Early- and mid-term outcomes of transcatheter aortic valve implantation in patients with logistic EuroSCORE less than 20%: A comparative analysis between different risk strata

• Published in: Catheterization and cardiovascular interventions Vol. 79; no. 1; pp. 132 - 140
• Main Authors: Tamburino, Corrado, Barbanti, Marco, Capodanno, Davide, Sarkar, Kunal, Cammalleri, Valeria, Scarabelli, Marilena, Mulè, Massimiliano, Immè, Sebastiano, Aruta, Patrizia, Ussia, Gian Paolo
• Format: Journal Article
• Language: English
• Published: Hoboken Wiley Subscription Services, Inc., A Wiley Company 01-01-2012
• Subjects: Aged; Aged, 80 and over; aortic stenosis; Aortic Valve Stenosis - diagnosis; Aortic Valve Stenosis - mortality; Aortic Valve Stenosis - therapy; Cardiac Catheterization - adverse effects; Cardiac Catheterization - instrumentation; Cardiac Catheterization - mortality; Cerebrovascular Disorders - etiology; Chi-Square Distribution; EuroSCORE; Female; Heart Diseases - etiology; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation - adverse effects; Heart Valve Prosthesis Implantation - instrumentation; Heart Valve Prosthesis Implantation - methods; Heart Valve Prosthesis Implantation - mortality; high-risk; Humans; Italy; Kaplan-Meier Estimate; Logistic Models; Male; Odds Ratio; Patient Selection; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; TAVI; Time Factors; Treatment Outcome; Italy
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.23100

Background: Transcatheter Aortic Valve Implantation (TAVI) is an emerging alternative to medical therapy reserved to a limited population with severe aortic stenosis. The European consensus document recommended TAVI for prohibitive‐risk patients not eligible for conventional surgery (prohibitive risk defined as expected mortality ≥ 20% calculated with the Logistic EuroScore (LES) in association with clinical judgment). To date, there is lack of clarity on data about outcomes of TAVI in lower risk patients. We sought to evaluate the outcomes of patients undergoing TAVI with LES ≥ 20% in comparison with patients with LES < 20%.
Method: Of 165 patients who underwent TAVI using the 18‐French Medtronic CoreValve (N = 153) and the Sapien Edwards™ (N = 12) at our Institution between June 2007 and September 2010, we identified those with LES < 20%, with prosthesis implantation (n = 84), and reported on their clinical outcome compared with patients with LES ≥ 20% (n = 78). The primary endpoint was the incidence of overall death and major adverse cerebrovascular and cardiac events (MACCE) at 30‐day and midterm follow‐up stratifying patients by clinical characteristics.
Results: At 30‐day, a significant higher incidence of MACCE (20.8% vs. 6.0%, odds ratio [OR] 4.08 95% confidence interval [CI] 1.42–11.74, P = 0.009) and death (15.6% vs. 2.4%, OR 7.45 95% CI 1.61–34.48, P = 0.010) was reported in the LES ≥ 20% group as compared with the LES < 20% group, respectively. The 12‐month MACCE rates was (27.1% vs. 11.4%, hazard ratio [HR] 2.47 95% CI 0.93–6.63, P = 0. 071) for LES ≥ 20% and LES < 20% patients, respectively (mortality rates was 25.7% vs. 6.8% HR 4.21 95% CI 1.24–14.30, P = 0.021).
Conclusion: This study tends to suggest that current mortality reported after TAVI could be significantly affected by the very‐high risk profile of the population which currently undergoes this procedure, making comparison with surgical series rather unreliable. © 2011 Wiley Periodicals, Inc