Path From Clinical Research to Implementation: Endovascular Treatment of Ischemic Stroke in the Netherlands.

Before 2015, endovascular treatment (EVT) for acute ischemic stroke was considered a promising treatment option. Based on limited evidence, it was performed in several dedicated stroke centers worldwide on selected patients. Since 2015, EVT for patients with intracranial large vessel occlusion has quickly been implemented as standard treatment in many countries worldwide, supported by the revised international guidelines based on solid evidence from multiple clinical trials. We describe the development in use of EVT in the Netherlands before, during, and after the pivotal EVT trials. We used data from all patients who were treated with EVT in the Netherlands from January 2002 until December 2018. We undertook a time-series analysis to examine trends in the use of EVT using Poisson regression analysis. Incidence rate ratios per year with 95% CIs were obtained to demonstrate the impact and implementation after the publication of the EVT trial results. We made regional observation plots, adjusted for stroke incidence, to assess the availability and use of the treatment in the country. In the buildup to the MR CLEAN (Multicenter Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands), a slow increase of EVT patients was observed, with 0.2% of all ischemic stroke patients receiving EVT. Before the trial results were formally announced, a statistically significant increase in EVT-treated patients per year was observed (incidence rate ratio, 1.72 [95% CI, 1.46-2.04]), and after the trial publication, an immediate steep increase was seen, followed by a more gradual increase (incidence rate ratio, 2.14 [95% CI, 1.77-2.59]). In 2018, the percentage of ischemic stroke patients receiving EVT increased to 5.8%. A well-developed infrastructure, a pragmatic approach toward the use of EVT in clinical practice, in combination with a strict adherence by the regulatory authorities to national evidence-based guidelines has led to successful implementation of EVT in the Netherlands. Ongoing efforts are directed at further increasing the proportion of stroke patients with EVT in all regions of the country.

Time to Endovascular Treatment and Outcome in Acute Ischemic Stroke: MR CLEAN Registry Results.

BACKGROUND: Randomized, clinical trials in selected acute ischemic stroke patients reported that for every hour delay of endovascular treatment (EVT), chances of functional independence diminish by up to 3.4%. These findings may not be fully generalizable to clinical practice because of strict in- and exclusion criteria in these trials. Therefore, we aim to assess the association of time to EVT with functional outcome in current, everyday clinical practice. METHODS: The MR CLEAN Registry (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands) is an ongoing, prospective, observational study in all centers that perform EVT in The Netherlands. Data were analyzed from patients treated between March 2014 and June 2016. In the primary analysis we assessed the association of time from stroke onset to start of EVT and time from stroke onset to successful reperfusion with functional outcome (measured with the modified Rankin Scale), by means of ordinal logistic regression. RESULTS: We analyzed 1488 patients with acute ischemic stroke who underwent EVT. An increased time to start of EVT was associated with worse functional outcome (adjusted common odds ratio, 0.83 per hour; 95% confidence interval, 0.77-0.89) and a 2.2% increase in mortality. Every hour increase from stroke onset to EVT start resulted in a 5.3% decreased probability of functional independence (modified Rankin Scale, 0-2). In the 742 patients with successful reperfusion, every hour increase from stroke onset to reperfusion was associated with a 7.7% decreased probability of functional independence. CONCLUSIONS: Time to EVT for acute ischemic stroke in current clinical practice is strongly associated with functional outcome. Our data suggest that this association might be even stronger than previously suggested in reports on more selected patient populations from randomized, controlled trials. These findings emphasize that functional outcome of EVT patients can be greatly improved by shortening onset to treatment times.

Long-term single-center results with AneuRx endografts for endovascular abdominal aortic aneurysm repair.

PURPOSE: To evaluate the long-term single-center results with the AneuRx stent-graft in endovascular abdominal aortic aneurysm (AAA) repair (EVAR). METHODS: Between December 1996 and August 2003, 212 patients (197 men; mean age 71.3+/-7.0 years) were treated with the AneuRx stent-graft for an infrarenal AAA. Postoperatively, patients were enrolled in a fixed surveillance protocol, and data were prospectively captured into a database. RESULTS: Graft deployment was successful in 98.6% (209/212). Thirty-day mortality was 2.4%. Median hospital stay was 4.3+/-5.5 days. Median follow-up was 52.0 months (range 1-109); only 1 patient was lost to follow-up. At 9 years, patient survival was 56% and freedom from secondary interventions was 48%. In 68% of cases, these reinterventions were needed for a fixation-related complication, and most of these complications (75%) encompassed the area of the proximal aneurysm neck. Primary clinical success was 37% at 9 years. After secondary interventions, the assisted primary clinical success improved to 73% at 9 years. Freedom from aneurysm-related death was 97% at 1 year and 90% at 9 years. CONCLUSION: As an alternative to open repair, EVAR with the AneuRx device has low perioperative mortality. Reinterventions are mostly due to fixation-related complications. While the overall mortality risk in this population was 5% per year, annual aneurysm-related death was only 1%. The focus should be on surveillance and reducing the rate of long-term complications, which might be possible with improved proximal stent-graft fixation.