Heart Failure Prevention Protocol
How BridgeCare LA deploys SYNC-PREVENT™ to fold interoperability-sourced clinical data, advanced biomarker surveillance, Vivio LVEDP screening, and at-home lung-impedance monitoring into one protocol — one that runs from population-level risk identification through early detection to continuous monitoring at home, finding heart failure before symptoms appear and stepping in before the hospitalization.
The heart failure detection gap — and how the protocol closes it
Heart failure is at once the most expensive and the most preventable catastrophic event in chronic disease. Expensive, because it drives repeated hospitalizations, post-acute care, and a steadily mounting medication burden. Preventable, because the bodily changes that lead up to a decompensation — unfolding over days, weeks, or months — can now be measured without a single invasive test, both in the primary-care office and in the patient's own living room.
Two recent publications give this protocol direct, peer-reviewed backing for its core tools — one in JACC Advances in August 2025, the other presented at the ACC.26 Scientific Session in March 2026. Read together, they show that noninvasive LVEDP screening finds elevated filling pressure in roughly 40% of high-risk primary care patients, and that lung-impedance-guided outpatient management cut heart failure hospitalizations by 81% and all-cause mortality by 60% against standard care.
By the time heart failure reaches the emergency department, it has already been underway for years — building quietly in the cardiorenal-metabolic milieu long before the first hospitalization. Any protocol serious about catching it has to start in that same place.
Starting where conventional care usually doesn't
The 2022 AHA/ACC/HFSA Heart Failure Guideline reworked how heart failure is staged — trading a model that only started at symptomatic disease for one that puts explicit names to the pre-symptomatic phases that come before it. That shift wasn't cosmetic. The guideline holds that Stage A and Stage B patients should be the primary targets of preventive intervention, not merely of observation. Standard medicine has yet to answer that at scale. SYNC-PREVENT™ is the infrastructure that lets BridgeCare LA answer it in Louisiana.
Risk factors present — hypertension, diabetes, obesity, metabolic syndrome, CKD, family history. No structural heart disease. No symptoms.
The protocol deploys here: biomarker and device surveillance from age 50, identifying developing risk before structural disease sets in.
Structural heart disease, elevated filling pressures, or biomarker evidence (elevated NT-proBNP). No current or prior HF symptoms.
The protocol deploys here: Vivio LVEDP screening identifies Stage B patients. 31.4% of Vivio-positive patients in Cantu-Martinez et al. were asymptomatic Stage B.
Structural heart disease with current or prior HF symptoms. NYHA Class I–IV. The primary target of pharmacologic and device therapy.
Standard care begins here. At-home lung-impedance monitoring is deployed for confirmed HFpEF — an 81% reduction in hospitalization was demonstrated in the IMPEDANCE-HFPEF trial.
Severe refractory symptoms despite maximal therapy. High mortality. Limited options: transplant or palliative care consideration.
Prevention has failed. High-cost interventions, frequent hospitalization, poor prognosis. Stages A and B were the only modifiable window.
Source: Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. Circulation. 2022;145(18):e895–e1032. The 2022 revision introduced Stage A (“at risk”) and Stage B (“pre-HF”) as explicit categories, replacing the older classification that began only at symptomatic disease.
Why monitoring begins at age 50
The window to prevent heart failure opens long before symptoms appear — and closes around the time standard care typically starts. The Stage A physiology (insulin resistance, hypertension, metabolic syndrome, CKD) begins developing in the fifth decade of life. By 65, when Medicare monitoring infrastructure is first widely applied, most patients have already accumulated years of Stage A or Stage B pathology.
- Age 40–50
Subclinical cardiometabolic changes begin — insulin resistance, lipid dysregulation, early hypertension. No monitoring. No detection.
- Age 50–65
AHA Stage A risk factors are active and Stage B structural and biomarker changes are developing. The monitoring window opens here: Vivio LVEDP screening identifies Stage B patients (a 38.5% positive rate in this population), biomarker surveillance catches early NT-proBNP elevation, and at-home monitoring is deployed for confirmed HFpEF.
- Age 65+
Medicare enrollment. 70–80% of new enrollees already carry 2+ chronic conditions (CMS Chronic Conditions Report). Standard monitoring begins here — typically at Stage C. For most patients, the Stage A and B window has already closed.
- Age 70+
First hospitalization. A DRG 291/292 claim is filed, the ACO benchmark breaks, and the Medicare loss ratio climbs. The cost of the Stage A/B detection gap finally arrives — 10 to 20 years after the window to prevent it closed.
The clinical evidence base
The protocol rests on two independent bodies of peer-reviewed evidence published in 2025 and 2026. Each one puts the specific tools the protocol deploys to the test and reports measured results that underwrite its clinical and financial case.
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. 2025;4:102002.
JACC Advances, Vol. 4, No. 8, August 2025. Open access (CC BY). Conducted at 3 primary care clinics, funded in part by NHLBI.
- Study design
- A cross-sectional convenience sample of 2,040 adults screened at three primary care clinics between August and November 2024 — patients with diabetes, CKD Stage 3+, or a physician's clinical suspicion of HF. Patients with a known HF diagnosis were excluded. The Vivio System screened for estimated LVEDP greater than 18 mm Hg.
- Key finding 1
- Among 2,040 screened patients (mean age 74 ± 8; 49.8% women; 64.6% with diabetes; 34.9% with CKD), 38.5% had an estimated elevated LVEDP. Older patients, women, and those with CKD were significantly more likely to screen positive (P < 0.01 for all).
- Key finding 2
- Of 653 patients with elevated LVEDP who completed the KCCQ-12, 31.4% were asymptomatic (AHA/ACC Stage B, pre-HF), while 26.5% had KCCQ-OS scores below 80, consistent with NYHA Class II–IV. More than two-thirds of patients with elevated LVEDP already had meaningful health-status impairment at first detection.
- Device specifications
- The Vivio System is 510(k) FDA-cleared. It uses a modified pneumatic brachial blood-pressure cuff synchronized with a single-lead ECG to capture 40 seconds of brachial pulse waveform and ECG data. Estimated elevated LVEDP (>18 mm Hg) is identified with reported sensitivity of 80% and specificity of 83%.
- Clinical implication
- At a 38.5% positive rate, a 1,000-patient panel would be expected to identify roughly 385 patients with elevated LVEDP. About 30% (≈115) would be asymptomatic Stage B — the patients for whom early intervention can prevent progression — with 100+ more carrying NYHA Class II–IV symptoms that warrant immediate attention. These are patients standard care is currently missing.
Kleiner-Shochat M, et al. IMPEDANCE-HFPEF: Early Noninvasive Detection of Lung Fluid Reduces Death, Hospitalization. Presented at ACC.26, March 2026.
American College of Cardiology Annual Scientific Session 2026. Single-center, single-masked RCT. 150 patients with HFpEF. Median follow-up 38.4 months. Device: CardioSet Edema Guard Monitor.
- Study design
- 150 patients with HFpEF (mean age ~75, 62% women, LVEF ~60%) randomized 1:1 to lung-impedance-guided care versus standard care. The monitor measured pulmonary congestion at each outpatient visit, and the intervention group's clinicians adjusted medications per protocol. Clinic-visit counts were equal between groups.
- Regulatory status
- The CardioSet Edema Guard Monitor's current FDA clearance (2025) is for HFrEF. The IMPEDANCE-HFPEF trial evaluated it in an HFpEF population; deploying it for HFpEF monitoring in this protocol therefore rests on that published evidence rather than the device's cleared indication, and should be weighed in light of the treating physician's clinical judgment.
- Primary endpoint
- Recurrent HF hospitalization at 38.4-month median follow-up. The lung-impedance-guided group saw a substantial reduction versus standard care — time to first HF hospitalization was 602 days versus 83 days.
- Secondary endpoints
- 60% lower all-cause mortality and 74% lower HF-specific mortality in the lung-impedance-guided group. No device-related adverse events.
- Mechanism
- Clinicians in the lung-impedance group adjusted medications more than twice as often, and earlier — at the preclinical stage of lung congestion, when the response to treatment is strongest. That earlier action headed off the fluid-accumulation cascade that drives HF hospitalization.
- Clinical implication
- For a 1,000-patient panel with ~385 patients screening positive for elevated LVEDP, at-home monitoring for confirmed HFpEF could reduce HF hospitalizations by 74% (first-event) to 81% (recurrent, the trial's full primary endpoint) in that subgroup. At an average Medicare HF hospitalization cost above $14,000, preventing even 10 hospitalizations a year represents roughly $140,000 in avoided medical cost — before counting mortality reduction.
The data layer that does its work before the patient walks in
The protocol starts before the first device is deployed. The SYNC-PREVENT™ interoperability layer — built on Carequality and TEFCA connectivity — draws clinical data from many sources to identify heart failure risk and decide who should get Vivio screening and downstream monitoring, much of it pulled from records the ordering physician would never encounter in a routine visit.
| Data Source | What the platform ingests | HF risk signal identified |
|---|---|---|
| Hospital ADT feed | Admissions, discharges, transfers via TEFCA | Recent HF admission, HF-related ED visit, diuretic administration during admission |
| Reference laboratory | NT-proBNP, hs-Troponin from Quest / LabCorp | NT-proBNP elevation, rising troponin trend, BNP above age-adjusted threshold |
| Pharmacy network | Active medication list, including cardiology prescriptions | Loop diuretic, SGLT-2 inhibitor, MRA, ARNI — all markers of HF therapy |
| Specialist notes | Cardiology, nephrology, endocrinology visit summaries | Prior echocardiogram findings, diastolic dysfunction notation, CKD staging |
| Imaging summaries | Radiology and echocardiogram reports | LVEF, LA enlargement, E/e' ratio, pulmonary vascular congestion on chest X-ray |
| Primary care EMR | Problem list, vital trends, recent labs | Hypertension, diabetes, CKD — the exact comorbidity triad from Cantu-Martinez et al. |
The layer applies the same eligibility criteria validated in Cantu-Martinez et al.: diabetes, CKD Stage 3+, or a physician's clinical suspicion of HF. Any enrolled patient meeting one or more is automatically flagged for Vivio screening — protocol-driven, triggered by interoperability data, and routed to the clinical team, rather than depending on the physician recalling it at the point of care.
The pathway in four steps, first flag to continuous watch
The protocol moves as an evidence-based sequence. What each step turns up determines whether the next one fires, which keeps the most intensive monitoring aimed at the patients who stand to gain the most from it.
- What happens
- The system continuously queries the Carequality/TEFCA network for enrolled patients and ingests ADT feeds, lab results, medication lists, and specialist notes. Patients matching the Cantu-Martinez et al. eligibility criteria are automatically flagged for Vivio screening.
- Triggering signals
- NT-proBNP above age-adjusted threshold · rising hs-Troponin trend · loop diuretic in active medications · CKD Stage 3+ · diabetes · prior HF-related hospitalization · echocardiogram showing diastolic dysfunction.
- Expected yield
- In a 1,000-patient panel with 64.6% diabetes and 34.9% CKD prevalence (per the study population), roughly 700–800 patients would meet one or more Vivio screening criteria.
- What happens
- Physician-ordered Layer 1–4 biomarker testing supplies the cardiometabolic context for interpreting the Vivio result — arriving before or alongside the assessment so the physician understands the full metabolic environment behind the hemodynamic finding.
- HF-relevant biomarkers
- NT-proBNP and hs-Troponin (cardiac stress and injury) · Cystatin-C / ACR (cardiorenal coupling) · ApoB / GlycA (atherogenic burden) · HbA1c / LP-IR (metabolic drivers of HFpEF) · FIB-4 / Ferritin / TSAT (hepatic-cardiometabolic interconnection).
- Clinical significance
- The study found CKD patients significantly more likely to have elevated LVEDP (38.3% vs 32.7%, P=0.010). Cystatin-C and ACR detect renal impairment earlier than creatinine-based eGFR, flagging the cardiorenal patients most likely to screen positive before the Vivio screen is even performed.
- What happens
- A BridgeCare LA technician deploys the Vivio System in the physician's office. The 40-second brachial-cuff and ECG assessment returns an estimated LVEDP, categorized as elevated (>18 mm Hg) or normal and routed to the ordering physician in real time — with a KCCQ-12 health-status assessment attached to elevated results.
- Evidence basis
- Cantu-Martinez et al. (JACC Adv. 2025;4:102002) reported a 38.5% positive rate in a primary care population with diabetes, CKD, or suspected HF, at sensitivity 80% and specificity 83% for LVEDP >18 mm Hg. It is the first study to characterize patients' health status at the moment of potential HF recognition — establishing that moment as a clinically significant detection event, not an incidental finding.
- Expected yield
- In a 1,000-patient panel: about 385 positive screens — of which roughly 115 asymptomatic Stage B (pre-HF) for early intervention, about 162 with NYHA Class I, 55 with Class II, and 47 with Class III/IV requiring urgent evaluation.
- What happens
- Patients with confirmed elevated LVEDP and an HFpEF diagnosis are enrolled in at-home lung-impedance monitoring with the CardioSet Edema Guard, which measures pulmonary congestion between visits by isolating the lung signal from chest-wall noise. Clinicians get early warning of fluid accumulation — days to weeks before symptoms — allowing medication adjustment at the preclinical stage.
- Evidence basis
- The IMPEDANCE-HFPEF trial (ACC.26, March 2026) in 150 HFpEF patients over 38.4 months: 81% fewer recurrent HF hospitalizations (74% in first-event hospitalizations), time to first hospitalization 602 versus 83 days, 60% lower all-cause mortality, 74% lower HF-specific mortality, and zero device-related adverse events.
- Expected yield
- Applying a conservative 74% reduction (the trial's full primary endpoint reached 81%) to the ~385 Vivio-positive patients, monitoring could prevent on the order of 43 hospitalizations a year per 1,000 enrolled — roughly $600,000 in avoided medical cost at $14,000 per Medicare HF hospitalization.
Protocol summary — interoperability to at-home monitoring
| Step | Tool / method | Expected yield | Evidence source |
|---|---|---|---|
| 1 · Interoperability risk ID | Carequality / TEFCA — ADT, labs, medications, specialist notes | ~700–800 / 1,000 flagged for Vivio screening (DM + CKD criteria) | Cantu-Martinez et al. eligibility criteria |
| 2 · Biomarker assessment | Layer 1–4 panel — NT-proBNP, hs-Troponin, Cystatin-C, ApoB, LP-IR, HbA1c, FIB-4 | Cardiorenal risk context delivered before the Vivio result | SYNC-PREVENT™ 11-layer architecture |
| 3 · Vivio LVEDP screening | Ventric Health Vivio System — 510(k) FDA-cleared brachial cuff / ECG | ~385 / 1,000 positive (38.5%): ~115 asymptomatic Stage B, ~260 symptomatic NYHA I–IV | Cantu-Martinez et al. JACC Adv. 2025;4:102002 |
| 4 · At-home monitoring | CardioSet Edema Guard — at-home lung impedance | 81% fewer recurrent HF hospitalizations (74% first-event), 60% lower all-cause mortality | IMPEDANCE-HFPEF, ACC.26 March 2026 |
Per-1,000-patient impact model
This model applies published trial figures directly to a 1,000-patient panel. Every number is grounded in peer-reviewed evidence — the 38.5% Vivio positive rate (Cantu-Martinez et al.) and a conservative 74% hospitalization reduction drawn from IMPEDANCE-HFPEF, whose full primary endpoint reached 81%. Assumptions are stated plainly and kept conservative. These are modeled projections, not results BridgeCare LA has already produced.
- 1,000Total enrolled patients
Base panel — 50 / 30 / 20 Stable / Moderate / Complex tier distribution
100% - ~700–800Meet Vivio screening criteria
Diabetes, CKD Stage 3+, or physician suspicion — Cantu-Martinez et al. criteria applied through the interoperability feed
70–80% - ~385Vivio-positive (elevated LVEDP)
38.5% positive rate — Cantu-Martinez et al., JACC Adv. 2025. Sensitivity 80%, specificity 83%
38.5% - ~115Asymptomatic Stage B (pre-HF)
31.4% of Vivio-positive — AHA/ACC Stage B, no HF symptoms. The highest-value target, while disease is still reversible
31.4% of positive - ~150–200HFpEF confirmed — at-home monitoring deployed
Conservative estimate from the Vivio-positive pool. Outpatient medication adjustment guided by lung-impedance readings
~40% of positive - ~19–30HF hospitalizations prevented annually
Conservative 74% reduction (the trial's full primary endpoint reached 81%) — IMPEDANCE-HFPEF, ACC.26 2026 — applied to 25–40 expected annual hospitalizations in the unmonitored HFpEF group
74% reduction
19–30 prevented hospitalizations × $14,000+ average Medicare cost
IMPEDANCE-HFPEF (ACC.26 2026) · 74% reduction applied (conservative; primary endpoint 81%)
~19–30 prevented readmissions × $4,000–$5,000 average 30-day readmission cost
CMS HF 30-day readmission penalty program
MSSP shared savings at a 50–75% share rate; Medicare Advantage Star Rating quality-bonus protection
HF readmission rate — MSSP quality measure
Conservative range · hospitalization avoidance + readmission avoidance + ACO/Star value, per 1,000-patient panel annually
These projections apply published evidence to conservative population assumptions. Actual results will vary with panel composition, CKD and diabetes prevalence, physician response rates to alerts, and symptom burden at enrollment.
Methodology: a conservative 74% hospitalization reduction (the IMPEDANCE-HFPEF full primary endpoint reached 81%) is applied to the expected Vivio-positive population from Cantu-Martinez et al. (38.5%). These are evidence-based estimates, not guarantees.
Why the published evidence directly applies
A common weakness in applying trial evidence to a real program is population mismatch. Here, the alignment between the published study populations and the patients BridgeCare LA enrolls is unusually close.
| Population variable | Published studies | BridgeCare LA target population |
|---|---|---|
| Mean age | 74 ± 8 (Cantu-Martinez) · ~75 (IMPEDANCE) | 50–64 (pre-Medicare) + 65+ (Medicare) — an overlapping cohort |
| Sex distribution | 49.8–62% women | Consistent with the general Medicare population |
| Diabetes prevalence | 64.6% in Cantu-Martinez et al. | 40% planning assumption — conservative; rural Louisiana Medicare may exceed 50% |
| CKD prevalence | 34.9% in Cantu-Martinez et al. | Consistent with the Layer 2 monitoring trigger population |
| Setting | Primary care outpatient clinics | Operates inside physicians' primary care and specialty clinics |
| HFpEF (IMPEDANCE trial) | LVEF ~60%, mean age ~75, 62% women | HFpEF is the dominant HF subtype in the Medicare 65+ population |
| No prior HF diagnosis | Exclusion criterion in Cantu-Martinez | Targets pre-diagnosis monitoring — an identical population definition |
The populations line up closely enough that the published yield figures — 38.5% LVEDP elevation, 26.5% NYHA Class II–IV symptom burden, and an 81% hospitalization reduction — are the most clinically defensible basis available for projecting what this program can do. Close to 40% of high-risk primary care patients are carrying elevated filling pressure today, and over 80% of the hospitalizations they are headed toward can be prevented. The underlying evidence is peer-reviewed, the tools are FDA-cleared, and the protocol is already running.
- Cantu-Martinez O, Girard AA, Jin W, Rinderknecht D, Cheek T, Spertus JA. Noninvasive Screening for Elevated LVEDP and Health Status in Outpatients at Risk for Heart Failure. JACC Adv. 2025;4(8):102002. Open access CC BY.
- Kleiner-Shochat M, et al. IMPEDANCE-HFPEF: Early Noninvasive Detection of Lung Fluid Reduces Death, Hospitalization. Presented at ACC.26, American College of Cardiology Annual Scientific Session; March 29–31, 2026.
- Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. Circulation. 2022;145(18):e895–e1032.
- 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(10):1412–1451.
- Ndumele CE, Rangaswami J, Chow SL, et al. Cardiovascular-Kidney-Metabolic Health: A Presidential Advisory From the American Heart Association. Circulation. 2023;148(20):1606–1635.
- Virani SS, et al. Heart Disease and Stroke Statistics — 2022 Update. J Am Coll Cardiol. 2022;80(6):565–578.
This white paper applies peer-reviewed clinical evidence to modeled population assumptions for illustration; the figures are evidence-based estimates, not guarantees, and actual results vary by population. Statistics attributed to published studies are findings from those studies, not outcomes produced by BridgeCare LA. The CardioSet Edema Guard Monitor is FDA-cleared for HFrEF; its use for HFpEF monitoring reflects the IMPEDANCE-HFPEF trial evidence rather than its cleared indication and remains subject to the treating physician's clinical judgment. The treating physician retains full authority over every clinical decision. SYNC-PREVENT™ is a trademark of Synchronize Health, LLC.
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