Device success and 30-day clinical outcome in patients undergoing preimplant valvuloplasty in transfemoral versus omitting valvuloplasty in transapical transcatheter aortic valve replacement.
OBJECTIVE
The study objective was to evaluate the impact of preimplantation balloon valvuloplasty on procedural outcomes in high-risk or no-option patients with aortic stenosis undergoing Edwards Lifesciences (Irvine, Calif) Sapien valve placement. Paravalvular aortic regurgitation has been associated with long-term mortality after transcatheter aortic valve replacement. Whether omitting preimplant balloon valvuloplasty affects paravalvular aortic regurgitation after Edwards Sapien transcatheter aortic valve replacement is currently unknown.


METHODS
We retrospectively analyzed the clinical outcome of 121 consecutive patients undergoing transapical (N = 50) or transfemoral (N = 71) Edwards Sapien transcatheter aortic valve replacement. Routinely, no preimplant balloon valvuloplasty was performed in transapical procedure as opposed to uniform preimplant balloon valvuloplasty in transfemoral cases. The incidence and severity of total and paravalvular aortic regurgitation and 30-day clinical outcomes were compared between the 2 cohorts.


RESULTS
The average patient's age was 84.4 years, with a higher prevalence of smoking history (68% vs 42%, P = .005) and peripheral vascular disease (38% vs 20%, P = .03) in the patients undergoing transapical replacement. The preprocedural transthoracic echocardiographic and computed tomography findings were similar between the 2 cohorts. After transcatheter aortic valve replacement, the incidence of mild to moderate total aortic regurgitation (42% transfemoral vs 38% transapical), paravalvular aortic regurgitation (39% transfemoral vs 30% transapical), device success (88.7% transfemoral vs 94.0% transapical), and 30-day composite end points (9.9% transfemoral vs 14.0% transapical) were comparable in both groups. Multivariate regression analysis revealed male gender (odds ratio, 2.7; 95% confidence interval, 1.18-6.35; P = .02) but not preimplant balloon valvuloplasty as an independent predictor for mild or greater total aortic regurgitation.


CONCLUSIONS
Compared with transapical transcatheter aortic valve replacement without preimplant balloon valvuloplasty, preimplant balloon valvuloplasty before transfemoral transcatheter aortic valve replacement resulted in a similar degree of prosthesis-related regurgitation, device success, and 30-day composite safety outcomes.
Division of Cardiology, Department of Medicine, Weill Medical College of Cornell University, New York, NY. Electronic address: scwong@med.cornell.edu.
S Chiu
SC
Wong
Division of Cardiology, Department of Medicine, Weill Medical College of Cornell University, New York, NY.
Sumeet
S
Pawar
Division of Cardiology, Department of Medicine, Weill Medical College of Cornell University, New York, NY.
Robert M
RM
Minutello
Division of Cardiology, Department of Medicine, Weill Medical College of Cornell University, New York, NY.
Evelyn M
EM
Horn
Department of Anesthesiology, Weill Medical College of Cornell University, New York, NY.
Nikolaos J
NJ
Skubas
Division of Cardiology, Department of Medicine, Weill Medical College of Cornell University, New York, NY.
Richard B
RB
Devereux
Department of Cardiothoracic Surgery, Weill Medical College of Cornell University, New York, NY.
Arash
A
Salemi
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000503:physiopathology; D001022:Aortic Valve Insufficiency / Q000175:diagnosis / Q000209:etiology; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D063126:Balloon Valvuloplasty / Q000009:adverse effects; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D016009:Chi-Square Distribution; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D016017:Odds Ratio; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
aortic stenosis; predilation; transcatheter aortic valve replacement; valvuloplasty