ModifiedCignaPolicy 0574

Cardiac Omnibus Devices and Procedures

Defines Cigna's coverage stance for multiple implantable cardiac sensors and device-based cardiac therapies (baroreflex activation, left atrial and pulmonary artery pressure sensors, cardiac contractility modulation, and inferior vena cava sensor) for members whose plans reference this policy.

Policy Summary

PayerCigna

PolicyCardiac Omnibus Devices and Procedures

Policy CodePolicy 0574

Change TypeFocused review with coding and content updates

Effective Date2/15/2026

Next Review Date10/15/2026

Key ActionUse updated CPT code 64654 when applicable and verify prior authorization and documentation align with device-specific FDA indications and GDMT status.

SourceLink

POLICY UPDATE CHANGES

Added CPT code 64654 effective 1/1/26.

Added new policy statement for inferior vena cava sensor.

Revised policy statement for carotid sinus baroreflex activation device.

Added codes to an existing policy statement during annual review.

5 device/procedure categoriesdevice/procedure groups

1CPT code added (64654)

1New device policy added (IVC sensor)

All listed E/I/Ucoverage stance

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Determinations and Evidence Summaries

Not Medically Necessary / Experimental Groups

For the devices and procedures listed below:

Listing

Carotid Sinus BAT codes: 64654, 0266T, 0268T, C1825 are considered experimental/investigational/unproven
See policy statements and code descriptions.
Left atrial pressure sensor codes: 0933T is considered experimental/investigational/unproven
See policy statements and code descriptions.
Pulmonary artery pressure sensor codes: 33289, C2624, G0555 are considered experimental/investigational/unproven
See policy statements and code descriptions.
CCM therapy codes: 0408T, 0915T-0918T, 0930T-0931T, C1824 are considered experimental/investigational/unproven
See policy statements and code descriptions.
Inferior vena cava sensor codes: 0981T is considered experimental/investigational/unproven
See policy statements and code descriptions.

Device indication and patient selection

Covered when ALL of the following are met (per FDA trial indications and evidence presented):

Device-specific criteria: Patient has NYHA class II or III heart failure (as specified by device indication) and either a heart failure hospitalization in the prior 12 months and/or elevated natriuretic peptides; patient is on stable, guideline-directed medical therapy (GDMT) for the required period and appropriate device therapy when indicated; implanting clinician documents rationale and peri-procedural management (including anticoagulation capability if required); device use aligns with its FDA indication (e.g., CardioMEMS, Cordella) or is within an approved clinical trial for other sensors.as stated

Derived from device PMA indications, trial inclusion criteria, and guideline statements.

BAT evidence summary

Evidence considerations influencing coverage:

Baroreflex activation therapy (BAT) evidence: Randomized trials (BeAT-HF, HOPE4HF) demonstrated improvements in quality of life, 6-minute walk distance, NYHA class, and reductions in NT-proBNP in selected HFrEF patients, but longer-term analyses did not show a significant effect on composite cardiovascular mortality and heart failure morbidity; subgroup findings and trial limitations (sample size, differential background therapy) are noted.

See BeAT-HF, HOPE4HF trial summaries and extended follow-up analyses.

LAP sensor evidence summary

Left atrial pressure sensor evidence considerations:

LAP sensor evidence: Randomized and single-arm studies (including LAPTOP-HF, V-LAP/ VECTOR-HF, HeartPOD, HOMEOSTASIS) show feasibility, measurement correlation with PCWP, and preliminary clinical signals; however, LAPTOP-HF was terminated early for implant-related complications and controlled evidence is limited, so larger trials are needed to establish long-term safety and efficacy.

Includes trial termination and small-sample feasibility outcomes.

PAP sensor evidence summary

Pulmonary artery pressure (PAP) sensor evidence considerations:

PAP sensor evidence: Randomized trials, registry and post-marketing studies (CardioMEMS PMA, MONITOR-HF, PROACTIVE-HF, SIRONA 2, COAST, meta-analysis of RCTs) report reductions in heart failure hospitalizations and improvements in quality-of-life and KCCQ scores; device safety and low device-failure rates are reported in many series, but mortality benefit remains uncertain and some studies lack randomized controls or have methodological limitations.

Includes PMA indications, trial outcomes, and meta-analysis findings.

Coverage criteria aligned to trial and device labeling

Covered when ALL of the following are met (clinical trial–based expectations and device indications as reported):

patient_selection: Patient has symptomatic heart failure consistent with trial populations (typical enrollment NYHA class III; some devices include NYHA II per updated labeling) and other device-specific eligibility as stated in the PMA or trial protocol.NYHA class III typical; some trials included class II–IV

See CardioMEMS, Cordella, and OPTIMIZER labeling and trial enrollment.

prior_therapy: Patient is on guideline-directed medical therapy (GDMT) and remains symptomatic despite optimization; patient has been stable on GDMT for the trial-specified duration when required.stable on GDMT (trial-specified durations varied)

CCM and PAP sensor trials required GDMT as background therapy.

objective_findings: Documented prior heart failure hospitalization within 12 months or elevated natriuretic peptides when required by device indication or trial inclusion.

Typical CCM trial eligibility

Common trial eligibility criteria observed in CCM studies (may inform coverage criteria):

CCM typical eligibility: Patients meeting ALL of: LVEF between approximately 25% and 45%; NYHA class III (or ambulatory IV) despite ≥90 days of guideline-directed medical therapy with stability prior to enrollment (commonly ~30 days); QRS duration typically <130 ms; not indicated for cardiac resynchronization therapy (CRT).LVEF >=25% and <=45%; NYHA III (or ambulatory IV); QRSd <130 ms (typical)

Derived from FIX-HF-5C, FIX-HF-5C2 and related CCM trials and registries.

Typical IVC sensor (FIRE1) eligibility

FIRE1 (IVC sensor) early studies enrolled patients meeting ALL of the following:

FIRE1 typical eligibility: Patients with a heart failure event in the prior 12 months (hospitalization, urgent HF visit, or HF treatment in a hospital day-care setting), elevated natriuretic peptide levels as specified by the study, and receiving ≥40 mg furosemide equivalent; studies included patients irrespective of ejection fraction in early feasibility cohorts.HF event in prior 12 months; NT-proBNP elevated; >=40 mg furosemide equivalent

Based on FUTURE-HF and FUTURE-HF2 trial descriptions and first-in-human data.

Services billed using codes that this policy designates as experimental, investigational, or unproven are not eligible for reimbursement under the Coverage Policy and may be denied if submitted without an applicable covered code. The policy lists specific CPT and HCPCS codes that correspond to carotid sinus baroreflex activation devices, left atrial pressure sensors, pulmonary artery pressure sensors, cardiac contractility modulation systems, and an inferior vena cava sensor; claims for the procedures and devices represented by those codes should be submitted and adjudicated in accordance with the member's benefit plan and this Coverage Policy.

Use of implantable monitoring or therapeutic devices outside the device-specific FDA indications or without documentation that aligns with trial-based inclusion criteria (for example, absence of prior heart failure hospitalization within 12 months or no evidence of elevated natriuretic peptides when required) is not supported by the cited evidence and may be excluded from coverage. Prior authorization reviews should verify that the patient meets the device labeling or trial-aligned clinical eligibility (NYHA class, prior HF hospitalization and/or elevated BNP/NT-proBNP, and stability on guideline-directed medical therapy) before approving implant procedures.

Use of non–FDA-approved pulmonary artery pressure monitoring systems (for example, Chronicle) or other PA monitoring devices that lack supportive randomized controlled evidence may be considered experimental or investigational and excluded from coverage. The CardioMEMS HF System and the Cordella PA Sensor System have explicit FDA PMA indications and supporting trial/registry data; devices without comparable approvals or randomized evidence should be evaluated as not proven.

Many clinical trials excluded patients who were indicated for cardiac resynchronization therapy (CRT) or who did not meet specified left ventricular ejection fraction (LVEF) or symptom criteria. Trial eligibility commonly required patients to be on stable guideline-directed medical therapy and to have NYHA class III (or ambulatory IV) symptoms with LVEF in the trial-specified range; use of devices in patients who do not meet these trial-based criteria may not be supported by the evidence and could be denied.

No additional explicit exclusion statements are provided in the cited policy excerpts beyond the device-specific investigational/not medically necessary designations and the trial- and labeling-aligned usage considerations documented elsewhere in this policy.

Implantation and monitoring of the following devices are classified in this policy as not medically necessary (experimental, investigational, or unproven): carotid sinus baroreflex activation devices (CPT 64654, 0266T, 0268T; HCPCS C1825), left atrial pressure sensors (CPT 0933T), pulmonary artery pressure sensors (CPT 33289; HCPCS C2624, G0555), cardiac contractility modulation systems (CPT 0408T, 0915T–0918T, 0930T–0931T; HCPCS C1824), and inferior vena cava sensors (CPT 0981T).

Implantable left atrial pressure monitoring remains investigational for routine clinical use. The LAPTOP-HF randomized trial was terminated early because of implant-related complications, and the body of evidence otherwise consists largely of small feasibility or single-arm studies (for example, V-LAP, HeartPOD, HOMEOSTASIS) that demonstrate feasibility and preliminary signals but lack large, controlled trials confirming long-term safety and efficacy.

If randomized evidence fails to show a reduction in composite outcomes such as all-cause mortality or heart failure events, or when findings are not replicated in blinded randomized controlled trials, routine use of the device or therapy may be considered not medically necessary outside defined trial populations. For example, some hemodynamic-guided management trials did not demonstrate improvement in combined mortality and HF hospitalization endpoints, underscoring uncertainty about broader clinical benefit.

Short-term randomized data for cardiac contractility modulation (CCM) demonstrate improvement in quality-of-life measures (MLWHFQ/KCCQ) but do not show significant differences in heart failure hospitalizations, 6-minute walk distance, arrhythmias, device malfunction rates, all-cause hospitalizations, or mortality over the short follow-up periods studied. Longer and larger randomized trials are needed to establish effects on clinical events.

No additional explicit coverage criteria or statements are provided in the cited excerpts beyond the investigational/not medically necessary groupings, trial-based eligibility considerations, and documentation/prior authorization guidance elsewhere in this policy.

Coding: Status of Codes and Updates

Carotid Sinus Baroreflex Activation Device - Considered Experimental/Investigational/UnprovenCPT/HCPCSExperimental

64654	Initial open implantation of baroreflex activation therapy (BAT) modulation system
0266T	Implantation or replacement of carotid sinus baroreflex activation device; total system
0268T	Implantation or replacement of carotid sinus baroreflex activation device; pulse generator only
C1825	Generator, neurostimulator (implantable), nonrechargeable with carotid sinus baroreceptor stimulation lead(s)

Left Atrial Pressure Sensor - Considered Experimental/Investigational/UnprovenCPTExperimental

0933T

Transcatheter implantation of wireless left atrial pressure sensor for long-term left atrial pressure monitoring

Pulmonary Artery Pressure Sensor - Considered Experimental/Investigational/UnprovenCPT/HCPCSExperimental

33289	Transcatheter implantation of wireless pulmonary artery pressure sensor for long-term hemodynamic monitoring
C2624	Implantable wireless pulmonary artery pressure sensor with delivery catheter
G0555	Provision of replacement patient electronics system for home pulmonary artery pressure monitoring

Cardiac Contractility Modulation Therapy - Considered Experimental/Investigational/UnprovenCPT/HCPCSExperimental

0408T	Insertion or replacement of permanent cardiac contractility modulation system
0915T	Insertion of permanent cardiac contractility modulation-defibrillation system component(s)
0916T	Insertion of permanent cardiac contractility modulation-defibrillation system; pulse generator only
0917T	Insertion of permanent cardiac contractility modulation-defibrillation system; single transvenous lead only
0918T	Insertion of permanent cardiac contractility modulation-defibrillation system; dual transvenous leads
0930T	Electrophysiologic evaluation of cardiac contractility modulation-defibrillator leads at initial implantation
0931T	Electrophysiologic evaluation of cardiac contractility modulation-defibrillator leads separate from implantation
C1824	Generator, cardiac contractility modulation (implantable)

Inferior Vena Cava Sensor - Considered Experimental/Investigational/UnprovenCPTExperimental

0981T

Transcatheter implantation of wireless inferior vena cava sensor for long-term hemodynamic monitoring

Device approvals and referenced systemsmixed

No codes listed

Added/Updated CPT CodesCPT

64654

CPT code added per revision details

NT‑proBNP threshold (evidence)

NT-proBNP threshold (evidence)< 1600 pg/ml as reported in BAROSTIM NEO PMA inclusion criteria and subgroup analyses

Use contextThreshold applied in BeAT-HF trial analyses and device labeling to identify lower-risk biomarker subgroup

Documentation implicationNT-proBNP values should be documented when aligning patients to trial-based indications

Left ventricular ejection fraction — BAROSTIM NEO

LVEF threshold (BAROSTIM NEO FDA indication)≤ 35%

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Coverage determination review — consider benefit plan, laws/regulations, policy, and case facts

Coverage determinations require individual review of the applicable benefit plan document, applicable laws/regulations, relevant Coverage Policies, and the specific clinical facts of the case. Medical directors may exercise clinical judgment; where coverage depends on specific circumstances, reimbursement is provided only when services are submitted with covered diagnosis and/or procedure code(s) and appropriate documentation. Claims for services not accompanied by covered codes under the applicable Coverage Policy will be denied as not covered.

Review the member's specific benefit plan and any state/federal mandates before approving coverage.
Ensure prior authorization requests include covered diagnosis and procedure codes current to the date of service.

Documentation Required

Device-specific indication verification and confirm device indication

Prior authorization should confirm that the patient meets device-specific FDA indication criteria (for example, CardioMEMS per PMA: NYHA Class II–III with prior HF hospitalization within 12 months and/or elevated natriuretic peptides; Cordella: NYHA Class III on diuretics and stable on GDMT for 30 days). For CCM (Optimizer Smart System) verify FDA indication (NYHA Class III, LVEF 25–45%, symptomatic despite GDMT, not indicated for CRT, historically required sinus rhythm though labeling has been modified).

Background and Rationale

Baroreflex activation therapy (BAT) stimulates carotid baroreceptors via an implanted pulse generator and lead(s) adjacent to the carotid sinus to modulate autonomic responses; BAT has been evaluated in randomized trials (for example, BeAT‑HF) for symptom improvement in heart failure with reduced ejection fraction, with mixed results on longer-term morbidity and mortality outcomes.

Definitions and Device Descriptions

Baroreflex activation therapy (BAT)

DefinitionBaroreflex activation therapy (BAT) is a device-based approach with an implanted pulse generator and leads placed adjacent to the carotid sinus to deliver electrical pulses activating the baroreflex system

Typical system componentsImplanted pulse generator (pectoral), external programming system, and carotid sinus leads

FDA status (example device)BAROSTIM NEO received FDA PMA approval (Aug 16, 2019) for selected HFrEF patients

Pulmonary artery pressure sensor

DefinitionAn implantable wireless sensor for long-term pulmonary artery pressure (PAP) monitoring (e.g., CardioMEMS)

PurposeProvides daily remote PA pressure measurements transmitted to clinicians to guide HF management

Policy Changes and Revision Notes

CPT coding was updated effective 1/1/2026 to add code 64654. Providers must use current, applicable CPT/HCPCS codes when submitting claims and should verify prior authorization requirements, as coding changes can affect prior authorization workflows and the adjudication of claims.

Policy Summary

PayerCigna

PolicyCardiac Omnibus Devices and Procedures

Policy CodePolicy 0574

Change TypeFocused review with coding and content updates

Effective Date2/15/2026

Next Review Date10/15/2026

Key ActionUse updated CPT code 64654 when applicable and verify prior authorization and documentation align with device-specific FDA indications and GDMT status.

SourceLink

On This Page

prior HF hospitalization within 12 months or elevated BNP/NT-proBNP per trial criteria

GUIDE-HF, MONITOR-HF and PROACTIVE-HF used prior HFH or elevated natriuretic peptides as inclusion criteria.

device_specific_indication: For CCM (Optimizer Smart), left ventricular ejection fraction (LVEF) and rhythm requirements must align with the device labeling; for PAP sensors, indications require NYHA class and prior HF hospitalization or elevated natriuretic peptides per PMA; peri-procedural contraindications (e.g., inability to take antiplatelet/anticoagulants for Cordella) should be considered.LVEF 25–45% for CCM per PMA; rhythm labeling modified to remove sinus rhythm requirement; Cordella contraindications include inability to take antiplatelet/anticoagulants

See OPTIMIZER Smart PMA and Cordella labeling.

Indication contextSpecified for patients who remain symptomatic despite guideline-directed medical therapy and are NYHA Class III or select Class II

Contraindication noteExcludes patients indicated for cardiac resynchronization therapy (CRT) per AHA/ACC/ESC guidelines

Left ventricular ejection fraction (CCM — Optimizer Smart)

LVEF range (Optimizer Smart System FDA indication)25% to 45%

Indication contextIndicated to improve 6-minute walk distance, quality of life, and functional status in NYHA Class III patients symptomatic despite GDMT

Rhythm requirement updateOriginal PMA required normal sinus rhythm; labeling modification in 2021 removed the normal sinus rhythm requirement

Confirm which FDA-approved device is being requested and that the indication aligns with the device-specific labeling.
For CardioMEMS, note expanded PMA indication includes NYHA Class II or III with prior HF hospitalization and/or elevated natriuretic peptides (P100045/S056).
For Cordella (P230040), ensure patient is NYHA Class III, on diuretics and GDMT, and stable on GDMT ≥30 days.

Documentation Required

Clinical eligibility documentation — show NYHA class, HF hospitalization/biomarkers, and GDMT status

Clinical documentation submitted for prior authorization should demonstrate the common eligibility elements used in pivotal trials and PMAs: NYHA functional class, history of HF hospitalization within 12 months and/or elevated natriuretic peptides, and evidence of adequate guideline-directed medical therapy (GDMT) and appropriate device therapy when indicated. Document duration and stability of GDMT and any contraindications to alternative therapies.

NYHA class (clinical assessment notes) and dates of symptom classification.
HF hospitalization(s) date(s) within prior 12 months or laboratory evidence of elevated natriuretic peptides (e.g., NT-proBNP) where applicable.
Medication list showing GDMT agents, doses, start dates, and documentation of stability on therapy (e.g., ≥30 days for Cordella; ≥90 days noted in CCM studies).
Reason patient is not a candidate for CRT when applicable (for CCM requests).

Documentation Required

Suggested baseline documentation — objective measures and GDMT/device status

Suggested baseline documentation to support medical necessity should include objective measurements used in trials and device approvals: LVEF by echocardiography (with date), baseline functional class, baseline and follow-up natriuretic peptide levels when relevant, and device-specific testing (e.g., CPX for CCM studies). Include prior device therapy status (ICD/CRT) and any prior cardiac interventions.

Echocardiogram report with LVEF and date.
Baseline NYHA class and functional testing results (6‑minute walk, peak VO2 if available).
Baseline NT-proBNP/BNP values when used to meet indication.
Medication reconciliation documenting GDMT and duration of stability prior to implant.

Documentation Required

Device identification and FDA documentation

Providers must identify the device model and cite FDA PMA or product information when relevant. Documentation of device indication per FDA labeling and any device-specific contraindications should be included with the request (for example, Cordella contraindication for inability to take dual antiplatelet or anticoagulants for one month post‑implant).

Include the device name/model and PMA number (e.g., CardioMEMS P100045; Cordella P230040; Optimizer Smart P180036).
Attach or reference FDA labeling or manufacturer product information when available.
State any device-specific contraindications (e.g., anticoagulation/antiplatelet requirements for Cordella).

Prior Authorization

Optimize GDMT before considering implant — document optimization and remaining symptoms

Prior to implant, confirm optimization of guideline-directed medical therapy (GDMT) and appropriate device therapy per guideline recommendations. For CCM, ensure GDMT optimization and that the patient remains symptomatic despite therapy; document attempts at medication titration and rationale for proceeding to device therapy.

Document specific GDMT agents, doses, titration history, and evidence of treatment adherence.
For CCM, document that the patient is symptomatic (NYHA III) despite GDMT and is not indicated for CRT.
For pulmonary artery sensors, document stability on GDMT per device labeling (e.g., Cordella stable on GDMT for 30 days; trials often required ≥30–90 days).

Denial Risk

Evidence limitations may trigger denial or additional review

Evidence limitations noted in the literature (e.g., open‑label designs, single‑arm studies, lack of robust blinded RCT data, study withdrawals, pandemic‑era impacts) may affect coverage decisions; absence of high‑certainty evidence for outcomes such as mortality could be a basis for denial or restricted coverage in some cases. Medical directors may require stronger supporting evidence on a case‑by‑case basis.

Highlight known study limitations in the submission if present (single-arm design, lack of control group, small sample size, high risk of bias).
Be prepared for requests for additional data or rationale when randomized controlled evidence is limited.

Billing Rule

Coding and submission — use current codes; CPT update may affect claims

Coding and billing must use the most appropriate and current codes as of the date of service. Note the CPT coding update effective 1/1/2026 that added CPT code 64654; providers must use updated codes on claims and prior authorization submissions to avoid coding denials or processing delays.

Use current CPT/HCPCS/ICD-10 codes appropriate to the service date when submitting authorizations and claims.
Be aware that omission of newly added codes (e.g., 64654 effective 1/1/26) on submissions may lead to claim denials until coding is updated.

Note

Not explicitly stated in this document — follow device labeling and local protocols

Not all procedural or peri‑procedural requirements are explicitly stated in this document; providers should confirm local or vendor-specific perioperative protocols. Where the policy is silent, follow manufacturer labeling and institutional standards of care.

If peri‑procedural anticoagulation or antiplatelet management is required (see device labeling), include a plan in the request.
For items not specified in the policy, attach manufacturer instructions or institutional protocols to support the request.

Prior Authorization

Peri‑procedural anticoagulation requirement — document ability to take antiplatelet/anticoagulants

Peri‑procedural anticoagulation/antiplatelet requirements must be addressed where applicable. For example, the Cordella Pulmonary Artery Sensor System is contraindicated in patients unable to take dual antiplatelet therapy or anticoagulants for one month after implant; omission of this contraindication or failure to document peri‑procedural anticoagulation plans may result in denial.

Document the patient's ability to tolerate required antiplatelet/anticoagulant therapy and the peri‑procedural plan.
If anticoagulation is contraindicated in the patient, include documentation and alternative management rationale.

Note

No explicit step therapy described in these excerpts

No explicit step‑therapy or additional provider action requirements are specified in the provided policy excerpts beyond GDMT optimization and device‑specific indications. Providers should not assume additional step therapy requirements unless specified in the member's benefit plan or delegated vendor guidance.

If the benefit plan or delegated vendor imposes step therapy, include documentation that step requirements were met.
Absent explicit step therapy in this policy, focus submissions on GDMT optimization and device indication criteria.

Regulatory noteCardioMEMS HF System received FDA PMA (May 28, 2014) with expanded indication to NYHA II or III (Feb 18, 2022)

NYHA functional class

DefinitionNYHA functional class is a four-class system (I–IV) describing degree of physical limitation from heart failure: I=no limitation, II=slight limitation, III=marked limitation, IV=symptoms at rest

Use in eligibilityNYHA class is commonly used in trial inclusion and device labeling to define symptomatic status

Documentation implicationClinical records should state NYHA class when aligning to device-specific indications

CardioMEMS HF System — Indication

Indication (CardioMEMS HF System)Wireless measurement and monitoring of PA pressure and heart rate in NYHA Class II or III patients who have been hospitalized for HF in the previous year and/or have elevated natriuretic peptides

Intended useHemodynamic data used by physicians to control PA pressures and reduce HF hospitalizations

Device componentsCM2000 implantable PA sensor, transvenous delivery catheter, patient electronics and hospital electronics systems

Pulmonary artery (PA) pressure sensor — functionality

FunctionImplantable wireless PA pressure sensor records daily pulmonary artery pressures transmitted to clinicians to guide heart failure management

Clinical workflowPatients transmit daily readings from home; clinicians review pressures to adjust therapy

Device examplesCardioMEMS, Cordella (FDA PMA referenced)

Cardiac contractility modulation (CCM) — therapy overview

DefinitionCardiac contractility modulation (CCM) delivers non‑excitatory electrical signals during the cardiac absolute refractory period to increase myocardial contractility

Typical systemOPTIMIZER Smart System includes implantable pulse generator, programmer, charger, and transvenous leads (2 ventricular ± atrial)

Therapeutic goalImprove exercise capacity, quality of life, and functional status in select HF patients

CCM (Cardiac contractility modulation) — evidence summary

Clinical benefits observedCCM has shown improvements in functional capacity and quality of life in RCTs and registries in selected patients

Typical trial eligibilityNYHA Class III despite ≥90 days of GDMT, LVEF 25–45%, not indicated for CRT

Evidence limitationsRCTs showed no mortality or hospitalization benefit to date; trials limited by size and follow-up

IVC sensor (FIRE1/Norm)

DefinitionAn implantable sensor placed in the inferior vena cava to monitor IVC area and collapsibility, used with an external belt and apps to guide volume management

System componentsImplantable IVC sensor, delivery tools (pusher/loader), external belt/hardware and patient/provider apps/portal

Regulatory statusFire1/Norm system received FDA Breakthrough Device designation (Jan 2025); early feasibility and first‑in‑human studies reported

Pulmonary artery pressure sensor — clinical role

DefinitionImplantable device (e.g., CardioMEMS, Cordella) enabling remote hemodynamic monitoring to guide heart failure management by providing PA pressure data to clinicians

Clinical aimGuide medication adjustments to control filling pressures and reduce HF hospitalizations

Evidence sourcesRandomized trials, registries, and PMA documentation support use in selected NYHA II–III patients with prior HF hospitalization or elevated natriuretic peptides

Left atrial pressure sensor (LAP sensor)

DefinitionWireless implantable left atrial pressure (LAP) sensor (e.g., V‑LAP) that measures left atrial pressure for remote heart failure monitoring

Evidence statusFeasibility and small trials show device performance and preliminary clinical signals but controlled evidence is limited and LAPTOP‑HF was terminated for implant complications

Use implicationConsidered investigational/investigational/unproven for routine clinical use outside trials

Carotid sinus baroreflex activation device

DefinitionCarotid sinus baroreflex activation device (e.g., Barostim neo) is an implantable neuromodulation system intended to modulate the baroreflex for heart failure treatment

FDA referenceBarostim neo PMA summary cited as regulatory reference for device indication and safety considerations

Implant componentsImplanted pulse generator, carotid leads, external programming hardware

Cardiac contractility modulation — device example

DefinitionOptimizer Smart System (OPTIMIZER Smart) is an implantable CCM system delivering non‑excitatory electrical therapy to improve contractility in select HF patients

FDA statusOPTIMIZER Smart received FDA PMA (March 2019) for NYHA Class III patients with LVEF 25–45%; labeling later modified to remove normal sinus rhythm requirement

Intended clinical effectImprove 6‑minute walk distance, quality of life, and functional status

Inferior vena cava (IVC) sensor

DefinitionInferior vena cava (IVC) sensor is an emerging implantable sensor placed in the IVC to assess volume status and guide heart failure management

Early evidenceFirst‑in‑human and feasibility trials (FUTURE‑HF, FUTURE‑HF2) reported initial implant experience and safety/feasibility outcomes

Implementation componentsImplantable sensor, delivery system, external belt and mobile/web applications for data transmission