Interventional Stroke Care in the Cath Lab Setting: Foundational Elements for Expansion

May is American Stroke Month, an annual event jointly sponsored by the American Heart Association (AHA) and the American Stroke Association (ASA). This month, throughout the healthcare community, is the time to promote awareness of stroke, its signs and symptoms, and ways to prevent the serious outcomes of delayed care for this acute condition. According to the AHA/ASA, someone in the U.S. has a stroke every 40 seconds, though 80% of strokes are preventable and an even greater percentage of strokes are treatable.  

Since the FDA’s approval of the thrombolytic tPA in 1996, care of the ischemic stroke patient has transitioned from largely a “spectator sport” to a well-defined treatment model. This model of care now consists of early symptom identification, uniform neurologic assessment, and care delivery within a coordinated system. As a result of this focus on rapid and aggressive treatment, more and more patients affected by ischemic stroke are not only surviving, but thriving — returning to a fully-functional independent life post-treatment.

Challenges continue to exist, however, mostly due to low utilization rates for tPA, averaging around just 7-10% nationally. This means that approximately 90-93% of patients who could potentially benefit from tPA, and who are eligible to receive the drug based on specific inclusion/exclusion criteria, do not receive it. Based on Corazon’s observations at programs across the country, concerns with medical-legal issues, lack of the necessary inpatient physician coverage, and only limited in-house neuroscience nursing expertise all contribute to this dismal program performance.

While tPA is (and will remain for the immediate future) the frontline treatment for patients with ischemic stroke, advances in endovascular therapies are exploding in the U.S., bringing new hope to patients with stroke. But, in order to be effective, patients must still first receive intravenous (IV) tPA, which is yet another reason that barriers to tPA administration must be corrected. 

For patients who do not respond to IV thrombolytics, catheter-based therapies for cerebral vessel clot removal provide a minimally invasive method to safely remove clots and thereby restore intracranial circulation. Patients who are treated in this manner are often “the sickest of the sick”, and require expert neuroscience care during all phases of the episode of care. 

Clot retrieval procedures are typically considered to be just one element of a full neuro-interventional service, or comprehensive stroke center, though this perception is changing. Many centers are now exploring the feasibility of an expanded primary stroke program model — one that includes clot retrieval, but does not include treatment of hemorrhagic stroke via more advanced coiling and embolization procedures. As approximately 87% of the strokes that occur in the U.S. annually are ischemic in nature, a national adoption of a primary stroke program model of care has the potential to positively impact stroke care on a broad scale.  

When evaluating the feasibility of implementing this type of program for an individual facility, Corazon believes that an assessment of the cardiac cath lab is an essential first step. Given the similarities in patient flow between an ST-elevation myocardial infarction (STEMI) patient and a patient slated for a clot retrieval procedure, capitalizing on an existing model of care can provide a significant advantage for an organization. A thorough assessment of the current cath program overall, including facility and equipment, staff training, ancillary areas, physician talent, capacity, and potential impact to existing programs must be performed.

Equipment

Existing labs with new imaging equipment may be well positioned to integrate clot retrieval services into the cath lab with only minimal capital upgrades required. In order to be suitable, imaging must be ‘new generation’ with the plate size and image resolution necessary to adequately visualize the small cerebral and pre-cerebral vessels. Older technology may be poorly suited for cranial imaging due to poor image quality in evaluating the smaller cranial vessels. If updated equipment is required, several vendors now offer dual-use imaging that performs well for cardiac diagnostic and intervention, full peripheral run-offs, and the cranial imaging necessary for clot retrieval procedures.

Image storage

A single cranial angiography diagnostic procedure alone can generate thousands of images. Corazon finds that many existing cath labs are challenged by a lack of storage capacity within the PACs or similar system. In most cases, images generated by computed tomography (CT) angiography of the head cannot be compressed and must be saved as dynamic images as opposed to a flat file images. Combined with the sheer number of images, this can tax many storage systems beyond capacity. Additionally, connectivity between the interventional suite and the storage system, along with the communication within and between various monitoring and imaging systems, must be evaluated. Understanding current capabilities and projecting future needs is a necessary step when considering a program expansion of this type. 

Monitoring

The monitoring necessary in a clot retrieval case extends well beyond hemodynamics and vital signs. The need for neuromonitoring capabilities, and in some cases, general anesthesia, adds a layer of complexity and additional considerations. 

While much of the necessary physiologic and procedural information can be captured in an existing cardiovascular information system (CVIS) within the lab, the need for interconnectivity in neurovascular systems adds yet another layer. Not only must data be collected and reported in real time, but it must also transfer to the medical record, be manipulable with respect to reporting and research, and be easily retrieveable at discrete field levels as well as in aggregate. 

Staff training

One of the greatest challenges in implementing a program of this sort is in ensuring that frontline staff have the necessary foundational and functional knowledge to prove competency in caring for the critically ill neuroscience patient. While much of the task-oriented patient care information can be learned via online tools and other resources, achieving competence in understanding neurological anatomy and physiology, and a comprehensive neurologic exam in the compromised patient, requires a different approach. 

Corazon finds that didactic education/learning provides a valuable opportunity for staff to interact with the instructor, as well as to perform and demonstrate the neurologic exam. Many organizations have migrated to a staff education process that incorporates both online learning and a face-to-face component to teach more complex aspects of care. In organizations that have a lack of internal neuro experts who can teach the topic, outside resources are often contracted to perform this education. 

Physician talent

In the U.S., there are several different training paths that prepare a physician to perform neuro-intervention: as interventional neuro radiologists, interventional radiologists, interventional neurologists, and interventional neurosurgeons. These highly-skilled clinicians come at a premium, especially given their small numbers and an increased demand. Likewise, high salary expectations can become a recuitment/retainment challenge, particularly in smaller community programs. 
Thus, attracting and engaging these physicians requires an innovative recruitment approach. Corazon oftern finds that the “build it and they will come” adage is applicable in assisting with recruitment initiatives. A well-apointed interventional suite and the presence of the foundational elements necessary to build the program demonstrate to a new recruit that the organization is supportive of the growing program and will be to her/him as well.

While there has been much talk about the role or proposed role for interventional cardiologists in neuro-intervention (particularly in clot retrieval procedures), fierce opposition from the neuroscience community continues to block this evolution. A recent position statement, drafted by 17 neuro-interventional centers across the world, holds firm in that the skill required to safely and effectively treat ischemic stroke patients with clot retrieval devices requires targeted training in the neurosciences in addition to catheter-based skills. Further, the differences between cerebrovascular anatomy and cardiovascular anatomy are substantial and the necessary skills do not easily transfer from cardiac to neuro. 

Ancillary and support clinical areas

Implementation of a neuro endovascular program will affect nearly every person in the organization. Additional demands on the medical staff, anesthesia, critical care, and hospitalists must be identified and discussed. In order to be successful, the full support of the medical staff must be secured, along with strong and unwavering support from administrative leaders and other key stakeholders.

Rehab services, case management, and social work will likewise feel an impact given the increased patient acuity and unique requirements in-hospital and post-discharge for this challenging patient population. Pre-hospital services will realize elevated demands with respect to training, transport protocols, and new treatment algorithms that must be implemented.

Capacity/patient flow

In Corazon’s experience, assessing capacity, and understanding the potential impact to existing programs and established patient flow algorithms, can be one of the most challenging aspects of planning a program expansion of this sort. While maximizing utilization of very expensive real estate (the interventional suite) must be at the top of people’s minds, it cannot be accomplished at the expense of existing programs. Understanding which patient populations can be safely combined without affecting time to treatment is of the utmost importance. Evaluating every step of the patient flow algorithm, from field to intervention, is a necessary exercise that can help to uncover opportunities for increased efficiency and expanded intra-suite capacity. 

In summary, the presence of a well-run and efficient cardiac interventional program can provide an excellent foundation for a well-defined neuro-interventional program. The treatment needs of the STEMI patient, and the steps necessary to deliver care accordingly, are remarkably similar to those of an ischemic stroke patient. Early identification of symptoms, rapid transport, and a treatment algorithm that facilitates opening of the affected vessel(s) as rapidly possible are all required. Through a frank evaluation of a cardiac program’s current state, and with a thoughtful and comprehensive planning effort for expansion, organizations can be well positioned to be successful in this rapidly growing clinical area.  

Taking advantage of the synergies of care for these two critical populations can no doubt bring increased volume and revenue to an existing cath lab; however, the resulting increased access to life-saving procedures of a different kind is the real benefit: a goal an organization can stand behind this month, and throughout the year. 

Stacey Lang is a Senior VP at Corazon, Inc, offering strategic program development for the heart, vascular, neuro, and orthopedic specialties. Corazon offers a full continuum of consulting, software solution, recruitment, and interim management services for hospitals, health systems, and practices of all sizes across the country and in Canada. To learn more, visit www.corazoninc.com or call (412) 364-8200. To reach the author, email slang@corazoninc.com.