Key result
Valve-in-valve implantation with Portico was associated with higher 1-year overall mortality compared to CoreValve (22.6% vs 9.1%; P=0.03) in patients with failed surgical bioprostheses.
Why the study?
Does the Portico transcatheter heart valve improve hemodynamics and clinical outcomes compared to CoreValve in patients with failed surgical aortic bioprosthesis?
Observational (n=162)
Single-blind
Yes
Does the Portico transcatheter heart valve improve hemodynamics and clinical outcomes compared to CoreValve in patients with failed surgical aortic bioprosthesis?
In patients undergoing valve-in-valve TAVR for failed surgical bioprostheses, the CoreValve device was associated with better postprocedural hemodynamics and lower 1-year mortality compared to the Portico device.
Background— Transcatheter valve-in-valve implantation is an established therapy for high-risk patients with failed surgical aortic bioprosthesis. There are limited data comparing outcomes of valve-in-valve implantation using different transcatheter heart valves (THV). Methods and Results— Patients included in the Valve-in-Valve International Data registry (VIVID) and treated with self-expanding THV devices were analyzed using centralized core laboratory blinded to clinical events. St. Jude Medical Portico versus Medtronic CoreValve were compared in a 1:2 fashion after propensity score matching. A total of 162 patients, Portico- (n=54) and CoreValve- (n=108) based valve-in-valve procedures comprised the study population with no significant difference in baseline characteristics (age, 79±8.2 years; 60% women; mean STS [Society of Thoracic Surgery] score 8.1±5.5%). Postimplantation, CoreValve was associated with a larger effective orifice area (1.67 versus 1.31 cm 2 ; P =0.001), lower mean gradient (14±7.5 versus 17±7.5 mm Hg; P =0.02), and lower core laboratory–adjudicated moderate-to-severe aortic insufficiency (4.2% versus 13.7%; P =0.04), compared with Portico. Procedural complications including THV malpositioning, second THV requirement, or coronary obstruction were not significantly different between the 2 groups. Survival and stroke rates at 30 days were similar, but overall mortality at 1 year was higher among patients treated with Portico compared with CoreValve (22.6% versus 9.1%; P =0.03). Conclusions— In this first matched comparison of THVs for valve-in-valve implantations, Portico and CoreValve demonstrated differences in postprocedural hemodynamics and long-term clinical outcomes. Although this could be related to THV design characteristics, the impact of other procedural factors cannot be excluded and require further evaluation.
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Alnasser et al. (2017) conducted an observational in Failed surgical aortic bioprosthesis (n=162). St. Jude Medical Portico vs. Medtronic CoreValve was evaluated on Overall mortality at 1 year (p=0.03). Valve-in-valve implantation with Portico was associated with higher 1-year overall mortality compared to CoreValve (22.6% vs 9.1%; P=0.03) in patients with failed surgical bioprostheses.
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