TY - JOUR
T1 - Leadless pacemaker implant, anticoagulation status, and outcomes
T2 - Results from the Micra Transcatheter Pacing System Post-Approval Registry
AU - El-Chami, Mikhael F.
AU - Garweg, Christophe
AU - Iacopino, Saverio
AU - Al-Samadi, Faisal
AU - Martinez-Sande, Jose Luis
AU - Tondo, Claudio
AU - Johansen, Jens Brock
AU - Prat, Xavier Viñolas
AU - Piccini, Jonathan P.
AU - Cha, Yong Mei
AU - Grubman, Eric
AU - Bordachar, Pierre
AU - Roberts, Paul R.
AU - Soejima, Kyoko
AU - Stromberg, Kurt
AU - Fagan, Dedra H.
AU - Clementy, Nicolas
N1 - Funding Information:
Funding Sources: Dr Piccini was supported by Grant R01HL128595 from the National Heart, Lung, and Blood Institute. Disclosures: The Micra Post-Approval Registry (ClinicalTrials.gov Identifier NCT02536118) is funded by Medtronic, Inc. Dr El-Chami reports consulting for Medtronic, Boston Scientific, and Biotronik. Dr Garweg reports research funding and speaker/consultancy fees from Medtronic. Dr Tondo reports honoraria from Abbott; and serving on the advisory board of Medtronic and Boston Scientific. Dr Johansen reports serving on a speakers bureau for Medtronic and Merit Medical; and honoraria/scientific board for Medtronic and Biotronik. Dr Piccini reports clinical research grants from Abbott, American Heart Association, Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, and Philips; and consulting for Abbott, Allergan, ARCA Biopharma, Biotronik, Boston Scientific, LivaNova, Medtronic, Milestone, MyoKardia, Sanofi, Philips, and Up-to-Date. Dr Roberts reports honoraria from Medtronic. Dr Soejima reports honoraria/lecturing for Medtronic Japan and Abbott Japan. Dr Stromberg is an employee/shareholder of Medtronic. Dr Fagan is an employee/shareholder of Medtronic. Dr Clementy reports consulting for Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Funding Information:
Funding Sources: Dr Piccini was supported by Grant R01HL128595 from the National Heart, Lung, and Blood Institute . Disclosures: The Micra Post-Approval Registry ( ClinicalTrials.gov Identifier NCT02536118 ) is funded by Medtronic, Inc. Dr El-Chami reports consulting for Medtronic, Boston Scientific, and Biotronik. Dr Garweg reports research funding and speaker/consultancy fees from Medtronic. Dr Tondo reports honoraria from Abbott; and serving on the advisory board of Medtronic and Boston Scientific. Dr Johansen reports serving on a speakers bureau for Medtronic and Merit Medical; and honoraria/scientific board for Medtronic and Biotronik. Dr Piccini reports clinical research grants from Abbott, American Heart Association , Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, and Philips; and consulting for Abbott, Allergan, ARCA Biopharma, Biotronik, Boston Scientific, LivaNova, Medtronic, Milestone, MyoKardia, Sanofi, Philips, and Up-to-Date. Dr Roberts reports honoraria from Medtronic. Dr Soejima reports honoraria/lecturing for Medtronic Japan and Abbott Japan. Dr Stromberg is an employee/shareholder of Medtronic. Dr Fagan is an employee/shareholder of Medtronic. Dr Clementy reports consulting for Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2021 Heart Rhythm Society
PY - 2022/2
Y1 - 2022/2
N2 - Background: Early results from the Micra investigational trial and Micra Post-Approval Registry (PAR) demonstrated excellent safety and device performance; however, outcomes based on anticoagulation (AC) status at implant have not been evaluated. Objective: The purpose of this study was to report implant characteristics, perforation rate, and vascular-related events based on perioperative oral AC strategy in patients undergoing Micra implant. Methods: We compared procedure characteristics, major complications, and vascular events, including pericardial effusion, stratified by any adverse event (including major complications, minor complications, and observations) or major complication only according to AC status in the Micra PAR. Results: Among 1795 patients with AC status available, 585 were not on AC, 795 had AC interrupted, and 415 had AC continued during Micra implant. Non-AC patients tended to be younger, with less history of atrial fibrillation and chronic obstructive pulmonary disease, and more history of dialysis than interrupted and continued patients. The implant success rate was similar for all groups (99.1%–99.8%). Through 30 days postimplant, the overall major complication rate was 3.1% for the non-AC group, 2.6% for the interrupted group, and 1.5% for the continued group. The combined rate for any vascular or pericardial effusion adverse event did not differ significantly among AC strategies (6.5%, 4.8%, and 3.6%, respectively). Conclusion: Implant of Micra seems to be safe and feasible regardless of an interrupted or continued periprocedural oral AC strategy, with no increased risk of perforation or vascular complications.
AB - Background: Early results from the Micra investigational trial and Micra Post-Approval Registry (PAR) demonstrated excellent safety and device performance; however, outcomes based on anticoagulation (AC) status at implant have not been evaluated. Objective: The purpose of this study was to report implant characteristics, perforation rate, and vascular-related events based on perioperative oral AC strategy in patients undergoing Micra implant. Methods: We compared procedure characteristics, major complications, and vascular events, including pericardial effusion, stratified by any adverse event (including major complications, minor complications, and observations) or major complication only according to AC status in the Micra PAR. Results: Among 1795 patients with AC status available, 585 were not on AC, 795 had AC interrupted, and 415 had AC continued during Micra implant. Non-AC patients tended to be younger, with less history of atrial fibrillation and chronic obstructive pulmonary disease, and more history of dialysis than interrupted and continued patients. The implant success rate was similar for all groups (99.1%–99.8%). Through 30 days postimplant, the overall major complication rate was 3.1% for the non-AC group, 2.6% for the interrupted group, and 1.5% for the continued group. The combined rate for any vascular or pericardial effusion adverse event did not differ significantly among AC strategies (6.5%, 4.8%, and 3.6%, respectively). Conclusion: Implant of Micra seems to be safe and feasible regardless of an interrupted or continued periprocedural oral AC strategy, with no increased risk of perforation or vascular complications.
KW - Anticoagulation
KW - Bradycardia
KW - Leadless pacemaker
KW - Pacing
KW - Vascular complications
UR - http://www.scopus.com/inward/record.url?scp=85120344720&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85120344720&partnerID=8YFLogxK
U2 - 10.1016/j.hrthm.2021.10.023
DO - 10.1016/j.hrthm.2021.10.023
M3 - Article
C2 - 34757189
AN - SCOPUS:85120344720
VL - 19
SP - 228
EP - 234
JO - Heart Rhythm
JF - Heart Rhythm
SN - 1547-5271
IS - 2
ER -