TAVR: Is The Glass Half Empty or Half Full? A Non-Interventional Cardiologist ’ s View of a New Technology

Transcatheter Aortic Valve Replacement (TAVR) is a new, disruptive technology that is currently being widely embraced and aggressively marketed. The technology has the potential to radically alter the conventional clinical approach to aortic stenosis, which affects ~1.5 million Americans, many of whom are elderly. Existing data suggest that the transcatheter strategy has advantages over a conventional surgical approach in the elderly, infirm patient population. However, TAVR remains associated with profound morbidity and mortality reflective of the underlying nature of the disease. Given this, it is important to temper enthusiasm for the technology with a realistic assessment of its impact on the natural progression of the disease, especially in the elderly and infirm population that is currently being targeted. The commercial roll-out of the percutaneous aortic valve program (TAVR) in the US began in the Spring of 2012 and as of March 2013 more than 200 sites have been opened and more than 4500 procedures have been performed. (In Europe, the TAVR approach has been sanctioned since 2007, and nearly 40,000 percutaneous valves have been deployed.) The FDA allowed this technology to move forward in the US based on a carefully documented randomized trial experience but with a series of caveats, most notably: 1. that the sites identified must have substantial experience and expertise with complex cardiac interventions (on both the surgical and interventional cardiology fronts); 2. That patients selected for TAVR must have sufficient co-morbidities so as not to be conventional surgical candidates and 3. That comprehensive registry data has to be collected in order to document real world experience in the US with this new technology [1-3]. The appropriate concern was that if the technology was released in a haphazard fashion without careful attention to patient selection and quality control, then the outcomes would likely be sub-optimal and the health care costs would be high [4]. From all indications, these safeguards are in place and are currently buffering (if not completely tamping down) the high level of enthusiasm for the procedure throughout the interventional cardiology community. Currently only one valve type is commercially available in the US (the Sapien Valve, made by Edwards Lifesciences) and it is anticipated that other manufacturers will shortly move their devices forward into