Author + information
- S193687981502227X-3d7c9066562843c38b23cbbf033c7d8fAlec Vahanian1,
- S193687981502227X-a7a0ed81b053a586fc019a0fa7f17fc1Karl-Heinz Kuck2,
- S193687981502227X-f16bf86cd479bd5f4184b2760c3864eeOttavio Alfieri3,
- S193687981502227X-03cafd5751137a9acdf972087318fb0dAntonio Colombo3,
- S193687981502227X-904b7fa63dde7eb6eec2515e6377b62bStephan Baldus4,
- S193687981502227X-9e922ba35a08b7e96394f88869dfaef3Georg Nickenig5 and
- S193687981502227X-b21d1ca64eb677e7716bf0720e0d83dbFrancesco Maisano6
Cardioband system enables percutaneous implantation of an adjustable “surgical-like” device for mitral reconstruction and MR reduction using a transseptal approach. The aim of this multi-center study was to evaluate the feasibility, safety and up to 12 month outcome of Cardioband in patients with secondary mitral regurgitation (MR).
Methods and Findings
Between February 2013 and August 2015, 45 high-risk patients with significant secondary MR were enrolled at 6 sites in Europe. All patients were screened by echocardiography and cardiac CT to assess feasibility.
Mean age was 71 years (range 49-81), thirty four patients were males (76%). Mean EuroScore II was 7.7% ± 6.7% and median STS score 7.2 % (1.0%-34.0%). At baseline 87% of patients were in NYHA class III-IV with mean left ventricular ejection fraction of 32 ± 11% (15%-59%). Device implantation was feasible in 100% patients. Procedural success (device successfully implanted with reduction of MR ≤2+ at discharge) was achieved in 95.6% of patients (43/45). After device cinching, an average ∼20% reduction of the septo-lateral diameter was observed (from 39 ± 6 mm to 34 ± 7 mm; p<0.01). Thirty-day mortality was 4.4% (adjudicated as unrelated to the device). At 12 months follow up (N=20), 71% of patients presented NYHA class I-II with improvement in quality of life (MLWHFQ from 38 to 19; p<0.05 and significant improvement in 6MWT from 256 to 386 meters; p<0.05); 95% of patients (N=19) had MR≤2+.
Transseptal mitral repair with the Cardioband device resulted in MR reduction by reconstruction of the mitral annulus. Safety profile is comparable to other transcatheter mitral procedures. MR severity reduction and clinical benefit are stable up to 12 months.