Transapical transcatheter aortic valve implantation: 1-year outcome in 26 patients.
ABSTRACT We reported the first case of successful transapical transcatheter aortic valve implantation in a human subject in 2005 and have now completed a 12-month follow-up on our first 26 patients. This is, to date, the longest follow-up of patients undergoing transapical aortic valve implantation.
Between October 2005 and January 2007, 26 patients (13 female) underwent transcatheter transapical aortic valve implantation with either 23- or 26-mm Edwards Lifesciences transcatheter bioprostheses. All patients with symptomatic aortic stenosis were declined for conventional aortic valve replacement because of unacceptable operative risks and were not candidates for transfemoral aortic valve implantation because of poor arterial access. Clinical and echocardiographic follow-up was performed before discharge and at 1, 6, and 12 months. Data from the 17 patients who survived over 12 months were used for comparisons of the baseline and follow-up results.
The mean age was 80 +/- 9 years, and the predicted operative mortality was 37% +/- 20% by using logistic EuroSCORE and 11% +/- 6% by using the Society of Thoracic Surgeons Risk Calculator. Valves were successfully implanted in all patients. Six patients died within 30 days (30-day mortality, 23%), and 3 patients died from noncardiovascular causes after 30 days (late mortality, 12%). Among patients who survived at least 30 days, 12-month survival was 85%. There were no late valve-related complications. New York Heart Association functional class improved significantly. The aortic valve area and mean gradient remained stable at 12 months (1.6 +/- 0.3 cm(2) and 9.6 +/- 4.8 mm Hg, respectively).
Our 1-year clinical and echocardiographic outcomes suggest that transapical transcatheter aortic valve implantation is a viable alternative to conventional aortic valve replacement in selected high-risk patients.
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ABSTRACT: We report our experience of percutaneous valve insertion in pulmonary position in humans. Over the past 40 years, prosthetic conduits have been developed to surgically establish continuity between the right ventricle and the pulmonary artery. However, stenosis and insufficiency of the conduit due to valvular degeneration or panus ingrowth frequently occur, limiting patients' lifespan. Percutaneous stenting of conduits has recently emerged as a technique for delaying surgical replacement, but it creates a pulmonary regurgitation when crossing the valve. Seven children and one adult with stenosis and/or insufficiency of the pulmonary graft underwent percutaneous implantation of a bovine jugular valve in pulmonary position. Percutaneous pulmonary valve (PV) replacement was successful in all patients. No complications occurred in early follow-up. Angiography, hemodynamic studies and echocardiography after the procedure showed no significant regurgitation of the implanted valve. Implantation was effective in relieving the obstruction in five patients. All patients showed improvement in their clinical status at the latest follow-up (mean 10.1 months). Non-surgical insertion of the PV is possible without any major complications. This new technique may have an important role in the management of conduit obstructions and pulmonary regurgitation.Journal of the American College of Cardiology 06/2002; 39(10):1664-9. · 14.09 Impact Factor
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ABSTRACT: To date, the surgical approach is the only option to replace the aortic valve. Percutaneous pulmonary valve replacement has recently opened new perspectives on transcatheter replacement of cardiac valves. We report our experience of aortic valve replacement through a percutaneous technique in lambs. A bovine jugular vein containing a valve was dissected and sutured into a stent. Twelve lambs were divided into 3 groups. In the first, a valved stent was implanted in the descending aorta after creation of an aortic insufficiency. In the second, the valve was implanted in the native position. In the third, we inserted a valved stent in the native position using an orientation mechanism. All valves were successfully delivered and functioned perfectly in short-term evaluation. All experiments in group 2 failed: 1 valve obstructed the coronary artery orifices, 1 stent was responsible for a major mitral valve insufficiency, and the third implant migrated prematurely. A paraprosthetic leak occurred in the last animal in this group. Animals in group 3 had successful implantation of the valved stent. The orientation mechanism allowed perfect alignment of the device without any damage to the coronary circulation or to mitral valve function. Nonsurgical implantation of an aortic valve is possible in lambs in the descending aorta and in the native position. An orientation mechanism is obviously needed to avoid obstruction of the coronary orifices. With further improvements, this technique should be feasible in humans.Circulation 03/2002; 105(6):775-8. · 15.20 Impact Factor
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ABSTRACT: 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. 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. 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. 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.European Journal of Cardio-Thoracic Surgery 02/2007; 31(1):16-21. · 2.67 Impact Factor