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9 Percutaneous Interventions inAdult Congenital Heart Disease

175

different ages with different anatomies and previous palliative or corrective surgery. More disease- specic tools are also available, such as the Netherlands Organisation for Applied Scientic Research Academic Medical Centre (TNO-AZL) adult quality of life questionnaire (TAAQOL). The TAAQOL started as a generic Dutch health questionnaire and was further developed to focus on cardiac diseases, especially in the CHD eld (CHD-TAAQOL) [26]. This tool aims to identify impairment in different health components (motor and social functioning, sleep, pain, etc) and to capture, if present, the psychological effect of those limitations. It also assesses the changes in QoL after surgical and interventional procedures. Finally, the most comprehensive and holistic assessment tools involve open or semi-struc- tured interviews to capture information in a wide variety of domains [25]. Although open interviews can potentially uncover important topics for patients that might have been excluded from more structured questionnaires, the comparison of these results across individuals and different populations is often very challenging.

The potential utility and pitfalls of each one of these QoL instruments in the setting of ACHD interventional procedures are discussed later in this chapter.

Methods

QoL Tools inACHD Interventions: Review ofExisting Literature

In order to review the relation between QoL and percutaneous interventions in ACHD, we conducted a scoping review of the literature in the following electronic databases: PubMed online libraries, Google Scholar, and ClinicalTrials.gov (search date 1st February 2020). Furthermore, we manually examined reference lists from all selected articles and reviews to identify additional studies. Non-English language papers, for which an English translation was not available, were excluded.

As authors often use the terms ‘quality of life’, ‘health status’, ‘functional status’, ‘HRQoL’ and

‘well-being’ interchangeably, all studies using these terms were included. Nevertheless, we excluded all publications in which QoL was solely assessed using the NYHA functional class.

Results

Summary ofInterventions

PROMs, mainly as HRQoL measures, have been used in the assessment of three types of percutaneous procedure:

• Percutaneous pulmonary valve implantation (PPVI)

• Percutaneous atrial septal defect (ASD) closure

• Percutaneous patent foramen ovale (PFO) closure

A description of the results obtained are described in the Table9.1.

Percutaneous Pulmonary Valve Implantation

Three studies on QoL after percutaneous pulmonary valve implantation were identied. In a prospective, single-centre study of patients receiving PPVI with Melody (n =56) or Sapien (n =3) valves, Muller and colleagues found that almost all 8 domains assessed in the SF-36 questionnaire improved at 6months following the procedure, accompanied by a signicant improvement in peak oxygen uptake on cardiopulmonary exercise testing [27]. The authors found the QoL improvement was disproportionately higher than the change in peak oxygen uptake, which the authors suggested could have been due to a favourable perception of the minimally invasive intervention when compared to their previous experience of open-heart surgery.

Hager etal. measured QoL both at 6months

and 5 years after PPVI using the EQ-5D QoL utility index and a visual analogue scale (VAS) [28]. Improvement in utility scores and VAS were

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percutaneous procedures.

Resuming normal life quickly

after procedure was greatly

valued

SF-36 domains, particularly in

physical domains

signicantly improved at

6months and 5years after

intervention

high levels of QoL after

intervention. Signicantly

better QoL reported by the

controls

All SF-36 domains similar to

age-matched controls after

procedure

A. Barradas-Pires et al.

symptoms after procedure,

particularly in patients

>40years

signicantly after the

procedure

All SF-36 domains similar to

age-matched controls after

procedure

Instrument(s)

used Matching variables Key ndings

Follow-up

(months)

Sex

female)

N (int. /

control) Age

– Patients happy with

Semi-

structured

30 3–6

[7–30]

10/– 17

Canadian reference

group

interview

29 0, 6 SF-36 – General improvement in most

[17–30]

53/– 23

63/– 22±11 33 0, 6, 60 EQ-5D, VAS – Utility indexes and VAS

27/27 69±6 63 12–84 TAAQOL Age, sex Patients reported high/very

72 28 SF-36 Age-adjusted

[60–86]

54/– 69

– Great improvement in

(patient

symptoms)

30/– 49±17 53 1, 6, 12 MCQ

75/– 65±16 60 0, 12 SF-36 – All SF-36 domains improved

economic status,

education level,

marital and

employment status

69/69 40±14 74 18 SF-36 Age, sex,

Case series,

Table 9.1 Studies using quality of life and patient reported outcome measures to assess the effectiveness of percutaneous procedures in adult congenital heart disease (ACHD)

cross-sectional

References Study design

etal. 2014

PPVI Andresen

Case series,

longitudinal

Case series,

Muller

etal.2014

Hager etal.

longitudinal

2018

Non-randomized,

Cohen etal.

Percutaneous

control study,

cross-sectional

2010

ASD closure

Retrospective chart

review and

prospective

Hanninen

etal. 2011

questionnaire,

cross-sectional

Case series,

longitudinal

Mangiaco

etal. 2013

Case series,

longitudinal

Case series,

Komar etal.

2014

Eren et a.

cross-sectional

2015

9 Percutaneous Interventions inAdult Congenital Heart Disease

quality of life after procedure,

with no signicant differences

with the control group

signicantly after the

procedure

All SF-36 domains similar to

age-matched controls after

procedure. Non-closure PFO

group had signicantly lower

scores than the closure group

and the matched controls

gender-matched

Swedish reference

group

TAAQOL Age Participants reported high

177

specied

89/60 54±12 58 Not

Non-randomized,

control study,

Cohen etal.

2010

34/– 46±10 59 0, 6 SF-36 – All SF-36 domains improved

cross-sectional

Case series,

longitudinal

Evola etal.

2013

51±12 37 36–156 SF-36 Age- and

208/136/208

(ref.)

Case series,

cross-sectional

Mirzada

etal. 2018

Percutaneous

PFO closure

(post-stroke)

ASD, atrial septal defect; MCQ, multiple choice questions; PFO, patent foramen ovale; PPVI, percutaneous pulmonary valve implantation; VAS, visual analogue scale

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A. Barradas-Pires et al.

reported on both periods. The improvement in the utility indexes was related to the severity of right ventricular obstruction in those receiving PPVI for pulmonary stenosis. Nevertheless, improvement in pulmonary regurgitation after the procedure was not related to QoL improvement.

Through semi-structured interviews of patients and their next-of-kin at 3–6months following PPVI, Andresen et al. were able to garner the priorities of patients undergoing this procedure. Those interviewed emphasised the importance of regaining independence and taking control of daily life following the intervention [29]. Compared to previous surgical management, patients reported the physical burden of the procedure as being “minimal”, and the next-of- kin highlighted the importance of a timely return to normal life following the procedure.

Percutaneous Atrial Septal Defect Closure

Most studies assessing QoL after percutaneous ASD closure have focused on patients over 60years of age. Cohen etal. reported that almost 80% of patients had a “good” or “very good” quality of life after ASD closure [30]. Nevertheless, when compared to age-matched controls, their QoL was still signicantly lower. QoL in these patients was associated with depression and anxiety scores, but not with functional class. In a Canadian study that included older adults following both surgical and percutaneous ASD repair, patients achieved similar scores on SF-36 QoL questionnaires to age-matched controls [31], associated with an improvement in functional class. Komar etal. corroborated these results in a longitudinal study, assessing older adults at 12months following percutaneous ASD closure [32]. Patients reported a signicant improvement in all the SF-36 domains along with a signicant improvement in exercise capacity.

In younger patients who underwent ASD closure, QoL scores after the procedure in the SF-36

were similar to the general population [33]. An Italian group described similar results, although the authors did not use a specic QoL instrument and chose to assess QoL based on functional class, physical capacity and symptoms [34].

Patient Foramen Ovale Closure (Post-Stroke)

A patent foramen ovale (PFO) is a common condition, affecting around one quarter of the general population [35]. It is not considered a congenital heart defect, but is often managed by CHD specialists, especially in rare cases when a PFO allows paradoxical emboli causing (otherwise cryptogenic) strokes in younger patients. A meta-analysis of observational studies has shown a stronger association of PFO with cryptogenic stroke in patients <55 years compared to older patients, particularly when atrial septal aneurysms are present [36]. PFO closure following a cerebrovascular event is often performed by CHD interventionalists, who have experience in the percutaneous closure of other intra-cardiac communications.

Cohen and colleagues were the rst authors to study the QoL implications of PFO closure, using the TAAQOL instrument [37]. Participants were divided into 2 age-groups and their responses were compared to age-matched controls. After PFO closure, the reported QoL was high in both age groups, with no difference to the matched controls. Optimism, estimated with a life orientation test (LOT-R), was higher in patients than in the control group. Older age and nancial status were correlated to anxiety, depression and worse QoL. These three domains were highly interrelated, and negatively associated to optimism.

Evola et al. reported a signicant improvement in QoL, measured using the SF-36 questionnaire, at 6 months after PFO closure [38]. This was largely attributed to an improvement in migraine symptoms. In a long term follow-up study, 3–12 years after PFO closure, Mirzada etal. reported a sustained improvement in QoL

9 Percutaneous Interventions inAdult Congenital Heart Disease

179

over time after the procedure [39]. Importantly, patients after PFO closure reported similar QoL metrics to a group of matched healthy adults, which was not the case for the non-closure group who described signicant impairment in their physical, vitality, and general health domains.

Discussion

QoL After Percutaneous Procedures inACHD

Surgical closure of atrial septal defects of pulmonary valve implantation have been the goldstandard in the ACHD eld for the last 50years. Nevertheless, percutaneous procedures have gained notoriety in the last three decades. In terms of QoL, longitudinal CHD studies reported a consistent improvement in different HRQoL domains after percutaneous intervention. These results contrast with a few studies of HRQoL after surgical intervention, where QoL was described as impaired compared to the general population [40–42]. These difference seems more pronounced for motor domains in patients with complex anatomies [43]. In more simple procedures, such as ASD closure, a small study comparing HRQoL after percutaneous versus surgical procedures showed that, although both groups improved their QoL, the patients in the percutaneous intervention group reported better scores in some SF-46 dimensions than their surgical counterparts [44]. Shorter admissions and speedy recovery time can explain some of the differences reported, as the amount of physically disability after surgery is seen as a core determinant of poor health status. Patients especially mention the ability to resume their usual daily activities quickly as one of the main positive experiences of percutaneous interventions compared to their previous surgical experience. Nevertheless, it is important to remember that patients undergoing surgery are more likely to have more complex CHD, which, together with comorbidities and CHD-related complications, might also inuence their self-perceived QoL.

The Utility ofDierent Quality ofLife Tools intheSetting ofPercutaneous Procedures inAdult Congenital Heart Disease

Overall, studies assessing HRQoL around percutaneous procedures in ACHD patients have used 3 main instruments: SF-36, EQ-5D and TAAQOL.Each tool aims to assess a different set of domains (Fig.9.2). The QoL instrument most frequently used in percutaneous interventions in ACHD was the SF-36 questionnaire, which is a generic assessment tool and also the most frequently used PROM in clinical trials worldwide [45]. It assesses health status using 36 items focused on 8 “health perception” domains: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, vitality, pain, and general health perceptions. It has been used in a variety of populations and clinical scenarios, including ACHD [43]. Therefore, it is a good choice for enabling comparisons between clinical groups or with healthy controls. Nevertheless, extrapolating general QoL from the results of the SF-36 questionnaires requires caution, as this tool tends to link general health perceptions with “health-related disability”, when we know that patients with disabilities might still feel overall “healthy” [2]. Another common pitfall in the use of the SF-36 is reporting a total score based on all 8 dimensions. Each questionnaire domains should be reported separately, and the overall score that is often calculated using different algorithms is not standardised and has conceptual and methodological drawbacks [46, 47].

Another generic instrument used to assess QoL in ACHD patients after a pulmonary valve implantation was the EQ-5D.This HRQoL tool has been used for over 30years [48]. It is simpler than the SF-36 and developed to standardise the value of QoL associated with health. The EQ-5D instrument asks subjects to describe their health status in 5 specic domains (mobility, self-care, main activity, pain/discomfort and anxiety/ depression) and then requests an evaluation of

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A. Barradas-Pires et al.

SF-36

Physical functioning

Social functioning

Physical problems

Emotional Problems

Mental health

Pain

Vitality

General health perceptions

Fig. 9.2 Comparison of the domains included by the different tools used to investigate changes in quality of life (QoL) after percutaneous interventions in adult congenital heart disease (ACHD)

their “overall health status” using a Visual Analogue Scale (VAS). These components can be incorporated into one single index, facilitating comparison across different settings. As with the SF-36, however, this tool does not capture social or environmental domains, which are of interest in the ACHD population.

The third instrument used was the Netherlands Organisation for Applied Scientic Research Academic Medical Centre (TNO-AZL) adult quality of life questionnaire (TAAQOL). The TAAQOL was developed by Bruils etal. in 2001 as a generic HRQoL instrument [49, 50] and then adapted to the congenital cardiac setting by Kamphuis in 2004 under the name CHDTAAQOL [26]. Since then, variations of this questionnaire have been validated in children, adolescents and adults with CHD.The TAAQOL

EQ-5D

Mobility, self-care, main

activity

Anxiety/depression

Pain/discomfort

Overall, the instruments used to assess QoL after percutaneous interventions rely on PROMs that are often generic, simplistic and focused on health-related domains, therefore, interpretations on overall QoL should be avoided. Most of these tools also lack the sensitivity required to detect changes in QoL over time or around an intervention. New tools designed for the ACHD population are needed to better detect and report such changes, but these will need to be tested and validated against established measures. When reporting PROMs, statements should be limited to the dimensions directly assessed by the instruments used. Sweeping statements, such as that “QoL of patients with ACHD improves” after a given procedure, based only on the results of a single questionnaire, fail to recognise QoL as a broad, multidimensional concept and should be discouraged.

CHD-TaaQol

Symptoms

Worries

Impact Cardiac

Surveillance

tool has been used in 2 studies in this review, assessing patients following ASD and PFO closure [30, 37]. This tool focuses on three main domains: symptoms, worries, and the impact of

Comparison ofPROMs withOther Established Health Outcomes

cardiac surveillance on QoL. The nal score ranges from 1 to 12 and, contrary to previous tools, higher scores describe a worse HRQoL.This tool is original for 2 reasons: rstly, it is designed to capture the perceptions and emotional reactions to illness; secondly, it aims to assesse the changes in a patient’s QoL after surgery or other intervention. Both are particularly relevant to ACHD patients.

An association between functional class and QoL has previously been documented in ACHD patients, including those with cyanotic CHD or following a surgical procedure [42, 44]. Nevertheless, most studies assessing QoL in ACHD patients following percutaneous procedures failed to demonstrate a denitive link between QoL and more traditional outcome indi-

9 Percutaneous Interventions inAdult Congenital Heart Disease

181

cators, such as peak oxygen uptake, functional class or survival [51].

The association between QoL indicators and mortality was not addressed in any of the studies on percutaneous procedures in ACHD. In other settings, such as in patients with pulmonary arterial hypertension associated with CHD, negative changes in QoL measured by SF-36 questionnaires were identied as a mortality predictor, along with functional class, 6-min walk distance or BNP levels [52]. Favoccia etal. found that QoL measured by Emphasis-10 questionnaires in patients with pulmonary hypertension, including those with pulmonary arterial hypertension associated with CHD, was an independent predictor of mortality in addition to functional class or age [53]. In congenital patients with cyanosis or Eisenmenger syndrome, iron replacement therapy was also associated with an improvement in QoL [54].

This literature review has highlighted the signicant heterogeneity in terms of methodology and population between studies measuring PROMs, including QoL, which is a signicant barrier when attempting to compare or pool data (Table 9.2). Even within specic ACHD cohorts of patients undergoing the same procedure, study

Table 9.2 Sources of heterogeneity encountered when measuring patient reported outcomes (PROMs) and quality of life (QoL) in adult congenital heart disease (ACHD) patients undergoing percutaneous interventions

Domain Sources of heterogeneity ACHD patients Wide age range

Anatomy and congenital heart disease complexity Pre-procedural symptoms

Procedure being assessed First procedure, repeated

or combined

Outcome measure Choice of patient-reported

outcome Denition of QoL

Scope, heterogeneity and applicability of QoL instruments/PROMs

Heterogeneity of study design

Format of instrument (short questionnaire vs. semi-structured interview) QoL domains assessed Applicability to the ACHD population Reporting of results

Longitudinal vs. cross-sectional Use and choice of control group

designs were heterogeneous, for example: longitudinal (such as pre- and post-procedural changes in QoL) versus cross-sectional; different control groups (local community versus general population or standardised QoL indices), etc. A wide range of QoL instruments were also used, from generic versus disease-specic, and directed questionnaires versus open-interview structures.

In order to expand and improve the use of HRQoL tools in daily practice worldwide, clinical guidelines and consensus statements should include QoL domains as desirable endpoints in cardiovascular studies and encourage its use in combination with more classical outcomes. This has been done for interventional procedures such as transcatheter aortic valve implantation (TAVI) and coronary interventions, where academic research consortiums have included QoL endpoints and provided guidance about tools and their interpretation [55, 56]. In the case of ACHD catheter interventions, to the best of our knowledge, no such guidance is yet available.

Concluding Remarks

QoL tools should be used more often in ACHD research and clinical practice and should complement functional status, imaging data and objective measures of exercise capacity (Fig. 9.3). PROMs associate with an intervention should be interpreted in a broader context, taking into account the patients’ characteristics and all the factors that may inuence their perception regarding the procedure’s benets and drawbacks (including age, CHD complexity and the presence of anxiety or depression).

Patient preference is fundamental in the management choices we make. The published ACHD QoL literature lacks standardisation in concepts and methodology, making it very difcult to compile and interpret outcomes. Standardisation is crucial in order to speak the same language and be able to compare information between different centres, diseases, ages etc. Moreover, particularly in the ACHD eld where patients are followed throughout different stages of their lives, an effort to shift from health-related quality of life instruments to more comprehensive tools should be

182

Conclusions

Quality of life (QoL) tools should be used in clinical practice as complement to functional status, imaging

data and objective measures of exercise capacity.

assessment should incorporate social, environmental, and physical and mental characteristics.

QoL after important treatment landmarks, such as surgery or interventional procedures, but also across different stages of patients’ lives. The definition of QoL should, therefore, retain a dynamic component.

Standardisation of QoL tools in research is key to compile and interpret outcomes from different studies.

interventions. Predictors of poor QoL after percutaneous interventions are scarce in ACHD research. Nevertheless, some studies have identified low educational or financial status, presence of symptoms and coexistence of depression / anxiety as poor predictors of QoL after procedures.

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QoL in Adult Congenital Heart Disease (ACHD) extends beyond health-related dimensions, and its

Patient-reported outcome measures in ACHD research should be able to capture the changes in

Studies in health related QoL in ACHD suggest an improvement in some QoL domains after catheter

A. Barradas-Pires et al.

Fig. 9.3 Highlighted conclusions

made, so other signicant QoL domains can be adequality captured and analysed in research, and then incorporated in our daily practice.

6. Baumgartner H.Geriatric congenital heart disease: a new challenge in the care of adults with congenital heart disease? Eur Heart J. 2014;35:683–5. https://

doi.org/10.1093/eurheartj/eht358.

7. Briston DA, Bradley EA, Sabanayagam A, Zaidi AN. Health Care Costs for Adults With Congenital Heart Disease in the United States 2002 to 2012. Am

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