Transcatheter Annuloplasty For Mitral Regurgitation With The Iris Ring
W. Douglas Boyd1, Jason H. Rogers1, Thomas W. R. Smith1, Steven F. Bolling2.
1University of California, Sacramento, CA, USA, 2University of Michigan, Ann Arbor, MI, USA.
Transcatheter Annuloplasty for Mitral Regurgitation with the IRIS Ring
Objective: To demonstrate the safety and efficacy of a novel complete, semi-rigid transcatheter annuloplasty ring.
Methods: Seven patients were treated with the IRIS ring. Inclusion criteria included 3-4+ functional MR, symptomatic NYHA II-IV, and LV end systolic dimension < 65mm. Exclusion criteria included: LVEF < 20%, aortic valve disease, right-sided heart failure, and PA systolic pressure > 70mmHg. Baseline and 30 day transthoracic echocardiography and CT imaging was performed.
Results: In Phase 1, 4 patients had surgical IRIS mitral ring implantation, and two had rings placed for associated functional TR. In Phase 2, 3 patients had transfemoral, transseptal delivery of the IRIS mitral ring. There was no procedural death, or MI. One patient from phase 1 expired 2 days post-procedure from chronic renal failure complications. The mitral SL diameter was reduced from 38.0+/- 4.1mm to 25.9 +/- 4.9mm at 30 days (31.8% SL reduction, n=7). MR was reduced from baseline 3-4+ to 0-1+ in all patients at 30days. There were improvements in NYHA class and there was a decrease in diastolic LV volumes from 182.4 +/- 54.3mL to 115.3 +/- 98.8 mL at 30 days (36.8 %reduction). In the 2 patients with tricuspid annuloplasty, the tricuspid annular reductions were 35.7% and 36.9%
Conclusion: This initial experience with the Millipede IRIS ring demonstrates the efficacy of a novel transcatheter mitral annuloplasty device that resulted in robust reductions in MR grade, Mitral SL diameter and LV volumes.
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