The utilization of percutaneous methods for the treatment of peripheral arterial disease (PAD) is an increasing national trend, aided by advances in technology that help improve clinical outcomes. Interventionalists are increasingly willing to attempt revascularization of more complex lesions that have traditionally been treated with open surgical procedures..1-6 Balloon angioplasty is commonly accepted as the first-line treatment for PAD because of its proven effectiveness in disrupting atherosclerotic plaque, as well as its cost efficiency compared to other percutaneous revascularization methods.2,7-11 However, acute arterial injury from balloon angioplasty can lead to unwanted sequelae. Balloon angioplasty that results in arterial dissection causes a reactive inflammatory response that can lead to the development of neointimal hyperplasia and long-term arterial restenosis.2,7,8,12-15 Arterial dissections are a common sequela of balloon angioplasty, with incidence rates as high as 84%, regardless of lesion type classification. Arterial segments that experience dissections have target lesion revascularization rates 3.5-fold higher (10.5% vs 37%) than lesions without identifiable acute dissections.6,7,12,16-18
The development of drug-eluting technology effectively addressed the reactive inflammatory response to arterial trauma by suppressing the development of neointimal hyperplasia with anti-proliferative drugs such as paclitaxel.19-31 The U.S. FDA has since issued a statement of safety concern regarding a potential increased mortality risk from use of paclitaxel for treatment of PAD, which has led many interventionalists to exercise caution in their use of drug-eluting technology.32-34 This shift highlights the need to address dissection in the current landscape of PAD treatment.
Due to increased risk factors for restenosis after dissection, provisional stenting is generally performed in order to act as a mechanical scaffold that assists in the vessel wall apposition of the dissected tissue.6,8,28,35 Provisional stenting provides optimal short-term hemodynamic outcomes; however, the insertion of a rigid foreign body into the vasculature initiates an inflammatory response similar to what was previously discussed, negatively affecting the long-term patency of the treated segment.4,14,36-46 A novel re-design of the traditional nitinol stent may offer better clinical outcomes for arterial dissections following balloon angioplasty.6,7,35 The Tack implant (Intact Vascular) minimizes many of the factors that increase the risk of in-stent restenosis, such excessive outward radial force that results in adventitial stretching, long stented segments, and dynamic frictional forces between the artery and stent.4,38-44 The Tack implants achieve the same mechanical scaffold effect as traditional self-expanding nitinol stents. However, the Tack implants have lower radial force and 70% less of a metallic imprint, and they demonstrate reduced short-term neointimal proliferation, inflammation, and restenosis rates when compared to a traditional self-expanding nitinol stent.6,35
The case herein describes a 64-year-old man with lifestyle-limiting right lower extremity claudication. This case highlights the use of Tack implants to address two grade D dissections of the mid-right superficial femoral artery (SFA) following balloon angioplasty.
A 64-year-old man with a history of coronary artery disease, hyperlipidemia, and hypertension presented in clinic with right calf pain upon walking approximately 100 meters that resolved with rest (Rutherford 3). Bilateral abdominal aortography with runoff was performed, revealing a severe stenosis (80%) of the mid-right SFA.
During the index procedure for the right lower extremity, an OmniFlush catheter (AngioDynamics) was positioned at the level of the right common femoral artery (CFA) for selective angiography with runoff (Figure 1). A Runthrough NS Extra Floppy guidewire (Terumo) was used to traverse the diseased segment. The Runthrough guidewire was exchanged for an .018-inch NiT-Vu guidewire (AngioDynamics) through a Glidecath support catheter (Terumo), and the lesion was prepared with a 5 × 80 mm Armada PTA balloon (Abbott Vascular). After vessel preparation, another balloon angioplasty was performed with a 6 × 120 mm Lutonix drug-coated balloon PTA catheter (BD). Angiography demonstrated less than 10% residual stenosis, but there were two grade D, flow-limiting dissections that were located in the mid-right SFA (Figure 2), disrupting an optimal hemodynamic result.
A .035-inch Rosen guidewire (Cook Medical) was exchanged through a Glidecath support catheter to accommodate the Tack implant .035-inch platform. The 6-French delivery catheter with the six preloaded, self-expanding Tack implants was loaded over the wire and positioned at the distal edge of the most distal dissection. Three Tack implants were deployed, with approximately 5 mm of distance between the stent edges. The remaining three Tack implants were deployed to resolve the proximal dissection (Figure 3). An additional balloon angioplasty with a 6 × 100 mm Armada PTA balloon was performed to seat the Tack implants in the desired location to optimize vessel flap apposition to the intima. Final angiography demonstrated resolution of the flow-limiting dissections, and post-intervention imaging confirmed less than 10% residual stenosis of the mid-right SFA (Figure 4).
Arterial dissections are an undesirable outcome of balloon angioplasty, but with new balloon technologies such as low-pressure cutting/scoring and intravascular lithotripsy, there is promise for better clinical outcomes in the treatment of PAD. The recently commercially available Tack implants offer several advantages over traditional provisional stenting for arterial dissection following balloon angioplasty. As the arterial vascular tree tapers in the more distal segments, a uniform stent exerts greater radial force in segments of the vessel for which the stent is oversized. Tack implants self-size for vessel diameters 3.5 mm to 6 mm, and the 6-mm length allows for focal treatment of dissections. The smaller metallic imprint of the Tack implants permits earlier discontinuation of dual-antiplatelet therapy at the 30-days post-operative interval. A smaller metallic imprint also preserves healthy tissue for future potential treatment options. The Tack implants are an ideal treatment solution for patients who have a satisfactory angiographic result post-balloon angioplasty but have poor hemodynamic results due to arterial dissection, as in the case herein. At a 2-year follow-up post intervention, our patient reported resolution of claudication symptoms (Rutherford 0). An arterial duplex ultrasound demonstrated a widely patent mid-right SFA segment with no evidence of stenosis.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Gabriel T. Brandner, BS, has no disclosures. George L. Adams, MD, MHS, FACC, is a trainer and consultant for Cook Medical, as well as a consultant for Abbott Vascular.
Manuscript submitted on June 24, 2019; accepted on June 30, 2019.
Address for correspondence: George L. Adams, MD, MHS, FACC, Rex Hospital in Raleigh, North Carolina, and the University of North Carolina in Chapel Hill, North Carolina. Email: firstname.lastname@example.org.
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