The impact of diabetes mellitus on foot perfusion measured by ICG NIR fluorescence imaging.

INTRODUCTION: Diabetes Mellitus (DM) is a common chronic disease, affecting 435 million people globally. Impaired vasculature in DM patients leads to complications like lower extremity arterial disease (LEAD) and foot ulcers, often resulting in amputations. DM causes additional peripheral neuropathy leading to multifactorial wound problems. Current diagnostics often deem unreliable, but Near-Infrared Fluorescence with Indocyanine Green (ICG NIR) can be used to assess the foot perfusion. Therefore, this study explores DM's impact on foot perfusion using ICG NIR. METHODS: Baseline ICG NIR fluorescence imaging was performed in LEAD patients with and without DM. Ten perfusion parameters were extracted and analyzed to assess differences in perfusion patterns. RESULTS: Among 109 patients (122 limbs) of the included patients, 32.8 % had DM. Six of ten perfusion parameters, mainly inflow-related, differed significantly between DM and non-DM patients (p-values 0.007-0.039). Fontaine stage 4 DM patients had the highest in- and outflow values, with seven parameters significantly higher (p-values 0.004-0.035). CONCLUSION: DM is associated with increased in- and outflow parameters. Patients with- and without DM should not be compared directly due to different vascular pathophysiology and multifactorial wound problems in DM patients. Quantified ICG NIR fluorescence imaging offers additional insight into the effect of DM on foot perfusion.

Prognostic performance of the maximal systolic acceleration at the hallux in healing of foot ulcers: a retrospective cohort study.

OBJECTIVES: The accurate prediction of foot ulcer healing remains a major challenge in clinical practice. To date, no reliable bedside tests are available. The primary aim of this study was to determine the prognostic performance of the maximal systolic acceleration (ACCmax) to predict ulcer healing. Secondary objectives comprised the investigation of the prognostic accuracy in patients prone to medial arterial calcification, and to assess the potential risk of amputation. METHODS: A single-centre retrospective cohort study was conducted. Patients ≥ 18 years-old who presented with a new-onset ulcer (i.e. Fontaine IV and neuropathic ulcers) on the foot and underwent an ACCmax measurement at the hallux were included. Ulcer healing was defined as an intact skin with epithelialization after three or 12 months of follow-up. Prognostic performance was calculated by using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR) and negative likelihood ratio (NLR). RESULTS: In total, 136 patients with 143 wounds were included. Almost half of the patients were diagnosed with diabetes mellitus (47%) and wound infection was present in 42% of cases. After three months of follow-up, a NPV of 97.9%, PLR of 3.25 and NLR of 0.19 was found when applying an ACCmax threshold of 0.5 m/s2. When looking at 12 months, these numbers were 85.6%, 2.72 and 0.50, respectively. Subgroup analysis for patients with diabetes mellitus and chronic kidney disease showed comparable results. The risk of amputation increased significantly when a measurement below 1.0 m/s2 was present (odd ratio 5.3, p = 0.010). CONCLUSIONS: ACCmax measurements at the hallux can have additional prognostic value in patients with foot ulcers. An ACCmax below 1.0 m/s2 is associated with non-healing of an ulcer and a higher risk of amputation, while higher ACCmax values are associated with limb salvage. Therefore, ACCmax could be used for grading ischemia in a wound classification system.

Lessons learned from Dutch medical disciplinary law regarding aortic aneurysm and dissection care.

OBJECTIVES: The current study is an explanatory analysis of Dutch disciplinary law regarding aortic aneurysm and aortic dissection care. We aim to give insight in the way disciplinary judges rule on quality of care and to extract the lessons to be learned. METHODS: The online open-access governmental database, which includes all disciplinary rulings since 2010, was searched using search terms related to aortic aneurysm and dissection care. First, abstracts were screened for relevance. Thereafter, the full text of all remaining cases was read. Cases related to the diagnosis, treatment, or the postoperative phase of an aortic aneurysm or aortic dissection were included. Characteristics were registered and analyzed for quantitative assessment. Each case was summarized and coded for qualitative analysis. RESULTS: Forty-eight first-instance cases were included, of which 19 (40%) were founded. Reprimands (n=9) and warnings (n=7) were the prevailing measures. Seven out of 8 appeal cases filed by plaintiffs were unfounded. Six out of 9 appeals filed by defendants were adjudged and led to a less severe measure. Most cases concerned the subject of 'wrong treatment/wrong diagnosis' (75%). Whether not recognizing an aneurysm or dissection led to disciplinary culpability depended on case-specific circumstances, and much importance was attached to adequate documentation. In many complaints, an element of inadequate communication was recognized. CONCLUSIONS: Patient-involvement, clear communication, and implementing changes after a mistake could increase patient satisfaction, avert complaints, and prevent time-consuming trials. Maintaining adequate documentation and having knowledge on the analytical framework of the court is beneficial when confronted with a complaint.

Toward Uniform Case Identification Criteria in Observational Studies on Peripheral Arterial Disease: A Scoping Review.

BACKGROUND: The diagnosis of peripheral arterial disease (PAD) is commonly applied for symptoms related to atherosclerotic obstructions in the lower extremity, though its clinical manifestations range from an abnormal ankle-brachial index to critical limb ischemia. Subsequently, management and prognosis of PAD vary widely with the disease stage. A critical aspect is how this variation is addressed in administrative database-based studies that rely on diagnosis codes for case identification. The objective of this scoping review is to inventory the identification strategies used in studies on PAD that rely on administrative databases, to map the pros and cons of the International Classification of Diseases (ICD) codes applied, and to propose a first outline for a consensus framework for case identification in administrative databases. METHODS: Registry-based reports published between 2010 and 2021 were identified through a systematic PubMed search. Studies were subcategorized on the basis of the expressed study focus: claudication, critical limb ischemia, or general peripheral arterial disease, and the ICD code(s) applied for case identification mapped. RESULTS: Ninety studies were identified, of which 36 (40%) did not specify the grade of PAD studied. Forty-nine (54%) articles specified PAD grade studied. Five (6%) articles specified different PAD subgroups in methods and baseline demographics, but not in further analyses. Mapping of the ICD codes applied for case identification for studies that specified the PAD grade studied indicated a remarkable heterogeneity, overlap, and inconsistency. CONCLUSIONS: A large proportion of registry-based studies on PAD fail to define the study focus. In addition, inconsistent strategies are used for PAD case identification in studies that report a focus. These findings challenge study validity and interfere with inter-study comparison. This scoping review provides a first initiative for a consensus framework for standardized case selection in administrative studies on PAD. It is anticipated that more uniform coding will improve study validity and facilitate inter-study comparisons.

Diagnostic accuracy of the maximal systolic acceleration to detect peripheral arterial disease.

BACKGROUND: Diagnosing peripheral arterial disease (PAD) can be challenging owing to medial arterial calcification (MAC) in patients with diabetes mellitus (DM) and chronic kidney disease (CKD). Current bedside tests, such as the ankle-brachial index and toe-brachial index, are often insufficient. The maximal systolic acceleration (ACCmax) is a velocimetric Doppler-derived parameter and could be a new promising test in the diagnostic workup of these patients. The primary aim of this study was to evaluate the diagnostic performance of the ACCmax to detect PAD. METHODS: A retrospective cohort study was performed in a tertiary referral hospital. Patients ≥18 years old with suspected PAD who underwent ACCmax measurement(s) along with computed tomography angiography of the abdominal aorta and lower extremities (reference test) were eligible for inclusion. ACCmax measurements of the posterior tibial artery, anterior tibial artery and peroneal artery were collected. Diagnostic performance was assessed by using sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and area under the curve (AUC). RESULTS: In total, 340 patients (618 limbs) were included. Approximately 40% suffered from DM and 30% had CKD. Diagnostic performance of the ACCmax to detect PAD for the posterior tibial artery showed a sensitivity of 90%, specificity of 93%, positive likelihood ratio of 12.83, and negative likelihood ratio of 0.11 (AUC, 0.953). For the anterior tibial artery, these results were 94%, 97%, 32.06, and 0.06 (same sequence as presented before) with an AUC of 0.984. The peroneal artery had a performance of 86%, 89%, 7.51, and 0.16, respectively (AUC, 0.893). Diagnostic accuracy of the ACCmax did not diminish in subgroup analysis for patients with DM or CKD. CONCLUSIONS: The ACCmax showed excellent diagnostic performance to detect PAD, independent of patients prone to medial arterial calcification.

Perspectives of Patients and Professionals on Patient Education in Complex Endovascular Aortic Repair.

BACKGROUND: Misinterpretation of patient preferences in perioperative education can lead to an undesired treatment decision. This explorative interview study presents differences in perspectives of patients and professionals on patient education in complex endovascular aortic aneurysm management. METHODS: Using convenience sampling, a cross-sectional interview study was performed among patients who were in various stages of the decision-making process for complex endovascular aortic repair. Five physicians were interviewed, representing the main providers of clinical information. Interviews were transcribed verbatim and analyzed inductively. RESULTS: Twelve patients (mean age 76.6 [standard deviation: 6.4], 83% male) were interviewed. Ten (83%) felt like they had no other realistic option besides undergoing surgery, whereas all professionals (5/5) stressed the importance of delicate patient selection. Five patients out of 10 (50%) who commented on their preferred decisional role considered the professional's advice as decisive. All but 1 patient (11/12) reported that the information was easy to understand, whereas 4 out of 5 professionals (80%) doubted whether patients could fully comprehend everything. Patients experienced a lack of information on the recovery process, although professionals stated that this was addressed during consultation. CONCLUSIONS: Several differences were found in the perspectives of patients and professionals on education in complex aortic aneurysm management. In order to optimize patient involvement in decision-making, professionals should be aware of these possible discrepancies and address them during consultation. Future research could focus on these differences in more detail by including more patients depending on their treatment and decision stages.

Pilot Study on Feasibility and Outcome of a Nerve-Preserving Aortoiliac Exposure Technique.

BACKGROUND: Dysfunctional ejaculation is a common complication following open aortoiliac aneurysm surgery. It may occur in 49-63% of patients and is caused by iatrogenic damage to the sympathetic lumbar splanchnic nerves and superior hypogastric plexus. A nerve-preserving operative technique based on a unilateral right-sided approach to the abdominal aorta, was implemented in clinical practice. The aim of this pilot study was to establish the safety and feasibility of the technique, and whether a sympathetic pathway and ejaculatory function was preserved. METHODS: Patients were asked to fill out questionnaires preoperatively, and 6 weeks, 6 months, and 9 months postoperatively. The International Index of Erectile Function, Cleveland Clinic Incontinence Score (CCIS), Patient assessment of constipation symptoms (Pac-Sym), and International Consultation on Incontinence Questionnaire on male lower urinary tract symptoms were used. Surgeons were asked to complete a technical feasibility questionnaire. RESULTS: Twenty-four patients undergoing aortoiliac aneurysm surgery were included. The nerve-sparing phase of the procedure added an average of 5-10 min of operating time and was technically feasible in twenty-two patients. No major complications occurred during nerve-sparing exposure. Fifteen of twenty-four patients were sexually active at some point throughout the study. No postoperative loss of ejaculation was seen in sexually active patients. CCIS, Pac-sym, International Index of Erectile Function, and Incontinence Questionnaire on male lower urinary tract symptoms scores remained similar throughout the study. CONCLUSIONS: Nerve-preserving aortoiliac reconstruction surgery is safe and feasible. Ejaculatory function is preserved. Given the low number of patients in the study, further research is needed to provide robust data.

The association between sarcopenia and adverse outcomes after complex endovascular aortic repair.

BACKGROUND: Sarcopenia is identified as a predictive factor for adverse outcomes after complex endovascular aortic repair (complex EVAR). Consensus on preferred parameters for sarcopenia is not yet reached. The current study compares three CT-assessed parameters on their association with adverse outcomes after complex EVAR. METHODS: This was a single-center retrospective cohort study. Psoas Muscle Index (PMI), Skeletal Muscle Index (SMI), and lean psoas muscle area (LPMA) were examined by CT-segmentation. PMI, SMI, and LPMA were analyzed as continuous variables. In addition, cut-off values from previous research were used to diagnose patients as sarcopenic or non-sarcopenic. Outcomes were: all-cause mortality, major adverse events (MAE), length of hospital stay, and non-home discharge. A sub-analysis was made for severe sarcopenia; sarcopenia combined with low physical performance (gait speed, Time Up and Go test, Metabolic Equivalent of Task-score). RESULTS: We included 101 patients. A higher PMI (HR=0.590, CI: 0.374-0.930, P=0.023), SMI (HR=0.453, CI: 0.267-0.768, P=0.003), and LPMA (HR=0.559, CI: 0.333-0.944, P=0.029) were associated with a lower risk of mortality. Sarcopenia based on cut-off values for PMI and LPMA was not significantly associated with survival. Sarcopenia based on SMI did present a higher mortality risk (P=0.017). A sub-analysis showed that severely sarcopenic patients were at even higher risk of mortality (P=0.036). None of the parameters were significantly associated with the other outcomes. CONCLUSIONS: SMI had a slightly stronger association with mortality compared to PMI and LPMA. High-risk patients were selected by adding physical performance scores. Future research could focus on complex EVAR-specific PMI and LPMA cut-off values.

Therapeutic management of in-stent thrombosis after thoracic endovascular aortic repair for blunt thoracic aortic injury in a coronavirus disease 2019 patient.

A 27-year-old man underwent thoracic endovascular aortic repair for blunt thoracic aortic injury. Fourteen months later, he presented with intermittent paraplegia, congestive heart failure, and a decline of kidney function as a result of high-grade aortic stenosis caused by in-stent thrombosis. He had a concurrent infection with coronavirus disease 2019. The patient was successfully treated using axillofemoral bypass, followed by stent relining 2 weeks later. The possible risk factors and the optimal therapeutic approach for in-stent thrombosis remain unknown, because only a limited number of cases describing this rare complication have been reported.

Increased Aortic Exclusion in Endovascular Treatment of Complex Aortic Aneurysms.

PURPOSE: Perioperative risk assessments for complex aneurysms are based on the anatomical extent of the aneurysm and do not take the length of the aortic exclusion into account, as it was developed for open repair. Nevertheless, in the endovascular repair (ER) of complex aortic aneurysms, additional segments of healthy aorta are excluded compared with open repair (OR). The aim of this study was to assess differences in aortic exclusion between the ER and OR of complex aortic aneurysms, to subsequently assess the current classification for complex aneurysm repair. METHODS: This retrospective observational study included patients that underwent complex endovascular aortic aneurysm repair by means of fenestrated endovascular aneurysm repair (FEVAR), fenestrated and branched EVAR (FBEVAR), or branched EVAR (BEVAR). The length of aortic exclusion and the number of patent segmental arteries were determined and compared per case in ER and hypothetical OR, using a Wilcoxon signed-rank test. RESULTS: A total of 71 patients were included, who were treated with FEVAR (n = 44), FBEVAR (n = 8), or BEVAR (n = 19) for Crawford types I (n = 5), II (n = 7), III (n = 6), IV (n = 7), and V (n = 2) thoracoabdominal or juxtarenal (n = 44) aneurysms. There was a significant increase in the median exclusion of types I, II, III, IV, and juxtarenal aneurysms (p < 0.05) in ER, compared with hypothetical OR. The number of patent segmental arteries in the ER of type I-IV and juxtarenal aneurysms was significantly lower than in hypothetical OR (p < 0.05). CONCLUSION: There are significant differences in the length of aortic exclusion between ER and hypothetical OR, with the increased exclusion in ER resulting in a lower number of patent segmental arteries. The ER and OR of complex aortic aneurysms should be regarded as distinct modalities, and as each approach deserves a particular risk assessment, future efforts should focus on reporting on the extent of exclusion per treatment modality, to allow for appropriate comparison.

Persistent High Long-term Excess Mortality After Elective AAA Repair Especially in Women: A Large Population-based Study.

OBJECTIVE: The aim of this time-trend analysis is to estimate long-term excess mortality and associated cardiovascular risk for abdominal aortic aneurysm (AAA) patients after elective repair while addressing the changes in AAA management and patient selection over time. BACKGROUND: Despite the intensification of endovascular aneurysm repair and cardiovascular risk management, Swedish population data suggest that AAA patients retain a persistently high long-term mortality after elective repair. The question is whether this reflects suboptimal treatment, a changing patient population over time, or a national phenomenon. METHODS: Nationwide time-trend analysis including 40,730 patients (87% men) following elective AAA repair between 1995 and 2017. Three timeframes were compared, each reflecting changes in the use of endovascular aneurysm repair and intensification of cardiovascular risk management. Relative survival analyses were used to estimate disease-specific excess mortality. Competing risk of death analysis evaluated the risk of cardiovascular versus noncardiovascular death. Sensitivity analysis evaluated the impact of changes in patient selection over time. RESULTS: Short-term excess mortality significantly improved over time. Long-term excess mortality remained high with a doubled mortality risk for women (relative excess risk=1.87, 95% CI: 1.73-2.02). Excess mortality did not differ between age categories. The risk of cardiovascular versus noncardiovascular death remained similar over time, with a higher risk of cardiovascular death for women. Changes in patient population (ie, older and more comorbid patients in the latter period) marginally impacted excess mortality (2%). CONCLUSIONS: Despite changes in AAA care, patients retain a high long-term excess mortality after elective repair with a persistent high cardiovascular mortality risk. In this, a clear sex - but no age - disparity stands out.

Near-Infrared Fluorescence Imaging With Indocyanine Green to Predict Clinical Outcome After Revascularization in Lower Extremity Arterial Disease.

Contemporary quality control methods are often insufficient in predicting clinical outcomes after revascularization in lower extremity arterial disease (LEAD) patients. This study evaluates the potential of near-infrared fluorescence imaging with indocyanine green to predict the clinical outcome following revascularization. Near-infrared fluorescence imaging was performed before and within 5 days following the revascularization procedure. Clinical improvement was defined as substantial improvement of pain free walking distance, reduction of rest- and/or nocturnal pain, or tendency toward wound healing. Time-intensity curves and 8 perfusion parameters were extracted from the dorsum of the treated foot. The quantified postinterventional perfusion improvement was compared within the clinical outcome groups. Successful near-infrared fluorescence imaging was performed in 72 patients (76 limbs, 52.6% claudication, 47.4% chronic limb-threatening ischemia) including 40 endovascular- and 36 surgical/hybrid revascularizations. Clinical improvement was observed in 61 patients. All perfusion parameters showed a significant postinterventional difference in the clinical improvement group (P-values <.001), while no significant differences were seen in the group without clinical improvement (P-values .168-.929). Four parameters demonstrated significant differences in percentage improvement comparing the outcome groups (P-values within .002-.006). Near-infrared fluorescence imaging has promising additional value besides clinical parameters for predicting the clinical outcome of revascularized LEAD patients.

Elastic Deformation Measurement Using Duplex Ultrasound for the Detection of High Aneurysm Sac Pressure Following EVAR.

PURPOSE: To describe the concept of aortic elastic deformation (ED) measurement using duplex ultrasonography (DUS) as a tool for detection of high aneurysm sac pressure following endovascular aortic repair (EVAR). TECHNIQUE: High aneurysm sac pressure, with or without proven endoleak, will result in a less compressible aneurysm. Using the dual image function in B-mode of the DUS device and a standardized amount of applied probe pressure, ED can be measured. It is defined as the percentage of deformation of the aneurysm sac on probe pressure application. We hypothesize that less ED of the aneurysm sac can be related with high aneurysm sac pressure and possibly the presence of clinically relevant endoleak. In this note, we describe the technical details of the procedure and report on the applicability and results of ED measurements in the framework of aortic aneurysm and EVAR follow-up in a cohort of 109 patients. CONCLUSION: ED measurement is the first noninvasive pressure-based method in the quest to find a practical and reliable diagnostic tool to exclude high aneurysm sac pressure. In our patient cohort, patients with proven endoleak showed a smaller ED (less compressible), implying the presence of high aneurysm sac pressure. Further research should confirm whether ED measurement using DUS could reliably exclude endoleak after EVAR and further explore its potential for clinical application in EVAR follow-up. CLINICAL IMPACT: For the first time, a simple, fast, and inexpensive diagnostic tool is presented in this study for detecting high sac pressure following EVAR. High sac pressure is typically caused by clinically significant endoleaks, which can have significant consequences. Currently, computed tomography scanning is the most common method used to identify and characterize endoleaks. However, measuring elastic deformation may potentially replace more invasive and expensive modalities, such as the computed tomography in the future.

Learning Curve Analysis of Complex Endovascular Aortic Repair.

BACKGROUND: When introducing new techniques, attention must be paid to learning curve. Besides quantitative outcomes, qualitative factors of influence should be taken into consideration. This retrospective cohort study describes the quantitative learning curve of complex endovascular aortic repair (EVAR) in a nonhigh-volume academic center and provides qualitative factors that were perceived as contributors to this learning curve. With these factors, we aim to aid in future implementation of new techniques. METHODS: All patients undergoing complex EVAR in the Leiden University Medical Center (LUMC) between July 2013 and April 2021 were included (n = 90). Quantitative outcomes were as follows: operating time, blood loss, volume of contrast, hospital stay, major adverse events (MAE), 30-day mortality, and complexity. Patients were divided into 3 temporal groups (n = 30) for dichotomous outcomes. Regression plots were used for continuous outcomes. In 2017, the treatment team was interviewed by an external researcher. These interviews were reanalyzed for factors that contributed to successful implementation. RESULTS: Length of hospital stay (P = 0.008) and operating time (P = 0.010) decreased significantly over time. Fewer cardiac complications occurred in the third group (3: 0% vs. 2: 17% vs. 1: 17%, P = 0.042). There was a trend of increasing complexity (P = 0.076) and number of fenestrations (P = 0.060). No significant changes occurred in MAE and 30-day mortality. Qualitative factors that, according to the interviewees, positively influenced the learning curve were as follows: communication, mutual trust, a shared sense of responsibility and collective goals, clear authoritative structures, mutual learning, and team capabilities. CONCLUSIONS: In addition to factors previously identified in the literature, new learning curve factors were found (mutual learning and shared goals in the operating room (OR)) that should be taken into account when implementing new techniques.

Evaluation of the Angiosome Concept Using Near-Infrared Fluorescence Imaging with Indocyanine Green.

BACKGROUND: The angiosome concept is defined as the anatomical territory of a source artery within all tissue layers. When applying this theory in vascular surgery, direct revascularization (DR) is preferred to achieve increased blood flow toward the targeted angiosome of the foot in patients with lower extremity arterial disease (LEAD). This study evaluates the applicability of the angiosome concept using quantified near-infrared (NIR) fluorescence imaging with indocyanine green (ICG). METHODS: This study included patients undergoing an endovascular- or surgical revascularization of the leg between January 2019 and December 2021. Preinterventional and postinterventional ICG NIR fluorescence imaging was performed. Three angiosomes on the dorsum of the foot were determined: the posterior tibial artery (hallux), the anterior tibial artery (dorsum of the foot) and the combined angiosome (second to fifth digit). The angiosomes were classified from the electronic patient records and the degree of collateralization was classified based on preprocedural computed tomography angiography and/or X-ray angiography. Fluorescence intensity was quantified in all angiosomes. A subgroup analysis based on endovascular or surgical revascularized angiosomes, and within critical limb threatening ischemia (CLTI) patients was performed. RESULTS: ICG NIR fluorescence measurements were obtained in 52 patients (54 limbs) including a total of 157 angiosomes (121 DR and 36 indirect revascularizations [IR]). A significant improvement of all perfusion parameters in both the directly and indirectly revascularized angiosomes was found (P-values between <0.001-0.007). Within the indirectly revascularized angiosomes, 90.6% of the scored collaterals were classified as significant. When comparing the percentual change in perfusion parameters between the directly and indirectly revascularized angiosomes, no significant difference was seen in all perfusion parameters (P-values between 0.253 and 0.881). Similar results were shown in the CLTI patients subgroup analysis, displaying a significant improvement of perfusion parameters in both the direct and indirect angiosome groups (P-values between <0.001 and 0.007), and no significant difference when comparing the percentual parameter improvement between both angiosome groups (P-values between 0.134 and 0.359). Furthermore, no significant differences were observed when comparing percentual changes of perfusion parameters in directly and indirectly revascularized angiosomes for both endovascular and surgical interventions (P-values between 0.053 and 0.899). CONCLUSIONS: This study proves that both DR and IR of an angiosome leads to an improvement of perfusion. This suggests that interventional strategies should not only focus on creating in-line flow to the supplying angiosome. One can argue that the angiosome concept is not applicable in patients with LEAD.

Normalization of Time-Intensity Curves for Quantification of Foot Perfusion Using Near-Infrared Fluorescence Imaging With Indocyanine Green.

PURPOSE: Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) is gaining popularity for the quantification of tissue perfusion, including foot perfusion in patients with lower extremity arterial disease (LEAD). However, the absolute fluorescence intensity is influenced by patient-and system-related factors limiting reliable and valid quantification. To enhance the quality of quantitative perfusion assessment using ICG NIR fluorescence imaging, normalization of the measured time-intensity curves seems useful. MATERIALS AND METHODS: In this cohort study, the effect of normalization on 2 aspects of ICG NIR fluorescence imaging in assessment of foot perfusion was measured: the repeatability and the region selection. Following intravenous administration of ICG, the NIR fluorescence intensity in both feet was recorded for 10 mins using the Quest Spectrum platform®. The effect of normalization on repeatability was measured in the nontreated foot in patients undergoing unilateral revascularization preprocedural and postprocedural (repeatability group). The effect of normalization on region selection was performed in patients without LEAD (region selection group). Absolute and normalized time-intensity curves were compared. RESULTS: Successful ICG NIR fluorescence imaging was performed in 54 patients (repeatability group, n = 38; region selection group, n = 16). For the repeatability group, normalization of the time-intensity curves displayed a comparable inflow pattern for repeated measurements. For the region selection group, the maximum fluorescence intensity (Imax) demonstrated significant differences between the 3 measured regions of the foot (P = .002). Following normalization, the time-intensity curves in both feet were comparable for all 3 regions. CONCLUSION: This study shows the effect of normalization of time-intensity curves on both the repeatability and region selection in ICG NIR fluorescence imaging. The significant difference between absolute parameters in various regions of the foot demonstrates the limitation of absolute intensity in interpreting tissue perfusion. Therefore, normalization and standardization of camera settings are essential steps toward reliable and valid quantification of tissue perfusion using ICG NIR fluorescence imaging.

Near-infrared fluorescence imaging with indocyanine green for quantification of changes in tissue perfusion following revascularization.

OBJECTIVES: Current diagnostic modalities for patients with peripheral artery disease (PAD) mainly focus on the macrovascular level. For assessment of tissue perfusion, near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) seems promising. In this prospective cohort study, ICG NIR fluorescence imaging was performed pre- and post-revascularization to assess changes in foot perfusion. METHODS: ICG NIR fluorescence imaging was performed in 36 patients with PAD pre- and post-intervention. After intravenous bolus injection of 0.1 mg/kg ICG, the camera registered the NIR fluorescence intensity over time on the dorsum of the feet for 15 min using the Quest Spectrum Platform®. Time-intensity curves were plotted for three regions of interest (ROI): (1) the dorsum of the foot, (2) the forefoot, and (3) the hallux. Time-intensity curves were normalized for maximum fluorescence intensity. Extracted parameters were the maximum slope, area under the curve (AUC) for the ingress, and the AUC for the egress. The non-treated contralateral leg was used as a control group. RESULTS: Successful revascularization was performed in 32 patients. There was a significant increase for the maximum slope and AUC egress in all three ROIs. The most significant difference was seen for the maximum slope in ROI 3 (3.7%/s to 6.6%/s, p < 0.001). In the control group, no significant differences were seen for the maximum slope and AUC egress in all ROIs. CONCLUSIONS: This study shows the potential of ICG NIR fluorescence imaging in assessing the effect of revascularization procedures on foot perfusion. Future studies should focus on the use of this technique in predicting favorable outcome of revascularization procedures.

Assessment of Tissue Viability Following Amputation Surgery Using Near-Infrared Fluorescence Imaging With Indocyanine Green.

BACKGROUND: Patients with chronic limb threatening ischemia have a risk of undergoing a major amputation within 1 year of nearly 30% with a substantial risk of re-amputation since wound healing is often impaired. Quantitative assessment of regional tissue viability following amputation surgery can identify patients at risk for impaired wound healing. In quantification of regional tissue perfusion, near-infrared (NIR) fluorescence imaging using Indocyanine Green (ICG) seems promising. METHODS: This pilot study included adult patients undergoing lower extremity amputation surgery due to peripheral artery disease or diabetes mellitus. ICG NIR fluorescence imaging was performed within 5 days following amputation surgery using the Quest Spectrum PlatformⓇ. Following intravenous administration of ICG, the NIR fluorescence intensity of the amputation wound was recorded for 10 minutes. The NIR fluorescence intensity videos were analyzed and if a fluorescence deficit was observed, this region was marked as "low fluorescence." All other regions were marked as "normal fluorescence." RESULTS: Successful ICG NIR fluorescence imaging was performed in 10 patients undergoing a total of 15 amputations. No "low fluorescence" regions were observed in 11 out of 15 amputation wounds. In 10 out of these 11 amputations, no wound healing problems occurred during follow-up. Regions with "low fluorescence" were observed in 4 amputation wounds. Impaired wound healing corresponding to these regions was observed in all wounds and a re-amputation was necessary in 3 out of 4. When observing time-related parameters, regions with low fluorescence had a significantly longer time to maximum intensity (113 seconds vs. 32 seconds, P = 0.003) and a significantly lesser decline in outflow after five minutes (80.3% vs. 57.0%, P = 0.003). CONCLUSIONS: ICG NIR fluorescence imaging was able to predict postoperative skin necrosis in all four cases. Quantitative assessment of regional perfusion remains challenging due toinfluencing factors on the NIR fluorescence intensity signal, including camera angle, camera distance and ICG dosage. This was also observed in this study, contributing to a large variety in fluorescence intensity parameters among patients. To provide surgeons with reliable NIR fluorescence cut-off values for prediction of wound healing, prospective studies on the intra-operative use of this technique are required. The potential prediction of wound healing using ICG NIR fluorescence imaging will have a huge impact on patient mortality, morbidity as well as the burden of amputation surgery on health care.

Association of Hospital Volume with Perioperative Mortality of Endovascular Repair of Complex Aortic Aneurysms: A Nationwide Cohort Study.

OBJECTIVE: We evaluate nationwide perioperative outcomes of complex EVAR and assess the volume-outcome association of complex EVAR. SUMMARY OF BACKGROUND DATA: Endovascular treatment with fenestrated (FEVAR) or branched (BEVAR) endografts is progressively used for excluding complex aortic aneurysms (complex AAs). It is unclear if a volume-outcome association exists in endovascular treatment of complex AAs (complex EVAR). METHODS: All patients prospectively registered in the Dutch Surgical Aneurysm Audit who underwent complex EVAR (FEVAR or BEVAR) between January 2016 and January 2020 were included. The effect of annual hospital volume on perioperative mortality was examined using multivariable logistic regression analyses. Patients were stratified into quartiles based on annual hospital volume to determine hospital volume categories. RESULTS: We included 694 patients (539 FEVAR patients, 155 BEVAR patients). Perioperative mortality following FEVAR was 4.5% and 5.2% following BEVAR. Postoperative complication rates were 30.1% and 48.7%, respectively. The first quartile hospitals performed <9 procedures/yr; second, third, and fourth quartile hospitals performed 9-12, 13-22, and ≥23 procedures/yr. The highest volume hospitals treated the significantly more complex patients. Perioperative mortality of complex EVAR was 9.1% in hospitals with a volume of < 9, and 2.5% in hospitals with a volume of ≥13 (P = 0.008). After adjustment for confounders, an annual volume of ≥13 was associated with less perioperative mortality compared to hospitals with a volume of < 9. CONCLUSIONS: Data from this nationwide mandatory quality registry shows a significant effect of hospital volume on perioperative mortality following complex EVAR, with high volume complex EVAR centers demonstrating lower mortality rates.