When did you first start using the Cribier-Edwards percutaneous aortic heart valve?
We received FDA approval in August 2003 for a one-time compassionate use. Dr. Alain Cribier, who did the first human clinical implants with the valve, had started using it about a year earlier in Europe, also just for compassionate use. Our first patient at Beaumont Hospital was a 73-year-old man with no other treatment options. He came into the hospital with recurrent heart failure, previous bypass surgery, multiple admissions for heart failure, severe aortic stenosis and was deemed to be high risk for surgery three cardiac surgeons had turned him down. We did the procedure using the antegrade approach, and were able to deploy the valve successfully; it looked like the patient was going to do well. For 24 hours, he did spectacularly, and then 36 hours after the procedure, he abruptly decompensated, and four days later he died. At autopsy, we found that the anterior leaflet of the mitral valve had been torn by the catheter as it had gone around the mitral valve. Three days post-op, the
