The document discusses guidelines for setting up a new neurointervention cath lab. It covers necessary physical space, equipment, staffing, protocols, and inventory. The lab should be near imaging modalities like CT and have biplane angiography equipment. Staffing includes a medical director, neurointerventionalists, technicians, nurses and support as needed. Standard protocols are outlined for procedures, informed consent, monitoring and radiation safety. A variety of medical devices, medications and supplies must be maintained and inventoried.

1. Setting up of a new
neurointervention cath lab
Dr Vaishal Shah
DM neurology resident
MBS hospital

2.  Neuro intervention is a relatively new field of medicine.
 Neurointervention is a word used to describe a treatment approach to
conditions that occur within the vessels of the brain or within the spinal
cavity.
 Time is of the essence in neurology
 Be it a stroke, aneurysm or head trauma, fast, safe and timely intervention is
essential.

3.  Neurointerventional procedures are minimally invasive.
 Dramatic advances in neuro intervention have been possible due to
improvements in medical technology, such as advanced neuroimaging
and revolutionary developments in medical devices.

4. Procedures
Diagnostic:
 Digital subtraction cerebral angiography
 Digital subtraction spinal angiography

5. Therapeutic
 Cerebral aneurysm
 AVM
 Subarachnoid hemorrhage
 Stroke
 Carotid Stenosis/blockage
 Carotid-cavernous fistula (CCF)
 Vasospasm
 Tumour embolization of Meningiomas and brain tumors

6. Volume of Procedures

7. Machines – Physical Facilities and
Angiographic Equipment

8. 1. Physical space
 Basic equipment and laboratory need to be located in a setting that
provides electrical service, air conditioning, air exchange, sterile
conditions, room and task lighting, telephone, computer, and patient
amenities required for these types of procedures.
 Neuro interventional laboratory is ideally situated close to other
modalities of imaging including CT, MR, as well as proximity to the
emergency room for the purpose of minimizing time to treatments in
acute stroke.

9. Atomic energy regulatory board

10. The interventional laboratory should also factor in accessory
components such as
 Staff changing areas
 Tele-stroke station
 Computers for ease of access to medical records
 Conference areas
 Patient holding rooms
 Family counselling areas

11. 2. Angiographic equipment, instrumentation,
software
In addition to the cognitive knowledge of stroke interventional
techniques, radiographic equipment is also rapidly evolving.
Biplane angiography with DSA, high-resolution image
intensifier, and imaging chain, digital subtraction imaging
(1,024 × 1,024 matrix is ideal) should be standard.
Road map fluoroscopy capabilities with simultaneous live
unsubtracted imaging are also required.

12.  Road mapping is useful for
placement of catheters and
wires in complex and small
vasculature
 Frame with max vessel
opacification becomes road
map.

13. Single plane

14. Bi plane

15.  Real time Imaging
 Bi-plane systems capture image data from detectors on two axes, they
are able to show 3D images in real time. Useful in neurovascular and
cardiac procedures.
 Single plane labs are also capable of 3D imaging but with delay
1. c-arm to moving time
2. software’s reconstruction process

16. Cath Lab Site Preparation
Double the c-arms = double the site prep
Overall larger footprint.
Cost Difference
 The amount of radio-opaque dye used in a biplane system is
considerably less compared to a single plane system.

17. Neuro-angio pack
(courtesy of Texas Stroke
Institute)

18. Manpower – Personnel and Supervision

19. 1. Medical Director
 The medical director is a physician with extensive experience and
leadership qualities to maintain the optimal laboratory environment.
 The director should have an unrestricted medical license according
to local state regulations, should be fellowship trained in
neurointervention, and should be board certified in their respective
primary disciplines

20.  The medical director of the stroke interventional laboratory is
necessarily involved in active participation in ‘door to needle’ (IV t-
PA) task force , ‘door to perfusion’ (stroke intervention) task force.
 Certification and renewal process with certifying bodies such as state
regulatory bodies.

21. The medical director is responsible for
 Quality assurance
 Periodical review of staff performances
 Appropriate renewal of laboratory privileges
 Review performance of nonprofessional staff,
 Provide necessary training to personnel.
 The medical director is further responsible for quality control
including morbidity and mortality

22. 2. Stroke Interventionalist
 This person should be knowledgeable in all aspects of performing
the procedure, including pre- and postprocedural management of the
patient.
 Any assisting physicians or physician extenders, other than the
attending, are considered to be secondary operators and must be
documented and accounted in the informed consent.

23.  All procedures must be staffed with at least one primary operator and
any number of secondary operators in order to safely and efficiently
complete each procedure

24. 3. Physician Extenders and Interventional
Fellows
 Trainees or physicians in fellowship are considered secondary
assisting operators and must be directly supervised by the primary
operator.

25. 4. Technical/Administrative Director
 He is responsible in conjunction with the medical director for the
quality control of the stroke interventional laboratory.
 Control over patient scheduling, equipment maintenance, budget
preparation, monitoring radiation doses, organization of conferences
for laboratory personnel, and regular reports on laboratory activity.

26. 5. Interventional Technologist(s)
 At least one technologist, preferably a certified radiological
technologist, should be skilled in radiographic and angiographic
imaging principles and techniques.
 This technologist should be experienced in the proper performance
of X-ray generators, cine pulse systems, image intensification,
automatic film processing, pressure injection systems, video
systems, and cine cameras.

27.  He or she in conjunction with radiological service engineers should
be responsible for routine care and maintenance of radiological
equipment.
 This technologist, in cooperation with radiation physicist, must
monitor radiation safety techniques for both the patient and
laboratory personnel.
 Immediate availability of radiological engineer in the event of the
equipment failure is his responsibility.

28. 6. Interventional Nurse(s)
 Depending on case load, nurse practitioners, registered nurses,
licensed vocational or practical nurses, or nursing assistants are
required.
 In most laboratories, the nursing supervisor is a registered nurse.
 Nursing staff may directly participate in observation, emergency
response, and charge the pre and post-procedural holding areas.

29.  They must assist with hemodynamic and neurological monitoring
for regular documentation of vital signs and neurological
assessments

30. 7. Imaging Technologist(s) for CT/MRI
 Although imaging technologists are not necessarily required to be
present during the procedure.
 If advanced imaging services such as MRI or CT are required, such
services should be readily accessible.
 Imaging technologist involved in patient management should be
familiar with stroke interventional techniques, imaging protocols per
facility, and national guidelines related to stroke.

31.  He must also participate at regular intervals in continuing education,
quality assurance, and quality improvement.

32. 8. Neurological Assessment Examiner
 Neurological assessments must be performed before, during, and
after any stroke intervention including diagnostics at regular
intervals, as appropriate.

33. 9. Stroke coordinator and ancillary personnel
 Stroke coordinators are the cornerstones of any stroke program.
 Must actively participate in numerous task forces such as ‘door to
needle’ task force, ‘door to perfusion’ task force, quality assurance,
and quality improvement.
 Must be familiar with national guidelines in stroke interventional
care.

34. 10. Institutional review board and research
coordinator
 It is strongly recommended that any neuro interventional
laboratory to participate in national registries, data reporting, and
statistical analysis of information.

35. 11. Anaesthesia support
 The utility of general anaesthesia during stroke interventional
procedures has not been validated and remains a topic of controversy.
 The majority of stroke interventionalists nationally practice conscious
sedation or monitored anaesthesia for LVO AIS cases unless the patient
needs airway protection, in which case general anaesthesia is provided.

36.  Full anaesthesia support must be available for complicated cases
during which intubation and sedation is indicated.
 It is not recommended to practice routine general anaesthesia for all
patients and must be reviewed by individual cases.
 Level 1 conscious sedation practices are recommended for stroke
interventional procedures, under the supervision of appropriately
trained providers.

37. MATERIALS – MEDICAL DEVICE
INVENTORY, MEDICATIONS, AND
ANGIOGRAPHIC SUPPLIES

38. 1. Medical Device Inventory
 Certain degree of preparedness to handle any possible stroke
interventional cases
 Multiple sizes and types of each basic device should be stocked at all
times with adequate par levels for each device

39. Basic devices include
 Guide catheters
 Guidewires
 Balloon catheters
 Microcatheters
 Microwires
 Embolic materials
 Thrombectomy devices.
 Inventory tracking system to assess the par levels of various devices
on an ongoing basis.

40. Supplementary machines
 Defibrillator
 ECG machine
 Gas, air and vaccum ports
 Boyle apparatus
 Bedside cardiac monitor
 Injector

41. 2. Equipment and Instrumentation Quality
Control
 Unit contains sophisticated radiographic, electronic, and computer-
based systems, which require maintenance and troubleshooting.
 The biplane/single plane and X-ray imaging system should be
especially monitored for early deterioration.
 24/7 access to IT help desk.

42.  Backup systems for storage of essential information.
 Adequate digital storage and capabilities for archiving of images so
that there is no risk of accidental deletion of images acquired during
a procedure due to lack of file storage or digital memory space.

43. 3. Pharmacy and Medications
 In addition to hemodynamic monitoring capabilities, should be
equipped to treat certain medical and neurological emergencies such
as hypertension, raised ICT, acute life-threatening bleeding, and
seizures.
 For this reason, the neuro interventional laboratory should contain a
medication storage system as per institution preference.
 Speedy access to the facility’s pharmacy for medications

44. METHODS – STANDARDIZED PROTOCOLS

45. 1. Reporting of Study Results in Medical Record
Neurointervention procedure report
1. A brief description of pertinent history and clinical events
2. Name of procedure and indication
3. Primary and all secondary operators and anaesthesiologist if present

46. 4. Access technique with findings.
5. Description of named procedure itself with positive and negative
findings.
6. Vascular closure device use and technique.
7. Documentation of family discussion explaining key findings of
stroke interventional procedure.

47. 2. Procedure Indications and Informed Consent
 Prior to all procedures, both diagnostic and intervention, standard
informed consent and time-outs should be obtained prior to
procedure.
 Informed consent should note all participants of the procedure and
describe all possible procedures including ad-hoc interventions,
should they become a consideration.

48. 3. Procedure preparation and conduct
 Premedication as per institute protocol.
 Protocol for conscious sedation.
 Sterile preparation is mandatory for all vascular access sites.
 Adequate monitoring including hemodynamic monitoring of basic
vital signs (blood pressure, heart, rate, respiratory rate, and oxygen
saturation) along with frequent neurological checks.

49.  Post-procedural hemostasis may be achieved by several means
including manual pressure, mechanical compression devices, or
percutaneous closure devices.
 Should be monitored after procedure for hematoma and
pseudoaneurysms, and event rates of each method and each device
must be tracked

50. 4. Radiation safety
 Accumulation of study data showing the impact of radiation exposure
on the job.
 Interventional neurologists having higher rates of left-sided brain
tumors, skin cancer, posterior subcapsular lens changes (a precursor
to cataracts), thyroid disease and neuro-degenerative disease.
 Additionally, wearing heavy lead aprons over the course of their
careers, interventional cardiologists suffer higher rates of orthopedic
back pain issues.

51.  Four radiation dose metrics should be kept in mind
1. Reference air kerma in milligrays
2. Kerma-area product in centigray-square centimeters
3. Fluoroscopy time
4. Number of fluoroscopic images
 To Monitor throughout every stroke interventional procedure

52.  Average doses of stroke interventions nationally by procedure are
currently unknown.
 Reference levels are a guide to good practice.

54.  Radiation exposure must be measured by single device monitoring.
 Ceiling suspended radiation protection system
 Double sided type of lead apron
 Thyroid guard
 Lead spectacles

55. Random click of DSA machine in MBS
hospital

56. References
 S. Karger AG, Basel, Intervent Neurol 2016;5:1–28
 https://info.blockimaging.com/bid/99559/Bi-Plane-Cath-Labs-vs-
Single-Plane-Cath-Labs.
 www.Medscape.com

57. Thank you