Paniagua heart valve preclinical testing and transcatheter implantation of an aortic valve prosthesis

Background: After extensive in vitro and animal testing, we performed the first retrograde transcatheter implantation of a new aortic valve prosthesis, in a 62-year-old man with inoperable calcific aortic stenosis. Methods and results: A 16 F sheath was advanced into the abdominal aorta via the right femoral artery. The aortic valve was crossed with a straight wire, and a pigtail catheter was advanced into the left ventricle to obtain pressure-gradient and anatomic measurements. Predilatation was done with an 18-mm valvuloplasty balloon. A balloon-expandable frame was used to deliver the valve. After device implantation, transvalvular gradient was <5 mmHg. Cardiac output increased from 1 to 5 L/min, and urine production increased to 200 mL/h. The patient was extubated on the second post-implant day. Twelve hours later, he had to be re-intubated because of respiratory distress and high pulmonary pressures. His condition deteriorated, and he died on day 5, of biventricular failure and refractory hypotension. Despite the severe hypotension, valve function was satisfactory on echo-Doppler evaluation. Conclusions: Retrograde transcatheter implantation of a prosthetic aortic valve yielded excellent haemodynamic results and paved the way for further use of this technique in selected high-risk patients.