: A Prospective Study Investigating the Use of the Eko CORE and Eko DUO Electronic Stethoscopes in Pediatric Patients.
Condition: Heart Murmurs
MeSH terms: Heart Murmurs
Study type: Observational

Summary: 
      The Eko CORE and DUO stethoscopes are FDA approved electronic devices which have the capacity
      to record heart sounds. This study will utilize these devices to see if they can
      differentiate between pathologic and innocent heart murmurs in children.
    

Detailed description: 
      It is estimated that 50-70% of all children will have had a detectable heart murmur at some
      point in early life, but fortunately, the vast majority of these murmurs are benign
      asymptomatic "innocent" murmurs and not indicative of heart disease. However, there is
      concern about the ability of front-line pediatricians and family providers to distinguish
      between an innocent and pathological murmur. Thus, it is of no surprise that the largest
      number of new patient referrals to pediatric cardiologists is due to the detection of a
      murmur. Of those referred, 20-30% are typically diagnosed with trivial to significant heart
      disease based on auscultation and confirmatory echocardiography follow-up when necessary.

      Having a child referred for a heart murmur evaluation causes significant anxiety for parents,
      even if the murmur is suggested to be innocent by the pediatrician and in some cases,
      clinical diagnostic testing is done unnecessarily. Interestingly, studies have shown that
      performing diagnostic electrocardiography, chest radiography, or echocardiography prior to
      clinical assessment by pediatric cardiologists did not offer additional assistance in
      differentiating murmurs. Unnecessary echocardiograms or other diagnostic tests for innocent
      murmur evaluation add unnecessary cost to the healthcare system.

      Unfortunately, the unnecessary use of echocardiography for the diagnosis of innocent murmurs
      is also high among pediatric cardiologists. Thus, with the rising cost of health care, it is
      essential that we identify and target areas of practice that will enable us to increase
      efficiency and reduce unnecessary costs.

      Specific characteristics of the sound of the murmur may help differentiate innocent from
      other murmurs, so improving auscultation skills and diagnosis based on auscultation and
      electrocardiography is very important in accurate diagnosis and reducing cost associated with
      the diagnosis of innocent and pathologic heart murmurs in children. The use of new
      technologies to improve auscultation and auscultation-based diagnosis could lead to improved
      diagnoses with decreased cost. New systems that used telemedicine techniques to transfer
      phonocardiogram (PCG) recordings to a cloud server have shown benefit in differentiating
      innocent versus pathologic murmurs, but cannot be used large scale, and are based on
      cardiology involvement.

      The FDA-cleared Eko CORE device (Eko, Berkeley, California, USA) is a digital stethoscope
      that allows recording of the audio to produce a PCG. The FDA-cleared Eko DUO device is a
      digital stethoscope that allows recording of the audio to produce a PCG combined with a
      single lead electrocardiograph. The CORE and DUO both feature sound amplification and audio
      transmission to a smart phone, laptop or tablet via Bluetooth® that allows the user to open
      and playback sounds using an iOS, Android, or Microsoft Windows compatible application. The
      App provides the ability to save sounds within select Electronic Health Record (EHR) systems,
      share patient recordings with other practitioners, and annotate notes on recorded audio. Eko
      is intended for use on pediatric and adult patients. These features uniquely situate this
      device to accumulate large sets of auscultatory data on patients both with and without
      congenital heart disease (CHD).

      In this study, we seek to use auscultatory audio recordings and phonocardiograms collected
      from pediatric patients using Eko CORE and DUO digital stethoscopes to develop a clinically
      significant algorithm that differentiates innocent from pathologic heart murmurs. As the Eko
      CORE and DUO devices are similar to a traditional stethoscope, an iconic tool widely accepted
      by patients and providers alike, its use to drive an automated detection algorithm is both
      feasible and attractive as a substitute for traditional auscultation. Furthermore, by
      providing an algorithmic analysis that can supplement clinical acumen, we hypothesize that we
      will improve overall diagnostic accuracy and show a decreased need for referral
      echocardiograms for innocent murmurs.
    

Intervention name(s): Use of EKO Core and EKO Duo electronic stethoscopes
Intervention type(s): Device
Intervention description(s): Listen to heart murmurs
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children attending the Nemours Cardiac Center to include patients referred for a heart
        murmur who are aged from 0 to 17 years, patients with previously diagnosed heart
        conditions, patent ductus arteriosus (PDA) or valvular stenosis, who have not undergone
        corrective surgery and had a detectable murmur at their last visit. Patients who have an
        innocent or no detectable heart murmur will be from new referrals for a heart murmur, chest
        pain, syncope, or arrhythmia, or are currently outpatients in the cardiac clinic who had an
        innocent murmur or no detectable heart murmur in their previous (and current) clinic
        appointments, and meet the inclusion/exclusion criteria for the study.