Maximal Systolic Acceleration and Near-Infrared Fluorescence Imaging With Indocyanine Green as Predictors for Successful Lower Extremity Revascularization.

BACKGROUND: Patients with lower extremity arterial disease (LEAD) frequently require revascularization procedures. Currently used diagnostic methods are insufficient in predicting successful outcomes and focus on macrovascular rather than microvascular state. Several promising modalities to increase diagnostic accuracy are emerging, including maximal systolic acceleration (ACCmax), measured by duplex ultrasound (DUS). For the assessment of tissue perfusion, near-infrared fluorescence (NIR) imaging using indocyanine green (ICG) demonstrates promising results. This study aims to identify the usefulness of combining these two methods for macrovascular and microvascular perfusion assessment to predict successful clinical outcomes. METHODS: A retrospective study was performed collecting preinterventional and postinterventional DUS and ICG NIR fluorescence imaging measurements from LEAD patients undergoing revascularization. The correlation between the preinterventional and postinterventional perfusion parameters, described as the delta (Δ) ACCmax and ΔICG NIR fluorescence parameters, were analyzed. Improvements in perfusion parameters were compared to clinical outcomes, defined as improvement in pain-free walking distance, freedom from rest pain, or tendency toward wound and ulcer healing. RESULTS: A total of 38 patients (42 limbs) were included. ACCmax and ICG NIR fluorescence perfusion parameters improved significantly after revascularization (p<0.001). Patients with a poor clinical outcome had a significantly lower improvement of both parameters after revascularization (p<0.001-0.016). Lack of correlation was found between the delta of ACCmax and ICG NIR fluorescence imaging. Multiple non-congruent improvements of macrovascular parameters (ACCmax) and perfusion (ICG NIR fluorescence) were seen within patients. However, for all patients with a successful clinical outcome, at least one parameter improved. CONCLUSION: Combining ACCmax and ICG NIR fluorescence imaging revealed improvement in at least one parameter within all patients with a successful clinical outcome. This study highlights the potential of assessing both the macrovascular state and tissue perfusion following lower extremity revascularization, as both appear to reflect different aspects of vascularization. CLINICAL IMPACT: Numerous techniques have been developed to assess tissue perfusion to predict clinical outcomes following revascularization in patients with peripheral artery disease. However, none are widely implemented in clinical practice. This study emphasized the importance of employing multiple modalities from different perspectives for more accurate prediction. By focusing on both the macrovascular state and tissue perfusion, clinicians can better guide themselves in their treatment strategies.

Indocyanine green near-infrared fluorescence bowel perfusion assessment to prevent anastomotic leakage in minimally invasive colorectal surgery (AVOID): a multicentre, randomised, controlled, phase 3 trial.

BACKGROUND: Anastomotic leakage is a severe postoperative complication in colorectal surgery and compromised bowel perfusion is considered a major contributing factor. Conventional methods to assess bowel perfusion have a low predictive value for anastomotic leakage. We therefore aimed to evaluate the efficacy of real-time assessment with near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) in the prevention of anastomotic leakage. METHODS: This multicentre, randomised, controlled, phase 3 trial was done in eight hospitals in the Netherlands. We included adults (aged >18 years) who were scheduled for laparoscopic or robotic colorectal surgery (with planned primary anastomosis) for benign and malignant diseases. Preoperatively, patients were randomly assigned (1:1) to fluorescence-guided bowel anastomosis (FGBA) or conventional bowel anastomosis (CBA) by variable block randomisation (block sizes 4, 6, and 8) and stratified by site. The operating surgeon and investigators analysing the data were not masked to group assignment. Patients were unmasked after the surgical procedure or after study end. In the FGBA group, surgeons marked anastomosis levels per conventional perfusion assessment and then administered 5 mg of ICG by 2 mL intravenous bolus. They assessed bowel perfusion using NIR fluorescence imaging and adjusted (or kept) transection lines accordingly. Only conventional methods for bowel perfusion assessment were used in the CBA group. The primary outcome was the difference in the rate of clinically relevant anastomotic leakage (ie, requiring active therapeutic intervention but manageable without reoperation [grade B] or requiring reoperation [grade C], per the International Study Group of Rectal Cancer) between the FGBA group and the CBA group within 90 days post-surgery. The primary outcome and safety were assessed in the intention-to-treat population. This study was registered with ToetsingOnline.nl (NL7502) and ClinicalTrials.gov (NCT04712032) and is complete. FINDINGS: Between July 2, 2020, and Feb 21, 2023, 982 patients were enrolled, of whom 490 were assigned to FGBA and 492 were assigned to CBA. After excluding 51 patients, the intention-to-treat population comprised 931 (463 assigned FGBA and 468 assigned CBA). Patients had a median age of 68·0 years (IQR 59·0-75·0) and 485 (52%) were male and 446 (48%) were female. Ethnicity data were not available. The overall 90-day rate of clinically relevant anastomotic leakage was not significantly different between the FGBA group (32 [7%] of 463 patients) and the CBA group (42 [9%] of 468 patients; relative risk 0·77 [95% CI 0·50-1·20]; p=0·24). No adverse events related to ICG use were observed. 313 serious adverse events in 229 (25%) patients were at 90-day follow-up (159 serious adverse events in 113 [24%] patients in the FGBA group and 154 serious adverse events in 116 [25%] patients in the CBA group). 18 (2%) people died by 90 days (ten in the FGBA group and eight in the CBA group). INTERPRETATION: ICG NIR fluorescence imaging did not reduce 90-day anastomotic leakage rates in this trial across all types of colorectal surgeries. Further research should be done in subgroups, such as rectosigmoid resections, for which evidence suggests ICG NIR might be beneficial. FUNDING: Olympus Medical, Diagnostic Green, and Intuitive Foundation.

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.

BACKGROUND: 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-center retrospective cohort study was conducted. Patients aged ≥18 years 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 3 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 3 months of follow-up, an NPV of 97.9%, PLR of 3.25, and NLR of 0.19 were 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 nonhealing 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.

BACKGROUND: 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.

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.

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.

Outcomes of Omniflow® II prosthesis used for revascularization in the femoral tract both in infected and non-infected setting.

BACKGROUND: Evidence regarding the outcomes of Omniflow® II prosthesis in peripheral arterial revascularization at different anatomical sites and for different indications is scarce. Therefore, the aim of this study was to evaluate the outcomes of the Omniflow® II used at various positions within the femoral tract both in infected and non-infected setting. METHODS: Patients who underwent reconstructive lower leg vascular surgery with implantation of an Omniflow® II from 2014 until 2021 at five medical centers were retrospectively included (N.=142). Patients were subdivided into the following categories: femoro-femoral crossover (N.=19), femoral interposition (N.=18), femoro-popliteal (above-the-knee [N.=25; AK] or below-the-knee [N.=47; BK]), and femoro-crural bypass grafts (N.=33). Primary outcome was primary patency and secondary outcomes included primary assisted patency, secondary patency, major amputation, vascular graft infection, and mortality. Outcomes were compared according to different subgroups and the surgical setting (infected versus non-infected). RESULTS: The median follow-up was 35.0 (17.5-54.3) months. Three years primary patency of 58% was observed for femoro-femoral crossover bypass, 75% for femoral interposition graft, 44% for femoro-popliteal above-the-knee bypass, 42% for femoro-popliteal below-the-knee bypass, and 27% in the femoro-crural position (P=0.006). Freedom from major amputation at three years were 84% for femoro-femoral crossover bypass, 88% for femoral interposition bypass, 90% for femoro-popliteal AK bypass, 83% for femoro-popliteal BK bypass, and 50% for femoro-crural bypass (P<0.001). CONCLUSIONS: This study demonstrates the safety and feasibility of the use of Omniflow® II for femoro-femoral crossover-, femoral interposition-, and femoro-popliteal (AK and BK) bypass. Omniflow® II seems to be less suitable for femoro-crural bypass with a significantly lower patency compared to other positions.

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.

Quantification of indocyanine green near-infrared fluorescence bowel perfusion assessment in colorectal surgery.

BACKGROUND: Indocyanine green near-infrared fluorescence bowel perfusion assessment has shown its potential benefit in preventing anastomotic leakage. However, the surgeon's subjective visual interpretation of the fluorescence signal limits the validity and reproducibility of the technique. Therefore, this study aimed to identify objective quantified bowel perfusion patterns in patients undergoing colorectal surgery using a standardized imaging protocol. METHOD: A standardized fluorescence video was recorded. Postoperatively, the fluorescence videos were quantified by drawing contiguous region of interests (ROIs) on the bowel. For each ROI, a time-intensity curve was plotted from which perfusion parameters (n = 10) were derived and analyzed. Furthermore, the inter-observer agreement of the surgeon's subjective interpretation of the fluorescence signal was assessed. RESULTS: Twenty patients who underwent colorectal surgery were included in the study. Based on the quantified time-intensity curves, three different perfusion patterns were identified. Similar for both the ileum and colon, perfusion pattern 1 had a steep inflow that reached its peak fluorescence intensity rapidly, followed by a steep outflow. Perfusion pattern 2 had a relatively flat outflow slope immediately followed by its plateau phase. Perfusion pattern 3 only reached its peak fluorescence intensity after 3 min with a slow inflow gradient preceding it. The inter-observer agreement was poor-moderate (Intraclass Correlation Coefficient (ICC): 0.378, 95% CI 0.210-0.579). CONCLUSION: This study showed that quantification of bowel perfusion is a feasible method to differentiate between different perfusion patterns. In addition, the poor-moderate inter-observer agreement of the subjective interpretation of the fluorescence signal between surgeons emphasizes the need for objective quantification.

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.

Use of Omniflow® II Biosynthetic Graft for the Treatment of Vascular Graft and Endograft Infections.

BACKGROUND: Vascular graft/endograft infection is a rare but life-threatening complication of cardiovascular surgery and remains a surgical challenge. Several different graft materials are available for the treatment of vascular graft/endograft infection, each having its own advantages and disadvantages. Biosynthetic vascular grafts have shown low reinfection rates and could be a potential second best after autologous veins in the treatment of vascular graft/endograft infection. Therefore, the aim of our study was to evaluate the efficacy and morbidity of Omniflow® II for the treatment of vascular graft/endograft infection. METHODS: A multicenter retrospective cohort study was performed to evaluate the use of Omniflow® II in the abdominal and peripheral region to treat vascular graft/endograft infection between January 2014 and December 2021. Primary outcome was recurrent vascular graft infection. Secondary outcomes included primary patency, primary assisted patency, secondary patency, all-cause mortality, and major amputation. RESULTS: Fifty-two patients were included with a median follow-up duration of 26.5 (10.8-54.8) months. Nine (17%) grafts were implanted in intracavitary position and 43 (83%) in peripheral position. Most grafts were used as femoral interposition (n = 12, 23%), femoro-femoral crossover (n = 10, 19%), femoro-popliteal (n = 8, 15%), and aorto-bifemoral (n = 8, 15%) graft. Fifteen (29%) grafts were implanted extra-anatomically and 37 (71%) in situ. Eight patients (15%) presented with reinfection during follow-up, most of these patients received an aorto-bifemoral graft (n = 3, 38%). Intracavitary vascular grafting had a 33% (n = 3) reinfection rate and peripheral grafting 12% (n = 5; P = 0.025). The estimated primary patencies at 1, 2, and 3 years were 75%, 72%, and 72% for peripherally located grafts and 58% (at all timepoints) for intracavitary grafts (P = 0.815). Secondary patencies at 1, 2, and 3 years were 77% (at all timepoints) for peripherally located prostheses and 75% (at all timepoints) for intracavitary prostheses (P = 0.731). A significantly higher mortality during follow-up was observed in patients who received an intracavitary graft compared to patients with a peripheral graft (P = 0.003). CONCLUSIONS: This study highlights the efficacy and safety of the Omniflow® II biosynthetic prosthesis for the treatment of vascular graft/endograft infection, in absence of suitable venous material, with acceptable reinfection, patency, and freedom of amputation prevalences, especially in replacing peripheral vascular graft/endograft infection. However, a control group with either venous reconstruction or another alternative graft is needed to make firmer conclusions.