Femoral haemostasis after transcatheter therapeutic intervention: a prospective randomised study of the angio-seal device vs. the femostop device.

BACKGROUND: A number of haemostatic devices are available to facilitate early haemostasis following transfemoral interventional procedures. METHODS AND RESULTS: We have prospectively compared 150 patients (age: 57+/-12 years, mean+/-S.D.) who were randomly assigned to either external compression using the FemoStop device or direct closure of the arterial puncture using the Angio-Seal device. The Angio-Seal was deployed in the catheter laboratory after the conclusion of the procedure. Patients, randomised to FemoStop, had their sheath removed when the activated clotting time (ACT) was less than 100 s before applying the device. The primary endpoint was the composite of bleeding, haematoma formation, bruise, requirement for blood transfusion, clinical indication for ultrasound examination at 2 h and 24 h following the procedure and crossover to either method at 2 and 24 h after the device deployment. The 95% of the Angio-Seal and 96% of FemoStop patients were discharged on the day following the procedure. An increased number of patients in the Angio-Seal group reached a clinical end-point within the first 2 h (45% vs. 3%, P<0.0001). This difference became insignificant at 24 h (25% vs. 30%, P=0.6). CONCLUSION: Although less comfortable, the overall efficacy of the FemoStop appeared to be higher than that of the Angio-Seal device.

Superiority of endothelin-1 over norepinephrine in exercise-induced alterations of the conduit artery tone of the non-exercised arm in patients with chronic heart failure.

This study is aimed at examining the relative importance of norepinephrine and endothelin-1 in treadmill exercise-induced changes in brachial arterial tone of the non-exercised arm in patients with chronic heart failure (CHF). Brachial artery diameter and blood flow were measured before and after exercise in eight healthy volunteers and 18 patients with stable chronic heart failure by high-resolution ultrasound. Maximal exercise resulted in brachial artery dilatation in controls (4.42+/-0.39 vs. 4.77+/-0.39 mm; P<0. 0001) in contrast to constriction seen in the patients (5.27+/-0.67 vs. 5.12+/-0.66 mm; P=0.07). Both groups demonstrated a significant increase in blood flow after exercise. The pre-exercise (2.83+/-0.76 vs. 1.69+/-0.15 pmol/l; P=0.0004), post-exercise (4.15+/-1.5 vs. 2. 02+/-0.34 pmol/l; P=0.0004) and the percent increase (47.15+/-32.5 vs. 19.0+/-10.5%; P=0.02) in endothelin-1 levels were significantly greater in patients than in controls. In contrast to endothelin-1, the exercise-induced percent increase in norepinephrine was greater in controls than patients (100.7+/-51.8 vs. 49.8+/-43.4%; P=0.01). The percent change in the diameter of the brachial artery in response to maximal exercise was significantly correlated to pre- (r=0.634; P=0.003) and post-exercise (r=0.467; P=0.05) endothelin-1 levels in patients but not in controls [pre-exercise (r=0.07; P=0. 86), post-exercise (r=0.310; P=0.47)]. The change in the diameter of the brachial artery did not correlate with pre- or post-exercise plasma norepinephrine levels in either group. These findings suggest that endothelin-1 is potentially more important than norepinephrine in contributing exercise-induced brachial artery constriction in patients with chronic heart failure.

Non-elective intra-coronary stenting: are the clinical outcomes comparable to elective stenting at 6 months?

The aim of this study was to compare prospectively the clinical outcome of patients treated with intra-coronary stents as a non-elective/bailout procedure for acute or threatened vessel closure, with those undergoing elective stenting at 6 months. Sixty-four patients (60.2+/-11.7 y) who underwent non-elective stenting for abrupt or threatened vessel closure and/or sub-optimal results were prospectively compared with 68 patients (62+/-10.0 y) who were stented electively. All patients had broadly similar pre-procedural clinical profiles. However, patients in the elective group had a higher incidence of previous PTCA (10.2% vs. 0%, P = 0.01) and bypass surgery (30.9% vs. 6.3%, P = 0.0003) compared with the non-elective group. A total of 158 stents (1.19 per patient) were implanted in 132 patients with a procedural success rate of 99.3%. At 6 months follow-up there was no statistical difference in the primary composite end-point of death, myocardial infarction and the need of repeat revascularisation (10.9% vs. 5.8%, P = 0.35) between the two groups. However, patients in the non-elective group showed a higher incidence of unstable angina compared with the elective group (25% vs. 1.4%, P = 0.0004). The findings of this study suggest that stents (single or multiple) can be effectively implanted in non-elective situations with no increase in the incidence of death, non-fatal myocardial infarction, and the need of repeat revascularisation at 6 months compared with elective stenting.