Percutaneous WATCHMAN Left Atrial Appendage Closure for Japanese Patients With Nonvalvular Atrial Fibrillation at Increased Risk of Thromboembolism - First Results From the SALUTE Trial -

被引：39

作者：

Aonuma, Kazutaka ^{[1
]}

Yamasaki, Hiro ^{[1
]}

Nakamura, Masato ^{[2
]}

Ootomo, Tatsushi ^{[3
]}

Takayama, Morimasa ^{[4
]}

Ando, Kenji ^{[5
]}

Hirao, Kenzo ^{[6
]}

Morino, Yoshihiro ^{[7
]}

Hayashida, Kentaro ^{[8
]}

Kusano, Kengo ^{[9
]}

Main, Michael L. ^{[10
]}

Saito, Shigeru ^{[11
,12
]}

机构：

[1] Univ Tsukuba Hosp, Cardiovasc Div, Tsukuba, Ibaraki, Japan

[2] Toho Univ, Ohashi Med Ctr, Div Cardiovasc Med, Tokyo, Japan

[3] Sendai Kousei Hosp, Dept Cardiol, Sendai, Miyagi, Japan

[4] Sakakibara Heart Inst, Dept Cardiol, Fuchu, Tokyo, Japan

[5] Kokura Mem Hosp, Div Cardiol, Kitakyushu, Japan

[6] Tokyo Med & Dent Univ, Dept Cardiovasc Med, Tokyo, Japan

[7] Iwate Med Univ, Div Cardiol, Dept Internal Med, Morioka, Iwate, Japan

[8] Keio Univ, Dept Cardiol, Sch Med, Tokyo, Japan

[9] Natl Cerebral & Cardiovasc Ctr, Dept Cardiovasc Med, Suita, Osaka, Japan

[10] St Lukes Mid Amer Heart Inst, Kansas City, MO USA

[11] Shonan Kamakura Gen Hosp, Div Cardiol, Kamakura, Kanagawa, Japan

[12] Shonan Kamakura Gen Hosp, Catheterizat Labs, Kamakura, Kanagawa, Japan

来源：

CIRCULATION JOURNAL | 2018年 / 82卷 / 12期

关键词：

Left atrial appendage; Nonvalvular atrial fibrillation; Stroke; WATCHMAN LAA closure device; INTERNATIONAL NORMALIZED RATIO; SECONDARY PREVENTION; ORAL ANTICOAGULANTS; WARFARIN; OUTCOMES; PREVALENCE; GUIDELINES; STROKE;

D O I：

10.1253/circj.CJ-18-0222

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 proceduresafety 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.

引用

页码：2946 / +

页数：9

共 22 条

[1] Inappropriate Use of Oral Anticoagulants for Patients With Atrial Fibrillation-1-Year Outcomes of the Fushimi AF Registry [J].

Akao, Masaharu ;

Chun, Yeong-Hwa ;

Esato, Masahiro ;

Abe, Mitsuru ;

Tsuji, Hikari ;

Wada, Hiromichi ;

Hasegawa, Koji .

CIRCULATION JOURNAL, 2014, 78 (09) :2166-2172

[2] Current status of clinical background of patients with atrial fibrillation in a community-based survey: The Fushimi AF Registry [J].

Akao, Masaharu ;

Chun, Yeong-Hwa ;

Wada, Hiromichi ;

Esato, Masahiro ;

Hashimoto, Tetsuo ;

Abe, Mitsuru ;

Hasegawa, Koji ;

Tsuji, Hikari ;

Furuke, Keizo .

JOURNAL OF CARDIOLOGY, 2013, 61 (3-4) :260-266

[3] Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation [J].

Blackshear, JL ;

Odell, JA .

ANNALS OF THORACIC SURGERY, 1996, 61 (02) :755-759

[4] Performance of the subcutaneous implantable cardioverter-defibrillator in patients with a primary prevention indication with and without a reduced ejection fraction versus patients with a secondary prevention indication [J].

Boersma, Lucas V. ;

Barr, Craig S. ;

Burke, Martin C. ;

Leon, Angel R. ;

Theuns, Dominic A. ;

Herre, John M. ;

Weiss, Raul ;

Kremers, Mark S. ;

Neuzil, Petr ;

Husby, Michael P. ;

Carter, Nathan ;

Stivland, Timothy M. ;

Gold, Michael R. .

HEART RHYTHM, 2017, 14 (03) :367-375

[5] Mortality outcomes in patients receiving direct oral anticoagulants: a systematic review and meta-analysis of randomized controlled trials [J].

Chai-Adisaksopha, C. ;

Hillis, C. ;

Isayama, T. ;

Lim, W. ;

Iorio, A. ;

Crowther, M. .

JOURNAL OF THROMBOSIS AND HAEMOSTASIS, 2015, 13 (11) :2012-2020

[6] Estimates of Current and Future Incidence and Prevalence of Atrial Fibrillation in the US Adult Population [J].

Colilla, Susan ;

Crow, Ann ;

Petkun, William ;

Singer, Daniel E. ;

Simon, Teresa ;

Liu, Xianchen .

AMERICAN JOURNAL OF CARDIOLOGY, 2013, 112 (08) :1142-1147

[7] Dabigatran versus Warfarin in Patients with Atrial Fibrillation. [J].

Connolly, Stuart J. ;

Ezekowitz, Michael D. ;

Yusuf, Salim ;

Eikelboom, John ;

Oldgren, Jonas ;

Parekh, Amit ;

Pogue, Janice ;

Reilly, Paul A. ;

Themeles, Ellison ;

Varrone, Jeanne ;

Wang, Susan ;

Alings, Marco ;

Xavier, Denis ;

Zhu, Jun ;

Diaz, Rafael ;

Lewis, Basil S. ;

Darius, Harald ;

Diener, Hans-Christoph ;

Joyner, Campbell D. ;

Wallentin, Lars .

NEW ENGLAND JOURNAL OF MEDICINE, 2009, 361 (12) :1139-1151

[8] Edoxaban versus Warfarin in Patients with Atrial Fibrillation [J].

Giugliano, Robert P. ;

Ruff, Christian T. ;

Braunwald, Eugene ;

Murphy, Sabina A. ;

Wiviott, Stephen D. ;

Halperin, Jonathan L. ;

Waldo, Albert L. ;

Ezekowitz, Michael D. ;

Weitz, Jeffrey I. ;

Spinar, Jindrich ;

Ruzyllo, Witold ;

Ruda, Mikhail ;

Koretsune, Yukihiro ;

Betcher, Joshua ;

Shi, Minggao ;

Grip, Laura T. ;

Patel, Shirali P. ;

Patel, Indravadan ;

Hanyok, James J. ;

Mercuri, Michele ;

Vogelmann, O. ;

Gonzalez, C. ;

Ahuad Guerrero, R. ;

Rodriguez, M. ;

Albisu, J. ;

Rosales, E. ;

Allall, O. ;

Reguero, M. ;

Alvarez, C. ;

Garcia, M. ;

Ameriso, S. ;

Ameriso, P. ;

Amuchastegui, M. ;

Caceres, M. ;

Beloscar, J. ;

Petrucci, J. ;

Berli, M. ;

Budassi, N. ;

Valle, M. ;

Bustamante Labarta, G. ;

Saravia, M. ;

Caccavo, A. ;

Fracaro, V. ;

Cartasegna, L. ;

Novas, V. ;

Caruso, O. ;

Saa Zarandon, R. ;

Colombo, H. ;

Morandini, M. ;

Cuello, J. .

NEW ENGLAND JOURNAL OF MEDICINE, 2013, 369 (22) :2093-2104

[9] Apixaban versus Warfarin in Patients with Atrial Fibrillation [J].

Granger, Christopher B. ;

Alexander, John H. ;

McMurray, John J. V. ;

Lopes, Renato D. ;

Hylek, Elaine M. ;

Hanna, Michael ;

Al-Khalidi, Hussein R. ;

Ansell, Jack ;

Atar, Dan ;

Avezum, Alvaro ;

Cecilia Bahit, M. ;

Diaz, Rafael ;

Easton, J. Donald ;

Ezekowitz, Justin A. ;

Flaker, Greg ;

Garcia, David ;

Geraldes, Margarida ;

Gersh, Bernard J. ;

Golitsyn, Sergey ;

Goto, Shinya ;

Hermosillo, Antonio G. ;

Hohnloser, Stefan H. ;

Horowitz, John ;

Mohan, Puneet ;

Jansky, Petr ;

Lewis, Basil S. ;

Luis Lopez-Sendon, Jose ;

Pais, Prem ;

Parkhomenko, Alexander ;

Verheugt, Freek W. A. ;

Zhu, Jun ;

Wallentin, Lars .

NEW ENGLAND JOURNAL OF MEDICINE, 2011, 365 (11) :981-992

[10] Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy [J].

Holmes, David R., Jr. ;

Kar, Saibal ;

Price, Matthew J. ;

Whisenant, Brian ;

Sievert, Horst ;

Doshi, Shephal K. ;

Huber, Kenneth ;

Reddy, Vivek Y. .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2014, 64 (01) :1-12

← 1 2 3 →