Ian T Meredith1, Darren L Walters2, Nicolas Dumonteil3, Stephen G Worthley4, Didier Tchétché5, Ganesh Manoharan6, Daniel J Blackman7, Gilles Rioufol8, David Hildick-Smith9, Robert J Whitbourn10, Thierry Lefèvre11, Rüdiger Lange12, Ralf Müller13, Simon Redwood14, Ted E Feldman15, Dominic J Allocco16, Keith D Dawkins16. 1. MonashHeart, Monash Medical Centre and Monash University, Clayton, Victoria, Australia. Electronic address: ian.meredith@myheart.id.au. 2. The Prince Charles Hospital, Brisbane and University of Queensland, Brisbane, Queensland, Australia. 3. Rangueil University Hospital, Cardiovascular and Metabolic Pole, Toulouse, France. 4. Royal Adelaide Hospital, Adelaide, South Australia, Australia. 5. Clinique Pasteur, Toulouse, France. 6. Royal Victoria Hospital, Belfast, United Kingdom. 7. Leeds Teaching Hospitals, Leeds, United Kingdom. 8. Hôpital Cardiologique de Lyon, Bron, France. 9. Sussex Cardiac Centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom. 10. Cardiovascular Research Centre, St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia. 11. Institut Cardiovasculaire-Paris Sud, Massy, France. 12. Deutsches Herzzentrum München, Munich, Germany. 13. HELIOS Klinikum, Siegburg, Germany. 14. Guy's and St. Thomas NHS Foundation Trust, London, United Kingdom. 15. NorthShore University HealthSystem, Evanston Hospital, Evanston, Illinois. 16. Boston Scientific Corporation, Marlborough, Massachusetts.
Abstract
OBJECTIVES: This analysis presents the first report of 1-year outcomes of the 120 patients enrolled in the REPRISE II (Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance) study. BACKGROUND: The fully repositionable and retrievable Lotus Valve (Boston Scientific, Marlborough, Massachusetts) was designed to facilitate accurate positioning, early valve function, and hemodynamic stability during deployment and to minimize paravalvular regurgitation in patients undergoing transcatheter aortic valve replacement. METHODS: The study enrolled 120 symptomatic patients 70 years of age or older at 14 centers in Australia and Europe. Patients had severe calcific aortic stenosis and were deemed to be at high or extreme risk of surgery based on assessment by the heart team. RESULTS: The mean age was 84.4 ± 5.3 years, 57% (68 of 120) of patients were women, and the mean Society of Thoracic Surgeons score was 7.1 ± 4.6. The mean baseline aortic valve area was 0.7 ± 0.2 cm(2), and the mean transvalvular pressure gradient was 46.4 ± 15.0 mm Hg. All patients were successfully implanted with a Lotus Valve, and 1-year clinical follow-up was available for 99.2% (119 of 120 of patients). The mean 1-year transvalvular aortic pressure gradient was 12.6 ± 5.7 mm Hg, and the mean valve area was 1.7 ± 0.5 cm(2). A total of 88.6% patients had no or trivial paravalvular aortic regurgitation at 1 year by independent core lab adjudication, and 97.1% of patients were New York Heart Association functional class I or II. At 1 year, the all-cause mortality rate was 10.9% (13 of 119 patients), disabling stroke rate was 3.4% (4 of 119 patients), disabling bleeding rate was 5.9% (7 of 119 patients), with no repeat procedures for valve-related dysfunction. A total of 31.9% (38 of 119 patients) underwent new permanent pacemaker implantation at 1 year. CONCLUSIONS: At 1 year of follow-up, the Lotus Valve demonstrated excellent valve hemodynamics, no moderate or severe paravalvular regurgitation, and significant and sustained improvement in New York Heart Association functional class status, with good clinical outcomes. (Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance [REPRISE II]; NCT01627691).
OBJECTIVES: This analysis presents the first report of 1-year outcomes of the 120 patients enrolled in the REPRISE II (Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance) study. BACKGROUND: The fully repositionable and retrievable Lotus Valve (Boston Scientific, Marlborough, Massachusetts) was designed to facilitate accurate positioning, early valve function, and hemodynamic stability during deployment and to minimize paravalvular regurgitation in patients undergoing transcatheter aortic valve replacement. METHODS: The study enrolled 120 symptomatic patients 70 years of age or older at 14 centers in Australia and Europe. Patients had severe calcific aortic stenosis and were deemed to be at high or extreme risk of surgery based on assessment by the heart team. RESULTS: The mean age was 84.4 ± 5.3 years, 57% (68 of 120) of patients were women, and the mean Society of Thoracic Surgeons score was 7.1 ± 4.6. The mean baseline aortic valve area was 0.7 ± 0.2 cm(2), and the mean transvalvular pressure gradient was 46.4 ± 15.0 mm Hg. All patients were successfully implanted with a Lotus Valve, and 1-year clinical follow-up was available for 99.2% (119 of 120 of patients). The mean 1-year transvalvular aortic pressure gradient was 12.6 ± 5.7 mm Hg, and the mean valve area was 1.7 ± 0.5 cm(2). A total of 88.6% patients had no or trivial paravalvular aortic regurgitation at 1 year by independent core lab adjudication, and 97.1% of patients were New York Heart Association functional class I or II. At 1 year, the all-cause mortality rate was 10.9% (13 of 119 patients), disabling stroke rate was 3.4% (4 of 119 patients), disabling bleeding rate was 5.9% (7 of 119 patients), with no repeat procedures for valve-related dysfunction. A total of 31.9% (38 of 119 patients) underwent new permanent pacemaker implantation at 1 year. CONCLUSIONS: At 1 year of follow-up, the Lotus Valve demonstrated excellent valve hemodynamics, no moderate or severe paravalvular regurgitation, and significant and sustained improvement in New York Heart Association functional class status, with good clinical outcomes. (Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance [REPRISE II]; NCT01627691).
Authors: Ted E Feldman; Michael J Reardon; Vivek Rajagopal; Raj R Makkar; Tanvir K Bajwa; Neal S Kleiman; Axel Linke; Dean J Kereiakes; Ron Waksman; Vinod H Thourani; Robert C Stoler; Gregory J Mishkel; David G Rizik; Vijay S Iyer; Thomas G Gleason; Didier Tchétché; Joshua D Rovin; Maurice Buchbinder; Ian T Meredith; Matthias Götberg; Henrik Bjursten; Christopher Meduri; Michael H Salinger; Dominic J Allocco; Keith D Dawkins Journal: JAMA Date: 2018-01-02 Impact factor: 56.272