Abstract 62: Refining Angiographic Biomarkers of Reperfusion: Modified TICI Is Superior to TIMI for Predicting Clinical Outcomes After Intra-arterial Therapy
Background: Tissue reperfusion is a critical determinant of outcomes after intra-arterial therapy (IAT). However, there is no standardized method for grading angiographic reperfusion. We sought to compare the two most commonly used reperfusion scales, TIMI and modified TICI (m-TICI), for predicting good long-term outcome following IAT. Methods: From a multicenter database, we evaluated acute stroke patients presenting with middle cerebral artery (MCA) M1 occlusions who underwent IAT. Clinical and angiographic data were collected. Reperfusion for each case was graded using the TIMI and m-TICI scales. The primary distinction between these scales is that partial reperfusion (TIMI 2) is sub-divided into minor (m-TICI 2A: <50%) and major (m-TICI 2B: 50-99%) grades in the m-TICI system. The performance of these scales for predicting a good 90-day outcome (mRS 0-2) was evaluated using the c-statistic. Results: There were 313 acute stroke patients with MCA M1 segment occlusions who underwent IAT at 6 academic centers; 171 (54.6%) were female. Mean age was 65.3±16.5 years. There were 157 (50.2%) right-sided strokes. Median baseline NIHSS score was 17 (IQR 15-20). Good outcome at 90 days was achieved in 32.5%. For predicting good outcome, the c-statistic was significantly higher for m-TICI (0.74 vs. 0.68; p<0.0001). The threshold that maximized predictive accuracy was m-TICI ≥2B (sensitivity 78%, specificity 65%; figure). Conclusions: The modified TICI scale is superior to the TIMI scale for predicting clinical outcome after IAT, and should be the standard tool for grading angiographic reperfusion. An m-TICI score ≥2B (≥50% reperfusion) is the optimal biomarker for successful reperfusion.
Abstract TP119: Credentialing of Interventionists in a Large Randomized Trial
Introduction: Outcomes from endovascular procedures are highly dependent on the experience and skill of the operating physician. The multi-disciplinary CREST-2 Interventional Management Committee (IMC) was charged with credentialing a cohort of skilled interventionists with adequate contemporary case volumes. Methods: Applicants were required to submit 25 consecutive cases completed within 5 years as primary operator out of a required total experience of ≥ 50 cases (≥ 20 for operators completing training). Interventionists not approved on initial review were asked to submit additional cases (with procedural angiograms), the number depending on quality and recent-quantity of the cases. Results: The IMC has had 102 meetings, and 283 interventionists have been evaluated: 104 (37%) interventionists were cardiologists, 64 (23%) vascular surgeons, 42 (15%) neurosurgeons, 32 (11%) neuroradiologists, 26 (9%) neurologists, 9 (3%) interventional radiologists, and 6 (2%) other. The mean total experience among the 226 interventionists with available information was 220±263 carotid stent cases (median 135; range 10-2500). A total of 7037 cases have been reviewed by the IMC, dating from August 2001 to April 2016, with 3366 symptomatic, 3541 asymptomatic and 130 undetermined. The range of cases reviewed per interventionist was 5 to 50. Of the 251 interventionists with sufficient periprocedural follow-up data, no stroke events were reported by 152 (60.5%), and at least one or more stroke events were reported by 99 (39.5%). The IMC has approved 115 interventionists, 29 at the first review and 86 subsequently, based upon submission and review of 631 additional contemporary cases (mean=7 cases per interventionist); 122 have approval pending submission of additional cases; 33 have been denied; 8 have been deferred; 4 have been approved for the CREST-2 Companion Registry only; and 1 is pending decision. Discussion: Rigorous evaluation and credentialing of carotid stenters in CREST-2 has been demanding, for the candidates and for the evaluators. Yet the cohort of interventionists so selected should be able to provide the high-quality stenting outcomes necessary for acceptance of the trial results.
The Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): A Randomized Controlled Trial of the Second-Generation Hydrogel Coil
Abstract BACKGROUND Aneurysm recurrence after coiling has been associated with aneurysm growth, (re)hemorrhage, and a greater need for follow-up. The second-generation HydroCoil Embolic System (HES; MicroVention, Inc) consists of a platinum core with integrated hydrogel and was developed to reduce recurrence through enhancing packing density and healing within the aneurysm. OBJECTIVE To compare recurrence between the second-generation HES and bare platinum coil (BPC) in the new-generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT). METHODS HEAT is a randomized, controlled trial that enrolled subjects with ruptured or unruptured 3- to 14-mm intracranial aneurysms amenable to coiling. The primary endpoint was aneurysm recurrence using the Raymond-Roy scale. Secondary endpoints included minor and major recurrence, packing density, adverse events related to the procedure and/or device, mortality, initial complete occlusion, aneurysm retreatment, hemorrhage from target aneurysm during follow-up, aneurysm occlusion stability, and clinical outcome at final follow-up. RESULTS A total of 600 patients were randomized (HES, n = 297 and BPC, n = 303), including 28% with ruptured aneurysms. Recurrence occurred in 11 (4.4%) subjects in the HES arm and 44 (15.4%) subjects in the BPC arm ( P = .002). While the initial occlusion rate was higher with BPC, the packing density and both major and minor recurrence rates were in favor of HES. Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms. CONCLUSION Coiling of small-to-medium aneurysms with second-generation HES resulted in less recurrence when compared to BPC, without increased harm. These data further support the use of the second-generation HES for the embolization of intracranial aneurysms. Video Abstract
Refining Angiographic Biomarkers of Revascularization
Background and Purpose— Angiographic revascularization grading after intra-arterial stroke therapy is limited by poor standardization, making it unclear which scale is optimal for predicting outcome. Using recently standardized criteria, we sought to compare the prognostic performance of 2 commonly used reperfusion scales. Methods— Inclusion criteria for this multicenter retrospective study were acute ischemic stroke attributable to middle cerebral artery M1 occlusion, intra-arterial therapy, and 90-day modified Rankin scale score. Post–intra-arterial therapy reperfusion was graded using the Thrombolysis in Myocardial Infarction (TIMI) and Modified Thrombolysis in Cerebral Infarction (mTICI) scales. The scales were compared for prediction of clinical outcome using receiver-operating characteristic analysis. Results— Of 308 patients, mean age was 65 years, and median National Institutes of Health Stroke Scale score was 17. The mean time from stroke onset to groin puncture was 305 minutes. There was no difference in the time to treatment between patients grouped by final TIMI (ie, 0 versus 1 versus 2 versus 3) or mTICI grades (ie, 0 versus 1 versus 2a versus 2b versus 3). Good outcome (modified Rankin scale, 0–2) was achieved in 32.5% of patients, and mortality rate was 25.3% at 90 days. There was a 6.3% rate of parenchymal hematoma type 2. In receiver-operating characteristic analysis, mTICI was superior to TIMI for predicting 90-day modified Rankin scale 0 to 2 (c-statistic: 0.74 versus 0.68; P <0.0001). The optimal threshold for identifying a good outcome was mTICI 2b to 3 (sensitivity 78.0%; specificity 66.1%). Conclusions— mTICI is superior to TIMI for predicting clinical outcome after intra-arterial therapy. mTICI 2b to 3 is the optimal biomarker for procedural success.