Article Abstract

Early experience with Millipede IRIS transcatheter mitral annuloplasty

Authors: Jason H. Rogers, Walter D. Boyd, Thomas W. Smith, Steven F. Bolling

Abstract

The IRIS mitral annuloplasty ring is a transcatheter, transfemoral and transseptal-delivered complete, semi-rigid annuloplasty ring. The IRIS system mimics surgical annuloplasty by reducing the mitral septal-lateral dimension and improving leaflet coaptation. We report the early experience with the IRIS system in seven patients. These patients had 3–4+ mitral regurgitation (MR) with annular dilation and were symptomatic NYHA II-IV with LV end systolic dimensions ≤65 mm. Patients were excluded for LVEF <20%, aortic valve disease, right-sided heart failure and PA systolic pressure >70 mmHg. Baseline and 30-day transthoracic echocardiography and CT imaging was performed. In phase 1, 4 patients had surgical IRIS mitral ring implantation. In Phase 2, 3 patients had transfemoral, transseptal delivery of the IRIS mitral ring. There was no procedural death, or MI. The mitral SL diameter was reduced from 38.0±4.1 to 25.9±4.9 mm at 30 days (31.8% SL reduction, n=7). MR was reduced from baseline 3–4+ to 0–1+ in all patients at 30 days. There were improvements in NYHA class and there was a decrease in diastolic LV volumes from 182.4±54.3 to 115.3±98.8 mL at 30 days (36.8% reduction). Based on these initial positive findings, ongoing clinical trials are underway to further evaluate the safety and efficacy of the IRIS ring.


Annals of Cardiothoracic Surgery (Ann Cardiothorac Surg. Print ISSN 2225-319X; Online ISSN 2304-1021).
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