The latest innovation in intravascular ultrasound: Reconnaissance PV .018 OTW digital IVUS catheter

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This advertorial is sponsored by Philips.

Frank R. Arko III

Intravascular ultrasound (IVUS) is now used in a wide variety of peripheral vascular interventions after having first been utilized in coronary circulation in the late 1980s. The increased complexity of endovascular interventions has required improved imaging, and IVUS is the one tool besides angiography that can easily allow direct visualization of the vessel and improve outcomes. IVUS-guided interventions resulted in a significantly larger mean diameter while reducing the odds of TLR (target lesion revascularization) at 6-, 12-, 18-, 24-, months in coronary studies. Lesions at high risk were studied in a randomized controlled trial of 150 patients. IVUS use resulted in larger minimal lumen gain, a lower six-month restenosis rate, while TLR at 12 months was also significantly decreased.1

The use of IVUS in peripheral interventions, while not randomized, has demonstrated improved outcomes—for example, in aortoiliac occlusive disease.2 In a retrospective analysis of 1,198 patients (28% critical limb ischemia [CLI]) to investigate whether IVUS improves primary patency following nitinol stenting for TASC II A–C femoropopliteal lesions, 2,324 propensity score-matched patients were compared with those treated without IVUS. IVUS was used in 22% of the overall population—in those with more severe TASC classification—with a mean follow-up of 1.9 +/– 1.5 years. Five-year patency was 65% compared to 35% for patients with and without IVUS (p<0.001), respectively.3

Case review

Here, we present a case of a severely limited claudicant who presented with three years of worsening calf pain. The patient was a prior smoker who was treated with maximum medical therapy and a walking program. This initially improved the symptoms, but after three months she regressed. Exercise ankle-brachial indices (ABIs) were performed. At rest, the ABI on the left leg was 0.67. With exercise this decreased to 0.17. On the angiogram, there was a long segment stenosis of the superficial artery (SFA), but otherwise there were three-vessel runoffs to the foot (see figure 1).

Pre-intervention IVUS was used to size the diameter of the SFA through the long segment of diseased artery. Pre-dilatation was performed followed by the Stellarex drug-coated balloon (DCB). Completion arteriogram showed marked improvement in flow but a possible dissection in the mid-segment of the SFA. IVUS’ unique ChromaFlo feature was then used to identify and confirm the areas of dissection (see figure 2). Most of the vessel had significant luminal gain but there were multiple areas of short-segment dissection.

These were then treated with placement of a total of six Tack Endovascular System implants. The Tack implants were then post-dilated using plain old balloon angioplasty (POBA). Completion angiogram and IVUS (see figure 3) demonstrated resolution of the dissections. Follow-up ABI was 0.95 at rest.

The benefits of utilizing IVUS have been shown in the literature. In nearly every vascular bed studied, we have seen an improvement in overall outcomes. Over the last several years, especially with the introduction of DCBs, as well as atherectomy, there has been a move away from utilizing the use of stents to minimize in-stent restonosis, stent fractures and stent thrombosis. The Tack system optimizes percutaneous transluminal angioplasty (PTA), especially with DCB therapy, to individually treat dissections and to avoid the need to place long segments of stents. In reviewing data on PTA with Tack and PTA alone, there was a marked improvement in the primary patency of 67–87% in patients treated with a DCB compared to 95% 12-month patency in patients treated with DCB and Tack.4 This case shows the utility of utilizing IVUS with a DCB to allow for treatment with the Tack system, minimizing the need for longer stents.

Featured products

The newly developed Reconnaissance PV .018 OTW IVUS has several benefits that allow for improved image quality and durability, and enhanced catheter design with an over-the-wire platform. It is easily deliverable through complex lesions due to enhanced tapered tip, improved hydrophilic coating, and is 5F compatible. It is constructed with a stainless-steel shaft for improved pushability. The over-the-wire design also allows for fluid infusion up to 300psi, easy guidewire exchanges between 0.014 and 0.018, and an extra 15cm working length.

The Tack system is a first-of-its-kind dissection repair device that allows for precision treatment of peripheral arterial dissections following balloon angioplasty in both above- and below-knee lesions. The device comes in various sizes. There are four or six preloaded Tack implants for the below- and above-knee systems, respectively. The system is accurate to <=1mm deployment. The Tack itself is made out of nitinol with gold markers. It has been studied in the TOBA trials.4–6 These studies demonstrate that post-PTA dissection repair with the Tack system improves outcomes for both POBA and DCB angioplasty for patients with peripheral arterial disease (PAD) and CLI. The case example shows how these systems can be combined to improve outcomes and improve long-term patency.

References

  1. Medical Advisory Secretariat. Intravascular ultrasound to guide percutaneous coronary interventions: An evidence-based analysis. Ont Health Technol Assess Ser. 2006;6(12):1–97. Epub 2006 Apr 1. PMID: 23074482; PMCID: PMC3379536.
  2. Arko F., Mettauer M., McCollough R., et al. Use of intravascular ultrasound improves long-term clinical outcomes in the endovascular management of atherosclerotic aortoiliac occlusive disease. Journal of Vascular Surgery. Apr 1998; volume 27, issue 4, P614–623.
  3. Iida O., Takahara M., Soga Y., et al. Efficacy of intravascular ultrasound in femoropopliteal stenting for peripheral artery disease with TASC II class A to C lesions. J Endovasc Ther. 2014 Aug;21(4):485–92. doi: 10.1583/14-4721R.1. PMID: 25101575.
  4. Brodmann M., Wissgott C., Brechtel K., et al. Optimized drug-coated balloon angioplasty of the superficial femoral and proximal popliteal arteries using the Tack Endovascular System: TOBA III 12-month results. Journal of Vascular Surgery. Volume 72, Issue 5, 2020, Pages 1636–1647.
  5. Gray W., Cardenas J., Brodmann M., et al. Treating post-angioplasty dissection in the femoropopliteal arteries using the Tack Endovascular System: 12-Month results from the TOBA II study. JACC. 2019 Dec, 12(23) 2375–2384.
  6. Geraghty P.J., Adams G.L., Schmidt A., et al, on behalf of the TOBA II BTK Investigators. Twelve-month results of Tack-optimized balloon angioplasty using the Tack Endovascular System in below-the-knee arteries (TOBA II BTK). Journal of Endovascular Therapy 27.4 (2020): 626–636.

Frank R. Arko III, MD, is chief of vascular and endovascular surgery, and co-director of the Aortic Institute at Sanger Heart & Vascular Institute, Atrium Health, in Charlotte, North Carolina. Arko has been compensated for his services for Philips’ further use and distribution.

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