Diagnostic Yield from Screening and Health Status Burden of Outpatients at Risk for Heart Failure

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Girard , Weiwei Jin , Derek Rinderknecht , Thomas Cheek , John A. Spertus doi: https://doi.org/10.1101/2025.02.25.25322868 Omar Cantu-Martinez a University of Missouri – Kansas City’s Healthcare Institute for Innovations in Quality , Kansas City, MO b Saint Luke’s Mid America Heart Institute , Kansas City, MO MD Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Omar Cantu-Martinez For correspondence: omaar.cantu92{at}gmail.com ocantumartinez{at}saintlukeskc.org Andrew A. Girard a University of Missouri – Kansas City’s Healthcare Institute for Innovations in Quality , Kansas City, MO b Saint Luke’s Mid America Heart Institute , Kansas City, MO MD Find this author on Google Scholar Find this author on PubMed Search for this author on this site Weiwei Jin c Ventric Health , Pasadena, CA d King’s College London , London, UK PhD Find this author on Google Scholar Find this author on PubMed Search for this author on this site Derek Rinderknecht c Ventric Health , Pasadena, CA PhD Find this author on Google Scholar Find this author on PubMed Search for this author on this site Thomas Cheek c Ventric Health , Pasadena, CA MD Find this author on Google Scholar Find this author on PubMed Search for this author on this site John A. Spertus a University of Missouri – Kansas City’s Healthcare Institute for Innovations in Quality , Kansas City, MO b Saint Luke’s Mid America Heart Institute , Kansas City, MO MD, MPH Find this author on Google Scholar Find this author on PubMed Search for this author on this site Abstract Full Text Info/History Metrics Data/Code Preview PDF Abstract Background Heart failure (HF) is frequently underrecognized in primary care due to nonspecific symptoms and limited screening, resulting in many patients presenting with severely compromised health status (symptoms, functional ability, and quality of life) at the time of diagnosis. Objectives To evaluate the diagnostic yield of screening outpatients at risk for HF using a noninvasive assessment of left ventricular end-diastolic pressure (LVEDP) and to describe the health status of patients newly identified with elevated LVEDP. Methods A convenience sample of adults with diabetes mellitus (DM), chronic kidney disease (CKD), or suspected HF were screened at three primary care clinics using the Vivio System to identify patients with LVEDP >18 mmHg (positive screening). Among patients with a positive screening result, their health status was evaluated using the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score. Results Among 2040 screened patients (mean age 74±8 years; 49.8% women; 64.6% with DM; and 34.9% with CKD) 38.5% had an elevated LVEDP. Older patients, women, and those with CKD were more likely to have an elevated LVEDP (p<0.01 for all). Of 653 KCCQ-OS scores collected (mean 85±20), 31.4% had a KCCQ-OS of 100 (asymptomatic), and 26.5% had a KCCQ-OS <80, consistent with NYHA class II-IV. Conclusion Nearly 40% of patients had a positive screening, and over two-thirds reported significant health status impairments. Combining the KCCQ with noninvasive LVEDP assessment can identify patients who may require further HF evaluation. Future studies can assess the impact of these strategies on patients’ subsequent health status and clinical events. INTRODUCTION While the prevalence of Heart failure (HF) continues to rise, 1 diagnosing it in primary care is challenging, particularly among elderly patients with multiple comorbidities 2 , 3 and nonspecific symptoms often attributed to aging or comorbidities 4 . Earlier recognition could support initiating effective therapies to slow progression, reduce mortality, and improve patients’ health status. Previous studies to improve HF diagnosis often rely upon tools not routinely available in primary care 2 , 3 . The Vivio System was recently cleared by the US Food and Drug Administration (FDA) to noninvasively screen for elevated left ventricular end-diastolic pressure (LVEDP) 5 . This report describes the real-world diagnostic yield of the Vivio System in outpatients and examines HF-specific health status at the time of elevated LVEDP detection to identify patients’ symptom burden at the time of diagnosis. METHODS Study Population and Design Three primary care sites implemented the Vivio System (Ventric Health, Pasadena, CA) in routine clinical practice between August 13, 2024, and November 11, 2024. Adults with diabetes mellitus (DM), chronic kidney disease (CKD) stage ≥3, or a clinical suspicion for HF were encouraged to be screened. Patients with known HF or contraindications to the Vivio System (intravascular access, arterio-venous shunt/fistula, mastectomy, or lymph node dissection on the involved arm and any implantable electrical cardiac device) were excluded. Recorded comorbidities included hypertension, DM, CKD, chronic obstructive pulmonary disease, and arrhythmias. The 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ) was recommended for patients identified as having an elevated LVEDP (positive screening) 6 . As this was an analysis of de-identified data obtained from routine clinical care, it was reviewed by the Saint Luke’s Institutional Review Board and deemed to be non-human subjects research for which patient-level consent was not required. Vivio System The 510k FDA-cleared Vivio System uses a modified pneumatic brachial blood pressure cuff that re-inflates to a supra-systolic blood pressure (+35 mmHg from systolic) to collect 40 seconds of brachial pulse waveform that is synchronized with a single-lead electrocardiogram to detect elevated LVEDP (>18 mmHg) via a classification model with 80% sensitivity and 83% specificity 5 . Health Status Assessments The KCCQ is a validated patient-reported measure that quantifies symptoms, function, and quality of life of HF patients. The Overall Summary (OS) score quantifies the full impact of HF on patients’ health status. The 12-item questionnaire (KCCQ-12) was used, which retains the psychometric properties of the original 23-item version 6 . KCCQ-OS scores of 0–44, 45–59, 60– 79, and ≥80 roughly correspond to New York Heart Association (NYHA) functional classes IV, III, II, and I, respectively 7 . Statistical Analysis Continuous variables are reported as mean ± standard deviation and categorical variables as counts (%). T-tests and chi-squared tests were used to compare the characteristics of patients with and without elevated LVEDP. Ages >90 were imputed as 90 to comply with the Health Insurance Portability and Accountability Act. The distribution of KCCQ-OS scores (100, 80–99, 60–79, and <60) were described. Analyses were conducted by Ventric Health, with oversight by all authors, using Python 3.9.13 with pandas 1.4.3 and scipy 1.13.1. RESULTS Population Characteristics and Diagnostic Yield among Screened Patients The overall study cohort included 2040 screened patients. The mean age was 74±8 years; 1015 (49.8%) were women, 1318 (64.6%) had a history of DM, and 711 (34.9%) had CKD. Among screened patients, 785 (38.5%) had an elevated LVEDP. Patients with an elevated LVEDP were older (74±8 versus 73±8, <0.01), more often women (62.2% versus 42.0%, p<0.001), and more likely to have CKD (38.3% versus 32.7%, p=0.01; Figure 1 ). Download figure Open in new tab Figure 1. Central illustration. Cohort characteristics and health status of patients with elevated LVEDP. Abbreviations: KCCQ: Kansas City cardiomyopathy questionnaire, LVEDP: left ventricular end-diastolic pressure. Caption: This figure summarizes the flow diagram of included patients, the health status distribution of patients with elevated left ventricular end-diastolic pressure measured by the Kansas City cardiomyopathy questionnaire, and patient characteristics of those patients with elevated left ventricular end-diastolic pressure (LVEDP) compared to those with normal LVEDP . LVEDP: left ventricular end-diastolic pressure, KCCQ: Kansas City cardiomyopathy questionnaire, SD: standard deviation, BMI: body mass index, COPD: chronic obstructive pulmonary disease. a Patients with age ≥90 were imputed as 90 as the exact age was unavailable due to HIPPA privacy rules. b Only counting hypertension, diabetes mellitus, COPD, chronic kidney disease, and arrhythmia. Health Status of patients with elevated LVEDP at the time of diagnosis Among the 785 patients with an elevated LVEDP, 653 (83.2%) completed the KCCQ-12. Almost a third, 205 (31.4%), had KCCQ-OS scores of 100, suggesting that they were asymptomatic (American Heart Association (AHA) stage B, pre-HF). Of those with AHA stage C HF, 275 (42.1%) had scores of 80-99, 94 (14.4%) had scores of 60-79, and 79 (12.1%) had scores <60, consistent with NYHA Class I, II, and III/IV, respectively. DISCUSSION Despite advances in HF treatment, undiagnosed patients do not receive them. To overcome diagnostic delays in primary care, the FDA-cleared Vivio System was implemented as part of a screening protocol in patients with HF risk factors and no prior diagnosis. In this first-ever report, over one-third of screened patients had an elevated LVEDP, consistent with the diagnostic yield of previous efforts to screen high-risk elderly outpatients with comorbidities 2 , 3 . Over two-thirds were symptomatic, with a quarter likely to be NYHA Class II-IV and at elevated risk for HF hospitalization and death 8 . These data highlight a novel strategy to improve HF diagnoses in primary care. However, additional studies are needed to define the proportion confirmed to have HF and the impact of diagnosis on subsequent care and outcomes. This study supports and extends the extant literature on screening high-risk patients for HF 2 , 3 . Moreover, a higher proportion of women had elevated LVEDP, reinforcing previous research suggesting delayed HF diagnoses, lower treatment rates, and poorer health status compared with men 9 , 10 . Future studies should also assess whether systematic HF screening can reduce sex-, race-, and socioeconomic-associated disparities in HF care and outcomes. Study Limitations This study should be interpreted in the context of several potential limitations. It used a convenience sample from three primary care practices, limiting generalizability. The completeness of screening was not assessed and could inform future implementation strategies. Finally, HF was not independently confirmed despite elevated LVEDP and HF symptoms (KCCQ-OS), nor could these cross-sectional data assess treatment changes or outcomes after detecting elevated LVEDP. CONCLUSION Considering the growing prevalence of HF and evolving treatments, there is a need for earlier diagnosis in primary care. In this initial experience with the Vivio System, nearly 40% of patients had a positive screening result, with over two-thirds having significant health status impairment. Combining the KCCQ with noninvasive LVEDP assessment could help identify patients who may benefit from further HF evaluation and treatment, potentially improving their health status and reducing clinical events. Data Availability All data produced in the present study are available upon reasonable request to the authors Acknowledgments None. Footnotes Funding: This study was funded by Ventric Health. Disclosures: Dr. Cantu Martinez receives funding from NHLBI award number T32HL110837-13 Dr. Girard receives funding from NHLBI award number T32HL110837. Dr. Jin discloses providing consultative services to and incentive compensation with Ventric Health. Dr. Rinderknecht discloses providing consultative services to and incentive compensation with Ventric Health. Dr. Cheek discloses providing consultative services to and incentive compensation with Ventric Health. Dr. Spertus discloses providing consultative services on patient-reported outcomes and evidence evaluation to Alnylam, AstraZeneca, Bayer, Janssen, Bristol Meyers Squibb, Terumo, Cytokinetics, BridgeBio, Ventric Health, and Imbria. He holds research grants from the National Institutes of Health, the Patient-Centered Outcomes Research Institute, the American College of Cardiology Foundation, Lexicon, Imbria, and Janssen. He owns the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire and serves on the Board of Directors for Blue Cross Blue Shield of Kansas City. Abbreviations HF heart failure FDA Food and Drug Administration LVEDP left ventricular end-diastolic pressure DM diabetes mellitus CKD chronic kidney disease KCCQ Kansas City Cardiomyopathy Questionnaire OS overall summary NYHA New York Heart Association AHA American Heart Association References 1. ↵ Bozkurt B , Ahmad T , Alexander KM , et al. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America . Journal of Cardiac Failure . 2023 ; 29 ( 10 ): 1412 – 1451 . doi: 10.1016/j.cardfail.2023.07.006 OpenUrl CrossRef PubMed 2. ↵ Van Riet EES , Hoes AW , Limburg A , Landman MAJ , Van Der Hoeven H , Rutten FH . Prevalence of unrecognized heart failure in older persons with shortness of breath on exertion . European J of Heart Fail . 2014 ; 16 ( 7 ): 772 – 777 . doi: 10.1002/ejhf.110 OpenUrl CrossRef PubMed 3. ↵ Hancock HC , Close H , Mason JM , et al. High prevalence of undetected heart failure in long-term care residents: findings from the Heart Failure in Care Homes (HFinCH) study . Eur J Heart Fail . 2013 ; 15 ( 2 ): 158 – 165 . doi: 10.1093/eurjhf/hfs165 OpenUrl CrossRef PubMed 4. ↵ Abovich A , Matasic DS , Cardoso R , et al. The AHA/ACC/HFSA 2022 Heart Failure Guidelines: Changing the Focus to Heart Failure Prevention . Am J Prev Cardiol . 2023 ; 15 : 100527 . doi: 10.1016/j.ajpc.2023.100527 OpenUrl CrossRef PubMed 5. ↵ Shavelle D , Rinderknecht D , Jin W , et al. Abstract 16544: A Multicenter Validation of a Noninvasive Brachial Cuff-ECG System for Estimation of Elevated Left Ventricular End Diastolic Pressure . Circulation . 2023 ; 148 ( Suppl_1 ): A16544 - A16544 . doi: 10.1161/circ.148.suppl_1.16544 OpenUrl CrossRef 6. ↵ Spertus JA , Jones PG . Development and Validation of a Short Version of the Kansas City Cardiomyopathy Questionnaire . Circ Cardiovasc Qual Outcomes . 2015 ; 8 ( 5 ): 469 – 476 . doi: 10.1161/CIRCOUTCOMES.115.001958 OpenUrl Abstract / FREE Full Text 7. ↵ Tran AT , Chan PS , Jones PG , Spertus JA . Comparison of Patient Self-reported Health Status With Clinician-Assigned New York Heart Association Classification . JAMA Netw Open . 2020 ; 3 ( 8 ): e2014319 . doi: 10.1001/jamanetworkopen.2020.14319 OpenUrl CrossRef 8. ↵ Heidenreich PA , Spertus JA , Jones PG , et al. Health Status Identifies Heart Failure Outpatients at Risk for Hospitalization or Death . Journal of the American College of Cardiology . 2006 ; 47 ( 4 ): 752 – 756 . doi: 10.1016/j.jacc.2005.11.021 OpenUrl FREE Full Text 9. ↵ Khariton Y , Nassif ME , Thomas L , et al. Health Status Disparities by Sex, Race/Ethnicity, and Socioeconomic Status in Outpatients With Heart Failure . JACC Heart Fail . 2018 ; 6 ( 6 ): 465 – 473 . doi: 10.1016/j.jchf.2018.02.002 OpenUrl Abstract / FREE Full Text 10. ↵ Dewan P , Rørth R , Jhund PS , et al. Differential Impact of Heart Failure With Reduced Ejection Fraction on Men and Women . J Am Coll Cardiol . 2019 ; 73 ( 1 ): 29 – 40 . doi: 10.1016/j.jacc.2018.09.081 OpenUrl FREE Full Text View the discussion thread. Back to top Previous Next Posted February 27, 2025. Download PDF Data/Code Email Thank you for your interest in spreading the word about medRxiv. NOTE: Your email address is requested solely to identify you as the sender of this article. Your Email * Your Name * Send To * Enter multiple addresses on separate lines or separate them with commas. 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