Six-month outcome of transapical transcatheter aortic valve implantation in the initial seven patients.

BACKGROUND: The current treatment of choice for symptomatic aortic stenosis is aortic valve replacement (AVR) with cardiopulmonary bypass (CPB), but AVR is associated with significant operative morbidity and mortality in elderly patients with multiple co-morbid conditions. We recently reported the first successful aortic valve implantation procedure (AVI) via a mini-thoracotomy and left ventricular apical puncture without cardiopulmonary bypass. We now report 6-month follow-up in our initial seven patients.

METHODS: Seven patients (77+/-10 years old) with symptomatic aortic stenosis were deemed to be non-surgical candidates for AVR and not suitable for a transfemoral percutaneous heart valve implantation due to aorto-iliac disease. The predicted 30-day operative mortality was 31+/-23% according to logistic Euroscore. Patients underwent minimally invasive transapical AVI. With the guidance of fluoroscopy and transesophageal echocardiography, balloon predilation was followed by deployment of a 26mm Cribier-Edwardstrade mark valve (Edwards Lifesciences Inc., Irvine, CA) during rapid ventricular pacing to reduce forward flow and cardiac motion.

RESULTS: Valve implantation was successful in all seven patients. There were no intra-procedural mortalities or complications. Thirty-day operative mortality was 14%. One patient died at day 12 due to pneumonia. Two patients died from non-cardiac diseases at day 51 and 85. The remaining four patients completed 6-month follow-up. The aortic valve area increased from 0.7+/-0.3 to 1.8+/-0.7 and 1.5+/-0.5cm(2) at 1 and 6 months, respectively. The mean transaortic gradient was reduced from 32+/-8 to 10+/-5 and 11+/-8mmHg at 1 and 6 months, respectively. Following AVI, none or trivial, mild, and moderate aortic regurgitation was observed in 4, 2, and 1 patients, respectively. There were no valve-related complications during the follow-up.

CONCLUSION: Aortic valve implantation can successfully be performed via a minimally invasive apical approach without the need for cardiopulmonary bypass. The early results in this initial series are encouraging. This initial experience suggests that the minimally invasive transapical approach is a viable alternative for patients in whom open-heart surgery is not feasible or poses unacceptable risks.