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1.
PLoS One ; 19(7): e0304413, 2024.
Article in English | MEDLINE | ID: mdl-38954679

ABSTRACT

BACKGROUND: Sedatives are commonly used to promote sleep in intensive care unit patients. However, it is not clear whether sedation-induced states are similar to the biological sleep. We explored if sedative-induced states resemble biological sleep using multichannel electroencephalogram (EEG) recordings. METHODS: Multichannel EEG datasets from two different sources were used in this study: (1) sedation dataset consisting of 102 healthy volunteers receiving propofol (N = 36), sevoflurane (N = 36), or dexmedetomidine (N = 30), and (2) publicly available sleep EEG dataset (N = 994). Forty-four quantitative time, frequency and entropy features were extracted from EEG recordings and were used to train the machine learning algorithms on sleep dataset to predict sleep stages in the sedation dataset. The predicted sleep states were then compared with the Modified Observer's Assessment of Alertness/ Sedation (MOAA/S) scores. RESULTS: The performance of the model was poor (AUC = 0.55-0.58) in differentiating sleep stages during propofol and sevoflurane sedation. In the case of dexmedetomidine, the AUC of the model increased in a sedation-dependent manner with NREM stages 2 and 3 highly correlating with deep sedation state reaching an AUC of 0.80. CONCLUSIONS: We addressed an important clinical question to identify biological sleep promoting sedatives using EEG signals. We demonstrate that propofol and sevoflurane do not promote EEG patterns resembling natural sleep while dexmedetomidine promotes states resembling NREM stages 2 and 3 sleep, based on current sleep staging standards.


Subject(s)
Dexmedetomidine , Electroencephalography , Hypnotics and Sedatives , Machine Learning , Propofol , Sevoflurane , Sleep , Humans , Hypnotics and Sedatives/pharmacology , Hypnotics and Sedatives/administration & dosage , Male , Adult , Female , Sleep/drug effects , Sleep/physiology , Propofol/pharmacology , Propofol/administration & dosage , Sevoflurane/pharmacology , Sevoflurane/adverse effects , Sevoflurane/administration & dosage , Dexmedetomidine/pharmacology , Sleep Stages/drug effects , Young Adult
2.
World J Urol ; 42(1): 396, 2024 Jul 10.
Article in English | MEDLINE | ID: mdl-38985296

ABSTRACT

PURPOSE: To investigate and implement semiautomated screening for meta-analyses (MA) in urology under consideration of class imbalance. METHODS: Machine learning algorithms were trained on data from three MA with detailed information of the screening process. Different methods to account for class imbalance (Sampling (up- and downsampling, weighting and cost-sensitive learning), thresholding) were implemented in different machine learning (ML) algorithms (Random Forest, Logistic Regression with Elastic Net Regularization, Support Vector Machines). Models were optimized for sensitivity. Besides metrics such as specificity, receiver operating curves, total missed studies, and work saved over sampling were calculated. RESULTS: During training, models trained after downsampling achieved the best results consistently among all algorithms. Computing time ranged between 251 and 5834 s. However, when evaluated on the final test data set, the weighting approach performed best. In addition, thresholding helped to improve results as compared to the standard of 0.5. However, due to heterogeneity of results no clear recommendation can be made for a universal sample size. Misses of relevant studies were 0 for the optimized models except for one review. CONCLUSION: It will be necessary to design a holistic methodology that implements the presented methods in a practical manner, but also takes into account other algorithms and the most sophisticated methods for text preprocessing. In addition, the different methods of a cost-sensitive learning approach can be the subject of further investigations.


Subject(s)
Machine Learning , Meta-Analysis as Topic , Systematic Reviews as Topic , Urology , Humans , Algorithms
3.
Phys Rev E ; 109(6-1): 064801, 2024 Jun.
Article in English | MEDLINE | ID: mdl-39020907

ABSTRACT

Nanoporous materials provide high surface area per unit mass and are capable of fluids adsorption. While the measurements of the overall amount of fluid adsorbed by a nanoporous sample are straightforward, probing the spatial distribution of fluids is nontrivial. We consider literature data on adsorption and desorption of fluids in nanoporous glasses reported along with the measurements of ultrasonic wave propagation. We analyze these using the so-called dynamic equivalent medium approach, which is based on Biot's theory of dynamic poroelasticity with coefficients that are continuous random functions of position. When further constrained by optical scattering data for similar systems, the calculations show that on adsorption the characteristic patch size is of the order of 100 pore diameters, while on desorption the patch size is comparable to the sample size. Our analysis suggests that one can employ ultrasound to probe the uniformity of the spatial distribution of fluids in nanoporous materials.

4.
Article in English | MEDLINE | ID: mdl-38871213

ABSTRACT

OBJECTIVE: One year aneurysm sac dynamics after endovascular abdominal aortic aneurysm repair (EVAR) were independently associated with greater risk of all-cause mortality in prior registry studies but were limited in completeness and granularity. This retrospective analysis aimed to study the impact of sac dynamics on survival within the Endurant Stent Graft Global Registry (ENGAGE) with five year follow up. METHODS: A total of 1 263 subjects were enrolled in the ENGAGE Registry between March 2009 and April 2011. One year aneurysm sac changes were calculated from one month post-operative imaging scans and the scan closest to the time of one year follow up. Sac regression was defined as a sac decrease of ≥ 5 mm and sac expansion as aneurysm sac growth ≥ 5 mm. The primary outcome was rate of five year all-cause mortality. Kaplan-Meier estimates for freedom from all-cause mortality were calculated. Multivariable Cox regression was used to determine the association between sac dynamics and all-cause mortality. RESULTS: At one year, 441 of the 949 study participants with appropriate imaging (46%) had abdominal aortic aneurysm sac regression, 462 (49%) remained stable, and 46 (4.8%) had sac expansion. For patients with sac regression, five year all-cause mortality was 20%, compared with 28% for stable sac (p = .007) and 37% for the sac expansion (p = .010) cohorts. After adjustment, sac expansion and stable sac cohorts were associated with greater all-cause mortality (expansion: hazard ratio [HR] 1.8; 95% CI 1.1 - 3.2; p = .032; stable: HR 1.4; 95% CI 1.1 - 1.9; p = .019). CONCLUSION: In the ENGAGE Global Registry, one year rate of sac regression was 46%, and one year sac regression was observed to be associated with greater five year survival, corroborating prior findings utilising data from vascular registries. Sac regression could become the new standard for success after EVAR.

5.
Target Oncol ; 2024 Jun 18.
Article in English | MEDLINE | ID: mdl-38890221

ABSTRACT

BACKGROUND: The antibody-drug conjugate sacituzumab govitecan is approved for metastatic triple-negative breast cancer and has shown promising results in various other types of cancer. Its costs may limit patient access to this novel effective treatment modality. OBJECTIVE: The purpose of this study was to develop an evidence-based rational dosing regimen that results in targeted drug exposure within the therapeutic range while minimizing financial toxicity, to improve treatment access. PATIENTS AND METHODS: Exposure equivalent dosing strategies were developed based on pharmacokinetic modeling and simulation by using the published pharmacokinetic model developed by the license holder. The alternative dose was based on the principle of using complete vials to prevent spillage and on the established non-linear relationship between body weight and systemic exposure. Equivalent exposure compared to the approved dosing regimen of 10 mg/kg was aimed for. Equivalent exposure was conservatively defined as calculated geometric mean ratios within the 0.9-1.11 boundaries for area under the concentration-time curve (AUC), trough concentration (Ctrough) and maximum concentration (Cmax) of the alternative dosing regimen compared to the approved dosing regimen. Since different vial sizes are available for the European Union (EU) and United States (US) market, because body weight distributions differ between these populations, we performed our analysis for both scenarios. RESULTS: Dosing regimens of sacituzumab govitecan for the EU (< 50 kg: 400 mg, 50-80 kg: 600 mg, and > 80 kg: 800 mg) and US population (< 40 kg: 360 mg, 40-65 kg: 540 mg, 65-90 kg: 720 mg, and > 90 kg: 900 mg) were developed, based on weight bands. The geometric mean ratios for all pharmacokinetic outcomes were within the predefined equivalence boundaries, while the quantity of drug used was 21.5% and 19.0% lower for the EU and US scenarios, respectively. CONCLUSIONS: With the alternative dosing proposal, an approximately 20% reduction in drug expenses for sacituzumab govitecan can be realized while maintaining an equivalent and more evenly distributed exposure throughout the body weight range, without notable increases in pharmacokinetic variability.

6.
Nanotechnology ; 35(37)2024 Jun 28.
Article in English | MEDLINE | ID: mdl-38897181

ABSTRACT

While silver nanowires (Ag NWs) have been demonstrated as a highly efficient transparent conducting material, they suffer from strong light scattering, which is quantified by a large haze factor (HF) in the optical spectrum. Here we investigate the influence of the dielectric environment on the light scattering of Ag NWs by comparing experimental measurements and simulations. In air, two peaks on the HF spectra are observed experimentally at the wavelength ofλI= 350 nm andλII= 380 nm and are attributed by simulations to the influence of the Ag NWs pentagonal shape on the localized surface plasmon resonance. The relative intensity between the two peaks is found to be dependent on whether the Ag NWs are in contact with the glass substrate or not. The HF behaviour in the near IR region seems to be dominated by Rayleigh scattering following simulations results. Dielectric environments of Ag NWs with various refractive indexes were obtained experimentally by the conformal deposition of different metal oxide coatings using atomic layer deposition, including Al-doped zinc oxide, Al2O3and SiO2coatings. The HF is found to be correlated with the refractive index environment in terms of HF peaks position, intensity and broadening. This trend of HF peaks is supported by a theoretical model to understand the optical mechanism behind this phenomenon.

7.
Br J Cancer ; 2024 Jun 11.
Article in English | MEDLINE | ID: mdl-38862741

ABSTRACT

BACKGROUND: Small-molecule inhibitors (SMIs) have revolutionised the treatment of non-small cell lung cancer (NSCLC). However, SMI-induced drug-drug interactions (DDIs) with frequently co-administered direct oral anticoagulants (DOACs), increase thromboembolic and bleeding risks. This study investigated and proactively managed the consequences of DOAC-SMI DDIs. METHODS: This prospective, observational study enrolled patients with NSCLC concomitantly using a DOAC and SMI. The primary outcome was the proportion of patients with DOAC plasma trough (Ctrough) and peak (Cpeak) concentrations outside expected ranges. Secondary outcomes included DOAC treatment modifications, incidence of bleeding and thromboembolic events and feasibility evaluation of pharmacokinetically guided DOAC dosing. RESULTS: Thirty-three patients were analysed. Thirty-nine percent (13/33) had DOAC Ctrough and/or Cpeak were outside the expected ranges in 39% (13/33). In 71% (5/7) of patients with DOAC concentrations quantified before and during concurrent SMI use, DOAC Ctrough and/or Cpeak increased or decreased >50% upon SMI initiation. In all patients in whom treatment modifications were deemed necessary, DOAC concentrations were adjusted to within the expected ranges. CONCLUSION: Proactive monitoring showed that a substantial proportion of patients had DOAC concentrations outside the expected ranges. DOAC concentrations were successfully normalised after treatment modifications. These results highlight the importance of proactive monitoring of DOAC-SMI DDIs to improve treatment in patients with NSCLC.

8.
Invest Ophthalmol Vis Sci ; 65(6): 9, 2024 Jun 03.
Article in English | MEDLINE | ID: mdl-38837167

ABSTRACT

Purpose: Optical coherence tomography (OCT) representations in clinical practice are static and do not allow for a dynamic visualization and quantification of blood flow. This study aims to present a method to analyze retinal blood flow dynamics using time-resolved structural OCT. Methods: We developed novel imaging protocols to acquire video-rate time-resolved OCT B-scans (1024 × 496 pixels, 10 degrees field of view) at four different sensor integration times (integration time of 44.8 µs at a nominal A-scan rate of 20 kHz, 22.4 µs at 40 kHz, 11.2 µs at 85 kHz, and 7.24 µs at 125 kHz). The vessel centers were manually annotated for each B-scan and surrounding subvolumes were extracted. We used a velocity model based on signal-to-noise ratio (SNR) drops due to fringe washout to calculate blood flow velocity profiles in vessels within five optic disc diameters of the optic disc rim. Results: Time-resolved dynamic structural OCT revealed pulsatile SNR changes in the analyzed vessels and allowed the calculation of potential blood flow velocities at all integration times. Fringe washout was stronger in acquisitions with longer integration times; however, the ratio of the average SNR to the peak SNR inside the vessel was similar across all integration times. Conclusions: We demonstrated the feasibility of estimating blood flow profiles based on fringe washout analysis, showing pulsatile dynamics in vessels close to the optic nerve head using structural OCT. Time-resolved dynamic OCT has the potential to uncover valuable blood flow information in clinical settings.


Subject(s)
Regional Blood Flow , Retinal Vessels , Tomography, Optical Coherence , Tomography, Optical Coherence/methods , Humans , Retinal Vessels/physiology , Retinal Vessels/diagnostic imaging , Blood Flow Velocity/physiology , Regional Blood Flow/physiology , Optic Disk/blood supply , Optic Disk/diagnostic imaging , Signal-To-Noise Ratio , Male , Female , Adult , Middle Aged
9.
JSES Rev Rep Tech ; 4(2): 189-195, 2024 May.
Article in English | MEDLINE | ID: mdl-38706678

ABSTRACT

Background: In baseball, repetitive pitching leads to medial elbow injuries, particularly to the ulnar collateral ligament (UCL). To prevent pitchers from UCL injuries, it is important to quantify the response to elbow stress. Repetitive elbow external valgus torque and muscular fatigue induced by repetitive pitching could affect markers of the response, that is, humeroulnar joint gap and UCL morphology. The aims of the study were three-folded: to investigate the effect of (1) exerted handgrip force on the humeroulnar joint gap, (2) repetitive pitching on the humeroulnar joint gap and the UCL morphology, and (3) exerted handgrip force on the humeroulnar joint gap for different levels of elbow valgus stress is different after compared to before repetitive pitching in asymptomatic baseball pitchers. Methods: Medial elbow ultrasound images were collected in 15 asymptomatic male baseball pitchers. Three levels of static elbow valgus stress (0N, 50N, 100N) were applied with a TELOS device before and after repetitive pitching and with or without handgrip force. These images were used to assess the humeroulnar joint gap size and UCL length and thickness. After 110 fastball pitches or when 80% self-perceived fatigue on a VAS scale was reached, participants were instructed to stop throwing. Repeated measures ANOVAs were used to statistically test significant differences. Results: Handgrip force did not significantly affect the humeroulnar joint gap. The UCL thickness and length and the humeroulnar joint gap were also not different after compared to before repetitive pitching. While higher levels of applied valgus stress significantly increased the humeroulnar joint gap (P < .001), this effect was not significantly different in the interaction with handgrip force and repetitive pitching. Conclusion: The humeroulnar joint gap changes for different levels of elbow valgus stress. However, adult baseball pitchers did not respond to elbow stress after a single pitching session with or without submaximal handgrip force in the humeroulnar joint gap and UCL morphology.

10.
Semin Arthritis Rheum ; 67: 152475, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38810568

ABSTRACT

OBJECTIVE: Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) primarily affects small vessels. Large-vessel involvement (LVI) is rare. We aimed to describe the characteristics of LVI, to identify associated risk factors, and to describe its therapeutic management. METHODS: This multicenter case-control (1:2) study included patients with AAV according to the ACR/EULAR classification and LVI as defined by the Chapel Hill nomenclature, together with controls matched for age, sex, and AAV type. RESULTS: We included 26 patients, 15 (58 %) of whom were men, with a mean age of 56.0 ± 17.1 years. The patients had granulomatosis with polyangiitis (n = 20), or microscopic polyangiitis (n = 6). The affected vessels included the aorta (n = 18; 69 %) supra-aortic trunks (n = 9; 35 %), lower-limb arteries (n = 5; 19 %), mesenteric arteries (n = 5; 19 %), renal arteries (n = 4; 15 %), and upper-limb arteries (n = 2; 8 %). Imaging showed wall thickening (n = 10; 38 %), perivascular inflammation (n = 8; 31 %), aneurysms (n = 5; 19 %), and stenosis (n = 4; 15 %). Comparisons with the control group revealed that LVI was significantly associated with neurological manifestations (OR=3.23 [95 % CI: 1.11-10.01, p = 0.03]), but not with cardiovascular risk factors (OR=0.70 [95 % CI: 0.23-2.21, p = 0.60]), or AAV relapse (OR=2.01 [95 % CI: 0.70-5.88, p = 0.16]). All patients received corticosteroids, in combination with an immunosuppressant in 24 (92 %), mostly cyclophosphamide (n = 10, 38 %) or rituximab (n = 9, 35 %). CONCLUSION: Regardless of distinctions based on vessel size, clinicians should consider LVI as a potential manifestation of AAV, with the aorta commonly affected. The risk of developing LVI appears to be greater for clinical phenotypes of AAV with neurological involvement. Standard AAV treatment can be used to manage LVI.


Subject(s)
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis , Humans , Male , Female , Middle Aged , Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/complications , Case-Control Studies , Aged , Adult , Risk Factors , Immunosuppressive Agents/therapeutic use
12.
J Med Imaging (Bellingham) ; 11(3): 037001, 2024 May.
Article in English | MEDLINE | ID: mdl-38765874

ABSTRACT

Purpose: To investigate the accuracy of high-framerate echo particle image velocimetry (ePIV) and computational fluid dynamics (CFD) for determining velocity vectors in femoral bifurcation models through comparison with optical particle image velocimetry (oPIV). Approach: Separate femoral bifurcation models were built for oPIV and ePIV measurements of a non-stenosed (control) and a 75%-area stenosed common femoral artery. A flow loop was used to create triphasic pulsatile flow. In-plane velocity vectors were measured with oPIV and ePIV. Flow was simulated with CFD using boundary conditions from ePIV and additional duplex-ultrasound (DUS) measurements. Mean differences and 95%-limits of agreement (1.96*SD) of the velocity magnitudes in space and time were compared, and the similarity of vector complexity (VC) and time-averaged wall shear stress (TAWSS) was assessed. Results: Similar flow features were observed between modalities with velocities up to 110 and 330 cm/s in the control and the stenosed model, respectively. Relative to oPIV, ePIV and CFD-ePIV showed negligible mean differences in velocity (<3 cm/s), with limits of agreement of ±25 cm/s (control) and ±34 cm/s (stenosed). CFD-DUS overestimated velocities with limits of agreements of 13±40 and 16.1±55 cm/s for the control and stenosed model, respectively. VC showed good agreement, whereas TAWSS showed similar trends but with higher values for ePIV, CFD-DUS, and CFD-ePIV compared to oPIV. Conclusions: EPIV and CFD-ePIV can accurately measure complex flow features in the femoral bifurcation and around a stenosis. CFD-DUS showed larger deviations in velocities making it a less robust technique for hemodynamical assessment. The applied ePIV and CFD techniques enable two- and three-dimensional assessment of local hemodynamics with high spatiotemporal resolution and thereby overcome key limitations of current clinical modalities making them an attractive and cost-effective alternative for hemodynamical assessment in clinical practice.

16.
Article in English | MEDLINE | ID: mdl-38693759

ABSTRACT

This study aimed to compare implant stabilities between the immediate and early loaded, immediately placed bone-level tapered dental implants in the maxilla and to evaluate marginal bone loss (MBL), oral health-related quality of life (OHRQoL), and patient satisfaction at a 2-year follow-up. A pilot, prospective, randomized, controlled clinical trial was conducted on 24 maxillary failing dentition patients. The bone-level tapered implants of 12 patients were immediately loaded with temporary restorations, while the other 12 patients did not receive any kind of temporization. Implant-supported screw-retained complete porcelain-fused-to-metal prostheses were delivered to all patients in the seventh postoperative week. The insertion torque values of implants assigned to the immediate and early loading groups were 33.0 ± 4.87 and 29.26 ± 8.31 Ncm, respectively. The dynamics of implant stability changes from implant placement up to a 2-year follow-up were similar for both groups (Penguin®, p = 0.268; Ostell®, p = 0.552), while the MBL was at submillimeter level. The cumulative implant survival rate was 91.80% for immediately loaded implants and 97.22% for early loaded implants, without significant difference (p = 0.162). The total score on the Oral Health Impact Profile questionnaire significantly decreased over time in both groups, indicating improvement in OHRQoL (p < 0.001), and the high level of patient satisfaction remained after 2 years of function regardless of a loading protocol. Both loading protocols, immediate and early, of six immediately placed bone-level tapered dental implants are an adequate treatment choice for fixed rehabilitation of the maxillary failing dentition.

17.
Anaesthesia ; 79(8): 849-855, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38606765

ABSTRACT

BACKGROUND: Recommendations exist that aim to mitigate the substantial ecological impact of anaesthesia. One option is to use anaesthetic gas capturing technology at anaesthesia workstation exhausts to harvest and recycle volatile agents. However, the efficiency of such technology is mainly unverified in vivo. METHODS: The efficiency of CONTRAfluran™ in capturing sevoflurane from an anaesthesia workstation exhaust (when set to minimal flow and end-tidal control mode) was evaluated in 70 adult patients scheduled for general or bariatric laparoscopic surgery. The weight of the sevoflurane vaporiser and CONTRAfluran canister was measured before and after each case, to calculate total sevoflurane consumption and retention. Retention was measured after the minimal flow maintenance phase and after the high flow washout phase. The total retention efficiency was the fraction of all consumed sevoflurane captured by the CONTRAfluran canister. The primary objective was to examine the retention efficiency of CONTRAfluran in a clinical surgical setting, where all feasible strategies to minimise sevoflurane consumption and optimise the efficacy of CONTRAfluran were utilised. The secondary objective was to analyse the correlation between mass transfer and the duration of the case. RESULTS: Mean (SD) volume of sevoflurane captured using CONTRAfluran was 4.82 (1.41) ml, representing 45% (95%CI 42-48%) of all sevoflurane administered. The highest amount of retention was found during the washout phase. Retention efficiency did not correlate with the duration of the case. CONCLUSIONS: Over half of the sevoflurane administered was not captured by the CONTRAfluran canister when minimal flow techniques were used, likely due to residual accumulation of sevoflurane in the patient after tracheal extubation or, to a lesser extent, due to ventilation system leakage. However, as every prevented emission is commendable, CONTRAfluran may be a potentially valuable tool for reducing the environmental footprint of sevoflurane-based anaesthesia.


Subject(s)
Anesthetics, Inhalation , Laparoscopy , Sevoflurane , Sevoflurane/administration & dosage , Humans , Anesthetics, Inhalation/administration & dosage , Laparoscopy/methods , Male , Middle Aged , Female , Adult , Aged , Anesthesia, Inhalation/methods , Anesthesia, Inhalation/instrumentation , Air Pollution, Indoor/prevention & control
18.
J Endovasc Ther ; : 15266028241245602, 2024 Apr 09.
Article in English | MEDLINE | ID: mdl-38590283

ABSTRACT

OBJECTIVE: To assess the impact of heparin-bonded endoprosthesis compared with femoropopliteal bypass on key hospital resources and revenues up to 1-year follow-up. DESIGN: A 2-arm scenario resource consumption data analysis was modeled based on a multicentre prospective randomized controlled trial. SETTING: Six centers in the Netherlands. PARTICIPANTS: A total of 100 patients were assigned to 2 arms (50 each arm). The first arm evaluated endovascular treatment using the heparin-bonded Viabahn endoprosthesis and the second the femoropopliteal bypass. Resource consumption rates were compared between arms. PRIMARY AND SECONDARY OUTCOMES MEASURES: Resource consumption rates, including hospital stay for bypass procedure, operating room time, type of anesthesia, number of used (endo)grafts, use of different types of bed locations (vascular ward, medium or intensive care), readmission for wound infections, and reinterventions over a period of 12 months. RESULTS: Endovascular repair used fewer hospital resources, with an overall difference of €149.983. Hospital stay was 118 days less (261 vs 379), including 21 fewer days in medium/intensive care (5 vs 26) and 50 fewer operating room hours (100 vs 150). Fewer patients required general anesthesia (31 vs 39), and there were less surgical site infections (3 vs 12). In the surgical bypass group, there were 18 fewer days of hospital stay related to reinterventions (80 vs 62), and the cost of the devices was €309.996, cheaper. The total monetary difference was € 160.013, in favor of the femoropopliteal bypass (€3.200, per patient). CONCLUSIONS: Endovascular repair of the superficial femoral artery reduces the use of valuable hospital resources. Its major limitation is the cost of the devices, which should be balanced against the reduction in peri-procedural morbidity and faster recovery. In the context of shortage of hospital beds, it offers capacity benefits, allowing for the treatment of more patients overall. These benefits may outweigh the fewer reinterventions in the surgical bypass group. REGISTRATION: The SuperB Trial was registered in clinicaltrials.gov; NCT-ID: NCT01220245. CLINICAL IMPACT: Modeling is a useful technique to predict the impact of treatment modalities on hospital resources and revenue. This study uses real-world data from the SuperB Trial to compare two treatment strategies of superficial femoral artery disease, reflecting actual clinical practice and patient outcomes. The analysis focused on direct costs associated with hospital resources and device usage without considering indirect costs or long-term cost-effectiveness. The analysis showed that endovascular repair reduces the use of valuable hospital resources. Its major limitation is device costs, which should be balanced against the reduction in peri-procedural morbidity and faster recovery. In the context of shortage of hospital beds, it offers capacity benefits, allowing for the treatment of more patients overall.

19.
Article in English | MEDLINE | ID: mdl-38670221

ABSTRACT

OBJECTIVE: The Gore Excluder Conformable Endoprosthesis (CEXC) is designed to treat challenging infrarenal anatomy because of its active angulation control, repositionability, and enhanced conformability. This study evaluated 30 day and one year position and apposition of the CEXC in the infrarenal neck. METHODS: Patients treated with the CEXC between 2018 and 2022 with an available 30 day computed tomography angiogram (CTA) were selected from four hospitals in a prospective registry. Endograft apposition (shortest apposition length [SAL]) and position (shortest fabric distance [SFD]) were assessed on the 30 day and one year CTAs. Maximum infrarenal aortic curvature was compared between the pre- and post-operative CTAs to evaluate conformability of the CEXC. RESULTS: There were 87 patients with a 30 day CTA, and for 56 of these patients the one year CTA was available. Median (interquartile range [IQR]) pre-operative neck length was 22 mm (IQR 15, 32) and infrarenal angulation was 52° (IQR 31, 72). Median SAL was 21.2 mm (IQR 14.0, 29.3) at 30 days for all included patients. The SAL in 13 patients (15%) was < 10 mm at 30 days, and one patient had a SAL of 0 mm and a type Ia endoleak. There was no significant difference in SAL between patients within and outside instructions for use. The SAL significantly increased by 1.1 mm (IQR -2.3, 4.7; p = .042) at one year. The SAL decreased in seven patients (13%), increased in 13 patients (23%), and remained stable in 36 patients (64%). Median SFD was 2.0 mm (IQR 0.5, 3.6) at 30 days, which slightly increased by 0.3 mm (IQR -0.5, 1.8; p = .019) at one year. One patient showed migration (SFD increase ≥ 5 mm). Median endograft tilt was 15.8° (IQR 9.7, 21.4). Pre-operative maximum infrarenal curvature was 36 m-1 (IQR 26, 56) and did not significantly change thereafter. CONCLUSION: In most patients, the CEXC was implanted close to the renal arteries, and sufficient (≥ 10 mm) post-operative apposition was achieved at 30 days, which slightly increased at one year. Post-operative endograft tilt was relatively low, and aortic geometry remained unchanged after implantation of the CEXC, probably due to its high conformability.

20.
Ann Vasc Surg ; 106: 80-89, 2024 Apr 04.
Article in English | MEDLINE | ID: mdl-38579908

ABSTRACT

BACKGROUND: The study aims to describe midterm outcomes following treatment of infrarenal abdominal aortic aneurysms (AAAs) with short necks by endosutured aneurysm repair using the Heli-FX EndoAnchor system. METHODS: This is a retrospective study of prospectively collected data from 9 vascular surgery departments between June 2010 and December 2019, including treated AAAs with neck lengths ≤10 mm. The decision for the use of EndoAnchors was made by the treating surgeon or multidisciplinary aortic committee according to each center's practice. There were 2 Groups further assessed according to neck length, A (≥4 and <7 mm) and B (≥7 and ≤10 mm). The main outcomes analyzed were technical success, freedom from type Ia endoleaks (TIaELs), sac size increase, all-cause and aneurysm-related mortality. RESULTS: Seventy-six patients were included in the study, 17 fell into Group A and 59 into Group B. Median follow-up for the cohort was 40.5 (interquartile range 12-61) months. A median of 6 (interquartile range 3) EndoAnchors were deployed in each subject. Technical success was 86.8% for the total group, 82.4% and 88.1% (P = 0.534) for Groups A and B respectively. Six out of 10 (60%) of TIaELs at the completion angiographies showed spontaneous resolution. Cumulative freedom from TIaEL at 3 and 5 years for the total group was 89% and 84% respectively; this was 93% and 74% for Group A and 88% at both intervals in Group B (P = 0.545). In total, there were 7 (9.2%) patients presenting with TIaELs over the entire study period. Two (11.8%) in Group A and 5 (8.5%) in Group B (P = 0.679). There were more patients with sac regression in Group B (Group A = 6-35.3% vs. Group B = 34-57.6%, P = 0.230) with no statistical significance. All-cause mortality was 19 (25%) patients, with no difference (4-23.5% vs. 15-25.4%, P = 0.874) between groups; whereas aneurysm-related mortality occurred in 1 patient from Group A and 3 from Group B. CONCLUSIONS: This study demonstrates reasonable outcomes for patients with short-necked AAAs treated by endosutured aneurysm repair in terms of TIaELs up to 5-year follow-up. EndoAnchor use should be judiciously evaluated in short necks and may be a reasonable option when anatomical constraints are encountered, mainly for those with 7-10 mm neck lengths. Shorter neck length aspects, as indicated by the results from Group A, may be an alternative when no other options are available or feasible.

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