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The Kora Pacemaker is Safe and Effective for Magnetic Resonance Imaging.

ABSTRACT: BACKGROUND:The impact of magnetic resonance imaging (MRI) on pacemakers is potentially hazardous. We present clinical results from a novel MRI conditional pacing system with the capability to switch automatically to asynchronous mode in the presence of a strong magnetic field. AIMS:The IKONE (Assessment of the MRI solution: KORA 100™ and Beflex™ pacing leads system) study is an open-label, prospective, multicenter study aimed at confirming the safety and effectiveness of the system, when used in patients undergoing MRI of anatomical regions excluding the chest. METHODS:Primary eligibility criteria included patients implanted with the system, with or without a clinically indicated MRI. The primary endpoint was to confirm no significant change in pacing capture thresholds at 1 month after an MRI, with an absolute difference of ?0.75 V between the pre- and 1-month post-MRI for both atrial and ventricular capture thresholds. RESULTS:Out of 33 patients enrolled (mean age: 72.8 ± 11.4 years, 70% male, implant indication or device), 29 patients implanted with the MRI conditional system underwent an MRI 6-8 week postimplant. The study reached its primary endpoint: the mean absolute difference in pacing capture threshold at 1-month post-MRI versus pre-MRI was less than 0.75 V in the atrium (? = 0.18 ± 0.16 V, P-value < 0.001) and in the ventricle (? = 0.18 ± 0.22 V, P-value < 0.001). There were no adverse events related to the MRI procedure nor were there reports of patient symptoms or discomfort associated. MR image quality was of diagnostic quality in all patients. CONCLUSION:Lead electrical performance as measured by difference in capture thresholds were not impacted by MRI. This first clinical evaluation of a novel MRI conditional system demonstrates it is safe and effective for use in out-of-chest, 1.5-T MR imaging.

SUBMITTER: Savoure A

PROVIDER: S-EPMC4536771 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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The Kora Pacemaker is Safe and Effective for Magnetic Resonance Imaging.

Savouré Arnaud A Mechulan Alexis A Burban Marc M Olivier Audrey A Lazarus Arnaud A

Clinical Medicine Insights. Cardiology 20150812

<h4>Background</h4>The impact of magnetic resonance imaging (MRI) on pacemakers is potentially hazardous. We present clinical results from a novel MRI conditional pacing system with the capability to switch automatically to asynchronous mode in the presence of a strong magnetic field.<h4>Aims</h4>The IKONE (Assessment of the MRI solution: KORA 100™ and Beflex™ pacing leads system) study is an open-label, prospective, multicenter study aimed at confirming the safety and effectiveness of the syste ...[more]

PMID: 26327785

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Project description:Background?:Magnetic resonance imaging (MRI) is increasingly becoming the imaging modality of choice for many clinical disorders due to superior image quality and absence of radiation. However, access to MRI remains limited for most patients with cardiac implantable electronic devices due to potential safety concerns. In line with guidelines, there is no absolute contraindication to perform MRI, but warrants careful risk-benefit assessment. Case summary?:A 59-year-old man was admitted with a 5-day history of central chest pain and few week's history of general malaise, dry cough, and breathlessness. Electrocardiogram confirmed complete atrioventricular block (CAVB). A slight increase in cardiac enzyme was noted. Coronary angiogram revealed atheromatous changes, but no obstructive coronary lesion. A temporary transvenous pacemaker was inserted. Transthoracic echocardiogram confirmed a dilated left ventricle with severely reduced left ventricular function. To facilitate diagnosis (hence prognosis), management and mobilization, investigation with cardiovascular magnetic resonance (CMR) was warranted but contraindicated by the temporary transvenous pacemaker. An active fixation pacemaker lead was therefore placed in the right ventricle via percutaneous puncture of the right subclavian vein and connected to a pulse generator, both secured to the skin with sutures and adhesive medical dressing. Appropriate device programming and close patient monitoring ensured that CMR could be performed without any adverse effects. A diagnosis of acute myocarditis was confirmed. Regular device interrogation during an extended 3-week period with temporary pacing ruled out any device failure. As there was no resolution of CAVB, the patient received a dual-chamber pacemaker. Discussion?:Cardiovascular magnetic resonance was feasible and safely performed on a patient with a temporary permanent external pacemaker system using a standard screw-in pacing lead and a regular pulse generator fixed to the skin. Although more studies are needed for generalizability, CMR may be used in highly selected patients with a temporary pacemaker.

Project description:Cardiac magnetic resonance imaging (CMR) is considered the gold standard for measuring cardiac function. Further, in a single CMR exam, information about cardiac structure, tissue composition, and blood flow could be obtained. Nevertheless, CMR is underutilized due to long scanning times, the need for multiple breath-holds, use of a contrast agent, and relatively high cost. In this work, we propose a rapid, comprehensive, contrast-free CMR exam that does not require repeated breath-holds, based on recent developments in imaging sequences. Time-consuming conventional sequences have been replaced by advanced sequences in the proposed CMR exam. Specifically, conventional 2D cine and phase-contrast (PC) sequences have been replaced by optimized 3D-cine and 4D-flow sequences, respectively. Furthermore, conventional myocardial tagging has been replaced by fast strain-encoding (SENC) imaging. Finally, T1 and T2 mapping sequences are included in the proposed exam, which allows for myocardial tissue characterization. The proposed rapid exam has been tested in vivo. The proposed exam reduced the scan time from >1 hour with conventional sequences to <20 minutes. Corresponding cardiovascular measurements from the proposed rapid CMR exam showed good agreement with those from conventional sequences and showed that they can differentiate between healthy volunteers and patients. Compared to 2D cine imaging that requires 12-16 separate breath-holds, the implemented 3D-cine sequence allows for whole heart coverage in 1-2 breath-holds. The 4D-flow sequence allows for whole-chest coverage in less than 10 minutes. Finally, SENC imaging reduces scan time to only one slice per heartbeat. In conclusion, the proposed rapid, contrast-free, and comprehensive cardiovascular exam does not require repeated breath-holds or to be supervised by a cardiac imager. These improvements make it tolerable by patients and would help improve cost effectiveness of CMR and increase its adoption in clinical practice.

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The Kora Pacemaker is Safe and Effective for Magnetic Resonance Imaging.

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The Kora Pacemaker is Safe and Effective for Magnetic Resonance Imaging.

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