Six-month results of a repositionable and retrievable pericardial valve for transcatheter aortic valve replacement: The Direct Flow Medical aortic valve

TY - JOUR

T1 - Six-month results of a repositionable and retrievable pericardial valve for transcatheter aortic valve replacement: The Direct Flow Medical aortic valve

AU - Treede, Hendrik

AU - Tübler, Thilo

AU - Reichenspurner, Hermann

AU - Grube, Eberhard

AU - Pascotto, Andrea

AU - Franzen, Olaf

AU - Mueller, Ralf

AU - Low, Reginald

AU - Bolling, Steven F.

AU - Meinertz, Thomas

AU - Schofer, Joachim

N1 - Funding Information: This study was sponsored by Direct Flow Medical, Inc, Santa Rosa, Calif .

PY - 2010/10

Y1 - 2010/10

N2 - Objective: Transcatheter aortic valve implantation is considered an alternative for patients at high risk for conventional surgery. The Direct Flow Medical aortic valve (Direct Flow Medical, Inc, Santa Rosa, Calif) is a nonmetallic tissue valve prosthesis intended to treat patients with severe aortic stenosis at high risk for surgery. Methods: Thirty-one patients at high surgical risk were enrolled in the trial (logistic EuroSCORE 28% ± 7%, Society of Thoracic Surgeons score 23% ± 9%). Twenty-two patients underwent successful retrograde transcatheter aortic valve implantation, and 9 patients did not undergo implantation owing to excessive calcifications or access issues. Mean preinterventional gradient and effective orifice area were 49 ± 14 mm Hg and 0.54 ± 0.16 cm2, respectively, and 71% of patients were in New York Heart Association functional class III. Results: Mean postprocedural gradient was 14.9 ± 5.5 mm Hg with an effective orifice area of 1.4 ± 0.31 cm2. Two patients were converted to surgery and 2 patients died after implantation: 1 of myocardial infarction and 1 of congestive heart failure. One patient had a stroke 2 days after the procedure and 3 patients required a pacemaker. At 6 months the mean aortic valve gradient and effective orifice area were 19.8 mm Hg and 1.30 cm2, respectively. The majority of patients had no paravalvular leak (58%) and 42% had grade 1/4 paravalvular leak; 69% were in New York Heart Association functional class I and 25% were in class II. The 3- and 6-month survivals were 87.1% and 80.6%, respectively (4/6 deaths in 31 patients). Conclusions: Transcatheter aortic valve implantation using the study valve appears safe and results are promising at 6 months. Severe leaflet and left ventricular outflow tract calcification affects procedural outcome; therefore, careful patient selection is crucial.

AB - Objective: Transcatheter aortic valve implantation is considered an alternative for patients at high risk for conventional surgery. The Direct Flow Medical aortic valve (Direct Flow Medical, Inc, Santa Rosa, Calif) is a nonmetallic tissue valve prosthesis intended to treat patients with severe aortic stenosis at high risk for surgery. Methods: Thirty-one patients at high surgical risk were enrolled in the trial (logistic EuroSCORE 28% ± 7%, Society of Thoracic Surgeons score 23% ± 9%). Twenty-two patients underwent successful retrograde transcatheter aortic valve implantation, and 9 patients did not undergo implantation owing to excessive calcifications or access issues. Mean preinterventional gradient and effective orifice area were 49 ± 14 mm Hg and 0.54 ± 0.16 cm2, respectively, and 71% of patients were in New York Heart Association functional class III. Results: Mean postprocedural gradient was 14.9 ± 5.5 mm Hg with an effective orifice area of 1.4 ± 0.31 cm2. Two patients were converted to surgery and 2 patients died after implantation: 1 of myocardial infarction and 1 of congestive heart failure. One patient had a stroke 2 days after the procedure and 3 patients required a pacemaker. At 6 months the mean aortic valve gradient and effective orifice area were 19.8 mm Hg and 1.30 cm2, respectively. The majority of patients had no paravalvular leak (58%) and 42% had grade 1/4 paravalvular leak; 69% were in New York Heart Association functional class I and 25% were in class II. The 3- and 6-month survivals were 87.1% and 80.6%, respectively (4/6 deaths in 31 patients). Conclusions: Transcatheter aortic valve implantation using the study valve appears safe and results are promising at 6 months. Severe leaflet and left ventricular outflow tract calcification affects procedural outcome; therefore, careful patient selection is crucial.

UR - http://www.scopus.com/inward/record.url?scp=77956212922&partnerID=8YFLogxK

U2 - 10.1016/j.jtcvs.2010.01.017

DO - 10.1016/j.jtcvs.2010.01.017

M3 - SCORING: Journal article

C2 - 20392455

AN - SCOPUS:77956212922

VL - 140

SP - 897

EP - 903

JO - J THORAC CARDIOV SUR

JF - J THORAC CARDIOV SUR

SN - 0022-5223

IS - 4

ER -