1% versus 25.7%, respectively).14 Short-term procedural success was observed in 93.8% of patients, with reported complications
including stroke (2.5%), valve embolization (0.3%), and coronary obstruction (0.6%). Thirty-day mortality was 6.3% in transfemoral patients and 10.3% in transapical patients.14 The SOURCE registry reported a total Kaplan Meier 1-year survival of 76.1% overall, with 72.1% for transapical patients and 81.1% for transfemoral patients.14 At 1 year, Inhibitors,research,lifescience,medical 73.5% of surviving patients were in New York Heart Association (NYHA) class I or II.14 The cause of late mortality was cardiac in 25.1%, noncardiac in 49.2%, and unknown in 25.7%.14 The most frequent noncardiac causes of death were due to pulmonary complications (23.9%), renal failure (12.5%), cancer (11.4%), and stroke (10.2%).14 Multivariable analysis identified logistic EuroSCORE, renal disease, liver disease, and smoking as variables with the highest hazard ratios for 1-year mortality.14 Two randomized clinical trials demonstrated Inhibitors,research,lifescience,medical the value of balloon-expandable TAVR in patients poorly suited for sAVR (Table 2). The PARTNER I-B study included 358 patients who were deemed inorperable and randomly assigned to standard BMS-907351 cost therapy (including balloon aortic valvuloplasty) or transfemoral TAVR.15 Inhibitors,research,lifescience,medical The primary endpoint, 1-year all-cause mortality (Kaplan-Meier analysis), was 30.7% with TAVR and 50.7% with standard
Inhibitors,research,lifescience,medical therapy (hazard ratio with TAVI: 0.55; P <0.001).15 The frequency of severe cardiac symptoms (New York Heart Association class III or IV) in 1-year survivors was lower in
patients who had undergone TAVR than in those who had received standard therapy (25.2% versus 58.0%, P <0.001).15 Major strokes were higher at 30 days in patients treated with TAVR (5.0% versus 1.1% in medically-treated patients, P=0.06), and major vascular complications were also higher in patients undergoing TAVR (16.2% versus 1.1% in medically-treated patients, P <0.001).15 There was no deterioration in bioprosthetic valve functioning at 1 year, as assessed by evidence Inhibitors,research,lifescience,medical of stenosis or regurgitation on an echocardiogram.15 Carnitine palmitoyltransferase II Table 2 Trial design for ongoing and completed studies for TAVR. Cohort A of the PARTNER Trial randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either transcatheter aortic valve replacement with a balloon-expandable bovine pericardial valve (using a transfemoral or transapical approach) or surgical replacement (Table 2).16 The rates of death from any cause were 3.4% in the TAVR group and 6.5% in the sAVR group at 30 days (P=0.07) and 24.2% and 26.8%, respectively, at 1 year (P=0.44), a reduction of 2.6 percentage points in the TAVR group (P=0.001 for noninferiority).16 The rates of major stroke were 3.8% in the TAVR group and 2.1% in the sAVR group at 30 days (P=0.20) and 5.1% and 2.