R-Wave Sensing in an Implantable Cardiac Monitor without ECG-Based Preimplant Mapping: Results from a Multicenter Clinical Trial

Introduction Reducing the form factor of an implantable cardiac monitor (ICM) may simplify device implant. This study evaluated R-wave sensing at a range of electrode distances and a preferred device implant location without mapping. Methods Patients scheduled for a Medtronic Reveal (R) ICM implant (Medtronic Inc., Minneapolis, MN, USA) underwent a preimplant pocket recording using a diagnostic recording catheter. The ICM implant location was left to the discretion of the implanting physician, but a "recommended" position spanned the V-2-V-3 electrocardiogram electrode location in an oblique 45 degrees angle. R-wave amplitudes were analyzed from ICM follow-up. Results Seventeen of 41 subjects (15 male, age 57 +/- 16 years) had the maximum surface-filtered R-wave at the recommended location. Fourteen patients underwent diagnostic recording across the range of electrode spacing. There was a strong correlation between the R-wave amplitude and electrode distance (r(2) = 0.97, P < 0.001) with an increase of 29 mu V per 2.5 mm. Comparing normalized R-wave distributions between the recommended ICM implant group (Group 1, n = 19) and the remaining patients (Group 2, n = 7), the proportion of ICM R-wave counts of amplitude 0.25-1.2 mV was higher (79% vs 46%, P < 0.05). Of 17 patients in Group 1 who had >= 1-month ICM follow-up (79 +/- 45 days), no sensing-related false arrhythmia detection was found in 16 (93%) patients. Conclusions The subcutaneous R-wave amplitude correlates with electrode spacing in the implant zone of ICM patients. Implant locations at the V-2-V-3 position at a 45 degrees angle offer an adequate R wave for sensing. Preimplant mapping to achieve acceptable R-wave amplitude may not be necessary.