Late Loss Research Articles

Clinical safety and performance of the world's thinnest-strut Evermine50 everolimus-eluting stent: a 24-month follow-up of the Evermine 50 EES - 1 study.

Ultrathin-strut stents are considered the future of percutaneous coronary intervention for treating coronary artery disease (CAD). These drug-eluting stents with biodegradable-polymer technology have the potential to improve clinical outcomes in CAD patients. This study aimed to evaluate the safety and performance of newer-generation ultrathin-strut (50 µm) Evermine50 everolimus-eluting stents (EES) in patients with single or multiple long lesions. This is a prospective, single-arm, multicentre study conducted in India that enrolled 118 patients with de novo coronary lesions. The endpoints were defined based on the major adverse cardiac events (MACE; composite of cardiac death, myocardial infarction [MI] and clinically driven target lesion revascularisation) up to 24-month follow-up. A subset of patients (n=21) underwent angiographic follow-up for a mean follow-up period of 12 mon. A total of 138 lesions were successfully treated in 118 patients, the majority of whom were males (80.51%). The average stent length and diameter deployed were 26.02±9.24 mm and 2.97±0.36 mm, respectively. The results exhibited low MACE at 24-month follow-up (0.87%) with no stent thrombosis and 1 death (0.87%, which was cardiac). The core lab angiographic assessment showed in-segment and in-device late lumen loss of 0.12±0.31 mm and 0.17±0.31 mm, respectively, at a mean follow-up of 12 months, with clinically acceptable outcomes. The Evermine50 EES showed satisfactory primary clinical as well as angiographic outcomes, reaffirming the safety and performance of the world's thinnest-strut stent by exhibiting low rates of MACE at 24-month follow-up with an absence of any stent thrombosis and MI. Clinical Trials Registry-India (CTRI) number: CTRI/2017/02/007781.

Remote monitoring after elective colorectal surgery, a pilot study

BackgroundMultiple studies have demonstrated safety of short stay after colorectal resections. Remote patient monitoring may allow earlier discharge home after surgery. Remote patient monitoring feasibility after elective colorectal surgery in a largely rural state was evaluated. MethodsA pilot study was undertaken May-August 2023 for patients >18 years of age, fluent in English, with compensated medical morbidities who underwent elective minimally invasive colorectal surgery. Patients were monitored at home with pulse oximetry, heart rate, blood pressure, and weight for 2 weeks. A remote nurse assessed and escalated to the colorectal surgery department as needed. Patients answered daily surveys on pain, ostomy/incision, bowel function, and oral intake. Patient satisfaction was surveyed on days 5 and 12 using a 5-point Likert scale. ResultsSixteen patients undergoing laparoscopic colorectal surgery were enrolled preoperatively. The average length of stay was 3.0 days (1–9), 43% for malignancy, and 25% for inflammatory bowel disease. In 25% of cases, conversion to open surgery was required. The average home monitoring system set-up time was 53 minutes. Two patients were noncompliant. A third patient had a late loss of digital services. The remote nurse detected 2 complications: port site infection and delayed ileus. One required readmission. Patient satisfaction scores were high for the entire study period. Operation by third party failed in all attempted cases. ConclusionRemote home monitoring is a safe, feasible, and well-liked option for patients undergoing minimally invasive colorectal surgery in rural areas. Complex disease, compensated morbidities, and conversion to open surgery were not contraindications to early discharge.

Retrospective analysis of the drug-coated balloon-only strategy for chronic total occlusion coronary lesions.

The effects of the drug-coated balloon (DCB)-only strategy in the treatment of chronic total occlusion (CTO) coronary lesions remain controversial. Patients who underwent an in-stent restenosis (ISR) CTO percutaneous coronary intervention (PCI) had a significantly poorer prognosis than those who underwent a de novo CTO PCI. This retrospective analysis evaluated the efficacy and safety of the DCB-only strategy in the treatment of CTO lesions, and the factors associated with adverse events in the patients. Patients with CTO lesions who were treated with the DCB-only strategy from 1 January 2016 to 1 May 2021 were retrospectively enrolled in this study. The patients were stratified into the ISR and de novo (primary) groups. All the patients were re-admitted to the hospital and underwent clinical and/or angiographic follow-up. Of the 68 patients with CTO lesions, 38 (55.9%) were categorized as having ISR, and 30 (44.1%) were categorized as having de novo lesions. The outcomes measured included target lesion revascularization (TLR), lumen gain after intervention, and late lumen loss (LLL). After an average follow-up period of 16 months, a total of 15 patients experienced target lesion failure (13 in the ISR group and 2 in the de novo group). The rate of major adverse cardiac events (MACEs) was significantly lower in the de novo group than the ISR group (10% vs. 39%, P=0.004). There was a significant difference in LLL between the two groups, with the de novo group showing a decrease (-0.04±0.83 mm) and the ISR group showing an increase (0.97±1.45 mm) (P=0.03). The univariable Cox proportional hazard analyses revealed that the incidence of TLR was independently associated with the stenosis type (either ISR or de novo lesions) [odds ratio (OR): 7.28; 95% confidence interval (CI): 1.494-35.464; P=0.01]. Male gender (OR: 3.726; 95% CI: 1.014-12.818; P=0.03) and body mass index (BMI) (OR: 1.246; 95% CI: 1.022-1.518, P=0.03) were also associated with the incidence of TLR. However, after adjusting for the variables of age, gender, and BMI, no significant association was found between MACE occurrence and ISR (OR: 4.156, 95% CI: 0.734-23.522; P=0.11). Treatment using the DCB-only strategy was found to be beneficial for patients suffering from CTO coronary lesions, especially those presenting with de novo lesions.

Continuity of care during severe civil unrest with a model of community-based HIV care: a retrospective cohort study from Haiti

There are limited data on the effectiveness of differentiated service delivery (DSD) for HIV care during sociopolitical turmoil. We assessed outcomes with a DSD model of care that includes patient choice between community-based antiretroviral therapy (ART) centres, home-based ART dispensing, or facility-based care at GHESKIO clinic during a period of severe civil unrest in Port-au-Prince, Haiti. This retrospective analysis included data on patients with at least one HIV visit at GHESKIO between May 1, 2019, and December 31, 2021. Multivariable logistic regression models were used to assess predictors of attending ≥1 community visit during the study period, and failure to attend timely visits. HIV-1 RNA test results were reported among patients who had been ART for ≥3 months at last visit. Of the 18,625 patients included in the analysis, 9659 (51.9%) attended at least one community visit. The proportion of community visits ranged from 0.3% (2019) to 44.1% (2021). Predictors of ≥1 community visit includedmale sex (aOR: 1.13; 95% CI: 1.06, 1.20), secondary education (aOR: 1.07; 95% CI: 1.01, 1.14), income > $USD 1.00/day (aOR: 1.24; 95% CI: 1.14, 1.35), longer duration on ART (aOR: 1.08 per additional year; 95% CI: 1.07, 1.09), and residence in Carrefour/Gressier (p<0.0001 in comparisons with all other zones). Younger age and shorter time on ART were associated with late visits and loss to follow-up. Among 12,586 patients with an on-time final visit who had been on ART for ≥3 months, 11,131 (88.4%) received a viral load test and 9639 (86.6%) had HIV-1 RNA < 1000 copies/mL. The socio-political situation in Haiti has presented extraordinary challenges to the health care system, but retention and viral suppression rates remain high with a model of community-based HIV care. Additional interventions are needed to improve outcomes for younger patients, and those with shorter time on ART. No funding.

Effect of post-mating GnRH or TAK-683 (Kisspeptin analog) treatment on the reproductive performance and serum progesterone concentration in ewes during the non-breeding season

This study was designed to evaluate the effect of post-mating GnRH or TAK-683 (kisspeptin analog) treatment on serum progesterone (P4) concentrations and fertility parameters of ewes during the non-breeding season. One hundred and twenty multiparous, lactating Awassi ewes were used. For estrus synchronization, vaginal sponges containing 60 mg of medroxyprogesterone acetate (MAP) were inserted into the vagina and kept there for nine days. On the day of sponge removal (day 0), 500 IU of eCG and 75 µg of d-cloprostenol were given intramuscularly. Rams were introduced in the flock 24 h after sponge removal and kept with the ewes for 26 days, allowing a second mating period after synchronized estrus. On the fourth day after mating (day 6) the ewes mated by the rams between the 24th and 72nd hours (n = 105) were randomly divided into three groups. Control group (n = 36) received 1 ml of saline solution subcutaneously; GnRH group (n = 34) received 4 μg of buserelin acetate intramuscularly; TAK-683 group (n = 35) received 5 μg of TAK-683 acetate subcutaneously. Blood samples were taken to measure serum P4 concentrations (ng/ml) at sponge insertion and on the 6th, 9th, 12th, 15th, 19th, 35th, and 50th days after sponge removal. Pregnancy diagnosis was conducted via serum P4 concentration measurement on the 19th day and transrectal ultrasonography on days 35 and 50. The results showed that GnRH treatment (4.823 ± 0.238; 2.151 ± 0.272) increased (P<0.05) the mean P4 concentration (ng/ml) in pregnant and non-pregnant ewes during the first mating period compared to Control (3.708 ± 0.207; 1.515 ± 0.164), while TAK-683 treatment (4.457 ± 0.181; 1.967 ± 0.213) was not different between groups. GnRH (58.82 %) and TAK-683 (42.10 %) treatments increased the pregnancy rate in the second mating period in comparison to the Control group (17.39 %) (P<0.05). Cumulative pregnancy and fecundity rates were higher in GnRH (79.41 %; 120.58 %) and TAK-683 (68.57 %; 100.0 %) groups than in the Control group (17.39 %; 58.33 %) (P<0.05). There was no difference in late embryonic loss rate among the groups (P>0.05), whereas early fetal loss rate tended to be lower in the TAK-683 (0 %) and GnRH (0 %) groups than in the Control group (15.38 %) (P=0.07). The total pregnancy loss rate (from day 19 to day 50 post-mating) was lower in GnRH (0 %) and TAK-683 (0 %) groups relative to the Control group (21.42 %) (P<0.05). There were no statistical differences among the groups in terms of the first mating period pregnancy rate, twinning rate, and litter size (P>0.05). As a result, treatment with GnRH and TAK-683 on the fourth day after mating increased fecundity in lactating ewes outside the breeding season by preventing total pregnancy losses (from day 19 to day 50) and increasing second mating pregnancy rates.

Histopathology of Allograft Nephrectomies – A Ten Year Observational Study

Background Though infrequent, allograft nephrectomies are performed for early and late graft loss. The study aims to analyze the histopathologic characteristics of allograft nephrectomy specimens. Materials and Methods We conducted an observational study of 103 cases of allograft nephrectomies from 21 centers from 2013 to 2023. All the pathology slides, including hematoxylin and eosin-stained sections, masson trichrome, jones methenamine silver, PAS, GMS, AFB, and immunohistochemistry (C4d, SV40) were reviewed. Pathologic findings were analyzed based on the transplant to nephrectomy interval (0–3 months, &gt; 3 months) and type of donor (deceased, live donor). Results Of the total 103 cases, 77 were male. The mean age at the time of nephrectomy was 36.4 (range 5–64) years. The allografts were obtained from deceased (57) donors and live related (46) donors. Graft tenderness, oliguria/anuria, and fever were common clinical presentations. The majority (71.8%) of the nephrectomies were performed within the first 3 months of renal transplant. Renal vessel thrombosis (32.03%) was the most common pathologic finding. Infections were more common in the first 3 months after the transplant. Fungal infection had a significant association with deceased donor transplantation (p = 0.029). Conclusion Histopathological study of allograft nephrectomy specimens aids understanding of graft loss causes. The study also provides opportunities to prevent complications and implement measures to prolong graft survival in a subsequent transplant.

Effects of Exercise-Based Cardiac Rehabilitation on Patients Undergoing Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis

Objective: This study aims to systematically analyze the impact of exercise-based cardiac rehabilitation on patients undergoing percutaneous coronary intervention (PCI). Methods: We searched for original studies on the effect of exercise-based cardiac rehabilitation on patients undergoing PCI published in domestic and foreign databases such as PubMed, Web of Science, Embase, Cochrane Library, China Knowledge Network (CNKI), and VIP until December 2023. Studies retrieved were screened, and meta-analysis was extracted. The quality of the literature was evaluated; meta-analysis was carried out by RevMan5.4 software (Cochrane Collaboration, Oxford, UK). Results: A total of 1073 sufferers undergoing PCI were included in 11 literatures. Meta-analysis displayed that cardiogenic mortality [risk ratio (RR) = 0.23, 95% confidence interval (CI) (0.08, 0.64)], coronary restenosis rate [RR = 0.59, 95% CI (0.41, 0.87)], revascularization rate [RR = 0.58, 95% CI (0.43, 0.79)], incidence of recurrent angina pectoris [RR = 0.41, 95% CI (0.27, 0.62)], and late lumen loss [RR = –0.60, 95% CI (–0.98, –0.23)] in the trial group, were lower than those in the control group (p &lt; 0.05). No significant difference was found in the recurrence rate of myocardial infarction between the test group and the control group [RR = 0.52, 95% CI (0.22, 1.25)]. Conclusion: Exercise-based cardiac rehabilitation therapy can effectively reduce the risk of major adverse cardio-cerebrovascular events, such as cardiogenic death and coronary restenosis after PCI; it reduces the late lumen loss of the stent coronary segment and has no obvious effect on the recurrence of myocardial infarction. However, this therapy tends to reduce the recurrence rate of myocardial infarction.

Survival loss linked to guideline-based indications for degenerative mitral regurgitation surgery.

Operating on patients with severe degenerative mitral regurgitation (DMR) is based on ACC/AHA or ESC/EACTS-guidelines. Doubts persist on best surgical indications and their potential association with postoperative survival loss. We sought to investigate whether guideline-based indications lead to late postoperative survival loss in DMR-patients. : We analyzed outcome of 2833 patients from the MIDA-registry undergoing surgical correction of DMR. Patients were stratified by surgical indications: Class-I-trigger (symptoms, left ventricular end-systolic diameter≥40mm, or left ventricular ejection fraction<60%, n=1677), isolated-Class-IIa-trigger (atrial fibrillation [AF], pulmonary hypertension [PH], or left atrial diameter≥55mm, n=568), or no-trigger (n=588). Postoperative survival was compared after matching for clinical differences. Restricted-mean-survival time (RMST) was analyzed. During a median 8.5-year follow-up, 603 deaths occurred. Long-term postoperative survival was lower with Class-I-trigger than in Class-IIa-trigger and no-trigger (71.4±1.9%, 84.3±2.3%, 88.9±1.9% at 10 years, p<0.001). Having at least one Class-I-criterion led to excess mortality (p<0.001), while several Class-I-criteria conferred additional death-risk (HR:1.53, 95%CI:1.42-1.66). Isolated-Class-IIa-triggers conferred an excess mortality risk versus those without (HR:1.46, 95%CI:1.00-2.13, p=0.05). Among these patients, isolated-PH led to decreased postoperative-survival versus those without (83.7%±2.8% vs. 89.3%±1.6%, p=0.011), with the same pattern observed for AF (81.8%±5.0% vs. 88.3%±1.5%, p=0.023). According to RMST-analysis, compare to those operated on without triggers, operating on Class-I-trigger patients led to 9.4-month survival-loss (p<0.001) and operating on isolated-Class-IIa-trigger patients displayed 4.9-month survival loss (p=0.001) after 10-years. : Waiting for the onset of Class-I or isolated-Class-IIa-triggers before operating on DMR patients is associated with postoperative survival loss. These data encourage an early surgical-strategy.

P-691 Effect of body mass index on early and late pregnancy loss in women with polycystic ovary syndrome undergoing in vitro fertilization and embryo transfer

Abstract Study question Are early and late pregnancy loss both affected by elevated body mass index (BMI) in women with polycystic ovary syndrome (PCOS) undergoing IVF-ET? Summary answer Late pregnancy loss but not early pregnancy loss was adversely affected by elevated BMI in women with PCOS undergoing IVF-ET. What is known already PCOS, the most common endocrine disorder in women of reproductive age, affects 5–18% of women. Obesity appears to be closely associated with PCOS. High BMI of the women with PCOS has been clearly associated with pregnancy loss. However, available data are limited for distinguishing between early and late pregnancy loss in PCOS women with different BMI and age. We performed a large cohort study of PCOS women conceived after IVF-ET to access the risk of early and late pregnancy loss. Study design, size, duration A retrospective cohort study of 3213 pregnancies after IVF-ET in women with PCOS from January 2015 to October 2022. Participants/materials, setting, methods The participants were the PCOS women with a positive human chorionic gonadotropin (hCG) after IVF-ET treatment in the reproductive centre of an university hospital. We studied early (≤12 weeks and biochemical pregnancy loss included) and late (&amp;gt;12 weeks) pregnancy loss in overweight group (BMI≥24 kg/m2) compared to normal group (BMI&amp;lt;24 kg/m2). Main results and the role of chance From 3213 PCOS women conceived after IVF-ET treatment, 1715 (53.4%) women were in overweight group and 1498 (46.6%) in normal group. Baseline characteristics age, primary infertility, pregnancy loss history, endometrial thickness, numbers and types of embryo transferred were not different between two groups. Overweight women had higher serum basal total testosterone and androstenedione levels. Early pregnancy loss (EPL) occurred in 24.2% (415) of overweight women with PCOS versus 21.6% (323) of those with normal weight (OR 1.16, 95% CI 0.98–1.37, P = 0.08). Rates of ELP were also comparable in both groups stratified by age. Overweight women had higher rates of late pregnancy loss (LPL) (6.6% in overweight group versus 3.3% in normal group, OR 2.11, 95% CI 1.50–3.00, P &amp;lt; 0.001). In subgroup analyses, young and advanced-age women with PCOS both had increased chances of LPL with elevated BMI. Logistic regression showed BMI was an independent risk factor of LPL considering age, androgen level, history of previous pregnancy loss, and infertility type. Limitations, reasons for caution Due to the retrospective study, records about gestation-related disease history and smoking were not complete and not shown. However, all patients with IVF-ET were asked to control gestation-related conditions suitable for pregnancy. Proportion of smoking was low and women who planned to conceive were advised to stop smoking before treatment. Wider implications of the findings This study enables physicians to counsel PCOS women undergoing IVF their risk of pregnancy loss more accurately based on personal characteristics. Trial registration number not applicable

Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients.

Drug-coated balloon (DCB) is an established treatment option for in-stent restenosis and small vessel, de novo, coronary artery disease (CAD). Although the use of this tool is increasing in everyday practice, data regarding performance in the treatment of de novo, large vessel CAD (LV-CAD) is still lacking. A systematic review and meta-analysis were conducted to evaluate the efficacy and safety of DCB versus drug-eluting stent (DES) in this setting. A comprehensive literature search was performed including Medline, Embase, and Cochrane electronic databases up to January 24, 2024, for studies which compared the efficacy and safety of DCB versus DES in the treatment of de novo lesions in large vessels (≥ 2.5mm), reporting at least one clinical outcome of interest (PROSPERO ID: CRD42023470417). The analyzed outcomes were cardiovascular death (CVD), myocardial infarction (MI), target lesion revascularization (TLR), all-cause death (ACD), and late lumen loss (LLL) at follow-up. The effect size was estimated using a random effects model as risk ratio (RR) and mean difference (MD) and relative 95% confidence interval (CI). A total of 13 studies (6 randomized controlled trials and 7 observational studies) involving 2888 patients (DCB n = 1334; DES n = 1533) with de novo LV-CAD were included in this meta-analysis following our inclusion criteria. No differences were observed between DCB and DES in terms of CVD (RR 0.49; 95% CI [0.23-1.03]; p = 0.06), MI (RR 0.48; 95% CI [0.16-1.45]; p = 0.89), TLR (RR 0.73; 95% CI [0.40-1.34]; p = 0.32), ACD (RR 0.78; 95% CI [0.57-1.07]; p = 0.12), and LLL (MD - 0.14; 95% CI [- 0.30 to 0.02]; p = 0.10) at follow-up. DES proved a higher mean acute gain versus DCB [1.94 (1.73, 2.14) vs 1.31 (1.02, 1.60); p = 0.0006]. Our meta-analysis showed that DCB PCI might provide a promising option for the management of selected, de novo LV-CAD compared to DES. However, more focused RCTs are needed to further prove the benefits of a "metal-free" strategy in this subset of CAD.

Biolimus-coated versus paclitaxel-coated balloons for coronary in-stent restenosis (BIO ASCEND ISR): a randomised, non-inferiority trial.

The treatment of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation remains challenging in current clinical practice. The study was conducted to investigate a novel biolimus-coated balloon (BCB) for the treatment of coronary DES-ISR compared with the best-investigated paclitaxel-coated balloon (PCB). This was a prospective, multicentre, randomised, non-inferiority trial comparing a novel BCB with a clinically proven PCB for coronary DES-ISR. The primary endpoint was in-segment late lumen loss (LLL) at 9 months assessed by an independent core laboratory. Baseline and follow-up optical coherence tomography were performed in a prespecified subgroup of patients. A total of 280 patients at 17 centres were randomised to treatment with a BCB (n=140) versus a PCB (n=140). At 9 months, LLL in the BCB group was 0.23±0.37 mm compared to 0.25±0.35 mm in the PCB group; the mean difference between the groups was -0.02 (95% confidence interval [CI]: -0.12 to 0.07) mm; p-value for non-inferiority<0.0001. Similar clinical outcomes were also observed for both groups at 12 months. In the optical coherence tomography substudy, the neointimal area at 9 months was 2.32±1.04 mm2 in the BCB group compared to 2.37±0.93 mm2 in the PCB group; the mean difference between the groups was -0.09 (95% CI: -0.94 to 0.76) mm2; p=non-significant. This head-to-head comparison of a novel BCB shows similar angiographic outcomes in the treatment of coronary DES-ISR compared with a clinically proven PCB. (ClinicalTrials.gov: NCT04733443).

Intravascular Ultrasound vs Angiography-Guided Drug-Coated Balloon Angioplasty: The ULTIMATE Ⅲ Trial

BackgroundDrug-coated balloon (DCB) angioplasty seems a safe and effective option for specific de novo coronary lesions. However, the beneficial effect of intravascular ultrasound (IVUS)-guided DCB angioplasty in de novo lesions remains uncertain. ObjectivesThis study aimed to assess the benefits of IVUS guidance over angiography guidance during DCB angioplasty in de novo coronary lesions. MethodsA total of 260 patients with high bleeding risk who had a de novo coronary lesion (reference vessel diameter 2.0-4.0 mm, and lesion length ≤15 mm) were randomly assigned to either an IVUS-guided or an angioplasty-guided DCB angioplasty group. The primary endpoint was in-segment late lumen loss (LLL) at 7 months after procedure. The secondary endpoint was target vessel failure at 6 months. ResultsA total of 2 patients in the angiography-guided group and 7 patients in the IVUS-guided group underwent bailout stent implantation (P = 0.172). The primary endpoint of 7-month LLL was 0.03 ± 0.52 mm with angiography guidance vs −0.10 ± 0.34 mm with IVUS guidance (mean difference 0.14 mm; 95% CI: 0.02-0.26; P = 0.025). IVUS guidance was also associated with a larger 7-month minimal lumen diameter (2.06 ± 0.62 mm vs 1.75 ± 0.63 mm; P < 0.001) and a smaller diameter stenosis (28.15% ± 13.88% vs 35.83% ± 17.69%; P = 0.001) compared with angiography guidance. Five target vessel failures occurred at 6 months, with 4 (3.1%) in the angiography-guided group and 1 (0.8%) in the IVUS-guided group (P = 0.370). ConclusionsThis study demonstrated that IVUS-guided DCB angioplasty is associated with a lower LLL in patients with a de novo coronary lesion compared with angiography guidance. (Intravascular Ultrasound Versus Angiography Guided Drug-Coated Balloon [ULTIMATE-III]; NCT04255043)

Sirolimus-eluting iron bioresorbable scaffold versus cobalt-chromium everolimus-eluting stents in patients with coronary artery disease: Rationale and design of the IRONMAN-II trial

BackgroundThe previous first-in-human study established the preliminary safety and effectiveness of the novel thin-strut iron bioresorbable scaffold (IBS). The current study aims to directly compare the imaging and physiological efficacy, and clinical outcomes of IBS with contemporary metallic drug-eluting stents (DES). MethodsA total of 518 patients were randomly allocated to treatment with IBS (257 patients) or metallic DES (261 patients) from 36 centers in China. The study is powered to test noninferiority of the IBS compared with the metallic everolimus-eluting stent in terms of the primary endpoint of in-segment late lumen loss at 2 years, and major secondary endpoints including 2-year quantitative flow ratio and cross-sectional mean flow area measured by optical coherence tomography (OCT) (limited to the OCT subgroup, 25 patients in each group). ConclusionThis will be the first powered randomized trial investigating the safety and efficacy of the novel thin-strut IBS compared to a contemporary metallic DES. The findings will provide valuable evidence for future research of this kind and the application of metallic bioresorbable scaffolds.

Developmental Disruption of Mef2c in Medial Ganglionic Eminence–Derived Cortical Inhibitory Interneurons Impairs Cellular and Circuit Function

BackgroundMEF2C is strongly linked to various neurodevelopmental disorders including autism, intellectual disability, schizophrenia, and attention-deficit/hyperactivity disorder. Mice that constitutively lack 1 copy of Mef2c or selectively lack both copies of Mef2c in cortical excitatory neurons display a variety of behavioral phenotypes associated with neurodevelopmental disorders. The MEF2C protein is a transcription factor necessary for cellular development and synaptic modulation of excitatory neurons. MEF2C is also expressed in a subset of cortical GABAergic (gamma-aminobutyric acidergic) inhibitory neurons, but its function in those cell types remains largely unknown. MethodsUsing conditional deletions of the Mef2c gene in mice, we investigated the role of MEF2C in parvalbumin-expressing interneurons (PV-INs), the largest subpopulation of cortical GABAergic cells, at 2 developmental time points. We performed slice electrophysiology, in vivo recordings, and behavior assays to test how embryonic and late postnatal loss of MEF2C from GABAergic INs impacts their survival and maturation and alters brain function and behavior. ResultsLoss of MEF2C from PV-INs during embryonic, but not late postnatal, development resulted in reduced PV-IN number and failure of PV-INs to molecularly and synaptically mature. In association with these deficits, early loss of MEF2C in GABAergic INs led to abnormal cortical network activity, hyperactive and stereotypic behavior, and impaired cognitive and social behavior. ConclusionsMEF2C expression is critical for the development of cortical GABAergic INs, particularly PV-INs. Embryonic loss of function of MEF2C mediates dysfunction of GABAergic INs, leading to altered in vivo patterns of cortical activity and behavioral phenotypes associated with neurodevelopmental disorders.

Long-term time-course of atrial sensing and incidence of atrial fibrillation in patients with VDD versus DDD pacemakers

Abstract Introduction VDD pacemakers (PM) theoretically have the same advantages with respect to maintaining atrioventricular (AV) synchrony as dual-chamber (DDD) pacemakers, with lower costs and simpler implantation procedure. However, their use is often limited by concerns about the maintenance of atrial sensing (AS) and the occurrence of atrial fibrillation (AF). Purpose We aimed to compare long-term atrial sensing stability, the incidence of AF and complications in VDD and DDD systems. Methods We retrospectively enrolled patients who underwent VDD or DDD PM implantation for AV block between 2014 and 2021 from 2 centers. Clinical, analytical and electrical variables at implantation, their evolution and events at follow-up (25.2±16.2 months) were collected, comparing the groups by Kaplan-Meier and Cox multivariate analysis. Results 487 patients who underwent PM implantation were included, 189 (38,8%) received a VDD PM and 298 (61,2%) a DDD PM. Patients with VDD were older and had a higher prevalence of risk factors and lower atrial voltage at implantation (Table). Complications at implantation and early complications were scarce and without significant differences in both groups. During follow-up, there was a reduction in atrial voltage in the VDD group (implant 1.4+0.8 mV; follow-up 1.2+0.9 mV; p&amp;lt;0.01), with stability in the DDD group (3.8+2.1 vs 3.9+2.2 mV). Total percentages of AS loss were 23.2% (VDD) vs 2.3% (DDD); p&amp;lt;0.01) (Figure 1). In the Cox multivariate analysis the risk of late AS loss was higher in the VDD group (HR=7.6; 95% CI 2.86-20.3; p&amp;lt;0.001) together with the AS values at implant (HR=0.72; 95% CI 0.52-1.00; p=0.052). AS loss was corrected with reprogramming in 23 patients, reintervention was needed in 1 (2%) and VVI was abandoned in 27 (53%). The risk of AF occurrence was lower in the VDD group (HR=0.39 CI 95% 0.18-0.87; p=0.021) (Figure 2). Conclusions In the long term, AS is significantly reduced in VDD MPs, leading to its loss in a quarter of VDD patients. It is usually correctable with reprogramming, rarely requiring abandonment to VVI. AS at implantation is crucial as it is directed related to the AS during follow-up. DDD PMs were independently associated with a higher incidence of AF, with no differences in the remaining complications.TableFigure

Drug-Eluting Balloons in Calcified Coronary Lesions: A Meta-Analysis of Clinical and Angiographic Outcomes.

Background: The usefulness of drug-eluting balloons (DEBs) has not been fully elucidated in calcified coronary lesions (CCLs). This meta-analysis aimed to evaluate the efficacy of DEBs compared to a drug-eluting stent (DES) in this setting. Methods: PubMed, EMBASE and Cochrane were searched through December 2023. The primary endpoint was 12 months major adverse cardiac events (MACE). Secondary endpoints included clinical outcomes and angiographic results after PCI and at a 12-month follow-up. Results: Five studies and a total of 1141 patients with 1176 coronary lesions were included. Overall, the DEB was comparable to DES in MACE (RR = 0.86, 95% CI: 0.62-1.19, p = 0.36), cardiac death (RR = 0.59, 95% CI: 0.23-1.53, p = 0.28), myocardial infarction (RR = 0.89, 95% CI: 0.25-3.24, p = 0.87) and target lesion revascularization (RR = 1.1, 95% CI: 0.68-1.77, p = 0.70). Although the DEB was associated with worse acute angiographic outcomes (acute gain; MD = -0.65, 95% CI: -0.73, -0.56 and minimal lumen diameter; MD = -0.75, 95% CI: -0.89, -0.61), it showed better results at 12 months follow-up (late lumen loss; MD = -0.34, 95% CI: -0.62, -0.07). Conclusions: This meta-analysis showed that the DEB strategy is comparable to DES in the treatment of CCLs in terms of clinical outcomes. Although the DEB strategy had inferior acute angiographic results, it may offer better angiographic results at follow-up.

Pregnancy and obstetric outcomes after fertility-sparing management of endometrial cancer and atypical hyperplasia: a multicentre cohort study.

What are the pregnancy and obstetric outcomes in women with atypical hyperplasia (AH) or early-stage endometrial cancer (EC) managed conservatively for fertility preservation? The study found a live birth rate of 62% in patients with AH or EC after conservative treatment, with higher level of labour induction, caesarean section, and post-partum haemorrhage. Fertility-sparing treatment is a viable option for women with AH or EC during childbearing years, but the outcomes of such treatments, especially regarding pregnancy and obstetrics, need further exploration. This retrospective cohort study analysed data from January 2010 to October 2022, involving 269 patients from the French national register of patients with fertility-sparing management of AH/EC. Women above 18 years of age, previously diagnosed with AH/EC, and approved for fertility preservation were included. Patients were excluded if they were registered before 2010, if their treatment began <6 months before the study, or if no medical record on the pregnancy was available. In total, 95 pregnancies in 67 women were observed. Pregnancy was achieved using ART in 63 cases (66%) and the live birth rate was 62%, with early and late pregnancy loss at 26% and 5%, respectively. In the 59 cases resulting in a live birth, a full-term delivery occurred in 90% of cases; 36% of cases required labour induction and 39% of cases required a caesarean section. The most common maternal complications included gestational diabetes (17%) and post-partum haemorrhaging (20%). The average (±SD) birthweight was 3110 ± 736 g; there were no significant foetal malformations in the sample. No significant difference was found in pregnancy or obstetric outcomes between ART-obtained and spontaneous pregnancies. However, the incidence of induction of labour, caesarean section, and post-partum haemorrhage appears higher than in the general population. The retrospective nature of the study may introduce bias, and the sample size might be insufficient for assessing rare obstetric complications. This study offers valuable insights for healthcare providers to guide patients who received fertility-sparing treatments for AH/EC. These pregnancies can be successful and with an acceptable live birth rate, but they seem to be managed with caution, leading to possible tendency for more caesarean sections and labour inductions. No increase in adverse obstetric outcomes was observed, with the exception of suspicion of a higher risk of post-partum haemorrhaging, to be confirmed. No funding was received for this study. There are no conflicts of interest to declare. N/A.

1333: Predicting late taste loss with deep learning NTCP model using 3D dose, CT and OAR segmentations

1333: Predicting late taste loss with deep learning NTCP model using 3D dose, CT and OAR segmentations

Drug-coated balloon in the treatment of coronary artery de-novo large lesions angiography.

The superiority of drug-coated balloon (DCB) in treating small vessels, branching lesions, and high-risk bleeding lesions in coronary heart disease patients has been confirmed. However, its safety and efficacy in large vessels are still unclear. We aimed to investigate whether the efficacy of DCB in large vessels is not inferior to that of drug-eluting stent (DES). From November 2019 to April 2022, a total of 88 patients in our hospital who underwent coronary angiography for the first time and decided to receive DCB or DES treatment were selected. Indicators including late lumen loss (LLL), major adverse cardiovascular event (MACE) rate, major bleeding and all-cause mortality were evaluated at 9 months and 1-year post percutaneous coronary intervention (PCI) therapy. The primary endpoint of 9-month LLL was -0.07 in the DCB group and 0.19 mm in the DES group (p value＜0.001). 1-year cumulative MACE rates were similar in the DCB and DES groups (3.03% vs. 7.23%, P=0.519), TLR rates were similar (3.03% vs. 7.23%, P=0.519), Major bleeding was similar (3.03% vs. 5.45%, P=0.580), and 1 case of Cardiac death in DES group. For LLL, the DCB-only strategy was non-inferior to DES in treating de novo large lesions in the coronary arteries. Furthermore, the efficacy of DCB was comparable to DES at 1 year of follow-up for secondary clinical endpoints.

Exploring Early, Middle, and Late Loss in Basic Activities of Daily Living among Nursing Home Residents: A Multicenter Observational Study.

Nursing home (NH) residents commonly face limitations in basic activities of daily living (BADLs), following a hierarchical decline. Understanding this hierarchy is crucial for personalized care. This study explores factors associated with early, middle, and late loss in BADLs among NH residents. A multicenter cross-sectional study was conducted in 30 NHs in Catalonia, Spain. Dependent variables were related to limitations in BADLs: early loss (self-care-related BADLs: personal hygiene, dressing, or bathing), middle loss (mobility-related BADLs: walking or wheelchair handling, toileting, and transferring), and late loss (eating). Independent variables were based on a comprehensive geriatric assessment and institutional factors. Logistic regression was used for the multivariate analyses. The study included 671 older adults. Early loss in BADLs was significantly associated with urinary incontinence, cognitive impairment, and falls. Middle loss in BADLs was linked to fecal incontinence, urinary incontinence, ulcers, and cognitive impairment. Late loss in BADLs was associated with fecal incontinence, the NH not owning a kitchen, neurological disease, cognitive impairment, dysphagia, polypharmacy, and weight loss. These findings highlight the need to address geriatric syndromes, especially cognitive impairment and bladder/bowel incontinence. Monitoring these syndromes could effectively anticipate care dependency. The presence of kitchens in NHs may help to address limitations to eating, allowing for potential personalized meal adaptation.