52 research outputs found
Comparison of segmentation software packages for in-hospital 3D print workflow
Purpose: In-hospital three-dimensional (3D) printing of patient-specific pathologies is increasingly being used in daily care. However, the efficiency of the current conversion from image to print is often obstructed due to limitations associated with segmentation software. Therefore, there is a need for comparison of several clinically available tools. A comparative study has been conducted to compare segmentation performance of Philips IntelliSpace Portal(®) (PISP), Mimics Innovation Suite (MIS), and DICOM to PRINT(®) (D2P). Approach: These tools were compared with respect to segmentation time and 3D mesh quality. The dataset consisted of three computed tomography (CT)-scans of acetabular fractures (ACs), three CT-scans of tibia plateau fractures (TPs), and three CTA-scans of abdominal aortic aneurysms (AAAs). Independent-samples [Formula: see text]-tests were performed to compare the measured segmentation times. Furthermore, 3D mesh quality was assessed and compared according to representativeness and usability for the surgeon. Results: Statistically significant differences in segmentation time were found between PISP and MIS with respect to the segmentation of ACs ([Formula: see text]) and AAAs ([Formula: see text]). Furthermore, statistically significant differences in segmentation time were found between PISP and D2P for segmentations of AAAs ([Formula: see text]). There were no statistically significant differences in segmentation time for TPs. The accumulated mesh quality scores were highest for segmentations performed in MIS, followed by D2P. Conclusion: Based on segmentation time and mesh quality, MIS and D2P are capable of enhancing the in-hospital 3D print workflow. However, they should be integrated with the picture archiving and communication system to truly improve the workflow. In addition, these software packages are not open source and additional costs must be incurred
One-year follow-up after active aortic aneurysm sac treatment with shape memory polymer devices during endovascular aneurysm repair
Objective: To determine the safety and efficacy of treating abdominal aortic aneurysm (AAA) sacs with polyurethane shape memory polymer (SMP) devices during endovascular aneurysm repair (EVAR), using a technique to fully treat the target lumen after endograft placement (aortic flow volume minus the endograft volume). SMP devices self-expand in the sac to form a porous scaffold that supports thrombosis throughout its structure. Methods: Two identical prospective, multicenter, single-arm studies were conducted in New Zealand and the Netherlands. The study population was adult candidates for elective EVAR of an infrarenal AAA (diameter of ≥55 mm in men and ≥50 mm in women). Key exclusion criteria were an inability to adequately seal a common iliac artery aneurysm, patent sac feeding vessels of >4 mm, and a target lumen volume of <20 mL or >135 mL. Target lumen volumes were estimated by subtracting endograft volumes from preprocedural imaging-based flow lumen volumes. SMP devices were delivered immediately after endograft deployment via a 6F sheath jailed in a bowed position in the sac. The primary efficacy end point was technical success, defined as filling the actual target lumen volume with fully expanded SMP at the completion of the procedure. Secondary efficacy outcome measures during follow-up were the change in sac volume and diameter, rate of type II endoleak and type I or III endoleaks, and the rate of open repair and related reinterventions, with data collection at 30 days, 6 months, and 1 year (to date). Baseline sac volumes and diameters for change in sac size analyses were determined from 30-day imaging studies. Baseline and follow-up volumes were normalized by subtraction of the endograft volume. Results: Of 34 patients treated with SMP devices and followed per protocol, 33 patients were evaluable at 1 year. Preprocedural aneurysm volume was 181.4 mL (95% confidence interval [CI], 150.7-212.1 mL) and preprocedural aneurysm diameter was 60.8 mm (95% CI, 57.8-63.9 mm). The target lumen volume was 56.3 mL (95% CI, 46.9-65.8 mL). Technical success was 100% and the ratio of SMP fully expanded volume to estimated target lumen volume was 1.4 ± 0.3. Baseline normalized sac volume and diameter were 140.7 mL (95% CI, 126.6-154.9 mL) and 61.0 mm (95% CI, 59.7-62.3 mm). The adjusted mean percentage change in normalized volume at 1 year was −28.8% (95% CI, −35.3 to −22.3%; P < .001). The adjusted mean change in sac diameter at 1 year was −5.9 mm (95% CI, −7.5 to −4.4 mm; P < .001). At 1 year, 81.8% of patients (95% CI, 64.5%-93.0%) achieved a ≥10% decrease in normalized volume and 57.6% of patients (95% CI, 39.2%-74.5%) achieved a ≥5 mm decrease in diameter. No device- or study procedure-related major adverse events occurred through 1 year after the procedure. Conclusions: Treatment of AAA sacs with SMP devices during EVAR resulted in significant sac volume and diameter regression at 1 year with an acceptable safety profile in this prospective study.</p
Active aortic aneurysm sac treatment with shape memory polymer during endovascular aneurysm repair
Long-term prognostic risk in lower extremity peripheral arterial disease as a function of the number of peripheral arterial lesions
Background: Although patients with peripheral artery disease (PAD) are known to have an increased risk of adverse prognosis, simple techniques to further risk-stratify PAD patients would be clinically useful. A plausible but unexplored factor to predict such risk would be greater disease burden, manifested as multiple lower extremity lesions. The aim of this study was to examine the association between having multiple versus isolated lower extremity PAD lesions and long-term prognosis. Methods and results: A prospective cohort of 756 newly diagnosed PAD patients underwent duplex ultrasound testing to determine the number of lower extremity lesions. Cox regression models examined the independent association of lesion number (≥3 and 2 versus 1) and adverse prognosis (defined as a composite end point comprising first occurrence of either lower extremity amputation, admission for heart failure, nonfatal stroke, myocardial infarction, or unstable angina or mortality), adjusting for demographic and clinical risk factors. Analyses were replicated using an advanced Cox-based model for multiple events. A total of 173 patients (23%) had ≥3 lesions, 197 (26%) had 2 lesions, and 386 (51%) had 1 lesion. After a median follow-up of 3.2 years, patients with ≥3 lesions had an increased risk of experiencing a first adverse event (adjusted hazard ratio 1.60, 95% CI 1.08-2.38, P=0.020) and an increased risk of having multiple events (adjusted hazard ratio 1.53, 95% CI 1.08-2.18, P=0.018). Patients with 2 lesions had a prognosis similar to those with 1 lesion. Conclusions: Among PAD patients, a greater number of lesions is associated with an increased risk of an adverse prognosis over 3 years of follow-up. Assessing the number of lower extremity lesions might serve as a simple risk-stratification tool at initial PAD diagnosis
Geometric Analysis of the Gore Excluder Conformable Endoprosthesis in the Infrarenal Aortic Neck: One Year Results of the EXCeL Registry
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.</p
Randomized trial of Legflow® paclitaxel eluting balloon and stenting versus standard percutaneous transluminal angioplasty and stenting for the treatment of intermediate and long lesions of the superficial femoral artery (RAPID trial): Study protocol for a randomized controlled trial
Background: Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow® paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm.Methods/Design: A total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5-15 cm) or long (>15 cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera® stent in both groups (IDEV Technologies Inc., Webster, TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device-specific adverse events. Follow up consists of four visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention.Discussion: The RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning whether the use of the Legflow paclitaxel/shellac coated balloons with nitinol stenting significantly reduces the frequency of restenosis in intermediate and long SFA lesions compared to standard PTA and stenting.Trial registration: ISRCTN47846578
Patient Profiles and Health Status Outcomes for Peripheral Artery Disease in High-Income Countries:A Comparison Between the United States and the Netherlands
OBJECTIVES: Peripheral artery disease (PAD) is a global disease. Understanding variability in patient profiles and PAD-specific health status outcomes across health system countries can provide insights into improving PAD care. We compared these features between 2 high-income countries, the United States (US) and the Netherlands. MATERIALS AND METHODS: Patients were identified from the Patient-centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) study - a prospective, international registry of patients presenting to vascular specialty clinics for new onset, or exacerbation of PAD symptoms. PAD-specific health status was measured with the Peripheral Artery Questionnaire (PAQ). General linear mixed models for repeated measures were used to study baseline, 3-, 6-, and 12-month PAD-specific health status outcomes (PAQ summary score) between US and the Netherlands. RESULTS: Out of a total of 1,114 patients, 748 patients (67.1%) were from the US and 366 (32.9%) from the Netherlands. US patients with PAD were older, with more financial barriers, higher cardiovascular risk factor burden, and lower referral rates for exercise treatment (p < 0.001). They had significantly worse PAD-specific adjusted health status scores at presentation, 3-, 6- and 12 months of follow-up (all p < 0.0001). Magnitude of change in 1-year health status scores was smaller in the US cohort as compared with the Netherlands. CONCLUSION: Compared with the Dutch cohort, US patients had worse adjusted PAD-specific health status scores at all time point, improving less over time, despite treatment. Leveraging inter-country differences in care and outcomes could provide important insights into optimizing PAD outcomes
Two-Year Outcomes of the Nellix EndoVascular Aneurysm Sealing System for Treatment of Abdominal Aortic Aneurysms
Endothelial progenitor cell-seeded grafts: Rash and risky
The patency of prosthetic vascular grafts is impaired by intimal hyperplasia (IH) near the anastomotic regions. The absence of a functional endothelial monolayer on the prosthetic grafts is an important stimulus for IH. To improve the outcome of synthetic vascular bypass surgery, cell seeding is a promising concept that has been extensively investigated and is still evolving. In the present paper, the concept of prosthetic graft cell seeding is discussed, with emphasis on its newest era: seeding with endothelial progenitor cells. Although experimental studies on prosthetic graft seeding using endothelial progenitor cells have shown excellent results on graft endothelialization, none of these studies reported favourable effects on the more clinically relevant end points such as IH or graft patency
Treatment of acute type B aorta dissections
4 patiënten hadden een acute aortadissectie type B, die medicamenteus werd behandeld. Bij 3 van hen was echter aanvullende invasieve behandeling nodig. Een 67-jarige patiënt kreeg een spinale katheter vanwege neurologische symptomen. Een 57-jarige patiënt onderging endovasculaire fenestratie van de rechter nierarterie en stenting van beide Aa. iliacae, om acute ischemie te behandelen. Bij een 71-jarige patiënt werd een endovasculaire stent-graft geplaatst in de distale aortaboog, om een scheur in de wand te dichten. [...
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