What are the approved indications, contraindications, screening criteria, and alternative therapies for the Barostim neo system in adults with resistant hypertension or heart failure with reduced ejection fraction?

Barostim Neo System: Indications, Contraindications, and Clinical Application

Approved Indications

The Barostim Neo system is FDA-approved for two distinct indications: heart failure with reduced ejection fraction (HFrEF) and resistant hypertension. 1, 2

Heart Failure with Reduced Ejection Fraction

• Approved for patients with NYHA Class III heart failure 1
• Left ventricular ejection fraction ≤35% 1, 2
• Must be on chronic stable guideline-directed medical therapy (GDMT) 1, 2
• Patients should have persistent symptoms despite optimal medical management 1

Resistant Hypertension

• Indicated for patients with resistant hypertension who have failed medical therapy 3, 4
• Defined as uncontrolled blood pressure despite use of multiple antihypertensive medications 3
• Typically requires failure of 3 or more antihypertensive agents including a diuretic 5

Absolute Contraindications

Barostim is contraindicated in patients with bilateral carotid atherosclerosis or prior carotid surgery, as the device requires unilateral carotid sinus electrode placement. 3, 1

Additional contraindications include:

• Active infection or sepsis at time of implantation 3
• Baroreflex failure or autonomic dysfunction 1
• Patients requiring urgent cardiac surgery or intervention 1

Patient Screening and Selection Criteria

Optimal Candidates for HFrEF

Select patients with NYHA Class III symptoms, NT-proBNP <1600 pg/mL, and eGFR ≥30 mL/min, as these patients demonstrate the most consistent benefit. 6, 2

• Baseline NT-proBNP <1600 pg/mL predicts better outcomes 2
• eGFR ≥30 mL/min is associated with lower mortality risk 6
• Patients with NYHA Class IV or advanced disease have persistently high event rates despite BAT 6
• Prior heart failure hospitalization is common but not a contraindication 6

Optimal Candidates for Resistant Hypertension

• Office systolic BP ≥140 mmHg despite ≥3 antihypertensive medications 5, 3
• 24-hour ambulatory BP monitoring should confirm uncontrolled hypertension 3, 4
• Exclude secondary causes of hypertension before device consideration 5
• Medication adherence must be verified 5

Poor Candidates (High Risk)

Avoid BAT in patients with NYHA Class IV, NT-proBNP >1600 pg/mL, or eGFR <30 mL/min, as mortality remains unacceptably high despite therapy. 6

• Advanced heart failure with multiple organ dysfunction 6
• Severe renal impairment (eGFR <30 mL/min) 6
• Patients requiring frequent heart failure hospitalizations despite GDMT 6

Evidence-Based Medical Alternatives

For Heart Failure with Reduced Ejection Fraction

Prioritize the four pillars of GDMT before considering device therapy: ACE inhibitors/ARBs/ARNI, beta-blockers, mineralocorticoid receptor antagonists, and SGLT2 inhibitors. 5

First-Line Medical Therapy

• Sacubitril/valsartan (ARNI) provides superior mortality benefit compared to ACE inhibitors alone 5
• Beta-blockers (carvedilol, metoprolol succinate, or bisoprolol) reduce mortality by ≥20% 5
• Mineralocorticoid receptor antagonists (spironolactone or eplerenone) reduce sudden death 5
• SGLT2 inhibitors reduce cardiovascular death and heart failure hospitalizations 5

Device Alternatives

• Cardiac resynchronization therapy (CRT) is indicated for LVEF ≤35%, LBBB, QRS ≥150 ms, and NYHA Class II-IV despite 3 months of GDMT 5
• Implantable cardioverter-defibrillator (ICD) for primary prevention in LVEF ≤35%, NYHA Class II-III, at least 40 days post-MI 5
• CRT improves both survival and symptoms, unlike ICDs which provide only mortality benefit 5

For Resistant Hypertension

Maximize pharmacologic therapy with spironolactone as the fourth agent before considering device-based interventions. 5

Optimal Medical Regimen

• Three-drug combination: CCB + RAS inhibitor + chlorthalidone (long-acting thiazide) 5
• Fourth agent: Spironolactone provides substantial BP reduction compared to placebo or other active drugs 5
• Fifth agent considerations: Alpha-blockers, hydralazine, minoxidil, or centrally acting agents 5

Emerging Pharmacologic Options

• Aldosterone synthase inhibitors (baxdrostat, lorundrostat) show promise in Phase 2 trials 5
• Endothelin receptor antagonist (aprocitentan) reduced office and 24-hour BP in Phase 3 trials 5
• RNA interference agent (zilebesiran) provides sustained BP reduction over 6 months 5

Clinical Outcomes and Safety Profile

Efficacy in Heart Failure

BAT improves 6-minute walk distance by 49 meters, quality of life by 13 points on MLWHF score, and increases odds of NYHA class improvement by 3.4-fold at 6 months. 2

• Significant reduction in NT-proBNP in patients with baseline levels <1600 pg/mL 2
• Trend toward fewer heart failure hospitalization days 1
• LVEF improved modestly from 25.5% to 30.0% at 12 months 6
• Major adverse neurological and cardiovascular event-free rate of 97.2% 1

Efficacy in Resistant Hypertension

BAT reduces office systolic BP by approximately 21 mmHg at 6 months and 24 mmHg at 1 year, with concurrent reduction in antihypertensive medication burden. 3

• Number of antihypertensive drug classes decreased from 6.6 to 5.6 3
• 24-hour ambulatory BP monitoring shows significant reductions in both systolic and diastolic BP 4
• Nighttime SBP decreased from 165 to 151 mmHg 4

Common Adverse Events

Nearly all patients (97.6%) experience mild adverse events (Grade I) within the first 6 months, primarily device-related discomfort that resolves with parameter optimization. 3

• Grade I events (97.6%): Local discomfort, clinical observation only, no intervention required 3
• Grade II events (28.6%): Medically significant events including hypertensive crisis, syncope, or arrhythmias 3
• Most procedure-related events relate to incision or anesthetic complications 3
• Device parameter optimization resolves most adverse events without sequelae 3

Critical Clinical Pitfalls

Patient Selection Errors

• Avoid implanting in advanced disease stages (NYHA IV, severe renal dysfunction, very high NT-proBNP) where mortality remains high despite therapy 6
• Do not proceed without confirming medication adherence and excluding secondary hypertension in resistant hypertension candidates 5
• Verify adequate GDMT duration (at least 3 months) before considering device therapy in HFrEF 5, 1

Post-Implantation Management

• Schedule frequent follow-up visits in the first 6 months to identify and manage adverse events through parameter adjustment 3
• Individualize pulse generator settings as no standardization exists due to diverse BP responses 3
• Continue GDMT as BAT is adjunctive therapy, not a replacement for evidence-based medications 1, 2

Timing Considerations

BAT should be considered earlier in the disease trajectory rather than as a last resort in advanced stages where outcomes remain poor. 6

• Mortality at 1 year (20%) and 3 years (33%) in real-world cohorts matches predicted risk scores, indicating BAT does not eliminate baseline risk 6
• Earlier intervention in less advanced disease may yield better outcomes, though this requires further study 6