Abstract 4492: Eligibility to Percutaneous Aortic Valve Replacement in Patients at High-Risk for Surgery. Insight from PUREVALVE Registry Selection Phase
Background: symptomatic patients with severe aortic valve disease, if not operated, have a worst prognosis. The real amount of unoperated aortic patients is not well established, such as the percentage of eligibility to percutaneous treatment.
Objective: to analyze, in a high volume center, the amount of aortic patients who were denied surgery. Secondly, to establish the percentage of eligibility to percutaneous aortic valve replacement (p-AVR). Finally, to clarify the reasons for p-AVR ineligibility.
Methods: all patients referred to our cardiovascular department since April 2007, for severe aortic valve disease requiring valve replacement, were included in a prospective registry. Demographic and clinical data, as well as treatment received and 30-day outcome were collected. High surgical risk was defined by the presence of: 1. age ≥80 yrs with logistic Euroscore ≥15%; or 2. age ≥75 yrs with logistic Euroscore ≥20%; or 3. age > 65 yrs with one or more: porcelain aorta, previous cardiac surgery, neurological dysfunction, liver cirrhosis (Child > B), hostile thorax (radiation, burns,etc), severe connective tissue disease. Eligibility criteria for p-AVR were based on characteristics compatible with trans-femoral or trans-subclavian CoreValve III generation device implantation.
Results: Out of 191 patients with symptomatic aortic valve disease referred for aortic valve replacement, 124 were classified as mild-to-moderate risk and operated (30-day mortality =1.2%), whereas 67 were classified as high surgical risk. Among these, 57 (29.8% of total population) were refused by surgeons, and 10 were operated with a mortality rate of 16.7%. Of the 57 pts refused, 44 (77.2%) resulted eligible to p-AVR, and 13 did not. Causes of ineligibility to p-AVR were severe mitral regurgitation (≥3+/4) (8 pts) and/or inadequate size of aortic annulus/ascending aorta (7 pts) and/or too frail status (5 pts). Thirty-day mortality of patients who underwent p-AVR was 5%.
Conclusion: About one third of patients affected by severe aortic valve disease is denied surgery because of high-risk. However, the majority of these meet criteria for percutaneous aortic valve replacement.