Initial experience with directed laser atherectomy using the CLiRpath photoablation atherectomy system and bias sheath in superficial femoral artery lesions.
OBJECTIVE
To report a safety and efficacy study of directed excimer laser atherectomy with the Bias Sheath guiding catheter to create larger lumens in the superficial femoral artery (SFA).


METHODS
Fourteen patients (9 men; mean age 66+/-9 years, range 46-76) with chronic lower limb ischemia (Rutherford class 2 to 5) referable to SFA stenoses were treated with the 8-F-compatible Bias Sheath and a 1.7- or 2.0-mm laser catheter. Eight (57%) lesions were de novo and 6 (43%) were in-stent restenoses (ISR). Mean diameter stenosis was 96%+/-8% (range 80%-100%; 10 total occlusions), and mean lesion length was 126+/-78 mm (range 30-290). The primary study endpoint was laser success, defined as <50% angiographic residual stenosis post-laser, without major perforations.


RESULTS
The primary endpoint was achieved in 8 (57%) lesions; all patients underwent additional balloon angioplasty, which achieved an angiographic residual stenosis <30% in all. Three lesions could not be completely traversed with the study device. Two dissections were detected after Bias Sheath application; 1 required stenting. There were 2 embolic events (specific to the antegrade device design); both were treated with aspiration therapy. Intravascular ultrasound (IVUS)-based minimal lumen diameters were 0.23+/-0.2 mm (range 0-1.0) at baseline and 3.2+/-0.8 mm after Bias Sheath application. Rutherford category improved at 1 month in 10 (71%) patients. One patient remained unchanged, another worsened (category 2 to 3), 1 died, and the fourth was not examined. The ankle-brachial index improved from 0.41+/-0.18 at baseline to 0.79+/-0.19 at discharge and to 0.80+/-0.19 at 1 month. Primary 1-month patency (<50% restenosis by duplex) was 85% (11/13 lesions).


CONCLUSIONS
SFA lesions, including ISR, can be treated in the majority of cases with directed laser atherectomy, significantly reducing plaque burden as measured by IVUS. Embolization was attributed to device-specific features of the prototype antegrade sheath design, which was discontinued. Larger studies are mandatory to document the long-term technical and clinical impact of this new device.
Rastan
Aljoscha
A
Department of Angiology, Heart Centre Bad Krozingen, Germany.
Sixt
Sebastian
S
Schwarzwälder
Uwe
U
Kerker
William
W
Bürgelin
Karlheinz
K
Frank
Ulrich
U
Noory
Elias
E
Gremmelmeier
Daniel
D
Branzan
Daniela
D
Hauswald
Kirsten
K
Brantner
Regina
R
Schwarz
Thomas
T
Zeller
Thomas
T
D000368:Aged; D000792:Angiography; D000800:Angioplasty, Balloon; D017222:Angioplasty, Balloon, Laser-Assisted / Q000009:adverse effects / Q000295:instrumentation*; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D017073:Atherectomy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D002908:Chronic Disease; D003251:Constriction, Pathologic / Q000601:surgery; D004617:Embolism / Q000209:etiology; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D007511:Ischemia / Q000209:etiology* / Q000473:pathology / Q000503:physiopathology / Q000601:surgery; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D014654:Vascular Patency