The TVT Registry: Collaboration Leading to Quality Control

摘要

;Dr Ailawadi discloses a financial relationship with Abbott Vascular, Edwards Lifesciences, St. Jude Medical, Medtronic, and Atricure; Dr Iung with Edwards Lifesciences.;For related article, see page 1021;Patients undergoing TAVR reflect current indications, including symptomatic patients with aortic stenosis at high or inoperable risk for conventional surgical aortic valve replacement. Patients were similar to those seen in other nationwide registries, with a median age of 83 years and an STS risk score of 6.5% with multiple additional reasons for high risk/inoperable status, including frailty in >50% of patients. Despite a similar median age each year, the STS PROM (Predicted Risk of Mortality) decreased slightly each year. It is important to note that during this time period, the registry only included high-risk and inoperable patients. Recent reports documenting the superiority of TAVR over surgical aortic valve replacement in intermediate-risk patients have led to commercial approval in this risk group in the summer of 2016 [5][5]. Thus, future annual TVT reports will include a younger, healthier population than presented here.With respect to mortality, the 5.7% 30-day mortality still remains better than the STS 30-day predicted mortality risk of 6.5%. As in other large series, the 30-day mortality decreased over time from 7.5% in 2012 to 4.6% in 2015. The reasons for this continued improvement is likely a multitude of factors, including newer-generation valves, smaller delivery sheaths, increased center experience, and improvements in patient selection [6, 7].There are other notable trends. First, the use of the transfemoral approach was 71%, similar to the 71% to 73% rates in European series [2, 3]. Use of the transfemoral approach increased yearly, likely due to the introduction of smaller-caliber femoral delivery systems. Further, there is gradually increasing use of monitored sedation instead of general anesthesia, most dramatically in 2016. The stroke rates are exceedingly low, and the paravalvular leak rates have continued to improve, potentially as a result of more accurate sizing and device selection. Finally, there has been an increasing need for pacemakers, potentially due to the rising use of self-expanding valves; this trend needs to be followed, particularly as we are considering using this disruptive technology in lower-risk patients.As noted by Grover and colleagues [1][1], the STS/ACC TVT Registry has potentially allowed earlier device approval with close post-market surveillance. The 1-year mortality of >20% remains high in this population and is likely related to comorbidities. Nevertheless, device failure does not appear to be occurring at 1 year. Trends in complications may be detected at an earlier stage with systematic monitoring in registries. Another use of the registry is benchmarking and quality control of TAVR centers. The predictive performance of risk scores aimed at assessing 30-day mortality after TAVR is not optimal, even when considering multivariable scoring systems specifically developed and validated in TAVR populations [6, 7]. Therefore, particular caution will be needed when comparing results between centers adjusted on the level of risk scores. Nevertheless, the development of a TVT TAVR mortality model is a huge step forward in the evaluation of patients being considered for TAVR. With ongoing refinements, the accuracy of these predictive models will likely improve.The TAVR story is a fantastic success not only due to the rapid acceptance of such technology within 15?years after the first-in-man procedure, but also because it triggered a revolution in catheter-based valve procedures. We now have several, large randomized trials that allow guidelines to have high levels of evidence, which was not usual in the field of heart valve diseases. Continuous follow-up even beyond 1?year is necessary to provide unbiased information on the durability of valves, which is of utmost importance w