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Instruments | Anxiety | The data collection for this study involved the use of two tools: a demographic information form and the Sarason Anxiety Inventory. The demographic information form included questions related to participants’ age, gender, marital status, residence, and their grade point average from previous semester(s). The Sarason Anxiety Inventory, originally developed by Sarason et al. in 1975 [ | PMC10629063 |
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Interventions | Anxiety, Sarason anxiety, anxiety, pain | One hour before the test, the demographic information form, and the Sarason anxiety inventory were completed by the samples of both groups. The place of auricular acupressure in the experimental group was the Shen Men point. This point is located in the lateral triangular fossa of the auricles [The interventions in this study were conducted by two individuals, a male therapist who was a nursing graduate and a female therapist who was the first author of the study and a medical student. Prior to the study, both therapists received training in acupressure and their competence to perform the intervention was confirmed by an acupuncturist. The training involved seven one-hour face-to-face sessions conducted in the office of the acupuncturist.After obtaining permission from the university, the researchers visited the test location, which was situated in the medical school, to carry out the sampling process. During this visit, the objectives of the study were explained to the students, and those who expressed willingness to participate were included in the study.One hour before the test, both intervention and control groups completed the demographic information form and the Sarason Anxiety Inventory. The intervention group received auricular acupressure at the Shen Men point, which is located in the lateral triangular fossa of the auricles [The selection of the Shen Men point for acupressure was based on several considerations. Firstly, the well-established calming effects of this point in traditional Chinese medicine have been widely recognized. Previous studies have also examined its effectiveness in alleviating pain and anxiety (19, 24). Secondly, the accessibility of the Shen Men point makes it feasible to utilize acupressure in the ear, provided its efficacy is confirmed (24). Furthermore, various acupressure points have been employed in studies focusing on the management of test anxiety (21, 25, 26). Hence, our current study aimed to assess the potential impact of acupressure at the Shen Men point on reducing test anxiety among medical students.
Location of Shen Men and Sham pointsTo perform the intervention, the therapists first washed their hands thoroughly to ensure hygiene. The subjects were then instructed to sit in a chair, adopting a relaxed position. In the intervention group, the therapists applied acupressure to the Shen Men acupoint bilaterally. The technique involved using the index finger to apply circular, gentle, and uniform pressure to the acupoint. The pressure was exerted for a duration of ten minutes.In the control group, the Sham point was pressed in the same manner as the intervention group. Following the intervention, both the intervention and control groups completed the Sarason Anxiety Inventory to assess the effects of the intervention on test anxiety. It should be noted that no dropout occurred in the study (Fig.
The CONSORT diagram of the study | PMC10629063 |
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Data analysis | anxiety | The collected data were subjected to both descriptive and inferential statistical analyses. Descriptive statistics, including mean, standard deviation, frequency, and percentage, were employed to summarize the data. Inferential statistics, on the other hand, involved the use of several statistical tests, namely Chi-square, McNemar, independent t-tests, and paired t-tests. To compare the qualitative variables such as gender and marital status between the study groups, the chi-square test was utilized. For the quantitative variable of age, an independent t-test was employed for between-group comparisons. To assess the intensity of test anxiety before and after the intervention, the chi-square test was used to compare the scores between the two groups. Within each group, McNemar’s test was conducted to compare the anxiety scores before and after the intervention. Furthermore, the paired t-test was utilized to evaluate the mean test anxiety scores before and after the intervention within each group. Lastly, the independent t-test was applied to compare the mean test anxiety scores between the intervention and control groups. All statistical analyses were conducted using SPSS 18 software, with a confidence level set at 95%. | PMC10629063 |
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Ethical considerations | The study with the code R.KUMS.MED.REC.1400.093 received approval from the Ethics Committee of Kermanshah University of Medical Sciences. Additionally, the study was registered and assigned the code IRCT20100913004736N24 in Iran’s clinical trials database at | PMC10629063 |
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Discussion | anxiety | This trial aimed to examine the impact of auricular acupressure on test anxiety among medical students. Consistent with prior research [The findings of the study indicated that Shen Men auricular acupressure had a significant effect in reducing test anxiety. This outcome is consistent with the findings of Lee et al. (2021), where the intervention group received bilateral acupressure at the Shen Men point and the endocrine point, while the control group received a placebo intervention at the Sham point. The results revealed a notable decrease in both test anxiety and state anxiety, although no significant change was observed in trait anxiety [ | PMC10629063 |
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Limitations | anxiety | When applying the results of this study, several limitations should be taken into consideration. Firstly, the mental state of participants during acupressure could have potentially influenced the study outcomes, which was beyond the control of the researcher. Secondly, the study was conducted solely on university students, which may impact the generalizability of the findings to a broader population. Additionally, in this study, therapists of the same gender were utilized for both male and female students, potentially introducing a bias in the results. To address this limitation, both therapists underwent comprehensive training with an acupuncturist. Lastly, it’s important to note that the research findings are solely based on a subjective anxiety scale, as objective assessments were not included in the study. | PMC10629063 |
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Acknowledgements | The authors would like to express thanks to all the students who participated in the study. | PMC10629063 |
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Authors’ contributions | ZM, HK, MJ, SR, and AK contributed to designing the study. ZM collected the data, and the data was analyzed by SR. The final report and manuscript were written by ZM, HK, MJ, SR, and AK. All the authors read and approved the version for submission. | PMC10629063 |
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Funding | This study was funded by the Kermanshah University of Medical Sciences (Grant N0. 50000632). The funding was spent on sampling and conducting the study. | PMC10629063 |
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Data Availability | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10629063 |
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Declarations | PMC10629063 |
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Ethics approval and consent to participate | The study with the code R.KUMS.MED.REC.1400.093 was approved by the Ethics Committee of Kermanshah University of Medical Sciences. Also, the study was registered with the code IRCT20100913004736N24 in Iran’s clinical trials database at Irct.ir (12/01/2022). The objectives of the study were explained to all participants and written informed consent was obtained from all of them. All participants were assured of the confidentiality of their data and personal information. All methods were carried out in accordance with relevant guidelines and regulations. | PMC10629063 |
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Consent for publication | Not applicable. | PMC10629063 |
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Competing interests | The authors declare no competing interests. | PMC10629063 |
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References | PMC10629063 |
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Objective | DMO, peripheral retinal ischaemia | DIABETIC MACULAR OEDEMA | We tested the hypothesis that targeted retinal laser photocoagulation (TPRP) to peripheral retinal ischaemia reduces the overall burden of aflibercept injections when treating diabetic macular oedema (DMO) over a 24-month period. | PMC10630305 |
Methods | CMT | ADVERSE EVENTS | Prospective, double-masked, multicentre, randomised controlled trial in Australia comparing aflibercept monotherapy, following a treat-and-extend protocol, or combination therapy of aflibercept and TPRP for DMO. The aflibercept monotherapy group received placebo laser. The primary outcome measure was the mean number of intravitreal aflibercept injections for each group at 24 months. Secondary outcome included: mean change in central macular thickness (CMT) and vision at trial completion, the proportion of eyes whose DMO resolved and the mean injection treatment interval. Ocular and systemic adverse events were recorded. | PMC10630305 |
Results | We enrolled 48 eyes of 47 patients; 27 eyes were randomised to combination therapy (aflibercept and TPRP) and 21 to aflibercept monotherapy. Thirty-two eyes (67%) completed the 2-year study. The number of intravitreal treatments given were similar for combination therapy (10.5 (SD 5.8) and monotherapy (11.8 (SD5.6)) ( | PMC10630305 |
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Conclusions | RETINA, DIABETIC MACULAR OEDEMA | Laser to areas of ischaemic peripheral retina does not reduce the burden of intravitreal aflibercept injections when treating diabetic macular oedema. | PMC10630305 |
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Subject terms | PMC10630305 |
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Introduction | DMO, Retinal hypoxia, vision loss, diabetes [ | DIABETIC MACULAR OEDEMA | Diabetic macular oedema (DMO) is the most frequent cause of vision loss in patients with diabetes [Retinal hypoxia elevates levels of VEGF through activation of hypoxia-inducible factor [The present study treated DMO with aflibercept following a treat-and-extend (T&E) protocol from enrolment. The DAVE Trial randomised 40 eyes with DMO to either ranibizumab | PMC10630305 |
Materials and methods | PMC10630305 |
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Aim | peripheral retinal ischemia | The specific aim of this trial was to test the hypothesis that targeted laser therapy to areas of peripheral retinal ischemia reduces the overall number of intravitreal aflibercept injections required to control DMO over a 24-month period. | PMC10630305 |
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Outcome measures | cataract, ocular adverse, CMT | CATARACT, PROLIFERATIVE DIABETIC RETINOPATHY (PDR), ADVERSE EVENTS, LOSS OF VISION | The primary outcome measure was the number of intravitreal aflibercept injections in each of the two treatment arms at 24 months. Secondary outcome measures at 24 months compared with baseline included: the proportion of eyes that have central macular thickness (CMT) < 300 µm, mean change in CMT, mean change in best corrected visual acuity (BCVA) and mean treatment interval.Safety outcomes measures included: the incidence of rescue macular laser, the incidence of ocular adverse events including severe (>15 letter) loss of vision, new proliferative diabetic retinopathy (PDR), cataract progression and the incidence of non-ocular adverse events. | PMC10630305 |
Patient enrolment | panretinal, allergy, peripheral retinal ischemia, opacity, cataract, CMT, epiretinal, loss of vision | DISEASES, DIABETES MELLITUS, OPACITY, ALLERGY, CATARACT, EAR, MACULAR OEDEMA, EYE, LOSS OF VISION | This study was conducted in accordance with the Declaration of Helsinki and was approved by the Human Research Ethics Committees of Sydney Local Area Health Service, the University of Sydney and the Royal Victorian Eye and Ear Hospital (RVEEH) in Melbourne (Protocol number X14-0157). An independent safety monitoring committee reviewed safety data. Patients were recruited from the Sydney Eye Hospital and the RVEEH clinics from 2016 to 2018. All patients had a diagnosis of diabetes mellitus, were older than 18 years and completed written informed consent. Inclusion criteria included: Eyes with CMT > 300 microns on ocular coherence tomography (OCT), BCVA of 35–79 LogMAR letters and peripheral retinal ischemia affecting an area greater than 10-disc diameters on wide-field fundus fluorescein angiogram (FFA). Exclusion criteria included loss of vision due or macular oedema due to other causes, vitreomacular traction or significant epiretinal membrane. Study eye exclusion criteria included: treatment within 6-months with intravitreal triamcinolone or 3-months with anti-VEGF, cataract surgery within 3 months, previous panretinal photocoagulation (PRP) laser or vitrectomy, or media opacity that precluded adequate macular photography. Other exclusion criteria of the patient included pregnancy, unwillingness to use adequate contraception, allergy to fluorescein or aflibercept or intercurrent severe medical diseases. | PMC10630305 |
Treatment allocation | visual improvements | Each study eye was randomised by the unmasked research officer to either the experimental group “combination therapy” with TPRP and aflibercept, or the active control group “aflibercept monotherapy”. In patients with both eyes eligible for the study, the eyes were randomised to have different therapies.Stratification to the treatments was carried out to include equal proportions of patients with BCVA less than 70 LogMAR letters at entry to the study. This stratification was inferred from outcomes of DRCRnet Protocol T where participants with worse starting vision had larger visual improvements [ | PMC10630305 |
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Treatment with aflibercept | CMT | STERILE | Intravitreal aflibercept was administered in a designated treatment facility under sterile conditions as per local site practices. The injection eye was anaesthetised with topical drops and subconjunctival 2% lidocaine. Aflibercept (2 mg/0.05 ml) was injected into the vitreous 4 mm posterior to the limbus using a 30 G needle.The patient was reviewed four weeks later, and treatment continued following a T&E protocol. Treatment intervals were extended by 4 weeks if VA was ≥84 letters (Snellen equivalent 6/6) or CMT was ≤300 microns. If the treatment interval was greater than 4 weeks but VA was <84 letters or OCT macular thickness was >300 microns, an aflibercept injection was given and the next follow-up interval reduced by 4 weeks. | PMC10630305 |
Treatment with Targeted peripheral retinal photocoagulation (TPRP) | burns, peripheral retinal ischemia | LENS, RETINA | TPRP was applied with a single spot 532 nm laser to areas of peripheral retinal ischemia in the combination therapy group. No burns were placed within 3000 microns of the optic disc or fovea. Using an appropriate contact lens, the burn size was 400 microns at the retina, with a one-burn width spacing.In the “combination treatment” group, TPRP was applied 1 month after the initial aflibercept injection. A second was arranged at one months after initial laser depending on the patient’s tolerance of the first laser session. Sham TPRP was applied in the “aflibercept monotherapy” treatment group at 1 months after the initial aflibercept treatment. Patients who received sham laser were laser naïve and did not know about the technique. We turned the laser power down to zero. Laser power was set to zero and no burns were applied. The aiming light and sound still occurred at each pedal press. | PMC10630305 |
Rescue focal laser | Rescue focal laser could be added to treat the DMO at the investigator’s discretion. | PMC10630305 |
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Data collection and masking | Cataracts, stroke | CATARACTS, EYE DISEASE, STROKE, HEART ATTACK | Measurement of BCVA was performed with ETDRS charts using standardized procedures. Cataracts were graded using Age-Related Eye Disease Study photographic standards. CMT was measured from the central 1 mm subfield from spectral domain OCT (Cirrus; Zeiss). Wide-field fundus imaging and FFA was performed (Optos®). Patients underwent dilated fundal examination at each visit. Wide-field FFA was performed at baseline and the Exit visit. At each visit, patients were asked about stroke or heart attack since their last visit. If a patient withdrew their consent, an early exit visit was conducted where possible. When the interval between injections was greater than 3 months, an additional safety visit was arranged. Source data were verified by an independent study monitor of all BCVA and OCT data for all patients. | PMC10630305 |
Statistical analysis | Data were summarised using the mean, standard deviation (SD), median, first and third quartiles (Q1, Q3) and percentages. Baseline characteristics and 24-month outcomes were compared between the two groups using two sample t-tests, Wilcoxon rank sum tests and Chi-square tests for analysis of means, medians and categorical data, respectively. The time until achieving VA ≥ 85 letters was analysed using Kaplan-Meier survival curves. A | PMC10630305 |
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Power calculations | In Protocol T DRCRnet an average of 15 injections were given over 24 months in the aflibercept group [ | PMC10630305 |
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Results | Fifty-four eyes were screened, 48 eyes were randomised for treatment, 27 to combination therapy and 21 to monotherapy (Fig. | PMC10630305 |
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Intravitreal injections | The mean (SD) number of intravitreal injections over the 24 months trial was similar for each group (10.5 (5.8) combination; 11.8 (5.6) monotherapy group (Outcomes of Eyes at 24 months. | PMC10630305 |
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Visual acuity | The mean (95% CI) vision change was +4.0 (−1.8, 9.8) letters for combination and +7.8 (2.6, 12.9) letters for monotherapy ( | PMC10630305 |
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Spaghetti plot showing the visual acuity over 24 months for each eye (grey lines) and the locally weighted scatterplot smoothing (LOESS) curve of the overall trend with the shaded area showing the 95% confidence interval. | Analysis was performed on all eyes LOCF. | PMC10630305 |
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Kaplan-Meier curve of time until achieving VA ≥ 85 letters. | Note that it is possible to return below 85 letters by the final visit. | PMC10630305 |
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Diabetic macular oedema | Central macular thickness decreased by a mean of 154 µm in the combination therapy and 152 µm in the monotherapy group. Fourteen (67%) and 13 eyes (48%) did not have DMO at end of trial (combination therapy, monotherapy; | PMC10630305 |
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Non-completers | Eleven patients and 16 eyes did not complete the two-year study, 9 eyes from the combined therapy and 7 from the monotherapy arm. The median (Q1, Q3) time to patient drop out was 30 weeks (4, 60) (Suppl. Fig. | PMC10630305 |
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Safety outcomes | cataract, endophthalmitis, loss of vision | PROLIFERATIVE DIABETIC RETINOPATHY, ISCHAEMIC HEART DISEASE, ENDOPHTHALMITIS, CATARACT, CEREBROVASCULAR ACCIDENT, VITREOUS HAEMORRHAGE, LOSS OF VISION | Rescue focal macular laser was required for two eyes from the combination treatment arm and one eye in the aflibercept only group. One eye from each treatment arm developed a small vitreous haemorrhage due to the injection procedure. No eyes developed endophthalmitis or proliferative diabetic retinopathy. One eye in the monotherapy arm had worsening of cataract. Three eyes (11%) of the combination therapy group had >15 letter loss of vision (One patient in the combination therapy group was admitted to hospital for management of ischaemic heart disease. No patient had a cerebrovascular accident. | PMC10630305 |
Discussion | DMO, weakness, peripheral retinal ischemia, retinal ischemia | RETINAL ISCHEMIA | We found no evidence that the addition of targeted retinal laser photocoagulation to areas of retinal ischemia reduced the treatment burden of DMO compared with intravitreal aflibercept treatment alone. At 24 months, there were no significant differences in the vision gained, nor macular anatomical improvement. The 3-year DAVE trial of 49 eyes, and the 1-year UK based trial of 40 eyes by the RDP study group, found the same outcome as that of our study using ranibizumab instead of aflibercept [We found no difference in visual gains between either of the treatment arms (+4.0 letters for combination therapy and +7.8 letters for monotherapy (The DAVE trial found greater CMT reduction in the monotherapy group at both 24 (−296 ± 238 µm, −169 ± 172 µm) and 36 months (−302 ± 246 µm, −152 ± 149 µm monotherapy and combination therapy respectively). The authors hypothesised that this was because of heavy laser given at the start and again throughout the trial. In the UK RDP 2000 laser shots were given using the PASCAL laser in one session 2 weeks after the first ranibizumab treatment without further laser treatment. They found that CMT was 316 µm and 311 µm at the end of 1 year of treatment for the monotherapy and combination therapy group (The mean (SD) number of injections required for DMO in the present study was similar for the monotherapy (11.8 injections) and combination group (10.5 injections) over two years; In summary, we found no effect in TPRP in combination with anti-VEGF therapy in reducing injection load when treating DMO, which is similar to findings from the DAVE and the UK RDP studies, although using a different VEGF inhibitor. Previous 2-year DMO trials have reported a higher number of injections per year than ours, perhaps because our patients were treated with a T&E regimen from the start, whereas other studies begin with a loading course of injections followed by either T&E or pro rata (PRN). DRCR Protocol T used a PRN protocol after a fixed 4 weekly regimen to 6 months and required 15 injections over 2-years (inter quartile range 11–17) [A significant weakness of our study is the low study completion rate of 67% (32/48 eyes). Previous DMO studies have had higher rates of retention: DAVE (85%), UK RDP trial (87%), Protocol T (88%), and BEVORDEX (77%). Protocol S had 83% follow-up rates at 2 years and 61% at 5 years [Not surprisingly, we found no difference in ocular and systemic safety outcomes for patients in each arm of this study.Using a treat-and-extend treatment regimen, following an initial loading dose is a commonly used for treatment of neovascular age-related macular degeneration [In conclusion, we found no reduction in the requirement for aflibercept injections in eyes with DMO and peripheral retinal ischemia when treated with the addition of TPRP. We also found that T&E aflibercept treatment, without a loading phase, is a safe and effective treatment for DMO, leading to fewer clinic visits and a lower treatment burden. | PMC10630305 |
Summary | PMC10630305 |
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What was known before | diabetic macular oedema | DIABETIC MACULAR OEDEMA |
Targeted peripheral retinal laser (TPRP) photocoagulation with ranibizumab does not reduce the injection burden for patients with diabetic macular oedema compared to monotherapy ranibizumab.This was demonstrated with an initial intravitreal treatment with 3 monthly loading phase. | PMC10630305 |
What this study adds | peripheral retinal ischaemia | DIABETIC MACULAR OEDEMA |
This study tests demonstrated that aflibercept with TPRP to areas of peripheral retinal ischaemia in naive and previously treated eyes does not reduce the injection burden for the treatment of diabetic macular oedema.In contrast to the pervious TPRP studies with ranibizumab, this study did not have a loading phase of aflibercept and the treat and extend regimen increased using a 4-week extension interval.This increased the potential to find a difference between the number of injections between the two groups but this was not found. | PMC10630305 |
Supplementary information | The online version contains supplementary material available at 10.1038/s41433-023-02525-9. | PMC10630305 |
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Author contributions | Study conception and design: SFB, MG, HM, SW; Data collection: HM, EC, SW; Analysis and interpretation of results: EC, SW, VN, MG, SFB; Draft manuscript preparation: EC, VN, MG, SFB. All authors reviewed the results and approved the final version of the manuscript. | PMC10630305 |
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Funding | Diabetes | DIABETES | This clinical trial received funding from the Diabetes Australia Research Program and an unrestricted educational grant from Bayer. Aflibercept was provided by Bayer. Open Access funding enabled and organized by CAUL and its Member Institutions. | PMC10630305 |
Data availability | Data generated during the current study are available from the corresponding author upon reasonable request. | PMC10630305 |
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Competing interests | EEC: no financial disclosures; SW: no financial disclosures; HM: Consultant—Allergan, Bayer, Novartis, Roche; LLL: Consultant—Bayer, Novartis, AbbVie, Allergan; Speaker fees—Bayer, AbbVie; SSS: no financial disclosures; VN: no financial disclosures; MCG: Grant—Allergan; Personal fees—Bayer; Consultant—Allergan, Novartis, Bayer; Expert testimony—Bayer; SFB: Consultant—Allergan, Bayer, Novartis, Roche. | PMC10630305 |
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References | PMC10630305 |
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Objectives | radial artery occlusion | This study investigated the contemporary incidence and predictors of radial artery occlusion as well as the effectiveness of antithrombotic treatment for radial artery occlusion following transradial coronary angiography. | PMC10449957 |
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Background | Postprocedural radial artery occlusion | COMPLICATION | The radial artery is the standard access for coronary angiography and even complex interventions. Postprocedural radial artery occlusion is still a common and significant complication. | PMC10449957 |
Methods | This prospective study enrolled 2004 patients following transradial coronary angiography. After sheath removal, hemostasis was obtained in a standardized fashion. Radial artery patency was evaluated by duplex ultrasonography in all patients. In case of occlusion, oral anticoagulation was recommended and patients were scheduled for a 30-day follow-up including Doppler ultrasonography. | PMC10449957 |
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Results | new-diagnosed radial occlusion, radial occlusion | A new-diagnosed radial occlusion was found in 4.6% of patients. The strongest independent predictors of radial occlusion were female sex and active smoking status. In the subgroup of patients with percutaneous coronary interventions, female sex followed by sheath size > 6 French were the strongest predictors of radial occlusion. 76 of 93 patients with radial occlusion received an oral anticoagulation for 30 days. However, reperfusion at 30 days was found in 32% of patients on oral anticoagulation. | PMC10449957 |
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Conclusion | thrombotic, radial artery occlusion, radial occlusion, traumatic | COMPLICATION | The incidence of radial artery occlusion following coronary angiography in contemporary practice appears with 4.6% to be lower as compared to previous cohorts. Female sex and smoking status are the strongest independent predictors of radial occlusion followed by procedural variables. The limited effectiveness of oral anticoagulation for treatment of radial artery occlusion suggests a primarily traumatic than thrombotic mechanism of this complication. | PMC10449957 |
Graphical abstract | PMC10449957 |
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Supplementary Information | The online version contains supplementary material available at 10.1007/s00392-022-02094-z. | PMC10449957 |
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Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC10449957 |
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Introduction | radial artery occlusion, occlusion of the radial artery, pain | VASCULAR COMPLICATIONS, COMPLICATION | The transradial access is recommended by current guidelines as a standard approach for diagnostic coronary angiography and interventions [Despite many advantages, the radial access can be associated with certain disadvantages such as pain or vascular complications. The persistent occlusion of the radial artery is certainly the key complication of this vascular approach [In early studies, the incidence of radial artery occlusion following angiography varied from less than 1% to up to 33% [ | PMC10449957 |
Methods | PMC10449957 |
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Study population | dementia | HEART | The proRadial study was a prospective observational study enrolled patients undergoing coronary angiography with or without percutaneous coronary intervention (PCI) between March 2019 and August 2020 at the University Heart Center Freiburg · Bad Krozingen (Campus Bad Krozingen, Germany). All patients underwent coronary angiography were screened for this study. Key inclusion criteria were age ≥ 18 years and a successful transradial angiography. Patients not able to provide a valid written informed consent (e.g., due to dementia) or in a state of dependence to our hospital were not included. The main reasons for unsuccessful enrollment were early discharge of patients or transfer to another department for subsequent treatment (mainly cardiac surgery Fig. Flow diagram for study participants | PMC10449957 |
Procedural details | artery occlusion | ARTERY OCCLUSION | Transradial coronary angiography was performed in a very standardized fashion. Only hydrophilic coated introducer sheaths from 5 to 7 French and 10 cm length were used (Glidesheath SlenderOn the day following angiography, patients underwent a physical examination of the arm and the vascular access site. A duplex ultrasonography was performed in all patients using a portable device (Vscan Extend, Ultrasound GE Healthcare GmbH, Solingen, Germany). In case of absent flow of the radial artery, patients were sent for a further, more thorough ultrasound study to our department of angiology. Confirmation of radial artery occlusion was defined as an absence of antegrade flow determined by duplex ultrasonography. | PMC10449957 |
Statistics | Data are presented as median with interquartile range or numbers with percent. Continuous variables were compared using the Mann–Whitney | PMC10449957 |
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Results | PMC10449957 |
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Antithrombotic treatment of radial artery occlusion | death, radial artery occlusion, bleeding | BLEEDING | Patients diagnosed with a new radial artery occlusion received the recommendation for oral anticoagulation regardless of symptoms for at least 30 days according to the local standard of care. These patients were also scheduled for a clinical follow-up after 30 days. Of the 93 patients with radial artery occlusion, a complete follow-up including a repeat duplex sonography was available in 94% of patients (87 of 93). The reason for missing follow-up in the remaining six patients were non-cardiovascular death in two patients and patient refusal in 4 patients (mainly due to long distance travelling or limited mobility due to comorbidities). From the remaining 87 patients, 82% (71/87) received an oral anticoagulation. Key reasons for missing oral anticoagulation were planned major surgery within the next few days (mainly bypass and/or valve surgery) or an estimated high bleeding risk according to the treating physician (mainly history of recent major bleeding or high age).The selection of oral anticoagulation was left to the treating physician. The majority of patients received NOACs (66 out of 71: rivaroxaban The reperfusion rate of the radial artery at 30 days was 13% in patients receiving no oral anticoagulation and 32% in patients with oral anticoagulation. The highest reperfusion rate was seen in patients anticoagulated with phenprocoumon (4 out of 5; Fig. Reperfusion rates of radial artery at 30 days. | PMC10449957 |
Discussion | postprocedural radial occlusion, bleeding, transient ulnar compression, radial occlusion, lower radial occlusion, contemporary radial occlusion rate, obstructive coronary artery disease, vascular spasm, vascular damage, artery occlusion, radial artery occlusion | BLEEDING, VASCULAR SPASM, EVENT, VASCULAR ACCESS SITE COMPLICATION, PATHOGENESIS, ARTERY OCCLUSION, CORONARY HEART DISEASE, ARTERIAL HYPERTENSION | This study evaluated the incidence of vascular access site complications following transradial coronary angiography in a large cohort of unselected patients including a significant proportion of patients undergoing complex coronary intervention with large-bore access. Key finding was that the contemporary radial occlusion rate was with 4.6% lower as compared to many previously reported results [Radial patency was evaluated on the day following coronary angiography. This early point of time was chosen since the majority of patients were discharged on this day. In previous studies, radial artery patency was evaluated from 24 h up of 30 days following the procedure [In the present study, all patents were screened by duplex ultrasonography regardless of symptoms. This is an important feature of this study and might explain differences as compared to previous data. Earlier studies have infrequently reported even lower radial occlusion rates of less than 4%. However, these were mainly retrospective analyses with lower sample sizes. In some analyses, only symptomatic patients were apparently sent for ultrasound examination [Overall, patients diagnosed with radial occlusion were more often female, had a lower prevalence of arterial hypertension and less frequently a history of coronary heart disease, which might be explained by their younger age. However, these patients were more often active smokers, demonstrated less frequently an obstructive coronary artery disease needing revascularization and had higher creatine kinase levels, which might point to a higher level of physical activity.Young age has already previously been identified as predictor for radial artery occlusion [Another analysis of 1706 patients undergoing transradial catheterization found a correlation of radial artery diameter with female gender, but not with body mass index [The last key predictor of radial occlusion in the present cohort was active smoking, which can be also associated with vascular spasm and has previously been reported to be associated with radial occlusion [Thus, pathogenesis of radial artery occlusion appears to be multifactorial. Sheath insertion and a mismatch between radial artery diameter and sheath size can lead to vascular damage and create a pro-thrombotic environment [The results of the present analysis can certainly help to identify patients at risk for radial occlusion. Most cases of postprocedural radial occlusion occurred in patients undergoing only diagnostic coronary angiography (69 out of 93 in total) and in particular in female patients (In patients needing coronary intervention, key for reduction of radial occlusion appears to be the correct selection of sheath size. Overall, the use of large-bore sheaths was clinically safe in the present cohort with not any major bleeding or neurologic event, which is in line with previous clinical data [The optimal treatment for radial artery occlusion is still not well defined. Mechanical interventions such as an approach with transient ulnar compression has been suggested [ | PMC10449957 |
Limitations | spasm, Radial occlusion, radial occlusion | This is a monocentric study with all adherent limitations. The majority of patients received a 6 F sheath and only about 10% of patients a 5 F or 7 F sheath limiting the informative value for these less frequently used sizes.Radial occlusion was examined one day following coronary angiography given that most patients were discharged on this day. It cannot be excluded that evaluation of the primary endpoint at a later point of time would have shown different result. Data on treatment of radial occlusion were only observative and the majority of patients received oral anticoagulation, which was not standardized. Thus, this study cannot determine the natural course of radial occlusion or if other types of treatment would have had a higher success rate. Even if there was a standard for dosing of periinterventional drugs such as heparin or nitroglycerine, preferences of the operator or clinical circumstances have certainly caused some interindividual variations that might bias our results. Other potential reasons for bias are undetected differences in operator experience or radial vasomotility or spasm. | PMC10449957 |
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Conclusion | thrombotic, radial artery occlusion, radial occlusion, traumatic | COMPLICATION | The incidence of radial artery occlusion following coronary angiography in contemporary practice is with less than 5% lower as compared to previous studies. Female sex and smoking status are the strongest independent predictors of radial artery occlusion followed by procedural variables. These results might guide clinical decision making by facilitating identification of patients at risk for postprocedural radial occlusion, which might be preferable candidates for non-invasive imaging or use of smaller sheath sizes. The limited effectiveness of oral anticoagulation for treatment of radial artery occlusion suggests a primarily traumatic than thrombotic mechanism of this complication. | PMC10449957 |
Supplementary Information | Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 33 kb) | PMC10449957 |
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Abbreviations | Bleeding | BLEEDING | Bleeding academic research consortiumCoronary artery bypass graftingConfidence intervalChronical total occlusionEjection fractionLeft ventriclePercutaneous coronary interventionTransient ischemic attackOral anticoagulantNovel oral anticoagulant | PMC10449957 |
Funding | Open Access funding enabled and organized by Projekt DEAL. This research received no external funding. | PMC10449957 |
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Declarations | PMC10449957 |
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Conflict of interest | NEUMANN, EDWARDS | Franz-Josef Neumann received institutional research grants, consultancy fees and speaker honoraria from Daiichi-Sankyo, AstraZeneca, Sanofi-Aventis, Bayer, The Medicines Company, Bristol, Novartis, Roche, Boston Scientific, Biotronik, Medtronic and Edwards. Willibald Hochholzer received lecture fees from Bayer Vital, Boehringer Personal, Bristol-Myers Squibb and AstraZeneca; and consulting fees from Daiichi Sankyo, Ferrer, and The Medicines Company. Kambis Mashayekhi received consultancy fees and speaker honoraria from Abbott, Abiomed, Asahi Intecc, AstraZeneca, Biotronik, Boston Scientific, Cardinal Health, Daiichi Sankyo, Shockwave, Teleflex, and Terumo. All other authors declare no conflicts of interest. | PMC10449957 |
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References | PMC10449957 |
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2. Materials and Methods | hypothermia, fever, cognitive impairment, infections, anemia, burns, skin alterations, blood transfusions, shivering, diabetes | INFECTIONS, ANEMIA, PRESSURE ULCERS, PERIPHERAL NEUROPATHY, CHRONIC ANEMIA, DIABETES | We performed a single-center, pragmatic randomized clinical trial (RCT) with adults planned for elective non-cardiac surgery. The study was approved by the Getafe University Hospital Ethics Committee and by the Torrejón University Hospital research committee (30 November 2018, A10/18, President of Hospital Ethics Committee: Ricardo Sanz Fernandez), and written informed consent was obtained from all subjects participating in the trial. The RCT was registered prior to patient enrollment at We included adults (>18 years old) classified as American Society of Anesthesiologists (ASA) physical status I, II or III, scheduled for elective non-cardiac surgery performed under general and/or neuraxial anesthesia with a minimum expected duration of anesthesia of 60 min in the Torrejón University Hospital, Madrid, Spain.Exclusion criteria were cognitive impairment or any kind of lack of collaboration, pregnancy, diabetes with established peripheral neuropathy, pre-surgical treatment with drugs interfering with thermoregulation (i.e., ketamine, thyroxine), burns, pressure ulcers and other skin alterations that may worsen under application of heating devices, initial patient temperature < 35.5 °C or >37.5 °C, fever or active infections, chronic anemia requiring periodic transfusions.The primary objective was to evaluate the effect of a prewarming period lasting at least 10 min and performed with a forced air system on perioperative hypothermia. In terms of temporal window for the evaluation of perioperative hypothermia, we considered the period occurring from the induction of anesthesia to the arrival in the recovery room (or in the ICU). Perioperative hypothermia was evaluated in terms of incidence (defined as a temperature < 36 °C), magnitude (expressed in °C · hSecondary outcomes were (1) the core temperature at operating room arrival, (2) the occurrence of side effects defined as thermal discomfort (presence of shivering or sweating, which were directly objectified, or discomfort reported directly by the patient); and (3) the incidence of SSI, amount of blood losses and number of blood transfusions, occurrence of anemia (defined as episodes of hemoglobin levels below 7 mg/dl) and the duration of hospital stay (confirmed by electronic medical records). | PMC10744774 |
2.1. Procedures, Randomization and Interventions | tremors | BLIND | In the pre-assessment clinic, subjects were informed of the study and offered participation. For patients accepting participation and signing written consent, we used a block randomization schedule generated by the Epidat v4.1 (Consellería de Sanidade, Xunta de Galicia, Spain) program and placed in sealed envelopes. On the day of surgery, patients were randomly assigned to one of the study groups after opening the envelopes. Due to the nature of the intervention, it was not possible to blind patients to their allocation. For patients allocated to the intervention, active prewarming was initiated as soon as the patient arrived in the pre-anesthesia room with a preoperative hot air blanket (“3M™ Bair Hugger™ Preoperative Blanket”, St. Paul, MN, USA) and a hot air heating unit (“3M™ Bair Hugger™ Warming Unit”, St. Paul, MN, USA) initially set at 43 °C. If the patient felt overheated, the warming device was lowered as tolerated. In the control group, no prewarming was carried out and patients were kept in their gowns and leggings. Core body temperature was monitored in both groups using the Zero Heat Flux principle (“3M SpotOn™ Monitoring system”, St. Paul, MN, USA). The body temperature was recorded every 5 min in the pre-anesthesia room, during the intraoperative period and on arrival in the recovery room or in the ICU. In the pre-anesthesia room, patients did not receive any drugs nor receive intravenous fluid infusion, apart from a very slow drip of intravenous crystalloids to ensure the patency of the cannula. This choice was made to avoid interference from exogenous fluid on patient temperature.In the operating theatre, the attending anesthesiologist was aware of the group allocation for each patient. Although anesthetic drugs and also adjuvants commonly used in anesthesia practice (analgesics, anxiolytics, etc.) affect thermoregulation and affects also the defense mechanisms such as tremors, we opted for a pragmatic approach. Hence, in this RCT we left the attending anesthesiologist free to decide on the drugs for the anesthesiology conduction. Regarding the approach to warming during the intraoperative period, participants in both groups were actively warmed following a local protocol [ | PMC10744774 |
2.2. Statistical Analysis | Sample size calculation was based on the studies of Horn et al. [The analysis between groups for continuous variables was performed using Student’s T and Mann–Whitney U for quantitative variables according to normal or non-normal distribution, respectively. For the categorical variables, Chi square and Fisher’s tests were applied according to the normal or non-normal distribution, respectively. | PMC10744774 |
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3. Results | During a study period of one year (November 2018–October 2019), 197 patients were analyzed, with 104 allocated to the control group and 93 to the intervention (prewarming, | PMC10744774 |
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3.1. Preoperative Period | There were no significant differences in the temperatures of both groups of patients at any time during their stay in the pre-anesthesia room, with a maximum median difference of 0.2 °C ( | PMC10744774 |
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3.2. Intraoperative and Postoperative Period | SECONDARY | As shown in Intraoperative secondary endpoints only showed a significant difference in the interruption of intraoperative active warming (due to core temperature > 37.5 °C), which was less frequent in controls ( | PMC10744774 |
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4. Discussion | shivering, hypothermia | HEAT, SECONDARY, ADVERSE EFFECTS | In our study, we selected a population of patients scheduled for elective surgery and undergoing general or neuroaxial anesthesia with intraoperative warming. In these patients, a prewarming of at least 10 min with hot air devices did not show differences in the incidence of hypothermia, the duration of hypothermia or in the magnitude of hypothermia as compared to no prewarming. These results are not consistent with those obtained by Horn et al. [In our study, the downward trend in temperature after induction was not prevented in the prewarming group, despite the storage of heat. During the first 60 min of surgery, both groups of patients followed a similar downward temperature curve. These results were different from those reported by Lau et al. [Regarding the prewarming time, Horn et al. [It must be considered that the effect of prewarming subsides after some time after the completion of anesthetic induction if intraoperative warming is not promptly restarted. In patients receiving spinal anesthesia, Jun et al. [Such results were observed despite allowing the patient or the staff in the pre-anesthesia room to regulate the heat unit, thereby possibly reducing the adverse effects related to heating. Indeed, it was previously suggested that allowing the patient to regulate prewarming may also reduce both the patient’s heat discomfort (preoperative) and the interruption of intraoperative warming [Our study has some strengths and several limitations. Overall, although we performed an RCT with rigorous methodology, the blinding of patients and anesthesiologists was not feasible due to the nature of the intervention and represents the first limitation. Second, our study was limited to a single center with the influence of local protocols with profound attention given to perioperative normothermia. Indeed, our protocol includes the rigid control of the rooms’ temperature, early initiation of intraoperative warming, careful monitoring and the assessment of body temperature. All these factors can reduce the need for active prewarming. Third, the incidence of hypothermia in the control group was much lower than hypothesized during the study design and sample size calculation. Hence, our study may have been underpowered to detect significant differences. Fourth, our study did not have the statistical power to analyze subgroups and to explore whether some patients may experience greater benefits from prewarming as compared to others. This may be the case of patients with low body mass index, or those undergoing certain types of surgery. However, our study had a heterogeneous population and cannot answer this question. Finally, our study was also not powered to find differences in SSI, transfusions, hospital stay, shivering and secondary outcomes. | PMC10744774 |
5. Conclusions | hypothermia | In conclusion, our single center RCT does not suggest the usefulness of a period of at least 10 min of active preoperative warming with warm air blankets before the transfer to the operating room. In the presence of strict pre-anesthesia room temperature control, short distances to the operating room, a culture of intraoperative temperature monitoring and warming with a strict protocol for perioperative normothermia, prewarming is unlikely to reduce the incidence, duration and magnitude of perioperative hypothermia. | PMC10744774 |
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Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10744774 |
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Author Contributions | RECRUITMENT | J.R.-P.: This author helped in planning, design, patient recruitment and data collection, statistical analysis, writing and translation of the present study. M.M.M. (Miguel Miró Murillo): This author helped in planning, design, patient recruitment and data collection, statistical analysis, writing and translation of the present study. J.S.G.: This author helped in planning, design, patient recruitment and data collection, statistical analysis, writing and translation of the present study. M.M.M. (Marta Martin Mesa): This author helped in planning, design, patient recruitment and data collection, statistical analysis, writing and translation of the present study. C.S.: This author helped in planning, design, statistical analysis, writing and translation of the present study. F.S.: This author helped in planning, design, statistical analysis, writing and translation of the present study. A.A.: This author helped in planning, design, patient recruitment and data collection, statistical analysis, writing and translation of the present study. All authors have read and agreed to the published version of the manuscript. | PMC10744774 |
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Institutional Review Board Statement | The study was approved by the Getafe University Hospital Ethics Committee and by the Torrejón University Hospital research committee (30 November 2018, A10/18, President of Hospital Ethics Committee: Ricardo Sanz Fernandez). | PMC10744774 |
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Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10744774 |
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Data Availability Statement | Data will be available on request to the corresponding authors. | PMC10744774 |
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Conflicts of Interest | The authors certify that there are no conflict of interest with any financial organization regarding the material discussed in the manuscript. Miró Murillo, M. works with 3M as a consultant for teaching and training purposes. | PMC10744774 |
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References | hypothermia | Flow chart of patients’ enrolment, showing allocation and randomization of participants. ASA: American Society of Anesthesiologists classification on physical status.Median core temperature in the pre-anesthesia room. Values are median. Median core temperatures were not significantly different between groups. Active prewarming was initiated as soon as the patient allocated to prewarming arrived in the pre-anesthesia room.Mean temperature core in the operating room. Values are means. Mean core temperatures did not have statistically significant differences at any time between groups.Demographic and surgical characteristics.Data are presented as median (interquartile range) for continuous variables and as Outcomes of the study regarding core temperature (°C) and perioperative hypothermia.Data presented as median (interquartile range) for continuous variables and as | PMC10744774 |
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Methods | RECURRENCE | The open-label randomized crossover study enrolled 67 patients (63.1±10.6 years old, 53 men) who had undergone initial AF ablation. Three months after ablation, patients were randomly assigned to group 1 (n = 35), 2-week Garment ECG followed by 24-hour Holter ECG, or group 2 (n = 32), 24-hour Holter ECG followed by 2-week Garment ECG. The detection of AF recurrence was compared between the two devices. | PMC9955627 |
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Results | RECURRENCE | The Garment ECG showed AF recurrence in 12 patients (18%) compared to 4 patients for the Holter ECG (6%, p = 0.008). The ECG acquisition rate was higher for Holter ECG than for Garment ECG (100.0% [interquartile range 100.0–100.0%] versus 82.4% [71.1–91.0%], p<0.001), but the Garment ECG provided longer total analysis time (11.0 days [9.0–12.2 days] for Garment; 1.0 day [1.0–1.0 day] for Holter, p<0.001). | PMC9955627 |
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Conclusions | RECURRENCE | Despite the lower ECG acquisition rate, the 2-week Garment ECG revealed instances of AF recurrence after ablation in patients who were underdiagnosed by 24-hour Holter ECG. | PMC9955627 |
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Data Availability | Data cannot be shared publicly because of limited permission from the participating patients and University of Tsukuba Clinical Research Review Board has imposed them. Data are available from the Clinical Research Support Center, Tsukuba Clinical Research and Development Organization, University of Tsukuba (2-1-1 Amakubo, Tsukuba, Ibaraki, 305-8576, Japan. E-mail: | PMC9955627 |
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Introduction | death, dementia | EVENTS, ATRIAL FIBRILLATION (AF), CEREBRAL INFARCTION | Atrial fibrillation (AF) constitutes a major risk factor for cardiovascular events, cerebral infarction, dementia, and death [The actual rate of AF detection depends on the duration of electrocardiogram (ECG) monitoring, but the current standard of care for post-ablation AF relies on 24-hour continuous monitoring using a conventional Holter ECG. About 50% of recurrent AF may be missed under current ECG monitoring for only 24 hours [Consumers have recently begun to use handheld devices connected to smartphone applications for self-diagnosis, but those devices tend to be unreliable and are impractical for use in a clinical setting [The recent development of a novel dry textile electrode (hitoeBased on these preliminary findings and previous studies in healthy participants [ | PMC9955627 |
Materials and methods | PMC9955627 |
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Study design and participants | This was a randomized crossover comparative study with open design and block randomization ( | PMC9955627 |
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Patient flow diagram. | ECG, electrocardiogram.This study was registered in the Japan Registry of Clinical Trials (jRCT) as jRCTs 032180018. Patients provided written informed consent before enrollment. The protocol was approved by the University of Tsukuba Clinical Research Review Board, and the study was conducted in accordance with the Declaration of Helsinki and the Clinical Trials Act in Japan [This study was implemented at the University of Tsukuba Hospital. Eligible participants were 20 years of age or older at consent; had completed a first catheter ablation for AF; were scheduled for Holter ECG monitoring 3 months post-ablation at the University of Tsukuba Hospital; and consented to use a Garment ECG device ( | PMC9955627 |
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Garment ECG system with hitoe | A, The hitoe | PMC9955627 |
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Endpoints | redness, erosion, non-AF arrythmia | EROSION, RECURRENCE, SECONDARY, FLUTTER, SCARRING, EVENTS | The primary endpoint was the detection rate of patients with AF recurrence. AF recurrence was defined as AF or arterial flutter lasting 30 seconds or longer, a definition that is widely used for assessing AF after catheter ablation [The major secondary endpoint was the ECG acquisition rate, which was defined as the ratio of “time for analysis (recording time − noise)” to total recording time. Recording time was defined as monitoring time minus the time for which monitoring was not possible because the patient had removed the garment for bathing, etc. Device comfort while wearing was assessed by questionnaire, and incidence of non-AF arrythmia events was also assessed.Safety endpoints were presence of redness, erosion, or scarring. Before removing the investigational device, a clinical laboratory technologist and a clinical research coordinator reviewed the questionnaire and observed the site where the device was attached. If any injury to the skin was suspected, the site was examined by a physician. | PMC9955627 |
Procedures | burn injuries, cutaneous pruritus | ADVERSE REACTIONS, EVENTS, EVENT | After catheter ablation, patients provided informed consent to participate in this study. Those who met the inclusion criteria and did not meet the exclusion criteria were enrolled and randomly allocated to one of the two groups. Three months after catheter ablation, patients started ECG monitoring using the device that had been allocated to their group at randomization (2 weeks using the hitoe Medical Electrode II (Toray Medical Co., Ltd., Tokyo, Japan) with the hitoe ECG Recorder EV-301(Parama-Tech Co., Ltd., Fukuoka, Japan) and hitoe Medical Leads II (Toray Medical Co., Ltd., Tokyo, Japan) in the Garment ECG group or the disposable electrode NC-105CM (NIHON KOHDEN CORPORATION, Tokyo, Japan) with Long-term Recorder RAC-3103 (NIHON KOHDEN CORPORATION, Tokyo, Japan) and Patient Cables BJ-322D (NIHON KOHDEN CORPORATION, Tokyo, Japan) in the Holter group. At the end of the first time period, each patient was switched to the other device. The total for the two time periods was 15 days. Study staff reviewed all adverse reactions and undesirable events for each ECG device, and the patients completed questionnaires when they returned the last allocated ECG device. The ECG data were analyzed automatically using ECG analyzers: NEY-HEA3000 (Nexis Co., Ltd., Fukuoka, Japan) for the Garment ECG group and DSC-3300 (NIHON KOHDEN CORPORATION, Tokyo, Japan) for the Holter group. The results were entered into each patient’s electronic medical record. Patients were required to remove the Garment ECG device when bathing to protect the electrode from water, and in the event of magnetic resonance imaging because local heating from induced electromotive force might cause burn injuries. Use of topical agents for cutaneous pruritus was permitted.Block randomization was processed, and a sequential number for ECG session was assigned automatically by a computer system, the UHCT ACReSS (University Hospital Clinical Trial Alliance Clinical Research Support System). Block size was ten, and the allocation ratio was equalized between the two groups. The allocation sequence was concealed through a third-party assignment implemented by the clinical research coordinators. Patients were enrolled by investigators other than the statistician. | PMC9955627 |
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