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©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
Randomized controlled trial of remote ischemic preconditioning and atrial fibrillation in patients undergoing cardiac surgery
Amir S Lotfi, Hossein Eftekhari, Auras R Atreya, Ananth Kashikar, Senthil K Sivalingam, Miguel Giannoni, Paul Visintainer, Daniel Engelman
Amir S Lotfi, Hossein Eftekhari, Auras R Atreya, Senthil K Sivalingam, Miguel Giannoni, Department of Cardiology, Baystate Medical Center, Tufts University School of Medicine, Springfield, MA 01199, United States
Ananth Kashikar, Department of Anesthesiology, Baystate Medical Center, Tufts University School of Medicine, Springfield, MA 01199, United States
Paul Visintainer, Department of Epidemiology and Biostatistics, Baystate Medical Center, Tufts University School of Medicine, Springfield, MA 01199, United States
Daniel Engelman, Department of Cardiac Surgery, Baystate Medical Center, Tufts University School of Medicine, Springfield, MA 01199, United States
Author contributions: Lotfi AS, Eftekhari H and Visintainer P were responsible for the study conception and design; Eftekhari H, Atreya AR, Sivalingam SK, Giannoni M were responsible for data collection; Lotfi AS, Atreya AR and Visintainer P were responsible for data analysis and interpretation, and manuscript drafting; Kashikar A, Sivalingam SK, Giannoni M and Engelman D critically revised the article for important intellectual content; all the authors reviewed and approved the final version to be published.
Institutional review board statement: The study was reviewed and approved by the Institutional Review Board of Baystate Medical Center.
Clinical trial registration statement: The study was registered at http://www.clinicaltrials.gov prior to study enrollment (Identifier NCT01500369).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All authors declare no potential conflicting interests related to this paper.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Amir S Lotfi, MD, Department of Cardiology, Baystate Medical Center, Tufts University School of Medicine, 759 Chestnut St, Springfield, MA 01199, United States.
amir.lotfimd@bhs.org
Telephone: +1-413-7944492 Fax: +1-413-7940198
Received: April 25, 2016
Peer-review started: April 26, 2016
First decision: May 17, 2016
Revised: August 5, 2016
Accepted: August 27, 2016
Article in press: August 29, 2016
Published online: October 26, 2016
Processing time: 183 Days and 19.3 Hours
AIM
To study whether remote ischemic preconditioning (RIPC) has an impact on clinical outcomes, such as post-operative atrial fibrillation (POAF).
METHODS
This was a prospective, single-center, single-blinded, randomized controlled study. One hundred and two patients were randomized to receive RIPC (3 cycles of 5 min ischemia and 5 min reperfusion in the upper arm after induction of anesthesia) or no RIPC (control). Primary outcome was POAF lasting for five minutes or longer during the first seven days after surgery. Secondary outcomes included length of hospital stay, incidence of inpatient mortality, myocardial infarction, and stroke.
RESULTS
POAF occurred at a rate of 54% in the RIPC group and 41.2% in the control group (P = 0.23). No statistically significant differences were noted in secondary outcomes between the two groups.
CONCLUSION
This is the first study in the United States to suggest that RIPC does not reduce POAF in patients with elective or urgent cardiac surgery. There were no differences in adverse effects in either group. Further studies are required to assess the relationship between RIPC and POAF.
Core tip: This is the first study in the United States to suggest that remote ischemic preconditioning does not reduce post-operative atrial fibrillation in patients with elective or urgent cardiac surgery.