TALON Data

Early Results from the Treating Peripherals with SilverHawk: Outcomes Collection (TALON) Registry

Gammon R, Fail P, Walker C, Allie D, Cardenas J, Ramaiah V, Solis M, Runyon JP, Vale J, Kiesz S

Purpose: To evaluate 'real world' clinical experience in peripheral arterial catheter-based revascularization with the SilverHawk Plaque Excision System (FoxHollow, Redwood City, CA) through TALON, a prospective, non-randomized registry designed to capture patient outcomes data in conjunction with histology and gene expression patterns of the excised tissue.

Methods: Consecutive patients undergoing plaque excision for the treatment of lower extremity peripheral arterial disease (PAD) were included. Study endpoints include immediate procedural and angiographic outcomes and target lesion patency and revascularization at 6 and 12 months post-procedure.

Results: Plaque excision was performed in 220 patients and 442 lesions (table 1). 14% of the patients were treated for severe PAD (Rutherford-Becker scores ≥5). 73% of the lesions were above-the-knee and 27% were below-the-knee (table 2). 87% of the lesions were de novo and 12% were restenotic (7% ISR). Moderate-severe calcification was observed in 66% of lesions. Occlusions accounted for 26% of lesions. Pre-dilation was required in 13% of the lesions. Nearly half of the procedures treated ≥2 lesions (table 3). Stand-alone plaque excision was used in 74% of lesions; stents were placed in <5% of the lesions. Angiographic data shows a reduction in the average diameter stenosis from 87.1% to 9.9% in stand alone SilverHawk cases and 87.6% to 9.8% in cases utilizing adjunctive therapy. Post SilverHawk minor complications included perforation (0.7%), dissection A/B (2.5%), and dissection ≥C (0.5%). There were no reports of distal embolization, thrombosis, abrupt closures or re-occlusions.

Table 1: Demographics

Historical and Current Diagnoses	Percentage of Subjects
Gender (percentage of males)	59
Diabetes requiring therapy	55
History of claudication	97
History of MI, CABG, PCI	54
History of previous peripheral intervention	48
History of smoking	70

Table 2: Lesions

Lesion Location	No. of Lesions	%
Iliacs	21	4.8
Common Femoral/Profunda	26	5.9
SFA	211	47.7
Popliteal	66	14.9
TPT	58	13.1
AT/PT/Peroneal	56	12.7
Dorsalis Pedis	4	0.9

Table 3: Lesions treated/procedure

Lesions per Procedure	Number of Procedures	%
1	146	55.1
2	79	29.8
3-5	24	15.2

Conclusions: Percutaneous revascularization of peripheral arteries with the SilverHawk Plaque Excision System is associated with high rates of immediate procedural success in both above and below-the-knee lesions spanning a wide range of vessel sizes (<2.0 - 7.0 mm). The ability to treat multiple lesions of any length with one device combined with the low complication rate demonstrates the safety and efficacy of this Plaque Excision System for treatment of peripheral arteries.

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