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May 24-25, 2018
London, UK
Vascular Surgery 2018
3
rd
Edition of World Congress & Exhibition on
Vascular Surgery
Journal of Vascular and Endovascular Therapy
ISSN: 2573-4482
Objective:
Angioplasty often results in dissections and remains a
significant problem. Dissections are typically managed with stents,
which are associated with high rates of in-stent restenosis. Two
tack optimized balloon angioplasty (TOBA) studies evaluated the
safety and efficacy of a novel implant for dissection repair in both
above and below the knee lesions. The Tack combines low outward
force with minimal metal to provide focal treatment for dissections.
Methods:
TOBA was a prospective, single-arm study evaluated
patients with Rutherford Category 2-4 caused by lesions of the
superficial femoral and popliteal arteries. Patients were treated
with standard balloon angioplasty, and post-PTA dissections
were treated with Tacks. The primary endpoints were device
technical success (ability of the Tack implants to resolve post-
PTA dissection) and device safety (absence of new-onset major
adverse events). TOBA BTK, a separate study, evaluated patients
with CLI and infrapopliteal lesions. The primary safety endpoint
was a composite of MALE and POD at 30 days. Device success and
procedure success were also assessed.
Results:
In TOBA, Tacks were used in 130 patients with post-PTA
dissections (74.0% grade C). Technical success was achieved
in 98.5% of patients with no major adverse events at 30 days.
Twelve-month patency was 76.4%, and freedom from TLR was
89.5%. Significant improvement from baseline was observed in
Rutherford clinical category and ankle-brachial index at 12 months
(p<0.0001). In TOBA BTK, 32 patients received dissection repair
with Tacks. Freedom from MALE and POD at 30 days was 97.1%.
Twelve-month patency was 78.4% and freedom from CD-TLR at 12
months was 93.5%.
Conclusions:
Tack implant treatment of post-PTA dissection was
safe and resulted in low rates of TLR both above and below the
knee. Tack treatment represents a new, minimal metal paradigm
for dissection repair that can safely improve the clinical results
associated with PTA.
Figure 1:
Example of resolved BTK Post-PTA dissection. Left: Two dissections
(brackets) resulted from angioplasty. Right: Three Tack implants (arrows) were
placed.
Recent Publications
1. Werk M, Albrecht T, Meyer D R, et al. Paclitaxel-coated
balloons reduce restenosis after femoro-popliteal
angioplasty: evidence from the randomized PACIFIER
trial. Circ Cardiovasc Interv 2012; 5: 831-40.
2. Kiguchi MM, Marone LK, Chaer RA, et al. Patterns of
femoropopliteal recurrence after routine and selective
stenting endoluminal therapy. J Vasc Surg 2013; 57:37–
43.
3. Al-Nouri O, Krezalek M, Hershberger R, et al. Failed
super cial femoral artery intervention for advanced
infrainguinal occlusive disease has a signi cant negative
impact on limb salvage. J Vasc Surg 2012; 56:106–10.
4. Tosaka A, Soga Y, Iida O, et al. Classi cation and clinical
impact of restenosis after femoropopliteal stenting. J Am
Coll Cardiol 2012; 59:16–23.
5. Bosiers M, Scheinert D, Hendriks JMH et al. Results from
the Tack Optimized Balloon Angioplasty (TOBA) study
demonstrate the benefits of minimal metal implants for
dissection repair after angioplasty. J Vasc Surg 2016;
64:109-16.
Post-PTA dissection repair above and below the knee
Luboš Kubíček
Masaryk University, Czech Republic
Luboš Kubíček, J Vasc Endovasc Therapy 2018, Volume 3
DOI: 10.21767/2573-4482-C1-002