The study will evaluate a broader range of patients including those with intermediate risk for undergoing sAVR. Patients outside the United States will have an STS-PROM >3, and patients enrolled in the United States will have an STS-PROM >4. Clinical centers with previous experience in TAVR will be eligible to participate in the study. SURTAVI

Inhibitors,research,lifescience,medical will use a heart team approach that includes an interventional cardiologist and cardiac surgeon. The study’s primary endpoint is 2-year all-cause mortality and major stroke. Secondary endpoints include valve failure, endocarditis, and regression of the left ventricle and need for PPMI. Continuing Evidence Development The STS and American College Inhibitors,research,lifescience,medical of Cardiology have recommended that additional clinical study be performed to determine the value of TAVR in patients who are not included in the randomized trials and registries (Table 4).32 For the majority of patients who are poor candidates for sAVR, there is little question of the profound clinical benefit from undergoing TAVR. Implementation of a multidisciplinary team is essential for appropriate patient

selection. Several complications with TAVR require careful procedural attention during the periprocedural Inhibitors,research,lifescience,medical period, including stroke,33 vascular complications, perivalvular regurgitation,34, 35 and the need for permanent pacemaker placement.36 New TAVR designs will be available to potentially lower these complication rates (Table 4). In addition, multidetector CT imaging has been very valuable in predicting the appropriate valve size and guiding vascular access. Table 4 STS-ACC Inhibitors,research,lifescience,medical recommendations for continued evidence development.31 STS: Society of Thoracic Surgeons; ACC: American College of Cardiology; LVEF: left ventricular ejection fraction Based on growing evidence, TAVR is now recognized as superior to medical therapy in patients who are Inhibitors,research,lifescience,medical not suitable candidates for sAVR and equivalent for 1-year mortality

in patients who are deemed high-risk for sAVR, albeit with an improved quality of life within the first 6 months. Randomized clinical trials are assessing the value of TAVR in intermediate-risk patients. Registry studies will provide increasing insight into patients with bioprosthetic valve failure (valve-in-valve), bicuspid disease, low-gradient/low-output aortic Rolziracetam stenosis, and in other clinical subsets not currently included in randomized clinical trials. Conflict of Interest Disclosures: All authors have completed and submitted the Methodist DeBakey Cardiovascular Journal Conflict of Interest Statement and none were reported. Funding/Support: Dr. Popma acknowledges OSI-906 cost receiving institutional research grants from Medtronic, Inc. Contributor Information Shaheena Raheem, Beth Israel Deaconess Medical Center, Boston, Massachusetts. Jeffrey J.