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Left Axillary Implantation of Loop Recorder versus the Traditional Left Chest Area: A Prospective Randomized Study
Author(s) -
MIRACAPILLO GENNARO,
ADDONISIO LUIGI,
BRESCHI MARCO,
DE SENSI FRANCESCO,
MANFREDINI ENRICO,
CORBUCCI GIORGIO,
SEVERI SILVA,
BAROLD S. SERGE
Publication year - 2016
Publication title -
pacing and clinical electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.686
H-Index - 101
eISSN - 1540-8159
pISSN - 0147-8389
DOI - 10.1111/pace.12875
Subject(s) - medicine , implantable loop recorder , randomized controlled trial , surgery , prospective cohort study , cardiology , atrial fibrillation
Background Based upon the results of a previous small pilot study, we present the results of a prospective single‐center randomized study comparing the performance of the implantable loop recorder (ILR) at two implanting sites. Methods A group of patients whose ILRs were implanted via a left axillary approach were compared with a group who received an ILR in the traditional left site of the chest. Follow‐up (FU) was scheduled every 6 months or when symptoms occurred. All patients enrolled in the study had a complete FU from implantation to explantation. R‐ and P‐wave amplitudes were measured at implantation and during FU. Explantation of the device was programmed at the end of service life or when ILR analysis resulted in a complete and exhaustive diagnosis. Results Sixty‐three patients were enrolled (70 ± 12 years, range: 21–92, 59% male): 31 standard and 32 with axillary access. The R‐wave amplitude obtained with the new technique was comparable with that obtained with the standard procedure. The diagnostic accuracy of the ILR was comparable in the two groups. The axillary implantation procedure was slightly longer but no complications were observed. Conclusion This long‐term randomized study confirmed that axillary access for ILR implantation is feasible, safe, well tolerated, and reliable in terms of device performance. Moreover, it is aesthetically superior to the standard approach and carries the potential of minimizing permanent scarring after ILR extraction.