P460Up to 10-years long-term durability after transcatheter aortic valve implantation using balloon-expandable transcatheter valves: experience from the pioneer center

Abstract

Background: Being the pioneer center in the percutaneous treatment of calcified aortic stenosis from balloon aortic valvuloplasty to Fist-In-Man transcatheter aortic valve implantation, our experience provides the longest worldwide follow-up. Purpose: We aimed to report long-term outcomes (up to 10 years) with balloonexpandable valve and assess valve durability by evaluating structural valve deterioration on echocardiography in patients treated prior to 2011 and thus exposed to a follow-up a of at least 5 years. Methods: From April 2002 to April 2011, 242 patients underwent a balloonexpandable TAVI procedure in our center. All patients underwent systematic clinical and echocardiographic on site follow-up at one month, one year and yearly thereafter. In the absence of universal definition to define structural valve deterioration (SVD), we used both the surgical definition defined by survival without reintervention and proposed a personal definition to assess SVD using more precise echocardiographic criteria. We defined SVD as an elevation in mean transvalvular aortic gradient ≥20mmHg with an increase >10mmHg and/or central aortic regurgitation ≥ moderate /severe not present at baseline. SVD was defined as definite (on autopsy or macroscopic examination at the time of open-heart surgery), probable (when echo-criteria were met, and elevated gradient was not related to valve thrombosis) or possible. Results: Mean age was 82.2±7.0 years. Patients were highly symptomatic (79.1% in NYHA III/IV) and had severe and multiple comorbidities with a mean logistic Euroscore of 25.5±14.2%. 30-day mortality was 12.1%. Among the 242 patients implanted, 202 died during the follow-up (697.1 patients-years). Very few patients were excluded from analysis (lost for follow-up; 5 for clinical FU and 6 for echocardiography). Survival rate was 68.3±3.0%, 26.9±2.9%, and 5.3±2.0% at one-, 5- and 10-years, respectively. The mean aortic gradient as well as effective orifice area remained unchanged during follow-up. Using the surgical definition, only one patient required re-intervention for symptomatic SVD and freedom from SVD at 10y was 93.8±6.1%. Three additional patients fulfilled the criteria of SVD using our personal definition: one patient had definite SVD, 2 patients had probable SVD, and 1 patient possible. With our definition, freedom from SVD at 10 years is 87.7±6.6% (figure). Conclusions: Durability of transcatheter valves is a major issue when discussing the extension of indications to lower risk and in particular younger patients. Our data even though the number of patients at risk is limited due to the ?recent? technique are quite reinsuring and do not demonstrate an alarm on durability. Further studies are required to estimate accurately the TAVI durability. Furthermore, when assessing SVD and comparing SVD between TAVI and surgery, definition has to be similar and SVD definition should be universal.