Six-month results of a repositionable and retrievable pericardial valve for transcatheter aortic valve replacement: the Direct Flow Medical aortic valve.
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 cm(2), 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 cm(2). 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 cm(2), 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.
Treede
Hendrik
H
Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany. treede@uke.de
Tübler
Thilo
T
Reichenspurner
Hermann
H
Grube
Eberhard
E
Pascotto
Andrea
A
Franzen
Olaf
O
Mueller
Ralf
R
Low
Reginald
R
Bolling
Steven F
SF
Meinertz
Thomas
T
Schofer
Joachim
J
D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D001705:Bioprosthesis; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002404:Catheterization; D002417:Cattle; D005260:Female; D005858:Germany; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D007902:Length of Stay; D008297:Male; D018579:Patient Selection; D010496:Pericardium / Q000637:transplantation*; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome