著者
Shogo Fukui Michiyuki Kawakami Yohei Otaka Aiko Ishikawa Fumiaki Yashima Kentaro Hayashida Yuko Oguma Keiichi Fukuda Meigen Liu
出版者
The Japanese Circulation Society
雑誌
Circulation Reports (ISSN:24340790)
巻号頁・発行日
vol.2, no.2, pp.83-88, 2020-02-10 (Released:2020-02-10)
参考文献数
32
被引用文献数
1 4

Background:This aim of this study was to clarify prognosis after transcatheter aortic valve implantation (TAVI) in patients with aortic stenosis (AS) and to identify baseline factors associated with mortality.Methods and Results:We prospectively enrolled 257 consecutive elderly persons with AS who were referred to Keio University Hospital and who underwent assessment of cardiac, physical (walking speed), cognitive, and renal functions, nutritional status, activities of daily living (ADL), instrumental ADL (IADL) assessed with the Frenchay activities index (FAI), and comorbidities. The primary outcome was postoperative death. Differences in basic characteristics were compared between a group that survived for a median of 661 days (IQR, 0–1,289 days) after TAVI and a group that did not. Multivariate hazard ratios (HR) were calculated for independent factors selected in Cox proportional hazard models. Thirty-one individuals died during follow-up. Walking speed was significantly faster (0.87±0.25 vs. 0.70±0.24 m/s, P<0.001) and FAI was significantly higher (21.2±8.0 vs. 15.7±8.0, P=0.026) in the survival group compared with those who died. Multivariate HR for mortality according to walking speed was 0.05 (95% CI: 0.028–0.091) in model 1 and 0.04 (95% CI: 0.020–0.081) in model 2, and those for FAI were 0.94 (95% CI: 0.92–0.95) and 0.92 (95% CI: 0.90–0.92), respectively.Conclusions:Preoperative walking speed and IADL are crucial factors associated with prognosis after TAVI even after adjustment.
著者
Kazutaka Aonuma Hiro Yamasaki Masato Nakamura Takashi Matsumoto Morimasa Takayama Kenji Ando Kenzo Hirao Masahiko Goya Yoshihiro Morino Kentaro Hayashida Kengo Kusano Yutaka Gomi Michael L. Main Takahiro Uchida Shigeru Saito
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-20-0196, (Released:2020-06-26)
参考文献数
16
被引用文献数
15

Background:The SALUTE trial was a prospective, multicenter, single-arm trial to confirm the safety and efficacy of the WATCHMAN left atrial appendage closure (LAAC) device for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in Japan.Methods and Results:A total of 54 subjects (including 12 roll-in subjects) with a WATCHMAN implant procedure were followed in 10 investigational centers. Follow-up visits were performed up to 2 years post-implant. The baseline CHA2DS2-VASc score was 3.6±1.6 and the baseline HAS-BLED score was 3.0±1.1. All 42 subjects in the intention to treat (ITT) cohort underwent successful implantation of the LAAC device without any serious complications, achieving the prespecified performance goal. The effective LAAC rate was maintained at 100% from 45 days to 12 months post-implant, achieving the prespecified performance goal. During follow-up, 1 subject died of heart failure, and 3 had ischemic strokes, but there were no cases of hemorrhagic stroke or systemic embolism. All events were adjudicated as unrelated to the WATCHMAN device/procedure by the independent Clinical Events Committee. All 3 ischemic strokes were classified as nondisabling based on no change in the modified Rankin scale score.Conclusions:Final results of the SALUTE trial demonstrated that the WATCHMAN LAAC device is an effective and safe alternative nonpharmacological therapy for stroke risk reduction in Japanese NVAF patients who are not optimal candidates for lifelong anticoagulation. (Trial Registration: clinicaltrials.gov Identifier NCT 03033134)
著者
Kazutaka Aonuma Hiro Yamasaki Masato Nakamura Tatsushi Ootomo Morimasa Takayama Kenji Ando Kenzo Hirao Yoshihiro Morino Kentaro Hayashida Kengo Kusano Michael L. Main Shigeru Saito
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
vol.82, no.12, pp.2946-2953, 2018-11-24 (Released:2018-11-24)
参考文献数
22
被引用文献数
34

Background: The PROTECT AF and PREVAIL trials demonstrated that the WATCHMAN left atrial appendage (LAA) closure device is a reasonable alternative to warfarin therapy for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in the USA and Europe. We conducted the SALUTE trial to confirm the safety and efficacy of the LAA closure therapy for patients with NVAF in Japan. Methods and Results: A total of 54 subjects (including 12 Roll-in) with NVAF who had a CHA2DS2-VASc score ≥2 were enrolled. All subjects were successfully implanted with the LAA closure device. No serious adverse events related to the primary procedure-safety endpoint occurred. The 2nd co-primary endpoint was a composite of all stroke, systemic embolism and cardiovascular/unexplained death. One ischemic stroke (1/42) occurred during the 6-month follow-up. The effective LAA closure rate defined as the 3rd co-primary endpoint was 100% (42/42) at both 45-day and 6-month follow-up. Conclusions: The procedural safety and 6-month results from the SALUTE trial demonstrated that the LAA closure device was safe and effective, similar to the results of large-scale randomized clinical trials, and provides a novel perspective of LAA closure for Japanese patients with NVAF in need of an alternative to long-term oral-anticoagulation. (Trial Registration: clinicaltrials.gov Identifier NCT 03033134)
著者
Nobuhiro Ikemura Mitsuaki Sawano Yasuyuki Shiraishi Ikuko Ueda Hiroaki Miyata Yohei Numasawa Shigetaka Noma Masahiro Suzuki Yukihiko Momiyama Taku Inohara Kentaro Hayashida Shinsuke Yuasa Yuichiro Maekawa Keiichi Fukuda Shun Kohsaka
出版者
日本循環器学会
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
vol.81, no.6, pp.815-822, 2017-05-25 (Released:2017-05-25)
参考文献数
37
被引用文献数
12

Background:Door-to-balloon (DTB) time ≤90 min is an important quality indicator in the management of ST-elevation myocardial infarction (STEMI), but a considerable number of patients still do not meet this goal, particularly in countries outside the USA and Europe.Methods and Results:We analyzed 2,428 STEMI patients who underwent primary PCI ≤12 h of symptom onset who were registered in an ongoing prospective multicenter database (JCD-KiCS registry), between 2008 and 2013. We analyzed both the time trend in DTB time within this cohort in the registry, and independent predictors of delayed DTB time >90 min. Median DTB time was 90 min (IQR, 68–115 min) during the study period and there were no significant changes with year. Predictors for delay in DTB time included peripheral artery disease, prior revascularization, off-hour arrival, age >75 years, heart failure at arrival, and use of IABP or VA-ECMO. Notably, high-volume PCI-capable institutions (PCI ≥200/year) were more adept at achieving shorter DTB time compared with low-volume institutions (PCI <200/year).Conclusions:Half of the present STEMI patients did not achieve DTB time ≤90 min. Targeting the elderly and patients with multiple comorbidities, and PCI performed in off-hours may aid in its improvement.