Futility, Benefit, and Transcatheter Aortic Valve Replacement

Abstract

Transcatheter aortic valve replacement (TAVR) is a transformative innovation that provides treatment for high or prohibitive surgical risk patients with symptomatic severe aortic stenosis (AS) who were previously either not referred for or denied operative intervention. Trials have demonstrated improvements in survival and symptoms after TAVR compared to medical therapy, however there remains a sizable group of patients who die or lack improvement in quality of life soon after TAVR. This raises important questions about the need to identify and acknowledge the possibility of futility in some patients considered for TAVR. In this very elderly population, a number of factors in addition to traditional risk stratification need to be considered including multimorbidity, disability, frailty, and cognition in order to assess the anticipated benefit of TAVR. Consideration by a multidisciplinary heart valve team with broad areas of expertise is critical for assessing likely benefit from TAVR. Moreover, these complicated decisions should take place with clear communication around desired health outcomes on behalf of the patient and provider. The decision that treatment with TAVR is futile should include alternative plans to optimize the patient's health state or, in some cases, discussions related to end of life care. We review issues to be considered when making and communicating these difficult decisions.

Periprocedural Cardiopulmonary Bypass or Venoarterial Extracorporeal Membrane Oxygenation During Transcatheter Aortic Valve Replacement: A Systematic Review

“…We recommend a multidisciplinary team approach for the care of these patients to decide among available therapies including medical management, use of balloon aortic valvuloplasty, durable LV assist devices, and palliative care 26. Ideally, these teams should comprise physicians from cardiology, interventional cardiology, cardiac surgery, critical care medicine, heart failure, palliative medicine, and anesthesiology 26, 27. It is important to incorporate input from palliative medicine physicians to balance the need for using sophisticated MCS devices against the use of futile, resource‐intensive therapies that may be unlikely to improve clinical outcomes.…”

Experiencia inicial del implante percutáneo de válvula aórtica en el Instituto Nacional del Tórax: Experience in 26 patients

“…Lo anterior permite inferir que en aquellos pacientes en que la estenosis aórtica severa es la patología fundamental, el reemplazo valvular percutáneo logrará una franca mejoría de su CF, semejante al resultado obtenido con el reemplazo quirúrgico 5 . Esto señala el importante rol que tiene la adecuada selección de los pacientes en diferenciar al paciente con estenosis aórtica severa con patología asociada de aquellos con morbilidad severa en que la estenosis aórtica es un evento mórbido asociado 22 . Esta experiencia inicial reproduce la experiencia internacional de que el implante percutáneo de válvula aórtica es una alternativa de tratamiento válida en población con estenosis aórtica severa sintomática y considerada de alto riesgo quirúrgi-co o inoperable, permitiendo una franca mejoría en su calidad de vida y capacidad funcional.…”

Letter by Frigerio et al Regarding Article, “Long-Term Outcomes of Inoperable Patients With Aortic Stenosis Randomly Assigned to Transcatheter Aortic Valve Replacement or Standard Therapy”

“…Nevertheless, disability has been assessed preoperatively as part of the complex concept of "frailty" and correlated with outcomes but has not been specifically evaluated as an end point in TAVR trials. 4 To translate the statistical success of TAVR into substantial usefulness in inoperable patients with aortic stenosis, we should identify those for whom the added survival time will also provide enough improvement in symptoms, quality of life, and disability. These soft end points are not less important just because we lack objective and universally accepted tools to measure them.…”