Faculty Bibliography

BACKGROUND:Transcatheter aortic valve replacement (TAVR) has emerged as a less invasive option for valve replacement of patients with severe aortic stenosis. Although it has been recommended that TAVR should not be offered to patients who will not improve functionally or derive meaningful survival benefit from the procedure, no guidance exists on how best to identify such patients. The first step in this process is to define a poor outcome that can then be used as a foundation for subsequent case identification. We sought to evaluate potential definitions of a poor outcome after TAVR that combine both mortality and quality of life components. METHODS AND RESULTS/RESULTS:Using data from 463 patients who underwent TAVR as part of the Placement of AoRTic TraNscathetER Valve (PARTNER) trial, we evaluated 6-month mortality and quality of life outcomes using the Kansas City Cardiomyopathy Questionnaire to explore potential definitions of a poor outcome. We then compared the strengths and weaknesses of each potential definition by examining the relationship between baseline and 6-month Kansas City Cardiomyopathy Questionnaire scores for each patient. Based on these analyses, we argue that the most appropriate definition of a poor outcome after TAVR is (1) death, (2) Kansas City Cardiomyopathy Questionnaire overall summary score <45, or (3) Kansas City Cardiomyopathy Questionnaire decrease of ≥10 points, which best reflects a failure to achieve the therapeutic goals of TAVR. CONCLUSIONS:Using empirical data on a large number of patients enrolled in the PARTNER trial, we propose a definition for poor outcome after TAVR that combines both mortality and quality of life measures into a single composite end point. Use of this end point (or other similar end points) in future studies can facilitate development of predictive models that may be useful to identify patients who are poor candidates for TAVR and to provide such patients and their families with appropriate expectations of functional recovery after TAVR.

Patients with severe aortic stenosis are commonly elderly and with significant comorbidity. Surgical intervention can improve symptoms and survival in severe aortic stenosis. However, a large proportion of patients do not undergo surgical intervention because they are deemed to be inoperable or too high risk. Over the last decade, transcatheter aortic valve replacement (TAVR) has been developed, providing an effective, less-invasive alternative to open cardiac surgery for inoperable or high-risk patients. The purpose of this review is to provide an overview of risk assessment in TAVR. Specifically, this article reviews the epidemiology of aortic stenosis, describes the risks and benefits of TAVR across multiple outcome measures, explores frailty and other elderly risk factors as metrics for improved risk assessment and discusses the application of improved risk assessment in TAVR decisions.

Transcatheter aortic valve replacement (TAVR) has transformed the treatment of aortic stenosis in high-risk older adults in Europe and has begun to do so in the United States. Recent Food and Drug Administration approval of the Edwards Lifesciences SAPIEN Transcatheter Heart Valve (Irvine, Calif) in inoperable and high-risk patients led to enthusiasm for widespread implementation of this technology. Experts have highlighted the central role of the multidisciplinary heart team in implementing a successful TAVR program. Other experts, such as Joseph Bavaria, have suggested that access to TAVR should be restricted to high-volume surgical aortic valve replacement centers. In our opinion, access to TAVR should not be limited to high-volume surgical centers for the following reasons. First, high surgical volume does not ensure good outcomes in complex interventional procedures. Second, centers with low or no surgical volume can have excellent interventional results. Third, new multidisciplinary heart teams have achieved excellent results in part because of the transmission of accumulated knowledge from experienced centers. Finally, in the absence of evidence suggesting that high-volume surgical centers produce superior TAVR results, therapeutic options for patients should not be limited.

AIMS/OBJECTIVE:In the USA, transthyretin cardiac amyloidosis usually results from 'wild-type' transthyretin (senile cardiac amyloidosis [SCA]) or the V122I variant. PATIENTS & METHODS/METHODS:We compared presentations and outcomes among SCA and V122I patients referred to the Center for Advanced Cardiac Care at Columbia University Medical Center (NY, USA) between 2001 and 2012. RESULTS:V122I patients were younger (mean: 71 years, standard deviation [SD]: 7) than SCA patients (mean: 77, SD: 6; p = 0.0002) and 96% were black compared with 3% of SCA patients (p < 0.0001). Average ejection fraction was lower among V122I patients (mean: 25% [SD: 12] vs mean: 47% [SD: 15]; p = 0.0001), as was mean cardiac index. Median time to death or orthotopic heart transplant was 36.4 months for V122I patients and 66.5 for SCA patients (p = 0.09). CONCLUSION/CONCLUSIONS:In this study of patients with transthyretin cardiac amyloidosis, V122I patients presented to a tertiary academic medical center at a younger age than SCA patients but had higher levels of cardiac dysfunction, despite genetic screening availability. There was a trend toward shorter time to orthotopic heart transplant or death among V122I patients. Whether this is a result of a different biologic progression or late diagnosis requires further study.