Abstract
Cardiac tamponade is a life-threatening complication during transcatheter aortic valve implantation (TAVI), often caused by perforation of the right ventricle (RV) by the temporary pacemaker used for rapid pacing during valve deployment. We aimed to assess the feasibility of performing rapid pacing while maintaining inflation of the pacing lead balloon in the RV during TAVI. Among 749 consecutive patients who underwent TAVI with SAPIEN XT valves between October 2013 and July 2015, 726 treated using rapid pacing with a transvenous balloon-tip lead were enrolled in our study, and were stratified into three groups according to the extent of balloon inflation in the RV as follows: full inflation (n = 100), partial inflation (n = 196), and deflation (n = 430). We compared the following clinical outcomes: pacing lead-related RV perforation, rapid pacing failure, valve malpositioning due to rapid pacing failure, device success, and 30-day mortality. Pacing lead-related RV perforation occurred only in patients in the deflation group (6 cases, 1.4%), but the differences among the groups were not statistically significant (p = 0.13). Rapid pacing failure, but no valve malpositioning, occurred most frequently in patients in the full inflation group (4.0% vs. 0.5% in the other groups, p = 0.004). The rate of device success (> 94%) and the 30-day mortality (2.0%) were similar among the three groups. Partial inflation of the balloon of the pacing lead may reduce the risk of RV perforation without increasing the risk of pacing failure or valve malpositioning.
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The OCEAN-TAVI registry is supported by Edwards Lifesciences, Medtronic, and Daiichi-Sankyo Company.
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Dr. Yamamoto, Dr. Tada, Dr. Naganuma, Dr. Shirai, and Dr. Watanabe are clinical proctors for Edwards Lifesciences and Medtronic. Dr. Araki, Dr. Shimizu, and Dr. Hayashida are clinical proctors of Edwards Lifesciences. The remaining authors have nothing to disclose.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The protocol was initially approved by the institutional review board committee of the Keio University School of Medicine (reference number: 20130270) and was subsequently approved by the ethical committee of each center.
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Informed consent was obtained from all individual participants included in the study.
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Tanaka, M., Yanagisawa, R., Yashima, F. et al. A novel technique to avoid perforation of the right ventricle by the temporary pacing lead during transcatheter aortic valve implantation. Cardiovasc Interv and Ther 36, 347–354 (2021). https://doi.org/10.1007/s12928-020-00676-0
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DOI: https://doi.org/10.1007/s12928-020-00676-0