A study comparing the extent of early infrapopliteal recoil after serration and plain balloon angioplasty has found the former produces “substantially less” arterial recoil in the treatment of these lesions and has demonstrated “technical feasibility” in measuring early recoil using standard angiography.
The investigation, led by Venita Chandra, MD, of Stanford University in Stanford, California, as well as Michael Lichtenberg, MD, and Stefan Stahlhoff, MD, of Arnsberg Clinic in Arnsberg, Germany, was driven by the rising prevalence of peripheral arterial disease (PAD), and the rapidly developing arsenal of balloon devices imbued with new technologies, which are aimed at providing more effective treatment options. Recoil following balloon angioplasty of tibial arteries is a known mechanism of lumen loss in this patient population and is considered to be a contributing factor in early failure or later restenosis.
The findings were published online in the Journal of Endovascular Therapy in early December.
The Serranator (Cagent Vascular) balloon, which is designed to provide a controlled lumen gain while minimizing vessel injury when performing percutaneous transluminal angioplasty for PAD, was compared to plain balloon angioplasty. Chandra and colleagues—including first author Arash Fereydooni, MD, a Stanford vascular surgery resident—aimed to assess the ability to define and measure post-angioplasty recoil in infrapopliteal arteries, as well as to compare the two devices’ effect on recoil.
The multicenter, sequential comparative study enrolled patients with lesions of the infrapopliteal arteries who underwent alternating plain balloon angioplasty or serration angioplasty with the Serranator device. Capturing angiographic imaging pre-, immediately post-and 15-minutes following angioplasty, the study core lab measured and analyzed vessel recoil, final diameter stenosis and dissection grade.
A total of 36 patients were enrolled, with 39 infrapopliteal lesions treated. There were no significant differences concerning demographics or lesion characteristics between the Serranator (n=20) and plain balloon angioplasty (n=19) groups. Arterial recoil, defined as greater than 10% lumen loss at 15 minutes, occurred in 25% of Serranator-treated lesions compared to 64% in the plain balloon angioplasty group. The investigators also report that clinically relevant recoil, defined as greater than 30% lumen loss at 15 minutes, was present in only 10% of patients who underwent serration and in 53% of patients after plain balloon angioplasty.
The authors note that, although their study was undertaken to test the feasibility of measuring early arterial recoil, they were able to compare the performance of a serration balloon against plain balloons in a prospective, randomized fashion.
Fereydooni et al conclude that, to their knowledge, theirs is the “first demonstration” of a head-to-head core lab adjudicated angiographic outcome assessment of infrapopliteal artery recoil between a plain balloon and any specialty balloon. Situating their findings among concurrent research, the investigators highlight the consistency of their results with the earlier PRELUDE (Prospective study for the treatment of atherosclerotic lesions using the Serranator device) study conducted by Andrew Holden, MD, from the Auckland Regional Public Health Service in Auckland, New Zealand, which found one- and six-month patency rates to be 100% and 64%, respectively, between the Serranator and plain balloon angioplasty. Similarly, Fereydooni and colleagues also point to the single-center PRELUDE-BTK follow-on study, which reported an average final residual stenosis of 17% vs. 34% between the groups.
Fereydooni et al contend that a possible explanation for these favorable results may be due to the serration mechanism allowing for “more controlled and predictable delivery of radial force” compared with plain balloons.
Although their findings may add to a body of literature that favors serration angioplasty, Fereydooni and colleagues underline that their small sample size and the “preliminary nature” of their feasibility endpoints “[limit] the analysis power” for comparing serration and plain balloon angioplasty in specific patient anatomy.
Among other limitations, the authors add that the study protocol did not include an assessment of long-term outcomes of early arterial recoil and how this translates to long-term patency between the two devices. “It would be of interest to obtain three-dimensional data using intravascular ultrasound (IVUS) to better characterize changes in area and lesion morphology with SA [serration angioplasty],” they write.
