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.

A 5Fr catheter approach reduces patient discomfort during transradial coronary intervention compared with a 6Fr approach: a prospective randomized study.

Smaller guiding catheters can help reduce local complications and patient morbidity during transradial coronary intervention (TRI). This study was designed to compare the patient's morbidity, success rate, and the operator's convenience between 5-French (5Fr) and 6-French (6Fr) TRIs. This is a single-center prospective randomized study. Patients who underwent TRI, in 2003, were prospectively randomized to either 5Fr or 6Fr catheter groups (100 patients in each group). Procedure-related patient morbidity as well as clinical and procedural characteristics was scored and analyzed. Procedural success rate was not significantly different between the groups. The number of unsatisfactory supports (6% in 5Fr group, 3% in 6Fr group; P=0.31) and the incidence of local wound complications were not significantly different between the groups. Local wound pain scores were significantly lower in the 5Fr group compared with the 6Fr group, particularly during sheath insertion and removal, and during procedures. Pain scores were higher in female patients than in male patients during sheath removal (male: 1.3+/-1.3, female: 1.7+/-1.5; P=0.049). Radial artery diameter was well correlated with local pain score during sheath removal (r=0.31, P<0.001), and with the height and weight of the patients (height: r=0.33, P<0.001; weight: r=0.27, P<0.001). In conclusion, using a 5Fr catheter during TRI reduce, local access site pain, particularly in female patients with smaller body size, whereas the success and local complication rates were similar to a 6Fr approach.