Mikhael F El-Chami1, Nicolas Clementy2, Christophe Garweg3, Razali Omar4, Gabor Z Duray5, Charles C Gornick6, Francisco Leyva7, Venkata Sagi8, Jonathan P Piccini9, Kyoko Soejima10, Kurt Stromberg11, Paul R Roberts12. 1. Division of Cardiology, Section of Electrophysiology, Emory University Hospital, Atlanta, Georgia. Electronic address: melcham@emory.edu. 2. Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours, France. 3. Universitaire Ziekenhuizen Leuven-Campus Gasthuisberg, Leuven, Belgium. 4. Cardiac Vascular Sentral, Kuala Lumpur, Malaysia. 5. Clinical Electrophysiology Department of Cardiology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary. 6. Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota. 7. Aston Medical Research Institute, Aston Medical School, Aston University, Birmingham, United Kingdom. 8. Southern Heart Group, Jacksonville, Florida. 9. Duke University Medical Center, Durham, North Carolina. 10. Kyorin University Hospital, Tokyo, Japan. 11. Medtronic, Mounds View, Minnesota. 12. University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom.
Abstract
OBJECTIVES: This study sought to report periprocedural outcomes and intermediate-term follow-up of hemodialysis patients undergoing Micra implantation. BACKGROUND: Leadless pacemakers may be preferred in patients with limited vascular access and high-infection risk, such as patients on hemodialysis. METHODS: Patients on hemodialysis at the time of Micra implantation attempt (n = 201 of 2,819; 7%) from the Micra Transcatheter Pacing Study investigational device exemption trial, Micra Transcatheter Pacing System Continued Access Study Protocol, and Micra Transcatheter Pacing System Post-Approval Registry were included in the analysis. Baseline characteristics, periprocedural outcomes, and intermediate-term follow-up were summarized. RESULTS: Patients on hemodialysis at the time of Micra implantation attempt were on average 70.5 ± 13.5 years of age and 59.2% were male. The dialysis patients commonly had hypertension (80%), diabetes (61%), coronary artery disease (39%), and congestive heart failure (27%), and 72% had a condition that the implanting physician felt precluded the use of a transvenous pacemaker. Micra was successfully implanted in 197 patients (98.0%). Reasons for unsuccessful implantation included inadequate thresholds (n = 2) and pericardial effusion (n = 2). The median implantation time was 27 min (interquartile range: 20 to 39 min). There were 3 procedure-related deaths: 1 due to metabolic acidosis following a prolonged procedure duration in a patient undergoing concomitant atrioventricular nodal ablation and 2 deaths occurred in patients who needed surgical repair after perforation. Average follow-up was 6.2 months (range 0 to 26.7 months). No patients had a device-related infection or required device removal because of bacteremia. CONCLUSIONS: Leadless pacemakers represent an effective pacing option in this challenging patient population on chronic hemodialysis. The risk of infection appears low with an acceptable safety profile. (Micra Transcatheter Pacing Study; NCT02004873; Micra Transcatheter Pacing System Continued Access Study Protocol; NCT02488681; Micra Transcatheter Pacing System Post-Approval Registry; NCT02536118).
OBJECTIVES: This study sought to report periprocedural outcomes and intermediate-term follow-up of hemodialysis patients undergoing Micra implantation. BACKGROUND: Leadless pacemakers may be preferred in patients with limited vascular access and high-infection risk, such as patients on hemodialysis. METHODS:Patients on hemodialysis at the time of Micra implantation attempt (n = 201 of 2,819; 7%) from the Micra Transcatheter Pacing Study investigational device exemption trial, Micra Transcatheter Pacing System Continued Access Study Protocol, and Micra Transcatheter Pacing System Post-Approval Registry were included in the analysis. Baseline characteristics, periprocedural outcomes, and intermediate-term follow-up were summarized. RESULTS:Patients on hemodialysis at the time of Micra implantation attempt were on average 70.5 ± 13.5 years of age and 59.2% were male. The dialysis patients commonly had hypertension (80%), diabetes (61%), coronary artery disease (39%), and congestive heart failure (27%), and 72% had a condition that the implanting physician felt precluded the use of a transvenous pacemaker. Micra was successfully implanted in 197 patients (98.0%). Reasons for unsuccessful implantation included inadequate thresholds (n = 2) and pericardial effusion (n = 2). The median implantation time was 27 min (interquartile range: 20 to 39 min). There were 3 procedure-related deaths: 1 due to metabolic acidosis following a prolonged procedure duration in a patient undergoing concomitant atrioventricular nodal ablation and 2 deaths occurred in patients who needed surgical repair after perforation. Average follow-up was 6.2 months (range 0 to 26.7 months). No patients had a device-related infection or required device removal because of bacteremia. CONCLUSIONS: Leadless pacemakers represent an effective pacing option in this challenging patient population on chronic hemodialysis. The risk of infection appears low with an acceptable safety profile. (Micra Transcatheter Pacing Study; NCT02004873; Micra Transcatheter Pacing System Continued Access Study Protocol; NCT02488681; Micra Transcatheter Pacing System Post-Approval Registry; NCT02536118).
Authors: Jonathan P Piccini; Ryan Cunnane; Jan Steffel; Mikhael F El-Chami; Dwight Reynolds; Paul R Roberts; Kyoko Soejima; Clemens Steinwender; Christophe Garweg; Larry Chinitz; Christopher R Ellis; Kurt Stromberg; Dedra H Fagan; Lluis Mont Journal: Europace Date: 2022-07-21 Impact factor: 5.486