著者

Tomotsugu Seki Makoto Murata Kensuke Takabayashi Takashi Yanagisawa Masayuki Ogihara Ritsuko Kurimoto Keisuke Kida Koichi Tamita Xiaoyang Song Neiko Ozasa Ryoji Taniguchi Miho Nishitani-Yokoyama Shinji Koba Ryosuke Murai Yutaka Furukawa Maki Hamasaki Hirokazu Kondo Hironori Hayashi Asako Ootakara-Katsume Kento Tateishi Satoaki Matoba Hitoshi Adachi Hirokazu Shiraishi for the START Investigators

出版者

The Japanese Circulation Society

雑誌

Circulation Reports (ISSN:24340790)

巻号頁・発行日

vol.5, no.3, pp.90-94, 2023-03-10 (Released:2023-03-10)

参考文献数

18

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Background: Clinical practice guidelines strongly recommend optimal medical therapy (OMT), including lifestyle modification, pharmacotherapy, and exercise-based cardiac rehabilitation (CR), in patients with stable ischemic heart disease (SIHD). However, the efficacy and safety of CR in patients with SIHD without revascularization remain unclear.Methods and Results: The Prospective Registry of STable Angina RehabiliTation (Pre-START) study is a multicenter, prospective, single-arm, open-label pilot study to evaluate the efficacy and safety of CR on health-related quality of life (HRQL), exercise capacity, and clinical outcomes in Japanese patients with SIHD without revascularization. In this study, all patients will undergo guideline-based OMT and are encouraged to have 36 outpatient CR sessions within 5 months after enrollment. The primary endpoint is the change in the Seattle Angina Questionnaire-7 summary score between baseline and the 6-month visit; an improvement of ≥5 points will be defined as a clinically important change. Secondary endpoints include changes in other HRQL scores and exercise capacity between baseline and the 6-month visit, as well as clinical outcomes between enrollment and the 6-month visit.Conclusions: The Pre-START study will provide valuable evidence to elucidate the efficacy and safety of CR in patients with SIHD and indispensable information for a subsequent randomized controlled trial. The study was registered with the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (ID: UMIN000045415) on April 1, 2022.

著者

Yasuaki Takeji Tomohiko Taniguchi Takeshi Morimoto Shinichi Shirai Takeshi Kitai Hiroyuki Tabata Kazuki Kitano Nobuhisa Ono Ryosuke Murai Kohei Osakada Koichiro Murata Masanao Nakai Hiroshi Tsuneyoshi Tomohisa Tada Masashi Amano Hiroki Shiomi Hirotoshi Watanabe Yusuke Yoshikawa Ko Yamamoto Mamoru Toyofuku Shojiro Tatsushima Norino Kanamori Makoto Miyake Hiroyuki Nakayama Kazuya Nagao Masayasu Izuhara Kenji Nakatsuma Moriaki Inoko Takanari Fujita Masahiro Kimura Mitsuru Ishii Shunsuke Usami Kenichiro Sawada Fumiko Nakazeki Marie Okabayashi Manabu Shirotani Yasutaka Inuzuka Tatsuhiko Komiya Kenji Minatoya Takeshi Kimura on behalf of the CURRENT AS Registry-2 Investigators

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-21-1062, (Released:2022-04-19)

参考文献数

29

被引用文献数

2

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Background: There is scarce data evaluating the current practice pattern and clinical outcomes for patients with severe aortic stenosis (AS), including both those who underwent surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) and those who were managed conservatively in the TAVI era.Methods and Results: The Contemporary outcomes after sURgery and medical tREatmeNT in patients with severe Aortic Stenosis (CURRENT AS) Registry-2 is a prospective, physician-initiated, multicenter registry enrolling consecutive patients who were diagnosed with severe AS between April 2018 and December 2020 among 21 centers in Japan. The rationale for the prospective enrollment was to standardize the assessment of symptomatic status, echocardiographic evaluation, and other recommended diagnostic examinations such as computed tomography and measurement of B-type natriuretic peptide. Moreover, the schedule of clinical and echocardiographic follow up was prospectively defined and strongly recommended for patients who were managed conservatively. The entire study population consisted of 3,394 patients (mean age: 81.6 years and women: 60%). Etiology of AS was degenerative in 90% of patients. AS-related symptoms were present in 60% of patients; these were most often heart failure symptoms. The prevalence of high- and low-gradient AS was 58% and 42%, respectively, with classical and paradoxical low-flow low-gradient AS in 4.5% and 6.7%, respectively.Conclusions: The CURRENT AS Registry-2 might be large and meticulous enough to determine the appropriate timing of intervention for patients with severe AS in contemporary clinical practice.

著者

Atsushi Kobori Yasuhiro Sasaki Misun Pak Masahiro Ishikura Ryosuke Murai Taiji Okada Toshiaki Toyota Tomohiko Taniguchi Kitae Kim Natsuhiko Ehara Makoto Kinoshita Yasuki Kihara Yutaka Furukawa

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

vol.86, no.2, pp.290-298, 2022-01-25 (Released:2022-01-25)

参考文献数

27

被引用文献数

4

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Background:Outcomes of cryoballoon ablation for persistent atrial fibrillation (AF) are unclear, especially in Japanese patients, so the effectiveness and safety of cryoballoon ablation in clinical practice were retrospectively compared with those of contact force-sensing radiofrequency (CFRF) ablation including the high-power protocol.Methods and Results:Consecutive patients with persistent AF were reviewed, and 253 and 265 patients who underwent cryoballoon and CFRF ablation, respectively, were enrolled. The primary endpoint was atrial arrhythmia recurrence. The secondary endpoints were periprocedural complications and repeat ablation. The rate of additional left atrial (LA) ablation after pulmonary vein isolation (PVI) was similar between groups (68.8% cryoballoon vs. 74.0% CFRF, P=0.19). Freedom from atrial arrhythmia recurrence was comparable between groups over a follow-up of 25.5±12.5 months (72.3% cryoballoon vs. 69.8% CFRF; adjusted hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.59–1.21, P=0.36). Outcomes were similar in the subgroups of PVI alone and PVI plus additional LA ablation. LA posterior wall isolation, absence of defragmentation, and low creatine clearance, but not catheter selection, were associated with the primary endpoint. Periprocedural complications (adjusted HR 0.73, 95% CI 0.34–1.54, P=0.41) and repeat ablation (adjusted HR 1.11, 95% CI 0.71–1.74, P=0.64) were similar for both procedures.Conclusions:Cryoballoon ablation for persistent AF in Japanese clinical practice had acceptable outcomes comparable to those of advanced CFRF ablation.

著者

Tomotsugu Seki Makoto Murata Kensuke Takabayashi Takashi Yanagisawa Masayuki Ogihara Ritsuko Kurimoto Keisuke Kida Koichi Tamita Xiaoyang Song Neiko Ozasa Ryoji Taniguchi Miho Nishitani-Yokoyama Shinji Koba Ryosuke Murai Yutaka Furukawa Maki Hamasaki Hirokazu Kondo Hironori Hayashi Asako Ootakara-Katsume Kento Tateishi Satoaki Matoba Hitoshi Adachi Hirokazu Shiraishi for the START Investigators

出版者

The Japanese Circulation Society

雑誌

Circulation Reports (ISSN:24340790)

巻号頁・発行日

pp.CR-22-0131, (Released:2023-02-25)

参考文献数

18

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Background: Clinical practice guidelines strongly recommend optimal medical therapy (OMT), including lifestyle modification, pharmacotherapy, and exercise-based cardiac rehabilitation (CR), in patients with stable ischemic heart disease (SIHD). However, the efficacy and safety of CR in patients with SIHD without revascularization remain unclear.Methods and Results: The Prospective Registry of STable Angina RehabiliTation (Pre-START) study is a multicenter, prospective, single-arm, open-label pilot study to evaluate the efficacy and safety of CR on health-related quality of life (HRQL), exercise capacity, and clinical outcomes in Japanese patients with SIHD without revascularization. In this study, all patients will undergo guideline-based OMT and are encouraged to have 36 outpatient CR sessions within 5 months after enrollment. The primary endpoint is the change in the Seattle Angina Questionnaire-7 summary score between baseline and the 6-month visit; an improvement of ≥5 points will be defined as a clinically important change. Secondary endpoints include changes in other HRQL scores and exercise capacity between baseline and the 6-month visit, as well as clinical outcomes between enrollment and the 6-month visit.Conclusions: The Pre-START study will provide valuable evidence to elucidate the efficacy and safety of CR in patients with SIHD and indispensable information for a subsequent randomized controlled trial. The study was registered with the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (ID: UMIN000045415) on April 1, 2022.

著者

Ryosuke Murai Yuichi Kawase Tomohiko Taniguchi Takeshi Morimoto Kazushige Kadota Masanobu Ohya Takenobu Shimada Takeshi Maruo Yasushi Fuku Tatsuhiko Komiya Kenji Ando Michiya Hanyu Norio Kanamori Takeshi Aoyama Koichiro Murata Tomoya Onodera Fumio Yamazaki Takeshi Kitai Yutaka Furukawa Tadaaki Koyama Makoto Miyake Chisato Izumi Yoshihisa Nakagawa Kazuo Yamanaka Hirokazu Mitsuoka Manabu Shirotani Masashi Kato Shinji Miki Hiroyuki Nakajima Yutaka Hirano Shunichi Miyazaki Toshihiko Saga Sachiko Sugioka Shintaro Matsuda Mitsuo Matsuda Tatsuya Ogawa Kazuya Nagao Tsukasa Inada Shogo Nakayama Hiroshi Mabuchi Yasuyo Takeuchi Hiroki Sakamoto Genichi Sakaguchi Keiichiro Yamane Hiroshi Eizawa Mamoru Toyofuku Takashi Tamura Atsushi Iwakura Mitsuru Ishii Masaharu Akao Kotaro Shiraga Eri Minamino-Muta Takao Kato Moriaki Inoko Koji Ueyama Tomoyuki Ikeda Yoshihiro Himura Akihiro Komasa Katsuhisa Ishii Kozo Hotta Yukihito Sato Keiichi Fujiwara Yoshihiro Kato Ichiro Kouchi Yasutaka Inuzuka Shigeru Ikeguchi Senri Miwa Chiyo Maeda Eiji Shinoda Junichiro Nishizawa Toshikazu Jinnai Nobuya Higashitani Mitsuru Kitano Yuko Morikami Shouji Kitaguchi Kenji Minatoya Takeshi Kimura on behalf of the CURRENT AS Registry Investigators

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

vol.86, no.3, pp.427-437, 2022-02-25 (Released:2022-02-25)

参考文献数

26

被引用文献数

2

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Background:The clinical significance of concomitant mitral regurgitation (MR) has not been well addressed in patients with severe aortic stenosis (AS).Methods and Results:We analyzed 3,815 patients from a retrospective multicenter registry of severe AS in Japan (CURRENT AS registry). We compared the clinical outcomes between patients with moderate/severe MR and with none/mild MR according to the initial treatment strategy (initial aortic valve replacement [AVR] or conservative strategy). The primary outcome measure was a composite of aortic valve-related death or heart failure hospitalization. At baseline, moderate/severe MR was present in 227/1,197 (19%) patients with initial AVR strategy and in 536/2,618 (20%) patients with a conservative strategy. The crude cumulative 5-year incidence of the primary outcome measure was significantly higher in patients with moderate/severe MR than in those with none/mild MR, regardless of the initial treatment strategy (25.2% vs. 14.4%, P<0.001 in the initial AVR strategy, and 63.3% vs. 40.7%, P<0.001 in the conservative strategy). After adjusting confounders, moderate/severe MR was not independently associated with higher risk for the primary outcome measure in the initial AVR strategy (hazard ratio [HR] 1.11, 95% confidence interval [CI] 0.67–1.83, P=0.69), and in the conservative strategy (HR 1.13, 95% CI 0.93–1.37, P=0.22).Conclusions:Concomitant moderate/severe MR was not independently associated with higher risk for the primary outcome measure regardless of the initial treatment strategy.