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Department of Cardiothoracic Surgery, University of Texas Health Science Center, San Antonio, Texas
* Address correspondence to Dr Calhoon, Department of Cardiothoracic Surgery, University of Texas Health Science Center, 7703 Floyd Curl Dr, MC #7841, San Antonio, TX 78284 (Email: calhoon{at}uthscsa.edu).
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Published in this issue is a very comprehensive position paper on the state of catheter-based aortic valve replacement, or TAVR [1]. This new technology has been available now for several years in Europe and is in the process of being approved for use in the United States at programs meeting criteria for volume and expertise. The paper is comprehensive and covers all of the technical and outcomes-related information that anyone of us would hope to know when implementing new technology.
It was a pleasure to be a part of the writing committee and to learn from the many content experts that were part of the broad pool of talent involved. My participation as a content expert was limited because my selection was a result of one of the participating societies identifying a willing participant with a lack of conflicts of interest with industry. Presumably this means that I have limited or no biases. It was my desire, and the desire of others on the writing committee, to put this document together with a minimum of bias, with the goal of providing a maximum benefit to our discipline of cardiac care. This document should provide insight for knowledgeable lay people, allied health personnel, and primary care physicians concerned about older, sicker patients with aortic valve disease for whom a conventional operation is questionable. The section for which I had the most concern is aptly titled "frailty versus futility."
It seems that frailty vs futility is a concept that is more and more front and center in the context of patients that we treat, whether we do it as cardiologists or thoracic surgeons. It is very clear today that there are patients with cardiac disease who are best treated from an evidence standpoint by a thoracic surgical procedure and other patients who are similarly best treated by relatively less invasive cardiologic techniques. In addition, there are patients, who by virtue of their extensive comorbid conditions or advanced age, are best treated expectantly with management of their other medical problems.
The purpose of this editorial is to remind us in the current economic climate, and indeed, the economic climate for the foreseeable future, that capital is limited. Thus, any therapy should be directed in a most cost-effective and beneficial way to provide value to the potential patient. To be sure, the potential to replace someone's aortic valve by a catheter-based method is truly awe-inspiring. The ability to obtain a hemodynamic result equivalent to surgical aortic valve replacement with fairly limited morbidity in a very sick subset of patients that are described within this expert consensus document was unthinkable a few years ago.
The costs of this new approach must be weighed with its relative benefits. These potential benefits should be contrasted with the possibility of significant morbidity. Older, sicker patients face more frequent prolonged hospitalization and a much higher chance of failing to recover a life the patient feels is meaningful. An increasing risk of expensive and insurmountable complications simply goes hand-in-hand with taking care of ever sicker, more aged patients. The problem confronting us in health care today is how to appropriately deploy new and exciting technology like TAVR in the most cost-effective and beneficial way. We need to be sure of the evidence that would support use or nonuse of technology before we do something to someone simply because we can.
As stated by many others before, it is better that medicine polices itself, rather than someone else doing it for us. In trying to outline the best possible benefit and value to our patients, the expert consensus document addresses all of those issues, yet in some ways struggles to fully supply those definitions. Although many trials use an end point of noninferiority, our goal should be to select the best individual strategy by weighing the relative advantages and disadvantages. The expert consensus document clearly outlines safety and benefit, while underscoring the potential risks of stroke, death, paravalvular leaks, and pacemakers, among others. It also appropriately makes demands of our combined specialties, and indeed, the heart team, to carefully evaluate the potential upside and potential negatives for each potential patient.
One thing that goes beyond the scope of this expert consensus document is where TAVR therapy sits in relative value to more traditional procedures for valves, revascularizations, and pacemakers that are currently done. We should be careful that TAVR is applied to those who might truly benefit. Otherwise, more conventional therapy will be denied or devalued as our government and payers ratchet down the amount of capital that is made available for cardiac care. No doubt, there are many candidates best served by TAVR, and over time, it may serve a larger proportion of valve patients. In the meantime, it will be difficult for all of us to avoid interest in this new technology as a driver for referrals, a metric for programmatic excellence, and a procedure that patients "desire." Nonetheless, as this new technology is adopted and perfected, it is first our job to do no harm. The rest of our job is to appropriately consider the ever-increasing number of technologies (like TAVR) that we are able to deploy in view of their relative benefits in the marketplace and our society.
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  R. L. J. Osnabrugge, S. J. Head, T. S. S. Genders, N. M. Van Mieghem, P. P. T. De Jaegere, R. M. A. van der Boon, J. M. Kerkvliet, B. Kalesan, A. J. J. C. Bogers, A. P. Kappetein, et al. Costs of Transcatheter Versus Surgical Aortic Valve Replacement in Intermediate-Risk Patients Ann. Thorac. Surg., December 1, 2012; 94(6): 1954 - 1960. [Abstract] [Full Text] [PDF]
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