作者: Harada, Tomoo ; Fukui, Akio ; Soejima, Kyoko ; Okai, Chie ; Holmes, Thomas R ; Yoshida, Yukihiko ; Watari, Yuji ; Shizuta, Satoshi ; Nishii, Nobuhiro ; Shiose, Akira ; Shoda, Morio ; Hosoda, Junya ; Onuki, Tatsuya ; Inoue, Kanki ; Kusano, Kengo ; Ando, Kenji ; Sasaki, Shingo ; Stromberg, Kurt ; Murphy, Jeffrey

BACKGROUNDThe Micra leadless pacemaker has demonstrated favorable outcomes in global trials, but its real-world performance and safety in a Japan-specific population is unknown.Methods and Results: Micra Acute Performance (MAP) Japan enrolled 300 patients undergoing Micra VR leadless pacemaker implantation in 15 centers. The primary endpoint was the acute (30-day) major complication rate. The 30-day and 6-month major complication rates were compared to global Micra studies. All patients underwent successful implantation with an average follow-up of 7.23±2.83 months. Compared with previous Micra studies, Japanese patients were older, smaller, more frequently female, and had a higher pericardial effusion risk score. 11 acute major complications were reported in 10 patients for an acute complication rate of 3.33% (95% confidence interval: 1.61-6.04%), which was in line with global Micra trials. Pericardial effusion occurred in 4 patients (1.33%; 3 major, 1 minor). No procedure or device-related deaths occurred. Frailty significantly improved from baseline to follow-up as assessed by Japan Cardiovascular Health Study criteria.CONCLUSIONSIn a Japanese cohort, implantation of the Micra leadless pacemaker had a high success rate and low major complication rate. Despite the Japan cohort being older, smaller, and at higher risk, the safety and performance was in line with global Micra trials.

2020-06-25·Circulation Journal3区 · 医学

Evaluation of an Integrated Device Diagnostics Algorithm to Risk Stratify Heart Failure Patients　― Results From the SCAN-HF Study ―

3区 · 医学

Article

作者: Fujii, Kenshi ; Sharma, Vinod ; Mukai, Yasushi ; Numata, Tetsuya ; Mine, Takanao ; Yamabe, Hiroshige ; Sunagawa, Osahiko ; Kihara, Yasuki ; Shimane, Akira ; Ishikawa, Toshiyuki ; Tsuboi, Naoya ; Takeishi, Yasuchika ; Ishii, Shunsuke ; Koehler, Jodi ; Okumura, Ken ; Sasaki, Shingo ; Takahashi, Naohiko ; Kusano, Kengo ; Shizuta, Satoshi ; Tada, Hiroshi ; Aonuma, Kazutaka ; Hidaka, Kazuhiro ; Iwasa, Atsushi ; Tsunoda, Ryusuke

BACKGROUNDIntegrated device diagnostics, Triage-HF, is useful in risk stratifying patients with heart failure (HF), but its performance for Japanese patients remains unknown. This is a prospective study of Japanese patients treated with a cardiac resynchronization therapy defibrillator (CRT-D), with a Medtronic OptiVol 2.0 feature.METHODS AND RESULTSA total of 320 CRT-D patients were enrolled from 2013 to 2017. All received HF treatment in the prior 12 months. Following enrollment, they were followed every 6 months for 48 months (mean, 22 months). Triage-HF-stratified patients at low, medium and high risk statuses at every 30-day period, and HF-related hospitalization occurring for the subsequent 30 days, were evaluated and repeated. The primary endpoint was to assess Triage-HF performance in predicting HF-related hospitalization risk. All device data were available for 279 of 320 patients (NYHA class II or III in 93%; mean left ventricular ejection fraction, 31%). During a total of 5,977 patient-month follow-ups, 89 HF-related hospitalization occurred in 72 patients. The unadjusted event numbers for Low, Medium and High statuses were 19 (0.7%), 42 (1.6%) and 28 (4.1%), respectively. Relative risk of Medium to Low status was 2.18 (95% CI 1.23-3.85) and 5.78 (95% CI 3.34-10.01) for High to Low status. Common contributing factors among the diagnostics included low activity, OptiVol threshold crossing, and elevated night heart rate.CONCLUSIONSTriage-HF effectively stratified Japanese patients at risk of HF-related hospitalization.

2020-04-24·Circulation Journal3区 · 医学

Partnership Between Japan and the United States for Early Development of Pediatric Medical Devices　― Harmonization By Doing for Children ―

3区 · 医学

Article

作者: Gillette, Nicole ; Yamagishi, Masaaki ; Sekiguchi, Kazuaki ; Ringel, Richard ; Takahashi, Sara ; Ibrahim, Nicole ; Yasukochi, Satoshi ; Kim, Sung-Hae ; Becker, Lisa A. M. ; Haskin, Russel ; Fearnot, Neal ; Sakamoto, Kisaburo ; Sugiyama, Hisashi ; Dineen, Declan ; Forbes, Thomas J. ; Vang, Eric ; Ruiz, Carlos E. ; Mineta, Koji ; Tomita, Hideshi ; Nakamura, Yasuko ; Ing, Frank ; Ho, Mami

BACKGROUNDThe Harmonization By Doing (HBD) program was established in 2003 as a partnership among stakeholders of academia, industry and regulatory agencies in Japan and the United States, with a primary focus on streamlining processes of global medical device development for cardiovascular medical devices. While HBD has traditionally focused on development of devices intended to treat conditions prevalent in adults, in 2016, HBD established the "HBD-for-Children" program, which focuses on the development of pediatric devices as the development of medical devices for pediatric use lags behind that of medical devices for adults in both countries.METHODS AND RESULTSActivities of the program have included: (1) conducting a survey with industry to better understand the challenges that constrain the development of pediatric medical devices; (2) categorizing pediatric medical devices into five categories based on global availability and exploring concrete solutions for the early application and regulatory approval in both geographies; and (3) facilitating global clinical trials of pediatric medical devices in both countries.CONCLUSIONSThe establishment of the HBD-for-Children program is significant because it represents a global initiative for the introduction of pediatric medical devices for patients in a timely manner. Through the program, academia, industry and regulatory agencies can work together to facilitate innovative pediatric device development from a multi-stakeholder perspective. This activity could also encourage industry partners to pursue the development of pediatric medical devices.

100 项与 Medtronic Japan Co. Ltd. 相关的药物交易

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100 项与 Medtronic Japan Co. Ltd. 相关的转化医学

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