Résumé
Bleeding and femoral access complications which occurred after balloon aortic valvuloplasty (BAV) may be enhanced by the systematic use of heparin during the procedure. We assessed the hypothesis that BAV performed without heparin may be associated with lower complications rates.
We conducted a retrospective analysis of all consecutive patients who had undergone BAV in our center between 2008 and 2011. We evaluated 3 groups: group 1 included patients whose BAV was performed with large sheaths (10 to 12 F) and use of unfractionated heparin (UH) (50IU/kg bolus IV); patients whose BAV was performed with use of smaller size sheaths (8 or 9 F) who were divided into group 2 (with UH bolus) and group 3 (without UH bolus). We collected all major in-hospital adverse events, bleeding (≥BARC 3), vascular complications (including pseudoanerysm or arterio venous fistula) and acute limb ischemia.
Overall, 132 patients were included in this study. The 3 groups had similar median age (84 years) or previous lower extremity artery disease (overall n= 36, 27%, p=0.79). Vascular and bleeding complications were observed in 17 patients (12.8%) and were significantly higher when UH was used (table 1) with a relative risk of 2.89 (1.18-6.1). Conversely, absence of heparin did not increase ischemic complications or major in-hospital adverse events (p=0.5). Vascular complications were similar among patients who received heparin whatever the size of the used sheath (table 1).
Balloon aortic valvuloplasty performed without heparin appears to be safe and is associated with a dramatic reduction of vascular and bleeding events. Although randomization was not used, this marked difference is difficult to explain by confounding factors.Table 1Vascular and bleeding complications.group 1 (UH+, LS) n=23group 2 (UH+, SS) n=46group 3 (UH-, SS) n=63p valueFemoral access and/or bleeding n=17 (12.8%)4 (17.3%)9 (19.5.%)4 (6.3%)*0.007Bleeding n=15 (11.3%)4 (17.3%)8 (17.3%)3 (4.7%)*0.004Acute limb ischemia n=4 (2.2%)02 (4.3%)2 (3.1%)0.82UH+: unfractionated heparin bolus 50ui/kg; UH-: no heparin bolus; LS: large sheath; SS: small sheath