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This manuscript bravely describes an innovative treatment of 13 patients with 14 critically ischemic limbs who by their criteria were not candidates for routine arterial revascularization. Two thirds of these patients were diabetic and had either poor run-off, no suitable vein conduit, or were in generally poor medical condition that obviated a major operation. Surprisingly, 9 of these limbs demonstrated a significant increase in pulse volume amplitude after 3 months, giving some proof of numbers to this voodoo-type therapy. All of these limbs were salvaged. The other 4 limbs did not have such an increase in their pulse volume amplitude, and their limbs were not salvaged. Three of the 4 patients who had a flat-line pulse volume recording noted at the ankle prior to treatment unfortunately went on to undergo amputation. An element of patient compliance was noted as well. Those patients using their device for a mean of 2.38 hours a day—almost the recommended time of 4 hours per day—had their limbs salvaged, whereas those only using their device for a mean of 1.14 hours per day required an amputation. The follow-up was short—8.7 ± 6.9 months as 2 patients died during the study period. But in these patients, that follow-up period is rather long as their life expectancy is lower than in those patients who can undergo revascularization.
I have had limited experience using this device and have reserved it for the identical indications as these authors have listed, with most of my patients not having any outflow artery suitable for a bypass. I have seen improvement in rest pain symptoms after 1 month of use, and a few patients have used the device for more than 1 month, some right up to their deaths. These patients tend to be fragile and by the "eyeball test" could not tolerate most any procedure. This device does provide an option to relieve their pain without using narcotics and other pain medications that, because of their poor medical condition, they cannot take owing to the adverse effects.
Many of these patients require a caregiver to place the device on their leg and to turn it on and off. Some patients cannot tolerate the squeezing action of the device and therefore are not compliant. We have had trouble with some payers in that they will not pay for renting of the compression device (about $100 per month) and also will not pay for the cuff bladder ($150) for the individual. Perhaps this article will give some credit where credit is due so that this kind of alternative treatment can be prescribed and paid for by these patients' health care insurance carriers. Certainly the cost of this nonsurgical treatment is less than a major bypass operation and also less than the cost of an amputation. As we all know, amputations in this group of patients rarely allows them to live independently again, and they must be placed in some rehabilitation facility or nursing home for the remainder of their life.
As our population ages, more and more patients who are not candidates for major arterial revascularizations for a variety of reasons will have to deal with limb-threatening ischemia. Many patients also come looking for treatment options that do not involve invasive surgical procedures that carry with them high morbidity and mortality rates. It is up to the surgeon to have not only major operations in his or her armamentarium but also other modalities of treatment that fit the patients' needs and wants. This device actually works by clinical improvement and seems to improve the physiologic blood flow to the extremity in some manner. I agree that a larger multicenter study would be advantageous for further evaluation of this device.
Freischlag JA. Limb Salvage Using High-Pressure Intermittent Compression Arterial Assist Device in Cases Unsuitable for Surgical Revascularization—Invited Critique. Arch Surg. 2001;136(11):1286. doi:10.1001/archsurg.136.11.1286
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