Nicolas M Van Mieghem1, Jochen Wöhrle2, David Hildick-Smith3, Sabine Bleiziffer4, Daniel J Blackman5, Mohamed Abdel-Wahab6, Ulrich Gerckens7, Axel Linke8, Hüseyin Ince9, Peter Wenaweser10, Dominic J Allocco11, Ian T Meredith11, Volkmar Falk12. 1. Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address: n.vanmieghem@erasmusmc.nl. 2. Internal Medicine II, University of Ulm, Ulm, Germany. 3. Sussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton, United Kingdom. 4. Department of Cardiovascular Surgery and Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, Technische Universität München, Munich, Germany. 5. Leeds General Infirmary, Leeds, United Kingdom. 6. Herzzentrum, Leipzig, University Clinic for Cardiology, Leipzig, Germany. 7. Department of Cardiology, University of Rostock, Rostock, Germany. 8. Technical University Dresden, Heart Center, Dresden, Germany. 9. Clinic for Internal Medicine, University of Rostock, Rostock, Germany; Vivantesklinikum im Friedrichshain und Am Urban, Berlin, Germany. 10. Swiss Cardiovascular Center Bern, University Hospital Bern, Bern, Switzerland. 11. Boston Scientific Corporation, Marlborough, Massachusetts. 12. Klinik für Herz-Thorax-Gefässchirurgie, Deutsches Herzzentrum Berlin, Berlin, Germany; Klinik für Kardiovaskuläre Chirurgie, Charite, Universitätsmedizin Berlin, Berlin, Germany.
Abstract
OBJECTIVES: The authors sought to evaluate 1-year clinical outcomes with the Lotus valve (Boston Scientific, Marlborough, Massachusetts) in a large international, multicenter prospective registry including patients eligible for transcatheter aortic valve replacement (TAVR) based on heart team consensus. BACKGROUND: TAVR is a safe and effective treatment for severe aortic valve stenosis; however, limited data are available on TAVR with the repositionable and fully retrievable Lotus valve in unrestricted contemporary clinical practice. METHODS: The RESPOND (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes) study enrolled 1,014 patients; 996 patients were implanted with the Lotus valve (mean age 80.8 years, 50.8% female, mean STS score 6.0 ± 6.9%). The primary endpoint was all-cause mortality in the intent-to-treat population at 30 days and 1 year. An Extension cohort of 50 patients was treated with the Lotus valve with Depth Guard including a modified delivery system. Mortality and stroke were independently adjudicated. An independent core laboratory assessed echocardiographic data. RESULTS: One-year clinical follow-up was available for 99.9% of Lotus valve-treated patients. At 1 year, the all-cause mortality rate was 11.7% and 4.1% of patients had experienced a disabling stroke. The permanent pacemaker implantation rate was 32% (37% among pacemaker-naive patients). Echocardiographic data at 1 year were available for core laboratory assessment in 62.6% of patients. Paravalvular leak was absent or trace in 94.5%, mild in 5.1%, and moderate in 0.4% of patients. Data from the Extension cohort confirmed good clinical outcomes at 30 days with an 18% permanent pacemaker rate (20% among pacemaker-naive patients). CONCLUSIONS: One-year outcomes from the RESPOND study confirm the safety and efficacy of the Lotus valve when used in routine clinical practice. (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes [RESPOND]; NCT02031302).
OBJECTIVES: The authors sought to evaluate 1-year clinical outcomes with the Lotus valve (Boston Scientific, Marlborough, Massachusetts) in a large international, multicenter prospective registry including patients eligible for transcatheter aortic valve replacement (TAVR) based on heart team consensus. BACKGROUND: TAVR is a safe and effective treatment for severe aortic valve stenosis; however, limited data are available on TAVR with the repositionable and fully retrievable Lotus valve in unrestricted contemporary clinical practice. METHODS: The RESPOND (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes) study enrolled 1,014 patients; 996 patients were implanted with the Lotus valve (mean age 80.8 years, 50.8% female, mean STS score 6.0 ± 6.9%). The primary endpoint was all-cause mortality in the intent-to-treat population at 30 days and 1 year. An Extension cohort of 50 patients was treated with the Lotus valve with Depth Guard including a modified delivery system. Mortality and stroke were independently adjudicated. An independent core laboratory assessed echocardiographic data. RESULTS: One-year clinical follow-up was available for 99.9% of Lotus valve-treated patients. At 1 year, the all-cause mortality rate was 11.7% and 4.1% of patients had experienced a disabling stroke. The permanent pacemaker implantation rate was 32% (37% among pacemaker-naive patients). Echocardiographic data at 1 year were available for core laboratory assessment in 62.6% of patients. Paravalvular leak was absent or trace in 94.5%, mild in 5.1%, and moderate in 0.4% of patients. Data from the Extension cohort confirmed good clinical outcomes at 30 days with an 18% permanent pacemaker rate (20% among pacemaker-naive patients). CONCLUSIONS: One-year outcomes from the RESPOND study confirm the safety and efficacy of the Lotus valve when used in routine clinical practice. (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes [RESPOND]; NCT02031302).
Authors: Petr Hájek; Eva Polaková; Radka Adlová; Martin Horváth; Eva Hansvenclová; Monika Pecková; Josef Veselka Journal: Postepy Kardiol Interwencyjnej Date: 2022-08-19 Impact factor: 1.065