Author + information
- Received July 30, 2018
- Revision received October 24, 2018
- Accepted October 30, 2018
- Published online January 7, 2019.
- Nicolas M. Van Mieghem, MD, PhDa,∗ (, )
- Jochen Wöhrle, MDb,
- David Hildick-Smith, MDc,
- Sabine Bleiziffer, MDd,
- Daniel J. Blackman, MDe,
- Mohamed Abdel-Wahab, MDf,
- Ulrich Gerckens, MDg,
- Axel Linke, MD, PhDh,
- Hüseyin Ince, MD, PhDi,j,
- Peter Wenaweser, MDk,
- Dominic J. Allocco, MDl,
- Ian T. Meredith, AM, MBBS, PhDl and
- Volkmar Falk, MDm,n
- aInterventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
- bInternal Medicine II, University of Ulm, Ulm, Germany
- cSussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton, United Kingdom
- dDepartment of Cardiovascular Surgery and Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, Technische Universität München, Munich, Germany
- eLeeds General Infirmary, Leeds, United Kingdom
- fHerzzentrum, Leipzig, University Clinic for Cardiology, Leipzig, Germany
- gDepartment of Cardiology, University of Rostock, Rostock, Germany
- hTechnical University Dresden, Heart Center, Dresden, Germany
- iClinic for Internal Medicine, University of Rostock, Rostock, Germany
- jVivantesklinikum im Friedrichshain und Am Urban, Berlin, Germany
- kSwiss Cardiovascular Center Bern, University Hospital Bern, Bern, Switzerland
- lBoston Scientific Corporation, Marlborough, Massachusetts
- mKlinik für Herz-Thorax-Gefässchirurgie, Deutsches Herzzentrum Berlin, Berlin, Germany
- nKlinik für Kardiovaskuläre Chirurgie, Charite, Universitätsmedizin Berlin, Berlin, Germany
- ↵∗Address for correspondence:
Dr. Nicolas Van Mieghem, Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, ’s Gravendijkwal 230, Office Bd 171, 3015 CE Rotterdam, the Netherlands.
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)
The RESPOND study was sponsored and funded by Boston Scientific Corporation. Dr. Van Mieghem has received grants from Boston Scientific, Claret Medical (a subsidiary of Boston Scientific), Medtronic, PulseCath, Abbott Vascular, and Edwards Lifesciences; and advisory fees from Boston Scientific. Dr. Wöhrle has received grants and personal fees from Boston Scientific and Edwards Lifesciences. Dr. Hildick-Smith has received personal fees from Boston Scientific, Medtronic, and Edwards Lifesciences. Dr. Bleiziffer has received personal fees from Medtronic, Boston Scientific, and JenaValve. Dr. Blackman has received grants and personal fees from Boston Scientific. Dr. Abdel-Wahab has received personal fees from Boston Scientific; and grants from St. Jude Medical and Biotronik. Dr. Gerckens has received personal fees from Boston Scientific and Medtronic as a consultant and proctor. Dr Linke has received personal fees from Medtronic, Boston Scientific, Edwards Lifesciences, Abbott, Claret Medical (a subsidiary of Boston Scientific), Transverse Medical; has been a consultant for AstraZeneca; has received speaker fees from Edwards Lifesciences, Boston Scientific, Medtronic, Abbott, AstraZeneca, Bayer, and Novartis; and owns stock options from Claret Medical, Transverse Medical Inc., and Emboline. Dr. Ince has received grants from Boston Scientific. Dr. Wenaweser has been a proctor for Boston Scientific, Medtronic, and Edwards Lifesciences. Drs. Allocco and Meredith are employees of and shareholders in Boston Scientific. Dr. Falk has received grants from Boston Scientific, Philips, HeartWare, Berlin Heart, Biotronik, and Edwards Lifesciences; and consulting, lecture, speaking, and other fees from Abbott, Medtronic, and Novartis.
- Received July 30, 2018.
- Revision received October 24, 2018.
- Accepted October 30, 2018.
- 2019 The Authors