ABSTRACT
BACKGROUND: Atherectomy is an important option for debulking atherosclerotic plaque from diseased arteries in patients with infrainguinal arterial disease. Laser atherectomy uses a high-powered laser to remove the plaque from the arteries to restore blood flow. AIMS: The Pathfinder multicenter registry was initiated to evaluate the safety and efficacy of the 355 nm laser atherectomy system in a real-world setting for the treatment of de novo, re-stenotic and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with peripheral artery disease (PAD). METHODS: The study was a prospective, single-arm, multicenter, open-label registry study for patients treated with the 355 nm laser system. Clinical and lesion characteristics, procedural safety and efficacy data, and baseline, 6-, and 12-month outcomes data, including Ankle Brachial Index (ABI), Rutherford class, and Walking Impairment Questionnaires (WIQ), were collected. The primary efficacy endpoint was the achievement of ≤30% final residual stenosis at the index lesion postatherectomy and adjunctive therapy evaluated by an angiographic Core Lab. The primary safety endpoint was the percentage of subjects who did not experience periprocedural major adverse events (PPMAEs) before discharge. RESULTS: One hundred and two subjects with 121 lesions treated with the 355 nm laser device at 10 centers were included in the analysis. Mean age was 68.4 ± 10.21 years, 61.8% of subjects were male, 44.6% had critical limb ischemia (CLI), and 47.3% had tibial lesions. The mean residual stenosis at the end of the procedure was 24.4 ± 15.5 with 69 lesions (69.0%) achieving technical procedural success (<30% stenosis); similar rates were observed for subjects with ISR (25.5 ± 14.9), chronic total occlusion (CTO) (28.1 ± 17.0), and severe calcification (36.5 ± 21.6) lesions. Mean ABI, Rutherford, and WIQ scores were improved at both 6 and 12 months. Ninety-seven of 102 subjects (95.1%) met the primary safety endpoint of not experiencing a PPMAE before discharge. CONCLUSIONS: The initial data from the Pathfinder Registry demonstrates the 355 nm laser system is safe and effective in a real-world setting for performing atherectomy in patients with infrainguinal PAD.
Subject(s)
Atherectomy , Peripheral Arterial Disease , Registries , Humans , Male , Female , Aged , Prospective Studies , Peripheral Arterial Disease/therapy , Peripheral Arterial Disease/physiopathology , Peripheral Arterial Disease/diagnostic imaging , Treatment Outcome , Atherectomy/adverse effects , Atherectomy/instrumentation , Time Factors , Aged, 80 and over , Lasers, Solid-State/therapeutic use , Lasers, Solid-State/adverse effects , Middle Aged , Recurrence , United States , Ankle Brachial Index , Recovery of Function , Vascular Patency , StentsABSTRACT
Recent data show that a high percentage of patients with systolic left ventricular dysfunction have sleep-disordered breathing (SDB), contributing to the incidence of morbidity and mortality in heart failure. This study examines the prevalence of sleep disorders in stable heart failure patients regardless of ejection fraction. On three consecutive days in a heart failure clinic, all patients were asked to participate in a screening for SDB. This screening involved the placement of an outpatient device (ClearPath, Nexan, Inc., Alpharetta, GA), which collects thoracic impedance, oxyhemoglobin saturation, and 2-lead electrocardiogram data. Sixteen patients (42%) had moderate or severe SDB, and 22 patients (55%) had mild or no significant SDB. Fourteen of the 16 patients with moderate or severe SDB subsequently received treatment by confirming SDB and the continuous positive airway pressure in a sleep lab. Forty-two percent of patients with stable heart failure presenting to a heart failure clinic screened positive for SDB, despite receiving optimal standard of care.
