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Inovise Medical, Inc.
Phone: (503) 431-3800

 

FAQs

Q: How do diseases like heart failure cause the heart to produce abnormal sound?
Q: What is the clinical relevance of the third heart sound in heart failure?
Q: Why is heart failure difficult to diagnose?
Q: How can AUDICOR® help emergency physicians diagnose heart failure?
Q: How has this technology been validated? 
Q: Why use AUDICOR® when physicians can perform auscultation with amplified stethoscopes to detect the third heart sound?
Q: How is AUDICOR® diagnostic utility different from phonocardiography?
Q: Does AUDICOR® replace biomarkers?
Q: Are there peer-reviewed publications on this technology?

 

Q: How do diseases like heart failure cause the heart to produce abnormal sound?
The heart produces both normal ("lub-dub") and abnormal sounds as blood moves throughout the heart. Cardiac diseases including heart failure cause the heart muscle to stiffen, making it difficult for the heart to properly contract and relax as it pumps blood. The abnormal third heart sound is produced when fast moving blood is suddenly stopped because the stiffened heart wall is unable to stretch.
Click here to visit Learn About Heart Sounds page to learn more.

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Q: What is the clinical relevance of the third heart sound in heart failure?
The presence of a third heart sound has high prognostic and diagnostic value in adults over 40 years old who exhibit signs and symptoms associated with heart failure. A landmark study published in the New England Journal of Medicine indicated the presence of a third heart sound (S3) is 99% specific for heart failure and leads to increased morbidity and mortality. The absence of a third heart sound, however, is not sufficient to exclude ventricular dysfunction, so further diagnostic investigations should be considered.
Click here to visit Clinical Trials and Events pages to learn more.

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Q: Why is heart failure difficult to diagnose?
Heart failure patients frequently represent diagnostic challenges to physicians because shortness of breath, a key symptom of heart failure, may be a non-specific finding in many elderly or obese patients. Clinicians need to differentiate patients with heart failure from other diseases, such as pulmonary disease. A patient's past history is helpful, but only 81% accurate; chest x-rays are also helpful, but only 75% accurate. Lab tests are good tools; however, studies indicate results are negatively deflated in obese patients, inflated in patients with chronic renal function and only have clinical utility at specific levels. AUDICOR® identifies the third heart sound, which studies confirm is a highly specific marker for ventricular dysfunction.

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Q: How can AUDICOR® help emergency physicians diagnose heart failure?
Eighty percent of heart failure admissions are diagnosed in the emergency departments, where the misdiagnosis rate for primary heart failure is between 10-20%.  In one study, AUDICOR® helped correct approximately 34% of the missed diagnosed patients. These missed patients had 3x the incidence of pulmonary disease, less history of heart failure, and lab BNP results under the 500 pg/ml cut-off, and longer lengths of hospital stays. AUDICOR® is helping reduce the missed diagnosis rate and shorten lengths of hospital stays by providing actionable diagnostic data at the patient's bedside.

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Q:  How has this technology been validated? 
The propriety electrocardiography and sound interpretation algorithms were created in collaboration with top experts and validated against state-of-the-art cardiovascular diagnostic equipment including cardiac catheterization, transthoracic echocardiography, physician auscultation and phonocardiography tracings.

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Q:  Why use AUDICOR® when physicians can perform auscultation with amplified stethoscopes to detect the third heart sound?
Auscultation is difficult. Overcrowded emergency departments and noisy clinical environments negatively impact clinicians' abilities to accurately detect these low-frequency sounds. Since amplified stethoscopes just make all the heart's sounds louder, in an already noisy clinical environment, these offer little diagnostic value to identify specific sounds including the third and fourth heart sounds. Studies indicate one-out-of-five third heart sounds are missed on auscultation. AUDICOR® proved to be more accurate in detecting S3s compared to attending physicians, fellows, residents, and interns. The experience and skill of the auscultator plus the patient's physical characteristics can greatly impact the practioner's performance. AUDICOR® delivers consistent, accurate results.

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Q: How is the diagnostic utility of AUDICOR® different from phonocardiography?
The diagnostic utility of AUDICOR® reaches well beyond the limits of a "sound only" recording obtained from time-consuming phonocardiography sessions. AUDICOR® performs beat-by-beat signal processing correlating electrical and sound activity based on multiple parameters including signal timing, frequency, and amplitude throughout the entire cardiac cycle. This technological analysis produces more accurate detection, interpretation and documentation of the heart's status and mechanical function in an easy-to-use bedside test.

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Q:  Does AUDICOR® replace biomarkers?
AUDICOR® does not replace biomarkers as a diagnostic tool for heart failure. Biomarkers have relatively high sensitivity yet low specificity; in contrast, AUDICOR® has relatively low sensitivity and very high specificity. This means the combination of both tests helps improve diagnostic accuracy in the emergency department, particularly when a biomarker BNP is within the intermediate range.

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Q:  Are there peer-reviewed publications on this technology? 
Yes. Over 40 clinical papers have been published in leading scientific medical journals authored by experts in heart failure care including the Journal of the American Medical Association, Congestive Heart Failure, American Journal of Emergency Medicine, and the Archives of Internal Medicine (in press).  Through these peer-reviewed publications, physicians are learning the clinical utility of AUDICOR® technology and helping them improve how they clinically manage heart failure patients.
Click here to visit Publications page to learn more.

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