Cath Lab Digest

Abstract

Intravascular hemolysis has been reported with a variety of atherectomy devices. We report a case of hemolysis after the use of the rotational aspiration Pathway Jetstream^® catheter in the treatment of severe superficial femoral artery stenosis.

Key words: atherectomy, peripheral vascular disease

VASCULAR DISEASE MANAGEMENT 2010;7:E110–E111

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Case Presentation

We describe a 77-year-old female ex-smoker with a known past medical history of stable coronary artery disease (CAD), diabetes mellitus, hypertension, dyslipidemia and mild carotid disease who presented with gradual worsening of left calf pain over a 2-week period.

Her history was notable for extensive symptomatic peripheral arterial disease requiring revascularization (Rutherford Category 3, ankle-brachial index [ABI] of 0.65). Her initial peripheral intervention consisted of percutaneous transluminal angioplasty and stenting of a long total occlusion of the left superficial femoral artery (SFA). The total occlusion started at the mid SFA and spanned a length of 150 mm, demonstrating reconstitution at the distal SFA level. The iliac artery system was patent, and there was 2-vessel runoff below the knee. Following the procedure, she became a Rutherford Category 1, with improvement in the ABI to 1.04. Seven months thereafter, she presented with progressively worsening left lower extremity claudication (Rutherford Category 3, ABI 0.68). Physical examination did not reveal any skin changes or wounds, but the left dorsalis pedis and posterior tibialis pulses were faint. Arterial duplex studies showed multiple hemodynamically significant stenoses within the left SFA stents with peak systolic velocities approaching 430 cm/sec.

After discussion with the patient regarding treatment options, the decision was made to undergo repeat percutaneous intervention. Angiography revealed a severe de novo lesion at the ostium of the left SFA, multiple areas of severe in-stent restenosis of the mid SFA and a subtotal in-stent restenosis within the distal SFA segment (Figure 1A). The total length of the diseased segment was 280 mm. Two-vessel runoff was observed.

Procedure. Access was obtained via the right common femoral artery using a 7 Fr 45 cm crossover sheath. The SFA lesions were crossed with a 0.014 inch x 300 cm guidewire supported by a 0.018 inch x 90 cm support catheter. Rotational atherectomy of the ostial SFA and the entire SFA in-stent restenosis was performed using the Pathway Jetstream® revascularization catheter (Pathway Medical Technologies, Inc., Kirkland, Washington) (Figure 1B). Three runs were performed using the 2.1 mm profile for a total of 5.5 minutes followed by three additional runs using the 3.0 mm profile for 6.2 minutes. Excellent luminal gain was noted in the mid-distal SFA in-stent restenosis segments with less than 20% residual stenosis (Figure 1C). No dissection was observed.

Post-procedure course. The intervention was completed uneventfully. During the routine post-procedure monitoring, the patient was noted to have dark-brown urine. A urinalysis revealed large hemoglobinuria and absent red blood cells. A peripheral blood sample was analyzed for markers of intravascular hemolysis showing a rise in the lactate dehydrogenase (LDH) from baseline 1,155–2751 U/L (reference range: 313–618 U/L) along with a low haptoglobin (< 20 mg/dL [reference range: 30–200 mg/dL]). The metabolic profile remained stable, including a serum creatinine of 0.6 mg/dL. The hemoglobin decreased from 12.1 g/dL to 10.8 g/dL. The platelets and coagulation factors did not fluctuate. The patient was monitored in the cardiac step-down unit for the next 24 hours, during which the urine cleared and the hemoglobin remained stable without requiring transfusion of blood products. There were no clinical symptoms reported, and the patient was discharged the following morning. At 1-week follow-up, the claudication improved (Rutherford Category 1) with an increase in ABI to 0.96. The urinalysis was normal, and the LDH decreased to 904 U/L.

Discussion

Currently, a variety of percutaneous treatment modalities are available to address peripheral arterial occlusive disease. Aside from conventional percutaneous transluminal angioplasty and stent implantation, there has been a resurgence of interest in plaque debulking technologies.^1,2 As such, there are several different types of atherectomy devices that have been added to the current armamentarium, including directional atherectomy (SilverHawk®, ev3, Inc., Minneapolis, Minnesota), orbital atherectomy (DiamondBack 360®, CSI, Minneapolis, Minnesota) and rotational atherectomy (Pathway Jetstream®, PMT, Inc., Kirkland, Washington).

The newest rotational aspiration atherectomy system (Pathway Medical PV device) uses expandable, rotating scraping blades (“flutes”) at a speed of 60,000 rpm. Aspiration ports located just proximal to the flutes enable active aspiration of fluid and debris, thus theoretically minimizing the risk of distal embolization.

To date, there have been only two pilot studies reporting on the efficacy and safety of this device. In 15 femoral-popliteal lesions, Zeller et al reported a technical success rate of 100% and a 6-month primary patency of 73%. They reported 3 adverse events including perforation, false aneurysm, dissection and distal embolism.³ In another report of 23 femoral-popliteal lesions, Wissgott et al demonstrated a technical success rate of 100% and a 6-month primary patency rate of 92%. They described 2 complications including dissection and distal embolization.⁴