P1789Outcomes of different approaches for severe aortic stenosis: “"The Deferred-TAVI”, a multicentre study investigating medical and percutaneous therapy in the era of TAVI

Abstract

Abstract Background In the era of TAVI, also very high surgical risk patients can be treated and the importance of the Heart Team is to address the patient to the right therapy. In some cases due to comorbidities, lack of symptoms and patients' decision not always a final decision is achieved after the first clinical evaluation and the final strategy could be deferred for months. Purpose The study aims to analyze outcomes in patients with severe aortic stenosis differently treated according to the various approaches proposed by the Heart Team. Methods All the patients with a diagnosis of severe aortic stenosis considered at high and very high surgical risk were enrolled. Three international cardiology departments participated in this multicentre study. All the patients were divided into four groups according to the Heart Team decision of approach. Patients with indication to medical therapy only (DTO Drug therapy only), Patients first deferred from heart team decision, personal reasons or lack of symptoms and then addressed to medical therapy (D-DTO Deferred-Drug therapy only), Patients deferred and then addressed to TAVI within 3 months (D-TP Deferred TAVI Procedure), Patients with direct indication to TAVI (ITP Immediate TAVI procedure). Primary endpoint were overall survive at follow up comparing the differences between the four groups and the impact of the deferred strategy. Results 795 patients were enrolled (80 DTO, 451 ITP, 264 initially deferred and then 155 D-DTO and 109 D-TP). Median follow-up was 465 days. Overall survive of the four groups at 1 year was 74% DTO, 73% D-DTO, 77% D-TP and 78% ITP, at 2 years 62% DTO, 38% D-DTO, 62% D-TP and 68% ITP, at 3 years 39% DTO, 11% D-DTO, 25% D-TP and 56% ITP (p≤0,001 at log rank test). At the multivariate analysis, compared to the referral group DTO, D-DTO was associated with higher mortality (HR=1,90; IC [95%]: 1,05–3,58; p=0,03 at 2 years; HR 1,66; IC [95%]: 1,01–2,76; p<0,05, at 3 years), while D-TP was not associated with lower mortality risk (HR 1,31 IC [95%]: 0,62–2,76; p=0,72 at 2 years, HR 1,37 IC [95%]: 0,77–2,44; p=0,77 at 3 years). ITP was associated with lower mortality risk only at 3 years (HR 0,60; IC [95%]: 0,42–0,99; p<0.05). Comparing the group deferred (D-DTO and D-TP) to the group not deferred (DTO and ITP), the deferred group was associated with higher mortality risk (HR 1,86; IC [95%]: 1,30–2.65; p=0,001 at 2 years, HR 2,21; IC [95%]: 1,61–3,05; p<0,001 at 3 years). Conclusions The Heart team decision on the approach of treatment strongly influence the survive of the patient. Compared to direct medical therapy, there is a higher risk of mortality for patients initially deferred and then treated with medical therapy and there is no survival benefit for patients initially deferred and then treated with TAVI. The choice of deferring the treatment of patients with severe aortic stenosis clearly decrease long term survive at follow up regardless the strategy of the approach.