Standardization of the Neuroendovascular Lab
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1 Standardization of the Neuroendovascular Lab Vallabh Janardhan, MD Director, Texas Stroke Institute Stroke & Interventional Neurologist HCA North Texas Division, Dallas-Fort Worth, TX Founding Board of Director & Treasurer, SVIN
2 Disclosures DSMB, Penumbra Pivotal Trial, Penumbra Inc., Consultant Scien:fic Advisory Board, Insera Therapeu:cs Inc., Na:onal Science Founda:on Grant # Principal Inves:gator FIRST Trial, Penumbra Inc., Principal Inves:gator
3 Standardization of Cardiac Cath Labs exists: 85.2% of all US hospitals have Cardiac Cath labs Hospitals in US Cardiac Cath Labs in US Source: 2012 ACCF/SCAI Expert Consensus document on Cardiac Cath Lab Standards J Am Coll Cardiol. 2012;59(24):
4 With certified PSC s and 60+ certified CSC s, there is an unmet need for the Standardization of Neuro-Angiography & Stroke Interventional Labs Source: JCAHO ( and DNV (
5 Are there any standards for how to develop and maintain a high quality Neuro-angiography lab as part of Primary stroke center Certification? Standards for Primary Stroke Centers TJC DNV HFAP Need for Availability of Diagnos:c Neuro- Angiography PSC Standards for Neuro- angiography labs: e.g., Equipment, Staffing, Quality PSC Standards for Neuro- angiography or Caro:d sten:ng performed in cardiac cath labs No No Op:onal No No No No No No
6 Are there any standards for how to develop and maintain a high quality Stroke Interventional lab as part of Comprehensive stroke center Certification? Standards for Comprehensive Stroke Centers TJC DNV HFAP Personnel; Lab Facili:es & Supplies; Volume of Procedures; Quality Metrics Some Some Some Procedures & Protocols No Some No Radia:on Safety, On- Call Staffing and compensa:on No No No
7 Standardization of Stroke Angiography & Interventional Labs: SVIN-SILC Program 7
8 Need for Standardization of Stroke Interventional Labs as well as Neuro/Stroke Angiography Labs: I. Personnel & Supervision Laboratory Medical Director: Qualifica:ons: E.g., can a stroke center medical director be the lab medical director of the Neuro- angiography lab at a PSC or a Stroke Interven:onal lab at a CSC? How many years of experience in catheter- based skills Should there be a minimum number of prior procedure logs Job descrip:on Monitoring physician and staff behavior & competence Advocate for adequate resources including equipment, devices, & staff Ensure safety and compliance to all regula:ons including radia:on safety Quality Improvement Management skills
9 Need for Standardization of Stroke Interventional Labs as well as Neuro/Stroke Angiography Labs: I. Personnel & Supervision Fellowship trainees: Creden:als: Func:on under direct supervision of Acending Physicians Criteria before they can be primary operators Physician extenders or Advanced nurse prac::oners Creden:als: Job descrip:on: Pre- and Post- procedural evalua:ons Follow- up
10 Need for Standardization of Stroke Interventional Labs as well as Neuro/Stroke Angiography Labs: I. Personnel & Supervision Personnel Techs and Nurses Staffing needs for On- call Back- up team in case of two stroke cases If also trauma center, should there be more back up Stroke Coordinators & Ancillary Staff IRB coordinator Anesthesia support
11 Need for Standardization of Stroke Interventional Labs as well as Neuro/Stroke Angiography Labs: II. Physical Facilities & Supplies Physical Facili:es & Supplies Physical space of the lab Equipment Biplane vs. Single Plane Digital Storage and Displays Device Inventory Emergency Medica:ons
12 Need for Standardization of Stroke Interventional Labs as well as Neuro/Stroke Angiography Labs: III. Volume of Procedures (Minimal case load / year) Ischemic Stroke: Neuro-angiography, IV t-pa, IA t-pa, angioplasty/stenting, thrombectomy/embolectomy Penumbra Solitaire Trevo Merci IV / IA tpa Hemorrhagic Stroke: Neuro-angiography, coiling, clipping, flow diversion, embolization, vasospasm treatment Verapamil Injection PTA Flow Divertors Onyx Coils Treatments for Vasospasm
13 Need for Standardization of Stroke Interventional Labs as well as Neuro/Stroke Angiography Labs:: IV. Process Procedures and Protocols Reporting of study results in medical record Including time metrics and scales Procedure indications and informed consent Procedure preparation and conduct Protocols Contrast induced nephropathy Radiation induced alopecia & dermatitis Brain attack activation protocol Nurses, techs, anesthesia, ED neurologist, neurointerventionalist
14 Stroke Interventional Labs: IV. Sample Brain attack activation Protocol
15 V. Quality Improvement Quality Improvement (Process and Outcomes) Pre- hospital metrics: e.g., 911- needle, Door- in Door- out at ini:al hospital, Inter- facility Transfer Efficiencies ER metrics: e.g., Door to needle, Door to imaging, Door to groin Diagnos:c Neuro/stroke angiography lab metrics Stroke Interven:onal lab metrics: e.g., 911- revasculariza:on, door to revasculariza:on, & groin puncture to revasculariza:on Quality improvement and peer review process Access site complica:ons and Cerebrovascular complica:ons
16 Stroke Interventional Labs: VI. Radiation & Procedure Safety Radia:on Safety Flat panel detectors vs. Standard image intensifiers Single monitoring device (thyroid) vs. 2- monitor technique Real :me Exposure informa:on: Air Kerma Pregnancy in pa:ent or staff Acceptable Fluroscopic :me Ionic contrast agents safety
17 Stroke Interventional Labs: VII. On-Call Compensation Physician and Staff compensa:on Emergency Interven:onal Stroke Call Tele- Stroke Call Tele- neurology Call
18 Operational Roll-out: SVIN-SILC Program Standards Publica:on Pilot Launch Launch 18
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