Noninvasive Primary Care Screening Identifies Elevated LVEDP in Nearly 40% of High-Risk Patients

A new study reveals that noninvasive LVEDP screening can enhance heart failure detection and improve patient outcomes in primary care settings.

In a multicenter primary care study, nearly 40% of outpatients at increased risk for heart failure (HF) screened positive for elevated left ventricular end-diastolic pressure (LVEDP) using a noninvasive device, with more than two-thirds of those participants reporting significant health status impairment.1

The findings, published in JACC: Advances, suggest that pairing noninvasive LVEDP measurement with patient-reported outcomes may aid in earlier HF detection and intervention.1

According to the Heart Failure Society of America, cases of HF in the US are projected to reach 8.5 million by 2023.2 Thus, “there is a pressing need to improve its diagnosis and treatment,” researchers wrote. Diagnosing HF in primary care, however, can be difficult for several reasons, which “include nonspecific presenting symptoms potentially attributed to age or comorbidities and the limited availability of effective HF screening modalities,” investigators added.1

For the current study, first author Omar Cantu-Martinez, MD, of the University of Missouri-Kansas City's Healthcare Institute for Innovations in Quality, and colleagues assessed the Vivio System (Ventric Health). The noninvasive device incorporates a brachial blood pressure cuff and a synchronized single-lead electrocardiogram to screen for elevated LVEDP, and the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ scores ranged from 0 to 100, with higher scores representing better health and lower scores representing worse health, according to the study.1

These tools were used among 2040 patients aged 65 years or older across 3 primary care practices. The mean age of participants was 74.8 years, 49.8% were women, 64.6% had diabetes, and 34.9% had chronic kidney disease (CKD), researchers noted.1

Results showed a high prevalence of elevated LVEDP (>18 mm Hg). Nearly 40%(38.5%) of screened patients at risk for HF had an elevated LVEDP. Cantu-Martinez and colleagues observed that older patients, women, and those with CKD were significantly more likely to have an elevated LVEDP (P < .01 for all).1

Of the 653 patients with elevated LVEDP who completed the KCCQ-OS, a large proportion reported impaired health status. While 31.4% were asymptomatic (KCCQ-OS score of 100), suggesting pre-HF (AHA/ACC stage B), over two-thirds (69%) reported significant health status impairment. Specifically, 26.5% had a KCCQ-OS score <80, consistent with NYHA functional class II-IV, indicating moderate to severe symptoms and functional limitations.1

"Combining the KCCQ with noninvasive LVEDP assessments can identify patients who may require further HF evaluation. Future studies should assess the impact of these strategies on patients’ subsequent treatment, health status, and clinical events," investigators concluded.1

The Vivio System, a 510k FDA-cleared device, offers a scalable, noninvasive method to screen for elevated LVEDP by using a modified pneumatic brachial blood pressure cuff and a synchronized single-lead electrocardiogram. This accessibility makes it particularly suitable for routine primary care settings, where more complex diagnostic tools like echocardiography are not always readily available.3

“In an average of five minutes and in one visit, PCPs can now accurately diagnose and assess the burden of heart failure in high risk patients with our Vivio System working in concert with the KCCQ,” Thomas Cheek, Chief Medical Officer for Ventric Health, said in a press release.3


References:

  1. Cantu-Martinez O, Girard AA, Jin W, et al. Noninvasive screening for elevated LVEDP and health status in outpatients at risk for heart failure. JACC Adv. Published online July 18, 2025. doi:10.1016/j.jacadv.2025.102002
  2. Bozkurt B, Ahmad T, Alexander KM, et al. Heart failure epidemiology and outcomes statistics: A report of the Heart Failure Society of America. J Card Fail. 2023;29:1412-1451. doi:10.1016/j.cardfail.2023.07.006
  3. New study demonstrates Vivio System from Ventric Health enables early detection of heart failure and effective triage of symptomatic patients in primary care setting. News release. Ventric Health. August 6, 2025. Accessed August 12, 2025. https://www.businesswire.com/news/home/20250806965864/en/New-Study-Demonstrates-Vivio-System-From-Ventric-Health-Enables-Early-Detection-of-Heart-Failure-and-Effective-Triage-of-Symptomatic-Patients-in-Primary-Care-Setting