Purpose: This work, aims to examine the incidence, associated with clinical and procedural factors, and the impact of peri-procedural bleeding during TAVI, in short and medium-term prognosis. Methods: It is a multicentre and prospective study, which considers all consecutive patients who underwent TAVI from May 2008 to July 2012 at our centers. The serious bleeding, divided into life-threatening (LT) or mayor (MB) groups, are classified according to Varc document. The primary end point regards all-cause mortality after 30 days or at medium-term (mean 400 days) while, the secondary end points are cardiovascular death after 30 days or at medium term. Results: The study have included 714 patients with a severe aortic valvular stenosis (average aortic valve area: 0.66±0.6 cm2) and a mean age of 81.97±5.8 years; besides many of these patients have showed a reduction of glomerular filtration rate (19.9%: GFR<30ml/min-46.1%:GFR<60ml/min). Peri-procedural haemorrhages, are reported in 242 patients (LT=130 MB=112) and 44 people have presented a minor bleeding. At 30 days, all-cause mortality was significantly higher in patients with LT and MB bleedings than in those without this complication (13.10% vs 8.90% vs 4.8% p 0.003), and equally after 400 days (37.4% vs 27.2% vs 17.3%; p<0.0001). The results are strengthened for cardiovascular death that was significantly elevated in patients who have presented serious haemorrhages at short and medium term (21.10% vs 10% vs 4.6%; p<0.0001-20.5% vs 13.5% vs 5.9%; p<0.0001).At 30 days life-threatening (OR 3.3 CI 1.1-9.7 p 0.0026) and major (OR 3.5;CI 1.4-8.6 p 0.007) haemorrhages, along with GFR<30ml/min (OR 2.3 CI; 1.1-5.5 p 0.04), are showed as independent predictors of death, while at mid-term only impaired renal function is remained a significant predictor of mortality (OR 2.3:CI 1.1-3.9; p 0.01).Moreover, GFR<30ml/min (OR 1.6: CI 1.1-2.7; p 0.04) and prosthetic valvular diameter greater than 23 mm (26mm p 0.05; 29mm; p 0.04; 31mm p 0.09) are indicated as independent predictors of LT or MB bleedings, while transfemoral approach is appeared a protective factor (OR 0.42: CI 0.26-0.68; p 0.035). Conclusions: Periprocedural bleedings during TAVI are common and they relates to an increased mortality after 30 days but not after mid-term follow up. Trans-femoral approach appears protective, while impaired renal function is the principal predictor of bleeding, thus allowing risk stratification and the selection of approach for these patients.
A mid-term follow-up of a multicentre prospective study about life-threatening and major bleedings after TAVI
D'ASCENZO, FABRIZIO;SALIZZONI, STEFANO;GAITA, Fiorenzo
2013
Abstract
Purpose: This work, aims to examine the incidence, associated with clinical and procedural factors, and the impact of peri-procedural bleeding during TAVI, in short and medium-term prognosis. Methods: It is a multicentre and prospective study, which considers all consecutive patients who underwent TAVI from May 2008 to July 2012 at our centers. The serious bleeding, divided into life-threatening (LT) or mayor (MB) groups, are classified according to Varc document. The primary end point regards all-cause mortality after 30 days or at medium-term (mean 400 days) while, the secondary end points are cardiovascular death after 30 days or at medium term. Results: The study have included 714 patients with a severe aortic valvular stenosis (average aortic valve area: 0.66±0.6 cm2) and a mean age of 81.97±5.8 years; besides many of these patients have showed a reduction of glomerular filtration rate (19.9%: GFR<30ml/min-46.1%:GFR<60ml/min). Peri-procedural haemorrhages, are reported in 242 patients (LT=130 MB=112) and 44 people have presented a minor bleeding. At 30 days, all-cause mortality was significantly higher in patients with LT and MB bleedings than in those without this complication (13.10% vs 8.90% vs 4.8% p 0.003), and equally after 400 days (37.4% vs 27.2% vs 17.3%; p<0.0001). The results are strengthened for cardiovascular death that was significantly elevated in patients who have presented serious haemorrhages at short and medium term (21.10% vs 10% vs 4.6%; p<0.0001-20.5% vs 13.5% vs 5.9%; p<0.0001).At 30 days life-threatening (OR 3.3 CI 1.1-9.7 p 0.0026) and major (OR 3.5;CI 1.4-8.6 p 0.007) haemorrhages, along with GFR<30ml/min (OR 2.3 CI; 1.1-5.5 p 0.04), are showed as independent predictors of death, while at mid-term only impaired renal function is remained a significant predictor of mortality (OR 2.3:CI 1.1-3.9; p 0.01).Moreover, GFR<30ml/min (OR 1.6: CI 1.1-2.7; p 0.04) and prosthetic valvular diameter greater than 23 mm (26mm p 0.05; 29mm; p 0.04; 31mm p 0.09) are indicated as independent predictors of LT or MB bleedings, while transfemoral approach is appeared a protective factor (OR 0.42: CI 0.26-0.68; p 0.035). Conclusions: Periprocedural bleedings during TAVI are common and they relates to an increased mortality after 30 days but not after mid-term follow up. Trans-femoral approach appears protective, while impaired renal function is the principal predictor of bleeding, thus allowing risk stratification and the selection of approach for these patients.
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