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1.
Int J Gen Med ; 17: 3689-3698, 2024.
Article in English | MEDLINE | ID: mdl-39219671

ABSTRACT

Objective: The research was carried out to determine and compare the efficiency of completely transradial access (cTRA) and transfemoral access (TFA) in retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Background: The cases of retrograde chronic total occlusion (CTO) percutaneous coronary intervention usually need the dual access. The transradial method is now used more frequently in CTO PCI, and improves the safety of CTO PCI. Methods: This retrospective, observational study was carried out in a single center. Participants were patients who underwent dual-access retrograde CTO PCI from January 2017 to October 2023, categorized into two groups: cTRA (biradial access) and TFA (bifemoral, or combined radial and femoral access). All patients in the cTRA group received conventional radial access. All punctures of the femoral artery were performed without fluoroscopic or ultrasound guidance. None of the patients in the TFA group accepted any arterial closure devices. Clinical, angiographic and procedural characteristics and the occurrence of in-hospital major adverse cardiovascular events (MACE) of the cTRA and TFA procedures were recorded. Results: This research involved 187 CTO PCI procedures with dual access, of which 88 were done using cTRA and the rest (99) were carried out through TFA. The J-CTO (Multicenter Chronic Total Occlusion Registry of Japan) score was lower in the cTRA group than TFA group (2.1± 0.6 vs 3.0± 0.8; P <0.001). The technical success (84.1% vs 82.8%; P= 0.817), procedural success (80.7% vs 79.8%; P= 0.906) and in-hospital MACE rates (5.7% vs 4.0%; P= 0.510) were the same for both groups. For a J-CTO score of 3 or higher, technical success rate was significantly lower in the cTRA group than the TFA group (58.1% vs 74.2%; P < 0.001). Conclusion: In the retrograde CTO PCI, the percentages of success and in-hospital MACE were similar for both cTRA and TFA. Meanwhile, cTRA may be used for simpler lesions (J-CTO score < 3) as compared to TFA.

2.
Clin Neurol Neurosurg ; 246: 108525, 2024 Sep 02.
Article in English | MEDLINE | ID: mdl-39241693

ABSTRACT

BACKGROUND: Transradial approach (TRA) has been increasingly utilized in various neuroendovascular interventions as a safe alternative to the transfemoral approach (TFA). As middle meningeal artery (MMA) embolization emerges as an effective therapy for treating chronic subdural hematomas (cSDH), some studies have explored using TRA. In this study, we compared procedural times and post-operative outcomes between those with TRA and TFA. METHODS: This is a single-institution retrospective study of patients undergoing MMA embolization for cSDH. The cohort was divided into the TRA and TFA subgroups. Baseline characteristics, procedural times, and immediate outcomes were compared. Univariate analysis was performed. RESULTS: We performed 62 MMA embolizations for treatment of cSDH, of which 37 (59.7 %) were performed transradial and 25 (40.3 %) were performed transfemoral. Those who underwent TRA were significantly younger than those who had TFA (p = 0.02). For patients who underwent unilateral MMA embolization, those with TRA had significantly shorter duration of procedure compared to the TRF group (p = 0.01). This difference was not observed in the bilateral MMA embolization subgroup. Only three patients had access site complications, and all were in the TFA group. There was no significant difference in length of hospital stay. CONCLUSION: As MMA embolization for cSDH becomes more prevalent, efforts to optimize the safety and efficacy of the technical aspects become critical. In this study we demonstrate that TRA is a safe and efficient alternative to traditional TFA in those undergoing unilateral MMA embolization.

3.
Egypt Heart J ; 76(1): 119, 2024 Sep 06.
Article in English | MEDLINE | ID: mdl-39240500

ABSTRACT

BACKGROUND: Cardiac catheterization via the transfemoral approach can be associated with access site bleeding complications such as inguinal hematoma, pseudoaneurysm, arteriovenous fistula and retroperitoneal hematoma. Scrotal hematoma is a rare presentation of bleeding complications after transfemoral cardiac catheterization. We report a case of this rare complication. CASE PRESENTATION: A 63-year-old male with previous coronary artery bypass surgery underwent percutaneous coronary intervention via transfemoral approach. Few hours after removal of the femoral sheath, he developed a big scrotal hematoma and hemodynamic deterioration. The patient responded successfully to conservative treatment and discharged from hospital after three days in a stable condition. CONCLUSIONS: Bleeding complications after transfemoral cardiac catheterization can rarely present as scrotal hematoma. The management of this complication is usually conservative, and only few cases may require surgical treatment.

4.
Arthroplast Today ; 28: 101463, 2024 Aug.
Article in English | MEDLINE | ID: mdl-39100422

ABSTRACT

Background: Some amputees with transfemoral osseointegration (TFOI) have ipsilateral hip arthritis which can be addressed with total hip arthroplasty (THA). This study reported the medium-term outcomes of THA in association with TFOI (THA + TFOI). Methods: Retrospective review was performed for eight patients with THA + TFOI performed at least 2 years prior. Primary outcomes include complications prompting surgical intervention. Secondary outcomes include changes in mobility (K-level, 6-minute walk test [6MWT], timed up and go) and patient-reported measures (hip pain, daily prosthesis wear hours, Questionnaire for Persons with a Transfemoral Amputation, and Short Form 36 [SF36]). Results: One patient died after 11 months (cancer); he was included to maximally report complications but excluded from mobility and reported outcomes. Three patients required subsequent surgeries: Two had skin refashioning, and the other underwent hip debridement of the replaced joint with subsequent removal of the TFOI. No perioperative complications, fractures, or arthroplasty explantations occurred. All patients reported complete hip pain relief. Of 6 patients reporting prosthesis wear time, 2 (33%) wore their prosthetic leg at least 4 hours daily before, vs all (100%) who did afterward (P = .061). K-levels improved in all responding patients. All 5 wheelchair-bound patients achieved and maintained ambulation. The Questionnaire for Persons with a Transfemoral Amputation and Short Form 36 did not significantly change. Conclusions: THA + TFOI does not appear to pose an inevitable risk for prosthetic hip infection and may improve mobility and enhance quality of life (QOL) for transfemoral amputees with concurrent arthritic hip pain who are dissatisfied with their outcome following traditional socket prosthesis rehabilitation.

5.
J Clin Med ; 13(15)2024 Jul 30.
Article in English | MEDLINE | ID: mdl-39124736

ABSTRACT

Background: The transfemoral (TF) approach is the most common route in TAVI, but it is still associated with a risk of bleeding and vascular complications. The aim of this study was to compare the clinical outcomes between surgical cut-down (SC) and percutaneous (PC) approach. (2) Methods: Between January 2018 and June 2022, 774 patients underwent a transfemoral TAVI procedure. After propensity matching, 323 patients underwent TAVI in each group. (3) Results: In the matched population, 15 patients (4.6%) in the SC group vs. 34 patients in the PC group (11%) experienced minor vascular complications (p = 0.02), while no difference for major vascular complication (1.5% vs. 1.9%) were reported. The rate of minor bleeding events was higher in the percutaneous group (11% vs. 3.1%, p <.001). The SC group experienced a higher rate of non-vascular-related access complications (minor 8% vs. 1.2%; major 2.2% vs. 1.2%; p < 0.001). (4) Conclusions: SC for TF-TAVI did not alter the mortality rate at 30 days and was associated with reduced minor vascular complication and bleeding. PC showed a lower rate of non-vascular-related access complications and a lower length of stay. The specific approach should be tailored to the patient's clinical characteristics.

6.
Article in English | MEDLINE | ID: mdl-39111535

ABSTRACT

OBJECTIVE: This systematic review and meta-analysis aimed to evaluate the safety and feasibility of transradial access for peripheral vascular interventions. DATA SOURCES: MEDLINE and Embase. REVIEW METHODS: MEDLINE and Embase databases were searched to June 2023 to identify studies investigating the outcomes of peripheral vascular interventions in lower extremity, carotid, and visceral arteries via transradial vs. transfemoral access. The primary outcome was procedural failure rate. Secondary outcomes were total access site complications, minor and major bleeding, stroke, access vessel occlusion, procedural time, fluoroscopy time, and contrast volume. RESULTS: Eight randomised controlled trials and 29 observational studies yielded a total of 70 882 patients treated via transradial (n = 2 616) vs. transfemoral access (n = 68 338). The overall failure rate was 2.3 ± 0.7%, and the transradial approach was associated with a statistically significantly higher procedural failure rate than the transfemoral approach (3.9 ± 0.7% vs. 1.0 ± 0.3%; odds ratio [OR] 3.07, 95% confidence interval [CI] 1.84 - 5.12; I2 = 32%; p < .001). Subgroup analysis showed the highest failure rate in lower extremity interventions with 12.4 ± 4.9% for transradial vs. 4.0 ± 1.2% for transfemoral access. Conversely, procedural complications were statistically significantly fewer with transradial access for total access site complications (OR 0.64, 95% CI 0.45 - 0.91; I2 = 36%; p = .010). Minor bleeding was statistically significantly less with the transradial approach (OR 0.52, 95% CI 0.31 - 0.86; I2 = 30%; p = .010), whereas major bleeding and stroke rates were similar. Transradial access had more access vessel occlusion than transfemoral access (1.9% ± 0.5% vs. < 0.1% ± 0.0%; p = .004), although most remained asymptomatic. Procedural time, fluoroscopy time, and contrast volume were all comparable. GRADE certainty was low to moderate in most outcomes. CONCLUSION: The transradial approach was associated with a higher procedural failure rate. Total access site complications and minor bleeding were lower with the transradial approach, albeit with more frequent access vessel occlusion. Transradial access may be a feasible and safe approach; however, appropriate patient selection is imperative.

7.
J Vasc Surg ; 2024 Aug 21.
Article in English | MEDLINE | ID: mdl-39179005

ABSTRACT

BACKGROUND: Preoperative anemia is associated with worse postoperative morbidity and mortality following major vascular procedures. Limited research has examined the optimal method of carotid revascularization in anemic patients. Therefore, we aim to compare the postoperative outcomes following carotid endarterectomy (CEA), transfemoral carotid artery stenting (TFCAS), and transcarotid artery revascularization (TCAR) among anemic patients. STUDY DESIGN: This is a retrospective review of anemic patients undergoing CEA, TFCAS, and TCAR in the Vascular Quality Initiative database between 2016-2023. We defined anemia as a preoperative hemoglobin level of <13 g/dL in men and <12 g/dL in women. The primary outcomes were 30-day mortality and in-hospital major adverse cardiac events (MACE). Logistic regression models were used for multivariate analyses. RESULTS: Our study included 40,383 (59.3%) CEA, 9,159 (13.5%) TFCAS, and 18,555 (27.3%) TCAR cases in anemic patients. TCAR patients were older and had more medical comorbidities than CEA and TFCAS patients. TCAR was associated with decreased 30-day mortality (aOR=0.45,95%CI:0.37-0.59],P<0.001), in-hospital MACE (aOR=0.58,95%CI:0.46-0.75,P<0.001) compared to TFCAS. Additionally, TCAR was associated with 20% reduction in the risk of 30-day mortality (aOR=0.80,95%CI:0.65-0.98,P=0.03), and similar risk of in-hospital MACE (aOR=0.86,95%CI:0.77-1.01, P=0.07) compared to CEA. Furthermore, TFCAS was associated with an increased risk of 30-day mortality (aOR= 2,95%CI: 1.5-2.68,P<0.001), in-hospital MACE (aOR=1.7,95% CI:1.4-2,P<0.001) compared to CEA. CONCLUSIONS: In this multi-institutional national retrospective analysis of a prospectively collected database, TFCAS is associated with a high risk of 30-day mortality and in-hospital MACE compared to CEA and TCAR in anemic patients. TCAR was associated with lower risk of 30-day mortality compared to CEA. These findings suggest TCAR as the optimal minimally invasive procedure for carotid revascularization in anemic patients.

8.
J Biomed Phys Eng ; 14(4): 397-406, 2024 Aug.
Article in English | MEDLINE | ID: mdl-39175560

ABSTRACT

Background: The knee joint must adapt to the changes in walking speed to stabilize the stance phase and provide fluency in the swing phase. Objective: This study aimed to report a comparison of the gait patterns of transfemoral amputees using a novel mechanical prosthetic knee that can adapt automatically to different walking speeds with 3R60 and 3R15 knee prostheses. Material and Methods: In this experimental study, biomechanical data were collected from six unilateral trans-femoral amputees walking with three knee prostheses. Gait data were gathered at slow, normal, and fast walking speeds across a 7-meter walkway using the Vicon motion system. Results: The results revealed a significant difference in knee angular velocity during the swing phase between prosthetic knees across three walking speeds (P-value=0.002). Prosthetic knee flexion decreased significantly by increasing walking speed for the novel mechanical auto-adaptive prosthetic knee (P-value<0.001). A lower value of hip power during early swing was considered when amputees walked with novel knee prosthesis (P-value<0.00). The intact leg ankle plantar flexion angle or vaulting did not significantly change while walking speed increased in the novel knee prostheses compared to walking with the 3R60 and 3R15 knee prostheses (P-value=0.002 and P-value<0.06, respectively). Conclusion: Based on the results, a novel mechanical auto-adaptive knee prosthesis has advantages compared to the other conventional designs for unilateral trans-femoral amputees walking at different speeds.

9.
JACC Cardiovasc Interv ; 17(16): 1891-1901, 2024 Aug 26.
Article in English | MEDLINE | ID: mdl-39197987

ABSTRACT

BACKGROUND: The introduction of radial-specific equipment has made transradial (TR) aortoiliac (AI) endovascular therapy (EVT) more convenient. OBJECTIVES: The authors aimed to investigate the perioperative outcomes of the TR approach in patients undergoing AI EVT for symptomatic peripheral artery disease. METHODS: The COMFORT (Contemporary Strategy for Aortoiliac Intervention) registry was a prospective, multicenter, observational study enrolling patients with symptomatic peripheral artery disease undergoing AI EVT between January 2021 and June 2023. The primary outcome was perioperative complications, whereas the secondary outcomes included core laboratory-evaluated residual stenosis >30%, time to hemostasis, time to ambulation, 30-day patency, and 30-day limb symptoms. These outcomes were compared between TR and non-TR AI EVT after propensity score matching. RESULTS: The TR approach was selected for 231 of the 947 patients (24.3%). The TR approach was chosen more in patients with a higher ankle-brachial index, chronic total occlusion, aortic lesion, bare nitinol stent implantation, and plain angioplasty, whereas it was chosen less in patients with dialysis, a history of AI EVT, chronic limb-threatening ischemia, bilateral calcification, and simultaneous infrainguinal EVT (all P < 0.05). After propensity score matching, the incidence of perioperative complications did not differ significantly between the groups (TR group: 6.0% vs non-TR group: 5.1%; P = 0.69). The proportions of residual stenosis, 30-day patency, and 30-day limb symptoms were not significantly different (all P > 0.05); however, the time to hemostasis and the time to ambulation were shorter in the TR group (both P < 0.05). CONCLUSIONS: Non-TR AI EVT and TR AI EVT using radial-specific equipment were associated with a similar risk of perioperative complications. The TR approach helps shorten the time required for hemostasis and ambulation.


Subject(s)
Endovascular Procedures , Iliac Artery , Peripheral Arterial Disease , Radial Artery , Registries , Vascular Patency , Humans , Female , Male , Aged , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Prospective Studies , Radial Artery/physiopathology , Treatment Outcome , Time Factors , Iliac Artery/diagnostic imaging , Iliac Artery/physiopathology , Iliac Artery/surgery , Middle Aged , Peripheral Arterial Disease/therapy , Peripheral Arterial Disease/physiopathology , Peripheral Arterial Disease/diagnostic imaging , Risk Factors , Risk Assessment , Aged, 80 and over , Catheterization, Peripheral/adverse effects , Stents , Punctures
10.
J Am Heart Assoc ; 13(17): e035425, 2024 Sep 03.
Article in English | MEDLINE | ID: mdl-39189482

ABSTRACT

BACKGROUND: Transfemoral carotid artery stenting (TFCAS) carries important perioperative risks. Outcome prediction tools may help guide clinical decision-making but remain limited. We developed machine learning algorithms that predict 1-year stroke or death following TFCAS. METHODS AND RESULTS: The VQI (Vascular Quality Initiative) database was used to identify patients who underwent TFCAS for carotid artery stenosis between 2005 and 2024. We identified 112 features from the index hospitalization (82 preoperative [demographic/clinical], 13 intraoperative [procedural], and 17 postoperative [in-hospital course/complications]). The primary outcome was 1-year postprocedural stroke or death. The data were divided into training (70%) and test (30%) sets. Six machine learning models were trained using preoperative features with 10-fold cross-validation. The primary model evaluation metric was area under the receiver operating characteristic curve. The algorithm with the best performance was further trained using intra- and postoperative features. Model robustness was assessed using calibration plots and Brier scores. Overall, 35 214 patients underwent TFCAS during the study period and 3257 (9.2%) developed 1-year stroke or death. The best preoperative prediction model was extreme gradient boosting, achieving an area under the receiver operating characteristic curve of 0.94 (95% CI, 0.93-0.95). In comparison, logistic regression had an AUROC of 0.65 (95% CI, 0.63-0.67). The extreme gradient boosting model maintained excellent performance at the intra- and postoperative stages, with area under the receiver operating characteristic curve values of 0.94 (95% CI, 0.93-0.95) and 0.98 (95% CI, 0.97-0.99), respectively. Calibration plots showed good agreement between predicted/observed event probabilities with Brier scores of 0.11 (preoperative), 0.11 (intraoperative), and 0.09 (postoperative). CONCLUSIONS: Machine learning can accurately predict 1-year stroke or death following TFCAS, performing better than logistic regression.


Subject(s)
Carotid Stenosis , Femoral Artery , Machine Learning , Stents , Stroke , Humans , Male , Female , Carotid Stenosis/surgery , Carotid Stenosis/therapy , Aged , Stroke/etiology , Risk Assessment/methods , Treatment Outcome , Risk Factors , Retrospective Studies , Middle Aged , Endovascular Procedures/adverse effects , Endovascular Procedures/methods , Predictive Value of Tests , Aged, 80 and over , Databases, Factual , Time Factors
11.
Unfallchirurgie (Heidelb) ; 127(9): 620-625, 2024 Sep.
Article in German | MEDLINE | ID: mdl-39136752

ABSTRACT

INTRODUCTION: In the evaluation of an internal analysis of data on the increased effort for nursing during rehabilitation of patients with amputations in the Baumrainklinik of the HELIOS Rehabilitation Center Bad Berleberg, the number of patients with transfemoral amputations (TFA) due to uncontrollable multiple infections after implantation of a total knee endoprosthesis (total knee arthroplasty, TKA) was clearly emphasized. OBJECTIVE: This article discusses the results of a retrospective, patient-controlled trial (PCT) and compares these with the data of the German Endoprosthesis Registry (EPRD). The study concentrated on patients who were admitted to rehabilitation after a TFA due to an uncontrollable infection after implantation of a knee TKA. The primary aims were the identification of patients who developed an uncontrollable infection after TKA with subsequent TFA and the comparison with national and international revision and amputation rates after TKA. METHOD: An analysis of the medical history questionnaire was carried out for all 787 patients with amputation of the lower extremities who underwent rehabilitation in the time period from 1st January 2007 to 31st December 2015. The patient records were systematically analyzed based on the standardized documentation methods of the medical and nursing personnel using the Barthel index, the activity/function classes, phantom pain and length of stay, including demography, infection history and insurance company. RESULTS: The analysis showed that 10 patients, 2.29% of all TFA, suffered the loss of a lower extremity due to an uncontrollable TKA infection. The revision rate 3 years after primary TKA in Germany is 3.0% (EPRD annual report 2023), whereas values of 1-4% are given in the international literature (status 2020). In the patient group of the EPRD, in 2022 revision surgery was necessary due to an infection in 15.0% of the cases. The current statistics of the EPRD (annual report 2023) show that 3 years after the initial revision surgery due to an infected TKA another revision was necessary in 23.5-30% of cases. CONCLUSION: These numbers are alarming and should be critically evaluated and monitored. The future aim is to identify the causes of infections, systematic errors in the TKA and the pathogens that lead to infections after TKA and to correlate the associations.


Subject(s)
Amputation, Surgical , Arthroplasty, Replacement, Knee , Prosthesis-Related Infections , Humans , Amputation, Surgical/adverse effects , Arthroplasty, Replacement, Knee/adverse effects , Male , Germany/epidemiology , Aged , Female , Retrospective Studies , Prosthesis-Related Infections/etiology , Middle Aged , Knee Prosthesis/adverse effects , Aged, 80 and over , Reoperation , Registries , Femur/surgery
12.
Eur Heart J Case Rep ; 8(6): ytae300, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38947146

ABSTRACT

Background: Delayed coronary obstruction (DCO) is a rare but potentially life-threatening complication after transcatheter aortic valve implantation (TAVI) mostly affecting the left main coronary artery (LMCA) and often caused by prosthesis endothelialization or thrombus formations. Herein, we report an unusual case of a delayed LMCA-obstruction caused by a calcium nodule, which was diagnosed 4 months after TAVI due to recurrent ventricular tachycardia (VT) episodes. Case summary: A 73-year-old patient was readmitted to an external hospital with syncope three months after TAVI. Fast VT could be induced in electrophysiological examination, why the patient received a two-chamber implantable cardioverter defibrillator (ICD). However, after 1 month the patient was readmitted to our department with another syncope. Implantable cardioverter defibrillator records revealed multiple fast VT episodes (200-220 b.p.m.). In addition, the patient reported new-onset exertional dyspnoea (New York Class Association Stage III) and elevated high-sensitive cardiac troponin of 115 ng/L. Due to the symptoms and laboratory markers indicating potential myocardial ischaemia, a cardiac computed tomography angiography (CCTA) was performed. Cardiac computed tomography angiography revealed obstruction of the LMCA likely caused by calcium shift during TAVI. After CCTA-guided percutaneous coronary intervention, patient's course remained uneventful. Discussion: The present case report highlights the role of CCTA as a powerful non-invasive diagnostic tool in complex settings after TAVI. Delayed coronary obstruction as a procedural complication can occur after TAVI and manifest with various symptoms, including new-onset or recurrent VTs, like in the present case. Cardiac computed tomography angiography provided accurate assessment of the implanted prosthesis and detection of DCO, thus guiding the subsequent PCI.

13.
J Endovasc Ther ; : 15266028241258662, 2024 Jul 24.
Article in English | MEDLINE | ID: mdl-39044646

ABSTRACT

PURPOSE: This trial was designed and aimed to compare safety and efficacy of Obtura™ vascular closure device (VCD) to manual compression (MC) among patients undergoing transfemoral catheterization. MATERIAL AND METHODS: This prospective, randomized, controlled, multicenter trial of Obtura VCD against MC randomized patients in 1:1 (n=268; 134:134) ratio. Safety and efficacy were measured by primary endpoints (time to hemostasis [TTH] and deployment success) and secondary endpoints which included technical success, device-related adverse events, and time to ambulation (TTA). RESULTS: The procedural access using right femoral artery was performed in 95.52% of patients in Obtura VCD versus 96.27% in standard MC method, whereas 2.99% of patients in each group underwent left femoral access. Bilateral access was performed in 1.49% (n=2) versus 0.75% (n=1) in Obtura VCD versus MC, respectively. Both the technical success and deployment success were 100%. Patients in Obtura VCD group had shorter TTH (3.26±3.39 vs 23.95±8.24 minutes; p<0.0001) and TTA (155.44±125.32 vs 723.84±197.98 minutes; p<0.0001) than MC group. No access site complications (re-bleeding, infection, arteriovenous fistula, and transient access site nerve injury) were noted at 2-week, 1-month, and 3-month follow-ups. There were 4 (3%) and 6 (4.5%) cases of hematoma, respectively, in Obtura VCD versus MC and 1 case (0.7%) of post-procedural arterial pseudoaneurysm each in both the groups which were successfully resolved and patients were discharged with no further complications. Further follow-up was without any adverse events. CONCLUSIONS: The study demonstrated favorable safety and efficacy of Obtura™ VCD with a significantly short TTH and TTA compared to MC. CLINICAL IMPACT: In patients undergoing cardiac catheterization, vascular closure devices (VCDs) can achieve hemostasis faster after successful implantation of the device with fewer complications such as bleeding and ambulation can be achieved faster. In terms of effectiveness, Obtura VCD was found to be better than manual compression in achieving early hemostasis and higher technical and deployment success was accomplished. Obtura VCD does not require enlargement of the route through the tissues, uses the same existing arterial sheath as its conduit, and does not cause patients' access sites to feel uncomfortable while it is being deployed.

14.
Ann Biomed Eng ; 2024 Jul 08.
Article in English | MEDLINE | ID: mdl-38977531

ABSTRACT

Evaluating the bone-implant interface (BII) properties of osseointegrated transfemoral (TFA) implants is important for early failure detection and prescribing loads during rehabilitation. The objective of this work is to derive and validate a 1D finite element (FE) model of the Osseointegrated Prosthetic Limb (OPL) TFA system that can: (1) model its dynamic behaviour and (2) extract the BII properties. The model was validated by: (1) comparing the 1D FE formulation to the analytical and 3D FE solutions for a simplified cylinder, (2) comparing the vibration modes of the actual TFA geometry using 1D and 3D FE models, and (3) evaluating the BII properties for three extreme conditions (LOW, INTERMEDIATE, and HIGH) generated using 3D FE and experimental (where the implant was embedded, using different adhesives, in synthetic femurs) signals for additional validation. The modes predicted by the 1D FE model converged to the analytical and the 3D FE solutions for the cylinder. The 1D model also matched the 3D FE solution with a maximum frequency difference of 2.02% for the TFA geometry. Finally, the 1D model extracted the BII stiffness and the system's damping properties for the three conditions generated using the 3D FE simulations and the experimental INTERMEDIATE and HIGH signals. The agreement between the 1D FE and the 3D FE solutions for the TFA geometry indicates that the 1D model captures the system's dynamic behaviour. Distinguishing between the different BII conditions demonstrates the 1D model's potential use for the non-invasive clinical evaluation of the TFA BII properties.

15.
J Invasive Cardiol ; 2024 07 18.
Article in English | MEDLINE | ID: mdl-39052515

ABSTRACT

Objectives: Calcific peripheral artery disease (PAD) is a common finding in patients scheduled for transcatheter aortic valve implantation (TAVI) and often requires iliofemoral axis preparation. However, evidence about the use of intravascular lithotripsy (IVL) in this setting is scarce. The aim of this study was to describe in-hospital and mid-term outcomes of IVL-assisted transfemoral (TF)-TAVI in patients with severe calcific PAD. Methods: The study included 13 patients with severe calcified PAD who were initially scheduled for balloon angioplasty (PTA)-assisted TF-TAVI but were eventually treated with peripheral IVL between October 2020 and February 2024. Accurate analysis of preoperative computed tomography scans revealed difficult TF access routes (severe calcified PAD with minimal lumen diameter ≤ 4.5 mm, circumferential calcification along iliofemoral axis, and marked vessels tortuosity). Results: In all cases, IVL was performed after PTA failure and allowed successful valve delivery. One patient had procedural bleeding (BARC-3a). The valve was successfully delivered without complications in 12 patients (92.3%), and no major adverse events were reported at the longest follow-up (median 18.5 months). Conclusions: IVL-assisted TF-TAVI may represent a feasible and safe option for patients presenting with severe aortic stenosis and severe calcified PAD. However, standardization of the access site severity as well as indications for a planned up-front IVL-assisted strategy are missing and require dedicated studies.

16.
Rev Cardiovasc Med ; 25(5): 152, 2024 May.
Article in English | MEDLINE | ID: mdl-39076463

ABSTRACT

Background: Early mobilization is one of the essential components of enhanced recovery after surgery (ERAS) pathways and has been shown to reduce complications and optimize patient outcomes. However, the effect of early mobilization for patients who undergo trans-femoral cardiac catheterization and the time for optimal mobilization timing remains controversial. We aimed to identify the safety of early mobilization and provide the optimum timing for early mobilization for patients undergoing trans-femoral cardiac catheterization. Methods: We searched MEDLINE, EMBASE, PubMed, Web of Science, Cochrane databases of systematic reviews, CINAHL, SCOPUS, China National Knowledge Infrastructure (CNKI), Wan Fang Database, and Chinese Science and Technology Periodical Database (VIP) comprehensively for randomized controlled trials associated with early mobilization, to explore its effects on patients after a trans-femoral cardiac catheterization. The risk of bias and heterogeneity of studies was assessed using the Revised Cochrane risk-of-bias tool for randomized trials (RoB 2) and I 2 index, respectively. The comprehensive Meta-analysis (CMA) was adopted to perform the meta-analysis. Results: We identified 14 trials with 2653 participants. Early mobilization was associated with significant decrease in back pain (mean difference (MD) = 0.634, 95% CI: 0.23-1.038; p = 0.002), especially in patients receiving instruction for early mobilization in 3 h~4 h versus 5 h~6 h (MD = 0.737, 95% CI: 0.431-1.043; p = 0.000) and 12 h versus 24 h (OR = 5.504, 95% CI: 1.646-18.407; p = 0.006) categories. The results of subgroup analysis also showed a significant risk reduction in urinary retention by early mobilization in 12 h versus 24 h (OR = 5.707, 95% CI: 1.859-17.521; p = 0.002) category. Conclusions: Early mobilization has not been shown to increase the risk of bleeding, hematoma, pseudoaneurysm, urinary retention, and pain at the puncture site after trans-femoral cardiac catheterization. Early mobilization is a practical initiative in ERAS, and it may be safe and feasible to advance the mobilization to 2 h~4 h.

17.
J Neuroeng Rehabil ; 21(1): 128, 2024 Jul 31.
Article in English | MEDLINE | ID: mdl-39085954

ABSTRACT

BACKGROUND: Systems that capture motion under laboratory conditions limit validity in real-world environments. Mobile motion capture solutions such as Inertial Measurement Units (IMUs) can progress our understanding of "real" human movement. IMU data must be validated in each application to interpret with clinical applicability; this is particularly true for diverse populations. Our IMU analysis method builds on the OpenSim IMU Inverse Kinematics toolkit integrating the Versatile Quaternion-based Filter and incorporates realistic constraints to the underlying biomechanical model. We validate our processing method against the reference standard optical motion capture in a case report with participants with transfemoral amputation fitted with a Percutaneous Osseointegrated Implant (POI) and without amputation walking over level ground. We hypothesis that by using this novel pipeline, we can validate IMU motion capture data, to a clinically acceptable degree. RESULTS: Average RMSE (across all joints) between the two systems from the participant with a unilateral transfemoral amputation (TFA) on the amputated and the intact sides were 2.35° (IQR = 1.45°) and 3.59° (IQR = 2.00°) respectively. Equivalent results in the non-amputated participant were 2.26° (IQR = 1.08°). Joint level average RMSE between the two systems from the TFA ranged from 1.66° to 3.82° and from 1.21° to 5.46° in the non-amputated participant. In plane average RMSE between the two systems from the TFA ranged from 2.17° (coronal) to 3.91° (sagittal) and from 1.96° (transverse) to 2.32° (sagittal) in the non-amputated participant. Coefficients of Multiple Correlation (CMC) results between the two systems in the TFA ranged from 0.74 to > 0.99 and from 0.72 to > 0.99 in the non-amputated participant and resulted in 'excellent' similarity in each data set average, in every plane and at all joint levels. Normalized RMSE between the two systems from the TFA ranged from 3.40% (knee level) to 54.54% (pelvis level) and from 2.18% to 36.01% in the non-amputated participant. CONCLUSIONS: We offer a modular processing pipeline that enables the addition of extra layers, facilitates changes to the underlying biomechanical model, and can accept raw IMU data from any vendor. We successfully validate the pipeline using data, for the first time, from a TFA participant using a POI and have proved our hypothesis.


Subject(s)
Amputation, Surgical , Artificial Limbs , Humans , Biomechanical Phenomena , Amputation, Surgical/rehabilitation , Femur/surgery , Osseointegration/physiology , Male , Proof of Concept Study , Amputees/rehabilitation , Walking/physiology , Adult , Bone-Anchored Prosthesis
18.
JACC Cardiovasc Interv ; 17(14): 1680-1690, 2024 Jul 22.
Article in English | MEDLINE | ID: mdl-39048255

ABSTRACT

BACKGROUND: Thromboembolic events, particularly strokes, remain a major complication of transcatheter aortic valve replacement (TAVR). Embolic protection devices have failed to show significant clinical benefit in large randomized clinical trials. Aortic wall thrombus (AWT) is often observed on multidetector computed tomography during TAVR work-up, but its prognostic significance is uncertain. OBJECTIVES: This study sought to evaluate the association between the presence of AWT and the incidence of thromboembolic outcomes in patients undergoing transfemoral (TF) TAVR for severe aortic stenosis. METHODS: This was a prospective cohort study of consecutive patients who underwent TF TAVR for severe aortic stenosis between January 2011 and April 2022. A dedicated scale (range: 0-10) was qualitatively used to assess AWT. The primary outcome was a composite of procedural thromboembolic events defined as ischemic stroke, blue toe syndrome, bowel ischemia, or other solid organ infarction. The secondary endpoints were ischemic strokes and procedural death. RESULTS: Of the 641 patients included, severe AWT (score ≥8) was identified in 73 (11.4%). The presence of severe AWT was strongly associated with an increase in the primary outcome (OR: 8.48; 95% CI: 3.36-21.40; P < 0.001). This relationship persisted following multivariable analysis, which adjusted for comorbidities and procedural characteristics. The presence of severe AWT was also found to be associated with an increased incidence of stroke and procedural death (OR: 5.66; 95% CI: 2.00-15.30; P = 0.002 and OR: 4.66; 95% CI: 1.80-11.30; P = 0.002, respectively). CONCLUSIONS: The presence of severe AWT on preprocedural multidetector computed tomography is strongly associated with thromboembolic complications including stroke and mortality after TF TAVR.


Subject(s)
Aortic Valve Stenosis , Femoral Artery , Severity of Illness Index , Thromboembolism , Thrombosis , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Transcatheter Aortic Valve Replacement/instrumentation , Female , Male , Aged, 80 and over , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Prospective Studies , Risk Factors , Aged , Femoral Artery/diagnostic imaging , Thrombosis/diagnostic imaging , Thrombosis/etiology , Thrombosis/mortality , Thrombosis/epidemiology , Treatment Outcome , Thromboembolism/etiology , Thromboembolism/diagnostic imaging , Thromboembolism/mortality , Thromboembolism/prevention & control , Incidence , Risk Assessment , Time Factors , Aortic Valve/surgery , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Multidetector Computed Tomography , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/mortality , Aortic Diseases/diagnostic imaging , Aortic Diseases/mortality , Punctures
19.
Vasa ; 2024 Jul 17.
Article in English | MEDLINE | ID: mdl-39017671

ABSTRACT

Background: Bifemoral arterial access is common in patients undergoing transcatheter aortic valve implantation (TAVI), with a primary treatment access (TAVI access) and a secondary non-TAVI access. Pseudoaneurysm (PSA) is an important complication of femoral arterial puncture. Major vascular complications after TAVI are well described, but little is known about PSA. Patients and methods: A total of 2063 patients underwent transfemoral TAVI between January 2014 and January 2020. Vascular ultrasound of the common femoral artery was assessed before and after TAVI. We compared patient characteristics, periprocedural risk scores, procedural characteristics, and access site bleeding events according to Valve Academic Research Consortium 3 (VARC-3) criteria, length of stay (LOS), and all-cause mortality at one year between patients with (46) and without (2017) PSA. Results: The incidence of PSA after TAVI was 2.2% (46/2063). All PSA were successfully treated with ultrasound-guided manual compression (UGMC) or thrombin injection (UGTI) without complications. Patients with PSA had lower platelet counts (210×1000/µl vs. 234×1000/µl; p<0.05), more heart failure symptoms on admission (91% vs. 25%; p<0.05), were more often treated with (N)OACs for atrial fibrillation (AF; 54% vs. 38%; p <0.05), and were less often treated with aspirin (35% vs. 51%; p<0.03). Multivariate analysis identified secondary access site (odds ratio [OR] 8.11; p<0.001) and (N)OAC therapy (OR 1.31; p = 0.037) as risk factors for PSA development. PSA is associated with VARC-3 type 1-3 access site bleeding and longer LOS (15.2 ± 11.3 d vs. 11.6 ± 8.9 d; p<0.01), but this did not affect one year mortality (17% vs. 14%; p = 0.53). Conclusions: Pseudoaneurysms are an important complication after TAVI and are associated with access site bleeding and prolonged hospital stay. (N)OAC therapy and secondary access are important risk factors. Pseudoaneurysms can be safely and effectively treated with thrombin injection and do not affect one-year mortality.

20.
Wideochir Inne Tech Maloinwazyjne ; 19(1): 107-112, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38974759

ABSTRACT

Introduction: The relationship between different puncture points and perioperative complications and length of stay in hospital (LOS) in SCCAG patients has rarely been reported. Aim: To compare the curative effect and safety of the transradial artery approach and the transfemoral artery approach in combined heart-brain angiography. Material and methods: 120 patients who received combined cardio-cerebral angiography in our hospital were selected and divided into a transradial artery approach group (TRA) and a transfemoral artery approach group (TFA) according to a random number table. The postoperative efficacy and safety of the 2 groups were compared. Results: There was no statistically significant difference in puncture time and operation time between the 2 groups (p > 0.05). Postoperative bed rest time, hospitalization time, and X-ray exposure time in the TRA group were shorter than those in the TFA group, and the difference was statistically significant (p < 0.05). Before operation and 3 days after operation, there was no significant difference in left ventricle ejection fraction between the 2 groups (p > 0. 05). The overall incidence of complications in the TFA group was higher than that in the TRA group. The incidence between haematoma and pseudoaneurysm in the TFA group was higher, and the difference was statistically significant (p < 0.05). Conclusions: For simultaneous heart-brain angiography, interventional therapy via radial artery and femoral artery has good curative effect and can improve cardiac function. However, interventional therapy through the radial artery can shorten the postoperative bed rest time and hospitalization time, and reduce the incidence of complications.

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