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      Transcatheter aortic valve replacement in atypical valve anatomy using the Lotus valve : A Chinese single-center experience Translated title: Transkatheter-Aortenklappenersatz bei atypischer Klappenanatomie unter Einsatz der Lotusklappe : Erfahrungen eines chinesischen Einzelzentrums

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          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 cm 2 to 1.5 ± 0.4 cm 2 ( 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.

          Translated abstract

          Hintergrund

          In der westlichen Welt wurden Sicherheit und Wirksamkeit der Lotus-Klappe nachgewiesen, für die chinesische Bevölkerung fehlen solche Daten jedoch. Nur in wenigen Studien wurden die klinischen Ergebnisse des Transkatheter-Aortenklappenersatzes (TAVR) mit der Lotus-Klappe bei Patienten mit Stenose einer bikuspiden oder trikuspiden Aortenklappe verglichen. Ziel war es, die Ergebnisse der TAVR mit der Lotus-Aortenklappe in einer chinesischen Patientenkohorte zu untersuchen.

          Methoden

          In die Studie wurden 23 Patienten mit symptomatischer schwerer Aortenklappenstenose und hohem Operationsrisiko einbezogen. Davon hatten 9 Patienten (39 %) eine bikuspide Aortenklappe, bei 3 Patienten lag ein großer Aortenklappenring vor. Die Lotus-Klappe wurde bei allen Patienten erfolgreich implantiert. Zur Erleichterung der genauen Platzierung wurde bei 10 Patienten (43,5 %) ein partielles Zurückführen der Klappe in den Einführkatheter erprobt, in einem Fall erfolgte die Wiederentfernung der Klappe. Bei allen wurde die Nachbeobachtung über ein Jahr komplett durchgeführt.

          Ergebnisse

          Bei 22 der 23 Patienten gab es nach 30 Tagen weder einen Todesfall, noch kam es zum Schlaganfall oder schweren unerwünschten kardialen oder zerebrovaskulären Ereignissen; die Rate der Mortalität jeglicher Ursache nach einem Jahr betrug 4,4 % (1 von 23 Patienten). Der mittlere Aortenklappengradient nahm von 51,5 ± 8,8 mm Hg zu Beginn auf 13,4 ± 4,9 mm Hg ( p < 0,001) ab, und die Klappenöffnungsfläche nahm von 0,6 ± 0,2 cm 2 auf 1,5 ± 0,4 cm 2 ( p < 0,001) nach 30 Tagen zu. Paravalvuläre Lecks traten nicht oder nur leichtgradig auf (22 %), in keinem Fall kam es zum schweren paravalvulären Leck. In 6 Fällen (26,1 %) war nach dem Eingriff eine Schrittmacherimplantation erforderlich. Zwischen Fällen mit Stenose einer bikuspiden und einer trikuspiden Aortenklappe bestand kein Unterschied beim prozeduralen und Einjahresergebnis.

          Schlussfolgerung

          Diese Erfahrungen des Einzelzentrums der Autoren zeigten, dass die Lotus-Klappe für chinesische Patienten mit Aortenklappenstenose, einschließlich atypischer Fälle mit bikuspider Aortenklappe oder großem Aortenringdurchmesser, geeignet und wirksam ist.

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          Most cited references 38

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          Two-year outcomes after transcatheter or surgical aortic-valve replacement.

          The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits. At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation. The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001). A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).
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            Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients.

            Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients.
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              Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.

              Many patients with severe aortic stenosis and coexisting conditions are not candidates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis. We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause. A total of 358 patients with aortic stenosis who were not considered to be suitable candidates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan–Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as compared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P=0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram. In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).
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                Author and article information

                Contributors
                wangjianan111@zju.edu.cn
                Journal
                Herz
                Herz
                Herz
                Springer Medizin (Heidelberg )
                0340-9937
                1615-6692
                29 January 2019
                29 January 2019
                2021
                : 46
                : 1
                : 63-70
                Affiliations
                [1 ]GRID grid.412465.0, Department of Cardiology, , The Second Affiliated Hospital, Zhejiang University School of Medicine, ; 310009 Hangzhou, China
                [2 ]GRID grid.412465.0, Department of Anesthesia, , The Second Affiliated Hospital, Zhejiang University School of Medicine, ; 310009 Hangzhou, China
                [3 ]GRID grid.412465.0, Department of Cardiac Surgery, , The Second Affiliated Hospital, Zhejiang University School of Medicine, ; 310009 Hangzhou, China
                [4 ]GRID grid.412465.0, Department of Radiology, , The Second Affiliated Hospital, Zhejiang University School of Medicine, ; 310009 Hangzhou, China
                [5 ]GRID grid.1002.3, ISNI 0000 0004 1936 7857, Monash Cardiovascular Research Centre, , Monash University, ; Victoria, Clayton Australia
                Article
                4778
                10.1007/s00059-018-4778-z
                7862532
                30694372
                © The Author(s) 2019

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

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                © Springer Medizin Verlag GmbH, ein Teil von Springer Nature 2021

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