Does Newer Mean Better?

By Neil Ruparelia, DPhil, MRCP1,2;  Azeem Latib, MD1;  Antonio Colombo, MD1
1San Raffaele Scientific Institute, Milan, Italy
2Imperial College, London, United Kingdom

Transcatheter aortic valve implantation (TAVI) has rapidly expanded following the first reported case in 2002 to now being the recommended treatment option for high-risk or inoperable patients with severe symptomatic aortic stenosis (AS). While the first studies clearly demonstrated safety and efficacy of this revolutionary technology, they also identified some limitations including vascular complications, stroke, the requirement for permanent pacemaker implantation, and residual aortic regurgitation. Subsequent studies have consistently demonstrated that the presence of more-than-mild paravalvular regurgitation and the occurrence of a vascular complication to be independent predictors of mortality. In an attempt to reduce the incidence of these limitations, a number of technological refinements have been made to TAVI devices and their delivery systems. We therefore aimed to investigate the impact of these changes relating to intraprocedural and 30-day safety.

We found that there was a significant safety benefit associated with newer devices when compared with first-generation devices. This was predominantly accounted for by a reduction in vascular and bleeding complications, while newer devices were also associated with a lower rate of significant paravalvular leak. These findings are of particular interest because they demonstrate an objective benefit of newer devices in a “real-world” patient population truly reflecting contemporary clinical practice and support their preferential use over first-generation devices.

There is currently great excitement with regard to the use of TAVI for the treatment of lower-risk patients; however, before this can be recommended as the default treatment option, complications should be comparable to the current “gold standard” of surgical aortic valve replacement. It would appear from this study that the use of newer devices is associated with a safety benefit in the short term, but future research will need to determine if these benefits translate into longer-term outcome benefits and also if the very reassuring valve durability data seen with first-generation devices are also true for the current-generation devices.

Read the entire article here:

A Comparison Between First-Generation and Second-Generation Transcatheter Aortic Valve Implantation (TAVI) Devices: A Propensity-Matched Single-Center Experience
Neil Ruparelia, DPhil, MRCP;  Azeem Latib, MD;  Hiroyoshi Kawamoto, MD;  Nicola Buzzatti, MD;  Francesco Giannini, MD;  Filippo Figini, MD;  Antonio Mangieri, MD;  Damiano Regazzoli, MD;  Stefano Stella;  Alessandro Sticchi, MD;  Akihito Tanaka, MD;  Marco Ancona, MD;  Eustachio Agricola, MD;  Fabrizio Monaco, MD;  Pietro Spagnolo, MD;  Alaide Chieffo, MD;  Matteo Montorfano, MD;  Ottavio Alfieri, MD;  Antonio Colombo, MD
J INVASIVE CARDIOL 2016;28(5):210-216