In this interview, we speak with Dr. Nicholas Skipitaris about a recent clinical trial at Lenox Hill Hospital evaluating the Peerbridge Cor™ electrocardiogram monitor. This study, which evaluated the feasibility of capturing multi-channel diagnostic grade ECG using the Cor monitor in patients with atrial fibrillation (AF) and other cardiovascular issues, demonstrated that the Cor was superior to the current Holter Monitor standard. Dr. Skipitaris is the Director of Cardiac Electrophysiology and the Heart Rhythm Center at Lenox Hill Hospital in New York.
Tell us about your EP program at Lenox Hill Hospital.
We are a full service, dedicated EP program performing all manner of consultative and invasive EP procedures. We have four full-time EP attendings and 6 allied professionals (3 PAs and 3 NPs). We oversee a busy inpatient consultative service as well as a full-time outpatient device and arrhythmia consultation/management clinic. We continue to see growth in our electrophysiology volume, particularly in the area of AF and complex arrhythmia ablation.
Describe the components of the Cor electrocardiogram monitor and how it works. What are some of the unique design and usability features of the Cor?
The Cor is a compact, lightweight, multi-channel wireless electrocardiogram monitor that delivers excellent, analyzable data. It enables remote patient monitoring through multiple on-body wireless electrodes, effortlessly conveying powerful intelligence. The product, which is currently pending its 510(k) clearance by the U.S. Food and Drug Administration (FDA), is a water-resistant wearable with patient-activated event logging function. The system includes a dedicated handheld transmitter for event transmission, and is worn long term for up to seven days. Patients can resume normal daily activities, including showering and light exercise, when wearing the device.
Tell us about the clinical trial that took place at Lenox Hill Hospital evaluating the Cor. For example, what other types of cardiovascular monitors was the Cor compared with in this trial? In how many patients was the Cor evaluated?
During an ambulatory electrocardiogram (ECG) clinical trial at Lenox Hill Hospital, a prototype of the Cor electrocardiogram monitor was evaluated side-by-side to the traditional gold standard ECG technology (Holter) on 14 patients with AF and other arrhythmias. The trial was to measure the Cor’s performance and to ensure efficacy. The trial demonstrated the Cor was superior to the Holter.
Describe your findings. What can you tell us about the analyzable data available from the Cor?
Both Holter and Peerbridge datasets were processed by an FDA-cleared arrhythmia algorithm. The mean analyzable time for Peerbridge (98.44 ± 0.98%) was higher (P=0.0125, unpaired t-test) than that of the Holter (93.44 ± 1.58%). To have a better understanding of the quality of ECG data, 1400 random pairs of time-match ECG strips (10 seconds each; 2800 strips in total) were selected from the Peerbridge and Holter datasets (100 pairs per patient). The ECG strips were randomized and presented to two certified cardiographic technicians (CCT) who were blinded to the device that captured the data. The strips were scored using a 5-point scale based on a set of criteria evaluating the number of interpretable channels and amount of noise in each channel.
Peerbridge data had higher mean scores compared to Holter when interpretable strips were considered [Peerbridge: 4.24 (CCT#1) and 4.20 (CCT#2) versus Holter: 3.09 (CCT#1) and 3.46 (CCT#2)]. The difference in the mean scores becomes larger when all strips were considered, including uninterpretable ones [Peerbridge: 4.11 (CCT#1) and 4.05 (CCT#2) versus Holter: 2.83 (CCT#1) and 3.08 (CCT#2)].
What are some of the ways that use of the Cor improves patient experience?
The Cor electrocardiogram monitor has several advantages over current technology: 1) it minimizes the adhesive footprint on body, 2) it has a gentle adherence and water-resistant seal, and 3) it allows for effective absorption of body moisture so users can stay active while being monitored. The design provides multi-channel information for diagnosis. Being able to wirelessly measure multiple channels of ECG within a limited location on the body is very challenging, but very helpful to physicians.
Did you receive patient feedback regarding their preference of on-body wireless sensors vs traditional Holter monitoring?
During the trial, patients seemed excited about this new technology. Our nurses also really liked the device and believed it helped with patient compliance. We are looking to survey results from treaters and patients later this year, and look forward to sharing their feedback and experiences.
Why is it important for physicians to consider new remote monitoring options in their practice?
Patient care is changing — it is becoming more personalized, with more emphasis placed on compliance and efficacy. With maturing technologies in batteries and telecommunication, remote monitoring will only become more mainstream as it provides a new way to deliver monitoring and care outside the traditional healthcare setting. It is important for healthcare systems to adopt new and innovative technology that can help to improve quality of care and patient compliance. Remote monitoring plays a key role in delivering this promise.
When is FDA approval expected?
The Cor is currently under FDA review, with clearance anticipated in 2017. Peerbridge also has rare pioneering patents that involve multiple on-body electrodes, enabling for more accurate monitoring and seamless communication between individuals and their doctors.
Lenox Hill Hospital is one of Northwell Health’s hospitals. What can you tell us about Northwell Health’s new partnership with Peerbridge Health, Inc.?
Northwell is one of the world’s leading hospital systems in terms of patient care and operational management with 21 hospitals and over 550 outpatient facilities, 4,000,000 patient contacts per year, and over 600,000 ER visits that could potentially visit from Peerbridge wearable sensors. Peerbridge approached Northwell in 2015 regarding a clinical trial to compare the Cor to the current gold standard for heart monitoring, the Holter monitor. After two years of testing, collaboration, and planning, it was clear a partnership was mutually beneficial.
Is there anything else you’d like to add?
Our vision is to help patients partner with their physicians through easily accessible remote monitoring options. Our healthcare organization, Northwell Health, by virtue of its sheer size, is a strong strategic partner for new technologies, and is committed to bringing effective, cutting-edge digital solutions to patients and health professionals to deliver the highest quality patient experience.
Disclosure: Dr. Skipitaris has no conflicts of interest to report regarding the content herein. He is employed by Northwell Health, which has a financial interest in Peerbridge Health.