Adhesive-based wearable cardioverter defibrillator beats performance goals
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Key takeaways:
- A novel adhesive-based wearable cardioverter defibrillator exceeded its safety and efficacy performance goals.
- The device is water-resistant and can be worn during activities of daily living.
PHILADELPHIA — A novel adhesive-based wearable cardioverter defibrillator was associated with high rates of patient compliance and low rates of adverse events, researchers reported at the American Heart Association Scientific Sessions.
For the JEWEL IDE study, researchers evaluated the safety and performance of the adhesive-based wearable cardioverter defibrillator (Jewel Patch Wearable Cardioverter Defibrillator, Element Science) with a machine learning algorithm in 305 patients at risk for sudden cardiac death indicated for a wearable cardioverter defibrillator (mean age, 58 years; 30% women). Inclusion criteria were left ventricular ejection fraction of 40% or less with diagnosis of acute MI, myocarditis, ischemic cardiomyopathy or nonischemic cardiomyopathy; or contraindication for, removal of or refusal of an implantable cardioverter defibrillator; or delay of ICD implantation due to COVID-19 or other intervening issues.
“Unlike current garment-based devices that you wear, the Jewel patch-wearable cardioverter defibrillator (P-WCD) is a low-profile, lightweight system that adheres to a patient’s torso, enabling near-continuous protection,” John D. Hummel, MD, FACC, FHRS, professor of internal medicine, Corrine Frick Chair in Cardiac Electrophysiology and director of cardiac electrophysiology research at Richard M. Ross Heart Hospital and The Ohio State University Wexner Medical Center, told Healio. “This device is water-resistant and can be worn during virtually all typical activities of daily living including showering. The device uses a novel machine learning algorithm that accurately detects abnormal heart rhythms, resulting in a low false alarm rate and timely defibrillation when needed.”
Among the cohort, 290 patients had analyzable device data and were included in the analysis of the primary efficacy endpoint, inappropriate shock rate. All patients were included in the analysis of the primary safety endpoint, clinically significant cutaneous adverse device effects rate. The device is not yet approved for commercial use in the United States.
The device met its primary efficacy endpoint, with a rate of 0.36 inappropriate shocks per 100 patient-months (upper one-sided 98% CI, 1.58), beating the performance goal of 2 per 100 patient-months, Hummel said during a presentation.
The device also met its primary safety endpoint, with a clinically significant cutaneous adverse device effects rate of 2.3% (upper one-sided 98% CI, 4.5), beating the performance goal of 15%, he said.
There were no device-related deaths or serious adverse events, he said.
The median compliance rate was 97.8% (interquartile range, 86.1-99.7), with a mean protected time of 21.5 hours per day and a median protected time of 23.5 hours per day, beating the predefined average protected time threshold of 14.1 hours per day, Hummel said during the presentation, noting that 91% of patients wore the defibrillator for longer than the 14.1 hours per day threshold.
There were eight adjudicated successful conversions, beating the prespecified performance goal of one, he said.
“This device is an entirely different approach to protecting patients from the risk of life-threatening heart rhythms,” Hummel told Healio. “Instead of having to teach and train patients how to manage the wearable defibrillator, this device aligns with the patient’s lifestyle and asks very little of the patient. With the advances made in medical therapy for heart failure, some patients are getting better and only have temporary risk for sudden cardiac arrest. Now that we have a defibrillator that patients can wear for extended periods, we can study whether the Jewel P-WCD can protect high-risk patients while their heart failure improves, possibly allowing them to delay or defer their need for an implantable defibrillator.”
In a discussant presentation, Gregory M. Marcus, MD, MAS, associate chief of cardiology for research and endowed professor of atrial fibrillation research at the University of California, San Francisco, said: “This device provides a solution, potentially, to those of us in cardiac EP who feel stuck. We are confronted by a patient [who] we are worried might die, but for various potential reasons, we either don’t feel comfortable putting in an implantable defibrillator or we suspect that maybe the underlying process will reverse. ... We do have these wearable vests, but they tend to be somewhat unwieldy. ... A key statistic in the current trial showed that the great majority of participants were able to wear the Jewel device pretty much all the time, at a rate that was substantially more than what has previously been observed with the nonadhesive-based wearable defibrillators. ... Some patients simply can’t tolerate [adhesive-based devices] due to hypersensitivity, and indeed this study found about 12% of patients had some sort of skin reaction. Thankfully, there are the other wearable types of devices available for those patients. ... This is a valuable addition [and] it will be very interesting to see, given that it appears to be an easy application for patients, how this may broaden the use [of wearable cardioverter defibrillators]. I would certainly encourage a post-approval registry, as there will be a lot to learn about the indications for this device.”
Perspective
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Meagan M. Wasfy, MD, MPH, FACC
This study evaluated the safety and efficacy of a new patch-based wearable cardioverter defibrillator (WCD). Other WCD systems are in general less palatable to patients, as these systems are larger and can’t be worn while showering or easily worn while exercising. The investigators found that amongst 305 individuals eligible for the WCD device, on the basis of elevated SCD risk but ineligibility for or refusal of ICD, both the prespecified safety and efficacy endpoints for the study were reached. Specifically, the rate of inappropriate shocks was low at 0.36 per 100 patient-months, and appropriate shocks successfully converted eight ventricular tachycardia/ventricular fibrillation (VT/VF) episodes. Device wear time was impressive at a median of 23 hours/day. Finally there was also a low prevalence of clinically significant skin-related complications in only 2.3% of participants. These all compare very favorably to other WCD systems.
This patch-based WCD system intuitively, by being lower-profile and water-resistant, fits into patients’ lives and we see in the study results that patients wear the device consistently. These devices have to be worn consistently to optimally prevent events because even in higher-risk populations like those studied, VT/VF events will be rare and difficult to predict. There don’t appear to be any tradeoffs for the lower-profile design; the device has a low rate of inappropriate therapies and was able to successfully treat the VT/VF events that did occur over the study period.
At the bedside, particularly the inpatient setting, we are most often counselling about the pros and cons of WCDs in patients who have just received a new cardiovascular diagnosis and are faced with a myriad of lifestyle changes upon discharge home. To have a WCD system that is more comfortable and easy to manage in that transition home stands to increase patient acceptability of these systems.
As any intervention becomes easier to employ, it becomes critical to assure we are utilizing it in the right patient population, and further work should continue to refine who benefits from WCD systems.
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Hummel JD, et al. FS.06. Exercise is life (and death) - Approaches in athletes, arrhythmias, and heart failure. Presented at: American Heart Association Scientific Sessions; Nov. 11-13, 2023; Philadelphia.
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