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Treatment of infrapopliteal post-PTA dissection with tack implants: 12-month results from the TOBA-BTK study
M. Brodmann, C. Wissgott, A. Holden, R. Staffa, T. Zeller, T. Vasudevan, P. Schneider,
Language English Country United States
Document type Journal Article, Multicenter Study
PubMed
29573541
DOI
10.1002/ccd.27568
Knihovny.cz E-resources
- MeSH
- Angioplasty, Balloon adverse effects instrumentation mortality MeSH
- Leg blood supply MeSH
- Time Factors MeSH
- Progression-Free Survival MeSH
- Endovascular Procedures adverse effects instrumentation mortality MeSH
- Ischemia diagnostic imaging mortality physiopathology therapy MeSH
- Critical Illness MeSH
- Humans MeSH
- Peripheral Arterial Disease diagnostic imaging mortality physiopathology therapy MeSH
- Vascular System Injuries diagnostic imaging etiology surgery MeSH
- Prospective Studies MeSH
- Prosthesis Design MeSH
- Vascular Patency MeSH
- Risk Factors MeSH
- Self Expandable Metallic Stents * MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Alloys MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Geographicals
- Europe MeSH
- New Zealand MeSH
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.
Auckland City Hospital Auckland New Zealand
Kaiser Permanente Honolulu Hawaii
Klinische Abteilung für Angiologie Medizinische Universtitätsklinik Graz Austria
St Anne's University Hospital and Faculty of Medicine Masaryk University Brno Czech Republic
Universitäts Herzzentrum Bad Krozingen Germany
References provided by Crossref.org
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