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Erschienen in: The Ultrasound Journal 1/2021

Open Access 01.12.2021 | Review

Applications of intraoperative Duplex ultrasound in vascular surgery: a systematic review

verfasst von: Pasha Normahani, Bilal Khan, Viknesh Sounderajah, Sepideh Poushpas, Muzaffar Anwar, Usman Jaffer

Erschienen in: The Ultrasound Journal | Ausgabe 1/2021

Abstract

Objective

This review aims to summarise the contemporary uses of intraoperative completion Duplex ultrasound (IODUS) for the assessment of lower extremity bypass surgery (LEB) and carotid artery endarterectomy (CEA).

Methods

We performed a systematic literature search using the databases of MEDLINE. Eligible studies evaluated the use of IODUS during LEB or CEA.

Results

We found 22 eligible studies; 16 considered the use of IODUS in CEA and 6 in LEB. There was considerable heterogeneity between studies in terms of intervention, outcome measures and follow-up. In the assessment of CEA, there is conflicting evidence regarding the benefits of completion imaging. However, analysis from the largest study suggests a modest reduction in adjusted risk of stroke/mortality when using IODUS selectively (RR 0.74, CI 0.63–0.88, p = 0.001). Evidence also suggests that uncorrected residual flow abnormalities detected on IODUS are associated with higher rates of restenosis (range 2.1% to 20%). In the assessment of LEB, we found a paucity of evidence when considering the benefit of IODUS on patency rates or when considering its utility as compared to other imaging modalities. However, the available evidence suggests higher rates of thrombosis or secondary intervention in grafts with uncorrected residual flow abnormalities (up to 36% at 3 months).

Conclusions

IODUS can be used to detect defects in both CEA and LEB procedures. However, there is a need for more robust prospective studies to determine the best scanning strategy, criteria for intervention and the impact on clinical outcomes.
Hinweise

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Introduction

Despite recent advances in the provision of enhanced risk factor modification strategies and personalised post-operative patient care, open arterial surgery remains a risky endeavour. In addition to its technical complexity, it is a practice that harbours, in relative terms, a high degree of morbidity and mortality.
In elective infra-inguinal arterial, lower extremity bypass surgery (LEB), early post-operative graft failure, can occur in up to 5% of cases [1], requiring further surgical intervention, and increased length of hospital stay. For carotid artery endarterectomy (CEA), there has been reported, 7% peri-operative risk of stroke/mortality in patients with symptomatic carotid artery disease [2].
Although the aetiology of such early complications is often multifactorial, it is estimated that up to 25% are caused by technical errors and are thus preventable [35]. To minimise preventable technical errors, intraoperative assessments of technical adequacy may be useful. Intraoperative assessments aim to identify technical problems that may need to be immediately revised. Visual inspection, palpation and continuous-wave Doppler assessment are limited by subjectivity. In contrast, completion angiography objectively evaluates technical adequacy and arterial run-off. However, complications of arterial puncture, the use of nephrotoxic contrast agents, time taken to perform and radiation exposure limit its use.
Duplex ultrasonography (DUS) incorporates both B-mode ultrasound and pulsed-wave Doppler to allow for non-invasive anatomical imaging as well as assessment of flow through colour Doppler, and qualitative assessment of graphically displayed waveforms. Although possibly less anatomically precise compared to angiography, it can identify defects in arterial anastomoses and can also identify low velocity flow which may be undetected by angiography.
This review aims to summarise the effectiveness of intraoperative completion DUS (IODUS) for the assessment of CEA and LEB.

Methods

Search strategy

Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations, an electronic database search was conducted using MEDLINE to include articles from January 1950 through to February 2020 written in English. Reference lists were examined from the retrieved full-text articles. ClinicalTrials.gov was searched for in-progress trials.
In our search strategy, we used the following key terms: “ultrasonography”, “Doppler”, “duplex”, “completion imaging”, “vascular surgical procedures”, “bypass grafting”, “lower limb arterial bypass”, “carotid artery endarterectomy” and “intra-operative”. Titles and abstracts were reviewed for relevance by two investigators (PN and BK) independently. Conference abstracts and protocol papers were not included. Full-text articles were then reviewed, and data collected on technique used, participants, interventions performed, outcomes and findings. Disagreements were resolved by consensus discussion with the senior author (UJ).

Eligibility criteria

We sought studies that evaluated the use of IODUS during LEB or CEA. Restrictions were not placed on study type. However, studies only considering the natural progression of lesions (i.e., results not used to inform management decisions peri-operatively) were excluded.

Outcomes measured

For the use of IODUS for CEA, outcomes of interest included (1) stroke/mortality at 30 days and (2) flow abnormalities on follow-up imaging. For LEB, the outcome of interest was primary graft patency at 30 days. For both CEA and LEB, we also consider the natural history of cases with normal and abnormal completion imaging.

Results

Through our initial search strategy, we identified 96 papers (Fig. 1). Of these, 36 papers were shortlisted for full-text review based on their title and abstract. A full-text screening resulted in a final selection of 22 studies. Of these studies, 16 considered the use of IODUS in CEA (Table 1) and 6 in LEB (Table 2).
Table 1
Summary of results from studies evaluating IODUS in CEA
Carotid endarterectomy
First author
Year
Study design
No of procedures
Imaging criteria (selective or routine)/revision criteria
Revision rate
Stroke (30 days)
Mortality (30 days)
Follow-up imaging; residual or recurrent stenosis
Studies comparing (a) completion imaging vs no imaging or (b) different completion imaging modalities
Knappich C
2017
Retrospective analysis of registry data; German statutory nationwide quality assurance database
142,074
Selective; Imaging in 66.9% (95 044/142 074) of cases. Mix of DUS/angiogram/flowmetry or other unspecified modalities. Differential count for imaging modalities not presented in data
Criteria for revision:
Surgeons discretion
Not known
Combined stroke/mortality rate
Scan: 1.7% (1654/95,044), RR 0.86 (CI 0.80–0.93)
No scan: 2% (957/47,030)
Adjusted risk of any stroke or mortality
Intraoperative completion study
Angiogram: RR 0.8 (CI 0.71–0.9) p < 0.001
DUS: RR 0.74 (CI 0.63–0.88) p = 0.001
Flowmetry: RR 0.87 (CI 0.74–1.04) p = 0.121
Other: RR 0.97 (CI 0.80–1.17) p = 0.756
Not known
Wallaert JB
2011
Retrospective analysis of registry data; Vascular Study Group of New England (VSGNE) Registry
6115
Selective; Completion imaging only performed in 2033 cases. DUS in 94% (1919/2033) of cases
Amongst 73 surgeons; completion imaging used rarely (51%), selectively (22%) or routinely (27%)
Criteria for revision:
Surgeon’s discretion
Practice pattern defined as routine (imaging used in ≥ 90% of cases), selective (5% to 90%) and rare (< 5%)
Routine: 7.6%
Selective: 0.8%,
Rare: 0.9%
Combined stroke/mortality rates
Routine: 2.4% (42/1763)
Selective: 1.2% (12/1018)
Rare: 1.7% (55/3334)
Routine v selective v rare; p = 0.048
Risk adjusted; Selective (OR, 0.75; 95% CI 0.40–1.41; p = .366), routine OR, 1.42; 95% CI .93–2.17; p = .106
Revised cases: 3.9% (7/178)
Not revised cases: 1.7% (102/5937)
Revised v not revised; p = 0.028
Risk adjusted; OR 2.1; 95% CI, 0.9–5.0; p = .076
Completion imaging: 2.6%
No completion imaging: 1.3%
Completion imaging v no completion imaging; p < 0.001
Risk adjusted; OR, 1.9; 95% CI, 1.2–2.7; P = .002
Restenosis (> 70%) at 1 year
Routine: 1.1%
Selective: 1.1%
Rare: 2.8%
Routine v selective v rare; p = 0.09
Rockman CB et al
2007
Retrospective analysis of data from the New York Carotid Artery Surgery (NYCAS) study
9278
Selective; Imaging in 35.8% (3318/9278)
Angiogram 5.4% (178/3318), continuous wave Doppler 70.3% (2331/3318), DUS 17.6% (585/3318), combination of angio ± Doppler or DUS 5.9% (196/3318)
Criteria for revision:
Surgeons discretion
Not known
Combined stroke/mortality rate
No scan: 3.8%
Any scan: 4.3%
Angiogram: 5.2%
Doppler: 4.3%
DUS: 4.3%
No statistical significance when comparing ‘no scan’ with ‘any scan’ or when comparing individual modalities with ‘no scan’
Not known
Kinney EV
1993
Prospective single center study
461
Selective; DUS in 410 cases
Criteria for revision:
Severe flow disturbance (PSV > 150 cm/s and spectral broadening) or occlusion in the CCA/ICA/ECA
6.3% (26/410)
Stroke rate
Combined: 2.2% (10/461)
No scan: 0% (0/51)
*Normal scan: 2.1% (7/337)
*Abnormal scan: 4.1% (3/73)
Revisions: 3.8% (1/26)
(*at completion)
Mortality rate
Combined:
2.6% (12/461)
No scan: 0% (0/51)
*Normal scan: 3.3% (11/337)
* Abnormal scan: 1.4% (1/73)
Flow abnormality at 3 months (> 50% category):
Combined: 2.4% (11/461)
No scan: 9.8% (5/51)
*No flow abnormality: 0.3% (1/337)
*Residual flow disturbance: 6.8% (5/73)
Lingenfelter KA
1995
Prospective single center study
53
Routine; combination of hand-held Doppler, DUS and angiogram in all cases
Criteria for revision:
Surgeon’s discretion
11.3% (6/53)
Stroke rate
Combined: 1.8% (1/53)
DUS detected all 6 defects requiring revision. Audible Doppler assessment detected only 1 and DSA 4
Mortality rate
Combined: 0% (0/53)
Not known
Lipski DA
1996
Retrospective study
86
Selective (at surgeons discretion); DUS in 39 procedures
Criteria for revision:
Surgeon’s discretion
23.1% (9/39)
Stroke rate
Combined: 3.5% (3/86)
Scan: 2.6% (1/39)
No scan: 4.3% (2/47)
Mortality rate
Combined: 0% (0/86)
Residual stenosis (> 50%):
Combined: 8.1% (7/86)
Scan: 0% (0/39)
No scan: 14.9% (7/47)
Restenosis (< 50%) at mean follow up of 20 months
Combined: 4.7% (4/86)
Scan: 5.1% (2/39)
No scan: 4.3% (2/47)
Note: significant variation in patch vs primary closure
Lane RJ
1987
Prospective single center study
380
Selective; DUS in 175 cases
Criteria for revision:
Unspecified criteria for 30% stenosis
6.9% (12/175)
Stroke rate
Combined: 2.1% (8/380)
No scan: 2.4% (5/205)
Normal scan: 2.2% (3/136)
Abnormal scan: 0% (0/39)
Mortality rate
Combined: 0.5% (2/380)
No scan: 0.4% (1/205)
Normal scan: 0.7% (1/136)
Abnormal scan: 0% (0/39)
Restenosis at mean follow up of 22 months
Combined: not available
No scan: not available
Abnormal scan: 6.3% (1/16)
Restenosis at mean follow up of 16 months
Normal scan: 9.2% (8/87)
*Only 103 patients followed up
Descriptive studies
Dorffner R
1997
Prospective single center study
50
Routine; DUS in all cases
Criteria for revision:
Surgeons’ discretion
18% (9/50)
Stroke rate
Combined: 4% (2/50)
*Normal scan: 0% (0/32)
Abnormal scan but not revised: 20% (2/10)
Revised: 0% (0/9)
*Normal at completion
Mortality rate
Combined: 0% (0/50)
Restenosis at mean follow up of 10 months
Normal scan: 6.3% (2/32)
Abnormal scan but not revised: 20% (2/10)
Revised: 0% (0/9)
Mays BW
2000
Prospective single center study
100
Routine; DUS in all cases
Criteria for revision:
PSV > 150 cm/s and spectral broadening indicating severe flow disturbance in CCA, ICA or ECA. If no obvious cause for flow disturbance was identified then angiogram was performed prior to revision. In addition, flaps in distal ICA and defects > 2 mm in the CCA or bulb were revised in the presence of a PSV > 125 cm/s colour mosaic or loss of spectral window
21% (21/100)
Stroke rate
Combined: 1% (1/100)
Mortality rate
Combined: 1% (1/100)
At 6 weeks:
Revisions: 1/21 showed an occluded ICA and 2/21 showed residual stenosis
No abnormality on completion: 10/79 showed recurrent stenosis (16% to 49% category)
Yuan
2014
Prospective single surgeon series
285
Routine; DUS in all cases
Criteria for revision:
Visible ICA kinking with PSV ≥ 120 cm/s
3.9% (11/285)
Stroke rate
Combined: 1.1% (3/285)
Repaired ICA kinking: 0% (0/11)
Unrepaired ICA kinking: 0% (0/16)
Mortality rate
Combined: 0% (0/285)
Repaired ICA kinking: 0% (0/11)
Unrepaired ICA kinking: 0% (0/16)
By 9–24 months:
Combined: 1.8% (5/284)
Repaired ICA kinking: 9.1% (1/11) restenosis (60–79%), 9.1% (1/11) occlusion
Unrepaired ICA kinking: 0% (3/15*) mild 0–40% stenosis
(*one patient lost to f/u)
Baker
1994
Retrospective single center study
316
Selective; DUS in 283 cases
Criteria for revision:
Surgeon’s discretion
2.8% (9/316)
Stroke rate
Combined: 1.6% (5/316)
Normal scan: 1.6% (4/254)
Unrepaired minor defects: 1.9% (1/53)
Revised defects: 0% (0/9)
Mortality rate
Combined: 0.3% (1/283)
(Single death was in the normal scan group)
*316 cases in 283 patients
Stenosis (> 75%) at mean follow up of 21.6 months:
Combined: 5.7% (18/316)
Normal scan: 3.2% (8/251*)
Unrepaired minor defects: 17.3% (9/52*). One of these arteries later occluded
Revised defects: 11.1% (1/9)
Note: restenosis was correlated with primary and patch closure (p = 0.025)
*No of patent vessels in surviving patients
Panneton JM
2001
Retrospective single center study
155
Routine; DUS in all cases
Criteria for revision:
PSV > 125 cm/s and marked plaque/thrombus or large intimal flap/dissection in the CCA, IC or ECA
9% (14/155)
Stroke rate
Combined: 1.9% (3/155)
Normal scan: 1.1% (1/91)
Minor defects: 0% (0/47)
Revised major defects: 0% (0/14)
Unrevised major defects: 66.7% (2/3)
Mortality rate
Combined: 0.7% (1/149*)
(1 death in patient with unrevised major defect)
*155 cases in 149 patients
Restenosis at 6 months*:
Normal scan: 1.1% (1/91) restenosis
Minor defects: 2.1% (1/47)
Revised major defects: 0% (0/14)
*(Asymptomatic > 50%)
Steinmetz OK
1998
Retrospective single surgeon series
100
Routine; DUS in all cases
Criteria for revision:
Intraluminal thrombosis or focal elevation of PSV > 120 cm/s and marked spectral broadening in either CCA, ICA or ECA
2% (2/100)
Stroke rate
Combined: 2% (2/100)
Mortality rate
Combined: 1% (1/100)
Abnormality at mean follow up of 9.2 months
Combined: 13.6% (12/88)
(< 50% stenosis in 6, > 50% stenosis in 5, asymptomatic occlusion in 1)
*Follow up scans available in 88 patients
Ascher E
2004
Prospective single center study
650
Routine; DUS in all cases
Criteria for revision:
Mobile flap > 2 mm in ICA, flap > 3 mm in the CCA and technical defects causing > 30% luminal ICA stenosis
2.3% (15/650)
Stroke rate
Combined: 0.3% (2/650)
Revised: 0% (0/15)
Mortality rate
Combined: 0.3% (2/590)
*650 cases in 590 patients
Flow abnormality at 2 weeks:
Combined: 3% (2/625*)—ICA occlusion in both cases
Revised: 0% (0/15)
Flow abnormality at 3 months:
Revised: 0% (0/15)
*625 f/u scan available for 650 patients
Mullenix PS
2003
Prospective single center study
100
Routine; DUS in all cases
Criteria for revision:
Surgeon’s discretion
7% (7/100)
Stroke rate
Combined: 2% (2/100)
Both stroked occurred in cases with an abnormal completion scan that was left unrepaired. However, one stroke was contralateral and likely unrelated
Mortality rate
Combined: 0% (0/100)
Re-stenosis* at follow up (range 6–45 months)
Combined: 10/100
3 of these regressed and 1 was high grade (> 80%)
*Defined as > 50%
Bandyk DF
1994
Prospective single center study
368 in total, of which 210 were CEA’s
Routine; DUS in all cases
Criteria for revision:
Defect on B mode with a PSV > 150 cm/s in CCA, ICA or ECA
8.1% (17/210)
Combined: 0% (0/210)
Not specified
Not specified
Table 2
Summary of results from studies evaluating IODUS in LEB
Lower limb revascularisations
First author
Year
Study design
No procedures
Imaging criteria (selective or routine)/revision criteria
Revision rate
Graft thrombosis/revision
Studies comparing a) completion imaging vs no imaging or b) different completion imaging modalities
Taze-Woei T
2014
Retrospective analysis of registry data; Vascular Study Group of New England (VSGNE) Registry
2032
Selective: completion imaging performed in 67% of cases (1368/2032). Angiography performed in in 89% and DUS in 11% of cases
Criteria for revision:
Surgeons discretion
 
No breakdown results for completion imaging strategy (i.e., DUS and angiography)
Selective vs routine completion imaging
The surgeon’s strategy of performing routine vs selective CIM was not associated with primary graft patency at discharge (RR, 0.8; 95% CI 0.6–1.1; p = .31) and at 1-year follow-up (RR, 1.1; 95% CI 0.9–1.2; p = .56)
Completion imaging vs no completion imaging
In multivariate models, completion imaging was not associated with improved primary graft patency at discharge (OR, 1.1; 95% CI 0.7–1.7; p = .64) or at 1 year (OR, 0.9; 95% CI 0.7–1.2; p = .47)
Gilbertson JJ
1991
Prospective single center study
20
Routine. Blinded comparison of DUS, angiography and angioscopy
Criteria for revision:
Residual valve cusp: Doubling of PSV or marked spectral broadening compared with adjacent graft. PSV < 40 cm/s or > 150 cm/s
Unligated side branch: B-mode or color flow image directed away from lumen
Anastomotic stenosis: High velocity jet or turbulence
unknown
Residual cusps (n = 9)
Angiography: (2/9)
Angioscopy: (9/9)
DUS: (1/9)
Unligated side branch (n = 32)
Angiography: (14/32)
Angioscopy: (21/32)
DUS: (4/32)
Anastomotic stenosis (n = 0)
Angiography: (4/0), FP rate 20%
Angioscopy: (0/0)
DUS: (2/0), FP rate 10%
Denominator = confirmed on exploration
Descriptive studies
Bandyk DF
1994 (series from 1990–1993)
Prospective single center study
368 in total, of which 135 were bypasses
Routine
Completion arteriography was also performed in 81% of cases (110/135)
Criteria for revision:
Severe (PSV > 180 cm/s with broadening or PSVR 2.5 to 4) or high grade (PSV > 300 cm/s or PSVR > 4) stenosis velocity spectra in the presence of anatomic lesion on DUS
14.1% (19/135)
Within 30 days
Combined graft thrombosis:
0.7% (1/135)
Combined secondary intervention: 2.2% (3/135)
Due to a lesion and low graft flow
Combined assisted patency: 100% (135/135)
All of the four cases had residual lesions on completion DUS. 60% (3/5) unrepaired vein graft lesions required revision. No patients with a normal completion scan required a secondary procedure during a minimum of 2-month follow-up
Completion angiography did not demonstrate any additional significant lesions
Bandyk DF
1996 (series from 1991–1995)
Prospective single center study
275
Routine
Criteria for revision:
Severe (PSV > 180 cm/s with broadening or PSVR 2.5 to 4) or high grade (PSV > 300 cm/s or PSVR > 4) stenosis velocity spectra in the presence of vessel lumen defect or narrowing
Lesions associated with low graft flow
Segments with borderline stenosis (125–180 cm/s) were rescanned after additional papaverine administration—if PSV increased to > 200 cm/s in a normal diameter vein or anastomosis revision was performed
When increased velocities (> 180 cm/s) were measured in outflow tibial arteries but the velocity ratio was less than < 2.5, an angiogram was performed confirm patency beyond distal anastomosis
15.6% (43/275)
Within 30 days
Graft thrombosis
Overall: 1.1% (3/275)
Unrepaired flow abnormality (PSV < 180 cm/s): 4% (1/25)
Secondary intervention
Unrepaired flow abnormality (PSV < 180 cm/s): 16% (4/25)
Assisted patency
Overall: 100% (275/275)
Mortality:
Overall: 1.1% 3/275
Between 30 and 90 days
Graft thrombosis
Normal imaging*: 0.4% (1/235)
Unrepaired flow abnormality (PSV < 180 cm/s): 4% (1/25)
Secondary intervention
Normal imaging*: 2.6% (26/235)
Unrepaired flow abnormality (PSV < 180 cm/s): 36% (9/25)
Abnormal imaging after repair: 40% (6/15)
Overall graft thrombosis/secondary intervention in normal imaging vs Unrepaired flow abnormality; p < 0.001
60% 15/25 uncorrected abnormalities had thrombosis or re-intervention in first 3 months
*202 without repair, 33 with repair
Johnson BL
2000 (series from 1991–1998)
Retrospective single center study
 
Routine
Criteria for revision:
Same criteria as Bandyk (1996). However, low flow and unrepaired graft lesions were managed with specified antithrombotic regimen or adjunctive procedure
Normal graft flow (> 45 cm/s, low PVR defined as antegrade flow throughout pulsed cycle)- dextran + aspirin (325 mg/day)
Low flow and low PVR- heparin + dextran + aspirin
Low flow and high PVR- adjunct procedure (e.g., arteriovenous fistula or jump graft to another outflow artery) if possible. If not treated as low flow + low PVR
Low flow graft stenosis (> 200 cm/s at site of stenosis- repair stenosis + heparin + dextran + aspirin
15.3% (96/626)*
Revision of 99 graft segments for stenosis and 5 adjunct procedures to improve graft flow *
*104 defects in 96 bypasses
Within 30 days (secondary intervention rate)
Combined: 4.2% (26/626)
Normal flow: 1.1% (5/464)
Normal flow (revised graft): 1.5% (1/67)
Residual flow abnormality (revised graft): 34.5%(10/29)
Unrepaired flow abnormality): 13.2% (7/53)
Low flow (but no stenosis): 23.1% (3/13)
Between 30 and 90 days (secondary intervention rate)
Combined: 4.3% (27/626)
Normal flow: 1.3% (6/464)
Normal flow (revised graft): 1.5% (1/67)
Residual flow abnormality (revised graft): 10.3% (3/29)
Unrepaired flow abnormality: 24.5% (13/53)
Low flow (but no stenosis): 15.4% (2/13)
Total (within 90 days) (secondary intervention rate)
Combined: 8% (51/626)
Normal flow: 2.4% (11/464)
Normal flow (revised graft): 3%(2/67)
Residual flow abnormality (revised graft): 44.8% (13/29)
Unrepaired flow abnormality: 37.7% (20/53)
Low flow (but no stenosis): 38.5% (5/13)
MacKenzie KS
1999
Retrospective single center study
78
Selective
Criteria for revision:
Surgeons discretion
15.3% (12/78)
Within 30 days (n = 76):
Secondary intervention rate/primary patency/secondary patency
Normal flow: 1.3%/100%/N.A
*Revised graft: 8.3%/100%/N.A
Unrepaired flow abnormality: 11.1%/83%/unknown
Between 30 days and an average intermediate follow-up of 7.4 months (n = 72)
Secondary intervention rate /primary patency/secondary patency
Normal flow: 1.3%/93%/97%
Revised graft: 8.3%/91%/100%
Unrepaired flow abnormality: 11.1%/53.1%/71.1%
Statistical significant difference in patency rates when comparing unrepaired flow abnormality to normal flow (p < 0.001) or to repaired group (p < 0.001)
*Repeat scan normal at completion in all 12 cases

Quality of studies

There were no randomised controlled trials comparing IODUS with no completion imaging or other completion imaging techniques. Sixteen studies investigated the role of IODUS in CEA: 3 were based on prospectively maintained registries; 9 were prospective single-centre studies; and 4 retrospective studies. Six studies investigated the role of IODUS for LEB: 4 were prospective (in one study data was Registry analysis); 2 were retrospective studies. There was considerable heterogeneity in terms of intervention, outcome measures and follow-up.

Carotid artery endarterectomy

Study characteristics and designs

IODUS was performed routinely in 9 of 16 studies and selectively in 7 of 16. Criteria for selective use of IODUS was left to surgeons’ discretion and was not specified in any of these studies.
Revision rates were available for 14 out of 16 studies and ranged between 0 and 23%. In 9 studies, the IODUS criteria for revision of the carotid reconstruction were unspecified and left to the discretion of the operating surgeon. In the remaining 7 studies, criteria for revision were variable depending upon the vessels scanned and were based-upon (1) spectral waveform criteria for flow disturbance and (2) B-mode criteria for determining significance of defects. In the majority of studies, all the three carotid vessels [610] were scanned. However, one paper only considered flow abnormalities in the presence of internal carotid artery (ICA) kinking [11] and another did not consider abnormalities of the external carotid artery (ECA) [12].
1.
Spectral waveform criteria
Criteria for defining severe flow abnormality were based on velocity readings (thresholds ranged from 120 to 150 cm/s) and qualitative arterial waveform features such as spectral broadening, colour mosaic and infilling of the spectral window. In three studies, vessels with flow abnormalities in the absence of an identifiable cause on B-mode ultrasound were surgically revised [7, 9, 10]. In two other studies, flow abnormalities with no identifiable cause on B-mode ultrasound were first assessed with an intraoperative angiogram prior to any revision [6, 12]. In one of these studies, an elevated peak systolic velocity (PSV) was measured in 27 cases (between 151 and 421 cm/s) with no evident technical defect or residual disease. In such cases, repeated measurements 15 to 20 min later were often improved (between 62 and 199 cm/s). If values were persistently abnormal, an intraoperative angiogram was then obtained.
 
2.
B-mode criteria
B-mode thresholds for revision were also variable and included the presence of ICA kinking, occlusion, thrombus, marked residual plaque, dissection or flap. Thresholds for determining the significance of flaps were also variable. Mays et al. [6] immediately revised all distal ICA flaps, and common carotid artery (CCA) or bulb defects > 2 mm in the presence of flow abnormalities. Panneton et al. [8] revised cases with intimal flaps or dissections > 3 mm in the presence of significant flow abnormalities. Ascher and colleagues [12] revised all cases with mobile flaps > 2 mm in ICA or > 3 mm in the CCA.
 

Comparing outcomes from completion imaging vs no completion imaging

The largest studies comparing utilisation of completion imaging vs no completion imaging are the retrospective analysis of large data sets from Knappich [13], Wallaert [14] and Rockman [15].
In the largest of these data sets, Knappich [13] demonstrated an association between completion imaging with lower rates of stroke/mortality (relative risk (RR) 0.86 (CI 0.80–0.93)). Rockman and colleagues, on the other hand, demonstrate no statistically significant difference in the rates of stroke [2.8% with imaging, 2.4% without imaging, p = not significant (NS)] or combined stroke/mortality rates (3.6% with imaging, 3.3% without imaging, p = NS) between cases in which intraoperative imaging was used and cases in which no intraoperative imaging was used [15]. Conversely, Wallaert and colleagues demonstrated higher rates of stroke/mortality in cases in which completion imaging was used as compared to cases in which no imaging was used (2.6% with imaging, 1.3% with no imaging; p < 0.001) [14]. This difference was still statistically significant after risk adjustment [odds-ratio (OR), 1.9; 95% CI 1.2–2.7; p = 0.002] [14].

Comparing outcomes from IODUS with other completion imaging modalities

Knappich et al. provide an analysis of 142,074 CEAs from the German statutory nationwide quality assurance database [13]. Within this large cohort, 66.9% (95,044) underwent completion imaging using IODUS, angiogram, flowmetry or other. In their results, they provide subgroup analysis demonstrating that utilisation of either intraoperative angiography (RR 0.8 (CI 0.71–0.9) p < 0.001) or IODUS (RR 0.74 (CI 0.63–0.88) p = 0.001) is associated with lower rates of stroke/mortality. Their analysis seems to show a slightly stronger affect for IODUS as compared to angiography.
Another study by Rockman and colleagues provides analysis from 9278 CEAs from the New York Carotid Artery Surgery (NYCAS) study [15]. Amongst these cases, completion imaging was performed in 3318 cases. In the majority of cases, imaging merely consisted of continuous wave Doppler assessment (70.3%; 2331/3318), followed by IODUS (17.6%; 585/3318), angiogram (5.4%; 178/3318), or a combination of angiogram ± Doppler or IODUS (5.9%; 196/3318). Stroke/mortality rates for each modality were not statistically significant (angiogram: 5.2%, Doppler: 4.3%, IODUS: 4.3%; p value not given).
A smaller prospective study of 53 patients compared the ability to detect abnormalities with audible handheld Doppler assessment, digital subtraction angiography (DSA) and IODUS colour flow [16]. In this cohort, 6 patients (11.3%) required revision due to significant abnormalities. IODUS detected all six defects requiring revision, whilst audible Doppler assessment detected only 1 and DSA 4 [16].

Primary revision surgery based on IODUS findings and 30-day stroke/mortality risk

Eight of the 16 studies presented data on stroke/mortality rates. The largest of these was a retrospective analysis of the Vascular Study Group of New England (VSGNE) Registry performed by Wallaert and colleagues [14]. In this studyWO completion imaging was performed in 2033 CEAs. The mainstay imaging modality of choice was IODUS (94% of cases; 1919/2033). They found the combined stroke/mortality rate was significantly higher in revised group as compared to cases not requiring revision (3.9% (7/178) v 1.7% (102/5937); p = 0.028). However, this was not statically significant after risk adjustment (OR 2.1 (CI 0.9–5.0); p = 0.076). Data regarding follow-up imaging for these two groups was not available for comparison.
The remaining 7 studies were either of too small sample size or did not include meaningful statistical comparisons of revised vs non-revised groups [7, 8, 11, 12, 17, 18]. Cumulatively, the stroke rates in these studies was 1% (1 of 101) in cases requiring revision and 1.2% (24 of 2026) in cases not requiring revision based on completion imaging.

Follow-up of revised cases

Six studies included data on follow-up imaging of revised cases [6, 8, 11, 12, 17, 18]. Cumulatively in these studies, abnormalities were detected in 7.6% of revised cases (6 of these 79 cases) and 2.6% (37/1448) of unrevised cases. However, meaningful comparison and interpretation of this data is challenging due to variable follow-up periods (2 weeks to 24 months), variable or unclear criteria for stenosis assessment, lack of risk adjustment and variable surgical techniques (e.g., patch plasty, primary closure, eversion). Of the 6 abnormalities described, 2 were of asymptomatic occlusions and 4 of stenosis.

Follow-up of ‘non-significant’ findings detected on IODUS

Six studies included descriptive analysis of stroke rates for cases in which abnormal completion imaging results were not considered significant and thus not revised [7, 8, 11, 1719]. Cumulatively for these studies, stroke rates were 1.6% (18/1108) in cases with normal completion studies as compared to 2.5% (6/238) in cases with abnormal completion imaging.
Similarly, 5 studies included descriptive analysis of abnormalities detected on follow-up imaging [7, 8, 11, 17, 18]. Cumulatively for these studies, abnormalities on follow-up scans were detected in 1.2% (12/968) in cases with normal completion imaging as compared to 10.3% (19/185) in cases with abnormal completion imaging.

Lower extremity bypass surgery

Study characteristics and designs

Six studies investigating the role of IODUS completion imaging in LEB were included. All studies considered infra-inguinal bypass procedures with vein conduit. Three of these studies are sequential publications from the University of South Florida group [10, 20, 21]. It is not made explicitly clear from the manuscripts whether each builds upon the previously published series, but this is implicitly suggested by the overlapping periods of data collection. Of the other studies, one compared completion imaging vs no completion imaging [22] and the other compared the accuracy of angiography, IODUS and angioscopy as completion imaging modalities [23]. IODUS was performed routinely in 4 of 6 [10, 20, 21, 23] studies and selectively in 2 of 5 [22, 24]. The decision to use selective IODUS was left to the discretion of individual surgeons. However, when used selectively, IODUS was performed mostly when the outflow artery was a tibial or tibioperoneal trunk [22]. Four out of 6 studies provided the revision rate, which ranged between 10 and 27% [10, 2022].
Two studies did not include their criteria for intraoperative revision, which was left to the discretion of the operating surgeon [22, 24]. In the remaining studies criteria for defining severe flow abnormalities were based on peak systolic velocity reading of > 180 cm/s, grading of residual lesions (velocity ratio of > 2.5 was considered significant), and qualitative arterial waveform features including spectral broadening and absence of diastolic flow. If abnormalities were found, the hemodynamic response to flow augmentation was either evaluated by transverse imaging or rescanned after the administration of papaverine. Three studies assessed flow abnormalities with no identifiable cause on B-mode ultrasound followed by on table angiography before any revision [10, 20, 21]. In addition, if high velocities were identified in the outflow tibial arteries, with a velocity ratio of less than 2.5, then angiography was performed [10, 21].

Comparing outcomes from completion imaging vs no completion imaging

Only one study compared primary graft patency following infra-inguinal lower extremity bypass (LEB) between cases in which completion imaging was used vs those in which it was not [22]. In this retrospective analysis of registry data, completion imaging was used by 67.3% (n = 1368/2032) of vascular surgeons, with 67% using it selectively (< 80% of LEBs) and 33% routinely (≥ 80% of LEBs). The most commonly used imaging modality was angiography (89%, n = 1217/1368) followed by IODUS (11%, n = 151/1368). They authors found no association between using completion imaging and improved primary graft patency at discharge (OR, 1.1; p = 0.64) or at 1 year (OR, 0.9; p = 0.47), with similar results in bypass procedures performed with or without completion imaging. However, number of patients who had IODUS performed were comparatively much smaller (n = 151) as compared to patients who had angiography (n = 1217). Similarly, no effect was found between the surgeons’ strategy to perform completion imaging selectively or routinely on bypass graft patency at discharge (RR, 0.8; p = 0.31) or at 1 year (RR, 1.1; p = 0.56).

Comparing IODUS with other completion imaging modalities

Only one study compared IODUS against other modalities in lower extremity bypass procedures. However, this paper considered diagnostic accuracy and not clinical outcomes such as primary patency. Gilbertson conducted a prospective analysis of 20 femoral-infragenicular bypass procedures using in situ saphenous vein grafts [23]. They compared the ability to detect three specific abnormalities (patent vein side branches, residual valve cups and anastomotic stenoses > 30%) with angiography, angioscopy and IODUS. Within this cohort, 63 critical graft defects were identified by at least one of the imaging modalities and 41 of these were confirmed by direct inspection. Their results suggest that sensitivity of angioscopy (66% n = 21/32) and angiography (44%, n = 14/32) is higher than IODUS (12%, n = 4/32) for detecting patent vein branches (p < 0.01). For the detection of residual valve cups, angioscopy was the most sensitive (100%, n = 9/9), followed by angiography (22%, n = 2/9) and IODUS (11%, n = 1/9). They detected no anastomotic stenoses but false-positive rates were highest for angiography (20%), followed by IODUS (10%) and angioscopy (0%).

Follow-up of revised cases and those with ‘non-significant’ findings detected on IODUS

Johnson et al. [21] retrospectively identified 626 infrainguinal vein bypass procedures, where IODUS was used as the completion imaging. Of these, 15% (n = 96/626) were found to be abnormal, leading to the revision of 99 graft segments. The most commonly identified problem on imaging was the result of incomplete valve lysis (63%, 31/49). They found an improvement in the velocity spectra of 71% of segments and residual moderate stenosis in 29% of segments following graft revision. They found a significantly higher revision rate (27%, p < 0.01) with the use of alternative vein grafts as well as an increase in the frequency of unrepaired graft defects (p < 0.05). Johnson et al. found that secondary intervention rates within the first 90 days were highest for cases were there was an unrepaired flow abnormality as compared to those with a normal flow profile (37.7% vs 2.4%). Interestingly, in cases, where repair was performed, outcomes were considerably better if normal flow profile was established compared to if residual flow abnormality was detected (3% vs 44.8%) [21].
Another retrospective study by Bandyk et al. [20], considered 275 infrainguinal vein bypasses assessed using colour IODUS. A total of 50 (16%) abnormalities were detected in 43 grafts and necessitated revision. The revision rate was lowest for reversed saphenous vein bypasses (7%, p < 0.02) compared to other grafting techniques. Revision rate for popliteal and tibial bypasses were similar (14% vs 17%). Combined graft thrombosis and secondary revision rates at 90 days in those cases with normal completion imaging as compared to those with unrepaired flow abnormalities was significantly lower (graft thrombosis 0.4% vs 4%, secondary revision 2.6% vs 36%; combined p < 0.001). Overall, 15 out of 25 (60%) cases with uncorrected flow abnormalities had thrombosis or re-intervention in the first 3 months.
In a single centre retrospective study by MacKenzie et al. of 78 cases, secondary intervention rates at 30 days were lowest for cases with normal completion imaging (1.3%), followed by revised cases (8.3%) and unrepaired flow abnormalities (11.1%) [24]. They detected a statistically significant difference in patency rates when comparing unrepaired flow abnormality to normal flow (p < 0.001) or to repaired group (p < 0.001).

Discussion

In this systematic review, we have summarised current evidence relating to the use of IODUS for CEA and LEB.

Carotid artery endarterectomy

For completion assessment of CEA, there is conflicting evidence regarding the benefits of completion imaging from analysis of registry data [1315]. However, the largest of these studies (over 140,000 cases) reports a modest reduction in adjusted risk of stroke/mortality when using IODUS selectively (RR 0.74, CI 0.63–0.88, p = 0.001) [13]. The results also suggest that outcomes when using IODUS are at least as good as intraoperative angiography. An opposing result reported by Wallaert and colleagues, suggests a higher stroke rate when using completion imaging (risk adjusted OR 1.9, CI 1.2–2.7, p = 0.002). However, when comparing different practice patterns, they found that the lowest rates were seen in cases, where completion imaging was used selectively (routine 2.4%, selective 1.2%, rare 1.7%; p = 0.048). This suggests that selective practice may be the most effective strategy, although the criteria for selecting cases was not explored in any of the studies. Wallaert and colleagues also noted that the rate of restenosis at 1-year follow-up was highest for cases, where completion imaging was rarely used (routine 1.1%, selective 1.1%, rare 2.8%; p = 0.09) [14]. This may be due to the failure to detect residual defects which may progress during the follow-up period. Data from other studies suggests that ‘non-significant’ residual defects detected on IODUS are associated with higher rates of restenosis during the follow-up (range 2.1% to 20%) [7, 8, 1719]. These finding would suggests that although revision surgery can improve outcome, it is certainly not without risk and not all abnormalities detected on IODUS necessitate surgical revision. Isolated high velocities in the absence of other concerning waveform features, such as waveform broadening, or B-mode abnormalities may be related to vessel spasm [6]. If acted upon, these may add risk of complication. Parsa et al., have proposed protocolised imaging and interpretation guidance for both carotid and lower limb completion imaging [25].

Lower extremity bypass surgery

There is paucity of evidence when considering the benefit of IODUS on patency rates following LEB. This may be because of perceived challenges in scanning smaller calibre vessels in a larger deeper surgical field. In the single study addressing IODUS, it was only used in 11% of cases [22], limiting its relevance.
A single paper comparing IODUS with other completion modalities. This study, by Gilbertson et al., compared angioscopy, angiography and IODUS and concluded that angioscopy and angiography were superior to IODUS in detecting residual cusps and un-ligated side branches. However, this study is also limited by its small sample size of 20 and was conducted almost 30 years ago.
Johnson and colleagues suggests that most benefit from IODUS scanning may be gained for in-situ and non-reversed translocated bypasses, as they have a significantly higher rate of lesions requiring revision [21]. Their results also report a 90-day secondary re-intervention rate of 37.7% in grafts with residual flow abnormalities. In comparison, grafts with normal flow, either without or following revision, revision rates of 2.4 and 3% respective, were reported. MacKenzie and colleagues report similarly, but with lower rates of secondary intervention in grafts with un-corrected flow abnormalities (11.1% within 7 months). This may have bearing on optimal post-operative surveillance strategy.

Limitations

None of the studies were of randomised controlled trial design. There was also considerable heterogeneity between studies in terms of intervention, outcome measures and follow-up. Therefore, it was not possible to perform a meta-analysis.

Future work

There is a need for well-designed prospective, multicentre randomised controlled trials to evaluate the effectiveness of IODUS in comparison to other modalities in reducing stroke/mortality outcomes in CEA procedures and primary patency in LEB. Further data are also required to determine the natural progression of different defects detected on IODUS to achieve evidence-based consensus on criteria for revision surgery.

Conclusion

IODUS is a sensitive method to detect defects in both CEA and LEB. However, there is a need for more robust prospective studies to determine the best scanning strategy, criteria for intervention and the impact on clinical outcomes.

Acknowledgements

None.
Not applicable.
Not applicable.

Competing interests

The authors declare that they have no competing interests.
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Metadaten
Titel
Applications of intraoperative Duplex ultrasound in vascular surgery: a systematic review
verfasst von
Pasha Normahani
Bilal Khan
Viknesh Sounderajah
Sepideh Poushpas
Muzaffar Anwar
Usman Jaffer
Publikationsdatum
01.12.2021
Verlag
Springer International Publishing
Erschienen in
The Ultrasound Journal / Ausgabe 1/2021
Print ISSN: 2036-3176
Elektronische ISSN: 2524-8987
DOI
https://doi.org/10.1186/s13089-021-00208-8

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