Elsevier

American Heart Journal

Volume 164, Issue 3, September 2012, Pages 402-409
American Heart Journal

Clinical Investigation
Valvular and Congenital Heart Disease
Adverse impact of bleeding and transfusion on the outcome post-transcatheter aortic valve implantation: Insights from the Pooled-RotterdAm-Milano-Toulouse In Collaboration Plus (PRAGMATIC Plus) initiative

https://doi.org/10.1016/j.ahj.2012.07.003Get rights and content

Background

Little is known about the impact of bleeding and red blood cells transfusion (RBC) on the outcome post transcatheter aortic valve implantation (TAVI).

Methods

Between November 2005 and August 2011, 943 consecutive patients underwent TAVI. Bleeding was assessed according to the Valve Academic Research Consortium definitions. Patients receiving RBC were compared to those not requiring transfusion.

Results

Life-threatening and major bleedings occurred respectively in 13.9% and 20.9% of the patients, significantly more frequently in the RBC cohort. Vascular complications occurred in 23.2% of the patients. Major and minor vascular complications were more frequent in the RBC group: 19.3 vs 5.2%, P < .001; 15.3 vs 9%, P = .003, respectively. Thirty-day all-cause mortality was 7.2%. Of the overall cohort, 38.9% required RBC transfusion; those receiving at least 4 U of RBC had higher 30-day all-cause mortality than those receiving 1 to 4 U of RBC and those not requiring transfusion: 14.4%, vs 6.3% vs 6.3%, respectively, P = .008. By multivariate analysis, transfusion of RBC was associated with an increased 30-day and 1-year mortality. Major stroke and all stages of acute kidney injury were significantly more frequent in the RBC cohort.

Conclusions

Bleeding is frequent after TAVI, mainly driven by vascular complications. RBC transfusion was associated with increased mortality at 1 year and increased risk of major stroke and acute kidney injury. Specific scores are needed to identify the patients at higher risk for TAVI-related bleeding and RBC transfusion.

Section snippets

PRAGMATIC initiative

The PRAGMATIC Plus initiative is a collaboration of four European centers with established TAVI experience. Baseline patient characteristics, procedural details, and clinical outcome data from a series of 943 consecutive patients who underwent TAVI were collected from November 2005 to August 2011: San Raffaele Scientific Institute, Milan (n = 330); Clinique Pasteur, Toulouse (n = 224); Thoraxcenter, Erasmus Medical Center, Rotterdam (n = 206); Hôpital Rangueil, Toulouse (n = 184). After the

Study population

The baseline characteristics of the overall study population and the subgroups dichotomized by need for RBC transfusion are listed in Table I. Among the 943 patients analyzed, 53.8% were men. The mean logistic EuroScore was 20.9%; 28.3% of the patients were diabetics; 62.9% had renal failure; 45.1% had coronary artery disease; 34.4% had chronic obstructive pulmonary disease; and 17% had left ventricle ejection fraction ≤35%. Patients in the RBC cohort were more often females (54.5 vs 41%, P <

Discussion

The PRAGMATIC Plus Initiative is one of the largest series of patients treated with transcatheter aortic valve implantation reporting on blood transfusion and its impact on clinical outcome.

VARC bleeding was frequent. More than one third of the study population experienced life-threatening or major bleeding. The most frequent cause of bleeding was vascular complication (23.2%). This vascular complication rate is higher than findings from Gurvitch et al (17.4%) or Nuis et al (16%).14, 15 The

Conclusion

Bleeding is frequent after TAVI and is mainly driven by vascular complications. Red blood cells transfusion is associated with an increased mortality at 1 year and an increased risk of major stroke and acute kidney injury. Specific scores are needed to identify the patients at higher risk of TAVI-related bleeding and RBC transfusion.

Disclosures

Conflicts of interest: Didier Tchetche, Nicolas Dumonteil and Bertrand Marcheix are proctors for Edwards and Medtronic. Peter P.T. De Jaegere is proctor for Medtronic.

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