Transcatheter aortic valve replacement in atypical valve anatomy using the Lotus valve : A Chinese single-center experience.

BACKGROUND: In the West, the safety and efficacy of the Lotus valve have been demonstrated; however, data in the Chinese population are still lacking. Few studies have compared the clinical outcomes of transcatheter aortic valve replacement (TAVR) with the Lotus valve in patients with bicuspid or tricuspid aortic valve stenosis. Our aim was to assess TAVR outcomes with the Lotus aortic valve in a Chinese patient cohort. METHODS: In total, 23 symptomatic, high-surgical risk patients with severe aortic valve stenosis were enrolled. Among them, nine patients (39%) had bicuspid aortic valves, and three patients had a large annulus dimension. The Lotus valve was successfully implanted in all patients. To facilitate accurate positioning, partial re-sheathing was attempted in ten patients (43.5%), while one patient had a full retrieval. One-year clinical follow-up was completed in all patients. RESULTS: There were no deaths, strokes, or major adverse cardiac and cerebrovascular events in 22 of the 23 patients at 30 days; the all-cause mortality rate at 1 year was 4.4% (1 of 23 patients). The mean aortic valve gradient decreased from 51.5 ± 8.8 mm Hg at baseline to 13.4 ± 4.9 mm Hg (p < 0.001) and the valve area increased from 0.6 ± 0.2 cm2 to 1.5 ± 0.4 cm2 (p < 0.001) at 30 days. Paravalvular leakage was absent or mild (22%), and no patient had severe paravalvular leakage. Six patients (26.1%) required a postprocedural pacemaker. There was no difference regarding the procedural and the 1­year outcomes between patients with bicuspid and tricuspid aortic valve stenosis. CONCLUSION: Our single-center experience demonstrated that the Lotus valve is feasible and effective for Chinese patients with aortic valve stenosis, including atypical cases with bicuspid aortic valves or large aortic annulus size.

Transcatheter Aortic Valve Implantation - Yesterday, Today and Tomorrow.

Since the first transcatheter aortic valve implantation (TAVI) was performed by Alain Cribier and colleagues in 2002 [1], the technology has garnered global support with more than 200,000 devices implanted. The rapid adoption of this technology has been driven by the need for a less invasive treatment modality in a cohort of patients often denied conventional surgical valve replacement due to an unacceptably high perioperative risk, whether real or perceived [2]. This, together with evidence that the technology confers morbidity and mortality advantages compared to medical therapy [3,4] and at least equivalent outcomes to surgical valve replacement [5,6] in select cohorts, has seen clinical approval in more than 50 countries. The last 13 years has seen an evolution of practises and equipment affecting almost every aspect of the TAVI procedure from pre-procedural assessment to device design and post-procedural care. The almost exponential rate of change has both benefits and risks. Benefits, in that impactful changes are translated into clinical practice very rapidly, but risks, in that meaningful comparative research studies potentially lag behind and can be outmoded by the time they are published. This instability may in turn delay regulatory review and approval processes that are based on such studies. The aim of this review is to provide an overview of the evolution of TAVI, its current clinical position and likely future directions.

The SADRA Lotus Valve System: a fully repositionable, retrievable prosthesis.

Transcatheter aortic valve implantation (TAVI) has become the preferred treatment option for patients with severe aortic stenosis at extreme surgical risk and an acceptable alternative to surgical aortic valve replacement in patients at high risk. Despite a growing amount of evidence in support of TAVI there remain important limitations and recognized complications. The SADRA Lotus Valve System is a novel TAVI device capable of allowing full repositionability and retrievability, which may address some of the first generation limitations.