Left Axillary Implantation of Loop Recorder versus the Traditional Left Chest Area: A Prospective Randomized Study.
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.


CONCLUSIONS
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.
Division of Cardiology, Misericordia Hospital, Grosseto, Italy.
Gennaro
G
Miracapillo
Division of Cardiology, Misericordia Hospital, Grosseto, Italy.
Luigi
L
Addonisio
Division of Cardiology, Misericordia Hospital, Grosseto, Italy.
Marco
M
Breschi
Division of Cardiology, Misericordia Hospital, Grosseto, Italy.
Francesco
F
DE Sensi
Biotronik Italia S.p.A, Italy.
Enrico
E
Manfredini
Formerly, Medtronic Bakken Research Center, Maastricht, The Netherlands.
Giorgio
G
Corbucci
Division of Cardiology, Misericordia Hospital, Grosseto, Italy.
Silva
S
Severi
Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York.
S Serge
SS
Barold
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001281:Atrial Fibrillation / Q000175:diagnosis*; D001365:Axilla / Q000601:surgery*; D015716:Electrocardiography, Ambulatory / Q000295:instrumentation*; D005260:Female; D006801:Humans; D016247:Information Storage and Retrieval / Q000379:methods; D008297:Male; D008875:Middle Aged; D019736:Prostheses and Implants; D019919:Prosthesis Implantation / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D019616:Thoracic Surgical Procedures; D016896:Treatment Outcome; D055815:Young Adult
cardiac arrhythmia; electrocardiographic monitoring; implantable loop recorder; subpectoral implantation; syncope