PracticeUpdate Cardiology June 2019

EDITOR’S PICKS 7

TAVR With a Balloon-Expandable Valve in Low-Risk Patients

The New England Journal of Medicine

Take-home message • Patients with severe aortic stenosis and at low surgical risk were randomized to undergo transcatheter aortic valve replacement (TAVR) with transfemoral placement of a balloon-expandable valve or surgical aortic-valve replacement to compare outcomes. The rate of the composite primary outcome of death, stroke, and rehospitalization at 1 year was significantly lower in the TAVR group compared with the surgical group. In addition, TAVR was associated with lower rates of stroke, death, and new-onset atrial fibrillation at 30 days compared with surgery. The length of hospital stay was shorter in the TAVR group than in the surgery group. • Among low-risk patients with severe aortic stenosis, TAVR is associated with better outcomes compared with surgical aortic valve replacement. Abstract

a mechanical-bearing axial-flow left ventricular assist device. METHODS We randomly assigned patients with advanced heart failure to receive either the centrifugal-flow pump or the axial-flow pump irrespective of the intended goal of use (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at 2 years. RESULTS This final analysis included 1028 enrolled patients: 516 in the centrifugal-flow pump group and 512 in the axial-flow pump group. In the analysis of the primary end point, 397 patients (76.9%) in the centrifugal-flow pump group, as compared with 332 (64.8%) in the axi- al-flow pump group, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (rel- ative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P<0.001 for superiority). Pump replace- ment was less common in the centrifugal-flow pump group than in the axial-flow pump group (12 patients [2.3%] vs. 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P<0.001). The num- bers of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in the centrifugal-flow pump group than in the axial-flow pump group. CONCLUSIONS Among patients with advanced heart failure, a fully magnetically levitated cen- trifugal-flow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. A Fully Magnetically Levitated Left Ventricular Assist Device—Final Report. N Engl J Med 2019 Apr 25;380(17)1618-1627, MR Mehra, N Uriel, Y Naka, et al. www.practiceupdate.com/c/82954

BACKGROUND Among patients with aortic ste- nosis who are at intermediate or high risk for death with surgery, major outcomes are simi- lar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk. " Among low-risk patients with severe aortic stenosis, TAVR is associated with better outcomes compared with surgical aortic valve replacement. " METHODS We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemo- ral placement of a balloon-expandable valve or surgery. The primary end point was a com- posite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population. RESULTS At 71 centers, 1000 patients under- went randomization. The mean age of the patients was 73 years, and the mean Soci- ety of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan-Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, -6.6 percentage points; 95% con- fidence interval [CI], -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P =0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P=0.02) and in lower rates of

death or stroke (P=0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treat- ment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascu- lar complications, new permanent pacemaker insertions, or moderate or severe paravalvu- lar regurgitation. CONCLUSIONS Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. Transcatheter Aortic-Valve Replacement With a Balloon-Expandable Valve in Low- Risk Patients. N Engl J Med 2019 Mar 17;[EPub Ahead of Print], MJ Mack, MB Leon, VH Thou- rani, et al. www.practiceupdate.com/c/81206

VOL. 4 • NO. 2 • 2019