SURPASS-HF: Safety and Utility of Remote Pulmonary Artery Sensor Shared-management in Heart Failure

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Abstract

Background

Insulin-dependent diabetics self-titrate therapy to self-obtained glucose values as standard of care, yet heart failure (HF) patients with implanted pulmonary artery (PA) pressure sensors never see their own readings; clinicians interpret and execute every dose change - a model that does not scale to a ∼200-patient HF panel. To our knowledge, SURPASS-HF is the first prospective feasibility study applying the insulin-titration paradigm to PA-pressure-guided HF care: patients executing a prescribed loop-diuretic sliding scale, supported by ARTHUR, a domain-trained large language model, with clinician confirmation of every adjustment.

Methods

Non-randomized, prospective, single-arm, single-center 90-day feasibility study (January 14-April 14, 2026; 60.1 patient-months). Twenty-one adults with implanted PA sensors enrolled (intention-to-treat, ITT); 19 completed full follow-up (per-protocol, PP). Regimens and individual PA diastolic (PAD) targets were explicitly prescribed; when daily pressures met published serial-reading thresholds, the software prepared the pre-determined adjustment, the clinician confirmed it, and the patient executed it. ARTHUR reinforced dose ceilings, prompted surveillance labs, and escalated edge cases for review. Pre-specified outcomes: adverse events, escalations, time in optimal PA range (TIR-PAP, +/-5 mmHg of goal), reading adherence, provider overrides, and paired delta_PAD (first vs last 7-day windows). Confidence intervals are descriptive; the study was not powered for significance.

Results

Mean age was 69+/-11 years, 52% women, mean baseline PAD 14.8 mmHg. No pre-specified safety event (KDIGO >or=1 AKI, hyperkalemia, hyponatremia, symptomatic hypotension) was detected (0/8 post-adjustment draws in 5/21 patients; exact 95% CI 0-37%); laboratory ascertainment was sparse, so a meaningful harm rate cannot be excluded. Seventeen of 19 PP patients (89%) required no protocol-triggered escalation; 4 escalations occurred in 2 patients. TIR-PAP was 88.4% (ITT)/91.3% (PP); reading adherence 92.1%; 53 provider alerts (0.88/patient-month) all resolved (median 24 h) with no overrides. delta_PAD was -0.89 mmHg (ITT; 95% CI -2.60 to +0.82) in a cohort already at goal at baseline. Two non-cardiac hospitalizations occurred.

Conclusions

LLM-mediated, clinician-confirmed patient execution of a published deterministic PA-pressure-guided diuretic algorithm was feasible over 90 days, with high time-in-range and adherence and no detected safety events. Findings from this prospective, single arm, non-randomized, small cohort are descriptive. The study was not designed or powered to demonstrate evidence of a treatment effect; a randomized, well powered prospective comparison study against provider-led PA-pressure management is the next ideal step.

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