Background While transcatheter aortic valve implantation (TAVI) is established for treating high-operative risk surgical aortic valve replacement candidates, until recently the smallest transcatheter heart valve (THV) measured 23 mm, posing greater risk for annular rupture and THV failure in patients with aortic stenosis (AS) with small aortic annuli (≤20 mm).
Objectives In the setting of a multicentre registry, we report on the safety, efficacy and early clinical outcomes of the SAPIEN XT 20 mm balloon-expanding THV.
Results Among TAVI 55 recipients (n=30 for native AS, n=25 for a valve-in-valve procedure (V-in-V)), median age and Society of Thoracic Surgeons score were 85 (81 to 87) years and 7.8 (4.7 to 12.4)%, respectively. Mean and minimum annular diameters were 19±1 and 17±2 mm, respectively, in native patients with AS, and 17±1 mm (internal diameter) in V-in-V recipients. Successful device implantation rate was 96%, with no procedural-related death. Overall in-hospital-30-day death, stroke and major bleeding rates were 5%, 2% and 9%, respectively. In native AS TAVI recipients, mean transaortic gradient decreased from 54±20 to 12±5 mm Hg (p<0.001), and from 45±17 to 24±8 mm Hg (p<0.001) in V-in-V recipients. Severe prosthesis-patient mismatch (PPM) rates were 10% and 48% in native AS and V-in-V TAVI recipients, respectively (p=0.03). Post-TAVI, the rate of moderate aortic regurgitation was 7% and 0% in native AS and V-in-V TAVI recipients, respectively.
Conclusions TAVI with the 20 mm SAPIEN XT THV appears safe and technically feasible, with acceptable short-term clinical outcomes and low rates of severe PPM in those with native AS.
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Contributors RP planned the study, collected all data, wrote the manuscript. JB, RM, HB, HE, SR, AC, CD, LI, HCW, AC, MG, KEK, MP, RB-M, RE, CG, DM, FM, J-MS, PS, VV and MV contributed patient data and performed these procedures, provided critical manuscript review. AR contributed patient data, performed these procedures and provided critical manuscript review. MT provided critical manuscript review. PP helped planned the study and provided critical manuscript review. EP-B collected data, performed statistical analysis, drafted manuscript and provided critical review, drafted figures. JR-C contributed patient data, planned the study and provided critical manuscript review.
Competing interests HE: proctor for Edwards Lifesciences. SR: travel support and lecture honoraria from Edwards Lifesciences. CD: Proctor for Edwards Lifesciences. LI: consultant for Edwards Lifesciences. HCW: research funding from Edwards Lifesciences. MP: consultant for Edwards Lifesciences. DM: advisory board member and proctor for Edwards Lifesciences. PS: proctor for Edwards Lifesciences. MV: travel expenses from Edwards Lifesciences. MT: employee of Edwards Lifesciences. PP: research support from Edwards Lifesciences for echocardiographic core laboratory analysis of THVs. JR-C: research grant support, and proctoring for Edwards Lifesciences.
Ethics approval The study protocol was performed in accordance with the institutional ethics committees.
Provenance and peer review Not commissioned; externally peer reviewed.