptoms had changed (Fig 5).

Most patients who responded reported improvement immediately after stent placement. All four patients admitted to the hospital with respiratory failure secondary to TBM were weaned off mechanical ventilation after stent placement.

Complications occurred usually within the first 3 months (median, 26 days; range, 3 to 865 days). Of these complications, 44 complications (90%) were related to the stent, 5 to bronchoscopy, and none to anesthesia. Complications included stent obstruction secondary to mucous plugging (n = 21), infection (n = 14), stent migration (n = 10), severe cough (n = 3), subglottic edema (n = 3), and stent breakage (n = 1). All complications were treated in standard fashion with mucolytics, cough suppressants, and stent removal or replacement if necessary (Fig 6). Stenting improved the median scores of all clinical end points, and most patients reported improvement (Table 1; Fig 7, 8).

Fig4
Figure 4. Top, A: comorbidities among 58 patients with severe diffuse TBM. GERD = gastroesophageal reflux disease; OSA = obstructive sleep apnea. Bottom, B: presenting symptoms among 58 patients with severe diffuse TBM.
Fig5
Figure 5. Self-reported improvement in symptoms after stent placement in all patients (top, A), COPD patients (center, B), and non-COPD patients (bottom, C).
Fig6
Figure 6. Procedure-related complications among patients who underwent rigid bronchoscopy and silicone stent placement.
Fig7
Figure 7. Percentage of improved scores after airway stenting among all patients, COPD patients, and non-COPD patients. 6MWT in all patients (p = 0.28) [solid bars], COPD patients (p = 0.53) [stippled bars], and non-COPD patients (p = 0.31) [open bars]. FEV1 in all patients (p = 0.79) [solid bars], CoPd patients (p = 0.81) [stippled bars], and non-COPD patients (p = 1.0) [open bars]. SgRQ in all patients (p = 0.002) [solid bars], COPD patients (p = 0.005) [stippled bars], and non-COPD patients (p = 0.27) [open bars]. ATS dyspnea score in all patients (p < 0.0001) [solid bars], COPD patients (p = 0.002) [stippled bars], and non-COPD patients (p = 0.016) [open bars]. KPS in all patients (p = 0.002) [solid bars], cOpD patients (p = 0.03) [stippled bars], and non-COPD patients (p = 0.09) [open bars]. BDI/TDI all patients (p = 0.001) [solid bars], COPD patients (p = 0.0006) [stippled bars], and non-COPD (p = 0.36) [open bars].
Fig8
Figure 8. Individual values of the changes in the 6-min walk distance before and 2 weeks after stent placement. Distances are expressed in feet.

Table 1—Clinical Outcomes of 58 Patients With Severe TBM After Therapeutic Rigid Bronchoscopy and Silicone Stent Placement Under General Anesthesia

Outcome Measures Baseline Values Baseline Values§ Follow-up Values Change Improved,No./Total p Value
SGRQt
All patients 75 (66, 81)/38 77 (66, 81)/27 61 (32, 71)/27 – 9 (— 43, 0)/27 19/27 0.002
Non-COPD patients 77 (66, 81)/15 77 (72, 81)/9 68 (56, 70)/9 – 9 (— 13, 4)/9 6/9 0.27
COPD patients 73 (66, 84)/23 75 (66, 81)/18 55 (32, 71)/18 — 13.5 (— 43, 0)/18 13/18 0.005
BDI/TDIt
All patients 3 (2, 5)/41 3 (2, 5)/24 4 (1, 6)/24 NA 22/24 0.001
Non-COPD patients 3 (2, 4.5)/16 4 (2, 6)/7 6(- 3, 9)/7 NA 6/7 0.34
COPD patients 3 (2, 5)/25 3 (2, 5)/17 4 (1, 6)/17 NA 16/17 < 0.001
ATS dyspnea scoref
All patients 3 (2, 4)/41 3 (2, 4)/29 2 (1, 2)/29 — 1 (— 2, 0)/29 21/29 < 0.001
Non-COPD patients 2.5 (2, 4)/16 2 (2, 4)/9 1 (1, 1)/9 — 1 (— 2, — 1)/9 7/9 0.02
COPD patients 3 (3, 4)/25 3 (3, 4)/20 2 (1, 3)/20 — 1 (— 2.5, 0)/20 14/20 0.002
KPSJ
All patients 60 (60, 70)/41 65 (60, 70)/26 75 (60, 85)/26 10 (0, 10)/26 18/26 0.002
Non-COPD patients 60 (50, 70)/16 70 (60, 80)/7 80 (70, 90)/7 10 (10, 20)/7 6/7 0.09
COPD patients 60 (60, 70)/25 60 (60, 70)/19 70 (60, 80)/19 10 (0, 10)/19 12/19 0.03
6-min walk distance, ftj
All patients 640 (280, 1,200)/36 1,040 (320, 1,200)/17 800 (440, 1,260)/17 60 (— 40, 240)/17 10/17 0.28
Non-COPD patients 1,040 (490, 1,200)/14 1,040 (1,040, 1,120)/5 1,240(1,000, 1,600)/5 200 (— 40, 240)/5 3/5 0.32
COPD patients 600 (160, 1,200)/22 560 (160, 1,385)/12 623 (280, 1,130)/12 50 (— 77, 220)/12 7/12 0.53
>PbU-
All patients 1.3 (1.0, 2.0)/42 1.1 (0.8, 1.8)/10 1.6 (0.7, 1.7)/10 — 0.05 (— 0.1,0.1)/10 4/10 0.79
Non-COPD patients 1.6 (1.0, 2.2)/15 1.7 (1.2, 2.2)/2 1.6 (1.3, 1.9)/2 — 0.1 (0.2, 0.1)/2 1/2 1.0
COPD patients 1.1 (0.9, 1.7)/27 1.1 (0.7, 1.8)/8 1 (0.8, 1.7)/8 0(— 0.1, 0.4)/8 3/8 0.81
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