Original Studies Clinical Profile and Outcome of Patients with Severe Aortic Stenosis at High Surgical Risk: Single-Center Prospective Evaluation According to Treatment Assignment Danny Dvir, 1 MD, Alexander Sagie, 1 MD, Eyal Porat, 2 MD, Abid Assali, 1 MD, Yaron Shapira, 1 MD, Hana Vaknin-Assa, 1 MD, Gideon Shafir, 3 MD, Tamir Bental, 1 MD, Roman Nevzorov, 1 MD, Alexander Battler, 1 MD, and Ran Kornowski, 1 * MD 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 6 7.2 years, 42.3% men): transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN or CoreValve device, 100 (29.2%); surgi- cal 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 5 0.006) and medical therapy group (3.9%; P 5 0.004), without significant difference from the SAVR group (11.5%, P 5 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 5 0.04; SAVR vs. balloon valvuloplasty or medical therapy, P 5 0.01). On multivariate regression analysis, renal failure (hazard ratio [HR] 5 5.3, P < 0.001), not performing TAVR (HR 5 4.9, P < 0.001), and pulmonary pressure (10 mm Hg, HR 5 1.2, P 5 0.02) were independent predictors of 1-year mortality. Conclusions: TAVR, per- formed 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. V C 2012 Wiley Periodicals, Inc. Key words: VALV - Valvular heart disease; CHF – Congestive Heart Failure; COMP - Complications adult cath/intervention 1 Department of Cardiology, Rabin Medical Center, Petach Tikva, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel 2 Department of Cadiothoracic Surgery, Rabin Medical Center, Petach Tikva, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel 3 Department of Radiology, Rabin Medical Center, Petach Tikva, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel Conflict of interest: Nothing to report. *Correspondence to: Dr. Ran Kornowski, Department of Cardiology, Rabin Medical Center, Petach Tikva 49100, Israel. E-mail: rkornowski@clalit.org.il Received 5 March 2012; Revision accepted 19 August 2012 DOI 10.1002/ccd.24623 Published online in Wiley Online Library (wiley onlinelibrary.com) V C 2012 Wiley Periodicals, Inc. Catheterization and Cardiovascular Interventions 00:000–000 (2012)