Contrast-enhanced ultrasound and/or colour duplex ultrasound for surveillance after endovascular abdominal aortic aneurysm repair

a systematic review and economic evaluation

Miriam Brazzelli (Corresponding Author), Rodolfo Hernández, Pawana Sharma, Clare Robertson, Michal Shimonovich, Graeme MacLennan, Cynthia Fraser, Russell Jamieson, Srinivasa Rao Vallabhaneni

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Abstract

BACKGROUND: Endovascular abdominal aortic aneurysm repair (EVAR) of abdominal aortic aneurysm (AAA) is less invasive than open surgery, but may be associated with important complications. Patients receiving EVAR require long-term surveillance to detect abnormalities and direct treatments. Computed tomography angiography (CTA) has been the most common imaging modality adopted for EVAR surveillance, but it is associated with repeated radiation exposure and the risk of contrast-related nephropathy. Colour duplex ultrasound (CDU) and, more recently, contrast-enhanced ultrasound (CEU) have been suggested as possible, safer, alternatives to CTA.

OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of imaging strategies, using either CDU or CEU alone or in conjunction with plain radiography, compared with CTA for EVAR surveillance.

DATA SOURCES: Major electronic databases were searched, including MEDLINE, EMBASE, Science Citation Index, Scopus' Articles-in-Press, Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE) and NHS Economic Evaluation Database from 1996 onwards. We also searched for relevant ongoing studies and conference proceedings. The final searches were undertaken in September 2016.

METHODS: We conducted a systematic review of randomised controlled trials and cohort studies of patients with AAAs who were receiving surveillance using CTA, CDU and CEU with or without plain radiography. Three reviewers were involved in the study selection, data extraction and risk-of-bias assessment. We developed a Markov model based on five surveillance strategies: (1) annual CTA; (2) annual CDU; (3) annual CEU; (4) CDU together with CTA at 1 year, followed by CDU on an annual basis; and (5) CEU together with CTA at 1 year, followed by CEU on an annual basis. All of these strategies also considered plain radiography on an annual basis.

RESULTS: We identified two non-randomised comparative studies and 25 cohort studies of interventions, and nine systematic reviews of diagnostic accuracy. Overall, the proportion of patients who required reintervention ranged from 1.1% (mean follow-up of 24 months) to 23.8% (mean follow-up of 32 months). Reintervention was mainly required for patients with thrombosis and types I-III endoleaks. All-cause mortality ranged from 2.7% (mean follow-up of 24 months) to 42% (mean follow-up of 54.8 months). Aneurysm-related mortality occurred in < 1% of the participants. Strategies based on early and mid-term CTA and/or CDU and long-term CDU surveillance were broadly comparable with those based on a combination of CTA and CDU throughout the follow-up period in terms of clinical complications, reinterventions and mortality. The economic evaluation showed that a CDU-based strategy generated lower expected costs and higher quality-adjusted life-year (QALYs) than a CTA-based strategy and has a 63% probability of being cost-effective at a £30,000 willingness-to-pay-per-QALY threshold. A CEU-based strategy generated more QALYs, but at higher costs, and became cost-effective only for high-risk patient groups.

LIMITATIONS: Most studies were rated as being at a high or moderate risk of bias. No studies compared CDU with CEU. Substantial clinical heterogeneity precluded a formal synthesis of results. The economic model was hindered by a lack of suitable data.

CONCLUSIONS: Current surveillance practice is very heterogeneous. CDU may be a safe and cost-effective alternative to CTA, with CTA being reserved for abnormal/inconclusive CDU cases.

FUTURE WORK: Research is needed to validate the safety of modified, more-targeted surveillance protocols based on the use of CDU and CEU. The role of radiography for surveillance after EVAR requires clarification.

STUDY REGISTRATION: This study is registered as PROSPERO CRD42016036475.

FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Original languageEnglish
Pages (from-to)1-220
Number of pages220
JournalHealth Technology Assessment
Volume22
Issue number72
DOIs
Publication statusPublished - Dec 2018

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Abdominal Aortic Aneurysm
Cost-Benefit Analysis
Color
Radiography
Quality-Adjusted Life Years
Costs and Cost Analysis
Databases
Mortality
Computed Tomography Angiography
Cohort Studies
Economic Models
Endoleak
Biomedical Technology Assessment
National Institutes of Health (U.S.)
Research
MEDLINE
Aneurysm
Thrombosis
Randomized Controlled Trials

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Contrast-enhanced ultrasound and/or colour duplex ultrasound for surveillance after endovascular abdominal aortic aneurysm repair : a systematic review and economic evaluation. / Brazzelli, Miriam (Corresponding Author); Hernández, Rodolfo; Sharma, Pawana; Robertson, Clare; Shimonovich, Michal; MacLennan, Graeme; Fraser, Cynthia; Jamieson, Russell; Vallabhaneni, Srinivasa Rao.

In: Health Technology Assessment, Vol. 22, No. 72, 12.2018, p. 1-220.

Research output: Contribution to journalArticle

Brazzelli, Miriam ; Hernández, Rodolfo ; Sharma, Pawana ; Robertson, Clare ; Shimonovich, Michal ; MacLennan, Graeme ; Fraser, Cynthia ; Jamieson, Russell ; Vallabhaneni, Srinivasa Rao. / Contrast-enhanced ultrasound and/or colour duplex ultrasound for surveillance after endovascular abdominal aortic aneurysm repair : a systematic review and economic evaluation. In: Health Technology Assessment. 2018 ; Vol. 22, No. 72. pp. 1-220.
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abstract = "BACKGROUND: Endovascular abdominal aortic aneurysm repair (EVAR) of abdominal aortic aneurysm (AAA) is less invasive than open surgery, but may be associated with important complications. Patients receiving EVAR require long-term surveillance to detect abnormalities and direct treatments. Computed tomography angiography (CTA) has been the most common imaging modality adopted for EVAR surveillance, but it is associated with repeated radiation exposure and the risk of contrast-related nephropathy. Colour duplex ultrasound (CDU) and, more recently, contrast-enhanced ultrasound (CEU) have been suggested as possible, safer, alternatives to CTA.OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of imaging strategies, using either CDU or CEU alone or in conjunction with plain radiography, compared with CTA for EVAR surveillance.DATA SOURCES: Major electronic databases were searched, including MEDLINE, EMBASE, Science Citation Index, Scopus' Articles-in-Press, Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE) and NHS Economic Evaluation Database from 1996 onwards. We also searched for relevant ongoing studies and conference proceedings. The final searches were undertaken in September 2016.METHODS: We conducted a systematic review of randomised controlled trials and cohort studies of patients with AAAs who were receiving surveillance using CTA, CDU and CEU with or without plain radiography. Three reviewers were involved in the study selection, data extraction and risk-of-bias assessment. We developed a Markov model based on five surveillance strategies: (1) annual CTA; (2) annual CDU; (3) annual CEU; (4) CDU together with CTA at 1 year, followed by CDU on an annual basis; and (5) CEU together with CTA at 1 year, followed by CEU on an annual basis. All of these strategies also considered plain radiography on an annual basis.RESULTS: We identified two non-randomised comparative studies and 25 cohort studies of interventions, and nine systematic reviews of diagnostic accuracy. Overall, the proportion of patients who required reintervention ranged from 1.1{\%} (mean follow-up of 24 months) to 23.8{\%} (mean follow-up of 32 months). Reintervention was mainly required for patients with thrombosis and types I-III endoleaks. All-cause mortality ranged from 2.7{\%} (mean follow-up of 24 months) to 42{\%} (mean follow-up of 54.8 months). Aneurysm-related mortality occurred in < 1{\%} of the participants. Strategies based on early and mid-term CTA and/or CDU and long-term CDU surveillance were broadly comparable with those based on a combination of CTA and CDU throughout the follow-up period in terms of clinical complications, reinterventions and mortality. The economic evaluation showed that a CDU-based strategy generated lower expected costs and higher quality-adjusted life-year (QALYs) than a CTA-based strategy and has a 63{\%} probability of being cost-effective at a £30,000 willingness-to-pay-per-QALY threshold. A CEU-based strategy generated more QALYs, but at higher costs, and became cost-effective only for high-risk patient groups.LIMITATIONS: Most studies were rated as being at a high or moderate risk of bias. No studies compared CDU with CEU. Substantial clinical heterogeneity precluded a formal synthesis of results. The economic model was hindered by a lack of suitable data.CONCLUSIONS: Current surveillance practice is very heterogeneous. CDU may be a safe and cost-effective alternative to CTA, with CTA being reserved for abnormal/inconclusive CDU cases.FUTURE WORK: Research is needed to validate the safety of modified, more-targeted surveillance protocols based on the use of CDU and CEU. The role of radiography for surveillance after EVAR requires clarification.STUDY REGISTRATION: This study is registered as PROSPERO CRD42016036475.FUNDING: The National Institute for Health Research Health Technology Assessment programme.",
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TY - JOUR

T1 - Contrast-enhanced ultrasound and/or colour duplex ultrasound for surveillance after endovascular abdominal aortic aneurysm repair

T2 - a systematic review and economic evaluation

AU - Brazzelli, Miriam

AU - Hernández, Rodolfo

AU - Sharma, Pawana

AU - Robertson, Clare

AU - Shimonovich, Michal

AU - MacLennan, Graeme

AU - Fraser, Cynthia

AU - Jamieson, Russell

AU - Vallabhaneni, Srinivasa Rao

N1 - Study registration: This study is registered as PROSPERO CRD42016036475. Funding: The National Institute for Health Research Health Technology Assessment programme.

PY - 2018/12

Y1 - 2018/12

N2 - BACKGROUND: Endovascular abdominal aortic aneurysm repair (EVAR) of abdominal aortic aneurysm (AAA) is less invasive than open surgery, but may be associated with important complications. Patients receiving EVAR require long-term surveillance to detect abnormalities and direct treatments. Computed tomography angiography (CTA) has been the most common imaging modality adopted for EVAR surveillance, but it is associated with repeated radiation exposure and the risk of contrast-related nephropathy. Colour duplex ultrasound (CDU) and, more recently, contrast-enhanced ultrasound (CEU) have been suggested as possible, safer, alternatives to CTA.OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of imaging strategies, using either CDU or CEU alone or in conjunction with plain radiography, compared with CTA for EVAR surveillance.DATA SOURCES: Major electronic databases were searched, including MEDLINE, EMBASE, Science Citation Index, Scopus' Articles-in-Press, Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE) and NHS Economic Evaluation Database from 1996 onwards. We also searched for relevant ongoing studies and conference proceedings. The final searches were undertaken in September 2016.METHODS: We conducted a systematic review of randomised controlled trials and cohort studies of patients with AAAs who were receiving surveillance using CTA, CDU and CEU with or without plain radiography. Three reviewers were involved in the study selection, data extraction and risk-of-bias assessment. We developed a Markov model based on five surveillance strategies: (1) annual CTA; (2) annual CDU; (3) annual CEU; (4) CDU together with CTA at 1 year, followed by CDU on an annual basis; and (5) CEU together with CTA at 1 year, followed by CEU on an annual basis. All of these strategies also considered plain radiography on an annual basis.RESULTS: We identified two non-randomised comparative studies and 25 cohort studies of interventions, and nine systematic reviews of diagnostic accuracy. Overall, the proportion of patients who required reintervention ranged from 1.1% (mean follow-up of 24 months) to 23.8% (mean follow-up of 32 months). Reintervention was mainly required for patients with thrombosis and types I-III endoleaks. All-cause mortality ranged from 2.7% (mean follow-up of 24 months) to 42% (mean follow-up of 54.8 months). Aneurysm-related mortality occurred in < 1% of the participants. Strategies based on early and mid-term CTA and/or CDU and long-term CDU surveillance were broadly comparable with those based on a combination of CTA and CDU throughout the follow-up period in terms of clinical complications, reinterventions and mortality. The economic evaluation showed that a CDU-based strategy generated lower expected costs and higher quality-adjusted life-year (QALYs) than a CTA-based strategy and has a 63% probability of being cost-effective at a £30,000 willingness-to-pay-per-QALY threshold. A CEU-based strategy generated more QALYs, but at higher costs, and became cost-effective only for high-risk patient groups.LIMITATIONS: Most studies were rated as being at a high or moderate risk of bias. No studies compared CDU with CEU. Substantial clinical heterogeneity precluded a formal synthesis of results. The economic model was hindered by a lack of suitable data.CONCLUSIONS: Current surveillance practice is very heterogeneous. CDU may be a safe and cost-effective alternative to CTA, with CTA being reserved for abnormal/inconclusive CDU cases.FUTURE WORK: Research is needed to validate the safety of modified, more-targeted surveillance protocols based on the use of CDU and CEU. The role of radiography for surveillance after EVAR requires clarification.STUDY REGISTRATION: This study is registered as PROSPERO CRD42016036475.FUNDING: The National Institute for Health Research Health Technology Assessment programme.

AB - BACKGROUND: Endovascular abdominal aortic aneurysm repair (EVAR) of abdominal aortic aneurysm (AAA) is less invasive than open surgery, but may be associated with important complications. Patients receiving EVAR require long-term surveillance to detect abnormalities and direct treatments. Computed tomography angiography (CTA) has been the most common imaging modality adopted for EVAR surveillance, but it is associated with repeated radiation exposure and the risk of contrast-related nephropathy. Colour duplex ultrasound (CDU) and, more recently, contrast-enhanced ultrasound (CEU) have been suggested as possible, safer, alternatives to CTA.OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of imaging strategies, using either CDU or CEU alone or in conjunction with plain radiography, compared with CTA for EVAR surveillance.DATA SOURCES: Major electronic databases were searched, including MEDLINE, EMBASE, Science Citation Index, Scopus' Articles-in-Press, Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE) and NHS Economic Evaluation Database from 1996 onwards. We also searched for relevant ongoing studies and conference proceedings. The final searches were undertaken in September 2016.METHODS: We conducted a systematic review of randomised controlled trials and cohort studies of patients with AAAs who were receiving surveillance using CTA, CDU and CEU with or without plain radiography. Three reviewers were involved in the study selection, data extraction and risk-of-bias assessment. We developed a Markov model based on five surveillance strategies: (1) annual CTA; (2) annual CDU; (3) annual CEU; (4) CDU together with CTA at 1 year, followed by CDU on an annual basis; and (5) CEU together with CTA at 1 year, followed by CEU on an annual basis. All of these strategies also considered plain radiography on an annual basis.RESULTS: We identified two non-randomised comparative studies and 25 cohort studies of interventions, and nine systematic reviews of diagnostic accuracy. Overall, the proportion of patients who required reintervention ranged from 1.1% (mean follow-up of 24 months) to 23.8% (mean follow-up of 32 months). Reintervention was mainly required for patients with thrombosis and types I-III endoleaks. All-cause mortality ranged from 2.7% (mean follow-up of 24 months) to 42% (mean follow-up of 54.8 months). Aneurysm-related mortality occurred in < 1% of the participants. Strategies based on early and mid-term CTA and/or CDU and long-term CDU surveillance were broadly comparable with those based on a combination of CTA and CDU throughout the follow-up period in terms of clinical complications, reinterventions and mortality. The economic evaluation showed that a CDU-based strategy generated lower expected costs and higher quality-adjusted life-year (QALYs) than a CTA-based strategy and has a 63% probability of being cost-effective at a £30,000 willingness-to-pay-per-QALY threshold. A CEU-based strategy generated more QALYs, but at higher costs, and became cost-effective only for high-risk patient groups.LIMITATIONS: Most studies were rated as being at a high or moderate risk of bias. No studies compared CDU with CEU. Substantial clinical heterogeneity precluded a formal synthesis of results. The economic model was hindered by a lack of suitable data.CONCLUSIONS: Current surveillance practice is very heterogeneous. CDU may be a safe and cost-effective alternative to CTA, with CTA being reserved for abnormal/inconclusive CDU cases.FUTURE WORK: Research is needed to validate the safety of modified, more-targeted surveillance protocols based on the use of CDU and CEU. The role of radiography for surveillance after EVAR requires clarification.STUDY REGISTRATION: This study is registered as PROSPERO CRD42016036475.FUNDING: The National Institute for Health Research Health Technology Assessment programme.

U2 - 10.3310/hta22720

DO - 10.3310/hta22720

M3 - Article

VL - 22

SP - 1

EP - 220

JO - Health Technology Assessment

JF - Health Technology Assessment

SN - 1366-5278

IS - 72

ER -