著者

Yuki Katagiri Kazumasa Yamasaki Noriyuki Hatanaka Hiroki Bota Tomoyuki Tani Tomonori Koga Yuki Setogawa Manabu Misawa Takashi Ueda Seiji Yamazaki

出版者

The Japanese Circulation Society

雑誌

Circulation Reports (ISSN:24340790)

巻号頁・発行日

vol.4, no.6, pp.274-284, 2022-06-10 (Released:2022-06-10)

参考文献数

28

被引用文献数

2

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Background: In patients with aortic stenosis (AS), measurement of aortic valve calcification (AVC) using computed tomography (CT) is recommended in cases where echocardiographic measurements are inconclusive. However, sex-specific AVC thresholds proposed in the guidelines for predicting severe AS (women: 1,200 arbitrary units [AU]; men: 2,000 AU) are based on studies from Western countries.Methods and Results: We retrospectively included 512 Japanese patients with at least moderate AS who underwent transthoracic echocardiography and CT. AVC was quantified using the Agatston method. AVC was positively correlated with peak aortic jet velocity and mean transvalvular gradient (mPG), and negatively correlated with aortic valve area (AVA) and the AVA index (AVAi). In 257 patients with concordant AS grading (152 severe AS [AVAi ≤0.6 cm2/m2, mPG ≥40 mmHg], 105 moderate AS [AVAi >0.6 cm2/m2, mPG <40 mmHg]), receiver operating characteristic curve analysis of AVC predicting severe AS yielded an area under the curve of 0.91 (95% confidence interval [CI] 0.87–0.95; P<0.001) in women and 0.86 (95% CI 0.75–0.98; P<0.001) in men. The optimal thresholds (women: 1,379 AU; men: 1,802 AU) were close to those proposed in the guidelines. The diagnostic accuracy of the thresholds in the guidelines was similar to that of the optimal thresholds.Conclusions: The sex-specific AVC thresholds proposed in international guidelines can be applied to Japanese AS patients, yielding similar diagnostic accuracy as the optimal cut-off derived from the study patients.

著者

Shigeru Saito Seiji Yamazaki Akihiko Takahashi Atsuo Namiki Tomohiro Kawasaki Satoru Otsuji Shigeru Nakamura Yoshisato Shibata for the Disrupt CAD IV Investigators

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

vol.85, no.6, pp.826-833, 2021-05-25 (Released:2021-05-25)

参考文献数

31

被引用文献数

2 58

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Background:Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhance vessel compliance and optimize stent deployment. The objective of this study was to assess the safety and effectiveness of IVL treatment of de novo stenoses involving severely calcified coronary vessels in a Japanese population.Methods and Results:Disrupt CAD IV (NCT04151628) was a prospective, multicenter study designed for Japanese regulatory approval of coronary IVL (SWM-1234). The primary safety endpoint was freedom from major adverse cardiac events (MACE) at 30 days. The primary effectiveness endpoint was procedural success (residual stenosis <50% by QCA without in-hospital MACE). Noninferiority analyses for the primary endpoints were performed by comparing the CAD IV cohort with a propensity-matched historical IVL control group. Patients (intent-to-treat, n=64) were enrolled from 8 centers in Japan. Severe calcification by core laboratory assessment was present in all lesions, with a calcified length of 49.8±15.5 mm and a calcium angle of 257.9±78.4° by optical coherence tomography. Primary endpoints were achieved with non-inferiority demonstrated for freedom from 30-day MACE (CAD IV: 93.8% vs. Control: 91.2%, P=0.008), and procedural success (CAD IV: 93.8% vs. Control: 91.6%, P=0.007). No perforations, abrupt closures, or slow/no-reflow events occurred at any time during the procedures.Conclusions:Coronary IVL demonstrated high procedural success with low MACE rates in severely calcified lesions in a Japanese population.

著者

Shigeru Saito Seiji Yamazaki Akihiko Takahashi Atsuo Namiki Tomohiro Kawasaki Satoru Otsuji Shigeru Nakamura Yoshisato Shibata

出版者

The Japanese Circulation Society

雑誌

Circulation Reports (ISSN:24340790)

巻号頁・発行日

pp.CR-23-0082, (Released:2023-11-29)

参考文献数

22

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Background: Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcification to enhance vessel compliance and optimize stent deployment. The Disrupt CAD IV study enrolled patients with severe coronary artery calcification. The primary safety (30-day major adverse coronary events [MACE], 6.3%) and effectiveness (procedural success, 93.8%) endpoints were achieved. The present analysis evaluated the 2-year outcomes of the study.Methods and Results: Disrupt CAD IV (NCT04151628) was a prospective, single-arm, multicenter study designed for regulatory approval of the Shockwave Coronary C2IVL system in Japan. Angiographic outcomes were analyzed by an independent core laboratory and adverse events were adjudicated by a Clinical Events Committee. Kaplan-Meier analysis was performed for MACE (composite of cardiac death, MI or target-vessel revascularization [TVR]), target lesion failure (TLF: composite of cardiac death, TV-MI, and target lesion revascularization [TLR]), and stent thrombosis (ST). At 2 years, 62 subjects had completed follow-up. MACE occurred in 12.6% (cardiac death 0.0%, MI 6.3%, TVR 7.9%) and TLF occurred in 7.8% of patients, with both rates driven by non-Q-wave MI events (6.3%). TLR was 3.2%; no ST occurred through 2 years.Conclusions: Treatment with IVL in patients with severely calcified coronary lesions was associated with low rates of MACE, TLR, and ST at 2 years, demonstrating continued durable safety and effectiveness of coronary IVL in a Japanese population.

著者

Takashi Horie Seiji Yamazaki Sayaka Hanada Shuzo Kobayashi Tatsuo Tsukamoto Tetsuya Haruna Katsuhiko Sakaguchi Ken Sakai Hideaki Obara Kiyofumi Morishita Kenichi Saigo Yoshiaki Shintani Kohmei Kubo Junichi Hoshino Teiji Oda Eiji Kaneko Masaharu Nishikido Tetsuya Ioji Hideaki Kaneda Masanori Fukushima for the Japan Study Group of Peripheral Vascular Regeneration Cell Therapy (JPRCT)

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-17-1220, (Released:2018-06-07)

参考文献数

25

被引用文献数

12

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Background:The clinical usefulness of peripheral blood (PB) mononuclear cell (MNC) transplantation in patients with peripheral arterial disease (PAD), especially in those with mild-to-moderate severity, has not been fully clarified.Methods and Results:A randomized clinical trial was conducted to evaluate the efficacy and safety of granulocyte colony-stimulating factor (G-CSF)-mobilized PBMNC transplantation in patients with PAD (Fontaine stage II–IV and Rutherford category 1–5) caused by arteriosclerosis obliterans or Buerger’s disease. The primary endpoint was progression-free survival (PFS). In total, 107 subjects were enrolled. At baseline, Fontaine stage was II/III in 82 patients and IV in 21, and 54 patients were on hemodialysis. A total of 50 patients had intramuscular transplantation of PBMNC combined with standard of care (SOC) (cell therapy group), and 53 received SOC only (control group). PFS tended to be improved in the cell therapy group than in the control group (P=0.07). PFS in Fontaine stage II/III subgroup was significantly better in the cell therapy group than in the control group. Cell therapy-related adverse events were transient and not serious.Conclusions:In this first randomized, large-scale clinical trial of G-CSF-mobilized PBMNC transplantation, the cell therapy was tolerated by a variety of PAD patients. The PBMNC therapy was significantly effective for inhibiting disease progression in mild-to-moderate PAD.