Author + information
- Received July 1, 2019
- Revision received November 18, 2019
- Accepted November 26, 2019
- Published online February 26, 2020.
- Masashi Fukunaga, MDa,∗ (, )
- Kenichi Fujii, MDb,
- Mitsuyoshi Takahara, MDc,d,
- Masahiko Fujihara, MDe,
- Makoto Utsunomiya, MDf,
- Shinya Sasaki, MDg,
- Yoshinori Tsubakimoto, MDh,
- Tatsuya Shiraki, MDi,
- Takumi Inoue, MDj,
- Hideaki Aihara, MDk,
- Yusuke Iwasaki, MDl,
- Kohei Azuma, MDm,
- Tsuyoshi Nakata, MDn,
- Osamu Iida, MDi,
- Hiroyoshi Yokoi, MDo,
- Yoshiaki Yokoi, MDe and
- Daizo Kawasaki, MDa
- aCardiovascular Division, Morinomiya Hospital, Osaka, Japan
- bCardiovascular Division, Hyogo College of Medicine, Nishinomiya, Japan
- cDepartment of Diabetes Care Medicine, Osaka University Graduate School of Medicine, Suita, Japan
- dDepartment of Metabolic Medicine, Osaka University Graduate School of Medicine, Suita, Japan
- eDepartment of Cardiology, Kishiwada Tokusyukai Hospital, Kishiwada, Japan
- fDepartment of Cardiology, Tokyo Rosai Hospital, Tokyo, Japan
- gDepartment of Cardiology, Saka General Hospital, Shiogama, Japan
- hDepartment of Cardiology, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan
- iCardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan
- jDepartment of Cardiology, Hyogo Prefectural Awaji Medical Center, Sumoto, Japan
- kDepartment of Cardiology, Tsukuba Medical Center Hospital, Ibaraki, Japan
- lDivision of Cardiology, Osaka General Medical Center, Osaka, Japan
- mDivision of Cardiology, Meiwa Hospital, Nishinomiya, Japan
- nDivision of Cardiology, Tane General Hospital, Osaka, Japan
- oDepartment of Cardiovascular Medicine Center, Fukuoka Sanno Hospital, Fukuoka, Japan
- ↵∗Address for correspondence:
Dr. Masashi Fukunaga, Morinomiya Hospital Cardiovascular Division, 2-1-88 Morinomiya Joto-ku Osaka, Osaka, 5360025, Japan.
Objectives This study investigated the correlation between vascular flow reserve (VFR) values and wound healing rate in patients with critical limb ischemia.
Background Peripheral VFR may be useful for predicting complete wound healing after endovascular therapy (EVT). However, published reports included small numbers of patients from single centers and long-term outcomes remain unknown.
Methods This was a prospective multicenter study that consecutively enrolled 104 patients (115 limbs) who received EVT for ischemic ulcerations. All lesions were treated with conventional balloon angioplasty. After EVT, VFR was measured using a pressure/temperature guidewire. The study endpoints were correlation between VFR values and wound healing rate at 3 months and 1 year.
Results The median VFR was 2.9. A total of 110 and 104 limbs completed the 3-month and 1-year follow-up, respectively. The 3-month and 1-year wound healing rates were 49% and 76%, respectively. VFR was significantly associated with the 3-month and 1-year wound healing (p < 0.001 for both). The crude hazard ratios of VFR (per 2-fold increase) for the 3-month and 1-year wound healing were 2.6 (1.7 to 3.9) and 2.9 (2.0 to 4.2), respectively. The estimated median time to wound healing was 5.0 (3.2 to 7.2) months, 3.3 (2.8 to 4.9) months, and 2.5 (2.0 to 3.0) months, when the VFR value was 2.4, 2.9, and 3.9, respectively.
Conclusions Post-procedure VFR is significantly associated with wound healing. VFR, measured in the catheterization laboratory, is useful in clinical risk stratification for patients with critical limb ischemia after EVT. (Predictor of Wound Healing in Patients with Critical Limb Ischemia-Multicenter Prospective Study; UMIN000012746)
This study was funded by Japan Endovascular Treatment Conference. Dr. Yoshiaki Yokoi is a consultant for Boston Scientific, Terumo, and JIMRO. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 1, 2019.
- Revision received November 18, 2019.
- Accepted November 26, 2019.
- 2020 American College of Cardiology Foundation
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