Stroke Center Certification

Excerpt

Stroke is one of the most significant causes of morbidity and mortality in the United States. Based on data from the Centers for Disease Control and Prevention (CDC), an estimated 795,000 individuals experience acute ischemic strokes (AIS) annually, and at least 150,000 of these cases lead to fatalities. The economic impact of AIS is significant, with the annual expenses for healthcare services, medications, and missed workdays totaling approximately $34 billion. Unfortunately, adherence to expert consensus guidelines for treating AIS is not consistently observed, resulting in poorer functional outcomes. In response to this challenge, stroke centers have been established to standardize evidence-based protocols within the inpatient setting and enhance nationwide access to high-quality care.

Thrombolytic Therapy in Acute Ischemic Stroke Management

Stroke treatment has undergone significant and rapid advancements in the past 2 to 3 decades, with ongoing research continuing to influence and refine management practices. A critical breakthrough in stroke therapy occurred in 1996 when the Food and Drug Administration (FDA) approved thrombolytic therapy using alteplase—an intravenous (IV) recombinant tissue plasminogen activator (tPA). Although this treatment has demonstrated remarkable effectiveness for strokes resulting from small vessel occlusions, its efficacy for strokes caused by large vessel occlusions (LVO) has proven to be more limited.

Recent studies have examined the standard dose of alteplase, which involves administering 0.9 mg/kg alteplase IV, with a maximum total dose of 90 mg. This dose is given by administering 10% of the total dose as an initial IV bolus over 1 minute, followed by infusing the remainder over 60 minutes. These studies have compared this standard regimen with a rapid infusion of tenecteplase at 0.25 mg/kg. Multiple studies have shown that tenecteplase at both 0.1 and 0.25 mg/kg did not exhibit superiority over alteplase regarding neurological outcomes in patients with AIS within the 3- to 4.5-hour window. However, for patients with LVO, the results did not reach statistical significance.

The NEJM Campbell study revealed a statistically significant disparity in achieving greater than 50% reperfusion or unretrievable thrombus during a diagnostic angiogram. The study reported a rate of 22% with tenecteplase compared to 10% with the standard-dose alteplase. Furthermore, the tenecteplase group exhibited superior 90-day functional outcomes compared to the alteplase group. In various studies, meta-analyses have consistently demonstrated either non-inferiority or superior trending results for tenecteplase over alteplase.

In terms of safety, research findings have been somewhat varied, with some studies indicating a tendency toward fewer intracranial bleeding complications with low-dose tenecteplase (0.1 or 0.25 mg/kg) compared to high-dose tenecteplase (0.4 mg/kg) and standard-dose alteplase. A larger randomized controlled trial with a higher statistical power could provide valuable insights into the efficacy and safety profiles of tenecteplase compared to alteplase in LVO patients eligible for embolectomy.

Ideally, conducting studies at various time frames, such as 3 hours, 4.5 hours, 6 hours, and 6 to 24 hours before mechanical thrombectomy (MT), could offer valuable insights into whether tenecteplase exhibits superiority in cases of LVO. Further research will be necessary to determine whether tenecteplase can be more effective in treating AIS with LVO within 4.5 to 24 hours or in cases of early wake-up strokes.

The TIMELESS study is currently in progress and aims to evaluate the safety and efficacy of tenecteplase in patients eligible for imaging and those within the late-time window. The study reached its conclusion on November 30, 2021.

Embolectomy Therapy in DNV-GLAcute Ischemic Stroke Management

LVO strokes are traditionally recognized as the most devastating in terms of morbidity and mortality. However, over the past 10 to 20 years, embolectomy or MT has significantly improved survival rates and functional outcomes for individuals with LVO strokes. These groundbreaking therapies have revolutionized modern stroke care, establishing a new LVO treatment standard.

The implementation of MT brought about a shift in the stroke center certification classification, now mandating facilities to have the capability to perform this life-saving procedure. The adage "time is the brain" emphasizes the critical importance of timely intervention. Earlier tPA administration is associated with improved functional outcomes, reduced intracranial bleeding risk, and lower hospital mortality rates. A mere 15-minute delay in tPA initiation is associated with a decline in the likelihood of achieving functional independence, surviving until discharge, accessing rehabilitation, and avoiding symptomatic intracranial bleeding. The odds of these outcomes decrease by 3% to 4% for every 15-minute delay interval. For LVO strokes, early intervention is critical for patients undergoing MT. Each additional hour of delay in achieving MT reperfusion is associated with reduced functional independence, increased morbidity, and a diminished quality of life.

According to the most recent guidelines released by the American Stroke Association (ASA) in 2018, eligible patients are advised to receive IV tPA as soon as possible, ideally within 3 hours of their last known normal state. In certain cases, selected patient groups may be considered for an extended time window of up to 4.5 hours. For eligible LVO patients, it is recommended to undergo MT as soon as possible, ideally within 6 to 16 hours from their last known normal. However, in certain cases, MT may still be a viable option within a broader time frame of up to 24 hours from the last known normal. Given these recommendations, healthcare practitioners must be well-informed about stroke center accreditation levels and capabilities to initiate timely and appropriate treatment.