Prosthetic Gait Achievement in an Elderly Patient with Chronic Limb-threatening Ischemia and High Complications Using a Novel Lipoprotein Apheresis

Hiroyuki Tashima; Mitsuhiro Ochi; Ryoko Hori; Akiko Hachisuka; Hideaki Itoh; Yasuyuki Matsushima; Satoru Saeki

doi:10.2490/prm.20240039

ABSTRACT

Background: Chronic limb-threatening ischemia is a condition of the lower extremities that requires therapeutic intervention. It is characterized by ischemia, tissue loss, neuropathy, infection, and risk of amputation.

Case: An 82-year-old woman with a history of bilateral total knee arthroplasty and rheumatoid arthritis underwent a left ankle arthroplasty. Wound healing was delayed, and chronic limb-threatening ischemia was diagnosed. When endovascular therapy was found ineffective, novel low-density lipoprotein apheresis was initiated. Pedicle flap and split-thickness skin grafting were performed to save the affected limb. However, skin necrosis progressed, and the patient underwent left lower limb amputation 17 days after ankle arthroplasty. The stump included a skin graft area, and the decision to fabricate a prosthetic leg was difficult because of the patient’s advanced age, rheumatoid arthritis, and poor upper limb function. However, her cognitive function, muscle strength, and joint range of motion were good. No sign of wound infection was observed, and the patient was able to walk before surgery. Therefore, we decided to fabricate a prosthetic leg. Seventy-five days after amputation, the patient achieved independent walking using a cane and a silver-wheel walker.

Discussion: The benefit of novel low-density lipoprotein apheresis helped our decision to fabricate a prosthesis when uncertainty existed about the maturity of a recent amputation in an elderly patient with chronic limb-threatening ischemia. The patient successfully achieved a prosthetic gait under challenging conditions.

INTRODUCTION

Chronic limb-threatening ischemia (CLTI) includes conditions of the lower extremities that require therapeutic intervention because of ischemia, tissue loss, neuropathy, infection, or other amputation risks.¹⁾ CLTI is a severe manifestation of lower extremity arterial disease (LEAD), and its primary treatment involves revascularization, such as surgery or endovascular therapy (EVT).¹⁾ Since March 2021, Rheocarna® (Kaneka Corporation, Osaka, Japan), a novel direct hemoperfusion adsorptive column, has been covered by the Japanese medical insurance system. It can be used for LEAD patients with Fontaine classification IV who are not suited to revascularization treatment to improve ulcers. Exercise therapy is the basic treatment for LEAD conditions other than CLTI and requires continuous effort to improve exercise tolerance and vascular function by maintaining walking habits. In a previous study, the lower extremity amputation rate was 31.86±2.85 per 100,000 people.²⁾ Approximately half of the patients with amputation caused by critical limb ischemia cannot ambulate at 10 months postoperatively, and regaining ambulation is particularly difficult with increasing age.³^,⁴⁾ The inability to ambulate after lower limb amputation (LLA) significantly correlates with mortality,⁵⁾ emphasizing the importance of regaining ambulation for improved quality of life and life expectancy. Typically, the decision to use a prosthetic leg for a lower limb amputee is based on a comprehensive evaluation using the International Classification of Functioning, Disability, and Health (ICF). However, determining the suitability of a prosthetic leg is challenging.

In the present study, we encountered a patient with rheumatoid arthritis (RA) (Steinbrocker stage IV, class 3) who underwent LLA after starting low-density lipoprotein apheresis (LDL-A) for CLTI and was diagnosed with skin necrosis after ankle joint replacement surgery. The patient was at risk for femoral amputation because of advanced age, skin grafts, and various comorbidities. However, we report the successful establishment of an independent prosthetic gait through effective wound management.

CASE

The patient, an 82-year-old woman, had received RA treatment for approximately 40 years. Despite the ongoing treatment, joint destruction advanced, leading to bilateral total knee arthroplasty approximately 25 years ago. The patient walked indoors holding on to objects and used a silver-wheel walker outdoors. However, severe pain from rheumatoid deformity in the patient’s left ankle impeded mobility, leading to hospitalization. Comorbidities included hypertension, diabetes, cervical myelopathy, and insomnia. Her medications included amlodipine (10 mg/day), pitavastatin (1 mg/day), sitagliptin (0.75 µg/day), eldecalcitol (0.75 µg/day), lansoprazole (15 mg/day), methotrexate (4 mg/day), folic acid (5 mg/day), trimethoprim/sulfamethoxazole (1 tablet/day), suvorexant (15 mg/day), brotizolam (0.25 mg/day), acetaminophen (1200 mg/day), Clostridium butyricum MIYAIRI (120 mg/day), and abatacept (500 mg/dose, one injection per month). The patient’s medical history included a left femoral neck fracture (osteosynthesis) approximately 20 years prior and esophageal cancer surgery (endoscopic treatment) approximately 10 years prior.

The patient underwent artificial ankle replacement surgery for pain relief; however, the patient had postoperative pain at rest and delayed wound healing, with a skin perfusion pressure (SPP) of 27 mmHg (plantar side of left foot) and 14 mmHg (dorsal side of left foot) (WIfI ischemic grade 1–3). The patient continued continuous negative pressure irrigation therapy for the wound for 8 weeks; however, no improvement was observed. Contrast-enhanced computed tomography of the lower extremities revealed calcified lesions in the arteries of both legs (Fig. 1). Lower extremity angiography revealed complete occlusion of the left anterior and posterior tibial arteries and 99% occlusion of the left peroneal artery. Based on these laboratory findings, the patient was diagnosed with CLTI. Therefore, the patient underwent EVT; however, the stenosis of the left peroneal artery only showed slight improvement.

Fig. 1.

Contrast-enhanced computed tomography of lower extremities. Calcified lesions were noted in the arteries of both legs.

Treatment with Rheocarna® was initiated, involving blood flow administered at 30–110 mL/min for 2 h per session twice weekly, leading to a total of 24 sessions. Subsequently, the patient underwent pedicle flap surgery (raised 5 cm proximal to the lateral malleolus of the fibula) and split-thickness skin grafting (harvested from the left femur) for the tissue defect. However, skin necrosis progressed. Therefore, left LLA was performed 12 weeks after ankle replacement surgery. The left knee joint was an artificial joint with a stump length of 15 cm (stump bone: 10.3 cm), part of which included a skin graft (Fig. 2). Stump bandage management and standing training were initiated on the third postoperative day, and the patient was transferred to our department for prosthesis creation 17 days after the amputation.

Fig. 2.

(a) Left lower leg after delayed flap surgery. (b) After LLA, the stump contained a portion of the skin graft from earlier surgery.

The following general findings were recorded at the time of transfer: Revised Hasegawa Dementia Scale, 26 points (calculation −2, recitation −2); height, 144.8 cm; weight, 34.3 kg; body mass index, 16.5 kg/m²; heart rate, 72 beats/min; and blood pressure, 120/70 mmHg. Grip strength (right/left) was 5.4/7.8 kg, the fingers of both hands deviated to the ulnar side, and the left middle and ring fingers each had a buttonhole deformity. The following range of motion (ROM) (right/left) measurements were recorded: shoulder flexion, 160/150°; elbow extension, 0/0°; hand dorsiflexion, 20/30°; palmar flexion, 20/20°; hip flexion, 120/120°; hip extension, 10/10°; hip abduction, 40/40°; knee flexion, 110/110°; knee extension, 0/0°; and right foot dorsiflexion, 5°. The manual muscle test (MMT) score for lower limb muscle strength was 5 on the unaffected side and 4 on the affected side. Routine laboratory tests revealed decreased levels of hemoglobin (7.5 g/dL), serum albumin (3.1 g/dL), and total cholesterol (126 mg/dL). HbA1c level (NGSP 5.2%) was within the normal range. The levels of inflammatory markers, including C-reactive protein (1.27 mg/dL) and erythrocyte sedimentation rate (39 mm/h), were slightly elevated. The patient had a functional independence measure (FIM) score of 81 (50 for motor items and 31 for cognitive items) and required light assistance to stand on one leg during transfer.

We evaluated function and disability based on the ICF (Fig. 3), identified problems, and considered the appropriateness of the prosthetic leg construction. As an elderly woman with RA, the patient had limited upper limb function, and her residual limb featured a skin graft area. The decision on whether to create a prosthesis was challenging because of concerns about potential deterioration of the patient’s health (CLTI and RA), mainly because use of a prosthesis can strain the skin of the residual limb. Normally, wearing a prosthesis is expected to worsen the condition of the stump. However, it was anticipated that Rheocarna® use would improve blood flow to the residual limb and help maintain the overall condition. Although the patient was able to walk and was motivated preoperatively, we decided to create a prosthetic leg. This choice was based on the belief that continued use of Rheocarna® and additional RA treatment could mitigate the risk factors. Given the patient’s hypoactivity and her need for stair-climbing ability, the prosthesis included a patellar tendon-bearing socket, thigh cuff belt for suspension, and energy-storing foot. The temporary prosthesis was completed on the 31st postoperative day, marking the commencement of walking training (Fig. 4). The permanent prosthesis was completed on the 73rd postoperative day (Fig. 5).

Fig. 3.

International Classification of Functioning, Disability, and Health framework used for patient evaluation after LLA. TKA, total knee arthroplasty.

Fig. 4.

Patient walking with the prosthesis.

Fig. 5.

Timeline of the patient’s clinical course and treatment after LLA.

Rehabilitation training was initiated upon admission. Before LLA, muscle strengthening and ROM training were performed, ensuring that no load was placed on the wound. Before surgery, the patient was confined to bed, except for toileting, to elevate the affected limb. After LLA, the patient was encouraged to get out of bed. After installation of the prosthetic leg, the patient underwent training in stump care, standing and walking, and activities of daily living (ADL); however, the patient had to be careful to prevent wound formation and suture separation because of the prosthetic leg attachment. The stump was appropriately protected with dressing and no wound or infection was observed. LDL-A required 2 h of rest; although the patient experienced stress from needle insertion, there was no fatigue before or after the procedure. Therefore, patients can be involved in rehabilitation on the day of the procedure. Active progress in getting out of bed continued, and, on postoperative day 75, MMT of lower limb muscle strength on the affected side was grade 5, grip strength (right/left) was 7.0/9.0 kg, and ROM was unchanged. In addition, the circumference of the left lower leg (5/10 cm from tip of the stump) also decreased from 25.5/25 cm to 21/21.5 cm, and the stump had matured. The patient achieved independent walking with a cane and with a silver-wheel walker, climbed a flight of seven stairs at home, and was discharged on postoperative day 81 with a FIM score of 102 (71 motor items and 31 cognitive items) (Fig. 5). Written informed consent for the publication of case details was obtained from the patient.

DISCUSSION

In the present case, an elderly patient with RA and CLTI required LLA because of progressive postoperative skin necrosis. Determining the indication for a prosthetic leg according to the ICF was challenging. Considering the positive impact of LDL-A on improving blood flow, we fabricated a prosthetic leg to address the issue of transected skin, which is considered the most inhibiting factor. The patient’s general condition and wound healing were good, and the patient could walk safely with a prosthetic leg.

In the decision to use a prosthesis in a patient with LLA, factors that promote and inhibit gait acquisition, including their importance, should be evaluated. Predictive factors for considering prosthetic candidacy are the level of amputation, age, physical strength, and comorbidities.⁶⁾ Predictors of good walking ability after LLA include cognitive ability, physical fitness, ability to stand on one leg, independence in ADL, and preoperative motor ability.⁷⁾ However, a long period from surgery to the start of rehabilitation, residual limb problems,⁷⁾ and blood flow problems are negative predictive factors.⁸⁾ In the present case, the most significant negative factor in deciding to create a prosthetic leg was the condition of the stump skin (skin grafting and insufficient blood flow). Achieving optimal wound healing and transection maturation is crucial for prosthesis creation in lower leg amputees. Rheocarna® was designed as a prototype LDL-A system. In Japan, plasma purifiers such as Selesorb® and Liposorber® are available for patients with LEAD under specific conditions. However, their sole purpose is to adsorb LDL-C in patients with refractory hypercholesterolemia.⁹⁾ Rheocarna® is known to adsorb lipoproteins, such as LDL-C, activate the kinin–kallikrein system, and induce the production of vasoactive factors such as nitric oxide, prostaglandin E2, and prostaglandin I2.¹⁰⁾ In addition, this system can efficiently remove fibrinogen, which is a risk factor for thrombotic diseases. It is worth noting that an advantage of this system over conventional LDL-A is that lower volumes of extracorporeal circulating plasma are required, it can be easily performed in the clinic using a common blood circulation device, and it is indicated for peripheral arterial disease of Fontaine classification IV, regardless of the patient’s LDL level.¹⁰⁾ Kojima et al.¹¹⁾ reported that Rheocarna® effectively improved SPP in patients with CLTI with no options; the study reported that it may improve capillary circulation, reduce blood viscosity, and improve wound microcirculation. To the best of our knowledge, studies on LDL-C levels and improved blood flow to the amputated limb are scarce. However, with the expectation that this mechanism would enhance blood flow and facilitate wound healing, we decided to create a prosthetic leg under these difficult conditions.

Creating a transtibial prosthesis requires more rehabilitation training than creating a single prosthesis. In cases of LEAD with Fontaine classification IV with ulcers or gangrene, exercise therapy is contraindicated for individuals with acute arterial occlusion or infection.¹⁾ Even in the absence of an infection, limiting the patient’s rehabilitation training to light exercise without weight bearing is recommended.¹⁾ We continued muscle strength training and ROM exercises for the limbs and trunk before surgery, ensuring no strain on the affected lower limb. Even after amputation, the patient resumed training early after surgery, with a focus on minimizing the load. Despite the challenge of wound care during loading, no infection, ulceration, or gangrene occurred, even in the grafted area. In addition to continuing Rheocarna®, the patient’s joint pain was managed by the resumption of rheumatism treatment; the patient’s walking ability improved as the patient actively moved out of bed. Even on the day of Rheocarna® treatment, patients can continue rehabilitation training. If this therapy can hasten wound healing or prevent the risk of amputation, it may reduce the need for bed rest and hospital stay associated with treatment. These circumstances would contribute to improved ADL status. In addition, maintaining good condition of the residual limb and undertaking rehabilitation training before and soon after surgery may have contributed to the patient’s independence in walking with the prosthesis.

Therefore, providing mobility to transtibial amputees with LEAD is crucial. Efforts to enhance blood flow, including the use of LDL-A, should be considered. Creating a prosthetic leg should be based on a comprehensive judgment utilizing promoting factors in accordance with the ICF, along with the initiation of preoperative and early postoperative rehabilitation. In the present case, the patient managed to walk with a prosthetic leg; however, the ability of patients with similar conditions to walk with a prosthetic leg remains uncertain. As medical science advances, numerous patients with LLAs may eventually walk with prosthetic legs and enjoy long and high-quality lives. However, the potential costs of failure must not be overlooked. Further research is needed to elucidate the balance between promoting and inhibiting factors.

CONCLUSION

For patients with CLTI, acquiring mobility post-LLA impacts both quality of life and prognosis. This report describes our comprehensive approach to prosthetic leg creation, detailing a case in which the patient achieved mobility with a prosthetic leg by effectively addressing associated challenges and enhancing wound care using LDL-A.

ACKNOWLEDGMENTS

We thank the rehabilitation therapists at the University of Occupational and Environmental Health Hospital, Kitakyushu, for their support with this case study.

CONFLICTS OF INTEREST

The authors declare no conflict of interest.

REFERENCES

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