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19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…
401
endovascular repair of aortic bifurcation (CERAB) to conventional aortoiliac bypass. There is also a relative paucity of studies evaluat­ing HRQOL outcomes of surgical bypass com­pared to the number of endovascular studies.
The reasons for poor HRQOL outcomes fol­lowing endovascular intervention or surgery remain poorly understood, but are likely complex and multifactorial. Procedure-related outcomes of interventions including failed revascularisa­tion and lesion recurrence may contribute to poor HRQOL outcomes [54, 55]. However, as men­tioned, the relationship between primary patency and HRQOL has not been denitively demon­strated. Equally, whilst there is some suggestion that avoidance of major limb amputation by means of revascularisation may lead to improved HRQOL, other studies have demonstrated that HRQOL can signicantly improve after amputa-
tion because of an elimination of pain, as well as CLTI induced complications such as ulceration and infection [56, 57]. HRQOL outcomes fol­lowing amputation were also found to be depen­dent on several patient factors, including family support and age. Patient factors may also contrib­ute to poorer HRQOL outcomes following revas­cularisation interventions; type D personality (i.e. tendency towards negative affectivity) and baseline frailty have both been demonstrated to be associated with worse HRQOL outcomes [58,
59]. Socioeconomic deprivation has been shown
to negatively impact clinical outcomes and may also play a role in HRQOL [60]. Further research to better understand patient-related predictors of poor HRQOL outcomes is necessary to guide appropriate patient selection. An overview of possible predictors of poor HRQOL outcomes following intervention is presented in Fig.19.2.
Patient Factors (Physical)
• Co-morbidities
• Cardiovascular Risk
• Background Frailty
Procedure Factors
• Failure to revascularize
• Restenosis/reocclusion
Fig. 19.2 Possible predictors of poor HRQOL outcomes following surgery and intervention for peripheral vascular disease
Patient Factors (Psychosocial)
• Type D Personality
• Socioeconomic status
Predictors of poor
quality of life post
intervention or
surgery
402
Highlighted Conclusions
• The approach to measuring HRQOL outcomes in existing studies is inconsistent and
both for research and clinical practice
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
Fig. 19.3 Highlighted conclusions
J. K. Tun et al.
• There is increasing recognition for the need to assess HRQOL outcomes following
invasive interventions for peripheral arterial disease.
• In general, invasive interventions for aortoiliac and femoropopliteal steno-occlusive
artery disease can lead to an improvement in HRQOL outcome
• Due to issues with research methodology, the inferences that can be drawn from
current research in HRQOL outcomes are limited.
highly variable.
• Further research is required to determine how best to measure HRQOL outcomes
Recent developments and trends in conduct­ing “big data” research by mining data collected through routine clinical care may hold great potential for HRQOL research in PAD interven­tion. Such an approach would provide a large volume of data from real-world practice and may overcome some of the limitations observed in existing RCTs and cohort studies previously mentioned. To facilitate this big data research, it is important for vascular clinicians to adopt eval­uation and standardised documentation of HRQOL measures into routine clinical practice.
In this systematic review, we purposefully identied studies which where specic to pre­dened anatomical segments, i.e. aortoiliac and femoropopliteal. However, as a result, we excluded many studies which included interven­tions across different anatomical segments and did not provide segment specic sub-analysis of the results; this is a potential limitation to this review.
In conclusion (Fig. 19.3), this systematic review demonstrated that in general, invasive interventions for aortoiliac and femoropopliteal steno-occlusive artery disease can lead to an improvement in HRQOL outcomes. However, the possibility to ascertain further clinically meaningful inferences are limited due to the clear methodological constraints within the current lit­erature. Perhaps the most pertinent limitations are that HRQOL are often secondary outcome measures and therefore likely to lack statistical
HRQOL tools also make it impossible to com­pare outcomes of different studies. To overcome these limitations, adequately powered studies, along with a standardised approach to measuring HRQOL outcomes, is required to improve the quality of future research and allow more patient­centric decision making.
Appendix: Scoring Criteria toAssess Methodological Quality ofIncluded Papers
• Socio-demographic and medical data are described (e.g. age, race, etc.)
• Inclusion and/or exclusion criteria are formulated
• The process of data collection is described (e.g. interview or self-report)
• The results are compared between two groups or more (e.g. healthy population groups with different treatment or age)
• Participation and response rates for patient groups must be described as >75%
• Information is presented about patient/disease characteristics of respondents and non-respondents
• A standardized or valid QOL questionnaire is used
• Results are not only described for QOL but also for the physical, psychological and social domains
19 Health-Related Quality of Life Outcomes for Endovascular and Open Surgical Interventions…
403
• Mean, median, standard deviations or percent­ages are reported for the most important out­come measures
• Patients signed an informed consent form before study participation
1 point is awarded for each criterion met. Maximum achieveable score = 10.
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Infrapopliteal Arteries (Classical andPercutaneous)
RichardAnthonyMeena andOlamideAlabi
20
The Emergence andImportance ofQOL andPROMS forPeripheral Artery Disease
Peripheral artery disease (PAD) is dened by chronic, atherosclerotic disease in arterial beds outside of the heart or brain. Arterial occlusive disease of the lower extremities is the third most common manifestation of systemic atherosclero­sis behind heart disease and stroke, and this con­dition affects over ten million cases nationwide and over 200 million people worldwide [1]. Risk factors associated with PAD include multiple standard cardiovascular risk factors including tobacco abuse, diabetes mellitus, hypertension, dyslipidemia, hyperhomocysteinemia, male sex, age, and renal insufciency. PAD manifests along a clinical spectrum from asymptomatic patients to tissue loss in the foot and carries a signicant risk of cardiovascular morbidity and mortality. This condition is associated with three times the average risk of cardiovascular events and mortal­ity [2] and carries a high risk for major amputa­tion with over 185,000 major amputations taking
R. A. Meena · O. Alabi (*) Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Emory University School of Medicine, Atlanta, GA, USA e-mail: richard.meena@emory.edu;
olamide.alabi@emory.edu
place each year in the United States [3]. The prevalence of PAD in the general population increases dramatically with age [4], and the num­ber of interventions provided to those with PAD has demonstrated a steady increase over time [5].
As more patients with PAD present to vascular specialists for medical attention, the necessity and timing of intervention(s) have become a topic of important inquiry. Lower extremity revascu­larization is often a temporizing measure because established goals include symptom improvement or resolution, wound healing, and limb preserva­tion; however, there are no curative medical or surgical therapies available to date. Given the sig­nicant morbidity associated with vascular inter­ventions and sequelae of potentially poor outcomes, vascular specialists are faced with even more complex decisions when formulating a plan of care for patients with PAD.
Whether or not to intervene on a patient with signicant lower extremity PAD can be a difcult decision to make. Traditionally, outcomes such as revascularization patency, readmission, limb loss, and mortality are frequently reported after lower extremity revascularization [68]. Although these outcomes are critical metrics to evaluate after operative intervention, for the interventionalist and healthcare system, they do not always embody what the individual patient values most. Therefore, providers have begun to
© Springer Nature Switzerland AG 2022 T. Athanasiou et al. (eds.), Patient Reported Outcomes and Quality of Life in Cardiovascular Interventions,
https://doi.org/10.1007/978-3-031-09815-4_20
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R. A. Meena and O. Alabi
Predictors of poor quality of life
Low or borderline ABI(12)
Tissue loss(13)
Rest pain(13)
Poor cognitive status(14)
Lack of therapeutic options(15)
Fig. 20.1 Predictors of poor quality of life in patients with peripheral artery disease
incorporate patient-reported outcome measures (PROMS), including quality of life (QoL) assess­ments, as part of their decision-making algo­rithm. In the 1960s and 1970s, clinicians began to use QoL assessments to evaluate the utility of new technologies in patient care [9]. Vascular interventionalists paralleled medicine as a whole
been associated with lower quality of life end­points [13]. Finally, poor cognitive status in patients with peripheral artery disease may fur­ther lead to a worse quality of life [14]. These known risk factors serve as a foundation on which providers can tailor care discussions with their patients.
in that early QoL metrics centered on cost effec­tiveness, such as quality-adjusted life years (QALYs). For example, a landmark vascular trial, Asymptomatic Carotid Artery Stenosis
Assessing QoL andPROMS inPeripheral Artery Disease
(ACAS), was re-analyzed under the scope of QALYs in 1997 [10]. Since 2000, these analyses extend far beyond cost effectiveness and have begun to incorporate patient-reported outcomes as guidance to proceed with and/or defer specic vascular interventions for some patients.
Measuring QoL on a larger scale has been shown to directly impact clinical medicine. Norman et al. demonstrated that minimally important difference estimates for QoL assess­ments only approach half a standard deviation. Therefore, even small shifts in QoL metrics could signicantly impact patient care [11].
Several studies have suggested certain factors that may predispose patients to a lower quality of life in peripheral artery disease (Fig.20.1). Lower ankle-brachial index alone has been associated with worse patient-reported outcome measures [12]. Chronic limb-threatening ischemia, as dened as rest pain or tissue loss, further has
In both the intermittent claudication (IC) and chronic limb threatening ischemia (CLTI) popu­lations, intervention has not clearly demonstrated improved or worsened QoL.This is in large part due to the non-binary nature of QoL measure­ments. As QoL has become an increasingly important topic of research, particularly with such a morbid disease process and overwhelm­ingly elderly patient population, great strides have been made to qualify these shades of gray, rather than black-and-white, outcomes.
Questionnaires have long been the primary tool used to assess QoL in surgical research, as they allow patients to express their opinions while maintaining a standard form from which researchers can capture data. Created in the late 1980s, the 36-item Short Form Health Survey (SF-36) sought to capture adult patients’ percep­tions regarding their health and wellbeing. This
Wu A, et al.
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Duff S, et al.
Gardner AW, et al.
Sprengers RW, et al.
20 Infrapopliteal Arteries (Classical andPercutaneous)
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instrument assesses eight domains, including physical function as it relates to one’s health, limitations related to physical and emotional con­cerns, social functioning, bodily pain, and gen­eral and mental health; the instrument has since been validated in the general population and gen­eral chronic disease states [16]. The European Quality of Life 5 Dimension scale (EQ-5D) simi­larly uses domains to assess quality of life in a general population. This tool’s prior iteration, the EuroQol instrument, was found to have relatively poor validity when compared to the SF-36 and with evidence of being less sensitive at the ceil­ing [17]. The instrument was further rened to a ve-domain scale, the EQ-5D.EQ-5D domains include assessment of mobility, self-care, usual activities, pain/discomfort, and anxiety/depres­sion. Clearly, patterns can be appreciated when comparing SF-36 and EQ-5D; physical and men­tal health, as well as “usual activities” and pain, all can be drawn from when assessing general QoL in health care.
Though useful, both SF-36 and EQ-5D are fairly generic tools used to assess a general popu­lation regarding QoL.The ability to provide such generalizable results is undoubtedly why these questionnaires have become so useful in health services research. However, it became evident that tools specic to PAD would provide a more appropriate assessment in this population. The Vascular Quality of Life questionnaire (now referred to VascuQoL-25) captures data using a 25 question review of ve domains—symptoms, pain, activities, social life, and emotional state— and a 7-point response scale [18]. When compar­ing the generalized questionnaires and VascuQoL-25 in the assessment of patients suf­fering from PAD, de Vries etal. suggested that the VascuQoL-25 should become the primary questionnaire when creating any future studies evaluating QoL in PAD given that this instrument provides a better description of the unique strug­gles vascular patients with chronic conditions experience daily [19].
Over time, it became evident that patient com­pliance with lengthy questionnaires was not sus­tainable. In the PREVENT III trial, for example, patient compliance with questionnaires was doc-
umented to decline signicantly over time, from 92% at the start of the study, to 61% at 3months, and ultimately to 52% at 1year [20]. To combat patient fatigue with questionnaires yet still obtaining accurate disease-specic measure­ments of QoL, these lengthy questionnaires have been modied. VascuQoL-25 has been limited to VascuQoL-6, cutting the length of the question­naire by nearly 75% [21].
Measurement of QoL in those who suffer from vascular disease is extremely important given associated burden including severe symp­toms, high morbidity either from their chronic disease state, risk of limb loss, and/or death, resource utilization from family members and healthcare facilities, and nancial costs associ­ated with their care. Over the years, clinicians have struggled with determining the best inter­vention, if any, for patients suffering from PAD just as investigators have attempted to rene their methods of assessing vascular intervention qual­ity and outcomes. What has traditionally been lacking in the literature is the voice of the patient and what matters most to them and their families. Many have met this charge with beginning to describe and better understand how patients with PAD view the quality of the lives they lead with or without PAD intervention.
QoL andPROMS inIntermittent Claudication (IC)
Patients with IC have a signicantly reduced QoL. In a 1995 multicenter study from the Scottish Vascular Audit Group, 201 patients with IC completed SF-36 health status questionnaires and, compared to the general population, had worse QoL in all domains [22]. Severity of dis­ease, dened as walking distance prior to onset of symptoms, was a signicant predictor of all parameters except mental and emotional wellbe­ing, as per QoL evaluations with the SF-36 form. The authors recommended that for IC, the goal should be improved QoL; therefore, use of these QoL assessments in clinical practice (as opposed to just within the connes of research) may assist PAD interventionalists in their decision making
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R. A. Meena and O. Alabi
with the PAD patient with IC.Malgor etal. pub­lished a systematic review compiling data on treatment in patients with intermittent lower extremity claudication symptoms [23]. They con­cluded that both endovascular and open interven­tion as well as exercise therapy improved QoL compared to medical management alone. They also acknowledged that procedures can beget complications and many procedures have limited long term durability in this population.
Multiple randomized controlled trials, such as the OBACT trial, MIMIC, and others, have com­pared the benet of intervention in the setting of IC and included QoL comparisons in their cohorts [2426]. The MIMIC trial reviewed 93 patients with IC on best medical therapy and participating in a supervised exercise program [25]. They were enrolled to a treatment arm with percutaneous transluminal angioplasty (PTA) versus no PTA. Using the SF-36, they found that those enrolled in the PTA treatment arm did not dem­onstrate improvement in QoL compared to no PTA.This was dissimilar to the CLEVER trial in that stent angioplasty conferred an improvement in reported QoL compared to supervised exercise programs [27]. Given IC as the symptomatology at the time of presentation in these studies, the majority of these interventions are targeting ves­sels above the level of the knee. Thus, while it is important to understand the body of literature regarding QoL effects after lower extremity revascularizations, this is not the focus of this chapter. As well, OBACT, a single center study following patients with IC for 2years and used the SF-36 as well as CLAU-S (a claudication spe­cic QoL questionnaire), found that patients with IC undergoing early peripheral intervention with medical therapy compared to patients on optimal medical therapy alone, had improved functional, hemodynamic, and QoL outcomes [24].
QoL andPROMS inChronic Limb­Threatening Ischemia (CLTI)
Chronic limb-threatening ischemia (CLTI) repre­sents the most severe manifestation of lower extremity PAD. The TransAtlantic Inter-Society
Consensus for the Management of Peripheral Artery Disease (TASC II) guidelines dene as chronic ischemic rest pain or ischemic skin lesions. CLTI is associated with signicant mor­bidity and mortality [2]. Due to the associated burden of high morbidity with or without inter­vention, high resource utilization, and associated excess healthcare costs, investigators have now begun to look toward patient-reported outcome measures (PROMs) and QoL measures early on when determining an appropriate plan of care for these patients.
Initial studies regarding QoL after LE open surgical bypass reviewed patients’ pre- and post­operative functional status. In 1996, Abou­Zamzam et al. reviewed functional status after infrainguinal bypasses [28]. Five hundred thir­teen patients in this patient underwent infraingui­nal bypass at a single center over 15years. All included patients had ischemic rest pain or tissue loss and over 90% of the patients reviewed had a distal bypass target below the level of the knee. Of those patients who ambulated with assist devices preoperatively, 97% were found to main­tain this level of function at 6months postopera­tively. Independent living status was assessed; of those patients living independently preopera­tively, 99% maintained their independence at 6 months after surgery. A similar review of patients with CLTI retrospectively looked at 334 patients who underwent 419 infrainguinal bypasses at two institutions over a 7-year period [29]. Sixty-two percent of these bypasses had a distal target located below the knee. Limb sal­vage was reported as 85% at 1year, with only a 6% drop over the course of the next 2years; how­ever, the authors emphasized that one-quarter of their patients had not achieved wound healing at 1year, nearly one-fth had lost ambulatory sta­tus, and 5% were no longer living independently. These studies clearly demonstrate the juxtaposi­tion of excellent provider-specic outcomes alongside poor/failing PROMs.
Markers of functional status, including inde­pendent living and ambulatory status, are not age-independent, as increasing age certainly impacts both the pathophysiology underlying CLTI and the potential risk of morbidity and