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
• 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

OBJECTIVE: The mechanism of angioplasty is disruption of atherosclerotic plaque, which often results in dissections. Dissection after percutaneous transluminal angioplasty (PTA) remains a significant clinical problem and untreated may cause acute occlusion or later restenosis. Stents are used to manage dissections, which is often followed by in-stent restenosis and occasionally stent fracture. Tack (Intact Vascular, Wayne, Pa) implants have minimal metal and low radial force and are specifically designed for dissection repair. This study evaluated Tack implants for treatment of dissections resulting from standard balloon PTA for femoral-popliteal arterial disease. Twelve-month outcomes after Tack treatment of post-PTA dissections are described. METHODS: This prospective, single-arm study evaluated patients with ischemia (Rutherford clinical 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 end points were core laboratory-adjudicated device technical success, defined as the ability of the Tack implants to resolve post-PTA dissection, and device safety, defined as the absence of new-onset major adverse events. Patients were followed up to 12 months after implantation. RESULTS: Tacks were used in 130 patients with post-PTA dissections (74.0% ≥ grade C). Technical success was achieved in 128 (98.5%) patients with no major adverse events at 30 days. The 12-month patency was 76.4%, and freedom from target lesion revascularization was 89.5%. Significant improvement from baseline was observed in Rutherford clinical category (82.8% with grade ≤1) and ankle-brachial index (0.68 ± 0.18 to 0.94 ± 0.15; P < .0001). CONCLUSIONS: Tack implant treatment of post-PTA dissection was safe, produced reasonable patency, and resulted in low rates of target lesion revascularization. Tack treatment represents a new, minimal metal paradigm for dissection repair that can safely improve the clinical results associated with PTA.

• MeSH
• Femoral Artery diagnostic imaging   injuries   physiopathology   MeSH
• Popliteal Artery diagnostic imaging   injuries   physiopathology   MeSH
• Angioplasty, Balloon adverse effects   MeSH
• Time Factors MeSH
• Blood Vessel Prosthesis * MeSH
• Blood Vessel Prosthesis Implantation adverse effects   instrumentation   MeSH
• Lower Extremity blood supply   MeSH
• Endovascular Procedures adverse effects   instrumentation   MeSH
• Metals * MeSH
• Middle Aged MeSH
• Humans MeSH
• Peripheral Arterial Disease diagnostic imaging   physiopathology   therapy   MeSH
• Retreatment MeSH
• Vascular System Injuries diagnostic imaging   etiology   therapy   MeSH
• Prospective Studies MeSH
• Prosthesis Design MeSH
• Vascular Patency MeSH
• Aged MeSH
• Treatment Outcome MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial MeSH
• Multicenter Study MeSH

While risk scores are invaluable tools for adapted preventive strategies, a significant gap exists between predicted and actual event rates. Additional tools to further stratify the risk of patients at an individual level are biomarkers. A surrogate endpoint is a biomarker that is intended as a substitute for a clinical endpoint. In order to be considered as a surrogate endpoint of cardiovascular events, a biomarker should satisfy several criteria, such as proof of concept, prospective validation, incremental value, clinical utility, clinical outcomes, cost-effectiveness, ease of use, methodological consensus, and reference values. We scrutinized the role of peripheral (i.e. not related to coronary circulation) noninvasive vascular biomarkers for primary and secondary cardiovascular disease prevention. Most of the biomarkers examined fit within the concept of early vascular aging. Biomarkers that fulfill most of the criteria and, therefore, are close to being considered a clinical surrogate endpoint are carotid ultrasonography, ankle-brachial index and carotid-femoral pulse wave velocity; biomarkers that fulfill some, but not all of the criteria are brachial ankle pulse wave velocity, central haemodynamics/wave reflections and C-reactive protein; biomarkers that do no not at present fulfill essential criteria are flow-mediated dilation, endothelial peripheral arterial tonometry, oxidized LDL and dysfunctional HDL. Nevertheless, it is still unclear whether a specific vascular biomarker is overly superior. A prospective study in which all vascular biomarkers are measured is still lacking. In selected cases, the combined assessment of more than one biomarker may be required.

• MeSH
• Cost-Benefit Analysis MeSH
• Carotid Arteries ultrasonography   MeSH
• Biomarkers blood   metabolism   MeSH
• C-Reactive Protein metabolism   MeSH
• Hemodynamics MeSH
• Carotid Intima-Media Thickness MeSH
• Cardiology standards   MeSH
• Cardiovascular Diseases blood   diagnosis   MeSH
• Humans MeSH
• Primary Prevention MeSH
• Risk MeSH
• Decision Making MeSH
• Secondary Prevention MeSH
• Societies, Medical MeSH
• Aging MeSH
• Ankle Brachial Index MeSH
• Vascular Stiffness MeSH
• Ultrasonography MeSH
• Treatment Outcome MeSH
• Research Design MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Review MeSH
• Geographicals
• Europe MeSH