About

The HoCM with Dynamic LVOT Obstruction algorithm (OA007) identifies and characterizes the medical management of patients diagnosed with hypertrophic obstructive cardiomyopathy, peak left ventricular outflow gradient of 50 mmHg or greater (at rest, after Valsalva maneuver or after exercise) and left ventricular ejection fraction of 55% or greater.

The algorithm is applied to the following input parameters extracted by members of the Ensho Health Clinical Operations Team as a service using the Apollo aEDC system:

• Prior clinical diagnosis of hypertrophic cardiomyopathy

• Evidence of obstructive disease

• Peak left ventricular outflow gradient measured on the most recent echocardiogram performed in the previous 12 months

• Left ventricular ejection fraction measured on the most recent echocardiogram performed in the previous 12 months (by Simpson's biplane or visual estimation)

• The most recent New York Heart Association Class recorded in the previous 12 months (status is not inferred based on symptoms)

• Shortness of breath, chest pain, palpitations or fatigue reported in the previous 12 months

• Current medical management with beta blockers, calcium channel blockers, diuretics, anti-arrhythmics, anticoagulants or cardiac myosin inhibitors

Ordering

Board certified cardiologists and internists can request that their electronic medical record databases be analyzed with the HoCM with Dynamic LVOT Obstruction algorithm once or on a recurrent basis.

Orders can be placed:

• Through Compass ↗︎

• From within an EMR system that supports direct ordering

• By email or efax

All requests placed between the hours of 8:00am and 8:00pm Monday through Friday Eastern Time are reviewed by a member of the Clinical Operations team within 48 hours. Requests for Whole Database screens are fulfilled within five business days for specialists with an active integration.

Reports

Comprehensive reports are prepared and distributed for each patient with:

• a summary of the results;

• the source data that was used in the analysis; and

• information about the algorithm and its input parameters.

Reports are made available online in HTML and PDF formats through Compass, or distributed by electronic fax or email.

Pricing

Intended Use

The HoCM with Dynamic LVOT Obstruction algorithm is intended for use as a decision support tool to aid qualified healthcare professionals in identifying individuals with HoCM in which changes to their medical management may be clinically appropriate. It is not diagnostic and does not replace the independent judgment of the treating physician. Any medical diagnosis and all decisions related to patient care and treatment choices should be based on the independent judgment of the treating physician and should take into account all information related to the patient, including without limitation, the patient and family history, direct physical examination and diagnostic tests.

Regulatory

The HoCM with Dynamic LVOT Obstruction algorithm is a process for converting input parameters to a likelihood estimate. It is deployed at the Toronto, Canada data lab of Ensho Health through the HoCM with Dynamic LVOT Obstruction ("CDL Module"). The CDL Module is deployed exclusively at the Toronto Data Lab of Ensho Health where it is applied to the data of requesting physicians as a service. The CDL Module was developed to the ISO 13485:2016 standard for medical devices in compliance with Ensho’s Quality Management System.

Canada

The CDL Module is classified as clinical decision support software in Canada.