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Quality ofLife andPatient Reported Outcome Measures Following Percutaneous Aortic Intervention forAortic Aneurysms andDissection

LeonardL.Shan, AkshatSaxena, andAlunH.Davies

Abbreviations

ADSORB Acute dissection: stent graft or

best medical therapy

AJAX Amsterdam acute aneurysm

trial

DREAM Dutch randomised endovascu-

lar aneurysm management

ECAR Endovasculaire ou Chirurgie

dans les Anevrysmes aortoiliaques rompus

EVAR-1 United Kingdom endovascular

aneurysm repair trial 1

EVAR-2 United Kingdom endovascular

aneurysm repair trial 2

L. L. Shan (*) St. Vincent’s Hospital Melbourne, Melbourne, VIC, Australia

Department of Surgery, The University of Melbourne, Melbourne, VIC, Australia e-mail: leonard.shan@unimelb.edu.au

A. Saxena Department of Cardiothoracic Surgery and Transplantation, Fiona Stanley Hospital, Murdoch, WA, Australia

A. H. Davies Charing Cross, London, UK

St. Mary’s Hospital, London, UK

Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK e-mail: a.h.davies@imperial.ac.uk

IMPROVE Immediate management of

patients with rupture: open versus endovascular repair

INSTEAD Randomised comparison of

strategies for type B aortic dissection: the investigation of stent graft in aortic dissection

INSTEAD XL Randomised comparison of

strategies for type B aortic dissection: the investigation of stent graft in aortic dissection with extended follow-up

OVER Open versus endovascular

repair veterans affairs cooperative study

Introduction

Aortic aneurysms and dissection are important public health issues. Screening studies report a prevalence of abdominal aortic aneurysms (AAA) of 4–8%, with an annual incidence of new diagnoses at 0.4–0.67% in Western populations [1–5]. Unlike AAA where the diagnosis is increasingly being made during an investigation for another abdominal pathology, thoracic aortic pathology tends to be silent until the acute presentation. The prevalence of thoracic aortic aneurysms (TAA) is estimated at 0.16–0.34%, with an annual incidence of up to 0.016% [6]. Forty

https://doi.org/10.1007/978-3-031-09815-4_15

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L. L. Shan et al.

percent of TAA involves the descending thoracic or thoracoabdominal aorta [7]. The annual incidence of aortic dissection is difcult to measure, but is estimated at 5–30 per one million people [8]. Even though the overall incidence of thoracic aortic pathology is relatively low, there is a signicant associated morbidity and mortality which is particularly poignant in the setting of rupture [1–6, 8, 9].

Endovascular intervention is often the preferred method of treatment for aortic pathologies in relation to aneurysms and dissection. Simple endovascular procedures include abdominal endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR). Complex endovascular procedures include fenestrated endovascular aneurysm repair (FEVAR), chimney endovascular aneurysm repair (CHEVAR), branched endovascular aneurysm repair (BEVAR), and custom made devices. Procedural outcomes for each of these are continually improving over time. The concept of quality of life (QOL) and patient reported outcomes measures (PROMS) has been introduced since the early 1990s as an important aspect of outcomes assessment [10], but it is only recently that these are being integrated into modern practice and management of aortic pathologies.

This chapter summarises the available literature on QOL and PROMS after percutaneous aortic intervention for aortic aneurysms and dissection. However, aortic interventions are a broad set of procedures that can be categorised according to anatomical site, pathology, indication for surgery, and type of surgery. It is therefore necessary to differentiate between these groups in order to accurately report on QOL and PROMS outcomes.

Currently, evidence exists for QOL and PROMS after endovascular intervention for; (a) standard EVAR for AAA, (b) standard TEVAR for TAA and type B aortic dissection (TBAD), and (c) thoracoabdominal aneurysms (TAAA). There is currently no published data on QOL or PROMS after (a) complex endovascular repair of AAA (FEVAR, CHEVAR, BEVAR, custom-

made devices), (b) endovascular repair of abdominal aortic dissection, (c) endovascular repair of ascending aortic and aortic arch pathology (which still generally requires open surgery), and (d) complex endovascular interventions for TAA, TAAA, TBAD (FEVAR, BEVAR, custom-made devices). Hence, four key groups of patients are presented in this chapter: (a) standard EVAR for AAA, (b) standard TEVAR for TAA, (c) standard TEVAR for TBAD, and (d) endovascular repair of TAAA.These include both elective and emergency procedures.

Current Interventions ontheAorta

Abdominal Aorta

Abdominal Aortic Aneurysms

The endovascular treatment options for AAA include EVAR, FEVAR, BEVAR, CHEVAR, and custom-made devices. Evidence on QOL and PROMS are limited to standard EVAR and this forms the focus of this section. In contemporary practice, elective EVAR is often the preferred option in patients with suitable anatomy.

The outcomes and relative merits of EVAR and open AAA repair in the elective setting are well described in numerous trials and metaanalyses including EVAR-1, EVAR-2, OVER, and DREAM [11–18]. EVAR has a proven low perioperative morbidity and mortality which is the primary reason for it is use in AAA. The trade-off is a greater rate of secondary reintervention compared to open AAA repair. The survival benet of EVAR is also generally thought to be lost after 2–3 years. A recent study suggests EVAR may actually have a worse long-term mortality compared to open AAA repair [19].

The ideal treatment for emergency cases is less clear. The IMPROVE, AJAX, and ECAR trials, as well as meta-analyses of these trials show no difference in early outcomes after EVAR compared to open AAA repair in the setting of rupture [20–24]. However, mid-term results from the IMPROVE trial suggest a survival advantage in EVAR patients [25].

15 Quality of Life and Patient Reported Outcome Measures Following Percutaneous Aortic Intervention…

269

Thoracic Aorta

Thoracic andThoracoabdominal Aortic Aneurysms

The endovascular treatment options for TAA and TAAA include TEVAR, BEVAR, and custommade devices. In contemporary practice, TEVAR is regarded as the preferred option in the majority of cases.

The preference for TEVAR over open repair for TAA and TAAA is based mainly on retrospective and observational studies coupled with anecdotal evidence and experience. Recent reviews and meta-analyses have supported this practice, demonstrating superior morbidity and mortality of TEVAR over traditional open repair techniques [26–28]. Evidence is still limited in regard to which method of repair is better for emergency cases, but TEVAR would still be preferred in most centres due to the much lesser invasiveness of TEVAR.

Type B Thoracic Aortic Dissection

This chapter focusses specically on TBAD as these are amenable to TEVAR.When intervention is required for the ascending aorta or aortic arch, some element of open repair is still required. TBAD can be classed as acute, subacute and chronic. Medical management was the traditional treatment paradigm for uncomplicated acute and subacute TBAD, with operative intervention reserved for complicated TBAD (refractory pain and hypertension, malperfusion, rupture). Treatment for chronic TBAD largely relates to aneurysmal dilatation and prevention of longterm rupture risk. In contemporary practice, TEVAR is the preferred treatment option in a large proportion of acute and chronic TBAD, with selected cases requiring FEVAR, BEVAR or custom made devices.

Most patients with complicated acute and subacute TBAD will receive urgent treatment. In uncomplicated TBAD, the ADSORB, INSTEAD, and INSTEAD XL trials supported the use of TEVAR in the subacute setting in carefully selected patients to decrease long-term aneurysm related mortality [29–32]. Chronic TBAD is treated with similar techniques to TAA and

TAAA as this is usually the primary indication for treatment. There is limited evidence on the best management of residual TBAD after repair of type A dissection.

Quality ofLife Instruments andProms inAortic Intervention

Denition ofQuality ofLife andPatient Reported Outcome Measures

PROMS ask patients to assess elements of their own health, QOL, and functioning [33]. The aim is to understand the impact of a treatment and its recovery, allow comparison of different patients’ outcomes with the same intervention [33]. QOL is the major element of PROMS and is dened as a patient’s perception of health as assessed in multiple domains [34, 35]. QOL is also the most frequently used form of assessment and their use in aortic intervention has been previously described [36].

One of the important considerations in QOL assessment is the type of instrument used and the measurement time points and time frame within which these assessments will be made. There is currently no consensus on this. However, research is underway to help determine these with core outcome sets in AAA [37]. Until then, investigators will need to use clinical judgment on the most appropriate methods of assessment.

Commonly Used Quality ofLife Instruments inAortic Intervention

QOL can be assessed by study designed questionnaires, and disease-specic or generic instruments. These instruments assess an individual’s physical, emotional and psychological health as well as social and functional status [34, 35].

Individual study designed questionnaires are constructed by study authors as arbitrary measures of QOL outcomes. Disease-specic QOL instruments are validated QOL scoring systems that measure the effect of an illness or treatment

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L. L. Shan et al.

on a specic condition [35]. These include Aneurysm-Dependent QOL Questionnaire (AneurysmDQOL) [38], Aneurysm Symptom Rating Questionnaire (AneurysmSRQ) [38], and Aneurysm Treatment Satisfaction Questionnaire (Aneurysm TSQ) [38]. Generic QOL instruments are validated QOL scoring systems that measure holistic QOL in a broad range of domains and allow comparisons with other conditions and reference populations [35]. Generic scoring systems used by studies reviewed in this chapter are Medical Outcomes Short Form 36 (SF-36) and 12 (SF-12) and 8 (SF-8) [39], Hospital Anxiety and Depression Scale (HAD) [40], European Quality of Life EQ-5D VASC Vascular Questionnaire (EQ-5D VASC) [41], and Nottingham Health Prole (NHP) [42]. These instruments are described in earlier chapters.

Quality ofLife andPatient Reported Outcomes

The aforementioned trials on the management of aortic aneurysms and dissection have focussed on technical outcomes after EVAR and TEVAR. However, recent reviews have highlighted the importance of QOL outcomes [23, 36,

43–47]. To date QOL has been the primary

method of PROMS assessment. Study characteristics and a brief quality appraisal is outlined in Table15.1. Detailed study information and QOL outcomes are shown in Table15.2. This section describes the key QOL ndings. Some of this information has been described in prior reviews [36, 43, 45].

Abdominal Aorta (29 Studies) [12, 16,

18, 25, 38, 48–68, 70–72]

The vast majority of studies focus on elective standard EVAR [12, 16, 18, 38, 48–64, 67, 68,

70, 72]. Broadly similar QOL outcomes have

been reported across all the instruments used. There is an initial postoperative decline after EVAR. Most health domains return to baseline levels between 1 and 4months. Between 6months

and 2years, QOL is maintained at preoperative levels. Within this time period, it should be noted that mental health has a distinct benet. A number of studies describe mental health domains to be superior to preoperative levels. This is an important aspect of treatment benet that is likely attributed to the alleviation of fear of rupture. After 2years, there was a gradual, but progressive age-related decline in all QOL domains up to 8years.

Compared to open AAA repair, EVAR has a more rapid recovery in QOL.This is particularly pertinent to physical health domains and is consistent with the greater physical toll from open aortic surgery. However, this difference is resolved by 6months and QOL remains similar up to 1year. Functional status and participation in activities of daily living is also similar in both groups at 1year. Patients perceive long-term surveillance and secondary reintervention be more difcult after EVAR whereas early physical recovery is the difculty after open AAA.This is an important concept because surveillance will tend to affect mental health domains more. The longer the surveillance occurs, the more likely there will be a detriment to mental health. This is an important trade-off for the early benets of EVAR.There is also some evidence that EVAR has worse QOL compared to open AAA repair.

Recently, three studies have reported QOL after emergency intervention [25, 65, 71]. Early QOL is similar or slightly better after EVAR compared to open AAA repair. However, the advantages of EVAR are lost after 3–4 years, with one study suggesting there is a better QOL after open AAA repair. This mirrors the longer term technical outcomes and durability advantage of open AAA repair.

The population is ageing with an ever increasing life expectancy. Aneurysmal disease of the aorta becomes more prevalent with increased age and the patients being treated for AAA will be increasingly elderly. This is an important subgroup because elderly patients have more comorbidities and are more likely to have EVAR over open AAA repair, yet they also have known increased anatomical challenges for EVAR compared to their younger counterparts. Outcomes

15 Quality of Life and Patient Reported Outcome Measures Following Percutaneous Aortic Intervention…

271

Response

rateYear

Follow-up

method

reported

QOL instruments

used

Validated QOL

instrument

(continued)

Study

design Patient demographics

Patients

Original studies—abdominal aorta

Author

Table 15.1 Study characteristics and quality appraisal

OR Elective: NR, Emergency: NR

n=48 Aortic pathology: AAA

Lloyd [48] EVAR P Male: NR, Age: 73, HTN: NR, DM: NR, Yes SF-36 Ye s 78%

2000 n=34 Smoking: NR, IHD: NR, CVA: NR, CKD: NR

Study objectives: QOL and cognitive function after open AAA repair or EVAR (preoperative vs. postoperative, EVAR vs. open AAA repair)

Malina [49] EVAR P EVAR Ye s NHP Yes 95%

2000 n=21 Male: 81%, Age: 74, HTN: 24%, DM: NR,

Aortic pathology: AAA

Open AAA repair

Male: 76%, Age: 74, HTN: 52%, DM: NR

OR Smoking: NR, IHD: 24%, CVA: NR, CKD: NR

n=21 Elective: 100%, Emergency: 0%

Smoking: NR, IHD: 24%, CVA: NR, CKD:

Elective: 100%, Emergency: 0%

Aortic pathology: AAA

Study objectives: QOL and functional status after open AAA repair or EVAR (preoperative vs. postoperative, EVAR vs. open AAA repair)

Aortic pathology: AAA

Open AAA repair

Male: 73%, Age: 70, HTN: 80%, DM: 38%,

Smoking: NR, IHD: 42%, CVA: NR, CKD: NR

Elective: NR, Emergency: NR

OR Smoking: NR, IHD: 48%, CVA: NR, CKD: NR

n=26 Elective: NR, Emergency: NR

Aquino [50] EVAR P EVAR Yes SF-36 Ye s 61%

2001 n=25 Male: 93%, Age: 71, HTN: 84%, DM: 11.5%,

Aortic pathology: AAA

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Response

rateYear

Follow-up

method

reported

QOL instruments

used

Validated QOL

instrument

L. L. Shan et al.

Aortic pathology: AAA

Surveillance

Male: 99.6%, Age: 68, HTN: 54.9%, DM: 9.9%,

Smoking: 36.9%, IHD: 40.2%, CVA: 12.7%, CKD:

Elective: 100%, Emergency: 0%

Aortic pathology: AAA

Study

design Patient demographics

Patients

Original studies—abdominal aorta

Author

Table 15.1 (continued)

Study objectives: QOL and functional status after open AAA repair or EVAR (preoperative vs. postoperative, EVAR vs. open AAA repair)

OR Smoking: NR, IHD: 79%, CVA: NR, CKD: 6%

Arko [51] EVAR P EVAR Ye s Study questionnaire Ye s 39%

2003 n=153 Male: 83%, Age: 74, HTN: 56%, DM: 36%,

Aortic pathology: AAA

Open AAA repair

Male: 86%, Age: 74, HTN: 61%, DM: 29%,

n=141 Elective: 100%, Emergency: 0%

Smoking: NR, IHD: 76%, CVA: NR, CKD: 9%

Elective: 100%, Emergency: 0%

Aortic pathology: AAA

Compare early (<6months) and late (>6months) functional outcomes after EVAR and open AAA repair (preoperative vs.

Study objectives: Compare periprocedural survival, and recovery times after EVAR and open AAA repair

postoperative, EVAR vs. open AAA repair)

OR Smoking: 41.4%, IHD: 43.6%, CVA: 12%, CKD:

n=569 Elective: 100%, Emergency: 0%

Lederle [52] EVAR P Immediate Open AAA repair Yes SF-36 Yes 85%

2003 n=567 Male: 99%, Age: 68, HTN: 57.8%, DM: 9.7%,

15 Quality of Life and Patient Reported Outcome Measures Following Percutaneous Aortic Intervention…

(continued)

273

repair)

Study objectives: Long-term QOL after open AAA repair or surveillance for sub-threshold AAA (preoperative vs. postoperative, surveillance vs.

Ballard [53] EVAR P EVAR Yes SF-12 Ye s 65%

Aortic pathology: AAA

Open AAA repair

Male: 76%, Age: 72, HTN: 81%, DM: 19%,

Smoking: NR%, IHD: 79%, CVA: NR, CKD: 18%

Elective: 100%, Emergency: 0%

Aortic pathology: AAA

OR Smoking: NR, IHD: 81%, CVA: NR, CKD: 10%

n=107 Elective: 100%, Emergency: 0%

2004 n=22 Male: 90%, Age: 77, HTN: 62%, DM: 38%

OR P EVAR Ye s SF-36, EuroQOL NR 91%

Study objectives: QOL after EVAR and retroperitoneal open AAA repair (preoperative vs. postoperative, EVAR vs. open AAA repair)

Lottman

[54]

2004 n=19 Male: 95%, Age: 69, HTN: NR, DM: NR,

Aortic pathology: AAA

Open AAA repair

Male: 64%, Age: 68, HTN: NR, DM: NR,

EVAR Smoking: NR, IHD: NR, CVA: NR, CKD: NR

n=57 Elective: 100%, Emergency: 0%

Smoking: NR, IHD: NR, CVA: NR, CKD: NR

Elective: 100%, Emergency: 0%

Aortic pathology: AAA

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Response

rateYear

L. L. Shan et al.

Follow-up

method

reported

Yes 73%

QOL instruments

used

Validated QOL

instrument

VASC

Yes 83%

SF-36

Aortic pathology: AAA

Surveillance

Male: 85%, Age: 76.0, HTN: NR, DM: 13%,

Smoking: 16%, IHD: 73%, CVA: NR, CKD: NR

Elective: 100%, Emergency: 0%

Aortic pathology: AAA

AAA repair (preoperative vs. postoperative, EVAR vs. medical treatment)

Study objectives: Does EVAR decrease risk of aneurysm related death and improve QOL compared to medical treatment in patients not t for open

Study

design Patient demographics

Patients

EVAR P EVAR Ye s SF-36, EQ-5D

Original studies—abdominal aorta

Author

Table 15.1 (continued)

Study objectives: Short-term QOL after EVAR compared to open AAA repair (preoperative vs. postoperative, EVAR vs. open AAA repair)

Prinssen

[55]

2004 n=78 Male: 92%, Age: 70.5, HTN: 51%, DM: 6%,

Aortic pathology: AAA

Open AAA repair

Male: 92%, Age: 69, HTN: 48%, DM: 5%,

OR Smoking: 62%, IHD: 32%, CVA: NR, CKD: 8%

n=75 Elective: 100%, Emergency: 0%

Smoking: 31%, IHD: 44%, CVA: NR, CKD: 7%

Elective: 100%, Emergency: 0%

Aortic pathology: AAA

EVAR P EVAR Ye s EQ-5D VASC,

Study objectives: Short-term QOL after EVAR compared to open AAA repair (preoperative vs. postoperative, EVAR vs. open AAA repair)

EVAR-2

Surveillance Smoking: 17%, IHD: 65%, CVA: NR, CKD: NR

n=172 Elective: 100%, Emergency: 0%

[16]

2005 n=166 Male: 85 %, Age: 76.8, HTN: NR, DM: 15%

15 Quality of Life and Patient Reported Outcome Measures Following Percutaneous Aortic Intervention…

Yes 100%

VASC

275

(continued)

Aortic pathology: AAA

Open AAA repair

EVAR P EVAR Ye s SF-36, EQ-5D

EVAR-1

OR Smoking: 21%, IHD: 44%, CVA: NR, CKD: NR

n=539 Elective: 100%, Emergency: 0%

[56]

2005 n=543 Male: 91%, Age: 74.2, HTN: NR, DM: 9%,

Male: 91%, Age: 74.0, HTN: NR, DM: 12%,

Smoking: 22%, IHD: 43%, CVA: NR, CKD: NR

Elective: 100%, Emergency: 0%

Aortic pathology: AAA

open AAA repair)

OR Smoking: 25%, IHD: 65%, CVA: NR, CKD: 5%

n=20 Elective: 100%, Emergency: 0%

Study objectives: Compare mortality, durability, QOL, costs for EVAR compared to open AAA repair (preoperative vs. postoperative, EVAR vs.

Soulez [57] EVAR P EVAR Ye s SF-36, Karnofsky Ye s NR

2005 n=20 Male: 95%, Age: 70.3, HTN: 40%, DM: 5%,

Aortic pathology: AAA

Open AAA repair

Male: 100%, Age: 71.2, HTN: 50%, DM: 25%,

Smoking: 15%, IHD: 70%, CVA: NR, CKD: 25%

Elective: 100%, Emergency: 0%

Aortic pathology: AAA

Study objectives: Functional autonomy, QOL, pain, after EVAR compared to open AAA repair (preoperative vs. postoperative, EVAR vs. open AAA repair)

Vogel [58] EVAR R EVAR Ye s SF-36 Yes NR

Aortic pathology: AAA

Open AAA repair

Male: 68%, Age: 70.8, HTN: 65%, DM: 11%,

Smoking: NR, IHD: 46%, CVA: NR, CKD: 6%

Elective: 100%, Emergency: 0%

Aortic pathology: AAA

OR Smoking: NR, IHD: 54%, CVA: NR, CKD: 8%

n=126 Elective: 100%, Emergency: 0%

2005 n=92 Male: 87%, Age: 71.5, HTN: 72%, DM: 13%,

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Response

rateYear

Follow-up

method

reported

QOL instruments

used

Validated QOL

instrument

L. L. Shan et al.

Study

design Patient demographics

Patients

Original studies—abdominal aorta

Author

Table 15.1 (continued)

Study objectives: Factors that inuence independence and functional health after EVAR or open AAA repair (EVAR vs. open AAA repair)

OR Smoking: NR, IHD: 67.4%, CVA: 13.9%, CKD:

Aljabri [59] EVAR P EVAR Ye s SF-36 Yes NR

2006 n=43 Male: 86.1%, Age: 76.1, HTN: 62.8%, DM: 11.6%,

Aortic pathology: AAA

n=33 Elective: 100%, Emergency: 0%

Open AAA repair

Male: 75.8%, Age: 68.6, HTN: 57.6%, DM: 21.2%

Smoking: NR, IHD: 66.7%, CVA: 9.1%, CKD: 3%

Elective: 100%, Emergency: 0%

Aortic pathology: AAA

Study objectives: QOL after EVAR compared to open AAA repair (preoperative vs. postoperative, EVAR vs. open AAA repair)

Dick [60] EVAR R EVAR Ye s SF-36 Yes 86.8%

OR Smoking: 44.1%, IHD: 41.2%, CVA: NR, CKD:

2008 n=68 Male: 94.1%, Age: 71.7, HTN: 54.4%, DM: 8.8%

n=244 Elective: 100%, Emergency: 0%

Male: 83.2%, Age: 66.4, HTN: 45.5%, DM: 14.3%

Smoking: 38.5%, IHD: 41.2%, CVA: NR, CKD:

Elective: 100%, Emergency: 0%

Aortic pathology: AAA

Emergency Open AAA repair.

Male: 92.1%, Age: 70.6, HTN: 58.4%, DM: 5.6%

EOR Aortic pathology:

n=89 Open AAA repair

Smoking: 43.8%, IHD: 38.2%, CVA: NR, CKD:

Elective: 0%, Emergency: 100%

Aortic pathology: AAA

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