OBJECTIVES: The Tack implant is designed for focal, minimal metal management of dissections. This study evaluated Tacks for treating postpercutaneous transluminal angioplasty (PTA) dissection in patients with below-the-knee (BTK) arterial occlusive disease. BACKGROUND: PTA is the most commonly used endovascular treatment for patients with occlusive disease of the BTK vessels. Post-PTA dissection is a significant clinical problem that results in poor outcomes, but currently there are limited treatment options for managing dissections. METHODS: This prospective, single-arm study evaluated patients with CLI and BTK lesions; 11.4% were Rutherford category (RC) 4 and 88.6% were RC 5. BTK occlusive disease was treated with standard PTA and post-PTA dissections were treated with Tack placement. The primary safety endpoint was a composite of major adverse limb events (MALE) and perioperative death (POD) at 30 days. Other endpoints included: device success; procedure success (vessel patency in the absence of MALE); freedom from clinically driven target lesion revascularization (CD-TLR); primary patency; and changes in RC. Data through 12 months are presented. RESULTS: Thirty-two of 35 (91.4%) patients had post-PTA dissection and successful deployment of Tacks. Procedural success was achieved in 34/35 (97.1%) patients with no MALEs at 30 days. The 12-month patency rate was 78.4% by vessel, 77.4% by patient, and freedom from CD-TLR was 93.5%. Significant (P < .0001) improvement from baseline was observed in RC (75% of patients improved 4 or 5 steps). CONCLUSION: Tack implant treatment of post-PTA dissection was safe and effective for treatment of BTK dissections and resulted in reasonable 12-month patency and low rates of CD-TLR.
- MeSH
- balónková angioplastika škodlivé účinky přístrojové vybavení mortalita MeSH
- bérec krevní zásobení MeSH
- časové faktory MeSH
- doba přežití bez progrese choroby MeSH
- endovaskulární výkony škodlivé účinky přístrojové vybavení mortalita MeSH
- ischemie diagnostické zobrazování mortalita patofyziologie terapie MeSH
- kritický stav MeSH
- lidé MeSH
- onemocnění periferních arterií diagnostické zobrazování mortalita patofyziologie terapie MeSH
- poranění cév diagnostické zobrazování etiologie chirurgie MeSH
- prospektivní studie MeSH
- protézy - design MeSH
- průchodnost cév MeSH
- rizikové faktory MeSH
- samoexpandibilní metalické stenty * MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- slitiny MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- Geografické názvy
- Evropa MeSH
- Nový Zéland MeSH
