Percutaneous implantation of the first repositionable aortic valve prosthesis in a patient with severe aortic stenosis.
OBJECTIVE
Percutaneous aortic valve replacement is a new less-invasive alternative for high-risk surgical candidates with aortic stenosis. However, the clinical experience is still limited, and the currently available 'first-generation devices' revealed technical shortcomings, such as lack of repositionability and presence of paravalvular leakages. We report the first-in-man experience with the new self-expanding Lotus Valve prosthesis composed of a nitinol frame with implemented bovine pericardial leaflets which is designed to address these issues, being repositionable and covered by a flexible membrane to seal paravalvular gaps. We implanted this prosthesis in a 93-year old patient presenting with severe symptomatic aortic stenosis (valve area: 0.6 cm(2)). Surgical valve replacement had been declined due to comorbidities.


RESULTS
We used a retrograde approach for insertion of the 21-French Lotus catheter loaded with the valve prosthesis via surgical cut-down to the external iliac artery. Positioning of the valve was guided by transesophageal echo and supra-aortic angiograms. The prosthesis was successfully inserted and deployed within the calcified native valve. Echocardiography immediately after device deployment showed a significant reduction of the transaortic mean pressure gradient (32 to 9 mmHg; final valve area 1.7 cm(2)) without evidence of residual aortic regurgitation. The postprocedural clinical status improved from NYHA-IV to NYHA-II. These results remained unchanged up to the 3 month follow-up.


CONCLUSIONS
Successful percutaneous aortic valve replacement can be performed using the new self-expanding and repositionable Lotus valve for treatment of high-risk patients with aortic valve stenosis. Further studies are mandatory to assess device safety and efficacy in larger patient populations.
Buellesfeld
Lutz
L
Department of Cardiology, HELIOS Heart Center Siegburg, Siegburg, Germany. Lutz.Buellesfeld@helios-kliniken.de
Gerckens
Ulrich
U
Grube
Eberhard
E
D000369:Aged, 80 and over; D000497:Alloys; D000818:Animals; D001024:Aortic Valve Stenosis / Q000473:pathology / Q000601:surgery*; D001027:Aortography; D001705:Bioprosthesis; D002417:Cattle; D017548:Echocardiography, Transesophageal; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D019060:Minimally Invasive Surgical Procedures; D010496:Pericardium / Q000637:transplantation*; D010865:Pilot Projects; D011474:Prosthesis Design; D015641:Radiography, Interventional; D012720:Severity of Illness Index; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
D000497:Alloys; C013616:nitinol