Georg Nickenig1, Robert Schueler2, Antonio Dager3, Pedro Martinez Clark3, Alexandre Abizaid4, Tomasz Siminiak5, Pawel Buszman6, Marcin Demkow7, Adrian Ebner8, Federico M Asch9, Christoph Hammerstingl2. 1. Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Bonn, Germany. Electronic address: georg.nickenig@ukb.uni-bonn.de. 2. Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Bonn, Germany. 3. Angiographia de Occidente, Cali, Colombia. 4. Institute Dante Pazzanese de Cardiologia, São Paulo, Brazil. 5. Centrum Medical Center HCP, Poznan, Poland. 6. American Heart of Poland, Bielsko-Biala, Poland. 7. National Institute of Cardiology, Warsaw, Poland. 8. Sanatorio Italiano, Asuncion, Paraguay. 9. Medstar Heart Institute at the Washington Hospital Center, Washington, DC.
Abstract
BACKGROUND: Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited and additional interventional approaches are required. OBJECTIVES: This study sought to report the safety and performance data from the feasibility study with a novel direct annuloplasty system. METHODS: Seventy-one patients with moderate to severe FMR (mean 67.7 ± 11.3 years of age, left ventricular [LV] ejection fraction 34.0 ± 8.3%), on stable medical heart failure medication were prospectively enrolled. RESULTS: Device success rate was 70.4% (n = 50 of 71). No intraprocedural death occurred. In patients receiving implants, 4 patients (8.9%) experienced cardiac tamponade. Thirty-day (n = 45) and 6-month (n = 41) rates for all-cause mortality, stroke, and myocardial infarction were 4.4%, 4.4%, and 0.0% and 12.2%, 4.9%, and 0%, respectively. At 6 months, nonurgent mitral surgery was performed in 1 patient (2.4%) and nonurgent percutaneous repair in 7 patients (17.1%). Echocardiographic core analysis after 6 months showed mitral regurgitation reduction in 50% of treated patients by a mean of 1.3 grades. Concerning mitral valve (MV) annular geometry, we found significant reduction of anterior-posterior (-0.31 ± 0.4 cm) and septal-lateral dimensions (-0.21 ± 0.3 cm), a decreased MV-tenting area (-0.57 ± 1.1 cm(2)) and increase in MV coaptation length (0.13 ± 0.2 cm). Transthoracic echocardiography indicated reverse LV remodeling with reduction of LV end-diastolic diameter (-0.20 ± 0.4 mm) and volume (-22 ± 39 ml). Treatment was associated with significant improvement in 6-min walking distances (56.5 ± 92.0 m) and improvements in New York Heart Association functional class III/IV at 6 months from 53.3% to 23.3%. CONCLUSIONS: Percutaneous direct annuloplasty is feasible and safe in high-risk FMR patients. This treatment initiates LV reverse remodeling, and provides clinical improvement during 6 months after treatment. (Mitralign Percutaneous Annuloplasty First in Man Study; NCT01852149).
BACKGROUND: Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited and additional interventional approaches are required. OBJECTIVES: This study sought to report the safety and performance data from the feasibility study with a novel direct annuloplasty system. METHODS: Seventy-one patients with moderate to severe FMR (mean 67.7 ± 11.3 years of age, left ventricular [LV] ejection fraction 34.0 ± 8.3%), on stable medical heart failure medication were prospectively enrolled. RESULTS: Device success rate was 70.4% (n = 50 of 71). No intraprocedural death occurred. In patients receiving implants, 4 patients (8.9%) experienced cardiac tamponade. Thirty-day (n = 45) and 6-month (n = 41) rates for all-cause mortality, stroke, and myocardial infarction were 4.4%, 4.4%, and 0.0% and 12.2%, 4.9%, and 0%, respectively. At 6 months, nonurgent mitral surgery was performed in 1 patient (2.4%) and nonurgent percutaneous repair in 7 patients (17.1%). Echocardiographic core analysis after 6 months showed mitral regurgitation reduction in 50% of treated patients by a mean of 1.3 grades. Concerning mitral valve (MV) annular geometry, we found significant reduction of anterior-posterior (-0.31 ± 0.4 cm) and septal-lateral dimensions (-0.21 ± 0.3 cm), a decreased MV-tenting area (-0.57 ± 1.1 cm(2)) and increase in MV coaptation length (0.13 ± 0.2 cm). Transthoracic echocardiography indicated reverse LV remodeling with reduction of LV end-diastolic diameter (-0.20 ± 0.4 mm) and volume (-22 ± 39 ml). Treatment was associated with significant improvement in 6-min walking distances (56.5 ± 92.0 m) and improvements in New York Heart Association functional class III/IV at 6 months from 53.3% to 23.3%. CONCLUSIONS: Percutaneous direct annuloplasty is feasible and safe in high-risk FMR patients. This treatment initiates LV reverse remodeling, and provides clinical improvement during 6 months after treatment. (Mitralign Percutaneous Annuloplasty First in Man Study; NCT01852149).
Authors: Jaffar M Khan; Toby Rogers; William H Schenke; Adam B Greenbaum; Vasilis C Babaliaros; Gaetano Paone; Rajiv Ramasawmy; Marcus Y Chen; Daniel A Herzka; Robert J Lederman Journal: Catheter Cardiovasc Interv Date: 2018-02-06 Impact factor: 2.692
Authors: Thilo Noack; Philipp Kiefer; Christian Besler; Philipp Lurz; Sergey Leontyev; Mohamed Abdel-Wahab; David Michael Holzhey; Joerg Seeburger Journal: Indian J Thorac Cardiovasc Surg Date: 2019-09-10
Authors: Mahboob Ali; Satya S Shreenivas; David N Pratt; Donald R Lynch; Dean J Kereiakes Journal: Circ Cardiovasc Interv Date: 2020-08-06 Impact factor: 6.546