Effects of balloon-based distal protection during primary percutaneous coronary intervention on early and late infarct size and left ventricular remodeling: a pilot study using serial contrast-enhanced magnetic resonance imaging.
BACKGROUND
Distal protection devices are effective in preventing distal embolization during primary percutaneous coronary intervention (PCI). We investigated whether balloon-based distal protection could reduce early and late infarct size and left ventricular (LV) remodeling using serial analysis of contrast-enhanced magnetic resonance imaging (CE-MRI).


METHODS
Patients undergoing primary PCI for ST-segment elevation myocardial infarction within 12 hours after symptom onset were randomized to a distal protection group (n = 19) or to a control group (n = 20). The primary end point was infarct size evaluated by the volume of delayed hyperenhancement on CE-MRI at 3 days. The secondary end point included infarct size on CE-MRI at 6 months and LV remodeling assessed by the change between LV end-diastolic volume on CE-MRI at 3 days (baseline) and 6 months (follow-up).


RESULTS
Percutaneous coronary intervention procedures were fully protected with balloon-based distal protection in all patients of the protection group. Infarct size was similar in the distal protection group and the control group at baseline (25.9 +/- 7.8% vs 26.1 +/- 8.2%; P = .93) and at follow-up (21.4 +/- 9.1% vs 18.5 +/- 9.1%; P = .51). The change in LV end-diastolic volume was 10.5 +/- 32.2 mL in the distal protection group and 8.9 +/- 40.7 mL in the control group (P = .86). There was no significant difference in the 6-month rate of major adverse cardiac events between groups (none in the distal protection group and 4 patients in the control group; P = .11).


CONCLUSIONS
Serial CE-MRI showed that the balloon-based distal protection during primary PCI did not reduce early and late infarct size or prevent LV remodeling.
Hahn
Joo-Yong
JY
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Gwon
Hyeon-Cheol
HC
Choe
Yeon Hyeon
YH
Rhee
Il
I
Choi
Seung Hyuk
SH
Choi
Jin Ho
JH
Lee
Sang Hoon
SH
Hong
Kyong Pyo
KP
Park
Jung Euy
JE
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects*; D002404:Catheterization; D003287:Contrast Media; D004617:Embolism / Q000209:etiology* / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis* / Q000628:therapy*; D010865:Pilot Projects; D011446:Prospective Studies; D020257:Ventricular Remodeling
D003287:Contrast Media