Efficacy and safety of the Lotus Valve System for treatment of patients with severe aortic valve stenosis and intermediate surgical risk: Results from the Nordic Lotus-TAVR registry

Götberg, Matthias; Ihlberg, Leo; Packer, Erik; Savontaus, Mikko; Nielsen, Niels Erik; Jørgensen, Troels Højsgaard; Nykänen, Antti; Baranowski, J. M.; Niemelä, Matti; Eskola, Markku; Bjursten, Henrik; Søndergaard, Lars

doi:10.1016/j.ijcard.2016.05.072

Cited by 31 publications

(16 citation statements)

References 16 publications

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“…ViV‐TAVI was associated with lower rates of PPM implantation. Newer generation devices showed improved outcomes over first generation devices in TAVI . Future studies carried out using newer generation transcatheter heart valve devices are needed.…”

Section: Resultsmentioning

confidence: 99%

Valve in valve transcatheter aortic valve implantation (ViV‐TAVI) versus redo—Surgical aortic valve replacement (redo‐SAVR): A systematic review and meta‐analysis

Nalluri

Atti

Munir

et al. 2018

J Interven Cardiology

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Section: Resultsmentioning

confidence: 99%

Valve in valve transcatheter aortic valve implantation (ViV‐TAVI) versus redo—Surgical aortic valve replacement (redo‐SAVR): A systematic review and meta‐analysis

Nalluri

Atti

Munir

et al. 2018

J Interven Cardiology

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“…6 registries with 4,607 patients (36.61%) used “Balloon-expandable SAPIEN Prosthesis” of Edwards Lifesciences (Irvine, California)[ 16 – 21 ], and one registry with 1,316 patients (10.46%) used “Self-expandable CoreValve Prosthesis” from Medtronic CoreValve (Minneapolis, Minnesota)[ 22 ], 10 registries with total 6,406 patients used both prostheses of SAPIEN Edwards and Medtronic CoreValve [ 23 – 31 ]. In addition, one registry with 154 patients used Lotus Valve System (Boston Scientific, MA) [ 32 ]; and one registry with 100 patients used a nonmetallic design TAVI system-Direct Flow Medical (DFM) TAVI system [ 33 ]. Transfemoral (TF) and transapical (TA) are two commonly used access routes in TAVI [ 34 ].…”

Section: 1 Bibliographic Research Resultsmentioning

confidence: 99%

“…11 studies reported early safety rate, but it ranged from 10% to 92.2% [ 15 , 19 , 20 , 23 – 26 , 29 , 31 – 33 ]. Only three registries reported clinical efficacy [ 19 , 20 , 32 ]. There is no registry reported time-related valve safety.…”

Section: 1 Bibliographic Research Resultsmentioning

confidence: 99%

How TAVI registries report clinical outcomes—A systematic review of endpoints based on VARC-2 definitions

Zhang

Kolominsky-Rabas

2017

PLoS ONE

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IntroductionTranscatheter aortic valve implantation (TAVI) has been demonstrated to be an alternative treatment for severe aortic stenosis in patients considered as high surgical risk. Since its first human implantation by Cribier et al., TAVI has been shown to increase survival rate and quality of life for high surgical risks patients. The objective of this study is to provide an overview of TAVI registries and the reporting clinical outcomes based on the VARC-2 definitions. In addition, the comparability and adherence of VARC-2 reporting within the identified TAVI registries was reviewed.Materials and methodsA systematic review of TAVI registries reporting VARC-2 definitions has been performed in line with PRISMA guidelines in PubMed, ScienceDirect, Scopus databases and EMBASE. Based on VARC-2, patients’ characteristics and procedure characteristics, 30-day clinical outcomes, 1-year mortality and composited endpoints were extracted from each registry’s publications.ResultsThis review identified 466 studies that were potentially relevant, and 20 TAVI registries reported VARC-2 definitions involved in our present review. Of all 20 registries, an overall sample size of 12,583 patients was involved. The 30-day all-cause mortality ranged from 0 to 12.7%. From 20 registries, 14 registries reported the cardiovascular mortality at 30 days. 9 registries reported myocardial infarction (MI) rate based on VARC-2 definitions, and 7 registries reported peri-procedural MI rate (<72h). In our review, most of registries presented MI rates ranging from 0.5% to 2%. The majority of registries have reported complications such as bleeding, vascular complications and new pacemaker implantation.ConclusionSince the introduction of VARC definitions from 2011, VARC and VARC-2 definitions are still not systematically used by all TAVI studies. These endpoint definitions warrant a concise and systemic analysis of outcome measures. Reporting TAVI-outcome uniformly makes study result comparison feasible. This definitely will increase patient safety, additionally to provide sufficient evidence to support decision makers like regulatory bodies, HTA agencies, payers.

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“…The valve is deployed via controlled mechanical expansion, which allows for precise positioning. The safety and efficacy of the Lotus valve have been demonstrated in patients with severe AS at high or intermediate surgical risk in the Western world [11][12][13][14][15]. However, data about the use of the Lotus valve for Chinese patients are still lacking.…”

Section: Transcatheter Aortic Valve Replacement In Atypical Valve Anamentioning

confidence: 99%

Transcatheter aortic valve replacement in atypical valve anatomy using the Lotus valve

Liu

Jiang

et al. 2019

Herz

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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 1‑year 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.

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Efficacy and safety of the Lotus Valve System for treatment of patients with severe aortic valve stenosis and intermediate surgical risk: Results from the Nordic Lotus-TAVR registry

Cited by 31 publications

References 16 publications

Valve in valve transcatheter aortic valve implantation (ViV‐TAVI) versus redo—Surgical aortic valve replacement (redo‐SAVR): A systematic review and meta‐analysis

Valve in valve transcatheter aortic valve implantation (ViV‐TAVI) versus redo—Surgical aortic valve replacement (redo‐SAVR): A systematic review and meta‐analysis

How TAVI registries report clinical outcomes—A systematic review of endpoints based on VARC-2 definitions

Transcatheter aortic valve replacement in atypical valve anatomy using the Lotus valve

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