Q Xu1, X Liu1, J Jiang1, Y He1, Q Zhu1, F Gao1, F Du1, W He2, J Cheng1, M Kong3, Z Pu1, Q Zhou4, R Gooley5, J Wang6. 1. Department of Cardiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, 310009, Hangzhou, China. 2. Department of Anesthesia, The Second Affiliated Hospital, Zhejiang University School of Medicine, 310009, Hangzhou, China. 3. Department of Cardiac Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, 310009, Hangzhou, China. 4. Department of Radiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, 310009, Hangzhou, China. 5. Monash Cardiovascular Research Centre, Monash University, Victoria, Clayton, Australia. 6. Department of Cardiology, The Second Affiliated Hospital, Zhejiang University School of Medicine, 310009, Hangzhou, China. wangjianan111@zju.edu.cn.
Abstract
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.
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.
Authors: Susheel K Kodali; Mathew R Williams; Craig R Smith; Lars G Svensson; John G Webb; Raj R Makkar; Gregory P Fontana; Todd M Dewey; Vinod H Thourani; Augusto D Pichard; Michael Fischbein; Wilson Y Szeto; Scott Lim; Kevin L Greason; Paul S Teirstein; S Chris Malaisrie; Pamela S Douglas; Rebecca T Hahn; Brian Whisenant; Alan Zajarias; Duolao Wang; Jodi J Akin; William N Anderson; Martin B Leon Journal: N Engl J Med Date: 2012-03-26 Impact factor: 91.245
Authors: Ganesh Athappan; Eshan Patvardhan; E Murat Tuzcu; Lars Georg Svensson; Pedro A Lemos; Chiara Fraccaro; Giuseppe Tarantini; Jan-Malte Sinning; Georg Nickenig; Davide Capodanno; Corrado Tamburino; Azeem Latib; Antonio Colombo; Samir R Kapadia Journal: J Am Coll Cardiol Date: 2013-04-16 Impact factor: 24.094
Authors: Janusz Kochman; Zenon Huczek; Piotr Scisło; Maciej Dabrowski; Zbigniew Chmielak; Piotr Szymański; Adam Witkowski; Radosław Parma; Andrzej Ochala; Piotr Chodór; Krzysztof Wilczek; Krzysztof W Reczuch; Piotr Kubler; Bartosz Rymuza; Lukasz Kołtowski; Anna Scibisz; Radosław Wilimski; Eberhard Grube; Grzegorz Opolski Journal: Am J Cardiol Date: 2014-06-19 Impact factor: 2.778
Authors: Hans Gustav Hørsted Thyregod; Daniel Andreas Steinbrüchel; Nikolaj Ihlemann; Henrik Nissen; Bo Juel Kjeldsen; Petur Petursson; Yanping Chang; Olaf Walter Franzen; Thomas Engstrøm; Peter Clemmensen; Peter Bo Hansen; Lars Willy Andersen; Peter Skov Olsen; Lars Søndergaard Journal: J Am Coll Cardiol Date: 2015-03-15 Impact factor: 24.094
Authors: David H Adams; Jeffrey J Popma; Michael J Reardon; Steven J Yakubov; Joseph S Coselli; G Michael Deeb; Thomas G Gleason; Maurice Buchbinder; James Hermiller; Neal S Kleiman; Stan Chetcuti; John Heiser; William Merhi; George Zorn; Peter Tadros; Newell Robinson; George Petrossian; G Chad Hughes; J Kevin Harrison; John Conte; Brijeshwar Maini; Mubashir Mumtaz; Sharla Chenoweth; Jae K Oh Journal: N Engl J Med Date: 2014-03-29 Impact factor: 91.245
Authors: Martine Gilard; Hélène Eltchaninoff; Bernard Iung; Patrick Donzeau-Gouge; Karine Chevreul; Jean Fajadet; Pascal Leprince; Alain Leguerrier; Michel Lievre; Alain Prat; Emmanuel Teiger; Thierry Lefevre; Dominique Himbert; Didier Tchetche; Didier Carrié; Bernard Albat; Alain Cribier; Gilles Rioufol; Arnaud Sudre; Didier Blanchard; Frederic Collet; Pierre Dos Santos; Nicolas Meneveau; Ashok Tirouvanziam; Christophe Caussin; Philippe Guyon; Jacques Boschat; Herve Le Breton; Frederic Collart; Remi Houel; Stephane Delpine; Geraud Souteyrand; Xavier Favereau; Patrick Ohlmann; Vincent Doisy; Gilles Grollier; Antoine Gommeaux; Jean-Philippe Claudel; Francois Bourlon; Bernard Bertrand; Eric Van Belle; Marc Laskar Journal: N Engl J Med Date: 2012-05-03 Impact factor: 91.245
Authors: Ian T Meredith; Stephen G Worthley; Robert J Whitbourn; Paul Antonis; Joseph K Montarello; Andrew E Newcomb; Siohban Lockwood; Nicole Haratani; Dominic J Allocco; Keith D Dawkins Journal: EuroIntervention Date: 2014-03-20 Impact factor: 6.534
Authors: Volkmar Falk; Jochen Wöhrle; David Hildick-Smith; Sabine Bleiziffer; Daniel J Blackman; Mohamed Abdel-Wahab; Ulrich Gerckens; Axel Linke; Hüseyin Ince; Peter Wenaweser; Dominic J Allocco; Keith D Dawkins; Nicolas M Van Mieghem Journal: Eur Heart J Date: 2017-12-01 Impact factor: 29.983