Patient Reported Outcomes and Quality of Life in Cardiovascular Interventions

432 Pages·2022·17.844 MB·English

by  Thanos Athanasiou, Ara Darzi, Aung Ye Oo

Patient Reported
Outcomes and Quality
of Life in Cardiovascular
Interventions
Thanos Athanasiou
Ara Darzi
Aung Ye Oo
Editors
123
Patient Reported Outcomes and Quality
of Life in Cardiovascular Interventions
Thanos Athanasiou • Ara Darzi
Aung Ye Oo
Editors
Patient Reported
Outcomes and Quality
of Life in Cardiovascular
Interventions
Editors
Thanos Athanasiou Ara Darzi
Imperial College London Imperial College London
London, UK London, UK
Aung Ye Oo
Aortovascular Surgery
Barts Heart Centre, St Bartholomew’s
Hospital
London, UK
ISBN 978-3-031-09814-7 ISBN 978-3-031-09815-4 (eBook)
https://doi.org/10.1007/978-3-031-09815-4
© Springer Nature Switzerland AG 2022
This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or
part of the material is concerned, specifically the rights of translation, reprinting, reuse of
illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way,
and transmission or information storage and retrieval, electronic adaptation, computer software,
or by similar or dissimilar methodology now known or hereafter developed.
The use of general descriptive names, registered names, trademarks, service marks, etc. in this
publication does not imply, even in the absence of a specific statement, that such names are
exempt from the relevant protective laws and regulations and therefore free for general use.
The publisher, the authors, and the editors are safe to assume that the advice and information in
this book are believed to be true and accurate at the date of publication. Neither the publisher nor
the authors or the editors give a warranty, expressed or implied, with respect to the material
contained herein or for any errors or omissions that may have been made. The publisher remains
neutral with regard to jurisdictional claims in published maps and institutional affiliations.
This Springer imprint is published by the registered company Springer Nature Switzerland AG
The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland
Preface
Over the last few decades, the combined effect of declining mortality and
major morbidities after cardiovascular interventions in combination with the
fact that medicine becoming more patient-centred has brought the impact on
functional status of patients under the spotlight.
The ability and the time patients can resume their day-to-day activities
post-intervention has been increasingly researched and considered as a key
indicator of outcomes.
More often physicians are also considering the impact of the disease and
the proposed interventions on patient’s functional status and aspects of qual-
ity of life that are important to them.
The World Health Organization (WHO) describes QOL as “an individu-
al’s perception of their position in life in the context of the culture and value
system in which they live and in relation to their goals, expectations, and
standards and concerns”.
In cardiovascular disease, patient-reported questionnaires help providing
subjective, valid and reliable measures for QOL, and not based on physician-
recognised cardiac symptoms.
QOL measures are increasingly becoming necessary to be incorporated in
clinical trials due to their relevance to patients’ functional status.
With the advances in percutaneous catheter interventions and with ageing
population, there will undoubtedly more comparisons between such novel
approaches to open cardiac surgery. The availability of valid QOL measures
will assist in such comparisons to benefit what matters to the patient.
An increment in the proportion of patients above the age of 80 years pre-
senting with cardiac disease will lead to increased demands on cardiovascular
specialties.
The use of generic and disease-specific QOL instruments in randomised
clinical trials (RCT) assists in quantifying the impact of cardiac intervention
on patients with chronic health status.
When deciding which QOL measure to utilise, it has been suggested that
concomitant use of both generic and disease-specific instruments is highly
recommended and optimal. However, it has also been suggested that disease-
specific QOL measures are more sensitive to change compared to generic
ones in case of RCT.
There are a few limitations in the methodology in applying QOL measures
in RCT. For instance, many studies utilise cross-sectional designs without
baseline QOL assessment, which makes it difficult in demonstrating the
v
vi Preface
efficacy of treatment. In general, the validity of QOL instruments use relies
on memory recall while filling questionaries without considering physical
and psychosocial adjustments over time to a chronic illness and how it is
perceived. There is also significant variability in QOL instruments with some
having lower sensitivity in detecting minor symptoms changes. So, it becomes
challenging to accurately quantify QOL changes from interventions given the
above limitations. Furthermore without a consensus in QOL use in RCT, one
should be attentive to how QOL measures were defined and measured.
Recently, a Consolidated Standards of Reporting Trials Patient Reported
Outcome (CONSORT PRO) has been set up to standardise QOL assessments
across clinical trials and improve QOL reporting and inform clinical practice
and health policy.
In clinical practice for patients undergoing emergency intervention or
those critically unwell, the clinical decision making would not be affected by
patient QOL scores. In comparison patients with already good pre-operative
health will unlikely to have QOL benefit from surgery but will have improved
survival.
Differential QOL trajectories can assist in informing patients more accu-
rately when having discussions before surgery for their post-operative recov-
ery. This would provide with realistic expectations when offering various
interventions and an insight into functional status using generic or disease-
specific QOL measures after surgery.
The importance of having accurate QOL data underpins its potential use to
inform clinical practice and decision making.
To then implement PROs into clinical practice, need to consider the work-
flow including how they are collected, the timings, the reporting of scores and
the actions that arise from it. Several RCTs have demonstrated the benefits of
incorporating QOL data into routine clinical practice such as helping in dis-
cussing QOL issues without prolonging clinic and keeping patient’s well-
being paramount.
National databases such as the Society for Thoracic Surgeons (STS) or
risk-scoring like Euroscore II provide accurate risk adjustments for common
procedures and help in guiding pre-operative decision making.
The STS measures surgical outcomes including complications rates, read-
missions and perioperative mortality, which are objective and easy to inter-
pret. However, they do not reflect on what is most significant to the patient. In
fact most of the post-operative complications are rare and would not be ade-
quate for evaluating the true quality of care delivered or to compare institu-
tions performances.
To have a better understanding of QOL measures and the outcomes associ-
ated with it, these PROs have to be assessed pre-operatively, post-operatively
and also at long-term follow-up.
PROMIS provides accurate, standardised measurements of PROs. These
have over 300 measures of mental, physical and social well-being that can be
used for the general population or specific group like cardiac surgery.
PROMIS questionnaires have been validated for the general public and in
patients with different medical conditions, so scores are obtained and com-
pared easily across various populations.
Preface vii
The PROMIS is also aligned with the goals of STS PRO Task Force and
the American Heart Association for exploring to incorporate PRO measures
into the STS national databases. Resource use and patient-reported outcomes
when added to National Databases would provide a more comprehensive per-
spective on quality as well as additional end points.
Incorporating PRO into National Databases will help surgeons to give
more patient-centred care.
Mortality outcome is an insufficient marker for success and cardiac sur-
gery has relied on this for too long. Operative success should not be the only
criteria for providing a procedure to a patient. There is a multitude of trials
that have reported improvement in QOL post-cardiac surgery and such high-
quality data can be utilised for more accurate and personalised pre-operative
counselling and risk stratification.
Such QOL measures can be used to benchmark in novel technologies such
as transcatheter cardiac procedures and minimal access surgeries.
The use of generic and disease-specific QOL measures is a promising
research field with many applications to RCT and in clinical practice.
The CONSORT PRO has been set up for assisting in adoption of validated
QOL measures more routinely in trials and clinical practice. There is a lot of
exciting opportunity for integrating PROs into routine clinical practice, clini-
cal trials and national databases in cardiac surgery for optimising compara-
tive effective research. Identifying anticipated trajectories for post-intervention
recovery will assist in providing more tailored outcomes that are meaningful
to patients, defining new markers for surgical success.
London, UK Thanos Athanasiou
London, UK Ara Darzi
London, UK Aung Ye Oo
Contents
1 Unveiling the Concept of Minimal Clinically Important
Difference (MCID) in Cardiac Surgery . . . . . . . . . . . . . . . . . . . . 1
Dimitrios E. Magouliotis, Grigorios Christodoulidis,
Arian Arjomandi Rad, and Thanos Athanasiou
2 Quality of Life Following the Use of Mechanical
Circulatory Support Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Antonios Kourliouros and Steven Tsui
3 What Factors Predict an Improved Quality of Life
Outcome Following Coronary Artery Bypass
Graft Surgery? A Systematic Review . . . . . . . . . . . . . . . . . . . . . . 17
Yusuf S. Abdullahi, Sanjay Chaubey, Roberto Casula,
and Thanos Athanasiou
4 Thoracic Aortic Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Matthew K. H. Tan, Omar A. Jarral, Yousuf Salmasi,
Michael Sabetai, and Thanos Athanasiou
5 Patient Reported Outcomes and Quality of Life
following Heart Transplantation . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Alex Jacob Poovathoor, Jason Ali, and Marius Berman
6 QOL and PROMS Following Transcatheter Aortic
Valve Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
M. Monteagudo-Vela, V. Panoulas, and G. Krasopoulos
7 Patient-Reported Quality of Life After Stand-Alone
and Concomitant Arrhythmia Surgery: A Systematic
Review and Meta-Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
Bart Maesen, Claudia A. J. van der Heijden, Elham Bidar,
Rein Vos, Thanos Athanasiou, and Jos G. Maessen
8 Transcatheter Mitral Valve Procedures . . . . . . . . . . . . . . . . . . . . 155
Matthew K. H. Tan and Omar A. Jarral
9 Percutaneous Interventions in Adult Congenital
Heart Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
Ana Barradas-Pires, Andrew Constantine,
and Konstantinos Dimopoulos
ix
x Contents
10 The Impact of Valve Surgery on the Health-Related
Quality of Life of Elderly Patients: Systematic Review . . . . . . . . 185
Yusuf S. Abdullahi, Sanjay Chaubey, Roberto Casula,
and Thanos Athanasiou
11 Quality of Life After Mitral Valve and Tricuspid
Valve Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211
Nicola Di Bari, Marco Moscarelli, Giuseppe Nasso,
and Giuseppe Speziale
12 Quality of Life and Patient Reported Outcomes
in Paediatric Cardiac Surgery Patients . . . . . . . . . . . . . . . . . . . . 217
Robyn Lotto, Amer Harky, and Attilio Lotto
13 Percutaneous Coronary Intervention . . . . . . . . . . . . . . . . . . . . . . 233
Adam Hartley and Sukhjinder Nijjer
14 Quality of Life and Patient Reported Outcome
Measures Following Carotid Artery Intervention . . . . . . . . . . . . 249
Leonard L. Shan, Akshat Saxena, and Alun H. Davies
15 Quality of Life and Patient Reported Outcome
Measures Following Percutaneous Aortic Intervention
for Aortic Aneurysms and Dissection . . . . . . . . . . . . . . . . . . . . . . 267
Leonard L. Shan, Akshat Saxena, and Alun H. Davies
16 QOL and PROMS in Catheter Ablation of Cardiac
Arrhythmia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 301
Kathleen L. Withers, Helen Morgan, and Mauro Lencioni
17 Patient Reported Outcomes and Quality of Life following
Percutaneous and Surgical Intervention for
Subclavian Artery Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 343
Lydia Hanna and Richard Gibbs
18 QoL and PROMS Following Percutaneous
and Surgical Intervention for Renal Artery Disease . . . . . . . . . . 351
Ankur Thapar and Phillip Puckridge
19 Health-Related Quality of Life Outcomes for
Endovascular and Open Surgical Interventions
in Aortoiliac and Femoropopliteal Steno-Occlusive
Arterial Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 361
Jimmy Kyaw Tun, Stefan Lam, Mohammed Rashid Akhtar,
and Ounali Jaffer
20 Infrapopliteal Arteries (Classical and Percutaneous) . . . . . . . . . 407
Richard Anthony Meena and Olamide Alabi
Contents xi
21 Quality-of-Life (QOL) and Patient- Reported Outcome
Measures (PROMs) Following Intervention for Chronic
Venous Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 415
Kosmas I. Paraskevas, Andrew N. Nicolaides, and George
Geroulakos
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 429