If the measurement of right ventricular volume of the heart is the "Holy Grail" of cardiology as VentrPoint Diagnostics (Seattle) believes it is then the company may just have the diagnostic tool that cardiologists have been searching for.
According to the company, the need for assessing right ventricular volume is well recognized by cardiologists, but often is unavailable to them because it is a time-consuming process that requires expensive equipment.
"Most people are not measuring the right ventricle because it's too costly to measure," Joe Ashley, CEO of VentriPoint, told Medical Device Daily. "The only acceptable method right now is MRI and manually tracing the borders, and that takes a lot of time, hours... so it ends up not being done."
Two-dimensional echocardiography is a less expensive and more accessible method; however, the results of this type of measurement are only about 50% to 65% accurate, according to VentriPoint.
In clinical practice, cardiologists "eyeball" echo images to form a visual impression of the size and function of the right ventricle, the company said, with clinicians falling back on estimating the status of heart-disease patients' right ventricles by repeating the 2-D echo studies multiple times or by ordering a more invasive procedure.
VentriPoint's diagnostic system is designed for use with traditional echocardiography or MRI. The technology uses a software-based analysis tool known as Knowledge-Based Reconstruction (KBR), which provides the computational engine for generating a 3-D surface reconstruction of the right ventricle and accompanying volume measurement, the company said.
"The method basically is accurate, it's simple and it's fast; that's the key attributes of it and that's what the cardiologist needs today," Ashley said.
VentriPoint's diagnostic system is based on technology it received through a license from the University of Washington (UW; Seattle). The system, together with its associated online service, is being developed for a variety of heart-related disease states, including congenital heart disease.
Right ventricular measurement is critical for diagnosing cardiovascular disease, he said, adding that the market for all right ventricular measurement is estimated at half a billion dollars.
"There are 80 million people with cardiovascular disease 80 million people. It's an unbelievable number, but that's what is published and that's what we're addressing, and the best way to do that is to do the right ventricle," Ashley said. "Everyone is asking for it."
VentriPoint recently reported that in a study of 20 patients with repaired tetralogy of fallot (TOF), the accuracy of the volume and ejection fraction of the right ventricle obtained with KBR was equal to or greater than the published accuracy of other methods of measurement. (TOF is the most common heart defect resulting from deoxygenation in the blood vessels and the most common cause of "blue baby" syndrome.)
TOF is a disease that impacts the heart in multiple ways, the company noted, such as creating a hole between the ventricles and developing levels of obstruction from the right ventricle to the lungs known as pulmonary stenosis.
Using the VentriPoint diagnostic system, KBR was applied as anatomical points identified on 2-D images of the right ventricle of TOF-diseased hearts were referenced with the KBR database comprised of 110 patients, including 54 with TOF.
UW's Florence Sheehan, MD, led the study. It is the first of four KBR databases that VentriPoint is developing and plans to deploy when its diagnostic system becomes commercially available.
The company said the data showed that KBR enables "accurate" 3-D reconstruction of right ventricular volume and function in patients with TOF in "significantly less time and for a lower cost than currently applied methods."
According to VentriPoint, the 3-D models also provided an understanding of changes to the shape of the right ventricle that doctors can use to analyze how the heart adapts to hemodynamic overload.
"Applying [KBR], our VentriPoint diagnostic system completes critical ventricular measurements in significantly less time and lower cost than traditional methods to enable the cardiologists to better diagnose, monitor and track the efficacy of treatments," Ashley said.
He added: "This validation of the [TOF KBR] database confirms the effectiveness of our collaborations and processes as we expand and accelerate the development of additional databases specific to other forms of congenital heart disease and proceed with our plans to initiate sales of the VentriPoint diagnostic system in early 2009."