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J Invasive Cardiol. 2014 Oct;26(10):528-33.

Decrease of vascular and bleeding complications after balloon aortic valvuloplasty performed without heparin.

Author information

1
Department of Cardiology, Arnaud de Villeneuve University Hospital, 295 avenue du doyen Giraud, 34295 Montpellier cedex 5, France. f-leclercq@chu-montpellier.fr.

Abstract

OBJECTIVES:

To determine whether vascular and bleeding complications may be reduced with balloon aortic valvuloplasty (BAV) performed without heparin.

BACKGROUND:

Vascular and bleeding complications are currently the main adverse events occurring after BAV.

METHODS:

This registry included 162 consecutive patients with severe aortic stenosis who underwent BAV by femoral approach in our center between 2008 and 2012. Eighty-five patients had unfractionated heparin (UH) 50 IU/kg bolus IV during the procedure, whereas 77 patients did not have heparin. Our primary combined endpoint included severe vascular or bleeding complications (BARC score ≥3), severe ischemic events (acute limb ischemia or systemic embolism) or death at 1-month follow-up.

RESULTS:

The primary composite endpoint was achieved in 25 patients overall (15.4%) and was significantly lower in the heparin-free group (10.3% vs 20.0%; P=.03). Vascular, bleeding, or ischemic events were dramatically lower in the heparin-free group (6.5%) compared with the heparin group (18.8%; P=.01). UH use was associated with an increased risk of vascular and bleeding complications (relative risk, 2.92; 95% confidence interval, 1.35-7.94), but not with a decreased risk of ischemic events (relative risk, 1.81, 95% confidence interval, 0.34-9.61). After adjustment for patient and procedure characteristics, including the sheath size, heparin use was the only significant predictor of the primary endpoint (adjusted odds ratio, 2.94; 95% confidence interval, 1.75-14.74).

CONCLUSION:

BAV performed without heparin is associated with a reduction of severe vascular events or death without increased ischemic risk. This marked difference is difficult to explain by confounding factors, but should be confirmed in a randomized controlled trial.

PMID:
25274863
[Indexed for MEDLINE]
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