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Health-Related Quality ofLife Outcomes forEndovascular andOpen Surgical Interventions inAortoiliac andFemoropopliteal Steno-Occlusive Arterial Disease

JimmyKyawTun, StefanLam, MohammedRashidAkhtar, andOunaliJaer

Abbreviations

ABPI Ankle-brachial pressure index BMT Best medical therapy CD-TLR Clinically-driven target lesion revas-

cularisation

CERAB Covered endovascular repair of aor-

tic bifurcation CLTI Critical limb-threatening ischaemia DCB Drug-coated balloon DES Drug-eluting stent EQ EuroQoL HRQOL Health-related quality of life ICQ Intermittent claudication question-

naire MCID Minimal clinically important differ-

ence OCT Optical coherence tomography

J. K. Tun · M. R. Akhtar · O. Jaffer (*) Department of Interventional Radiology, Royal London Hospital, Barts Health NHS Trust, London, UK e-mail: jimmy.kyawtun@nhs.net;

mohammedrashid.akhtar@nhs.net; ounali.jaffer@nhs.net

S. Lam Barts and the London School of Medicine & Dentistry, Queen Mary University of London, London, UK e-mail: stefan.lam@nhs.net

PAD Peripheral arterial disease PAQ Peripheral arterial questionnaire PTA Percutaneous transluminal angio-

plasty QALY Quality-adjusted life year RCT Randomised controlled trial SF Short form SFA Supercial femoral artery SET Supervised exercise therapy WIQ Walking impairment questionnaire

Introduction

There is an impending epidemic in peripheral arterial disease (PAD), largely due to an aging population and increased rates of obesity and diabetes, with the condition currently prevalent in

5.6% of the adult population worldwide.

Sufferers of PAD often experience a decreased quality of life and reduced functional independence. The symptoms experienced depend on disease severity and range from limited walking distance in claudicants, to rest pain and tissue loss with risk of major amputation in those with critical limb-threating ischaemia (CLTI) [1]. The quality of life in those with PAD is often further degraded by concomitant related disorders including hypertension, dyslipidaemia, diabetes and nephropathy [2].

https://doi.org/10.1007/978-3-031-09815-4_19

361

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J. K. Tun et al.

There is an ever-increasing armamentarium available for lower limb revascularisation, particularly in terms of endovascular treatment with the advent of drug-coated balloons (DCB) and drug-eluting stents (DES) to atherectomy and lithotripsy; but these innovations also come with signicantly increased costs. It is therefore necessary to evaluate both clinical effectiveness and health economics of these interventions. Conventionally, studies evaluating lower limb interventions have focused on physicianorientated outcome measures such as technical success (e.g. successful revascularisation of an occluded artery), patency rates, ankle-brachial pressure index (ABPI), freedom from clinicallydriven target lesion revascularisation (CD-TLR) and freedom from amputation [1]. However, these measures alone do not take into account the patient’s perspective. For instance, vascular clinicians generally consider major amputation to be an adverse outcome in PAD, yet it has been shown that health-related quality of life (HRQOL) can improve following major amputations [3]. A systematic review comparing primary amputations and revascularisation in CLTI found insufcient evidence to support one treatment over another in terms of HRQOL outcomes [4].

There is an increasing recognition for the need to evaluate HRQOL outcomes for intervention in PAD to take into account the patient’s perspective to better inform treatment decisions [5]. This is emphasised by the use of quality-adjusted life years (QALYs) by the National Institute for Health and Clinical Excellence (NICE) for health technology assessment. In order to generate QALYs, health utilities (or HRQOL weights) are needed. As such, the measure is reliant on both the quality and the quantity of the life lived in order to determine health outcomes and therefore health economics.

The focus of this study is to present a systematic review of the current evidence of HRQOL outcomes in relation to endovascular and open surgical treatment of aortoiliac and femoropopliteal steno-occlusive disease. A review of the evidence for intervention in infrapopliteal disease is presented in Chap. 20.

Materials andMethods

Search Strategy

This systematic review was conducted according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The initial search strategy focused on identifying papers based on specic interventions (e.g. iliac angioplasty, aortoiliac bypass graft). However, on manual review of the references of several key systematic reviews, it was evident that this search strategy omitted some relevant papers. Therefore, a much broader search strategy was employed as follows.

A systematic search using Embase (Including Embase Classic) (1947 to February 2020), Medline (1946 to February 2020) and PsycINFO (1950 to February 2020) was conducted. The search terms used were as follows: “quality of life” AND (“peripheral arterial disease” OR “peripheral vascular disease” OR “intermittent claudication” OR “critical limb ischaemia” OR “critical limb ischemia”).

Inclusion andExclusion Criteria

Studies published in the English language reporting HRQOL outcomes in adults undergoing invasive intervention—i.e. both open and endovascular surgery—for steno-occlusive disease in the aortoiliac and femoropopliteal segments were sought. Although the primary focus of this review was to evaluate the outcomes of invasive interventions, studies comparing noninvasive treatments such as supervised exercise therapy (SET) and best medical treatment (BMT) to invasive interventions were also included.

Studies were only included if they presented results specic to an anatomical segment. Papers which included patients treated across a range of anatomical segments were excluded if outcome data specic to an anatomical segment (aortoiliac or femoropopliteal) was not available. If the study included distal (below knee) intervention and/or distal bypass surgery, then these were also

19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…

363

excluded. Studies were excluded if they had less than 6months follow-up data.

Study Selection andData Extraction

The broad search criteria yielded an initial extensive list of abstracts. Therefore, one researcher (JKT) performed an initial screening of abstracts to remove articles that were clearly irrelevant. A second stage review of the full texts of the remaining articles was then performed by JKT and MRA and where there was uncertainty or difference in opinion, adjudication was performed by a third reviewer (OJ).

Data obtained included: author, year of publication, study objective, study type, number of patients, study centre location, HRQOL outcomes, follow-up period and completion rates.

The methodological quality of the studies was assessed by SL and MRA using a 10-point scoring system described by Mols etal. [6] Studies scoring ≥8 were considered to be of ‘high quality’, those scoring between 5 and 7 were deemed to be of a ‘moderate quality’ and <5 were categorized as ‘poor quality’ (Appendix).

Results

The literature search initially identied 3284 abstracts (reduced from 4893 following deduplication and limiting to English language studies in adult humans). In total, 89 papers remained after the initial screening process. Two additional studies were added following the review of reference lists of published related systematic reviews. Following the second stage review, 38 papers were included in this study (Fig.19.1).

Study Objectives, Design andPopulation

Of the 38 papers selected for review, there were four pairs of papers which reported the longer and shorter term follow-up outcomes of the same

studies, and thus were merged for analysis (34 studies in total) [7–14].

The study period ranged from 1993 to 2017, with the majority of included papers published after 2000 (33 out of 34). The clinical study design of the 34 studies included 15 randomised controlled trials (RCTs), 17 prospective cohort studies and two retrospective cohort studies. Eight studies were related to intervention in the aortoiliac segment, 25 studies were related to intervention in the femoropopliteal segment, and one additional paper studied interventions in both the aortoiliac and femoropopliteal segments.

Health-Related Quality ofLife Outcome Measures

A total of nine different QOL instruments were used (Table19.1). Five generic QOL instruments were used including: EuroQol (EQ)-5D-3L, EQ-5D-5L, RAND-36, Short form (SF)-36, SF-12, SF-8. Four disease specic QOL instruments were used including: Walking Impairment Questionnaire (WIQ), Peripheral Arterial Questionnaire (PAQ), VascuQOL and Intermittent Claudication Questionnaire (ICQ).

Many papers reported using the EuroQOL instrument but did not specify which variant was used, e.g. EQ-5D-3L versus EQ-5D-5L.

Studies Focused onAortoiliac StenoOcclusive Disease

Nine studies were identied which focused on surgical and/or endovascular interventions for aortoiliac steno-occlusive disease. Details of outcomes are shown in Table19.2.

One prospective multicentre observational study investigating outcomes of patients who had undergone endovascular intervention (angioplasty and/or stenting) for Rutherford 2–4 aortoiliac disease demonstrated signicant improvements in HRQOL outcome at the 12-month follow-up compared to baseline [16].

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J. K. Tun et al.

ScreeningIncluded Eligibility Identification

Same studies with

different follow-up times

merged for analysis

Records identified through

database searching

(n = 4893)

Records after duplicates and non-English

Full-text articles assessed

(n = 4)

studies removed

(n = 3286)

Records screened

(n = 91)

for eligibility

(n = 38)

Studies included in

systematic review

(n = 34)

Additional records identified

through reference lists

(n = 2)

Records excluded

(n = 3195)

Full-text articles excluded

(n = 53)

Reasons for exclusion:-

- No outcome data specific to segments of interest

- Inclusion of distal (below knee) intervention and/or distal bypass surgery

- Less than 6 months of follow-up data

Studies on aortoiliac

interventions

(n = 8)

Fig. 19.1 Flow diagram of literature review

Studies on femoropopliteal

interventions

(n = 25)

A further three multicentre prospective cohort studies specically investigated the use of primary stenting with bare metal stent for aortoiliac disease [17–19]. All three demonstrated an improvement in HRQOL measures at follow-up.

An RCT published in 2015 compared three treatment arms: BMT, stenting with BMT, and SET with BMT. The study demonstrated that patients who received either stenting or SET had

signicantly better HRQOL than those whom received BMT alone at both the 6- and 18-month follow-up timepoints [14]. No signicant difference in HRQOL outcomes was seen between the SET and stenting group. Another RCT comparing percutaneous transluminal angioplasty (PTA) combined with SET and BMT to BMT combined with SET demonstrated better HRQOL outcomes in the PTA group at 24-month follow-up [22].

Studies on interventions

at both segments

(n = 1)

19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…

Table 19.1 Description of health-related quality of life instruments utilised by included studies

Health-related quality of life (HRQOL) instrument Description

Short Form Health Survey (SF-36, SF-12, SF-8)

Walking Impairment Questionnaire (WIQ)

EuroQol Five Dimensions (EQ-5D)

RAND 36-item Health Survey (RAND-36)

Peripheral Artery Questionnaire (PAQ)

Vascular Quality of Life Questionnaire (VascuQoL)

Intermittent Claudication Questionnaire (ICQ)

SF-36—A 36-item, patient- reported survey of patient health status consisting of eight domains: Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning and Mental health (summarised physical and mental component scores are also calculated). Each domain is scored on a 0–100 scale, with a lower score representing greater disability.

SF-12 and SF-8—Shortened versions of SF-36 with 12 and 8 items respectively, evaluating the same eight domains.

A subjective measure of patient- reported walking performance in patients with peripheral arterial disease consisting of three domains: Walking distance, Walking speed and Stair-climbing ability (a total mean score is also calculated). Each domain is scored from 0% to 100%, with a lower percentage representing a poorer walking performance.

A self-reported, standardized instrument for measuring generic health status consisting of ve dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression—each dimension is rated on a three-level (EQ-5D-3L) or ve-level (EQ-5D-5L) scale based on severity. An evaluation of overall health is done on the day of questionnaire completion using a Visual Analogue Scale (EQ-VAS)— this is indicated on a vertical scale from 0 to 100.

This instrument utilises the same 36-item questionnaire as SF-36 and evaluates the same eight domains with minor differences in scoring the General health perceptions and Bodily pain scales.

A 20-item, patient-reported peripheral artery disease-specic HRQOL questionnaire consisting of six domains (Physical limitation, Symptoms, Symptom stability, Social limitation, Treatment satisfaction and Quality of life) and a summary score. Each domain is scored on a 0–100 scale, with higher scores indicating less functional limitation, fewer symptoms, better treatment satisfaction, higher social functioning, and better health status.

VQ-25—A 25-item patient- reported peripheral artery disease-specic HRQOL questionnaire consisting of ve domains (Activities, Symptoms, Pain, Social life, Emotions) and an overall (mean) score. Each item is scored on a 7-point response scale, with higher scores indicating better HRQOL.

VQ-6—A 6-item, short form of VQ-25 evaluating the same domains except on a 4-point response scale.

A 16-item self-administered intermittent claudication-specic HRQOL instrument evaluating severity of pain, limitations on activities of daily living, emotional impact and interference with activities. Each item is assessed on a 5-point adjectival scale and scored between 0 and 100 (0=worst, 100=best).

365

One paper presented a direct comparison of two endovascular procedures within an RCT study design. The trial compared stenting to PTA and demonstrated improvement in HRQOL outcomes in both groups at 24-month follow-up, but no signicant difference between the two groups [20]. Of the remaining two papers relating to intervention in the aortoiliac segment, one prospective cohort study demonstrated improved HRQOL measures at 6months following laparo-

scopic aorto-bifemoral bypass surgery [15]; while the other retrospective observational study—which compared stenting to aortobifemoral bypass surgery—demonstrated no signicant difference in HRQOL outcomes between the groups [21]. However, subgroup analysis did reveal signicantly improved outcomes in the endovascular group compared to the surgical group in one item of the WIQ questionnaire (difculty in walking 150m).

366

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Quality

score

Main ndings related to

HRQOL

Statistically signicant

improvement from baseline

with LABFB for

HRQOL

instrument(s) used,

method of delivery,

completion rate Key outcomes

was found in all domains as

well as in the summary scores.

Substantial at 1month,

sustained until 6month

Trans-Atlantic

Inter-Society

Consensus II,

type D lesions

follow-up.

showed signicant

improvement at all the

postoperative survey time

points as compared to the

preoperative scores, whereas

have substantial

and statistically

signicant

improvement in

the patients’

HRQL.

Not stated The PCS summary scores

80%

the MCS scores showed

improvement only at

6months

Concomitant operations had a

statistically signicant

negative impact on the

physical components of

SF-36 (PF, RP).

J. K. Tun et al.

When studying PCS, a positive

impact of smoking and a

negative impact of concomitant

operation and blood loss were

found. In case of MCS, only

the length of hospital stay had

a statistically signicant

(p<0.03) negative effect on

the score, but its magnitude

was not substantial (−0.3

points change per day).

Preop

Cohort size,

Author (year

publication),

Study

Follow-up

period

HRQOL

assessment

Yes 6months SF-36 Patients operated

with TASC II D lesions

presenting with IC.

study

centre(s) Patient characteristics

50 Consecutive patients

Study intent/

associated study

To examine

HRQOL in

patients operated

period,

Study type

(2017) [15]

Mean age 62year, Male

46%

University

with laparoscopic

aortobi femoral

bypass (LABFB)

for athero-

sclerotic

obstruction in

2005–2011 Oslo

All patients were in

Rutherford’s category 3,

except two patients who

were in Rutherford’s

category 5.

Hospital,

Sweden

aortoiliac

segment.

Prospective

study

Type of

intervention

Device type,

Brand name (if

applicable)

Table 19.2 Studies including interventions on aorto-iliac steno-occlusive disease

Surgery Kazmi et al.

19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…

Quality

score

Main ndings related to

HRQOL

EQ-5D: All global and

domain (utility score, VAS)

our ongoing

HRQOL

instrument(s) used,

method of delivery,

completion rate Key outcomes

scores showed improvement

at 1year after EVT

(p<0.001).

(pain, distance, speed,

multicentre

prospective study

indicate

acceptable safety

and efcacy of

aortoiliac EVT,

Not stated. Use of

climbing) scores showed

improvement at 1year after

EVT (p<0.001).

supporting the

recent

recommendation

that EVT can be a

multiple

imputations to

generate data for

patients lost to

rst-line

treatment for

aortoiliac disease.

follow-up

The WIQ PAD specic score,

walking distance score,

walking speed score and stair

climbing score each showed a

signicant increase from

baseline to 12months

(p<0.001).

12months was

2.1% (p<0.001).

The acute

procedural

success and

30-day clinical

success

outcomes were

both 95%. The

primary patency

system was

shown to be safe

Not stated The Astron stent

and effective in

WIQ: 89%

rate at 12months

was 89.8%.

the treatment of

patients with

atherosclerotic

disease. The

367

(continued)

observed MAE

rate met the

pre-specied

performance goal

of 15%. The stent

demonstrated a

high 12-month

primary patency

rate and showed

improvement in

quality of life

measures.

Preop

Cohort size,

Author (year

publication),

Study

Follow-up

period

HRQOL

assessment

Mean age of 73±9 No 1year WIQ, EQ-5D 1-year data from

study

centre(s) Patient characteristics

893 (1128

limbs)

Study intent/

associated study

1-year clinical

outcomes of

endovascular

period,

Study type

Yamauchi et

al. (2019)

[16]

83% male Not stated WIQ: All global and domain

Rutherford category:

2/3/4=42%/51%/7%

in Japan

therapy (EVT)

for de novo

aortoiliac lesions

in patients with

symptomatic

2014–2019 64 centres

Prospective

observa-

Chronic total occlusion

(per limb)=36%

Femoropopliteal lesion

(per limb)=37%

PAD (Rutherford

classication 2, 3

or 4).

tional study

Yes 12months WIQ The MAE rate at

evaluable patients was

63.6years with the

majority being male

(65.2%). Patient risk

factors included

hyperlipidemia (77.6%),

161 The mean age of the

To evaluate the

safety and

efcacy of a

self-expanding

bare-metal nitinol

stent (Astron) for

the treatment of

(2016) [17]

external iliac

arteries.

Common iliac 67%,

2011–2014 30 centres

hypertension (72.7%)

and patients that were

current smokers (48.4%).

athero sclerotic

lesions in the

common and

external iliac 33%

TASC II A/B =

62%/35%

De novo 91.3%,

moderate/severe

(USA,

Canada,

Austria)

Prospective

study

calcication 70.8%

Type of

intervention

Device type,

Brand name (if

applicable)

Endovascular

(balloon-

expandable

stent,

self-expand-

able stent,

PTA)

Stent Burket et al.

Self-

expandable,

bare nitinol

stent

Astron

368

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Quality

score

Main ndings related to

HRQOL

WIQ: signicant

improvement from baseline

signicantly

HRQOL

instrument(s) used,

method of delivery,

completion rate Key outcomes

in all three dimensions

(walking distance, walking

speed, and stair climbing).

SF-36: Signicant

improvement from baseline

for health dimensions of

improved from

0.64±0.15 to

0.89±0.19

(p<0.01).

Mean initial

claudication

duration

Self-administered

(optional help

from research

physical functioning, role

physical, bodily pain and

vitality; also, physical

component scale

improved (1.7 ±

1.0 to 4.7 ± 3.3

months) and

mean MWD on

treadmill test

improved (3.3 ±

1.8 to 8.7 ± 4.4

months).

assistant)

80%

J. K. Tun et al.

No 30-day

mortality.

Complication rate

9% (n=3).

High technical

success (97%).

Preop

Cohort size,

Author (year

publication),

Study

Follow-up

period

HRQOL

assessment

Yes 12months SF-36, WIQ Mean ABI

Mean age 61.1 (SD 9.5),

Male 71%, HTN 54%,

DM 14%

study

centre(s) Patient characteristics

35 (46

limbs)

Study intent/

associated study

To determine the

effect of

aortoiliac stent

placement on

period,

Study type

al. (2005)

[18]

Stenosis n=30, chronic

arterial occlusions n=16

Island

Hospital,

Rhode

walking ability

and health-

related quality of

life (QOL) for

aortoiliac

insufciency in

1996–1999 Rhode

Island, USA

elderly

individuals with

moderate to

severe

Prospective

study

intermittent

claudication.

Type of

intervention

Device type,

Brand name (if

applicable)

Table 19.2 (continued)

Stent Murphy et

Self-

expandable,

bare alloy

stent/

self-

expandable,

polyester

covered alloy

stent/

balloon-

expandable

bare

stainless-steel

stent

Wallstent/

Wallgraft/

Palmaz

19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…

Quality

score

Main ndings related to

HRQOL

The proportion of patients

with cumulative improvement

from baseline of at least one

Rutherford category at the

9-month visit was 90.5%

(124 of 137; 95% CI:

HRQOL

instrument(s) used,

method of delivery,

completion rate Key outcomes

composite

endpoint rate

was 16.2%

(93.5%

condence

84.3–94.9%).

interval [CI]:

10.6–23.2%),

primary patency

was 89.1% (95%

CI: 82.6–93.7%),

and freedom

score from baseline

32.1±26.84. Improvements

noted in all domains.

from TLR was

96%.

Not stated WIQ: mean change in total

LIFESTREAM

balloon-

expandable

covered stent

provided

satisfactory

9-month clinical

outcomes

including a low

rate of target

lesion

revascularization

for the treatment

of stenotic and

88% The

369

(continued)

occlusive lesions

of the iliac

arteries.

Preop

Cohort size,

Author (year

publication),

Study

Follow-up

period

HRQOL

assessment

Yes 9months WIQ The primary

symptoms of

lifestyle-limiting

study

centre(s) Patient characteristics

155 Eligible patients had

Study intent/

associated study

To assess the

performance of

the

period,

Study type

(2019) [19]

claudication or ischemic

rest pain (Rutherford

categories 2–4) and de

novo or re-stenotic,

non-stented lesions (!

50% of the reference

vessel diameter) in the

iliac artery.

LIFESTREAM

balloon-

expandable

covered stent for

the treatment of

iliac artery

atherosclerotic

lesions.

Mean age 64 years, Male

69%, HTN 76%, DM

32%

(Europe,

USA, NZ)

2014–2015 17 centres

Common iliac 73%,

external iliac 27%

study

TASC A/B/C and

D=62%/27%/11%

Rutherford 2/3/4 =

16%/76%/8%

Type of

intervention

Device type,

Brand name (if

applicable)

Stent Laird et al.

Balloon-

expandable,

ePTFE covered

stainless-steel

stent

LIFESTREAM Prospective

370

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Quality

score

Main ndings related to

HRQOL

When the two treatments

were compared, no signicant

Health-related

quality of life

HRQOL

instrument(s) used,

method of delivery,

completion rate Key outcomes

EQ-5D

difference was observed

(p<0.05). All measurements

showed a signicant

improves equally

after primary

stent placement

improvement in the quality of

life after treatment (p<0.05).

In both groups, scores of all

RAND-36 dimensions showed

signicant improvement after

revascularization. The scores

were still signicantly higher

than before treatment, with the

exception of the dimension of

and primary

angioplasty with

selective stent

placement in the

treatment of

intermittent

claudication

caused by iliac

artery occlusive

Telephone

interview

general health perception in

stent group (p=0.20) and

PTA group (p=0.09).

disease.

highest for physical

functioning, physical role

functioning, and bodily pain.

Scores on all RAND-36

dimensions were not

signicantly different

36% The effect of treatment was

between the groups.

All valuational quality-of-life

measures (time trade-off,

standard gamble, rating scale,

J. K. Tun et al.

health utilities index, EQ-5D)

demonstrated a signicant

improvement after treatment,

with the exception of the

standard gamble.

The values were not

signicantly different

between the groups.

Preop

Cohort size,

Author (year

publication),

Study

Follow-up

period

HRQOL

assessment

Yes 24 months RAND-36,

intermittent claudication

or critical ischemia

study

centre(s) Patient characteristics

279 All patients with

Study intent/

associated study

To assess the

quality of life in

patients with

period,

Study type

Bosch et al.

(1999) [20]

Stent (n=143): Mean

age 59, Male 71%;

compared

primary stent

placement versus

1993–1996 Six centres

common iliac 70%,

Netherlands

primary

caused by stenosis or

occlusion in the iliac

arteries.

iliac artery

occlusive

disease, we

external iliac 30%; 80%

>50% stenosis

angioplasty

followed by

selective stent

placement in a

multicentre

randomized

controlled trial.

PTA (n=136): Mean

age 60, Male 73%;

common iliac 67%,

external iliac 33%; 82%

>50% stenosis

Randomised

control trial

The treatment groups

demonstrated no

signicant differences

with respect to

descriptive variables,

baseline quality-of-life

measures, and baseline

clinical measures.

Type of

intervention

Device type,

Brand name (if

applicable)

Stent versus

Table 19.2 (continued)

Angioplasty

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