Long-term Results of Treatment for Critical Limb Ischemia

Miyahara, Takuya; Suhara, Masamitsu; Nemoto, Yuta; Shirasu, Takuro; Haga, Makoto; Mochizuki, Yasuaki; Matsukura, Mitsuru; Akai, Takafumi; Taniguchi, Rin Ichiro; Nemoto, Masaru; Yamamoto, Satoshi; Nishiyama, Ayako; Hosaka, Akihiro; Hoshina, Katsuyuki; Okamoto, Hiroyuki; Shigematsu, Kunihiro; Miyata, Tetsuro; Watanabe, Toshiaki

doi:10.7133/jca.13-00044

Cited by 5 publications

(8 citation statements)

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“…20 Furthermore, Miyahara et al showed that the 5-year MAF rate was 55.8%, and the 5-year AFS rate was 36.0% in patients with CLI who could not undergo revascularization. 13 In the present study, the 1-and 5-year MAF and AFS rates in all patients with CLI caused by ASO were 78.7% and 74.0%, respectively. The 1-and 5-year AFS rates were 71.6% and 55.0%, respectively.…”

Section: Discussionmentioning

confidence: 80%

“…Moreover, the 3-year MAF was 67.2% in patients with CDV-related CLI, regardless of whether they underwent revascularization surgery. 13 To the best of our knowledge, no results from large-scale, long-term epidemiological studies of patients with CDV-related CLI who have undergone the BM-MNC implantation have been reported. The results from the current study demonstrated that both the 5-year and 10-year AFS rates in patients with CDV-related CLI were 90.9% (95% CI: 79.2-96.1).…”

Section: Discussionmentioning

confidence: 99%

“…However, approximately one-third of patients with CLI cannot undergo surgery for various reasons, including complications (e.g., cardiac/respiratory dysfunction), unfavorable general condition (e.g., severe dementia, being bedridden, extensive necrosis, or infection), and technical issues (e.g., absence of an artery that can be grafted). 13 A major amputation rate of 24% and a minor amputation rate of 7% were reported for patients who did not undergo revascularization surgery. Significant differences in the 5-year limb salvage rate (83.5% vs. 55.8%) and the 5-year AFS rate (57.7% vs. 36.0%) were reported for patients who did or did not undergo revascularization.…”

Section: Discussionmentioning

confidence: 99%

“…Significant differences in the 5-year limb salvage rate (83.5% vs. 55.8%) and the 5-year AFS rate (57.7% vs. 36.0%) were reported for patients who did or did not undergo revascularization. 13 According to those reports, the OS, MAF, and AFS rates were still low in no-option CLI patients. BM-MNC implantation was developed almost 20 years ago, following the success of gene therapy in promoting angiogenesis.…”

Section: Discussionmentioning

confidence: 99%

“…21 However, many patients with CLI resist conventional treatment and cannot undergo revascularization. 13 Moreover, in many patients with CLI caused by ASO, above-the-knee vascular flow is also affected; in most cases, restoration of vascular flow to the level required for wound healing cannot be achieved merely with peripheral vessel regeneration. There are also concerns about the patency rate in revascularization procedures, such as EVT and bypass surgery, in patients with serious, refractory conditions.…”

Section: Discussionmentioning

confidence: 99%

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Long-Term Clinical Outcomes Survey of Bone Marrow-Derived Cell Therapy in Critical Limb Ischemia in Japan

Kondo

Yanishi

Hayashida

et al. 2018

Circ J

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Background:The Therapeutic Angiogenesis by Cell Transplantation (TACT) trial demonstrated the efficacy and safety of autologous bone marrow-derived mononuclear cells (BM-MNCs) in patients with critical limb ischemia (CLI). The present study aimed to assess the long-term clinical outcomes of therapeutic angiogenesis using autologous BM-MNC implantation under advanced medical treatment in Japan. Methods and Results:The study was retrospective, observational, and non-controlled. We assessed no-option CLI patients who had BM-MNC implantation performed in 10 institutes. Overall survival (OS), major amputation-free (MAF), and amputation-free survival (AFS) rates were primary endpoints of this study. The median follow-up duration was 31.7 months. The 10-year OS rate was 46.6% in patients with arteriosclerosis obliterans (ASO) (n=168), 90.5% in patients with thromboangiitis obliterans (TAO) (n=108), and 67.6% in patients with collagen disease-associated vasculitis (CDV) (n=69). The 10-year MAF rate was 70.1%, 87.9%, and 90.9%, respectively. The 10-year AFS rate was 37.8%, 80.9%, and 61.2%, respectively. Major adverse cardiovascular events occurred in 6.0% of patients with ASO, 1.9% of patients with TAO, and no patients with CDV.Conclusions: Therapeutic angiogenesis using autologous BM-MNC implantation may be feasible and safe in patients with no-option CLI, particularly those with CLI caused by TAO or CDV.Key Words: Bone marrow-derived mononuclear cells; Critical limb ischemia; Therapeutic angiogenesis ORIGINAL ARTICLE Peripheral Vascular DiseaseAdvance Publication by-J-STAGE KONDO K et al.previous (5 years) or current history of neoplasms, diabetes with untreated retinopathy, age >80 years, the possibility of pregnancy, or the lack of informed consent. 6 We obtained written informed consent from all patients, and the ethics committees of the participating hospitals approved the protocol. Data CollectionWe developed a web-based database using FileMaker Pro (FileMaker, Inc., Santa Clara, CA, USA) and an electronic clinical record form (eCRF) to collect information about patient characteristics, previous medical history, adverse events, and outcomes on the last day on which the physician confirmed the patient's status. All patient data were stored and analyzed independently at the Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan. In 2015, 14 Japanese hospitals participated in this part of the TACT trial. Data were collected with the permission of the Ministry of Health, Labour, and Welfare.This study was retrospective, observational, and noncontrolled. The primary endpoints were the rates of overall survival (OS), major amputation-free (MAF), and amputation-free survival (AFS). AFS in this study included OS and major amputation. The safety of the therapy was assessed in the context of major adverse cardiovascular events (MACE; death, non-fatal myocardial infarctions, decompensated heart failure, and stroke) and all-cause adverse events during the 6-month follow-up period after ...

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Section: Discussionmentioning

confidence: 80%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Long-Term Clinical Outcomes Survey of Bone Marrow-Derived Cell Therapy in Critical Limb Ischemia in Japan

Kondo

Yanishi

Hayashida

et al. 2018

Circ J

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Real-World Performance of Paclitaxel Drug-Eluting Bare Metal Stenting (Zilver PTX) for the Treatment of Femoropopliteal Occlusive Disease

Tran

Ullery

Kret

et al. 2017

Annals of Vascular Surgery

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Outcomes of Critical Limb Ischemia in Hemodialysis Patients After Distal Bypass Surgery　– Poor Limb Prognosis With Stage 4 Wound, Ischemia, and Foot Infection (WIfI) –

Hoshina

Yamamoto

Miyata

et al. 2016

Circ J

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Long-term Results of Treatment for Critical Limb Ischemia

Cited by 5 publications

References 15 publications

Long-Term Clinical Outcomes Survey of Bone Marrow-Derived Cell Therapy in Critical Limb Ischemia in Japan

Long-Term Clinical Outcomes Survey of Bone Marrow-Derived Cell Therapy in Critical Limb Ischemia in Japan

Real-World Performance of Paclitaxel Drug-Eluting Bare Metal Stenting (Zilver PTX) for the Treatment of Femoropopliteal Occlusive Disease

Outcomes of Critical Limb Ischemia in Hemodialysis Patients After Distal Bypass Surgery　– Poor Limb Prognosis With Stage 4 Wound, Ischemia, and Foot Infection (WIfI) –

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Long-term Results of Treatment for Critical Limb Ischemia

Cited by 5 publications

References 15 publications

Long-Term Clinical Outcomes Survey of Bone Marrow-Derived Cell Therapy in Critical Limb Ischemia in Japan

Long-Term Clinical Outcomes Survey of Bone Marrow-Derived Cell Therapy in Critical Limb Ischemia in Japan

Real-World Performance of Paclitaxel Drug-Eluting Bare Metal Stenting (Zilver PTX) for the Treatment of Femoropopliteal Occlusive Disease

Outcomes of Critical Limb Ischemia in Hemodialysis Patients After Distal Bypass Surgery – Poor Limb Prognosis With Stage 4 Wound, Ischemia, and Foot Infection (WIfI) –

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Outcomes of Critical Limb Ischemia in Hemodialysis Patients After Distal Bypass Surgery　– Poor Limb Prognosis With Stage 4 Wound, Ischemia, and Foot Infection (WIfI) –