Safety and feasibility of magnetic resonance imaging within the first week following transvenous pacing system implantation
Abstract Body (Do not enter title and authors here): Introduction Patients with transvenous cardiac implantable electrical devices (CIEDs) including pacemakers are typically excluded from magnetic resonance imaging (MRI) examinations for at least 6-weeks following implant. However, many MRI scans are required on urgent or emergency basis, potentially resulting in suboptimal management for patients following a recent CIED implant. The absolute risks of adverse lead/generator events with early MRI have not been quantified. Specific transvenous pacing systems from one manufacturer (Abbott) do not mandate a routine 6-week post-implant restriction for MRI conditionality, although real-world human data investigating lead parameter stability with MRI early (<7 days) post-implant are lacking.
Research Question Can MRI be performed early (<7 days) after pacemaker implantation without safety events or significant changes to lead parameters?
Methods Patients undergoing implantation of Abbott Assurity™ MRI pacemakers with active-fixation MRI conditional leads (Abbott Tendril™ 52cm/58cm or UltiPace™ 65cm) with no contraindication to MRI underwent cardiac MRI within 7 days of implant. Patients were scanned at 1.5 or 3T in an asynchronous pacing mode. Device interrogation was performed before and after MRI. All patients provided written consent.
Pre- and post-MRI lead parameter measurements were compared using the two one-sided t-Tests (TOST) equivalence test. Equivalence margins were prespecified: lead impedance ±30Ω, lead sensing ±0.5mV, lead threshold ±0.25V.
Results 20 patients (median age 77 (IQR 72-80) years, 75% male) were recruited. 65% received right ventricular pacing and 35% conduction system pacing.
Median time from implant to MRI was 3 [IQR 1-5] days. All lead parameters were statistically equivalent pre- and post-MRI:
Atrial lead impedance mean difference 5 Ω (90% CI -3 to +12), TOST p<0.001 Ventricular lead impedance -1 Ω (90% CI -9.2 to +7.2), TOST p<0.001 Sensed P wave 0.04 mV (90% CI -0.13 to +0.22), TOST p<0.001 Sensed R wave -0.06 mV (90% CI -0.28 to +0.17), TOST p=0.001 Atrial capture threshold -0.01 mV (90% CI -0.04 to +0.01), TOST p<0.001 Ventricular capture threshold -0.01 mV (90% CI -0.05 to +0.03), TOST p<0.001
Conclusion MRI within 7 days of pacemaker implantation was safe, with no adverse events and no significant change in lead parameters. These findings provide real-world data to complement manufacturer guidance and support access to early MRI when indicated for patients with conditional pacemaker systems.
Raby, Jonathan
(
University of Oxford
, Oxford , United Kingdom )
Bussmann, Benjamin
(
University of Oxford
, Oxford , United Kingdom )
Tang, Pok-tin
(
University of Oxford
, Oxford , United Kingdom )
Camm, C Fielder
(
Oxford University Hospitals NHS Trust
, Oxford , United Kingdom )
Panagopoulos, Dimitrios
(
Oxford University Hospitals NHS Trust
, Oxford , United Kingdom )
Betts, Tim
(
Oxford University Hospitals NHS Trust
, Oxford , United Kingdom )
Ginks, Matthew
(
Oxford University Hospitals NHS Trust
, Oxford , United Kingdom )
Ormerod, Julian
(
Oxford University Hospitals NHS Trust
, Oxford , United Kingdom )
Gamble, James
(
Oxford University Hospitals NHS Trust
, Oxford , United Kingdom )
Pedersen, Michala
(
Oxford University Hospitals NHS Trust
, Oxford , United Kingdom )
Morais, Shawn
(
Oxford University Hospitals NHS Trust
, Oxford , United Kingdom )
Rajappan, Kim
(
Oxford University Hospitals NHS Trust
, Oxford , United Kingdom )
Neubauer, Stefan
(
University of Oxford
, Oxford , United Kingdom )
Rider, Oliver
(
University of Oxford
, Oxford , United Kingdom )
Herring, Neil
(
University of Oxford
, Oxford , United Kingdom )
Lewis, Andrew
(
UNIVERSITY OF OXFORD
, Oxford , United Kingdom )
Author Disclosures:
Jonathan Raby:DO NOT have relevant financial relationships
| Michala Pedersen:No Answer
| Shawn Morais:DO NOT have relevant financial relationships
| Kim Rajappan:DO NOT have relevant financial relationships
| Stefan Neubauer:DO have relevant financial relationships
;
Consultant:Caristo Diagnostics:Active (exists now)
| Oliver Rider:No Answer
| Neil Herring:DO have relevant financial relationships
;
Research Funding (PI or named investigator):Abbott Medical:Active (exists now)
| Andrew Lewis:DO have relevant financial relationships
;
Consultant:AstraZeneca:Active (exists now)
; Speaker:Novartis:Past (completed)
; Research Funding (PI or named investigator):Abbott:Active (exists now)
; Consultant:Abbott:Past (completed)
| Benjamin Bussmann:No Answer
| Pok-Tin Tang:DO NOT have relevant financial relationships
| C Fielder Camm:No Answer
| Dimitrios Panagopoulos:DO NOT have relevant financial relationships
| Tim Betts:DO have relevant financial relationships
;
Speaker:Abbott:Active (exists now)
; Advisor:EnChannel:Active (exists now)
; Researcher:Medtronic:Active (exists now)
; Speaker:Boston Scientific:Active (exists now)
| Matthew Ginks:No Answer
| Julian Ormerod:DO NOT have relevant financial relationships
| James Gamble:DO NOT have relevant financial relationships
Xavier Roshan, Neubauer Stefan, Rider Oliver, Lewis Andrew, Ng Sher May, Pan Jiliu, Miller Jack, Mozes Ferenc, Valkovic Ladislav, Rayner Jennifer, Fronheiser Matthew, Rigolli Marzia
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