Edgar Tay1, Nasir Muda2, Jonathan Yap3, David W M Muller4, Teguh Santoso5, Darren L Walters6, Xianbao Liu7, Eric Yamen8, Paul Jansz9, James Yip1, Robaayah Zambahari2, Jurgen Passage10, Zee Pin Ding3, Jian'an Wang7, Gregory Scalia10, Amiliana M Soesanto11, Khung Keong Yeo3,12. 1. Department of Cardiology, National University Heart Centre, Singapore. 2. Department of Cardiology, Institut Jantung Negara, Kuala Lumpur, Malaysia. 3. Department of Cardiology, National Heart Centre Singapore, Singapore. 4. Department of Cardiology, St Vincent's Hospital, Sydney, Australia. 5. Medistra Hospital, Jakarta, Indonesia. 6. Department of Cardiology, Prince Charles Hospital, Brisbane, Australia. 7. Department of Cardiology, Second Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang Province, People's Republic of China. 8. Department of Cardiology, Sir Charles Gairdner Hospital, Perth, Australia. 9. Department of Cardiothoracic Surgery, St Vincent's Hospital, Sydney, Australia. 10. Department of Cardiothoracic Surgery, Sir Charles Gairdner Hospital, Perth, Australia. 11. Department of Cardiology, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia. 12. Duke-NUS Graduate Medical School, Singapore.
Abstract
OBJECTIVES: The objective of this study is to describe and compare the use of the MitraClip therapy in mitral regurgitation (MR) patients with degenerative MR (DMR) and functional MR (FMR). INTRODUCTION: Percutaneous edge-to-edge repair of severe MR using the MitraClip device is approved for use in the USA for high risk DMR while European guidelines include its use in FMR patients as well. METHODS: The MitraClip in the Asia-Pacific Registry (MARS) is a multicenter retrospective registry, involving eight sites in five Asia-Pacific countries. Clinical and echocardiographic characteristics, procedural outcomes and 1-month outcomes [death and major adverse events (MAE)] were compared between FMR and DMR patients treated with the MitraClip. RESULTS: A total of 163 patients were included from 2011 to 2014. The acute procedural success rates for FMR (95.5%, n = 84) and DMR (92%, n = 69) were similar (P = 0.515). 45% of FMR had ≥2 clips inserted compared to 60% of those with DMR (P = 0.064).The 30-day mortality rate for FMR and DMR was similar at 4.5% and 6.7% respectively (P = 0.555). The 30-day MAE rate was 9.2% for FMR and 14.7% for DMR (P = 0.281). Both FMR and DMR patients had significant improvements in the severity of MR and NYHA class after 30 days. There was a significantly greater reduction in left ventricular end-diastolic diameter (P = 0.002) and end systolic diameter (P = 0.017) in DMR than in FMR. CONCLUSIONS: The MitraClip therapy is a safe and efficacious treatment option for both FMR and DMR. Although, there is a significantly greater reduction in LV volumes in DMR, patients in both groups report clinical benefit with improvement in functional class.
OBJECTIVES: The objective of this study is to describe and compare the use of the MitraClip therapy in mitral regurgitation (MR) patients with degenerative MR (DMR) and functional MR (FMR). INTRODUCTION: Percutaneous edge-to-edge repair of severe MR using the MitraClip device is approved for use in the USA for high risk DMR while European guidelines include its use in FMR patients as well. METHODS: The MitraClip in the Asia-Pacific Registry (MARS) is a multicenter retrospective registry, involving eight sites in five Asia-Pacific countries. Clinical and echocardiographic characteristics, procedural outcomes and 1-month outcomes [death and major adverse events (MAE)] were compared between FMR and DMRpatients treated with the MitraClip. RESULTS: A total of 163 patients were included from 2011 to 2014. The acute procedural success rates for FMR (95.5%, n = 84) and DMR (92%, n = 69) were similar (P = 0.515). 45% of FMR had ≥2 clips inserted compared to 60% of those with DMR (P = 0.064).The 30-day mortality rate for FMR and DMR was similar at 4.5% and 6.7% respectively (P = 0.555). The 30-day MAE rate was 9.2% for FMR and 14.7% for DMR (P = 0.281). Both FMR and DMRpatients had significant improvements in the severity of MR and NYHA class after 30 days. There was a significantly greater reduction in left ventricular end-diastolic diameter (P = 0.002) and end systolic diameter (P = 0.017) in DMR than in FMR. CONCLUSIONS: The MitraClip therapy is a safe and efficacious treatment option for both FMR and DMR. Although, there is a significantly greater reduction in LV volumes in DMR, patients in both groups report clinical benefit with improvement in functional class.