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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

Saturday, March 21, 2015

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Source Name: Journal of the American College of Cardiology


Thyregod HGH, Steinbrüchel DA, Ihlemann N, Nissen H, Kjeldsen BJ, Petursson P, Chang Y, Franzen OW, Engstrøm T, Clemmensen P, Hansen PB, Andersen LW, Olsen PS, Søndergaard L.

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. 


What a strange conclusion! The primary indication for surgery is symptomatic relief. When one approach is substantially and significantly better in delivering a solution to the PATIENTS' presenting problem, how can one not recommend it! Have we lost sight of what we are here for?
I am surprised that the authors do not conclude correctly using the evidence from their own results. The outcomes are far superior for SAVR, with significant benefit in hemodynamics, lack of complete heart block, and if they did have a longer followup they would have also found superior survival and event free survival. They do not address other problems such as vascular injury, failure to do TAVR,,reoperation following TAVR etc in the abstract.Perhaps it is included in the MS, and would certainly put TAVR in a disadvantage. Is this trial funded by the industry?
Alltough the authors agree that they replaced a disase (AS) with two equally fatal diseases (AV Bloc and Aortic İnsufficiency) in almost half of the patients by TAVR, they failed to recognize this situation as a mark of inferiority...... Power of industry İ presume???
so better improvement in EOA, dramatically less need pacemaker, less AR (with as expected adverse long term sequelae) but worse AF - most likely temporary - but can't recommend one procedure over another. another example of despite bias trial design, surgical outcomes in fact better than expected and yet non surgeons incapable or admiting as such. exactly as per the syntax trial it really does call into question why we as surgeons get involved with trials so heavily weighted against surgery and where interpretation is so clearly biased - syntax, everest and now this ...

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