The patient underwent a Bruce protocol stress test in mid 2021 during which exercise was stopped at 1 minute due to bilateral lower extremity pain. The patient returned to the clinic approximately 1 year later in early 2021 where she underwent an exercise electrocardiogram to determine the claudication threshold. Despite progression of PAD, the patient did not have symptoms consistent with claudication, and conservative therapy was continued. Additionally, exercise ABI was obtained, which showed a change in left ABI from 0.85 to 0.67 after exercise. A duplex ultrasound conducted in early 2020 demonstrated progression of PAD with pulse wave velocity of the CFA of 456 cm/sec before dropping to 68 cm/sec in the SFA. The patient followed-up at regular intervals to be examined for progression of PAD. At the time, the patient experienced atypical symptoms of PAD, so conservative therapy consisting of an optimized medical regimen and recommended daily exercise therapy was pursued. Pulse wave velocities were elevated in her left common femoral artery (CFA) and proximal superficial femoral artery (SFA) at 220 and 247 cm/sec, respectively, before dropping to 97 cm/sec in the mid SFA. Her first arterial ultrasound was obtained in mid 2018, which demonstrated inflow abnormalities of her left limb. The patient has a history of hypertension but no significant coronary artery disease and has preserved systolic function. The patient is a woman in her late 80s known to the practice for several years. This case report further validates the successful utilization of the Auryon system in a real-world setting.* CASE 1 PATHFINDER serves as an exploratory study and structures the future data collection surrounding the Auryon laser. Ultimately, the goal of PATHFINDER is to observe the utilization of the Auryon laser by physicians in outpatient labs, hospitals, and ambulatory surgery centers to better understand the use of the device and explore future research questions. Secondary endpoints include freedom from major adverse events, patency, and clinical outcomes (ankle-brachial index, Walking Impairment Questionnaire, Rutherford class) at 6, 12, and 24 months. The primary safety endpoint was freedom from periprocedural major adverse events. The primary efficacy endpoint was defined as ≤ 30% final stenosis after laser atherectomy using the Auryon system and adjunctive therapy (if used), as assessed by a core lab. The first patient was enrolled in August 2020, and enrollment was completed in March 2021. Permissible lesion location included all infrainguinal arteries de novo, restenotic, and ISR lesions were allowed. 3 One hundred four patients with Rutherford class 2 to 5 PAD were prospectively enrolled in this postmarket registry. 2 The PATHFINDER registry explores the periprocedural, intermediate, and long-term safety and efficacy of the Auryon system in the treatment of patients with PAD in a real-world setting. Rundback et al showed that the Auryon system (previously called the B-Laser) was safe and effective across all lesion types, with no device-related embolizations, perforations, dissections requiring stenting, amputations, or pseudoaneurysms. 1,2 However, little is known about the real-world use of the laser system or how safe and effective it is when treating a more complex patient cohort. The Auryon laser atherectomy system (AngioDynamics, Inc.) is a solid-state platform with a unique wavelength of 355 nm and short pulse width of 10 to 25 ns that has been demonstrated to provide effective plaque reduction and associated durable clinical results across a wide range of arterial distribution and lesion morphologies, including in-stent restenosis (ISR) and moderate arterial calcification. Peripheral artery disease (PAD) affects an increasingly high number of patients with a spectrum of symptoms.
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