Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker
| Autor: | Mikhael F. El-Chami, Santosh K. Padala, Dedra H. Fagan, Jayanthi N. Koneru, Aatish Garg, Alan Cheng, Kurt Stromberg, Jonathan P. Piccini, Kenneth A. Ellenbogen, Paul R. Roberts |
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| Rok vydání: | 2020 |
| Předmět: |
Male
Pacemaker Artificial medicine.medical_specialty Time Factors 030204 cardiovascular system & hematology Pacemaker implantation 03 medical and health sciences 0302 clinical medicine Physiology (medical) medicine Humans In patient Prospective Studies Registries 030212 general & internal medicine Major complication Aged business.industry Incidence (epidemiology) Cardiac Pacing Artificial Arrhythmias Cardiac Equipment Design United States Surgery Venous access Survival Rate Total mortality Clinical trial Safety profile Treatment Outcome Female Morbidity Cardiology and Cardiovascular Medicine business Follow-Up Studies |
| Zdroj: | Heart Rhythm. 17:2056-2063 |
| ISSN: | 1547-5271 |
| DOI: | 10.1016/j.hrthm.2020.07.035 |
| Popis: | The Micra transcatheter pacemaker is a safe and effective alternative to transvenous permanent pacemakers (TV-PPMs). However, the safety profile and mortality outcomes of Micra implantation in patients deemed poor candidates for TV-PPM are incompletely understood.The purpose of this study was to evaluate safety and all-cause mortality in patients undergoing Micra implantation stratified by whether they were precluded for therapy with a TV-PPM.Patients from the Micra clinical trials were divided into groups on the basis of whether the implanter considered the patient to be precluded from receiving a TV-PPM. Micra groups were compared with one another as well as with a historical cohort of patients who received a single-chamber TV-PPM.A total of 2817 patients underwent a Micra implantation attempt, of whom 546 (19%) patients deemed ineligible for TV-PPM implantation for reasons such as venous access issues or prior device infections. Both acute mortality (2.75% vs 1.32%; P=.022) and total mortality at 36 months (38.1% vs 20.6%; P.001) were significantly higher in the precluded group than in the nonprecluded group. Mortality was similar among nonprecluded patients and patients implanted with a TV-PPM. The major complication rate through 36 months was similar between the 2 Micra groups (3.81% vs 4.30%; P=.40).All-cause mortality is higher in Micra patients deemed ineligible for TV-PPM implantation than in nonprecluded Micra patients and those who received a TV-PPM, in part related to a higher incidence of chronic comorbidities in these patients. The overall major complication rate was low and did not differ by preclusion status.Micra Post-Approval Registry ClinicalTrials.gov identifier: NCT02536118; Micra Continued Access Study ClinicalTrials.gov identifier: NCT02488681; Micra Transcatheter Pacing Study ClinicalTrials.gov identifier: NCT02004873; Medtronic Product Surveillance Registry ClinicalTrials.gov identifier: NCT01524276. |
| Databáze: | OpenAIRE |
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