Heart Failure Prevention Protocol
From interoperability to early detection to continuous at-home monitoring — how SYNC-PREVENT™ integrates interoperability-sourced clinical data, advanced biomarker testing, Vivio LVEDP screening, and at-home lung-impedance monitoring into a single physician-directed protocol built to put the earliest signs of heart failure in front of the ordering physician — before symptoms appear, and before hospitalization.
The heart failure detection gap — and how SYNC-PREVENT™ closes it
Heart failure is the most expensive and most preventable catastrophic event in the chronic disease management landscape. It is expensive because it generates repeated hospitalizations, post-acute care, and an escalating pharmacologic burden. It is preventable because the physiologic signals that precede clinical decompensation by days, weeks, or months are now measurable — noninvasively, in the primary care office and in the patient's home.
Two landmark publications — one in JACC Advances in August 2025 and one presented at the ACC.26 Scientific Session in March 2026 — provide direct peer-reviewed evidence for the core clinical tools in the protocol. Together they establish that noninvasive LVEDP screening identifies elevated filling pressure in roughly 40% of high-risk primary care patients, and that lung-impedance-guided outpatient management reduced HF hospitalizations by 74% and all-cause mortality by 60% compared to standard care, as publicly reported.
Heart failure does not begin in the emergency department. It begins silently, in the cardiorenal-metabolic milieu, years before the first hospitalization. The protocol that catches it must begin there too. Synchronize Health is not simply a monitoring program: it is a structured clinical support platform that organizes longitudinal patient data and coordinates care team workflows to support the treating physician in managing heart failure patients across the continuum of care.
Why SYNC-PREVENT™ begins where standard medicine does not
The 2022 AHA/ACC/HFSA Heart Failure Guideline redefined how heart failure is staged — shifting from a model that begins at symptomatic disease to one that explicitly names the pre-symptomatic phases that precede it. This was not semantic. The guidelines state that patients at Stage A and Stage B should be the primary targets of preventive intervention, not just monitoring. Standard medicine has not yet answered that call at scale. SYNC-PREVENT™ is the infrastructure that does.
Risk factors present — hypertension, diabetes, obesity, metabolic syndrome, CKD, family history. No structural heart disease. No symptoms.
SYNC-PREVENT™ deploys here: biomarker and device-based monitoring from age 50, giving the physician the data to identify developing risk before structural disease emerges.
Structural heart disease, elevated filling pressures, or biomarker evidence (elevated NT-proBNP). No current or prior HF symptoms.
SYNC-PREVENT™ 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. Primary target of pharmacologic and device therapy.
Standard care begins here. At-home lung-impedance monitoring is deployed for confirmed HFpEF — a 74% reduction in HF hospitalization was reported in the IMPEDANCE-HFPEF trial.
Severe refractory symptoms despite maximal therapy. High mortality. Limited options: transplant or palliative care consideration.
Prevention 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 SYNC-PREVENT™ begins monitoring at age 50
The intervention window for heart failure prevention opens long before symptoms appear — and closes by the time standard care typically begins. The physiologic changes of Stage A (insulin resistance, hypertension, metabolic syndrome, CKD) begin developing in the fifth decade of life. By age 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; Stage B structural and biomarker changes are developing. The SYNC-PREVENT™ monitoring window opens: Vivio LVEDP screening identifies Stage B patients (38.5% positive rate in this population), biomarker testing surfaces early NT-proBNP elevation for physician review, and at-home monitoring is deployed for confirmed HFpEF.
- Age 65+
Medicare enrollment. 70–80% of new enrollees already have 2+ chronic conditions (CMS Chronic Conditions Report). Standard monitoring begins here — typically at Stage C. The Stage A and B window has already closed for most patients.
- Age 70+
First hospitalization. DRG 291/292 claim filed. ACO benchmark breaks. Medicare MLR climbs. The cost of the Stage A/B detection gap arrives — 10–20 years after the window to prevent it closed.
The clinical evidence base
The protocol is grounded in two independent bodies of peer-reviewed evidence published in 2025 and 2026. Both directly evaluate the specific tools deployed in the protocol and provide quantified outcomes that form its clinical and financial justification.
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 3 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 >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 have elevated LVEDP (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. Over two-thirds of patients with elevated LVEDP had meaningful health status impairment at the time of 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 collect 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 screening rate, a 1,000-patient panel is expected to identify roughly 385 patients with elevated LVEDP. About 30% (≈115) will be asymptomatic Stage B — patients for whom early intervention can prevent progression — and 100+ more will have NYHA Class II–IV symptoms requiring immediate attention. These are patients whose standard care is currently missing them.
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 vs. standard care. The monitor measured pulmonary congestion at each outpatient visit; the intervention group's clinicians adjusted medications per protocol. Clinic visit counts were equal between groups.
- Regulatory status
- The CardioSet Edema Guard Monitor is FDA-cleared (510(k), 2025). Its cleared indication covers monitoring in heart failure patients and does not restrict by ejection fraction, so the HFpEF population monitored in this protocol falls within the cleared indication. The IMPEDANCE-HFPEF trial supplies the published outcome evidence for lung-impedance-guided management in HFpEF specifically, and deployment remains subject to the treating physician's clinical judgment.
- Primary endpoint
- HF hospitalization at 38.4-month median follow-up. The lung-impedance-guided group had a 74% reduction in HF hospitalizations versus standard care, as publicly reported — time to first HF hospitalization was 602 days vs. 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 response to treatment is most powerful. That earlier intervention prevented 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 the 74% reported in the trial in that subpopulation. At an average Medicare HF hospitalization cost of $14,000+, preventing even 10 hospitalizations a year represents $140,000 in medical cost avoidance — before mortality reduction.
The interoperability foundation — clinical data before the patient arrives
The protocol begins before the first device is deployed. The SYNC-PREVENT™ interoperability layer — built on Carequality and TEFCA connectivity — ingests multi-source clinical data and organizes it against the screening criteria the ordering physician adopts, so candidates for Vivio screening and downstream monitoring reach the physician's team from record data the physician may never see in a standard encounter.
| Data Source | What SYNC-PREVENT™ ingests | HF-relevant findings in the record |
|---|---|---|
| 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 HF therapy markers |
| 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 screening criteria are the ones validated in Cantu-Martinez et al. — diabetes, CKD Stage 3+, or physician clinical suspicion of HF — adopted by the ordering physician for their panel. Patients meeting those physician-established criteria are identified through structured data review and presented to the care team for physician-directed consideration of Vivio assessment; the care team routes each candidate to the treating physician for independent review and an ordering decision — so screening eligibility is worked from the record, not from what the physician happens to recall at the point of care.
Four steps from risk identification to continuous monitoring
The protocol operates as a sequential, evidence-based pathway. Each step is triggered by the preceding step's findings, so the most intensive monitoring resources reach the patients who need them most.
- What happens
- SYNC-PREVENT™ retrieves available patient data from the Carequality/TEFCA network — ADT feeds, lab results, medication lists, and specialist notes — and organizes it for care team review. When a patient's record matches the Cantu-Martinez et al. eligibility criteria the ordering physician has adopted, the care team presents that patient to the treating physician for independent review and an ordering decision on Vivio screening.
- Physician-established parameters
- NT-proBNP above age-adjusted threshold · hs-Troponin changes across serial measurements · loop diuretic in the active medication list · CKD Stage 3+ · diabetes · prior HF-related hospitalization · echocardiogram showing diastolic dysfunction — each presented to the treating physician for independent clinical assessment.
- 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 will meet one or more Vivio screening criteria.
- What happens
- Physician-ordered Layer 1–4 biomarker testing provides the cardiometabolic context for interpreting the Vivio result, arriving before or alongside the assessment so the physician understands the full metabolic environment driving 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, identifying the cardiorenal patients most likely to screen positive before the Vivio screen is performed.
- What happens
- A Synchronize Health technician deploys the Vivio System in the physician's office. The 40-second brachial-cuff/ECG assessment returns an estimated LVEDP, categorized as elevated (>18 mm Hg) or normal, routed to the ordering physician — with a KCCQ-12 health-status assessment for elevated results. When a result meets physician-established parameters, the care team is notified and the treating physician receives the organized biomarker data for independent clinical review; the physician determines any care plan adjustments, including updated tier assignment and consideration of additional monitoring support.
- Evidence basis
- Cantu-Martinez et al. (JACC Adv. 2025;4:102002) demonstrated a 38.5% positive rate in a primary care population with diabetes, CKD, or suspected HF; sensitivity 80%, specificity 83% for LVEDP >18 mm Hg. It is the first study to characterize patients' health status at the time of potential HF recognition — establishing this as a clinically significant detection event, not an incidental finding.
- Expected yield
- In a 1,000-patient panel: ~385 positive screens — of which ~115 asymptomatic Stage B (pre-HF) for early intervention, ~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 CardioSet Edema Guard monitoring consistent with the device's cleared indications and the treating physician's established plan of care. The Edema Guard device filters chest-wall artifact and transmits verified lung-impedance data to the care team; that organized, longitudinal impedance data is presented to the treating physician for review of fluid-status trends between clinical encounters, informing diuretic and medication decisions at the preclinical stage — consistent with the trial's findings.
- Evidence basis
- The IMPEDANCE-HFPEF trial (ACC.26, March 2026) in 150 HFpEF patients over 38.4 months, as publicly reported: 74% reduction in HF hospitalizations, time to first hospitalization 602 vs. 83 days, 60% lower all-cause mortality, 74% lower HF-specific mortality, and zero device-related adverse events.
- Expected yield
- Applying the trial's reported 74% hospitalization reduction to the ~385 Vivio-positive patients, monitoring could prevent roughly 43 hospitalizations a year per 1,000 enrolled — around $600,000 in medical cost avoidance 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 | 74% reduction in HF hospitalizations and 60% reduction in all-cause mortality, as publicly reported | IMPEDANCE-HFPEF, ACC.26 March 2026 |
Per-1,000-patient savings model
This model applies published trial yield figures directly to a 1,000-patient panel. Every number is based on peer-reviewed evidence — the 38.5% Vivio positive rate (Cantu-Martinez et al.) and the 74% HF-hospitalization reduction publicly reported from IMPEDANCE-HFPEF. Assumptions are stated explicitly and are conservative.
- 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 via 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. Highest-value target; disease 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
The trial's reported 74% reduction — IMPEDANCE-HFPEF, ACC.26 2026 — applied to 25–40 expected annual hospitalizations in the unmonitored HFpEF population
74% reduction
19–30 prevented hospitalizations × $14,000+ avg Medicare cost
IMPEDANCE-HFPEF (ACC.26 2026) · 74% reduction applied, as publicly reported
~19–30 prevented readmissions × $4,000–$5,000 avg 30-day readmission cost
CMS HF 30-day readmission penalty program
MSSP shared savings at 50–75% share rate; MA 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
The projections apply published evidence to conservative population assumptions. Actual results will vary with panel composition, CKD and diabetes prevalence, physician response to escalations, and symptom burden at enrollment.
Methodology: the 74% HF-hospitalization reduction publicly reported from IMPEDANCE-HFPEF 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 limitation of applying trial evidence to a clinical program is population mismatch. Here, the alignment between the published study populations and the SYNC-PREVENT™ enrolled population is exceptional.
| Population variable | Published studies | SYNC-PREVENT™ target population |
|---|---|---|
| Mean age | 74 ± 8 (Cantu-Martinez) · ~75 (IMPEDANCE) | 50–64 (pre-Medicare) + 65+ (Medicare) — 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 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 — identical population definition |
The populations are similar enough that the published yield figures — 38.5% LVEDP elevation, 26.5% NYHA Class II–IV symptom burden, and the publicly reported 74% HF-hospitalization reduction — are the most clinically defensible estimates available for projecting this program's impact. Nearly 40% of high-risk primary care patients have elevated filling pressure today. In the monitored trial population, nearly three-quarters of the HF hospitalizations they were headed toward were prevented. The evidence is peer-reviewed. The tools are FDA-cleared. The protocol is designed to operate on exactly this population.
- 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; figures are evidence-based estimates, not guarantees, and actual results vary by population. Trial statistics are findings from the cited studies, not outcomes produced by Synchronize Health. The CardioSet Edema Guard Monitor is FDA-cleared (510(k), 2025); its cleared indication is not limited by ejection fraction, and the IMPEDANCE-HFPEF trial supplies the published outcome evidence for lung-impedance-guided management in HFpEF. Deployment remains subject to the treating physician's clinical judgment, and the treating physician retains full authority over every clinical decision.
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