Endovascular Repair of Juxtarenal and Pararenal Abdominal Aortic Aneurysms Using a Novel Low-Profile Fenestrated Custom-Made Endograft: Technical Details and Short-Term Outcomes.

INTRODUCTION: The aim of this study is to share preliminary experiences and outcomes with a novel custom-made fenestrated TREO® Abdominal Stent-Graft System to treat juxtarenal and pararenal abdominal aortic aneurysms (AAAs). METHODS: Juxtarenal and pararenal AAA patients treated with the custom-made fenestrated TREO® Abdominal Stent-Graft System were included from 4 high-volume European academic medical centers from June 2021 to September 2023. Technical success and 30-day/in-hospital mortality and complications were analyzed. Technical success was defined as successful endovascular implantation of the stent graft with preservation of antegrade flow to the target vessels, and absence of type 1 or 2 endoleak (EL) at the first postoperative computed tomography angiography (CTA). RESULTS: Forty-two consecutive patients were included. The majority of the devices were constructed with 2 (N=4; 9.5%), 3 (N=9; 21.4%), or 4 (N=27; 64%) fenestrations. In 1 case, the device was constructed with a single fenestration (2.4%) and 1 device contained 5 fenestrations (2.4%); 17% had previous AAA repair. Target vessel cannulation with placement of a bridging stent was successful in all but 1 vessel (99, 3%). One aneurysm-related death occurred in the direct postoperative period and 2 limb occlusions necessitated reintervention during admission. In the median follow-up period of 101 (2-620) days, 3 more patients died due to non-aneurysm-related causes. Technical success was achieved in 90% of the cases. Nineteen ELs were seen on the first postoperative CT scan: 1 type 1b EL (N=1; 2%), 15 type 2 ELs (N=15; 36%), and 3 type 3 ELs (N=3%). Eleven patients received more than 1 CT scan during a median follow-up of 361 days (82-620): 3 type 2 ELs resolved and 1 type 3 EL was treated in this period. In the follow-up, 1 patient had a coagulation disorder that caused occlusions of the branches. CONCLUSION: The results of the first experiences using the custom-made fenestrated TREO® Abdominal Stent-Graft System in Europe are promising. There was a low short-term mortality and morbidity rate in these patients of which 17% had previous AAA repair. Mid-term and long-term follow-up data are needed to evaluate endograft durability and performance. CLINICAL IMPACT: This study shows the first experiences and short-term results of a novel low-profile custom-made device: the custom-made fenestrated TREO® Abdominal Stent-Graft System. Showing these results and experiences can help the physicians in clinical decision-making for their patients.

A comparison of continuous blood gas monitors during cardiopulmonary bypass LivaNova B-Capta, Terumo CDI 500, spectrum medical M4.

INTRODUCTION: Accurate and precise management of blood gas parameters during cardiopulmonary bypass (CPB) is crucial to patient care and outcome. This study compares the data provided by Livanova B-Capta, Terumo CDI500, and Spectrum Medical M4 with the results from a gold standard blood gas analyzer to test accuracy. METHODS: All three continuous blood gas monitoring (CBGM) devices were used simultaneously during CPB on one dedicated HLM. Arterial and venous blood samples of 40 adult patients who underwent elective cardiac surgery with CPB were taken from the CPB circuit. RESULTS: Pre- and post-alignment deviation in percentages are compared with CLIA guidelines. B-Capta data reveals that the deviation pre-alignment is small and within the CLIA threshold for all parameters. Pre-alignment data for CDI 500 is within CLIA threshold for SvO2 and PaO2. The pre-alignment data for the M4 exceeds the CLIA thresholds for all parameters. Post-alignment data for B-Capta and CDI 500 reveals an accurate agreement for Hb and Hct and strong agreement for PaO2. All values for B-Capta and CDI 500 are within CLIA threshold values except for SvO2. Post-alignment the M4 exceeded the CLIA threshold value only for PaO2. CONCLUSION: B-Capta is the only CBGM device that operates within the CLIA guidelines and is in agreement with laboratory values prior to alignment.

Clinical evaluation of the novel Capiox NX19 adult oxygenator-a multicenter study.

INTRODUCTION: The novel Capiox NX19 adult oxygenator is, compared to its predecessors, improved with enhanced air removal technology, a polymer heat exchanger and smaller, innovative hollow fibers resulting in a surface area reduction and a lower priming volume. The aim of this study was to evaluate the NX19 oxygenator performance in a clinical setting. METHODS: A prospective multicenter study was performed involving three large European university hospitals. The Capiox NX19 (n = 150) performance was assessed during adult cardiopulmonary bypass and involved gaseous microemboli handling and gas transfer efficiency. The heat exchanger performance was evaluated separately in vitro. RESULTS: The heat exchanger performance factors were 0.80 ± 0.03 and 0.58 ± 0.04 at pump flow rates of 3 L/min and 6 L/min, respectively. After priming, residual post-oxygenator gaseous microemboli count and volume were decreased by 91% and 93.7%, respectively. The gas compartment pressure was 6.0 ± 2.5 mmHg, while the O2 transfer was 69 ± 30 mL/min/m2 and the CO2 transfer 73 ± 34 mL/min/m2. The O2 gradient was 44 ± 19 mmHg/LPM and the O2 diffusing capacity 0.38 ± 0.14 mL/min/mmHg. The shunt fraction was 0.19 ± 0.13, whereas oxygenator resistance and shear stress were 10.5 ± 3.7 mmHg/LPM and 5.1 ± 3.1 dyn/cm2, respectively. CONCLUSION: This multicenter study displayed good clinical safety and performance of the NX19 oxygenator.

Midterm outcomes in patients undergoing endovascular repair of thoracic aortic aneurysms and penetrating atherosclerotic ulcers using the RelayPlus stent graft.

BACKGROUND: The Relay Thoracic Stent-Graft with Plus Delivery System (RelayPlus; Terumo Aortic, Sunrise, Fla) was designed to handle the curvature and tortuosity of the thoracic aorta. It was approved by the Food and Drug Administration in 2012; the postapproval study was stopped early because of adequate safety and efficacy data, and no difference was identified in experienced vs first-time users of RelayPlus. The purpose of this study was to report real-world outcomes of patients with thoracic aortic aneurysms and penetrating atherosclerotic ulcers (PAUs) undergoing thoracic endovascular aortic repair (TEVAR) with RelayPlus. METHODS: This is a prospective, multicenter, nonrandomized postapproval study that required the use of novice implanters in the United States. Primary and secondary end points included device-related adverse events (deployment failure, conversion to open repair, endoleaks, migration, rupture, and mortality) and major adverse events (stroke, paraplegia/paraparesis, renal failure, respiratory failure, and myocardial infarction), respectively. Continuous and categorical covariates were reported in means or medians and percentages, respectively. Kaplan-Meier survival estimates were used to report long-term TEVAR-related mortality, all-cause mortality, and reinterventions at 3 years. RESULTS: A total of 45 patients with mean age (standard deviation [SD]) of 73.5 (±7.20) years were treated for descending thoracic fusiform aneurysm (56%) or saccular aneurysm/PAU (44%). The patients were predominantly white (80.0%) and male (68.9%). Mean (SD) proximal neck, distal neck, and lesion lengths were 38.2 (±37) mm, 42.1 (±28) mm, and 103.8 (±74) mm, respectively. Mean (SD) aneurysm, proximal neck, and distal neck diameters were 53.9 (±13) mm, 31.3 (±4) mm, and 31.7 (±6) mm, respectively. Technical success was 100%. TEVAR-related mortality at 30 days was 4.4%; two patients died postoperatively, one of shock and the second of bilateral hemispheric stroke. No patient in the study had any conversion to open repair or post-TEVAR rupture. Two patients experienced three major adverse events, which included stroke (2.2%), paraplegia (2.2%), and respiratory failure (2.2%) at 30 days. Three-year freedom from TEVAR-related mortality, all-cause mortality, and reinterventions was 95.6%, 84.0%, and 97.2%, respectively. There were two type I endoleaks at 3 years: one type IB associated with no migration or aneurysm sac increase and one type IA associated with caudal migration of proximal neck and expansion of the proximal aorta. CONCLUSIONS: The RelayPlus postapproval study reported low operative mortality and morbidity and supported use of the device as a safe and effective thoracic aortic aneurysm and PAU endovascular treatment. Early midterm follow-up showed sustained freedom from TEVAR-related mortality in real-world practice. Follow-up continues to evaluate the durability of this endograft.

Spectrum Medical Quantum or Terumo CDI 500: Which Device Measures Hemoglobin and Oxygen Saturation Most Accurately When Compared to a Benchtop Blood Analyzer?

To examine the accuracy between analyzers, the Terumo CDI 500 and the Spectrum Medical Quantum were compared to each other and to the ABL90 FLEX benchtop blood analyzer. Patients were retrospectively identified who underwent cardiac surgery requiring cardiopulmonary bypass between August 1, 2018 and November 1, 2019. Hemoglobin and venous saturation (SvO2) values from all three analyzers were collected. Measurements from the Quantum and the CDI 500 were averaged over 1 minute to provide a single value for the minute for the given device. Blood analysis on the ABL90 benchtop device was performed at a minimum of every hour during congenital cardiopulmonary bypass (CPB). There were 519 patients included in the analysis. Data points numbering 69,404 and 70,598 were analyzed when comparing the CDI 500 to the Quantum for hemoglobin and SvO2, respectively. Comparison of hemoglobin and SvO2 for the CDI 500 and Quantum versus ABL90 used 2283 and 1414 data points respectively, in each group. The CDI 500 and Quantum reported hemoglobin within 1 g/dL of the ABL90 86.9% and 87.5% of the time, respectively. The CDI 500 and Quantum reported SvO2 within 3% of the ABL90 61.0% and 57.9% of the time, respectively. The mean difference between the CDI 500 and Quantum hemoglobin and SvO2 measurements equaled .194 g/dL (p < .001) and .861% (p < .001), respectively and were both significantly different from zero. All device comparisons were statistically significantly different when compared to zero difference, likely due to the large data set as the magnitudes of these differences are all quite small and may not be clinically significant. However, while the reader should judge for themselves based upon their specific practice, in our opinion, the 95% Limit of Agreement was too large for either the CDI 500 or Quantum hemoglobin and SvO2 values to be substituted for ABL90 values. As recommended by the manufacturers, the CDI 500 and Quantum should only be used as a trending device.

Accuracy of the Spectrum Medical M4 and Terumo CDI 500 compared to the Radiometer ABL90 FLEX benchtop blood analyzer.

The benchtop blood analyzer is the gold standard for blood oxygen saturation (SO2) and hemoglobin (Hb) analysis. However, the benchtop analyzer only provides values at a given point in time. In the field of cardiovascular perfusion and the practice of cardiopulmonary bypass (CPB), continuous measurement of SvO2 and hemoglobin values have become commonplace. Two devices currently available which monitor these values are the Terumo CDI 500 and Spectrum Medical M4. A retrospective study was conducted to examine the accuracy of the M4 technology and the CDI 500 as they compare to each other and the ABL90 FLEX, a benchtop blood gas analyzer. The data revealed the magnitude of mean differences were small, even when significant. However, the 95% Limits of Agreement were too large for either device to allow substitution of the CDI 500 and M4 hemoglobin or SvO2 values for ABL90 values. As recommended by the manufacturers, the CDI 500 and M4 should only be used as a trending device.

Genicular artery embolization for recurrent hemarthrosis: A case report.

A 44-year-old otherwise healthy male with a history of trauma and surgical interventions in his right knee presented to the emergency department with repeated hemarthrosis of the right knee. The patient underwent blood tests, X-rays, and magnetic resonance imaging of the knee. A computed tomography angiography revealed blushing of the synovium of the knee. The patient underwent successful embolization of the genicular artery branches. Hemarthrosis did not recur. The use of genicular artery embolization, in our case, not only successfully addressed recurrent hemarthrosis but also underscores its emerging role in comprehensive patient management. This minimally invasive approach, precisely targeting the vascular supply to the affected synovium, offers an effective alternative where conventional therapies may fall short. Beyond symptom relief, it holds promise for preventing hemarthrosis recurrence, a valuable addition to clinicians' interventions for challenging knee joint bleeding cases. Further investigation in larger cohorts and comparative studies may reveal its broader applicability and long-term efficacy, shaping treatment options for recurrent hemarthrosis.

The TREO abdominal aortic stent-graft system.

Endovascular aneurysm repair has become a primary treatment modality for patients with abdominal aortic aneurysms due to its less invasive nature and improved peri-operative mortality rates compared with conventional open surgery. Long-term, endovascular aneurysm repair is hindered by the need for reintervention due to a variety of reasons. Device improvements are directed toward improving these long-term outcomes. The current manuscript highlights some of the details of the Terumo Aortic TREO abdominal aortic stent-graft, which was approved in 2020 for clinical use by the US FDA. A brief review of the available clinical outcomes from the US trial, as well as experience in the rest of the world, are provided demonstrating its excellent performance.

Validity and reliability of a novel slow cuff-deflation system for noninvasive blood pressure monitoring in patients with continuous-flow left ventricular assist device.

BACKGROUND: Doppler ultrasound is the clinical gold standard for noninvasive blood pressure (BP) measurement among continuous-flow left ventricular assist device patients. The relationship of Doppler BP to systolic BP (SBP) and mean arterial pressure (MAP) is uncertain and Doppler measurements require a clinic visit. We studied the relationship between Doppler BP and both arterial-line (A-line) SBP and MAP. Validity and reliability of the Terumo Elemano BP Monitor, a novel slow cuff-deflation device that could potentially be used by patients at home, were assessed. METHODS AND RESULTS: Doppler and Terumo BP measurements were made in triplicate among 60 axial continuous-flow left ventricular assist device (HeartMate II) patients (30 inpatients and 30 outpatients) at 2 separate exams (360 possible measurements). A-line measures were also obtained among inpatients. Mean absolute differences (MADs) and correlations were used to determine within-device reliability (comparison of second and third BP measures) and between-device validity. Bland-Altman plots assessed BP agreement between A-line, Doppler BP, and Terumo Elemano. Success rates for Doppler and Terumo Elemano were 100% and 91%. Terumo Elemano MAD for repeat SBP and MAP were 4.6±0.6 and 4.2±0.6 mm Hg; repeat Doppler BP MAD was 2.9±0.2 mm Hg. Mean Doppler BP was lower than A-line SBP by 4.1 (MAD=6.4±1.4) mm Hg and higher than MAP by 9.5 (MAD=11.0±1.2) mm Hg; Terumo Elemano underestimated A-line SBP by 0.3 (MAD=5.6±0.9) mm Hg and MAP by 1.7 (MAD=6.0±1.0) mm Hg. CONCLUSIONS: Doppler BP more closely approximates SBP than MAP. Terumo Elemano was successful, reliable, and valid when compared with A-line and Doppler.