Results of the ICTuS 2 Trial (Intravascular Cooling in the Treatment of Stroke 2).

BACKGROUND AND PURPOSE: Therapeutic hypothermia is a potent neuroprotectant approved for cerebral protection after neonatal hypoxia-ischemia and cardiac arrest. Therapeutic hypothermia for acute ischemic stroke is safe and feasible in pilot trials. We designed a study protocol to provide safer, faster therapeutic hypothermia in stroke patients. METHODS: Safety procedures and 4°C saline infusions for faster cooling were added to the ICTuS trial (Intravascular Cooling in the Treatment of Stroke) protocol. A femoral venous intravascular cooling catheter after intravenous recombinant tissue-type plasminogen activator in eligible patients provided 24 hours cooling followed by a 12-hour rewarm. Serial safety assessments and imaging were performed. The primary end point was 3-month modified Rankin score 0,1. RESULTS: Of the intended 1600 subjects, 120 were enrolled before the study was stopped. Randomly, 63 were to receive hypothermia plus antishivering treatment and 57 normothermia. Compared with previous studies, cooling rates were improved with a cold saline bolus, without fluid overload. The intention-to-treat primary outcome of 90-day modified Rankin Score 0,1 occurred in 33% hypothermia and 38% normothermia subjects, odds ratio (95% confidence interval) of 0.81 (0.36-1.85). Serious adverse events occurred equally. Mortality was 15.9% hypothermia and 8.8% normothermia subjects, odds ratio (95% confidence interval) of 1.95 (0.56-7.79). Pneumonia occurred in 19% hypothermia versus 10.5% in normothermia subjects, odds ratio (95% confidence interval) of 1.99 (0.63-6.98). CONCLUSIONS: Intravascular therapeutic hypothermia was confirmed to be safe and feasible in recombinant tissue-type plasminogen activator-treated acute ischemic stroke patients. Protocol changes designed to reduce pneumonia risk appeared to fail, although the sample is small. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01123161.

Improving Door to Groin Puncture Time for Mechanical Thrombectomy via Iterative Quality Protocol Interventions.

INTRODUCTION: Delays in door to groin puncture time (DGPT) for patients with ischemic stroke caused by acute large vessel occlusions (LVO) are associated with worse clinical outcomes. We present the results of a quality improvement protocol for endovascular stroke treatment at the University of California, San Diego (UCSD) that aimed to minimize DGPT. MATERIALS AND METHODS: Our stroke team implemented a series of quality improvement measures to decrease DGPT, with a target of 90 minutes or less. Sixty-three patients treated at our center were retrospectively divided into three groups based on the date of their intervention as a proxy for the implementation of process improvement protocols: 23 patients treated from July to December 2015, 24 patients treated from January to July 2016, and 16 patients treated from July 2016 to December 2016. Multivariate log-linear and logistic regression analyses were used to assess the predictors of prolonged DGPT and compliance with target DGPT (<90 min), respectively. RESULTS: Date of intervention-a proxy for the implementation of process improvement protocols-was predictive of compliance with target DGPT. Patients treated from July 2016 to December 2016-after the full implementation of process improvements-were 3.2 times more likely to meet or exceed the target DGPT compared to patients treated from July 2015 to December 2015 (p=0.011). When adjusting for potential confounders in a multivariate analysis, patients in the final cohort were associated with shorter DGPT (Exp(B)=0.61, p=0.013) and remained significantly more likely to achieve the DGPT goal (OR=14.2, p=0.007). CONCLUSION: An iterative quality improvement process can significantly improve DGPT. This analysis demonstrates the utility of a formal quality improvement system at an academic comprehensive stroke center.