: A Prospective Study Investigating the Use of the Eko CORE and Eko DUO Electronic Stethoscopes in Pediatric Patients.
: A Prospective Study Investigating the Use of the Eko CORE and Eko DUO Electronic Stethoscopes in Pediatric Patients.
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.
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.
Inclusion Criteria:

 1. Patients aged 0 to 17 years, who are able to read and speak English, and/or with
 parents or legal guardians who are able to read and speak English

 2. New patients referred to the Nemours Cardiac Center for a heart murmur, chest pain,
 syncope, or arrhythmia. This could include children with suspected murmurs (but
 ultimately found to have no murmur by a cardiologist), innocent murmurs, and
 pathologic murmurs.

 3. Patients with previously diagnosed heart condition, if they have not had any
 corrective surgeries and had a detectable murmur at their last clinic visit (for
 pathological and innocent murmurs) or had no detectable murmur at their last clinic
 visit (for no murmurs).

 Exclusion Criteria:

 1. Patients aged 18 and over

 2. Patients and/or parents who are unable to read or speak English

 3. Patients who have had corrective heart surgery for a heart defect

 4. Auscultation cannot be performed properly at all locations

 5. Patients not wishing to participate in study recordings