Surgical Versus Dilational Tracheostomy in Patients with Severe Stroke: A SETPOINT2 Post hoc Analysis

Abstract

Background: Tracheostomy in mechanically ventilated patients with severe stroke can be performed surgically or dilationally. Prospective data comparing both methods in patients with stroke are scarce. The randomized Stroke-Related Early Tracheostomy vs Prolonged Orotracheal Intubation in Neurocritical Care Trial2 (SETPOINT2) assigned 382 mechanically ventilated patients with stroke to early tracheostomy versus extubation or standard tracheostomy. Surgical tracheostomy (ST) was performed in 41 of 307 SETPOINT2 patients, and the majority received dilational tracheostomy (DT). We aimed to compare ST and DT in these patients with patients.

Methods: All SETPOINT2 patients with ST were compared with a control group of patients with stroke undergoing DT (1:2), selected by propensity score matching that included the factors stroke type, SETPOINT2 randomization group, Stroke Early Tracheostomy score, patient age, and premorbid functional status. Successful decannulation was the primary outcome, and secondary outcome parameters included functional outcome at 6 months and adverse events attributable to tracheostomy. Potential predictors of decannulation were evaluated by regression analysis.

Results: Baseline characteristics were comparable in the two groups of patients with stroke undergoing ST (n = 41) and matched patients with stroke undergoing DT (n = 82). Tracheostomy was performed significantly later in the ST group than in the DT group (median 9 [interquartile range {IQR} 5-12] vs. 9 [IQR 4-11] days after intubation, p = 0.025). Patients with ST were mechanically ventilated longer (median 19 [IQR 17-24] vs.14 [IQR 11-19] days, p = 0.008) and stayed in the intensive care unit longer (median 23 [IQR 16-27] vs. 17 [IQR 13-24] days, p = 0.047), compared with patients with DT. The intrahospital infection rate was significantly higher in the ST group compared to the DT group (14.6% vs. 1.2%, p = 0.002). At 6 months, decannulation rates (56% vs. 61%), functional outcomes, and mortality were not different. However, decannulation was performed later in the ST group compared to the DT group (median 81 [IQR 66-149] vs. 58 [IQR 32-77] days, p = 0.004). Higher baseline Stroke Early Tracheostomy score negatively predicted decannulation.

Conclusions: In ventilated patients with severe stroke in need of tracheostomy, surgical and dilational methods are associated with comparable decannulation rate and functional outcome at 6 months. However, ST was associated with longer time to decannulation and higher rates of early infections, supporting the dilational approach to tracheostomy in ventilated patients with stroke.

Keywords: Decannulation; Intracerebral hemorrhage; Ischemic stroke; Stroke; Subarachnoid hemorrhage; Tracheostomy.

Fig. 1

Modified Rankin Scale scores at 6 months. Figure 1 shows the functional outcome of surgically and dilationally tracheotomized patients at 6 months according to the modified Rankin Scale (scores 0–6, ranging from 0 [no symptoms] to 5 [severe disability]; 6 = death). Functional outcome and mortality at 6 months were comparable in both patient groups. DT dilational tracheostomy, mRS modified Rankin Scale, ST surgical tracheostomy

Fig. 2

Time to event-analysis for probability of survival at 6 months. In Fig. 2, the Kaplan–Meier curves were shown for survival of patients with surgical tracheostomy (ST) and patients with dilational tracheostomy (DT), revealing comparable survival probabilities for patients of both treatment groups at 6 months

Fig. 3

Cumulative incidence functions for probability of decannulation or death at 6 months. This figure illustratesprobabilities for decannulation, taking the probable competing event death into account. Figure 3 shows that decannulation rates are comparable in patients treated with surgical tracheostomy (ST) and patients treated with dilational tracheostomy (DT), but patients with DT were decannulated earlier and had a significantly higher probability of cannulation-free time within the first months after tracheostomy