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result(s) for
"Taudorf, Mikkel"
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Current Status of Trans-Arterial Embolization in Pain Management of Musculoskeletal Inflammatory Conditions — An Evidence-Based Review
by
Riis Robert Gabriel Coumine
,
Hölmich Per
,
Petersen, Michael Mørk
in
Adverse events
,
Case reports
,
Embolization
2021
ObjectiveTo summarize the literature on trans-arterial embolization in inflammatory musculoskeletal conditions, focusing on efficacy and safety.Materials and MethodsPRISMA guidelines were followed. A systematic literature search revealed 19 studies, with a total of 394 participants, eligible for inclusion.ResultsThe included studies consisted of case reports/series and non-randomized interventional studies, with knee osteoarthritis and adhesive capsulitis of the shoulder as the most frequent conditions. In all studies except one, pain was reduced up to four years after treatment. All adverse events were transient. Due to high heterogeneity, meta-analysis was not possible.ConclusionThe included early studies showed encouraging results regarding efficacy and safety. However, randomized, placebo-controlled trials are warranted.
Journal Article
Non-inferiority, randomised, open-label clinical trial on the effectiveness of transurethral microwave thermotherapy compared to prostatic artery embolisation in reducing severe lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for the TUMT-PAE-1 trial
by
Lönn, Lars Birger
,
Kristensen-Alvarez, Anna
,
Widecrantz, Steven John
in
Aged
,
Benign prostatic hyperplasia
,
Biomedicine
2024
Background
One-fourth of men older than 70 years have lower urinary tract symptoms (LUTS) that impair their quality of life. Transurethral resection of the prostate (TURP) is considered the gold standard for surgical treatment of LUTS caused by benign prostatic hyperplasia (BPH) that cannot be managed conservatively or pharmacologically. However, TURP is only an option for patients fit for surgery and can result in complications. Transurethral microwave thermotherapy (TUMT) and prostatic artery embolisation (PAE) are alternative minimally invasive surgical therapies (MISTs) performed in an outpatient setting. Both treatments have shown to reduce LUTS with a similar post-procedure outcome in mean International Prostate Symptom Score (IPSS). It is however still unknown if TUMT and PAE perform equally well as they have never been directly compared in a randomised clinical trial. The objective of this clinical trial is to assess if PAE is non-inferior to TUMT in reducing LUTS secondary to BPH.
Methods
This study is designed as a multicentre, non-inferiority, open-label randomised clinical trial. Patients will be randomised with a 1:1 allocation ratio between treatments. The primary outcome is the IPSS of the two arms after 6 months. The primary outcome will be evaluated using a 95% confidence interval against the predefined non-inferiority margin of + 3 points in IPSS. Secondary objectives include the comparison of patient-reported and functional outcomes at short- and long-term follow-up. We will follow the patients for 5 years to track long-term effect. Assuming a difference in mean IPSS after treatment of 1 point with an SD of 5 and a non-inferiority margin set at the threshold for a clinically non-meaningful difference of + 3 points, the calculated sample size was 100 patients per arm. To compensate for 10% dropout, the study will include 223 patients.
Discussion
In this first randomised clinical trial to compare two MISTs, we expect non-inferiority of PAE to TUMT. The most prominent problems with MIST BPH treatments are the unknown long-term effect and the lack of proper selection of candidates for a specific procedure. With analysis of the secondary outcomes, we aspire to contribute to a better understanding of durability and provide knowledge to guide treatment decisions.
Trial registration
ClinicalTrials.gov NCT05686525. Registered on January 17, 2023,
https://clinicaltrials.gov/study/NCT05686525
.
Journal Article
Copenhagen Mesenteric stent study (COMESS)—a randomized trial of stent versus covered stent treatment for chronic mesenteric ischemia
by
Eiberg, Jonas P.
,
Taudorf, Mikkel
,
Resch, Timothy A.
in
Angioplasty
,
Atherosclerosis
,
Biomedicine
2024
Background
Current management of mesenteric ischemia is primarily endovascular stent treatment. Typical CMI symptoms are postprandial abdominal pain, food fear, weight loss, and diarrhea. Revascularization is often necessary, as mesenteric ischemia may progress to bowel necrosis and death if left untreated. This study aims to compare the outcome using bare metal stent (BMS) or covered stent (CS) in the endovascular treatment of chronic and acute on chronic mesenteric ischemia.
Methods
This is an investigator-driven, prospective, randomized, single-blinded, and single-center, national cohort study at the Copenhagen University Hospital, Denmark. A total of 98 patients with chronic mesenteric ischemia (CMI) and acute-on-chronic mesenteric ischemia (AoCMI) will be randomized to treatment with either BeSmooth BMS (Bentley Innomed GmbH) or BeGraft CS (Bentley Innomed GmbH). Randomization occurs intraoperatively after lesion crossing.
Discussion
There is currently no published data from prospective controlled trials regarding the preferred type of stent used for the treatment of chronic and acute-on-chronic mesenteric ischemia. This trial will evaluate the short- and long-term outcome of BMS versus CS when treating CMI and AoCMI, as well as the benefit of a more intense postoperative surveillance program.
Trial registration
ClinicalTrials.gov NCT05244629. Registered on February 8, 2022.
Journal Article
Ex vivo‐expanded autologous adipose tissue‐derived stromal cells ensure enhanced fat graft retention in breast augmentation: A randomized controlled clinical trial
by
Svalgaard, Jesper D.
,
Fischer‐Nielsen, Anne
,
Kølle, Stig‐Frederik T.
in
Adipose tissue
,
adipose‐derived stromal cells
,
Autografts
2020
Autologous fat grafting and implant surgery are used for volume restoration in plastic surgery. With the aim of producing a treatment superior to current solutions, we report a randomized, controlled, data assessor‐blinded clinical trial comparing fat grafts enriched with ex vivo‐expanded autologous adipose‐derived stromal cells (ASCs) to nonenriched fat grafts in breast augmentation. The intervention group received ASC‐enriched fat grafts (≥20 × 106 viable ex vivo‐expanded ASCs per milliliter fat), and the control group received conventional nonenriched fat grafts. Volume retention was measured by magnetic resonance imaging, and clinical photographs were taken simultaneously for outcome evaluation. ASC‐enriched fat grafts had significantly higher retention rates (mean = 80.2%) compared with conventional fat grafts (mean = 45.1%). Clinical photos showed statistically significant superior results in the intervention group, assessed by independent clinical experts. These results improve the prospects for using culture‐expanded ASCs in both reconstructive and cosmetic volume restoration and make the procedure an attractive alternative to conventional fat grafting and implants. This study is registered at www.ClinicalTrials.gov, number H‐16046960. Ex vivo‐expanded adipose tissue‐derived stromal cells ensure enhanced fat graft retention and superior clinical outcomes in breast augmentation. With a high survival of the injected volume, no second augmentation procedure was needed. The results improve the prospects for using expanded ASCs in reconstructive and cosmetic volume restoration and make the procedure an attractive alternative to conventional fat grafting and implants.
Journal Article
Center experience and other determinants of patient radiation exposure during prostatic artery embolization: a retrospective study in three Scandinavian centers
by
Kløw, Nils-Einar
,
Lönn, Lars Birger
,
Waltenburg, Hanne
in
Angiography
,
Angiography, Digital Subtraction - methods
,
Arteries - diagnostic imaging
2022
Objectives
To evaluate the effects of center experience and a variety of patient- and procedure-related factors on patient radiation exposure during prostatic artery embolization (PAE) in three Scandinavian centers with different PAE protocols and levels of experience. Understanding factors that influence radiation exposure is crucial in effective patient selection and procedural planning.
Methods
Data were collected retrospectively for 352 consecutive PAE procedures from January 2015 to June 2020 at the three centers. Dose area product (DAP (Gy·cm
2
)) was selected as the primary outcome measure of radiation exposure. Multiple patient- and procedure-related explanatory variables were collected and correlated with the outcome variable. A multiple linear regression model was built to determine significant predictors of increased or decreased radiation exposure as reflected by DAP.
Results
There was considerable variation in DAP between the centers. Intended unilateral PAE (
p
= 0.03) and each 10 additional patients treated (
p
= 0.02) were significant predictors of decreased DAP. Conversely, increased patient body mass index (BMI,
p
< 0.001), fluoroscopy time (
p
< 0.001), and number of digital subtraction angiography (DSA) acquisitions (
p
< 0.001) were significant predictors of increased DAP.
Conclusions
To minimize patient radiation exposure during PAE radiologists may, in collaboration with clinicians, consider unilateral embolization, pre-interventional CTA for procedure planning, using predominantly anteroposterior (AP) projections, and limiting the use of cone-beam CT (CBCT) and fluoroscopy.
Key Points
•
Growing center experience and intended unilateral embolization decrease patient radiation exposure during prostatic artery embolization.
•
Patient BMI, fluoroscopy time, and number of DSA acquisitions are associated with increased DAP during procedures.
•
Large variation in radiation exposure between the centers may reflect the use of CTA before and CBCT during the procedure.
Journal Article
Intraoperative Diagnostic Methods for Superior Mesenteric Artery Stenting in Chronic Mesenteric Ischemia
by
Lonn, Lars
,
Eiberg, Jonas P
,
Taudorf, Mikkel
in
Agreements
,
Aortic stenosis
,
Coronary vessels
2025
Chronic mesenteric ischemia (CMI) due to superior mesenteric artery (SMA) stenosis can be effectively treated with endovascular therapy (EVT). Appropriate intraoperative assessment is crucial for ensuring technical success and long-term patency. This study assesses intra-arterial pressure measurement (IAPM), and cone beam computed tomography (CBCT) for detecting residual stenosis during SMA stenting in CMI.
This prospective study included 50 consecutive elective patients with symptomatic, significant SMA stenosis scheduled for EVT. The patients in this study were a subset of an ongoing randomized trial with a different primary objective. Intraoperative diagnostic tools-digital subtraction angiography (DSA), IAPM and CBCT were performed after stent placement. Technical success was defined as <30% residual stenosis on DSA, a residual pressure gradient of <10 mmHg with IAPM and full stent expansion on CBCT.
Although there was a fair agreement between DSA and CBCT (Kappa 0.294,
= 0.024), the Odds ratio suggests that DSA detected fewer positive cases compared to CBCT (Odds ratio 0.176; 95% CI: 0.004-1.37;
= 0.13). DSA also differed significantly from IAPM (Kappa = 0.016,
= 0.882), (Odds ratio = 0.167; 95% CI: 0.018-0.749;
= 0.013), suggesting DSA under-detects residual stenosis (>10 mmHg). No significant difference was found between CBCT and IAPM (Kappa = 0.201,
= 0.161) (Odds ratio: 2.25, 95% CI: 0.628-10.0%;
= 0.27) indicating comparable results.
DSA overlooks clinically important residual stenosis that could be treated during the primary procedure. CBCT aids structural assessment of the stent and allows for on-table optimizing of the procedural outcomes.
Journal Article
Frequency and Effect of Access-Related Vascular Injury and Subsequent Vascular Intervention After Transcatheter Aortic Valve Replacement
by
Kofoed, Klaus F.
,
Schroeder, Torben V.
,
Taudorf, Mikkel
in
Aged
,
Aged, 80 and over
,
Angioplasty, Balloon - utilization
2016
Vascular access and closure remain a challenge in transcatheter aortic valve replacement (TAVR). This single-center study aimed to report the incidence, predictive factors, and clinical outcomes of access-related vascular injury and subsequent vascular intervention. During a 30-month period, 365 patients underwent TAVR and 333 patients (94%) were treated by true percutaneous transfemoral approach. Of this latter group, 83 patients (25%) had an access-related vascular injury that was managed by the use of a covered self-expanding stent (n = 49), balloon angioplasty (n = 33), or by surgical intervention (n = 1). In 16 patients (5%), the vascular injury was classified as a major vascular complication. Absence of a preprocedural computed tomography angiography (CTA) of the iliofemoral arteries (OR 2.04, p = 0.007) and female gender (OR 2.18, p = 0.004) were independent predictors of the need for access-related vascular intervention. In addition, a high sheath/common femoral artery ratio as measured on preoperative CTA was associated with a higher rate of post-TAVR vascular intervention. The radiation dose, iodine contrast volume, transfusion need, length of hospitalization, and 30-day mortality were not significantly different between patients with versus without access-related vascular intervention. In conclusion, access-related vascular intervention in patients who underwent transfemoral-TAVR is not uncommon. Female gender and a high sheath/common femoral artery ratio are risk factors for access-related vascular injury, whereas preprocedural planning with CTA of the access vessels may reduce the risk of vascular injury. Importantly, most access-related vascular injuries may be treated by percutaneous techniques with similar clinical outcomes to patients without vascular injuries.
Journal Article
Simulation-Based Virtual-Reality Patient-Specific Rehearsal Prior to Endovascular Procedures: A Systematic Review
by
Nielsen, Caroline Albrecht-Beste
,
Konge, Lars
,
Taudorf, Mikkel
in
assessment
,
Aviation
,
Carotid arteries
2020
Patient-specific rehearsal (PsR) is a new concept whereby a procedure can be rehearsed virtually using the exact patient’s anatomical data prior to performing the real procedure. The aim of this study was to ascertain if endovascular virtual-reality PsR simulation enhanced performance in real life. This was done by performing a systematic review following the preferred reporting items for systematic reviews and meta-analysis (PRISMA) guidelines. A literature search was conducted in PubMed, Embase, The Cochrane Library and Web of Science concerning PsR in endovascular procedures. All publications were handled using Covidence. Reference lists were also screened. Data extracted from the studies were realism rating, procedure time, fluoroscopy time, contrast volume, number of angiograms and reduction of errors. Kirkpatrick’s four-level model for measuring the efficiency of training was used for guidance of the relevance of studies. The search yielded 1155 results after the exclusion of duplicates, and 11 studies were included. Four studies had a control group, including one randomized trial; the remaining seven were feasibility studies. The realism was rated high, and overall, the studies showed improvements in procedure time, fluoroscopy time and contrast volume after PsR. One study assessed and confirmed the reduction in errors after PsR. Only two studies included more than 15 patients in their cohort. Kirkpatrick’s model was applied to all studies, with one study reaching level 4. All studies found the concept of PsR to be feasible and realistic. The studies with a control group showed a reduction of overall procedure time, radiation exposure and potential errors in endovascular procedures following PsR.
Journal Article
Postembolization Syndrome after Prostatic Artery Embolization: A Systematic Review
by
Røder, Martin Andreas
,
Svarc, Petra
,
Nielsen, Michael Bachmann
in
benign prostatic hyperplasia
,
Bias
,
Embolization
2020
Postembolization syndrome (PES) is the most common side effect of vascular embolization of solid organs. The aim of this review was to determine the incidence of PES and its individual components after prostatic artery embolization (PAE). A systematic review with a pre-specified search strategy for PubMed, Embase, Web of Science and Cochrane Library was performed according to PRISMA guidelines. Studies in English regarding PAE in humans with 10 or more participants were eligible for inclusion. No restrictions on participant demographics or PAE technique were imposed. The search returned 378 references, of which 32 studies with a total of 2116 patients met the inclusion criteria. The results for overall PES frequency and individual PES components were presented as median (interquartile range, (IQR)). Overall median PES frequency was 25.5% (12.5–45.8). The two most frequent individual PES components were dysuria/urethral burning and local pain, with a median frequency of 21.7% (13.8–33.3) and 20% (5.4–29.4), respectively. Most outcome measures were characterized by a marked lack of uniformity and inconsistency in reporting across studies. Development of a uniform reporting system would help the clinicians recognize and treat PES accordingly.
Journal Article
Transarterial Embolization of Geniculate Arteries Reduces Pain and Improves Physical Function in Knee Osteoarthritis—A Prospective Cohort Study
by
Nielsen, Michael B.
,
Taudorf, Mikkel
,
Petersen, Michael M.
in
Analgesics
,
Arthritis
,
Care and treatment
2024
Knee osteoarthritis (OA) affects millions worldwide, leading to pain and reduced quality of life. Conventional treatments often fail to provide adequate relief, necessitating new therapeutic approaches. This study evaluated the efficacy and safety of genicular artery embolization (GAE) using permanent microspheres in patients with mild-to-moderate knee OA. In this prospective, single-center study, 17 participants underwent GAE. KOOS (Knee injury and Osteoarthritis Outcome Score), WOMAC (The Western Ontario and McMaster Universities Arthritis Index), and IPAQ (International Physical Activity Questionnaire) scores, along with physical performance tests, medication use, and dual-energy X-ray absorptiometry (DEXA) scans, were assessed at baseline and at multiple follow-up points over six months. The primary endpoint, VAS at six months, showed significant improvement (median reduction from 66 mm to 40 mm, p = 0.0004). All pain and function scores, as well as physical performance tests, improved significantly. No clinically relevant changes in medication use or DEXA parameters were observed after six months. Only minor, self-limiting adverse events occurred. This study indicates that GAE is a promising minimally invasive treatment for knee OA, providing significant pain relief and functional improvement. However, further long-term, randomized trials are needed to confirm these findings and establish optimal patient selection criteria.
Journal Article