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Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with the Micra transcatheter pacemaker

Session Top of the pops in arrhythmia treatment - from life-style modification to lead extraction

Speaker Jayanthi Koneru

Event : ESC Congress 2019

  • Topic : arrhythmias and device therapy
  • Sub-topic : Device Complications and Lead Extraction
  • Session type : Abstract Sessions

Authors : A Garg (Richmond,US), JN Koneru (Richmond,US), D Fagan (Mounds View, Minnesota,US), K Stromberg (Mounds View, Minnesota,US), MF El-Chami (Atlanta,US), JP Piccini (Durham,US), PR Roberts (Southampton,GB), K Soejima (Tokyo,JP), A Cheng (Mounds View, Minnesota,US), KA Ellenbogen (Richmond,US)

Authors:
A. Garg1 , J.N. Koneru1 , D. Fagan2 , K. Stromberg2 , M.F. El-Chami3 , J.P. Piccini4 , P.R. Roberts5 , K. Soejima6 , A. Cheng2 , K.A. Ellenbogen1 , 1Virginia Commonwealth University - Richmond - United States of America , 2Medtronic - Mounds View, Minnesota - United States of America , 3Emory University - Atlanta - United States of America , 4Duke Clinical Research Institute - Durham - United States of America , 5University Hospital Southampton NHS Foundation Trust - Southampton - United Kingdom , 6Kyorin University - Tokyo - Japan ,

Topic(s):
Device Complications and Lead Extraction

Citation:
European Heart Journal ( 2019 ) 40 ( Supplement ), 3652

Background: The Micra transcatheter pacemaker has proven to be a safe and effective alternative to transvenous pacemakers (TVPs). However, the safety profile after Micra implantation in patients deemed poor candidates for TVPs is poorly understood.

Purpose: To evaluate the safety and all-cause mortality outcomes in Micra recipients stratified by whether or not they were precluded for therapy with TVP.

Methods: Micra patients from the Micra Transcatheter Pacing (IDE) Study, Continued Access (CA) study, and Post-Approval Registry (PAR) were divided into groups based upon whether or not the implanting physician considered the patient to be precluded from receiving a transvenous pacing system. All-cause mortality was compared between the Micra patient groups and patients receiving a single-chamber transvenous pacing system (SC-TVP) since 2010 from the Medtronic product surveillance registry using univariate and multivariate Cox models.

Results: Among 2,819 patients who underwent a Micra implant attempt, the overall major complication rate through 24 months was 3.5%. In these patients, 548 were deemed precluded from TVP implantation. Prior device infection or bacteremia (38.9%), venous access issues (36.1%) and thrombosis (10.2%) were amongst the most common causes of preclusion for TVP implantation. These patients were younger (71.7 vs. 76.7 years), more frequently on hemodialysis (26.3% vs. 2.5%), and more often had a prior CIED implanted (38.4% vs. 4.4%) than non-precluded patients. Over an average follow-up of 13.5±11.1 months, all-cause mortality was significantly higher in precluded Micra patients compared with SC-TVP patients (HR: 2.16, 95% CI: 1.54–3.2, P<0.001) (Figure 1). However, there was no significant difference in all-cause mortality when comparing non-precluded Micra patients and SC-TVP patients (HR: 1.12, 95% CI: 0.86–1.44, P=0.401). Acute all-cause death (within 1 month) among Micra patients was 2.74% and 1.32% in the precluded and non-precluded TVP groups, respectively. The procedure-related death rate was 0.55% for the TVP precluded group and 0.13% for the not precluded group (P=0.092). The major complication rate through 24-months was similar between the two Micra groups (4.0% vs 3.4%, P=0.630).

Conclusion: The overall safety profile of Micra remains is in line with previously reported data. All-cause mortality risk (both acute and long term) appears to be higher in patients who were precluded from receiving TVP.

All-cause mortality for Micra and SC-TVP

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