Commentary: Combined Approach to Limb Salvage With Cryoplasty Therapy and Transmetatarsal Amputation

Though this case is interesting and certainly has a good initial clinical outcome, it is not without significant controversy. As the authors point out, excellent limb salvage rates have been achieved with many technologies in the crural vessels. From plain balloon angioplasty to cutting balloon to excimer laser, acute clinical outcomes have been acceptable. However, this particular case was accomplished with a balloon system that costs significantly more than a plain balloon. In the BIG CHILL registry, the average lesion length was less than 5 cm and thus these results are best compared to the control, balloon angioplasty arms of recent randomized trials such as PARIS (brachytherapy) and Intracoil (stent). The average restenosis rate for these two trials ranged from 28–34%, very similar to the rate presented on cryoplasty. The 9-month target lesion revascularization rate is also similar for both cryoplasty and the balloon control arm from the Intracoil trial, 16 and 17%, respectively. Though the cryoplasty investigators quote dissection rates of 42% in historic controls, this is not the case in the more modern control arms such as Intracoil, with a 7% need for stent versus the 9% seen with cryoplasty. Thus, though the authors are commended for the excellent acute procedural outcome, the justification for the additional cost has not, to date, been born out by any data presented. This case points out the need for randomized trials where the benefit of a more expensive technology should be scientifically evaluated before rapid adoption, to help spare the potential waste of health care dollars.