Abstract
BACKGROUND: Exercise stress testing is the gold standard for evaluating peripheral arterial disease (PAD) and exercise-induced pulmonary hypertension, but traditional treadmill testing has operational limitations including need for patient transport, specialized facilities, and inability to perform invasive hemodynamic monitoring during exercise. METHODS: This prospective single-center feasibility study enrolled 54 consecutive patients undergoing ABI (n = 35) or RHC (n = 19) procedures at Owensboro Medical Practice. The Bedside Bike (Bedside Bike, LLC; 510(k)-exempt Class I device, product code ION) was integrated into routine vascular laboratory and catheterization laboratory workflows. Primary endpoints included exercise completion rates, data interpretability, and safety. Prespecified success criteria were: completion rate ⩾90% and interpretability ⩾80% for ABI; completion rate ⩾90% and interpretability ⩾70% for RHC; system usability ⩾80% for both. RESULTS: Exercise was attempted in 94.4% (51/54; 95% CI: 87.0-100%) of patients with a 94.1% (48/51; 95% CI: 86.3-100%) completion rate among those who attempted. Data interpretability was excellent: 97.1% (34/35; 95% CI: 91.4-100%) for ABI and 84.2% (16/19; 95% CI: 68.4-100%) for RHC. All prespecified feasibility criteria were met. System usability ratings were 85.7% (95% CI: 74.3-97.1%) for ABI and 89.5% (95% CI: 73.7-100%) for RHC. Adverse events were minor and occurred in 14.3% of ABI and 5.3% of RHC procedures. Among RHC patients with paired measurements, median cardiac output increased from 4.0 [IQR: 3.8-4.7] L/min at rest to 5.0 [4.8-6.5] L/min with exercise, with a median mPAP/CO slope of 8.26 [6.88-14.12] mmHg/L/min. CONCLUSION: This feasibility study demonstrates that bedside exercise testing using a portable pedaling device is technically feasible, safe, and well-tolerated for both ABI and RHC procedures. These preliminary results support larger studies to evaluate diagnostic validity and clinical utility.