ORIGINAL ARTICLE Long-term outcome after transcatheter aortic valve implantation Claire Bouleti, 1,2 Dominique Himbert, 1,3 Bernard Iung, 1,2,3 Benjamin Alos, 1 Caroline Kerneis, 1 Walid Ghodbane, 1 David Messika-Zeitoun, 1,2,3 Eric Brochet, 1 Amir-Ali Fassa, 1 Jean-Pol Depoix, 1 Phalla Ou, 4 Patrick Nataf, 1,2 Alec Vahanian 1,2,3 ▸ Additional material is published online only. To view please visit the journal online (http://dx.doi.org/10.1136/ heartjnl-2014-306694). 1 Department of Cardiology, Assistance Publique-Hôpitaux de Paris, Bichat Hospital, Paris, France 2 Faculté de Médecine Paris-Diderot University Paris 7, Paris, France 3 INSERM U698 Bichat Hospital, Paris, France 4 Department of Radiology, Assistance Publique-Hôpitaux de Paris, Bichat Hospital, Paris, France Correspondence to Dr Claire Bouleti, Department of Cardiology, Bichat Hospital, 46 rue Henri-Huchard, Paris 75018, France; claire.bouleti@gmail.com Received 21 August 2014 Revised 26 December 2014 Accepted 15 January 2015 To cite: Bouleti C, Himbert D, Iung B, et al. Heart Published Online First: [ please include Day Month Year] doi:10.1136/heartjnl- 2014-306694 ABSTRACT Objective To assess late outcome after transcatheter aortic valve implantation (TAVI) up to 6 years and to analyse its predictive factors with a particular emphasis on functional status. Very few data exist on the long- term results of TAVI, and these data are crucial for decision making. Methods Between October 2006 and December 2009, 123 consecutive patients were discharged alive after TAVI in our institution. Mean age was 82±8years, and 88% of patients were highly symptomatic in New York Heart Association (NYHA) class III–IV. Results Follow-up was complete in 122 patients (99%). The overall 6-year survival rate was 31%±5%, the majority of deaths being non-cardiac. Predictive factors of late mortality were the presence of lower limb arteritis ( p=0.009), a higher Charlson comorbidity index (p=0.03) and post-TAVI paraprosthetic aortic regurgitation ≥2/4 (p=0.01). Late outcomes according to Valve Academic Research Consortium-2 criteria were analysed, and the 5-year event-free survival rate was 28%±4%. Finally, the rate of good functional results, defined as survival in NYHA class I or II, was 32%±5% at 5-year follow-up. In the survivors, the EQ-5D questionnaire further confirmed the benefit in terms of quality of life. Conclusions About one-third of patients discharged alive after TAVI were alive at 6-year follow-up, and the survivors exhibited good functional results assessed by NYHA class and quality-of-life standardised evaluation. INTRODUCTION Degenerative aortic stenosis (AS) affects elderly patients who often have a number of comorbidities. Transcatheter aortic valve implantation (TAVI) is indicated for patients unsuitable for surgery and should be considered in cases of high surgical risk. 12 In this particular population, TAVI signifi- cantly reduces mortality compared with natural history. 3 Long-term results are a crucial contribu- tion to decision making. However, few studies reported follow-up results over 3 years after TAVI. 4–6 The aim of this study was therefore to analyse long-term outcome up to 6years after TAVI and its predictive factors, as well as focusing on late func- tional results based on the New York Heart Association (NYHA) class and quality of life (QoL). METHODS Population This study is a prospective single-centre registry of consecutive patients who were referred to our insti- tution from October 2006 to December 2009 with severe AS responsible for cardiac symptoms (NYHA class II or higher, syncope or angina), and who were considered to be unsuitable or at high risk for surgery after evaluation by the Heart Team according to the guidelines. 12 Because the aim of this paper was to evaluate long-term outcomes after TAVI, we only included in these analyses the patients who were discharged alive. Index hospitalisation As for description of the population, lower limb arteritis was defined as claudication or previous or planned intervention on the limb arteries. We used the age-adjusted Charlson comorbidity index to assess patients’ comorbidities. The variables of the Charlson comorbidity index are detailed in online supplementary table S1. Both the Edwards SAPIEN and the Medtronic CoreValve System were used in the study. The Edwards SAPIEN was used from the beginning of our experience while the Medtronic CoreValve System was available only from November 2008. Patients were selected for either transfemoral or transapical approach on the anatomy of iliofemoral arteries. Transfemoral access was favoured as the first approach, but transapical access was also used. Moreover, one patient benefited from subclavian access and one patient from retroperitoneal access. Transthoracic echocardiographic examinations were systematically performed at baseline and at day 7 after TAVI by experienced echocardiogra- phers. The severity of aortic regurgitation (AR) was graded from 0 to 4 using an integrative approach as recommended by guidelines. 278 After TAVI, patients were treated with aspirin and clopidogrel for 3 months, followed by a single antiplatelet therapy, which was continued lifelong. When oral anticoagulation was indicated, patients were treated with a vitamin K antagonist and only one antiplatelet agent. Follow-up Follow-up was conducted through clinical visits, phone contact with the referring cardiologist or general practitioner or direct phone contact with the patient. Data were prospectively entered in a Bouleti C, et al. Heart 2015;0:1–7. doi:10.1136/heartjnl-2014-306694 1 Valvular heart disease Heart Online First, published on February 5, 2015 as 10.1136/heartjnl-2014-306694 Copyright Article author (or their employer) 2015. 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