Abstract：
OBJECTIVE: This prospective, longitudinal, pragmatic study describes at home treatment with a proprietary advanced pneumatic compression device (APCD) for patients with lower extremity lymphedema (LED).
METHODS: Following institutiona review board approval, four participating Veterans Affairs centers enrolled LED patients from 2016 to 2022. The primary outcome measures were health-related quality of life (HR-QoL) questionnaires (lymphedema quality of life-leg and the generic SF-36v2) obtained at baseline and 12, 24, and 52 weeks. The secondary outcome measures were limb circumference, cellulitis events, skin quality, and compliance with APCD and other compression therapies.
RESULTS: Because a portion of the trial was conducted during the coronavirus disease 2019 pandemic, 179 patients had 52 weeks of follow-up, and 143 had complete measurements at all time points. The baseline characteristics were a mean age of 66.9 ± 10.8 years, 91% were men, and the mean body mass index was 33.8 ± 6.9 kg/m2. LED was bilateral in 92.2% of the patients. Chronic venous insufficiency or phlebolymphedema was the most common etiology of LED (112 patients; 62.6%), followed by trauma or surgery (20 patients; 11.2%). Cancer treatment as a cause was low (4 patients; 2.3%). Patients were classified as having International Society for Lymphology (ISL) stage I (68.4%), II (27.6%), or III (4.1%). Of the primary outcome measures, significant improvements were observed in all lymphedema quality of life-leg domains of function, appearance, symptoms, and emotion and the overall score after 12 weeks of treatment (P < .0001) and through 52 weeks of follow-up. The SF-36v2 demonstrated significant improvement in three domains at 12 weeks and in the six domains of physical function, bodily pain, physical component (P < .0001), social functioning (P = .0181), role-physical (P < .0005), and mental health (P < .0334) at 52 weeks. An SF-36v2 score <40 indicates a substantial reduction in HR-QoL in LED patients compared with U.S. norms. Regarding the secondary outcome measures at 52 weeks, compared with baseline, the mean limb girth decreased by 1.4 cm (P < .0001). The maximal reduction in mean limb girth was 1.9 cm (6.0%) at 12 weeks in ISL stage II and III limbs. New episodes of cellulitis in patients with previous episodes (21.4% vs 6.1%, P = .001) were reduced. The 75% of patients with skin hyperpigmentation at baseline decreased to 40% (P < .01) at 52 weeks. At 52 weeks, compliance, defined as use for 5 to 7 days per week, was reported for the APCD by 72% and for elastic stockings by 74%.
CONCLUSIONS: This longitudinal study of Veterans Affairs patients with LED demonstrated improved generic and disease-specific HR-QoL through 52 weeks with at home use of an APCD. Limb girth, cellulitis episodes, and skin discoloration were reduced, with excellent compliance.
METHODS: Following institutiona review board approval, four participating Veterans Affairs centers enrolled LED patients from 2016 to 2022. The primary outcome measures were health-related quality of life (HR-QoL) questionnaires (lymphedema quality of life-leg and the generic SF-36v2) obtained at baseline and 12, 24, and 52 weeks. The secondary outcome measures were limb circumference, cellulitis events, skin quality, and compliance with APCD and other compression therapies.
RESULTS: Because a portion of the trial was conducted during the coronavirus disease 2019 pandemic, 179 patients had 52 weeks of follow-up, and 143 had complete measurements at all time points. The baseline characteristics were a mean age of 66.9 ± 10.8 years, 91% were men, and the mean body mass index was 33.8 ± 6.9 kg/m2. LED was bilateral in 92.2% of the patients. Chronic venous insufficiency or phlebolymphedema was the most common etiology of LED (112 patients; 62.6%), followed by trauma or surgery (20 patients; 11.2%). Cancer treatment as a cause was low (4 patients; 2.3%). Patients were classified as having International Society for Lymphology (ISL) stage I (68.4%), II (27.6%), or III (4.1%). Of the primary outcome measures, significant improvements were observed in all lymphedema quality of life-leg domains of function, appearance, symptoms, and emotion and the overall score after 12 weeks of treatment (P < .0001) and through 52 weeks of follow-up. The SF-36v2 demonstrated significant improvement in three domains at 12 weeks and in the six domains of physical function, bodily pain, physical component (P < .0001), social functioning (P = .0181), role-physical (P < .0005), and mental health (P < .0334) at 52 weeks. An SF-36v2 score <40 indicates a substantial reduction in HR-QoL in LED patients compared with U.S. norms. Regarding the secondary outcome measures at 52 weeks, compared with baseline, the mean limb girth decreased by 1.4 cm (P < .0001). The maximal reduction in mean limb girth was 1.9 cm (6.0%) at 12 weeks in ISL stage II and III limbs. New episodes of cellulitis in patients with previous episodes (21.4% vs 6.1%, P = .001) were reduced. The 75% of patients with skin hyperpigmentation at baseline decreased to 40% (P < .01) at 52 weeks. At 52 weeks, compliance, defined as use for 5 to 7 days per week, was reported for the APCD by 72% and for elastic stockings by 74%.
CONCLUSIONS: This longitudinal study of Veterans Affairs patients with LED demonstrated improved generic and disease-specific HR-QoL through 52 weeks with at home use of an APCD. Limb girth, cellulitis episodes, and skin discoloration were reduced, with excellent compliance.
摘要：
目的：这项前瞻性纵向研究描述了在家中使用专有的高级气动压缩装置（APCD）治疗下肢淋巴水肿（LED）患者。
方法：在IRB批准后，4个参与的VA中心从2016年至2022年招募了LED患者。主要结局指标是健康相关生活质量（HR-QoL）问卷；（LYMQOL-leg）和基线时获得的通用SF-36v2™，12、24和52周。次要结果指标是肢体周长，蜂窝织炎事件,皮肤质量,以及对APCD和其他压缩疗法的依从性。
结果：由于试验的一部分是在COVID期间进行的，179名患者接受了52周的随访，而143在所有时间点都有完整的测量结果。基线特征为平均年龄66.9±10.8岁，91%男性,平均BMI为33.8±6.9。LED为双侧92.2%。慢性静脉功能不全或静脉血栓水肿是LED最常见的病因（112例；62.6%），其次是创伤/手术（20例；11.2%）。4例患者（2.3％）的癌症治疗原因较低。患者被归类为国际淋巴学会（ISL）第一阶段（68.4％），两个（27.6%）和三个（4.1%）。
方法：在所有LYMQOL腿功能域中观察到显着改善，外观,症状,情感，治疗12周后（p<0.0001）和随访52周后的总体评分。SF-36v2™在12周时在3个结构域中显示出显著的改善;在52周时在6个身体功能结构域中,身体疼痛,物理分量（p<0.0001），社会功能（p=0.0186），角色-物理（p<0.0006），心理健康（p<0.0333）。SF-36v2™评分<40表明与美国标准相比,LED患者的HR-QoL显著降低。52周时的次要结局指标：与基线相比，平均肢体周长减少1.4cm（p<.0001）；在ISL第2/3期肢体中，平均肢体周长测量值的最大减少为1.9cm（6.0％）。先前发作的患者出现新的蜂窝织炎发作（21.4％vs6.1％，p=0.001）减少。基线时75%的皮肤色素沉着患者在52周时下降到40%(p<0.01)。52周时,合规,定义为使用5-7天/周，据报道，APCD占72%，弹性长袜占74%。
结论：这项对患有LED的VA患者的纵向研究表明，在家庭使用APCD的情况下，通过52周，改善了通用和疾病特异性HR-QoL。四肢围长,蜂窝织炎发作和皮肤变色减少，同时保持良好的合规性。
方法：在IRB批准后，4个参与的VA中心从2016年至2022年招募了LED患者。主要结局指标是健康相关生活质量（HR-QoL）问卷；（LYMQOL-leg）和基线时获得的通用SF-36v2™，12、24和52周。次要结果指标是肢体周长，蜂窝织炎事件,皮肤质量,以及对APCD和其他压缩疗法的依从性。
结果：由于试验的一部分是在COVID期间进行的，179名患者接受了52周的随访，而143在所有时间点都有完整的测量结果。基线特征为平均年龄66.9±10.8岁，91%男性,平均BMI为33.8±6.9。LED为双侧92.2%。慢性静脉功能不全或静脉血栓水肿是LED最常见的病因（112例；62.6%），其次是创伤/手术（20例；11.2%）。4例患者（2.3％）的癌症治疗原因较低。患者被归类为国际淋巴学会（ISL）第一阶段（68.4％），两个（27.6%）和三个（4.1%）。
方法：在所有LYMQOL腿功能域中观察到显着改善，外观,症状,情感，治疗12周后（p<0.0001）和随访52周后的总体评分。SF-36v2™在12周时在3个结构域中显示出显著的改善;在52周时在6个身体功能结构域中,身体疼痛,物理分量（p<0.0001），社会功能（p=0.0186），角色-物理（p<0.0006），心理健康（p<0.0333）。SF-36v2™评分<40表明与美国标准相比,LED患者的HR-QoL显著降低。52周时的次要结局指标：与基线相比，平均肢体周长减少1.4cm（p<.0001）；在ISL第2/3期肢体中，平均肢体周长测量值的最大减少为1.9cm（6.0％）。先前发作的患者出现新的蜂窝织炎发作（21.4％vs6.1％，p=0.001）减少。基线时75%的皮肤色素沉着患者在52周时下降到40%(p<0.01)。52周时,合规,定义为使用5-7天/周，据报道，APCD占72%，弹性长袜占74%。
结论：这项对患有LED的VA患者的纵向研究表明，在家庭使用APCD的情况下，通过52周，改善了通用和疾病特异性HR-QoL。四肢围长,蜂窝织炎发作和皮肤变色减少，同时保持良好的合规性。
