Experts worry that the new criteria for certification of thrombectomy-capable stroke centers are insufficient to ensure quality of care.
In 2018, the Joint Commission, in collaboration with the American Heart Association (AHA) and American Stroke Association (ASA), initiated a new level of stroke care certification. Called the Thrombectomy-Capable Stroke Center (TSC) certification, the new designation represents an intermediate level of care between primary stroke centers and comprehensive stroke centers.
It also recognizes progress in treating ischemic stroke with thrombectomy. Updated guidelines from the AHA/ASA recently expanded the window of opportunity for thrombectomy, now considered a “reasonable option” in patients for whom 16 to 24 hours have passed since they were last at normal status.1
Expanded window for thrombectomy
These changes come on the heels of two landmark randomized controlled trials, DAWN (DWI or CTP Assessment with Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention with Trevo) and DEFUSE-3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke). DEFUSE-3 was stopped early for efficacy when results showed significantly improved 90-day functional outcomes with thrombectomy added to standard therapy 6 to 16 hours after the onset of symptoms, compared with standard therapy alone.2 DAWN extended that window to 24 hours when it also showed significantly improved 90-day disability for thrombectomy added to standard therapy versus standard therapy alone.3
Few would argue against thrombectomy as potentially beneficial for eligible patients, but will the new certification succeed in improving stroke care and outcomes? Before that can happen, the health care community may need to overcome several hurdles.
New certification raises concerns
While the AHA says the new certification reflects current practice, with about 30% of primary stroke centers already offering thrombectomy,4 the change has raised concerns. Some experts worry that the new TSC certification may offer a false sense of security if centers do not live up to standards that ensure quality care.
“Although these centers may be thrombectomy ‘capable’, the evidence suggests that the process and numerical requirements currently proposed for accreditation are insufficient to yield the favorable patient outcomes reported in recent randomized controlled trials,” William Mack, MD, of the University of Southern California, Los Angeles, and colleagues wrote in an editorial in the Journal of Interventional Surgery.5
The TSC certification enables primary stroke centers to provide thrombectomies without meeting all requirements for a comprehensive stroke center (CSC).
In particular, experts point out that physicians who perform thrombectomies will no longer require certification by the Society of Neurological Surgeons’ Committee on Advanced Subspecialty Training (CAST) and will not need to meet minimum caseloads. That, in effect, translates into abandoning formal training and experience standards for providers at TSCs, according to a 2018 joint public statement by the Society of NeuroInterventional Surgery, Joint Cerebrovascular Section of the AANS and CNS, and Society of Vascular and Interventional Neurology.6
“While well intended, the recent changes to CSC and TSC standards, unfortunately, fall well below the mutually agreed upon standards of the national neurovascular organizations. These changes will limit patients’ and frontline healthcare providers’ confidence that the doctors performing lifesaving stroke surgery have appropriate training or can demonstration adequate expertise. This is a step backward in developing our US stroke systems of care,” J Mocco, MD, MS, said in the statement. Dr Mocco is Chair of the Joint Cerebrovascular Section of the American Association of Neurological Surgeons and Congress of Neurological Surgeons.
Evidence from a recent literature review suggests that patients treated with thrombectomy at low-volume stroke centers have fewer positive outcomes than those at high-volume centers.7 Evidence for the benefits of thrombectomy come from clinical trials with high-volume, formally trained providers.
“Patients who require stroke intervention-especially those experiencing emergent large vessel occlusion (ELVO) and hemorrhagic strokes-must be triaged to centers with care teams that have extensive training and experience. Ultimately, patients will pay the price as a result of changes to CSC and TSC training and experience standards,” Italo Linfante, MD, FSVIN, FAHA, said in the statement. Dr Linfante is President of the Society of Vascular and Interventional Neurology.
Delayed care remains a problem
Yet, even if centers can ensure quality care, problems getting there may stand in the way. A study presented at ASA’s 2019 International Stroke Conference suggests that 64% of areas in the US lie outside a maximum 30 minutes’ drive and are classified as very high/high need for a TSC center.8
While the number of TSC centers is growing, for now they are concentrated on the East and West coasts. A broad swath of the middle of the country lies more than 60 minutes’ drive or helicopter flight from one of these facilities.4
Mobile stroke units (MSUs), with on-board imaging, laboratory and telemedicine capabilities to support diagnosis and treatment, may improve stroke triage decisions, especially in rural areas. But providers debate whether MSUs improve outcomes and are worth the high price tag (about $1 million each).9
Momentum is also building to transport stroke patients directly to higher level stroke centers, when possible, rather than to the closest facility followed by transfer.
Yet the longest delay often happens even before calling 911. Up to 75% of patients arrive outside of the window of opportunity when they can receive treatment. One study showed that just 3.8% of patients with ischemic stroke received tissue plasminogen activator between 2005 and 2011, although that number has been growing.10
Every effort should be made to expand access to these beneficial treatments for eligible stroke patients, without losing sight of the big picture. Continued efforts are needed to improve education about stroke in the community, in order to widen the pool of eligible patients who are likely to benefit from advances in stroke care.
1. Powers WJ, Rabinstein AA, Ackerson T, et al. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018;49:e46-e110. doi: 10.1161/STR.0000000000000158.
2. Albers GW, Marks MP, Kemp S, et al. Thrombectomy for stroke at 6 to 16 hours with selection by perfusion imaging. N Engl J Med. 2018;378:708-718. doi: 10.1056/NEJMoa1713973.
3. Nogueira RG, Jadhav AP, Haussen DC, et al. Thrombectomy 6 to 24 hours after stroke with a mismatch between deficit and infarct. N Engl J Med. 2018;378:11-21. doi: 10.1056/NEJMoa1706442.
4. AHA. 50th anniversary stroke coordinator bootcamp. March 27, 2018. Accessed April 24, 2019 at: https://www.heart.org/idc/groups/heart-public/@wcm/@gra/documents/downloadable/ucm_499924.pdf
5. Mack WJ, Mocco J, Hirsch JA, et al. Thrombectomy stroke centers: the current threat to regionalizing stroke care. J Neurointerv Surg. 2018;10:99-101. doi: 10.1136/neurintsurg-2017-013721.
6. Society of Neurointerventional Surgery. Public Statement from the Society of NeuroInterventional Surgery, Joint Cerebrovascular Section of the AANS and CNS, and Society of Vascular and Interventional Neurology. Accessed April 24, 2019.
7. Fargen KM, Fiorella DJ, Mocco J. Practice makes perfect: establishing reasonable minimum thrombectomy volume requirements for stroke centers. J NeuroIntervent Surg. 2017;9: 717-719. doi: 10.1136/neurintsurg-2017-013209.
8. AHA. Study shows need for thrombectomy-capable stroke centers remains high in 64 percent of communities studied. Accessed April 24, 2019 at: https://newsroom.heart.org/news/study-shows-need-for-thrombectomy-capable-stroke-centers-remains-high-in-64-percent-of-communities-studied
9. Bukata R. Are mobile CT stroke units worth the price tag?Emergency Physicians Monthly. 2017;1:15-18.
10. AHA. Many stroke patients do not receive life-saving therapy. American Stroke Association Meeting Report – Session A17 – Abstract 116. February 23, 2017. Accessed April 24, 2019 at: http://newsroom.heart.org/news/many-stroke-patients-do-not-receive-life-saving-therapy