Clinical profile and outcome of patients with severe aortic stenosis at high surgical risk: single-center prospective evaluation according to treatment assignment.
BACKGROUND
The study sought to assess the clinical profile, outcome, and predictors for mortality of "real-world" high-risk severe aortic stenosis patients according to the mode of treatment assigned.


METHODS
Patients were referred to a dedicated clinic for meticulous screening and multidisciplinary team assessment and 343 were finally assigned treatment (age 81.3 ± 7.2 years, 42.3% men): transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN or CoreValve device, 100 (29.2%); surgical aortic valve replacement (SAVR), 61 (17.8%); balloon valvuloplasty (as definitive therapy), 27 (7.9%); medication only, 155 (45.2%). No patient was lost to follow-up.


RESULTS
The balloon valvuloplasty group had a significantly higher 1-month mortality rate (18.5%) than the TAVR group (3%, P = 0.006) and medical therapy group (3.9%; P = 0.004), without significant difference from the SAVR group (11.5%, P = 0.5). One-year cumulative survival was significantly higher in the TAVR group (92%) than in the other groups (SAVR 71%, balloon valvuloplasty 61.5%, medication 65%; all P < 0.001). Among survivors, 1-year rates of high functional class (NYHA I/II) were as follows: TAVR, 84.6%; SAVR, 63.3%; balloon valvuloplasty, 18.2%; medication, 21.4% (TAVR vs. SAVR, P = 0.04; SAVR vs. balloon valvuloplasty or medical therapy, P = 0.01). On multivariate regression analysis, renal failure (hazard ratio [HR] = 5.3, P < 0.001), not performing TAVR (HR = 4.9, P < 0.001), and pulmonary pressure (10 mm Hg, HR = 1.2, P = 0.02) were independent predictors of 1-year mortality.


CONCLUSIONS
TAVR, performed in carefully selected high-risk patients, is associated with an excellent survival rate and high functional class. Patients treated with another of the available modalities, including SAVR, had a worse outcome, regardless of which alternative treatment they receive.
Department of Cardiology, Rabin Medical Center, Petach Tikva, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Danny
D
Dvir
Alexander
A
Sagie
Eyal
E
Porat
Abid
A
Assali
Yaron
Y
Shapira
Hana
H
Vaknin-Assa
Gideon
G
Shafir
Tamir
T
Bental
Roman
R
Nevzorov
Alexander
A
Battler
Ran
R
Kornowski
D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D063126:Balloon Valvuloplasty / Q000009:adverse effects / Q000401:mortality; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D002317:Cardiovascular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D007557:Israel; D053208:Kaplan-Meier Estimate; D008297:Male; D015999:Multivariate Analysis; D018579:Patient Selection; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D002317:Cardiovascular Agents