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Transcatheter Versus Surgical Aortic Valve Replacement in Patients with Severe Aortic Valve Stenosis: One-year Results from the All-comers Nordic Aortic Valve Intervention (NOTION) Randomized Clinical Trial
The authors describe the one-year results of a randomized trial comparing outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) among an all-comers cohort of 280 patients. Patients 70 years of age or older with severe degenerative aortic valve stenosis referred for SAVR but also a candidate for TAVR were eligible for inclusion regardless of their predicted risk of death after surgery. The primary hypothesis was that the rate of the composite outcome of death from any cause, stroke, or myocardial infarction after 1 year would be lower for patients receiving TAVR versus SAVR. In the intent-to-treat analysis, the primary outcome was similar in the two groups (13.1% vs.16.3% for TAVR and SAVR). The need for permanent pacemaker implantation was higher in TAVR patients (38.0% vs. 2.4%), while the rate of new-onset or worsening atrial fibrillation was lower (21.2% vs. 59.4%). After 1 year, patients undergoing TAVR had more dyspnea compared to SAVR patients (29.5% vs. 15.0%; P=0.01). There was more improvement in effective orifice area relative to baseline in SAVR patients, but TAVR patients experienced a higher rate of significant aortic valve regurgitation. The authors conclude that based on their findings, they are not able to recommend one procedure over the other in lower risk patients.