Procedural and 30-day clinical outcomes following transcatheter aortic valve replacement with lotus valve: Results of the RELEVANT study
Conflict of interest: Nedy Brambilla is proctor for Boston Scientific. Fausto Castriota is proctor for Boston Scientific. Anna Sonia Petronio is proctor for Medtronic and Boston Scientific, speaker and consultant for Abbott Vascular. Giuseppe Tarantini is consultant for Boston Scientific, Edwards Lifesciences and Medtronic. Francesco Bedogni is proctor for Boston Scientific, St. Jude Medical and Medtronic. Rocco A. Montone, Matteo Montorfano, Chiara Fraccaro, Roberto Nerla, Marco Angelillis, Luca Testa, Maurizio Tusa, Francesco Giannini, Andrea Garatti have no disclosures.
Abstract
Objectives
We report procedural and 30-day clinical outcomes following transcatheter aortic valve replacement (TAVR) with Lotus Valve system in a high-risk population.
Background
Lotus valve is a second-generation TAVR fully repositionable and retrievable device. RELEVANT (REgistry of Lotus valvE for treatment of aortic VAlve steNosis with Tavr) study is an Italian prospective multicentre registry.
Methods
Five major centers performing TAVR using Lotus participated. All high-risk symptomatic patients with severe aortic stenosis were evaluated by a heart team and screened for eligibility for TAVR. Primary end-points were procedural and 30-day mortality. Secondary endpoints included procedural and 30-day safety/effectiveness metrics according to Valve Academic Research Consortium (VARC)−2 criteria.
Results
Two hundred and twenty-five patients undergoing TAVR with Lotus were enrolled. Mean age was 82.6 ± 6.3 years, 51.6% females. Mean STS score for mortality was 8.3 ± 5.6. Procedural success was achieved in 98.7% of patients. All-cause mortality was 2.2% at discharge and 2.7% at 30-day. Stroke rate was 2.2% at discharge and 3.1% at 30-day. Patients requiring a new permanent pacemaker implantation were 30.7% at discharge and 31.8% at 30-day. Paravalvular regurgitation (PVR) was trace/mild in 99.1% of patients at discharge. Only two patients (0.9%) had moderate PVR at discharge and at 30-day, whereas none had severe PVR.
Conclusions
RELEVANT study showed that TAVR using Lotus, in a real-world population of patients with severe aortic stenosis at high surgical risk, was associated with excellent device success implantation and early safety according to VARC-2 definition. The pacemaker implantation rate was about a third of patients. © 2017 Wiley Periodicals, Inc.
