Chris* knew something was not working right with his heart, but this felt different from his previous heart attack five years ago. After a few hours of chest discomfort, his wife called 911. The paramedics responded quickly and rushed him to Providence Portland Medical Center, where he underwent an emergency coronary angiogram showing a completely blocked left anterior descending artery.
A stent was placed, but the damage had already been done. His heart muscle functioned at less than half of normal, with his left ventricular ejection fraction (LVEF) measuring 30%. Despite the stent and optimization of heart failure medications, his LVEF never recovered. About a year later, his cardiologist ordered an echocardiogram, which showed his LVEF remained at 30%. At that time, an electrophysiologist placed an implantable cardioverter-defibrillator (ICD) for primary prevention of sudden cardiac death.
Chris established care with his local device clinic. ICD interrogations occurred every 3 months through remote device transmissions he made from his home. Every 6 months, Chris visited the device clinic for an in-person interrogation. He had good rapport with the device clinic staff, and knew that if he had questions about his heart care, that he could call anytime. He felt well since his ICD implant, and had never received an ICD shock or experienced problems with the device.
Then one night, he kept waking up with the sensation of a racing heart, breathlessness, and dizziness. The episodes would last 10-15 minutes and then stop suddenly, only to return later. When morning arrived, he called the device clinic and spoke with a device clinic nurse. The nurse logged onto the ICD vendor website and saw an alert-driven transmission. This showed that Chris had been having high heart rates in his ICD monitor zone. The electrograms from these episodes revealed an irregular rapid heart rhythm, at times above 170 beats per minute, consistent with atrial fibrillation.
The nurse spoke with the covering doctor, who reviewed the tracings and confirmed the diagnosis. A blood thinner was prescribed, and his beta blockers were increased. Chris was given an appointment that day to meet with a physician assistant to discuss his diagnosis and treatment options. A follow-up with his electrophysiologist was also scheduled.
About the Device Clinic
Chris’s experience reflects a routine day for the device clinic staff within the Providence St. Joseph Health system in Oregon. With 6 device clinic locations in the Portland metropolitan area, and 3 device clinic locations elsewhere in the state, Providence Oregon device clinic staff care for over 7,000 patients with implanted cardiac devices. They perform over 14,000 remote device checks and over 7,000 in-person device checks on an annual basis. The clinics have experienced significant growth in volume, as over 1,000 patients receive new devices each year that need to be followed.
There are approximately 18 device clinic nurses, technicians, and support staff that care for Providence Oregon device clinic patients. Portland is geographically divided by the Willamette River, which runs south to north through the city. Ruthanne Keim, RN, CCDS manages the west side clinics, which include 4 device clinic locations. Delaine Barnes, RN, CCDS manages the east side clinics, which include 5 device clinic locations. Most team members are registered nurses. All staff are sent for device training through a third-party training program, and are encouraged to become credentialed as a Certified Cardiac Device Specialist (CCDS) through the International Board of Heart Rhythm Examiners (IBHRE).
Due to the growth in device volumes as well as rapidly advancing device and monitoring technologies, our workflow continues to evolve. Currently, patients with ICDs are checked remotely every 3 months and in person every 6 months. Patients with pacemakers are checked remotely every 6 months and once a year in person. Patients with implantable loop recorders are checked remotely on a quarterly basis and as needed.
When remote transmissions are received or in-person checks are performed, staff upload the data to the clinical management software application, which then uses HL7 integration to push the interrogation report and some discrete raw data to the electronic medical record (EMR). A template-driven note is then completed in the EMR and routed to the covering doctor to make changes as needed and sign. Urgent device- or arrhythmia-related issues are escalated to the covering doctor, nurse practitioner, or physician assistant.
Device clinic staff also provide inpatient care. The majority of cardiac devices within the Providence Oregon region are implanted at Providence St. Vincent Medical Center in Portland, which offers cardiac services including cardiac surgery, advanced heart failure care, high-risk percutaneous coronary intervention, and electrophysiology procedures. At this referral center, inpatient device services are provided by the device clinic staff during normal business hours. Services include patient education after device implants, inpatient device interrogations and reprogramming (including before and after surgical procedures), and attending magnetic resonance imaging (MRI) scans for patients with non-MRI conditional devices. The EMR enables any caregiver to order an inpatient device interrogation. Once the order is signed, a page is automatically sent to the device clinic staff person assigned to inpatient duties for the day. At the 7 other hospitals in the Providence Oregon region, vendor-provided remote patient management devices are used to transfer interrogations to the device clinics. Vendor representatives provide support at these hospitals if reprogramming is needed.
Advances in remote monitoring and device technologies have posed some significant challenges in recent years. The clinical benefit of remote monitoring has resulted in a push to set up all device clinic patients with home transmitters, causing a “data deluge” from mostly automatic alert-driven transmissions and unscheduled remote transmissions. Additionally, the advent of FDA-labeled MRI-conditional cardiac devices, as well as evidence supporting the safety of MRI scans in almost all device patients regardless of FDA labeling, has led to an increase in MRIs ordered in device patients. This demanded a strategy to provide device clinic support for MRI scans in these patients.
The tremendous amount of data generated from remote monitoring can be overwhelming and has been a hot topic of discussion among cardiac device clinics as they struggle to process the tide of information. Many alert-driven transmissions and unscheduled transmissions are clinically meaningless and non-actionable. The Providence Oregon device clinics use several approaches to reduce the data flow and focus on clinically actionable items. For example, atrial fibrillation alerts are turned off for patients with known atrial fibrillation on oral anticoagulation. When possible, high-rate detection settings are modified to increase both the number of beats required for detection and the rate required for detection. Patients are encouraged to call before sending an unscheduled remote transmission (transmissions can many times be avoided after a conversation with staff). These small changes, while not entirely solving the problem, have strategically enhanced patient care and limited unnecessary data review.
Collaboration with the radiology department has helped our workflow to allow MRI scans for patients with MRI-conditional devices and non-MRI conditional devices at Providence St. Vincent Medical Center. For patients with MRI-conditional devices, radiology staff process the order and send a note through the EMR to device clinic staff, who determine programming around the time of the scan. Device vendor representatives program the devices before and after the scans for these patients.
For patients with non-FDA labeled device systems, a protocol is used in accordance with the Medicare decision memo issued in 2018 that expanded coverage for patients with non-conditional devices.1 Radiology processes the order for an MRI scan for a patient with a non-conditional device and forwards it to device clinic staff for review. A template-driven note is then forwarded through the EMR to the covering doctor for review and approval. Non-conditional scans are currently limited to normal business hours, when electrophysiology staff are available in the hospital. An Advanced Cardiac Life Support (ACLS)-certified device clinic staff member attends the scans, and performs the appropriate programming before and after the scan. The number of non-conditional scans has increased to the point where the radiology department is in the process of hiring their own ACLS-certified nurses to staff the scans. A workflow similar to the one currently used for MRI-conditional devices will be implemented, with programming directed by the device clinic to be performed by vendors around the time of the scan. These changes have significantly increased access to MRI for our device patients.
The patient discussed here was ultimately started on an anticoagulant and antiarrhythmic drug, with improvement in his symptoms and reduction in his risk of stroke from atrial fibrillation. Knowledgeable device clinic staff and streamlined workflows were the key elements that allowed him to get the care he needed in a timely fashion.
The Providence Oregon device clinic teams continue to adapt and evolve to care for an increasing population of patients with increasingly complex devices. Ongoing staff education, training, and retention are critical aspects of maintaining excellent care for these patients. Collaboration with other specialties is also important to develop workflows that will ease the way for device clinic staff and patients with devices.
*Patient name and identifying details changed to protect patient privacy.
Disclosure: Dr. Brancato has no conflicts of interest to report regarding the content herein.
- Decision Memo for Magnetic Resonance Imaging (MRI) (CAG-00399R4). CMS. Published April 10, 2018. Available at https://go.cms.gov/38x3fHb. Accessed February 16, 2020.