Leadless pacemaker implant, anticoagulation status, and outcomes: Results from the Micra Transcatheter Pacing System Post-Approval Registry
Por:
El-Chami, MF, Garweg, C, Iacopino, S, Al-Samadi, F, Martinez-Sande, JL, Tondo, C, Johansen, JB, Prat, XV, Piccini, JP, Cha, YM, Grubman, E, Bordachar, P, Roberts, PR, Soejima, K, Stromberg, K, Fagan, DH, Clementy, N
Publicada:
1 feb 2022
Ahead of Print:
1 ene 2022
Resumen:
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.
Filiaciones:
El-Chami, MF:
Emory Univ, Div Cardiol, Sect Electrophysiol, Atlanta, GA USA
Garweg, C:
UZ Leuven, Dept Cardiovasc Sci, Leuven, Belgium
Iacopino, S:
Maria Cecelia Hosp, Arrhythmol Dept, Electrophysiol Unit, Cotignola, Italy
Al-Samadi, F:
King Salman Heart Ctr King Fahad Med City, Riyadh, Saudi Arabia
Martinez-Sande, JL:
Univ Clin Hosp Santiago Compostela, Unidad Arritmias, Serv Cardiol, Santiago De Compostela, Spain
Tondo, C:
Univ Milan, Dept Clin Sci & Community, Monzino Cardiac Ctr, IRCCS, Milan, Italy
Johansen, JB:
Hosp Santa Creu & Sant Pau, Arrhythmia Unit, Barcelona, Spain
Prat, XV:
Hosp Santa Creu & Sant Pau, Arrhythmia Unit, Barcelona, Spain
Piccini, JP:
Mayo Clin, Rochester, MN USA
Cha, YM:
Yale Univ, Sch Med, Sect Cardiovasc Med, New Haven, CT USA
Grubman, E:
Univ Bordeaux, Hosp Cardiol Haut Leveque, CHU Bordeaux, Bordeaux, France
Bordachar, P:
Univ Hosp Southampton NHS Fdn Trust, Southampton, Hants, England
Roberts, PR:
Kyorin Univ Hosp, Tokyo, Japan
Soejima, K:
Medtronic Inc, Mounds View, MN USA
Stromberg, K:
Ctr Hospitalier Reg Univ Tours, Dept Med Cardiol, Hop Trousseau, Tours, France
Odense Univ Hosp, Dept Cardiol, Odense, Denmark.
Duke Univ Med Ctr, Electrophysiol Sect, Duke Ctr Atrial Fibrillat, Duke Clin Res Inst, Durham, NC USA
|