cardiac magnetic resonance imaging safety following percutaneous coronary intervention

ORIGINAL PAPER

Cardiac magnetic resonance imaging safety followingpercutaneous coronary intervention

Jason W. Curtis • Donna C. Lesniak •

James H. Wible • Pamela K. Woodard

Received: 20 January 2013 / Accepted: 20 April 2013 / Published online: 27 April 2013

� Springer Science+Business Media Dordrecht 2013

Abstract In the first 8 weeks after percutaneous coronary

intervention (PCI), possible negative interactions exist

between the cardiac magnetic resonance (CMR) imaging

environment and the weakly ferromagnetic material in

coronary stents. There are circumstances when CMR

would be indicated shortly following PCI, such as acute

myocardial infarction (AMI). The purpose of this study is

to demonstrate CMR safety shortly following stent PCI in

AMI patients. We performed a retrospective analysis of

safety data in AMI patients with recently placed coronary

artery stents enrolled in a multi-center phase II trial for

gadoversetamide. Patients underwent 1.5T CMR within

16 days of PCI. Vital signs (blood pressure, heart rate,

respiratory rate, and body temperature) and ECGs were

taken pre-CMR, 1, 2, and 24 h post-CMR. Any major

adverse cardiac event (MACE) or other serious adverse

events in the first 24 h after MRI were recorded. There

were 258 stents in 211 AMI patients. The mean delay to

CMR following PCI was 6.5 ± 4 days, with 62 patients

(29 %) receiving CMR within 3 days and 132 patients

(63 %) within 1 week. Patients showed no significant vital

sign changes following CMR. Ten patients (4.7 %) showed

mild, transient ECG changes. Within the 24-h follow-up

group, 4 patients (1.9 %) had moderate to severe events,

including chest pain (1) and elevated cardiac enzymes (1),

resolving in 24 h; heart failure (1) and ischemic stroke (1).

There were no deaths. This study demonstrates fewer

MACE in AMI patients undergoing 1.5T CMR within

16 days of stent placement in comparison to post-stent

event rate reported in the literature. This study adds to the

CMR after stent PCI safety profile suggested by previous

studies and is the largest and first study that uses multi-

center data to assess stent safety following CMR

examination.

Keywords Percutaneous coronary intervention � Cardiac

magnetic resonance imaging � Acute myocardial infarction �Safety

Introduction

One out of every three adults in the United States has

cardiovascular disease [1] and over 90 % of ST-elevation

MI patients undergo percutaneous coronary intervention

(PCI) [2]. More than 1.3 million stent PCI procedures are

performed per year [3]. As the population continues to age,

the numbers of patients in the United States with coronary

stents will continue to increase. Given that there are over

40 million magnetic resonance imaging (MRI) examina-

tions performed per year, many of these patients will have

a need to undergo cardiovascular or non-cardiovascular

MRI shortly within the hours, days and months following

their stent procedures [4–6].

The combination of stent PCI and MRI, however, pre-

sents theoretical risks for patients. The stents used can be

weakly ferromagnetic and potentially can migrate in the

magnetic environment of MRI. Also, the radiofrequency

waves essential to MRI have the potential to increase stent

temperature. Stent migration and heating in the MR envi-

ronment could lead to adverse outcomes from stent

J. W. Curtis � D. C. Lesniak � P. K. Woodard (&)

Mallinckrodt Institute of Radiology, Washington University

School of Medicine, 510 S. Kingshighway Blvd., Saint Louis,

MO 63110, USA

e-mail: [email protected]

J. H. Wible

Covidien Imaging Solutions, 675 McDonnell Blvd., Hazelwood,

MO 63042, USA

123

Int J Cardiovasc Imaging (2013) 29:1485–1490

DOI 10.1007/s10554-013-0231-9

thrombosis or restenosis including death or recurrent

myocardial infarction (MI) [7–9]. These hypothetical risks

along with modest in vivo CMR data have historically led

coronary artery stent manufacturers to recommend that no

CMR studies be performed for at least 8 weeks after stent

implantation, under the premise that this time would allow

for endothelialization at the stent PCI site [6]. While it is

impossible to completely evaluate the impact that MRI

scanning delays have upon patient outcome, these recom-

mended delays for MRI studies in patients with stents

certainly limit the diagnostic MRI evaluation that may be

critical in achieving effective medical care. Recently non-

clinical stent testing as well as several clinical articles have

been published suggesting that patients may be scanned

safely immediately after stent implantation [6–17]. Our

study adds to the growing body of literature supporting the

safety profile of 1.5T CMR performed immediately and

soon after coronary artery stent implantation.

Methods

Patients

Patients for this study were recruited between February

2003 and April 2004, as part of a multicenter, Food and

Drug Administration (FDA) gadoversetamide dose-finding

trial (OptiMARK, Covidien, St. Louis, MO). The study was

approved by the Institutional Review Boards (IRB) at all

participating centers, and all patients participating in this

trial underwent informed consent at the time of the CMR

examination [18]. All patients in the FDA trial presented

with AMI within 16 days prior to the CMR examination.

For the purposes of this manuscript, only patients who had

also undergone stent PCI within 16 days prior to the CMR

examination were included in the evaluation. Inclusion

criteria into both this and the parent study included ele-

vated creatine kinase-MB (CK-MB) three times the upper

limit (C5 ng/mL) or critically elevated Troponin I or T

within the 16 days prior to MRI, age C18 years, a negative

pregnancy test within 24 h before contrast administration,

and a catheter coronary angiogram confirming stenoses in

coronary vessels. Exclusion criteria were administration of

an investigational drug within 30 days, history of prior MI,

clinical instability, a medical condition which could dras-

tically decrease study compliance, known or suspected

endstage renal disease, multivessel coronary artery disease

determined by a stenosis of [60 % in more than one cor-

onary artery, atrial flutter or fibrillation, high frequency of

atrial or ventricular arrhythmias, inability to maintain a

15-s breath-hold, a general contraindication to MRI

examinations, known or suspected hypersensitivity reac-

tion to Gd-chelate contrast agent, recent history of

hemolytic anemia, sickle cell anemia or other hemoglo-

binopathy, history of significant claustrophobia, pregnant,

breastfeeding, lactating, or prior coronary artery bypass

graft [18]. The time between stent placement and imaging,

number of stents, stent material and type (bare-metal or

drug-eluting), stent size, and stent location were recorded

for later evaluation.

CMR

All patients underwent a delayed contrast-enhanced cardiac

MRI exam (45 min in length) on a 1.5 Tesla scanner.

Patients underwent a basic CMR examination that included

short and long axis cine steady state free-precession

imaging (SSFP) and T1-weighted, delayed enhanced (DE)

MRI segmented k-space gradient-echo sequence with an

inversion recovery prepulse before and at 10 and 30 min

after 0.05–0.3 mmol/kg intravenous administration of

gadoversetamide [18].

Follow-up

All study patients received medical evaluations prior to and

immediately after the CMR examination. Patients com-

pleted a comprehensive medical history evaluation of CAD

risk factors (Table 1) within 24 h before CMR. Blood

pressure, heart rate, respiratory rate, and temperature were

recorded 2 h before and 2 and 24 h after CMR and com-

pared. Electrocardiograms (ECGs) were obtained 2 h

before and 1, 2, and 24 h after CMR. ECGs were evaluated

by board certified cardiologists at independent laboratories

and assessed for changes suggestive of ischemia or new MI

[16]. Patients were queried for symptoms of MACE

(ischemia, myocardial infarction, heart failure or stroke)

immediately and at 24 h after CMR.

Table 1 Patient baseline characteristics

Variable Subjects (n = 211)

Agea 53 ± 11

Male gender 165 (78)

Hypertensionb 107 (51)

Diabetes mellitus 40 (19)

Dyslipidemia 123 (58)

Smoking history 70 (33)

Obesity 19 (9)

Unless otherwise indicated, data are number of patients and data in

parenthesis are percentagesa Data reported as median ± SDb In four patients hypertension status was unknown

1486 Int J Cardiovasc Imaging (2013) 29:1485–1490

123

Results

Patient and stent characteristics

From the 303 AMI-group patients in the parent study, 211

patients had stents placed 16 days prior to the CMR

examination and were included in this study (Tables 1, 2).

In these 211 patients, a total of 258 stents were placed by

PCI. The majority of patients (168 or 80 %) had only one

stent implanted. In patients with multiple stents placed, 39

(18 %) had two stents placed and 4 (2 %) had three stents.

None of the 211 patients had more than three stents

implanted (Table 3). While stents were located in all three

epicardial coronary arteries, most were situated in left

anterior descending (LAD) or the right coronary artery

(RCA). Several stent types were used (Tables 3, 4). Bare

metal stents (BMS) were the most commonly used, com-

prising 59 % of the patient population and stents placed.

The other stents most commonly used were drug-eluting

stents (DES) (16 % of total). Similarly, the material used

for stent construction varied within the patient group, with

low-carbon stainless steel as the most common construc-

tion material (Table 4). Stent width ranged from 2 to 5 mm

with a mean of 3.2 ± 0.54 mm. Stent length ranged from 8

to 33 mm with a mean of 17.5 ± 5.3 mm (Table 4).

According to protocol, all CMR was done within 16 days

of PCI (Fig. 1). The average time between PCI and CMR

was 6.5 ± 4 days. Of note, 15 patients (7 %) had CMR

within 24 h of PCI and 62 patients (29 %) had CMR within

3 days. In all, 132 patients (63 %) had CMR done inside

1 week of PCI.

24-H follow-up

All 211 patients had vital sign and ECG monitoring at 1, 2,

and 24 h after CMR. At each of these time points, no

significant changes were found in mean systolic blood

pressure, diastolic blood pressure, temperature, respiratory

rate or heart rate (P = .733–.86), (Table 2). One patient

had an increase of diastolic pressure blood pressure of

[15 mmHg, but this finding resolved within 24-h.

Ten patients (4.7 %) had ECG changes within 24 h of

the CMR (Table 5). Eight of these patients had QT chan-

ges, of which 1 resolved within 24-h, 3 resolved after 24-h,

and 4 had no information reported after the 24-h follow-up

time-period. One patient had PR segment lengthening that

resolved within 24-h. One patient with ECG changes had

nonspecific ST and T wave abnormalities that did not

recover within the first 24 h after CMR. No data were

reported on this patient until 1.5 months later when a

subsequent ECG showed the abnormalities had resolved

without further clinical events.

Moderate events or MACE were found in 4 (1.9 %)

patients of the 211 (Table 5). Moderate adverse events

Table 2 Mean vital sign changes from baseline in stented acute myocardial infarction patients

Baseline 1 h 2 h 24 h

Systolic blood pressure (mmHg) 119.4 ± 16.8a 1.4 ± 10.6b -1.7 ± 10.7c -2.4 ± 12.4d

Diastolic blood pressure (mmHg) 73.0 ± 11.5a 1.2 ± 8.0b -0.2 ± 8.0c -0.6 ± 9.5d

Heart beat (bpm) 68.5 ± 11.9a -2.1 ± 5.8b 0.5 ± 7.1c 0.4 ± 7.6d

Respiratory rate (rpm) 18.2 ± 4.0a -0.1 ± 2.3e -0.2 ± 2.2c -0.2 ± 2.4f

Body temperature (�C) 36.4 ± 0.6e 0.1 ± 0.4 g 0.0 ± 0.4 h 0.0 ± 0.5i

Values expressed as mean ± SDa N = 211, bN = 205, cN = 209, dN = 207, eN = 204, fN = 206, gN = 198, hN = 201, iN = 200

Table 3 Patient placed-stent information

Variable Subjects (n = 211)

Number of stents placed

One 168 (80)

Two 39 (18)

Three 4 (2)

Construction material

316L stainless steel 118 (56)

Cobalt chromium alloy 38 (18)

Stainless steel and cobalt chromium alloy 1 (0)

Unknown 54 (26)

Type

Bare metal stent 124 (59)

Drug-eluting stent 35 (16)

Unknown 52 (25)

Location

Left anterior descending 87 (41)

Right coronary 84 (40)

Left circumflex 15 (7)

Right circumflex 14 (7)

Obtuse marginal 8 (4)

Posterior descending 1 (1/3)

Posterolateral circumflex 1 (1/3)

Unknown 1 (1/3)


parenthesis are percentages

Int J Cardiovasc Imaging (2013) 29:1485–1490 1487

123

occurred in 2 patients. One 45-year old male who under-

went CMR 1 day after stent placement exhibited moderate-

severity chest pain after CMR. The pain resolved within

9 h of onset with morphine and Percocet treatment with no

elevation of isoenzymes noted. A 58-year old male who

underwent CMR 1 day after stent placement had moder-

ately-elevated cardiac enzymes (CK-MB and troponin-I).

These were noted several hours after CMR, but no infor-

mation was provided as to whether they were also present

prior to the CMR examination. Cardiac enzymes returned

to normal 16 h after CMR and the patient was discharged.

MACE were seen in 2/211 (0.9 %) patients. One patient, a

60-year old male who underwent CMR 10 days after PCI

placement, exhibited moderately severe heart failure 1 h

after administration of gadoversetamide that led to a

3-week hospitalization [18]. The second serious adverse

event happened to a 44 year-old male who underwent

CMR 14 days after CMR. He suffered an ischemic stroke

within 24 h of CMR. The patient was hospitalized for

9 days, and was discharged after recovery. There were no

deaths.

Discussion

Our data demonstrates only 2 MACE in the 211 patients

imaged by CMR within 16 days of stent placement, and 2

moderate adverse events. Of note, the MACE rate in the

first month in a group of 452 AMI patients who had cor-

onary stents implanted was reported at 4.6 % [17]. MACE

reported in this patient population included death, stroke,

target-vessel revascularization and reinfarction [19].

Compared to published event rates after stent placement,

our study suggests that performing 1.5T CMR within

16 days of coronary stent placement does not lead to

increased MACE in AMI patient. These findings include

patients who received both bare metal stents and drug

eluting stents, both weakly ferromagnetic and nonferro-

magnetic materials, and stents of a wide variety of lengths

and locations.

The safety of CMR and MR imaging in general shortly

after PCI has been previously investigated. One early study

demonstrated MR imaging to be safe after PCI, but did not

specifically assess CMR [15]. Others assessed CMR

examination after PCI but either enrolled few patients or

performed CMR several days–months after stent placement

[17, 20]. Moreover, these studies only assessed BMS with

no inclusion of DES. More recent studies have further

established CMR’s safety soon after PCI in a variety of

ways. Looking only at BMS, Syed et al. reported a study of

51 AMI patients who had CMR 2.7 ± 3.1 days after stent

placement. After 4.4 ± 2.1 month follow-up, 4.3 % of the

case group had a cardiac event with one death compared to

16.9 % cardiac events and two deaths in the 68-patient

control group [12]. Porto et al. studied 49 acute coronary

syndrome patients who underwent stent placement (15

DES) followed by CMR 1–3 days later. At 9-month fol-

low-up, 2 of the 49 (4 %) had a MACE [13]. Patel et al.

had a study group of 66 AMI patients and a control group

of 124 AMI patients. In the study group, the median delay

to MR imaging was 3 days after stent implantation. After

30 days of follow-up, 2 % of the case group had an adverse

cardiac event. They found no significant difference in the

Table 4 Stent dimensions and characteristics

Variable Stents (n = 258)

Width

B3.0 mm 140 (54)

3.1–4.0 mm 86 (33)

4.1–5.0 mm 10 (4)

Unknown 22 (9)

Length

6–10 mm 14 (5)

11–15 mm 84 (33)

16–20 mm 86 (33)

21–25 mm 33 (13)

26–30 mm 13 (5)

31–35 mm 5 (2)

Unknown 23 (9)

Construction material

316L stainless steel 155 (60)

Cobalt chromium alloy 43 (17)

Unknown 60 (23)

Type

Bare metal stent 157 (61)

Drug-eluting stent 42 (16)

Unknown 59 (23)


parenthesis are percentage

Fig. 1 The number of days after stent PCI when CMR was performed

(x-axis) and the number of patients (y-axis)


123

event rate between the control and study group [11]. Larose

et al. studied CMR safety in the hyperacute phase of ST-

elevation myocardial infarction. Sixty-four patients under-

went CMR less than 12 h after PCI (median 4.8 ± 3.2 h).

They found CMR did not increase MACE or angina at

6 month follow-up [21]. Our study adds to the CMR after

stent PCI safety profile suggested by these previous studies

and is the largest and first study that uses multicenter data

to assess stent safety following CMR examination.

Acknowledgments Funding for the original trial (reference 18,

below) was provided by Covidien Imaging Solutions. The trial pre-

dates NCT clinicaltrials.gov identifiers. We wish to acknowledge Jane

Steffens, Covidien Imaging Solutions, for assistance in providing us

with access to some of the trial data.

Conflict of interest None.

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