Feasibility and outcomes of Micra implant after cardiac implantable electronic device extraction
Authors: Tamborrino P P , Barletta V , Parlato A , Parollo M , Mazzocchetti L , Sbragi S , Canu A , Di Cori A , De Lucia R , Segreti L , Bongiorni M G , Zucchelli G 
Published: May 2023

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
The specific and well-known design features of leadless pacing system (Micra Transcatheter Pacing System, M-TPS) have suggested his use in patients that previously underwent transvenous lead extraction (TLE) for any reason.
The study aimed to investigate feasibility and long-term outcomes of M-TPS implant in patients underwent TLE.

Methods
Patients undergone M-TPS implantation in our Institution from May 2014 to September 2022 were included in the study. All patients fulfilled standard criteria for PM implantation (VVI or VDD mode). Follow-up (FU) was scheduled at discharge, after 1 month and every 6 months thereafter and electrical parameters were checked. Major complications were defined as life-threatening events, requiring surgical intervention or any event causing significant hemodynamic instability or resulting in death. Study population was divided between "naïve pacing" and "post-extraction" patients.

Results
We enrolled 193 patients (76.7% males), 57 (29.5%) received M-TPS implantation after TLE, needed because of infection in 91.4% of cases. Indications for pacing were permanent AF with bradycardia in 107 (55.5%) patients, complete AVB in 59 (30.5%), symptomatic sinus node dysfunction in 20 (10%), and advanced AVB or bifascicular bock in 7 (4%). There were no statistically significant differences between groups for demographics characteristics and primary PM implant indications, except mean age at implant that was significantly inferior in the post-extraction group [80 (IQR 75-84) vs 78 (IQR 72-83), p=0.04]. Implant procedure was successful in all and no complications were recorded. No differences between groups in procedure duration [40 (IQR 30-50) vs 45 (30-65) min, p=0.34], fluoroscopy time [9 (6-14) vs 9 (6-11) min, p=0.31] and single device delivery (64.9% vs 67.9%, p=0.35) were observed. The mean FU was 12 (1-36) months, maximum 8 years. Pacing variables at implantation [pacing threshold 0.5 (0.38-0.63) vs 0.5 (0.38-0.88) V/0.24 ms, p=0.15; impedance 720 (600-837) vs 675 (615-825) Ohm, p=0.51; R wave amplitude 9 (6.25-12.87) vs 8.2 (5.65-12) mV, p=0.47], discharge [pacing threshold 0.38 (0.38-0.63) vs 0.38 (0.38-0.63) V/0.24 ms, p=0.27; impedance 685 (580-770) vs 610 (560-750) Ohm, p=0.16; R wave amplitude 10.25 (7.2-14.5) vs 9.3 (6.5-16.5) mV, p=0.6], and at 6 months [pacing threshold 0.5 (0.38-0.5) vs 0.5 (0.38-1.25) V/0.24 ms, p=0.64; impedance 580 (520-680) vs 570 (510-640) Ohm, p=0.63; R wave amplitude 11.9 (8.2-16.4) vs 11.7 (9-20) mV, p=0.68; battery voltage 3.09 (3.05-3.11) vs 3.09 (3.04-3.13) V, p=0.71] did not show differences.

Conclusion
M-TPS is an efficacious and safe alternative to conventional PM, with the main advantage of the absence of transvenous leads and a surgically created subcutaneous pocket, avoiding all the related complications. These devices are a reliable alternative after TLE, with similar electrical performances than those observed in patients who did not previously received pacing.