Author + information
- Received February 16, 2017
- Revision received May 11, 2017
- Accepted May 26, 2017
- Published online November 20, 2017.
- Brian D. Williamson, MDa,∗ (, )
- Douglas C. Gohn, MDb,
- Brian M. Ramza, MD, PhDc,
- Balbir Singh, MDd,
- Yan Zhong, PhDe,
- Shelby Li, MD, MSce,
- Liesa Shanahan, BSe,
- on behalf of the SureScan Post-Approval Study Investigators
- aBeaumont Health System, Troy and Royal Oak, Michigan
- bLancaster General Health, Lancaster, Pennsylvania
- cSaint Luke’s Mid America Heart Institute, Kansas City, Missouri
- dMedanta–The Medicity, Gurgaon, Haryana, India
- eMedtronic PLC, Minneapolis, Minnesota
- ↵∗Address for correspondence:
Dr. Brian D. Williamson, William Beaumont Hospital, 4600 Investment Drive, Suite 200, Troy, Michigan 48098.
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)
The SureScan Post-Approval Study was sponsored by Medtronic (Minneapolis, Minnesota). Although Medtronic funded the study, and Medtronic employees participated in data collection and analysis, Medtronic did not review or have final approval of the manuscript. Drs. Williamson, Gohn, and Ramza have reported that their institutions received compensation fees from Medtronic for conducting clinical research protocols. Dr. Ramza has reported that his institution received fellowship support from Medtronic, St. Jude Medical, and Boston Scientific; and he has been a paid speaker for St. Jude Medical. Dr. Singh is a consultant to and receives clinical trials funds from Medtronic. Dr. Zhong, Ms. Li, and Ms. Shanahan are employees of Medtronic.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received February 16, 2017.
- Revision received May 11, 2017.
- Accepted May 26, 2017.
- 2017 The Authors