Quality of life in patients with no-option critical limb ischemia underlines the need for new effective treatment

Abstract

on behalf of the JUVENTAS and SMART study groups, Utrecht and Bilthoven, The Netherlands Objective: To provide a solid baseline reference for quality of life (QoL) in patients with no-option critical limb ischemia (CLI). CLI is associated with surgery, endovascular interventions, hospitalization, and a poor prognosis. An increasing number of clinical trials are, therefore, investigating new treatment strategies (eg, therapeutic neovascularization) in patients with CLI. QoL serves as an important secondary endpoint in many of these trials, but solid reference QoL data for patients with no-option CLI are lacking. Methods: The Medical Outcomes Study Short Form 36 (SF-36) and the EuroQol-5D (EQ-5D) questionnaires were used to obtain baseline QoL scores from 47 patients with no-option CLI participating in a therapeutic neovascularization trial. To allow for easy comparability, a norm-based scoring (NBS) method was used to report the results of the SF-36. Scores of patients with CLI were furthermore compared with scores of patients with milder forms of peripheral arterial disease (PAD) and with patients with cardiovascular risk factors only. Determinants of QoL in patients with PAD were identified using multiple linear regression methods. Results: Patients with no-option CLI reported QoL scores below the general population mean on every health dimensionof the SF-36. Physical functioning, role physical functioning, and bodily pain were affected most intensively. These poor physical QoL scores were further underlined when compared with other patients with milder forms of PAD or patients with cardiovascular risk factors only. Patients with CLI scored poorly on the pain/discomfort and the usual activities domain of the EQ-5D. Diabetes, female gender, body mass index, and the ankle-brachial index at rest were significant determinants of the QoL in PAD on multivariate analysis. Conclusion: The QoL data of patients with no-option CLI using NBS methods for the SF-36 provide a baseline reference for ongoing clinical trials on new treatment strategies. Our data stress the need for new revascularization therapies in patients with no-option CLI. ( J Vasc Surg 2010;52:843-9.)

Metabolic reprogramming by HIF-1 promotes the survival of bone marrow–derived angiogenic cells in ischemic tissue

“…There are an increasing number of no-option patients for whom the only currently available treatment is surgical amputation, highlighting the need for novel therapeutic strategies. 49 Our data show that, even with DMOG treatment, most of the BMDACs that home to the ischemic limb are no longer present by 3 days after injection, indicating that these cells play a role in initiating the vascular response to ischemia but are not required for the progressive increase in perfusion that occurs over the subsequent weeks. Given the short time span over which the proangiogenic role of recruited BMDACs occurs, the observed doubling of BMDAC half-life in ischemic tissue that results from DMOG treatment probably enhances the therapeutic efficacy of these cells when they are combined with local AdCA5 gene therapy, which creates the homing signal required for BMDAC recruitment to ischemic tissue.…”

Critical Limb Ischemia: Current Trends and Future Directions

“…Besides poor survival rates, prognosis with respect to limb preservation in CLI patients is poor,11 particularly in no‐option CLI patients, where 6‐month major amputation rates have been reported to range from 10% to 40% 6, 7, 8. Additionally, CLI is associated with poor quality of life12 and high treatment costs,13 especially when amputation is inevitable 13, 14. With an estimated yearly incidence of 500 to 1000 new cases per million individuals in Western society,7 which is ever increasing in concert with the increase in cardiovascular risk factors,15, 16, 17 CLI poses a substantial burden on patients, healthcare providers, and resources.…”

Quality of life and burden of disease in peripheral arterial disease: a study among Hungarian patients

“…A Medline adatbázisban ' peripheral arterial disease' AND 'EQ-5D' keresőszóval irodalomkeresést végeztünk. Összesen 23 találatunk volt, 20 találatot kizártunk betegpopulációs és mód-szertani eltérések miatt, három releváns vizsgálatot azonosítottunk [11,12,13].…”

“…Sprengers és mtsai [13] revascularisatiós beavatkozásra nem alkalmas kritikus végtagischaemiás holland betegek életminőség-eredményeit vizsgálták. Negyvenhét beteg életminőség-értékeit mérték fel EQ-5D és SF-36 kérdőívekkel, összehasonlításnak 313 enyhébb (Fontaine II.…”

“…Sprengers és mtsai [13] elemzésükben arra jutottak, hogy a betegség előrehaladása életminőség-változással jár, csökkenést mutat. A kritikus végtagischaemiában szenvedő betegek szignifi kánsan alacsonyabb életminő-ség-értékeket jeleztek, mint az enyhébb stádiumban lévő betegek (Fontaine II), különösen a fi zikai terüle-teket (fájdalom, szokásos tevékenység) jelölték érintett-nek.…”