Real-World Evaluation of Magnetic Resonance Imaging in Patients With a Magnetic Resonance Imaging Conditional Pacemaker System
| Autor: | Douglas C. Gohn, Balbir Singh, Yan Zhong, Liesa Shanahan, Shelby Li, SureScan Post-Approval Study Investigators, Brian Ramza, Brian D. Williamson |
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| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
medicine.diagnostic_test business.industry Magnetic resonance imaging Atrial fibrillation 030204 cardiovascular system & hematology medicine.disease Pacemaker system 03 medical and health sciences Safety profile 0302 clinical medicine medicine Clinical endpoint Electrical performance In patient 030212 general & internal medicine Radiology Nuclear medicine business Prospective cohort study |
| Zdroj: | JACC: Clinical Electrophysiology. 3:1231-1239 |
| ISSN: | 2405-500X |
| Popis: | Objectives This global, multicenter, prospective study, initiated to meet U.S. Food and Drug Administration condition-of-approval requirements, evaluated the safety and efficacy of the Medtronic magnetic resonance imaging (MRI)–conditional pacing system when used in an MRI environment in routine clinical practice. The primary endpoint was MRI-related complications. The secondary endpoint was the cumulative change in pacing capture threshold (PCT) for patients undergoing multiple MRI scans. Background Large-scale, real-world evaluation of MRI in patients implanted with an MRI-conditional pacing system remains limited, with few published data for patients who undergo multiple MRI scans. Methods Patients were enrolled and followed up prospectively from the time of implantation. Evaluation of the pacemaker function was performed before and after MRI. The MRI-related complication-free rate was evaluated. Changes in electrical performance after each scan and cumulative changes over multiple scans were analyzed. Results In 81 centers, 2,629 patients were implanted with a complete SureScan pacing system (41.8% women, age 70.2 ± 12.5 years). A total of 526 patients (28.5%) received 872 clinically indicated MRI scans, including 58 thoracic scans. No MRI-related complications occurred during or after MRI, meeting the primary objective. Six (1%) MRI-related observations (atrial fibrillation, PCT increase, and chest symptoms) were reported. A total of 171 patients (32.5%) underwent 2 or more scans with no cumulative increase in PCT. Conclusions This report constitutes the largest longitudinal MRI experience in patients implanted with an MRI-conditional pacing system. Results support the safety profile of the SureScan system and demonstrate for the first time that patients may safely undergo multiple MRI scans. (SureScan Post-Approval Study; NCT01299675) |
| Databáze: | OpenAIRE |
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