Three-year Outcomes Research Articles

WW vs TME in patients with rectal cancer with a complete or near-complete response to TNT: Pooled analysis of CAO/ARO/AIO-12 and OPRA trials.

21 Background: Patients with locally advanced rectal cancer (LARC) and a clinical complete response (cCR) or near-complete response (nCR) to total neoadjuvant therapy (TNT) can be offered watch-and-wait (WW) with the intention of achieving organ preservation. However, one third of patients on WW develop tumor regrowth and require total mesorectal excision (TME). Assessing the safety of WW in patients with a cCR or nCR is challenging due to the difficulty of finding an adequate control group. Here we compare the survival outcomes of patients with LARC treated with TNT and either mandatory TME or selective WW stratified by tumor response. Methods: This is a pooled analysis of two multicenter, phase II trials (CAO/ARO/AIO-12 [CAO] and OPRA) that randomized patients with stage II/III rectal cancer to either induction or consolidation TNT. All patients in the CAO trial underwent TME within 6 weeks of TNT. Pathologic tumor regression grade (TRG) was categorized as complete (TRG 4), intermediate (TRG 2,3) or poor (TRG 0,1). Patients in the OPRA trial were restaged by endoscopy and MRI 8±4 weeks after end of TNT. Clinical response was graded as cCR, nCR, or incomplete clinical response (iCR). Patients with a cCR or nCR were offered WW; patients with an iCR were recommended for TME. Survival curves were estimated using the Kaplan-Meier method and the log-rank test. Results: The study included 628 patients ( n =304 CAO; n =324 OPRA). Median follow-up was 3.6 (IQR 1.13) and 5.1 (IQR 2.2) years. Patients in the CAO trial were more likely to have cT3/4 and cN positive disease while patients in the OPRA trial had tumors closer to the anal verge. Compliance with TNT and rates of grade 3+ adverse events were similar between studies. A total of 144 (47%) patients in the OPRA trial achieved long term organ preservation. We found no differences in survival between trials. In addition, we found no differences in DFS between studies for patients with an excellent (TRG4 87% [95% CI, 79-97%], cCR 87% [95% CI, 81-93%]) or intermediate (TRG2-3 69% [95% CI, 62-76%], nCR 71% [95% CI, 68-80%]) response. Conclusions: This pooled analysis demonstrated that almost half of LARC patients treated with TNT can achieve organ preservation and that a selective WW strategy yields similar survival outcomes compared to mandatory TME. In addition, we found no differences in survival based on paired clinical and pathologic tumor response grades following TNT. This data provides further evidence supporting the safety of WW for patients with LARC and a cCR or nCR to TNT. Three-year survival outcomes in the CAO/ARO/AIO-12 and OPRA trials. CAO/ARO/AIO-12(95% CI) OPRA(95% CI) P 3y DFS 73 (71–81)% 76 (68–78)% 0.3 3y DRFS 82 (78–87)% 82 (78–87)% 0.7 3y LRFS 95 (92–98)% 95 (92–97)% 0.4 3y OS 92 (89–95)% 94 (89–95)% 0.5 DFS: disease-free survival, DRFS: distant recurrence-free survival, LRFS: local recurrence-free survival, OS: overall survival.

Isolated congenital diaphragmatic hernia and three-year neurodevelopmental outcomes.

To retrospectively investigate the developmental outcomes at 3 years of age in patients with congenital diaphragmatic hernia (CDH) using a multicenter collaborative research approach. We evaluated patients with CDH and no other malformations born between 2010 and 2016 in seven facilities in the Japanese CDH Research Group. The developmental quotient (DQ) at 3 years of age was evaluated using the Kyoto Scale of Psychological Development 2001, the most standardized scale in Japan. Factors associated with a DQ score < 85 were also analyzed. Of 196 patients, developmental assessments at 3 years of age were performed in 132 patients (67%). Among these, 99 patients (75%) had a DQ score ≥ 85, 25 (19%) had a DQ score between 70 and 84, and 8 (6%) had a DQ score < 70. Multivariate analysis showed that the observed/expected lung area-to-head circumference ratio was an independent predictor of a DQ score < 85, with an adjusted odds ratio of 0.62 (95% confidence interval: 0.40-0.96; p = 0.03). Generally, isolated CDH is associated with good developmental outcomes for survivors, even after intensive care. However, there is a risk of neurodevelopmental impairment if pulmonary hypoplasia is present. This research highlights the observed/expected lung area-to-head circumference ratio (o/e LHR) as a crucial indicator to predict neurodevelopmental outcomes in 3-year-old children diagnosed with isolated congenital diaphragmatic hernia (CDH). Our results provide robust evidence from a large multicenter cohort, emphasizing the importance of o/e LHR in early risk stratification and prolonged neurodevelopmental follow-up. These findings highlight the need for comprehensive management and tailored follow-up care in CDH patients, potentially improving clinical protocols and enhancing the quality of life and outcomes for affected children.

Salpingectomy With Delayed Oophorectomy Versus Salpingo-Oophorectomy in BRCA1/2 Carriers: Three-Year Outcomes of a Prospective Preference Trial.

To compare menopause-related quality of life (QoL) after risk-reducing salpingectomy (RRS) versus risk-reducing salpingo-oophorectomy (RRSO) until 3 years of post-surgery. A prospective study (TUBA study) with treatment allocation based on patients' preference. Data were collected pre-surgery and at 3 months, 1 and 3 years of post-surgery. Multicentre prospective preference trial in thirteen hospitals in the Netherlands. BRCA1/2 pathogenic variant (PV) carriers aged 25-40 (BRCA1) or 25-45 (BRCA2), who were premenopausal, without a future child wish and without current (treatment for) malignancy. Treatment allocation was based on patients' preference: either RRS from the age of 25 years with delayed oophorectomy at the maximum age of 45 (BRCA1) or 50 (BRCA2), or RRSO between the ages of 35-40 (BRCA1) or 40-45 (BRCA2). After RRSO, hormone replacement therapy (HRT) was recommended, if not contraindicated. Primarily, menopause-related QoL as measured with the Greene Climacteric Scale (GCS) was compared between the RRS and RRSO without HRT group. Secondarily, GSC-scores of the RRS group were compared with the scores of the RRSO with HRT after surgery group. A higher GSC-score reflects more climacteric symptoms. Until April 2023, 410 participants had undergone RRS and 160 RRSO. The BRCA1/BRCA2 proportions were 51.4%/48.6%. The mean age at surgery (SD) was 37.9 (3.5) years. Participants 3 years after RRSO without HRT had a 4.3 (95% CI 2.1-6.5; p < 0.001) point higher increase in GCS-score from baseline compared to those after RRS, while the difference was 7.9 (95% CI 5.9-9.8) and 8.5 (95% CI 6.5-10.5) points at 3 and 12 months, respectively. Among participants with HRT after surgery, the RRSO group had a 2.4 (95% CI 0.8-3.9; p = 0.002) point higher increase in GCS-score from baseline compared to the RRS group. In this multicentre preference trial, menopause-related QoL was better after RRS than after RRSO, even with HRT after RRSO. Differences between arms were most pronounced until one-year post-surgery.

Three-Year Outcomes of a US Pivotal Trial Substudy for Conformable Endoprosthesis in >=10 mm Non-Angulated Neck Anatomy

To report the midterm clinical outcomes from the GORE® EXCLUDER® Conformable AAA Endoprosthesis system (EXCC) pivotal regulatory trial in the United States (U.S.). This is a prospective, multicenter, investigational device exemption clinical trial at 31 US. sites with Core Laboratory assessment of imaging and independent adjudication of safety. The study enrolled patients with abdominal aortic aneurysms (AAA) with a minimum proximal landing zone ≥10mm and proximal neck angulation of ≤60 degrees between December 2017 and February 2019 as part of a larger study to gain indications of the EXCC device. Endpoints included patient survival, freedom from secondary interventions, and stent-graft related outcomes. There were 80 patients enrolled (88.8% male, mean 73.5± 8.14 years-old). Mean maximum aortic diameter was 57.7±8.0mm (range, 42.5-82.7). There was 100% freedom from type I and III endoleak and aneurysm-related mortality at 36-months. Freedom from secondary intervention was 91.9± (0.83, 0.96, 95% C.I.) at 36-months. There were no device fractures, migrations (≥10mm), or aneurysm ruptures. At 36months, thirteen patients (26.5%) had type 2 endoleak, 32 patients (58.2%) had AAA sac regression, 17 (30.9%) had no change in diameter, and 6 (10.9%) had sac enlargement. Seven patients (8.8%) through 36months underwent reintervention. The 3-year outcomes have continued to show an adequate safety and efficacy profile of the EXCC device with no aneurysm related mortality or Type I/III endoleak. These results demonstrate durability for an EVAR device in US regulatory trials.

Three-year Clinical Outcome of Root Canal Treatment Using a Single-cone Technique and Ceraseal Premixed Bioceramic Sealer: A Prospective Cohort Study.

To evaluate the outcome of teeth filled with a single cone technique and a premixed bioceramic sealer at 3 years of follow-up. Healthy patients were consecutively treated by a cohort of postgraduate operators. Root canal filling procedures were performed with NiTi rotary instrumentation, while non-surgical retreatments were performed using NiTi reciprocating instruments. Root canal filling procedures were performed using Ceraseal and the single cone technique. Post-endodontic restorations were performed after 15 days. Provisional and definitive crowns were positioned in case of non-sufficient coronal structure. Periapical radiographs were made before treatment, after filling, and at each follow-up visit (6, 12, 24 and 36 months). The periapical Index (PAI) was used to assess the presence of periapical lesions and their modifications over time. Success (absence of periapical radiolucency, PAI <3) and survival rates were evaluated. The presence of apical extrusion was also radiographically assessed. Linear regression analysis was used to investigate changes in mean PAI scores, and logistic regression analysis was used to investigate changes in the percentage of healed cases. All analyses were replicated using two distinct approaches: per protocol (PP) (treatments who completed the follow-up) and intention to treat (ITT) (all root canal treatments). A significance level of 5% was used for all statistical tests (α=0.05). Fifty-eight endodontic treatments in 52 patients were performed (ITT). Thirty-eight endodontic treatments in 33 patients completed the 3 years of follow-up with a survival rate of 92.7%. The success rate was 85.4% (PP). The use of Ceraseal associated with the single cone technique was safe in maintaining endodontically affected teeth. (EEJ-2024-01-02).

Three-year outcomes of off-the-shelf Gore thoracoabdominal multibranch endoprosthesis and physician-modified endografts for complex abdominal and thoracoabdominal aortic aneurysms

Three-year outcomes of off-the-shelf Gore thoracoabdominal multibranch endoprosthesis and physician-modified endografts for complex abdominal and thoracoabdominal aortic aneurysms

Three-year outcomes of surgical bleb revision with mitomycin C for early scarring bleb after trabeculectomy.

To report the 3-year outcomes of surgical bleb revision (SBR) with mitomycin C (MMC) for early scarring bleb after trabeculectomy (TLE). Retrospective observational study. We included glaucoma patients aged ≧ 18 who underwent SBR with MMC within 6 months of their first TLE at Kobe University Hospital and were followed for at least 6 months. The primary outcome measure was the three-year success rate of SBR. We defined surgical success as: intraocular pressure (IOP) reduction ≧ 20% from baseline and 5 ≦ IOP ≦ 18 mmHg. Failure was defined when the IOP deviated from the criteria, when the eye required additional glaucoma surgery, and when the eye lost light perception. Complete success (CS) was success without glaucoma medications and qualified success (QS) was success with glaucoma medications. The secondary outcome measures included IOP, the number of glaucoma medications, mean deviation (MD), best corrected visual acuity (BCVA), corneal endothelial cell density (ECD), and surgical complications. Sixty-eight eyes of 68 patients were analyzed. The median interval between initial TLE and SBR was 2 months. Overall success rate at three-year after SBR were 45.1% and 9.6% for QS and CS, respectively. A greater number of medications used before TLE was a contributing factor to failure (P = 0.02). 22 eyes (32.4%) underwent additional glaucoma surgery, and 41 eyes (60.3%) were spared from additional glaucoma surgery within 3 years after SBR. The median IOP decreased form 24.0 mmHg to 11.0 mmHg 3 years after SBR, and the number of medications decreased from 4 to 2 (P < 0.01). MD remained unchanged, but BCVA and ECD decreased at 3years postoperatively. There were no serious complications of SBR. SBR may be an effective treatment option for early scarring blebs after TLE but is unsuccessful in eyes that have used many glaucoma medications prior to TLE.

Three-year outcome of a very young severe uncontrolled preschool wheezers cohort, a real-life study

Preschool wheeze is a public health issue. Disease control can be difficult to obtain in this population, in which no biologic therapy is indicated. We studied the evolution of severe preschool wheezers in real-life and identified the factors leading to no-control.We conducted a retrospective study at our tertiary asthma center. Each child under 3 years of age with severe, uncontrolled preschool wheeze was admitted to a pediatric day hospital for further investigations. We collected the results of clinical, biological and radiological exams, and follow-up data at 1 (Y+1), 2 (Y+2) and 3 years (Y+3).We included 135 patients; 63 (47 %) were still being followed at Y+3; 53 % were discontinued due to disease control. The median age at inclusion was 12 months. 29 % of patients followed up still had severe uncontrolled wheezing at Y+3. Eosinophils greater than 0.23G/L (p = 0.03) and a first case of bronchiolitis before the age of 2 months (p = 0.01) were factors in uncontrolled wheezing at Y1. Tobacco exposure was a factor associated with uncontrolled wheezing at Y+2 (p < 0.001). A first case of bronchiolitis before the age of 2 months (p = 0.007), male sex (p < 0.001) and a familial history of atopy (p = 0.05) were factors in uncontrolled disease at Y+3.We report a real-life study, with a very young population and very severe wheezing. Our therapeutic approach is original, enabling us to study the evolution of “therapeutic pressure” in the early years of this frequent disease, the pathophysiology of which is still poorly understood.

Three-year follow-up outcomes of postoperative quality of life from a randomized controlled trial comparing multi-port versus single-port laparoscopic distal gastrectomy.

Laparoscopic surgery for gastric cancer has become widely used; minimally invasive surgery has become the mainstream of treatment. This randomized controlled trial (RCT) aimed to compare long-term quality of life (QoL) and weight loss rates in patients who underwent single-port laparoscopic gastrectomy (SLG) or multi-port laparoscopic gastrectomy (MLG) for gastric cancer. This single-center RCT compared MLG and SLG in patients with clinical stage I gastric cancer, all of which underwent distal gastrectomy between April 2016 and September 2018. A total of 101 patients were evaluated for eligibility; all were randomized into either the SLG group (n = 50) or MLG group (n = 51). Blood tests, weight measurements, and postoperative questionnaires (DAUGS20, EORTC QLQ-C30, PGSAS-45) were performed at 3, 6, 12, and 36months after surgery to compare the QoL. At six months postoperatively, there was a higher trend toward lower weight loss in the SLG group compared with the MLG group. At 1, 3, 6, and 36months postoperatively, the neutrophil-to-lymphocyte ratio was significantly lower in the SLG group than that in the MLG group. The QoL, as measured using the postoperative questionnaires, was generally comparable. However, some favorable results, such as fewer diarrheas, were achieved. SLG was partially superior to MLG in terms of long-term QoL, in addition to assurance of esthetics and reduced pain. In addition, systemic inflammatory markers and weight loss rates were lower, suggesting a potential long-term benefit. SLG may be an option for stage I gastric cancer surgery. Further follow-up and multicenter studies should be considered.

Surrogate End Points in Apolipoprotein L1 - Associated Kidney Disease : Evaluation in Three Cohorts.

Surrogate endpoints for the clinical outcome of kidney failure have been accepted by the United States Food and Drug Administration. However, they have not been specifically evaluated in Apolipoprotein L1 (APOL1)-associated kidney disease. This random-effects meta-analysis included African-American participants in the Atherosclerosis Risk in Communities (ARIC) study (N=3071), the Chronic Renal Insufficiency Cohort (CRIC; N=998), and the African American Study of Kidney Disease and Hypertension (AASK; N=609). Surrogate endpoints included three-year 30% and 40% decline in glomerular filtration rate (GFR), doubling of urine protein-to-creatinine ratio (UPCR), and >3 ml/min/1.73 m2 per year decline in GFR. Clinical outcomes included kidney failure requiring kidney replacement therapy, heart failure, cardiovascular disease, and death after three years.Results: 22% in AASK, 18% in CRIC, and 13% in ARIC had the APOL1 high risk genotype. Participants with the APOL1 high-risk genotype had higher risk of all three-year GFR outcomes but not doubling of UPCR, as well as kidney failure after three years. The three-year outcomes were strongly associated with kidney failure, with weaker but statistically significant associations with the development of heart failure, cardiovascular disease, and mortality. There were no differences in associations between short-term and long-term clinical outcomes by APOL1 risk status. Individuals with the APOL1 high risk genotype were more susceptible to three-year GFR-related endpoints and long-term kidney failure than individuals with the APOL1 low-risk genotype. There was no consistent difference in short-term-clinical outcome associations by APOL1 genotype, supporting the use of surrogates in APOL1-associated kidney disease.

Metabolic Surgery in South Africa: Baseline Demographic Description and Three-Year Outcomes for Patients Receiving GBP and BPD-DS Surgeries

Metabolic Surgery in South Africa: Baseline Demographic Description and Three-Year Outcomes for Patients Receiving GBP and BPD-DS Surgeries

Benefits of Tadalafil and Sildenafil on Mortality, Cardiovascular Disease, and Dementia

BackgroundErectile dysfunction and lower urinary tract symptoms, from benign prostatic hyperplasia and bladder neck obstructions, are prevalent in men and associated with an increased risk of cardiovascular diseases. Phosphodiesterase-5 (PDE-5) inhibitors, such as tadalafil and sildenafil, are used to treat erectile dysfunction and may also offer cardiovascular benefits due to their vasodilatory effects. This study evaluates the impact of these PDE-5 inhibitors on all-cause mortality, cardiovascular disease, and dementia in middle-aged men with erectile dysfunction and lower urinary tract symptoms over a 3 year follow-up period. MethodsThis longitudinal study analyzed data from 50 million US men using the TriNetX database. Men at least 40 years of age prescribed tadalafil or sildenafil after an erectile dysfunction diagnosis, or tadalafil after lower urinary tract symptom diagnoses, from 2004 to 2021 were included. Three-year outcomes assessed included all-cause mortality, cardiovascular disease, and dementia, comparing men on PDE-5 inhibitors to those not on these medications. Propensity matching was performed for demographics and eight pre-existing conditions. ResultsThe final cohort included 509,788 men with erectile dysfunction and 1,075,908 with lower urinary tract symptoms. Tadalafil and sildenafil were associated with significantly reduced risks of all-cause mortality (RR 0.66/0.76), myocardial infarction (0.73/0.83), stroke (0.66/0.78), venous thromboembolism (0.79/0.80), and dementia (0.68/0.75) in erectile dysfunction patients, with tadalafil showing more significant benefits. In lower urinary tract symptom patients, tadalafil was similarly associated with reduced mortality, cardiovascular disease, and dementia. ConclusionsIn conclusion, tadalafil and sildenafil use in erectile dysfunction patients reduced mortality, cardiovascular disease, and dementia risks, with tadalafil providing more benefits. Tadalafil also conferred similar benefits to patients with lower urinary tract symptoms.

Three-Year Outcomes Following TAVR in Younger (

Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery. The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years. In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery (P=0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; P=0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; P<0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, P=0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients (P<0.001) and lower rates of severe prosthesis-patient mismatch (P<0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation. Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR. URL: https://clinicaltrials.gov; Unique identifier: NCT02701283.

Long-Term Health Outcomes of Huntington Disease and the Impact of Future Disease-Modifying Treatments: A Decision-Modeling Analysis.

Disease-modifying treatments (DMTs) such as gene therapy are currently under investigation as a potential treatment for Huntington disease (HD). Our objective was to estimate the long-term natural history of HD progression and explore the potential efficacy impacts and value of a hypothetical DMT using a decision-analytic modeling framework. We developed a health state transition model that separately analyzed 40-year-old individuals with prefunctional decline (PFD, HD Integrated Staging System [HD-ISS] stage <3, total functional score [TFC] 13), active functional decline Shoulson and Fahn category 1 (SF1, HD-ISS stage 3, TFC 13-11), and SF2 (HD-ISS stage 3, TFC 10-7). Three-year outcomes from the TRACK-HD longitudinal study were linearly extrapolated to estimate the long-term health outcomes and costs of each population. For PFD individuals, we used the HD-ISS to predict the onset of functional decline. HD costs and quality-adjusted life years (QALYs) were estimated over a lifetime horizon by applying health state-specific costs and utilities derived from a related HD burden-of-illness study. We then estimated the long-term health impacts of hypothetical DMTs that slowed or delayed onset of functional decline. We conducted sensitivity analyses to assess model uncertainties. The expected life years for 40-year-old PFD, SF1, and SF2 populations were 20.46 (95% credible range [CR]: 19.05-22.30), 13.93 (10.82-19.08), and 10.99 (8.28-22.07), respectively. The expected QALYs for PFD, SF1, and SF2 populations were 15.93 (14.91-17.44), 8.29 (6.36-11.79), and 5.79 (4.14-12.91), respectively. The lifetime costs of HD were $508,200 ($310,300 to $803,700) for the PFD population, $1.15 million ($684,500 to $1.89 million) for SF1 individuals, and $1.07 million ($571,700 to $2.26 million) for SF2 individuals. Although hypothetical DMTs led to cost savings in the PFD population by delaying the cost burdens of functional decline, they increased costs in SF1 and SF2 populations by prolonging time spent in expensive progressive HD states. Our novel HD-modeling framework estimates HD progression over a lifetime and the associated costs and QALYs. Our approach can be used for future cost-effectiveness models as positive DMT clinical trial evidence becomes available.

THREE-YEAR CLINICAL OUTCOMES IN GEOGRAPHIC ATROPHY: An Analysis of 18,712 Patient Eyes.

To assess visual outcomes and rate of neovascular age-related macular degeneration (nAMD) development in eyes with geographic atrophy (GA). Retrospective analysis of 18,712 eyes with GA using the CorEvitas Vestrum Health Retina Database. Mean age at index was 78.6 years (SD = 7.9) and mean visual acuity was 67.5 letters (SD = 13.0, Snellen equivalent 20/45). In total, 18.9% of eyes developed nAMD within 36 months. Eyes with fellow-eye nAMD developed nAMD at over twice the rate of eyes with fellow-eye GA (relative risk 2.34, 95% confidence interval [2.20-2.49]). Mean visual acuity of eyes that did not develop nAMD declined by 12.4 letters (95% confidence interval [12.0-12.9]) within 36 months. Older age and moderate baseline visual impairment (visual acuity <20/40-20/100) independently correlated with accelerated rate of decline. Eyes of patients in the oldest quartile with moderate visual impairment experienced the worst outcomes, losing an average of 19.7 letters over 36 months (95% confidence interval [18.1-21.3]). By 36 months, 70% of eyes had vision below threshold for driving (visual acuity ≤20/40), 42% had low vision (visual acuity ≤20/70), and 23% were legally blind (visual acuity ≤20/200). Geographic atrophy is associated with significant disease burden. Eyes with GA lose an average of two to three lines of visual acuity within 36 months of follow-up. Older age and moderate baseline visual impairment independently correlate with poorer visual outcomes. Presence of nAMD in the fellow eye is associated with 2-fold higher risk of exudative conversion within 36 months.

A three-year experience with the balloon expandable GORE VIABAHN VBX in the treatment of thoraco-abdominal aortic aneurysms within the EXPAND trial

ObjectiveThe EXPAND registry is a post-market, multicenter registry that aims at evaluating the safety and performance of the GORE VIABAHN VBX balloon expandable endoprosthesis (VBX stent) implanted in peripheral vessels. This subgroup analysis assesses the 3-year outcomes of the VBX stent as a bridging stent graft for visceral vessels during branched endovascular aortic repair. MethodsThis prospective, multicenter, observational registry includes 16 European sites. Patients were enrolled from November 2018 to March 2022. Endpoints included 3-year primary patency (PP), secondary patency (SP), and stent graft-related death and serious adverse events. ResultsSeventy-three patients, of whom 57 (78.1%) were male, with a mean age of 73 years (±8.1 years) were included. At 3 years, 42 patients (57.5%) returned for follow-up. Overall, 223 target vessels (TVs) were treated. The estimated freedom from loss of TV PP was 93.6%. Per TV PP rates were 97.0% for the celiac trunk, 93.9% for the superior mesenteric artery, 91.2% for the left renal artery, and 92.5% for the right renal artery. The overall estimated freedom from loss of SP was 96.8%, and freedom from TV instability was 94.5%. ConclusionsThe VBX stent demonstrated excellent sustained results at 3 years with almost 94% PP, 97% SP, and 94.5% freedom from TV instability. Patency in the renal arteries was lower than in the celiac trunk and superior mesenteric artery. The VBX stent appears to be a reliable bridging stent for target vessels in branched endovascular aortic repair.

TCT-445 Three-Year Outcomes of Drug-Coated Balloons Versus Drug-Eluting Stents for Small Coronary Arteries: A Systematic Review and Meta-Analysis

TCT-445 Three-Year Outcomes of Drug-Coated Balloons Versus Drug-Eluting Stents for Small Coronary Arteries: A Systematic Review and Meta-Analysis

Three-Year Safety and Efficacy of Endovascular Treatment of Common Femoral Artery in 150 PAD Patients.

Background: The gold standard treatment for peripheral arterial disease (PAD) of the common femoral artery (CFA) is open common femoral endarterectomy (CFAE). Interest in the less invasive endovascular treatment (EVT) is growing due to PAD patients' frequent co-morbidities. Aims: We aimed to evaluate three-year EVT outcomes in multimorbid PAD patients with severe calcified CFA lesions. Methods: Using the prospectively maintained "all-comers" Duesseldorf PTA Registry, we analysed the three-year outcomes of 150 patients with EVT of the CFA. Between January 2017 and October 2023, 66 patients received a rotational excisional atherectomy (REA) followed by a drug-coated balloon angioplasty (DCB), and 84 patients received a DCB alone. Results: All procedures involved the CFA, 49% additionally involved the proximal superficial femoral artery (SFA), and 10% of the lesions involved the profunda femoris artery (PFA). The procedural success rate was 97% and independent of PAD stage, with a higher level of stent implantation in the DCB group (58% vs. 39%, p < 0.05). The primary patency rate at one year was 83% for REA + DCB and 87% for DCB (p = 0.576), while secondary patency after three years was 97%. The MALE rate at three years was mainly driven by cdTLR (REA + DCB: (20%) vs. DCB: (14%), p = 0.377), while major amputations were low in both groups (REA + DCB: 3% vs. DCB: 1%). Overall, the major adverse cardiovascular events (MACEs) rate at three years was low (REA + DCB: (5%) vs. DCB: (11%), p = 0.170). Conclusions: The EVT of severely calcified CFA lesions is safe and effective, with high three-year patency rates and low rates of major adverse limb events (MALEs) and MACEs. This registry demonstrates that vessel preparation with REA minimizes the need for stenting.

Three-year outcomes following non-ST-segment elevation myocardial infarction and new-generation drug-eluting stent implantation, stratified by patient age (under and over 75 years) and left ventricular ejection fraction: A prospective cohort study.

Due to limited published data, we investigated 3-year outcomes according to left ventricular ejection fraction (LVEF) in patients older and younger than 75 years with non-ST-segment elevation myocardial infarction (NSTEMI) who underwent successful newer-generation drug-eluting stent (DES) implantation. This research analyzed the data of 4558 patients (1032 older adults [≥75 years] and 3526 younger adults [<75 years]) from the Korea Acute MI Registry-NIH. We further divided the older group based on LVEF: heart failure (HF) with reduced EF (HFrEF, ≤40%, n = 196; group A), HF with mildly reduced EF (HFmrEF, 41-49%, n = 228; group B), and HF with preserved EF (HFpEF, ≥50%, n = 608; group C). Similarly, the younger group was divided into HFrEF (group D, n = 353), HFmrEF (group E, n = 577), and HFpEF (group F, n = 2596). The primary outcome was a composite of major adverse cardiac events (MACE) at 3 years, including all-cause death, recurrent MI, any repeat revascularization, or hospitalization for HF. MACE rates were highest in the HFrEF groups (A and D), followed by the HFmrEF groups (B and E), and lowest in the HFpEF groups (C and F) for both age groups. All-cause death, cardiac death (CD), all-cause death or MI, and hospitalization for HF rates were higher in group A than in groups B and C, and higher in group D than in groups E and F. Across all LVEF categories, MACE, all-cause death, CD, and non-CD, and all-cause death or MI rates were higher in the older group. This multicenter cohort study demonstrates that older patients have higher mortality rates compared to younger patients. Additionally, MACE rates were highest in the HFrEF group, followed by the HFmrEF group, and lowest in the HFpEF group across both age groups. Further research is needed to confirm these findings.

Single preoperative radiation therapy with delayed surgery for low-risk breast cancer: Oncologic outcome, toxicity and cosmesis of the SPORT-DS phase I trial

BackgroundA novel approach using single-fraction preoperative partial breast irradiation (PBI) for low-risk breast cancer is under study. We sought to investigate the rate of pathologic response (pR), toxicities and cosmetic results related to this new treatment strategy. MethodsWomen of 65 years or older with stage I unifocal luminal A breast cancer were eligible for inclusion in this phase I prospective trial. Patients received a single 20 Gy dose of PBI followed by breast-conserving surgery (BCS) 3 months later. The primary endpoint was the pR rate, and the secondary endpoints were radiation therapy-related toxicity and cosmetic results. ResultsThirteen patients were treated, with a median age of 71. Eleven patients (84.6 %) had pR with a median residual cellularity of 1 % (range: 0–10 %). At median follow-up of 48.5 months, no recurrences or cancer-related deaths were recorded. Acute radiation therapy-related toxicity were limited to grade 1 dermatitis and breast pain. At the 1-year follow-up, there were one grade 2 fat necrosis and two grade 3 toxicities (wound infection and hematoma). Only grade 1 toxicities remained at 2 years, but one grade 2 toxicity (fibrosis/induration) developed by the 3-year follow-up. Three-year patient-reported cosmetic outcomes were good or excellent in 60 % of patients. ConclusionsSingle-fraction preoperative PBI preceding BCS for low-risk breast cancer is feasible, relatively well tolerated and leads to a high level of pR. The 3-month interval after PBI seems to place surgery in a post-radiation inflammatory phase. Further delay between PBI and surgery could improve pR and cosmetic outcome. NCT03917498.