Abstract

Transcatheter techniques to treat severe aortic stenosis (AS) or significant mitral regurgitation (MR) in patients deemed at high surgical risk have shown to be safe and efficacious in either clinical entity. For AS, transcatheter aortic valve replacement (TAVR) using the Sapien/Sapien XT prosthesis (Edwards Lifesciences) via transfemoral (TF) or transapical (TA) access or the CoreValve prosthesis (Medtronic) via TF access has become a viable therapeutic option, whereas in MR, considerable clinical experience has been gained with transvenous/transseptal implantation of the MitraClip (MC) device (Abbott Vascular). To date, little information is available on transcatheter treatment for both AS and MR in the same patient. By May 2011, 263 TAVR and 233 MC procedures had been performed at our center. Eleven patients (78 ± 6 years, 9 men [82%]) underwent both TAVR and MC implantation. In the first 8 patients treated, TAVR (5 TA, 3 TF) preceded MC by a median of 84 (range, 4 to 348) days, whereas in the last 3 patients TAVR (1 TA, 2 TF) and, subsequently, MC were performed in a single session. All TAVR procedures (7 Sapien [n=4]/Sapien XT [n=3], 4 CoreValve prostheses) were successfully completed, resulting acutely in a significant increase in effective orifice area from 0.90 ± 0.12 to 1.82 ± 0.58 cm 2 ( P = 0.0114) and a significant decrease in mean transaortic pressure gradient from 22 ± 10 to 7 ± 2 mmHg ( P = 0.0077). MC implantation (1 clip, n=8; 2 clips, n=2; 3 clips, n=1) succeeded in reducing MR severity to <=2+ in 10 patients (MR 1+, n=5; MR 2+, n=5); in 1 patient, MR severity remained at 3+ despite placement of 2 clips. Permanent pacemaker implantation was required in 5 patients (4 Sapien/Sapien XT, 1 CoreValve); 1 patient sustained a stroke 19 days after bivalvular treatment in a single session. Post TAVR, no patient had transvalvular aortic regurgitation (AR); minor (grade 1) paravalvular AR was present at discharge in 8 patients. Patients were followed for a median of 210 (range, 69 to 398) days. Two patients (18%; 95% CI, 2% to 52%) died of persistent cardiac decompensation at 73 and 398 days after successful bivalvular treatment. We conclude that bivalvular transcatheter treatment of concomitant AS and MR is feasible, efficacious and safe, even if performed in a single session.

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