Data presented by Jan Gralla, Bern, Switzerland, at CIRSE 2011 in Munich, Germany, showed that Solitaire FR from ev3/Covidien had a good recanalisation rate and good patient outcome at 90 days, as measured by the modified Rankin Scale.
Gralla, from the Department for Interventional and Diagnostic Neuroradiology, University of Bern, Switzerland, told delegates that in a cohort where the median baseline National Institutes of Health Stroke Scale (NIHSS) was 18, an 86% recanalisation rate as measured by thrombolysis in cerebral infarction (TICI) ≥2b and a median procedure time of 45 minutes from groin puncture to revascularisation, was observed. “The results show the positive effect of the use of Solitaire FR in the treatment of patients with acute ischaemic stroke to restore flow,” he said.
The objective of the study was to provide safety and efficacy data on the Solitaire FR device when used in real practice in revascularisation of patients with acute ischaemic stroke. Data were collected from retrospective, consecutive cases from six experienced European sites. The centres involved were Germans Trias Hospital, Barcelona, Geneva University Hospitals, Inselspital University Hospital of Bern, Hopital Gui de Chauliac in Montpellier, Karolinska University Hospital in Stockholm and AKK Hospital in Essen.
In the cases entered, Solitaire FR was used as a first choice device. Data were collected pre-procedure, during the procedure, 24–48 hours post-procedure, at discharge, and at three months. The exams collected for independent review were diagnosis CT/MRI, DSA of the procedure and a 24–48 hour CT/MRI. Thomas Tomsick from the University of Cincinnati was the corelab reviewer.
The investigators found that 206 patients were treated using Solitaire in the timeframe. In 65 of the cases, Solitaire was not used as first line device and these patients were excluded. Data were then collated for the 141 patients who had been treated by Solitaire in the first instance. Post-procedure TICI/TIMI was available in all 141 cases. At 90 days, modified Rankin scores were available for 138 of 141 patients treated, as three patients were lost to follow-up. Ninety-day NIHSS was available for 111/141 patients.
Patient and stroke characteristics
The mean age of patients was 66.3 (20–89); 62 (44%) were female and the median NIHSS score was 18 (1–32). Intravenous tissue plasminogen activator (IV tPA) was administered in 74 (52%) of cases; of these 11 patients received 0.6mg/kg, 49 patients received 0.9mg/kg and in 14 cases the dose was not specified. Forty six patients (32%) failed IV tPA and 28 (20%) underwent bridging therapy (the combination of intravenous and intra-arterial thrombolysis). Among the 67 (58%) patients who did not receive IV tPA, 56 (40%) had a contraindication to IV tPA and 11 patients (8%) went on directly to receive intra-arterial thrombolysis with no contraindication to IV tPA.
The corelab analysis of 143 occlusion sites from 138 patients found that the most common site of occlusions was the M1 (66, 46%). Thirty three (23%) occlusions occurred in the carotid T and 19 occlusions occurred in the M2 (13%). The other occlusions were in the vertebrobasilar, posterior cerebral artery, superior cerebellar artery and internal carotid artery.
Investigators assessed that successful revascularisation occurred in 86% of cases with TICI≥2b, 96% with thrombolysis in myocardial infarction (TIMI) ≥2.
With regard to procedural success, 74% of the time a balloon guide catheter was used. Technical success was achieved in 138/141 (97.8%) of the time. The median time from groin puncture to revascularisation was 45 minutes (14 minutes to four hours and three minutes). The mean number of passes required was 1.8 (1–7). Recanalisation success with two or fewer passes was achieved in 77% of cases. In the series which received prior IV tPA (n=74), 85% of recanalisation success was achieved with two, or fewer, passes. Rescue therapy was required in seven (4.9%) patients.
From the 141 patients, 45 (32%) had good early neurologic outcome and were discharged. Seventy seven (55%) had a modified Rankin Score of less than or equal to two at 90 days. There were 29 (21%) deaths at 90 days, and seven (6% of data from an available 124) symptomatic intracranial haemorrhages. With regard to device/procedure-related morbidity, there was one groin haematoma/false aneurysm and one arterial dissection.
Of the 74 patients who had had prior IV tPA, 33 had good early neurologic outcome and were discharged. Forty nine (66%) had an mRS score of two or less at 90 days. Thirteen patients (18%) of the group at the 90-day follow-up and five (8% of 65 available) had a symptomatic intracranial haemorrhage.