TAVI Care and Cure, the Rotterdam multidisciplinary program for patients undergoing transcatheter aortic valve implantation: Design and rationale

https://doi.org/10.1016/j.ijcard.2019.12.005Get rights and content

Highlights

  • To create a novel comprehensive patient centred pathway for patients eligible for TAVI.

  • To create an enhanced multi disciplinary heart team with the addition of the department of geriatrics.

  • To improve risk stratification and patient selection for transcatheter aortic valve implantation.

  • To predict more distinctly the differentiation between those patients who will benefit from TAVI and those who will not.

  • To access potential parameters applicable for an early discharge strategy.

Abstract

Background

The capacity of TAVI-programs and numbers of sites performing TAVI has rapidly increased. This necessitated the initiation of the Rotterdam TAVI Care & Cure Program, aiming to improve patient-centered care during the TAVI pathway.

Methods

Consenting patients with severe aortic stenosis and an indication for TAVI will be included. The TAVI Care & Cure program will facilitate prognostic contributions to improve outcomes, patient satisfaction and quality of life in patients with valvular heart disease who are treated with a transcatheter aortic valve implantation in collaboration with the departments of cardiology, cardio-thoracic surgery, anesthesiology and geriatrics.

Conclusion

With a single center observational registry, we aim to assess the TAVI patient clinical pathway, focusing on pre, peri and post interventional variables including functional status and HRQoL. We will evaluate the patient's complexity by applying an extended multidisciplinary approach, which includes a systematic application of geriatric assessments of frailty and cognitive function.

Introduction

Transcatheter aortic valve implantation (TAVI) is increasingly being utilized to treat patients with severe aortic stenosis (AS) who are considered at intermediate or high risk for surgical aortic valve replacement (SAVR). TAVI, a less-invasive therapeutic option, is expected to become the standard treatment in all patients with aortic stenosis but will predominantly be applied in an increasingly elderly population given the increase of this population group [[1], [2], [3]]. Elderly patients differ from younger patients in terms of frailty (a state of reduced physical, cognitive and social functioning, resulting in a reduction of reserve capacity for dealing with stressors) [4] due to a higher prevalence of medical co-morbidities leading to a more pronounced reduction in functional status and health related quality of life (HRQoL).

Despite improvements in immediate outcomes (i.e. safety) as a result of enhanced operator experience, progress in device technology and post-operative care, a proportion of patients do not survive beyond one year or at best show limited or no improvement in HRQoL after TAVI [1,2,5]. This is particularly evident for the elderly patient (>80 years) necessitating a more delicate and balanced decision-making (risk/benefit assessment) including the understanding of other factors that determine immediate and above all long-term outcomes [[6], [7], [8], [9]]. In this context frailty is of significance, as it is associated with chronic diseases and increased age, negatively influencing morbidity and mortality after TAVI. Importantly, through advocacy of the European Society of Cardiology, frailty has now been incorporated into the decision-making process [10].

Also other components such as mental status, nutrition and socio-economic status, which are not only relevant for the elderly patient population, will be taken into account. This in combination with a higher prevalence of medical antecedents and co-morbidities renders formulating treatment strategies in the elderly complex and requires further analysis into whether specific geriatric interventions before and/or after TAVI may improve immediate and long-term outcome after TAVI [10]. For this reason, a dedicated TAVI program entitled TAVI Care & Cure was initiated in our institution of which the details are herein further described.

Section snippets

Study design

The TAVI Care & Cure study is a prospective single-center multidisciplinary observational cohort study in which a comprehensive set of predefined cardiovascular and non-cardiovascular variables are collected (Table 1a). “Care” entails the management of the pre and post interventional patient pathway whilst “Cure” entails the interventional treatment phase. Inclusion criteria are all consecutive patients with severe symptomatic AS, not considered for conventional open heart valve surgery

Diagnostic assessments

Cardiac and geriatric examinations and assessments will be performed and include medical history and physical assessments, 12‑lead ECG, laboratory results, thorax X-rays, diagnostic coronary angiogram, multi–slice computed tomography (MSCT), trans-thoracic and/or trans esophageal echocardiography and quality of life measurements. The following geriatric domains will be assessed: cognition and nutritional status, (instrumental) activity of daily living, mobility and muscle loss (see Table 1b for

Data management

All demographic, clinical complications and related data such as laboratory assays, ECG and echocardiographic data will be collected during the outpatient visits at both the cardiac and geriatric departments. In addition a concise set of variables collected during TAVI are entered into a dedicated database.

Captured data is entered on a structural basis and a collaborative manner in the dedicated TAVI database by three groups of participants; a medical student team accompanying the

Discussion

Aortic stenosis is the most common valve disease in elderly adults with a growing prevalence due to the aging population [3]. TAVI, currently performed in over 70 countries [24], has evolved as a less invasive, safe and effective alternative treatment of patients with severe symptomatic AS who are at high or prohibitive risk for surgical aortic valve replacement [2].

Evidence from randomized clinical trials comparing outcomes of SAVR versus TAVI has led to a broadening of indications for TAVI

Conclusion

With a single center observational registry, we aim to assess the TAVI patient clinical pathway, focusing on pre, peri and post interventional variables including functional status and HRQoL. We will evaluate the patient's complexity by applying an extended multidisciplinary approach, which includes a systematic application of geriatric assessments of frailty and cognitive function.

Authors contributions

M. De Ronde-Tillmans, J. Goudzwaard, N. El Faquir, N. van Mieghem, F. Mattace-Raso, M. Lenzen, and P. de Jaegere contributed to the design and implementation of the research. M. De Ronde-Tillmans, P. Cummins and J. Goudzwaard were responsible for drafting the article or revising it critically for important intellectual content. All authors approved this version of the manuscript to be published.

Conflict of interest

The authors report no relationships that could be construed as a conflict of interest.

References (34)

  • A.P. Kappetein et al.

    Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document

    J. Thorac. Cardiovasc. Surg.

    (2013)
  • R.A. Kotronias et al.

    Early versus standard discharge after transcatheter aortic valve replacement: a systematic review and meta-analysis

    JACC Cardiovasc Interv

    (2018)
  • C.R. Smith et al.

    Transcatheter versus surgical aortic-valve replacement in high-risk patients

    N. Engl. J. Med.

    (2011)
  • M.B. Leon et al.

    Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery

    N. Engl. J. Med.

    (2010)
  • M.R. Reynolds et al.

    Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis

    Circulation

    (2011)
  • A.W. Schoenenberger et al.

    Predictors of functional decline in elderly patients undergoing transcatheter aortic valve implantation (TAVI).

    Eur Heart J.

    (2013)
  • Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D,...
  • View full text