HRS Guidelines and the Use of Remote Patient Monitoring: Alignment to Help Enhance Patient Care

The report, which can be found on the HRS website (www.hrsonline.org), summarizes the current environment as follows: HRS believes that patient and physician knowledge, confidence, and trust in cardiac rhythm management devices can be enhanced and strengthened through: Greater transparency in post-market surveillance, analysis, and reporting of information, Enhanced systems to increase the return of devices to manufacturers and to improve the analysis and reporting of device performance and malfunction information and Cooperation among industry, the Food and Drug Administration (FDA), and physicians in an effort to prevent injuries and deaths due to device malfunctions.¹ So what does this mean to our patients? Sometimes fear and confusion. When evaluating a patient for life-saving therapy, the conversations have become more complex. As a result of the increased level of reporting and news coverage, my patients have increased concerns about undergoing an implanted device procedure. I agree with the guidelines that Physicians and patients need timely, accurate, and understandable information regarding device performance in order to make appropriate decisions regarding medical care. They want confidence that the implanted device has been manufactured using state-of-the-art materials and techniques and that it will perform reliably. Furthermore, patients need to trust that physicians, industry, and the FDA will act with the best interest of patients in mind.¹ Providing patients that peace of mind can be a tough challenge. However, my practice has seen benefits by following another of the HRS recommendations that is, the utilization of remote patient monitoring to more closely monitor the patient and their implanted device post-operatively. The guidelines state The Heart Rhythm Society recommends that cardiac rhythm management device manufacturers develop and utilize wireless and remote monitoring technologies to: Identify abnormal device behavior as early as possible, and Reduce underreporting of device malfunctions by determining the functional status of an implanted device more frequently and more accurately.¹ My practice has taken advantage of the benefits of home monitoring by using one such system called the LATITUDE^® Patient Management system (Boston Scientific, Natick, Massachusetts). This system enhances surveillance of the patient's cardiac status and implanted device wirelessly from their home, and aligns directly with the HRS guidelines. The system also has optional tools to provide information on a patient's heart failure status in addition to the implanted device diagnostics, and includes a wireless weight scale and blood pressure cuff. These tools provide serial assessment of the patient's ability to perform activities of daily living and evaluation of the patient's weight and fluid volume status. The wireless technology has also had a positive effect on data transmission, because it does not require the patient to remember to send the data. We set the schedule at the clinic, and the in-home Communicator interrogates the device per our schedule while the patient sleeps. When my nurse logs into the secure Web site in the morning, the data is there for our review. Through a feature of the system called LATITUDE Active Monitoring, we also can do a device check as often as on a day-to-day basis to monitor the patient's device. Finally, there are two levels of notifications available: urgent notifications (e.g., battery at EOL), which are called to the office by a LATITUDE Customer Support Representative, and advisory notifications (e.g., change in lead status or patient weight), which are transmitted by secure fax.

Case Example

Approximately one month post-implant of a CONTAK RENEWAL^® 3 RF device, one patient initiated his wireless home Communicator, and we received a fax stating that the patient had a high left ventricular (LV) lead impedance (Figure 1). My nurse, Tracey, pulled the patient's chart and per my direction called the patient and scheduled him for an appointment the very next day to come into the clinic. Upon arrival, the patient's wife stated He has not been feeling as well as he had, but we thought we would wait until the next scheduled office appointment to come into the clinic. A full device interrogation was performed, including threshold testing. The LV lead impedance was confirmed at a level of greater than 2,000 ohms (Figure 2). We proceeded to evaluate the LV lead in four pacing vectors as well as two sensing vectors using a feature called Electronic Repositioning. The programmed pacing vector was from LV ring to RV coil, and sensing from LV tip to LV ring (Figure 3). This configuration was not allowing proper sensing or pacing. After lead testing was complete, which revealed normal pacing in all other vectors, we reconfigured the lead electronically to pace from LV tip to RV coil and sense from LV tip to RV coil (Figure 4). In the final configuration, we achieved a pacing threshold of 0.6 Volts @ 0.5 milliseconds, with an impedance value of 468 ohms. Thus, the Active Monitoring component of the LATITUDE Patient Management system, through earlier insight into a change in the patient's lead status, allowed me to provide a higher level of service in a more timely manner. Under normal operating procedures, this may not have been detected for several weeks. However, with the LATITUDE system, it was rapidly identified and corrected. Therefore, the benefits of a home monitoring system, depending on the alerting features available, the system configuration and notification mechanism, does provide an increased level of surveillance for our patients and may reduce underreporting of device malfunctions by determining the functional status of an implanted device more frequently and more accurately. Clinical situations can be unpredictable, but in highlighting the potential advantages of home monitoring systems such as the LATITUDE system, we can achieve better patient care outcomes.

Editor's Note: This article underwent double-blind peer review by members of EP Lab Digest's editorial board.