Term Safety Research Articles

Efficacy and safety of a patent hemostatic device (PHD) with quantitative pressure for radial artery hemostasis: a first-in-human feasibility study

Abstract Objectives: Hemostatic devices are commonly used after coronary angiography (CAG) or percutaneous coronary intervention (PCI) via the transradial approach. However, radial artery occlusion (RAO) and bleeding still occur due to uncertainties regarding the hemostatic pressure. The aim of this study is to evaluate the safety and feasibility of a patent hemostatic device (PHD) with individualized hemostatic pressure settings to mitigate the risks of RAO and bleeding. Methods: A single-center, prospective, feasibility study was conducted in patients undergoing CAG/PCI. Adults recruited from Peking University First Hospital received the PHD. RAO, bleeding, hematoma, compression time, self-reported syndromes (pain, numbness, swelling) and other access complications were measured. Results: PHD was attempted in 11 participants with a mean age of 59.0±10.8 years of whom 90.9% were male. The average hemostatic pressure after CAG/PCI was 141.8±19.5 mmHg with a compression time of 210.0±72.3 min. None of the participants exhibited RAO. Three participants had errhysis and one participant suffered minor bleeding. 72.7% (8 of 11) participants achieved successful hemostasis within 3 hours. No moderate or severe pain, numbness or swelling were observed. Conclusions: This study shows the feasibility of the novel PHD for radial hemostasis in a small cohort of patients. Considering the potential benefits, particularly the prevention of RAO, a larger sample size is needed to evaluate the long term safety and efficacy of the PHD.

Long term efficacy and safety profile of dexamethasone intravitreal implant in retinal vein occlusions: a systematic review

Long term efficacy and safety profile of dexamethasone intravitreal implant in retinal vein occlusions: a systematic review

Long term effectiveness and safety assessment of carbon dioxide laser treatment in Hailey-Hailey disease: a prospective cohort study

Long term effectiveness and safety assessment of carbon dioxide laser treatment in Hailey-Hailey disease: a prospective cohort study

Short term efficacy and safety of PD-1 inhibitor and apatinib plus S-1 and oxaliplatin as neoadjuvant chemotherapy for patients with locally advanced gastric cancer.

Surgical resection is the cornerstone of treatment for locally advanced gastric cancer (LAGC). Hence, downstaging of the tumor with neoadjuvant therapy is critical for R0 resection and prolongs the overall survival. Data from related studies are lacking, and the literature is scarce. Therefore, a single arm-study was performed on PD-1 inhibitor and apatinib plus S-1 and oxaliplatin as neoadjuvant chemotherapy for patients with LAGC. The findings are expected to serve as a reference for neoadjuvant therapy for LAGC. We assessed 130 LAGC patients using PD-1 inhibitor, apatinib plus S-1, and oxaliplatin as neoadjuvant chemotherapy from January 2021 to October 2022. A total of 104 patients received gastric transcatheter chemoembolization (GTC). The primary endpoint was the rate of clinical complete response, pathological complete response, and safety, while the secondary endpoints were the R0 resection rate and objective response rate of the disease and the disease control rate. A total of 130 patients completed the clinical assessment, of which 6 patients (4.6%) achieved clinical complete response, 87 patients (66.9%) achieved partial response, 30 patients (23.0%) achieved stable disease, and 7 patients (5.5%) experienced progressive disease. The overall response rate was 71.5% (93/130), and the disease control rate was 94.5% (123/130). A remarkable downstaging effect was observed in this study. Downstaging of the T stage and N stage was achieved in 71.5% and 80% of the patients, respectively, which translated into a high R0 resection rate. The findings revealed that 125 patients underwent R0 resection, and the R0 resection rate was 96.1%. According to the observed results, 21.6% of the patients achieved pathological complete response after neoadjuvant chemotherapy. Gastric transcatheter chemoembolization in the first cycle of neoadjuvant therapy was beneficial for tumor regression (P < .001). All adverse events were relieved and disappeared after symptomatic treatment, and no grade 4 adverse events were noted. PD-1 inhibitor and apatinib plus S-1 and oxaliplatin are safe and effective as neoadjuvant treatment of LAGC. Gastric transcatheter chemoembolization is useful for tumor regression during neoadjuvant therapy.

Short-term Outcomes of a Dedicated Pelvic Exenteration Unit in a Tertiary Hospital in Malaysia

Background : Pelvic exenteration offers potentially curative resection for locally advanced pelvic malignancy. A dedicated unit performing this complex surgery is recommended to achieve optimal outcomes. Objectives : The aim of this paper is to show that pelvic exenterations can be performed with acceptable oncological and safe perioperative results in an appropriately resourced specialist centre. Methods : Patients undergoing pelvic exenteration in the Colorectal Unit, Hospital Kuala Lumpur between January 2017 and January 2024 were included. Patients operated in the initial setup period of the unit (January 2017 – July 2020) were compared to the second half (August 2020 – January 2024) with univariate analysis. Results : A total of 30 patients were included, with a significant increase in the unit caseload over the study period (n = 11 versus n = 19). There was an increased use of neoadjuvant therapy and an increase in stage of disease at presentation (p = 0.014) in the second half of the study period. More complex procedures were performed in the latter period, involving both bony and pelvic side wall resections. There was no difference in complication severity (Clavien Dindo) (p = 0.257) and R0 resection was achieved in 76.7% of operated cases. Conclusion : The development of a dedicated pelvic exenteration unit, leads to an increase in patient volume and an increase in the complexity of the procedures performed, without compromising short term outcomes and safety.

Abstract 4120583: Long term Safety and Efficacy of Ultrathin Bioabsorbable polymer sirolimus eluting Stents Versus Thin Durable polymer everolimus eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: A systematic review and meta analysis

Background: First generation drug eluting stents (DES) with thick polymers may contribute to local vascular inflammation and late stent thrombosis. Thinner-strut DES (ultrathin), particularly those with biodegradable polymers, aim to reduce this risk by minimizing flow disturbance and vascular injury. However, the long-term safety and efficacy of ultrathin biodegradable polymer sirolimus eluting stents (BP-SES) compared to durable polymer everolimus eluting stents (DP-EES) are still uncertain. Thus, we performed a meta analysis to compare outcomes of these two stents. Methods: Inclusion criteria comprised randomized controlled trials comparing ultrathin BP SES and thin DP EES in patients undergoing percutaneous coronary interventions with long term follow-up of at least 3 years. We excluded cohort studies, case reports, editorials, conference abstracts, and animal studies. Primary outcomes were target lesion failure (TLF), cardiac death (CD), target-vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (CI-TLR). We systematically searched PubMed, Cochrane CENTRAL, and Scopus. Cochrane’s ROB 2.0 tool assessed trial quality, and RevMan software (5.4) performed the meta-analysis. Results: Our analysis included ten RCTs, totaling 16,216 patients, with 9,108 in the BP SES group and 7,108 in the DP EES group. TLF occurred in 905 patients (9.94%) in the BP-SES group and 821 patients (11.55%) in the DP-EES group, with no statistically significant differences between the groups (RR = 0.92, 95% CI = 0.85 to 1.01, p = 0.08). Additionally, there were no significant differences in cardiac death (RR = 1.00, 95% CI = 0.84 to 1.19, p = 1.00), TV-MI (RR = 0.91, 95% CI = 0.78 to 1.05, p = 0.19), and CI-TLR (RR = 0.88, 95% CI = 0.78 to 1.01, p = 0.06) between the two groups. Conclusion: The use of BP-SES did not result in higher rates of TLF, CD, TV-MI, or CI-TLR compared to DP-DES. These findings suggest that both BP-SES and DP-DES are viable options for PCI procedures, with comparable long-term safety profiles. However, some trials used strut thicknesses exceeding 70µm in cases requiring wider diameters, similar to the strut thickness in the DP-EES group. This makes it challenging to assess whether, in addition to biodegradable polymers, lower strut thickness contributes to reducing target lesion-related events. Further research may be needed to explore other relevant outcomes and to confirm these findings in diverse patient populations.

Abstract 4134320: Integrated safety and tolerability of mavacamten treatment over 5 years in patients with obstructive hypertrophic cardiomyopathy

Background: Mavacamten, a cardiac myosin inhibitor, is approved across 5 continents for the treatment of obstructive hypertrophic cardiomyopathy (HCM). Long-term data of mavacamten are available from multiple studies, providing the opportunity to further understand mavacamten long term safety, including adverse events (AEs) of clinical interest. Aim: To present integrated safety data of patients who received mavacamten treatment for obstructive HCM across 5 studies. Methods: The pooled population included all patients who received ≥1 dose of mavacamten in PIONEER-HCM, PIONEER-Open Label Extension (data cut-off: May 31, 2022), EXPLORER-HCM, MAVA-Long-Term Extension (EXPLORER cohort; data cut-off: August 31, 2023) and VALOR-HCM including long-term extension (data cut-off: November 11, 2022). Results: The population consisted of 368 patients (mean [SD] age: 59.4 [12.2] years; male: 57.1%; White: 90.8%), including 350 patients who continued onto an extension study after completing a parent study. The majority of patients (57.6%) had a cumulative time on study of ≥3 years. Forty (10.9%) patients permanently discontinued treatment (13 due to AEs). In total, 20.7% of patients had a treatment emergent AE (TEAE) of Grade ≥3 and 14.7% had a TEAE leading to drug interruption. Overall, 4.3% of patients had drug-related serious TEAEs and 1.6% had a TEAE leading to death. The cumulative exposure adjusted incidence rates (EAIR) of all TEAEs, including AEs of clinical interest (atrial fibrillation [AF], ejection fraction [EF] decreased and heart failure [HF]), decreased as exposure increased over time, from 347.1/100 patient-years (P-Y) at Week 60 (~year 1) to 271.8/100 P-Y at Week 252 (~year 5). The EAIR of AF decreased over time from 13.3/100 P-Y at Week 60 (~year 1) to 6.2/100 P-Y at Week 252 (~year 5) ( Figure ). The EAIR for EF decreased and HF also decreased over time ( Figure ). Conclusions: This integrated analysis of all patients with obstructive HCM treated with mavacamten across the 5 clinical studies over 5 years demonstrated that mavacamten treatment is generally well tolerated and that the EAIRs of selected TEAEs of clinical interest (AF, EF decreased and HF) decreased as exposure increased over time.

Comparison of the Long Term Safety and Effectiveness of Endovascular Sac Embolisation and the Isolation Technique for Treatment of True Saccular Splenic Artery Aneurysms

To compare the safety, effectiveness, hospital stay (HS), and total hospital cost (THC) of sac embolisation (SE) and the isolation technique (IT) for treating isolated saccular true unruptured splenic artery aneurysms (SAAs). A total of 208 patients with isolated saccular true unruptured SAAs receiving endovascular SE or IT treatment at four medical centres in China between January 2016 and December 2022 were retrospectively included. Technical success rates, splenic infarction (SI) rates, aneurysm revascularisation (AR) rates, HS, and THC were compared between groups. Each group was divided into three subgroups, based on the size of SAAs: 2.0 - 2.9 cm (S1), 3.0 - 3.9 cm (S2), and ≥ 4.0 cm (S3). The technical success was 100%. During the median follow up time of 48.8 (IQR 33.0, 70.4) months, no patients had SAA rupture or died. The two year and five year cumulative incidences of aneurysm revascularisation were 1.8% and 8.7% for the SE group and 2.2% and 2.2% for the IT group, respectively (p = .12). Compared with the SE group, the IT group had a higher SI rate (p < .001), a comparable AR rate (p = .12), a higher median HS (p < .001), and a lower median THC (p < .001). The median THC was comparable between the SE and IT groups in S1. The median THC of the SE group was approximately 1.36 times and 2.2 times of that in the IT group in S2 and S3 (both p < .001), respectively. Sac embolisation and IT are safe and effective methods for treating isolated saccular true unruptured SAAs. The isolation technique seems to be superior in reducing THC, whereas SE may be superior in reducing SI rates and HS. Sac embolisation may be more suitable for smaller SAAs, whereas IT could be a better choice for larger SAAs.

Effects of Intermittent Fasting on Human Metabolism and Evaluation of Its Effectiveness in Weight Loss

Intermittent Fasting (IF), a dietary modification through time-restricted feeding, has gained significant attention in the past few years owing to its advantages in metabolic health and weight management. Available evidence suggests that IF can improve insulin sensitivity; lower the levels of blood glucose and fat; prevent body fat accumulation; and reduce the risk of obesity-related chronic disease by mitigating oxidative damage and affecting the activity of antioxidant enzymes. However, a number of gaps in knowledge remain regarding IF, especially its long-term safety and the generalisability of IF. This paper discussed the effects of IF on metabolism and body health through the mechanism of high-intensity, nutrient-strong IF. It mentioned that IF led to improved insulin sensitivity, lower blood lipid levels and inhibition of body fat accumulation, and was easier to stick to than daily calorie restriction. Other clinical studies with longer intervals and durations also reported significant effects of IF on weight loss and body health. Long term strict IF is unfavorable for some patients – in particular the elderly and the chronically ill – due to the potential for nutritional and metabolic problems. This study serves as an important reference for the use of IF in health and weight loss management, and offers potential directions for future research. Even though IF showed clear benefits, its safety in the long term and applicability across different populations still need to be validated. Future investigations may look into the long-term effects of IF in different populations, and its potential application in various health conditions.

Intracardiac leadless pacemaker: long term safety over traditional pacemakers. a systematic review and meta-analysis

Abstract Introduction Leadless pacemaker (LP) is a novel technology designed to reduce lead-related, including pocket infections, associated with traditional pacemakers. LP can be used in patients with high-degree AV block, sinus node dysfunction, and bradycardia with syncope. We conducted a systematic review and meta-analysis to examine the long-term safety of intra-cardiac leadless pacemakers compared with traditional pacemakers. Methods Our protocol was registered in advance on PROSPERO. Studies were eligible if they compared complications, revision, cardiac perforation, infections, and all-cause mortality between patients who received leadless pacemakers versus traditional pacemakers. The systematic search was conducted in five databases (MEDLINE, EMBASE, CENTRAL, Web of Science, Scopus) without restriction. The random-effect model was implemented to calculate pooled odds ratio (OR) with a 95% confidence interval (CI). Also, the Mantel-Haenszel method, Paule-Mandel estimator for tau^2, Q-Profile method for the confidence interval of tau^2 and tau, and Hartung-Knapp adjustment for random effects model methods were used for the prediction of data extracted directly from the curves. ROBINS-I tool was used for the risk of bias assessment, and the certainty of the evidence was evaluated with the GRADE approach. Results Of 6450 studies screened, we identified 21 observational studies of Nanostim and Micra leadless pacemakers. The pooled incidence of complications of leadless versus traditional pacemakers at 1, 6, 12-24 months show the odds are clinically and statistically different (OR=0.66, 95% CI: 0.42–1.02; OR=0.44, 95% CI: 0.22–0.86; OR=0.41, 95% CI: 0.32–0.53 respectively). The pooled incidence of infection rate at 6, 12-24 months is lower in patients with LP (OR=0.37, 95% CI: 0.31–0.44; OR=0.20, 95% CI: 0.00–97.31). The studies comparing all-cause mortality during 6, 12-24 months in leadless versus traditional pacemakers did not show statistically significant differences in these outcomes (OR=1.26, 95% CI: 0.88–1.81; OR=0.86, 95% CI: 0.25–2.92 respectively. Conclusion Our results show that complications and infections occur less frequently in patients with leadless pacemakers than in patients with conventional pacemakers with no difference in all-cause mortality. However, there is a need for high-quality randomized clinical trials and propensity score-matched studies focusing on this clinically relevant question.Complication Forest plotsInfection Forest plots

PCSK9 inhibitors in HIV patients with dyslipidemia

Abstract Introduction Cardiovascular disease has become increasingly prevalent in the HIV (human immunodeficiency virus) population. Antiretroviral therapy and HIV itself independently increase the risk of dyslipidemia. While statins are currently the predominant therapy to treat dyslipidemia in HIV patients, drug-drug interactions and adverse drug events can limit their use. Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a naturally occurring inhibitor of the LDL-receptor pathway. PCSK9 inhibitors offer an alternative in patients who cannot tolerate or need additional therapy in addition to statin for optimal dyslipidemia management. Purpose The purpose of this study is to compare major adverse cardiovascular events in HIV patients on a PCSK9 inhibitor (evolucumab, alirocumab, inclisiran) vs patients not on a PCSK9 inhibitor. Methods A retrospective cohort study was conducted using electronic medical records from a global federated health research network. The TriNetX network was searched on February 10, 2024, including records from 2020 to 2024. Patients were included based on a diagnosis of HIV status and concomitant dyslipidemia. Patients with HIV and dyslipidemia on a PCSK9 inhibitor were propensity-score matched for age, sex, race, and comorbidities with patients who were not on a PCSK9 inhibitor. The outcomes were mortality, myocardial infarction, heart failure and stroke. Results A total of 485 patients were included in the study. PCSK9 inhibitor use associated with 9% lower odds of all-cause mortality (odds radio, .29; 95% CI, 0.18-0.48; p&amp;lt;.0001). PCSK9 inhibitor use was also associated with 8% lower odds of heart failure (odds radio, .63; 95% CI, 0.47-0.85; p&amp;lt;.0023). No significant associations were noted for myocardial infarction (odds radio, .87; 95% CI, 0.63-1.21; p=0.406) or stroke (odds radio, .67; 95% CI, 0.45-1.01; p=0.052). Conclusion The role of dyslipidemia in HIV is challenging due the complex pathophysiology of HIV. There is an apparent increased risk of cardiovascular disease from the infection itself as well current antiretroviral therapies. While current guidelines recommend the use of statins as first line therapy for dyslipidemia in this population, the drug-drug interaction of statins with ARTs, as well as their side effects, limit their use at times. PCSK9 inhibitors are associated with lower odds of all-cause mortality and heart failure. No significant association was seen for myocardial infarction or stroke. They should be considered as an early intervention alongside statins in HIV patients with dyslipidemia. Further research should be done for the long term safety and tolerance of this therapy as well as cost-effectiveness and access to PCSK9 inhibitors in this population.

Targeted non-invasive Metformin-Curcumin co-loaded nanohyaluosomes halt osteoarthritis progression and improve articular cartilage structure: A preclinical study

Osteoarthritis (OA) is a degenerative disease that affects the quality of life in elderly and young populations. Current therapies using corticosteroids and non-steroidal anti-inflammatory drugs via parenteral or oral routes show limited ability to retard progression of the disease and achieve long term effectiveness and safety. Herein, the potential of MT-Cur combinatorial nano-formulations in OA management was explored for the first time. MT-Cur loaded nanohyaluosomes (MT-Cur-HL1) were designed for topical administration of the combined therapy in OA. The optimized MT-Cur-HL1 showed particle size 247.7 ± 3.7 nm, zeta potential −37.3 ± 0.4 mV; and entrapment efficiency (%EE) 70.22 %±0.303 and 76.7 %±0.077 for MT and Cur, respectively. MT-Cur-HL1 exhibited sustained drug release over 24 h and were stable over 3 months at 4 °C in terms of P.S., ZP and %EE. A detailed preclinical study, using MIA-induced osteoarthritis rat model, revealed the most significant anti-arthritic effect and halted OA progression of MT-Cur-HL1. This was proved to be mainly through the potentiation of p-AMPK signaling that ultimately led to suppression of its downstream TLR4/ NF-κB signaling pathway with subsequent reduction in MMP13 and ADAMTS5 induced chondrocytes degeneration. This study proved that this trajectory effectively promotes a significant improvement in the articular cartilage structure and reinforcement of joint mobility with an efficient antinociceptive effect. In conclusion, the novel MT-Cur coloaded nanohyaluosomes offer a promising non-invasive approach for the local management of OA.

Safety and Efficacy of Transurethral Focal Laser Ablation of Prostatic Adenoma in Comparison with Transaurethral Prostatectomy for Management of Benign Prostatic Adenoma Comparative Randomized Prospective Study

Abstract Background Transurethral resection of the prostate (TURP) is considered the gold standard therapeutic approach in cases of average size prostate (30-80 grams). However, TURP is associated with possible intra- operative complications as bleeding (particularly in patients on anticoagulants treatment), steep learning curve and intravasation of hypotonic fluid with risk of TUR syndrome. Aim of the Work to compare the short term effectiveness, safety and complications Of transurethral focal laser ablation of prostatic adenoma (TU-FLAP) in comparison to monopolar TURP of prostate For Management Of benign prostatic adenoma. Patients and Methods A prospective randomized controlled study was conducted at Ain Shams university hospitals at the period from June 2021 till June 2023. 50 patients (25 in each group), group A underwent monopolar TURP under spinal anesthesia, Group B underwent TU-FLAP under local anesthesia by applying 15 watt of 980 nm diode laser through 600µm end firing fiber in the lateral and median lobe about 1.5 cm away from bladder neck with 1 cm distance between each puncture. We inserted the fiber 5 mm in depth in each puncture to fire laser for 2 minutes at each point. Number of points is correlated to supra-montanal length. Follow up was done at 1st week, 1st, 3rd and 6th months postoperative by improvement of IPSS, PAUS, PSA and uroflowmetry. Results There was no significant difference between the 2 groups as regard preoperative base line clinical and urological data average age was (67.56 ± 8.0) years, (66.08 ± 8.04) years in group A and group B respectively prostate size was 64.60 ± 16.6 gm, 57.8 ± 12.68 gm in group A and group B respectively, Median PSA (IQR) 2.7 (1.1-4.3), 3.4 (1.57-4.7) in group A and group B respectively, mean Q max 10.2±4.16, 8.16 ±3.5 in group A and group B respectively, (IPSS) total; Median (IQR) 24(23-27), 23(21-28) in group A and group B respectively, PVRU; Median (IQR) 220(186-500)ml, 750(620-850) ml in group A and group B respectively. After operation there was highly significant difference in favor of TURP in (prostate size, PSA and PVRU) as mean prostate size decreased to (38.12±10.91) mg and decreased to (47.28±10.6) mg in group A and group B respectively, PSA decreased to Median(IQR) 1 (1-2) and 3.5 (1.5-4.2) in group A and group B respectively and PVRU decreased to (median (IQR) 50(15-65)ml and100(50-150)ml in group A and group B respectively. The favourable difference toward TURP was not statistically significant in Q-max and IPSS scrore, Q max increased to 18.7±4.45 and 18.34±5.47 in group A and group B respectively and IPSS median decreasd to (IQR) 12(12-16), 6(5-9) in group A and group B respectively. However, FLAP was better as regard operative time and incidence of moderate to severe complications (operative time median (IQR) 60 (50-100) minutes, 30 (25-35) minutes in group A and group B respectively, moderate to sever complication according to modified Clavien_Dindo classification of post operative complications 24.0%, 4.0% in group A and group B respectively. Conclusion TURP is still considered the gold standard surgical approach for management of BPH, however FLAP showed favorable outcomes in comparison as it is less invasive procedure with significant decrease post-operative complications and shorter operative time especially with patients with multiple co- morbidities. Further long-term investigations are warranted for comprehensive evaluation.

Transurethral Diode Laser Ablation of Prostate Vs Bipolar Transurethral Vaporization of Prostate, A Prospective Randomized Controlled Study

Abstract Background Vaporization/Ablation of prostate is becoming one of the standard modalities for treating of symptomatic cases of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) especially in men with bleeding tendency. Objective to compare the short term safety and efficacy of bipolar plasma versus laser ablation of prostate and follow up over 6 months post operative. Patients and Methods This prospective randomized control study (double armed) included 60 patients with prostates less than 80 gm operated upon and followed up in the Urology Department of Ain Shams University hospitals. The patients were divided into 2 groups: Group A 30 Patients underwent Transurethral Diode Laser Ablation, Group B 30 Patients underwent Bipolar Transurethral Vaporization as the control group. Results When we compared both groups of patients there was no great difference and both techniques proved great efficiency and safety on patients especially in high risk group of patients, and both of them resulted in improvement in all parameters of LUTS secondary to BPH (decrease of IPSS, increase of Q max, decrease of residual urine and PSA). There was no risk or major complication encountered in the study e.g. no significant bleeding and no risk of TUR syndrome. However operation time was shorter in laser group 22 (mean) min compared to 49 min in bipolar group. Also the mean cost of laser group was about 30000 EGP and the mean cost of bipolar group was 20000 EGP in Ain Shams University hospital. Also catheter time was shorter in laser prostatectomy 24 hours versus 48 hours in bipolar, this is done in trial to lessen the irritative effect of vaporization on the nerve ending, and avoid the expected dysuria. Conclusion Both techniques are considered safe and effective, similar in the outcome and both techniques has excellent hemostatic profile with no serious complications occurred in both groups. Laser is a faster technique than bipolar however it's more expensive.

ThP1.13 - Short term safety outcomes of immediate pre-pectoral implant based reconstruction

Abstract Aims In the UK up to 43% of women undergo immediate breast reconstruction (IBR) following mastectomy for breast cancer. Implant reconstruction is the commonest form of breast reconstruction and pre-pectoral techniques have been introduced with the aim of improving cosmetic outcome and avoiding animation. To assess the safety of pre-pectoral implant based breast reconstruction (PPBR), including infection rates, 30 day re-admission to hospital, need for unplanned surgery and implant loss at 3 months. Methods A retrospective study of 80 consecutive women who underwent PPBR for breast cancer or risk reduction between October 2020 and October 2023. Demographic, operative and complication data were collected. Results Eighty women (70 cancer, 8 risk reducing and 2 cancer/risk reducing) underwent 94 PPBR procedures (80 Skin sparing mastectomies and 14 Nipple and skin sparing mastectomies) with a mean age of 51.5 (range 28 to 79) years and a BMI of 25.2 kg/m2. 7 (8.8%) of women were smokers. The mean implant size used was 385cc (range 160cc to 650cc) with a mean breast weight of 448.6g (range 45g to 1700g). 10 (12.5%) women required oral antibiotics for wound infection with a further 2 (2.5%) women requiring re-admission within 30 days for IV antibiotics. 17 (21.3%) developed a seroma with 8 (47.1%) requiring drainage. No implant losses were recorded within 3 months of reconstruction. Conclusion We have demonstrated that PPBR is a good option for patients of a wide age range with a large variation in breast size with minimal complications and no implant losses.

Long term safety and outcomes after atrial shunting for heart failure with preserved or mildly reduced ejection fraction: 5-year and 3-year follow-up in the REDUCE LAP-HF I and II trials

BackgroundThere is a little evidence regarding long-term safety and efficacy for atrial shunt devices in heart failure (HF). MethodsThe REDUCE LAP-HF I (n=44) and II (n=621) trials (RCT-I and -II) were multicenter, randomized, sham-controlled trials of patients with HF and ejection fraction >40%. Outcome data were analyzed from RCT-I, a mechanistic trial with 5-year follow-up, and RCT-II, a pivotal trial identifying a responder group (n=313) defined by exercise PVR <1.74 WU and no cardiac rhythm management device with 3-year follow-up. ResultsAt 5 years in RCT I, there were no differences in cardiovascular (CV) mortality, HF events, embolic stroke, or new-onset atrial fibrillation between groups. After 3 years in RCT II, there was no difference in the primary outcome (hierarchical composite of CV mortality, stroke, HF events, and KCCQ) between shunt and sham in the overall trial. Compared to sham, those with responder characteristics in RCT-II had a better outcome with shunt (win ratio 1.6 [95% CI 1.2-2.2], P=0.006; 44% reduction in HF events [shunt 9 vs. control 16 per 100 patient-years], P=0.005; and greater improvement in KCCQ overall summary score [+17.9±20.0 vs. +7.6±20.4], P<0.001), while non-responders had significantly more HF events. Shunt treatment at 3 years was associated with a higher rate of ischemic stroke (3.2% vs. 0%, 95% CI 2% - 6.1%, p=0.032) and lower incidence of worsening kidney dysfunction (10.7% vs. 19.3%, p=0.041). ConclusionsWith up to 5 years of follow up, adverse events were low in patients receiving atrial shunts. In the responder group, atrial shunt treatment was associated with a significantly lower HF event rate and improved KCCQ compared to sham through 3 years of follow-up.Clinicaltrials.gov registration: NCT02600234, NCT03088033

Long-term Efficacy and Safety of Sodium Oxybate in Treating Alcohol Use Disorder: A Systematic Review and Meta-Analysis.

Worldwide, three million deaths each year are reported due to the harmful use of alcohol. To date, only a few drugs have been approved for the treatment of Alcohol Use Disorder (AUD). This systematic review and meta-analysis aim to assess the long-term efficacy and safety of sodium oxybate (SMO) treatment in patients with AUD. We followed the PRISMA statement guidelines and searched PubMed and ISI Web of Science to retrieve the studies of interest. In total, 13 studies on long-term (>12 weeks) SMO administra- tion in patients with AUD were included in this systematic review, and 7 were included in the meta- analysis. Overall, the abstinence rate after 12 weeks of treatment was similar in the SMO and placebo groups, while it was significantly in favour of SMO compared to Naltrexone (NTX). The completion rate was similar in all three conditions. Mean corpuscular volume (MCV) levels favoured SMO over NTX, while Alcohol Craving Scale (ACS) scores did not favour SMO. The incidence of adverse reactions varied widely between studies. SMO in the chronic treatment of patients with AUD showed no superiority to placebo in our analysis of published RCTs, although many observational studies reported its beneficial effect in the long term. On the contrary, SMO was superior to NTX treatment on abstinence. The rate of study completion was similar in the three groups. Safety was not an issue in any of the studies included. Further studies are needed to better assess SMO efficacy and safety in the long term.</p>.

123 Long Term Safety and Efficacy of Radiosurgery for High-Risk Brain Cavernomas

123 Long Term Safety and Efficacy of Radiosurgery for High-Risk Brain Cavernomas

290. EVALUATION OF THE POST-OPERATIVE GERD AND RESIDUAL CHEST PAIN AFTER POEM

Abstract Background Per-oral endoscopic myotomy (POEM) for esophageal achalasia has increasingly become a mainstream procedure worldwide, and its short and middle term efficacy and safety are more and more recognized. However, the long-term outcomes are still unclear and we sometimes experience the cases with severe post-operative GERD and residual chest pain. Methods We retrospectively reviewed 241 cases who were performed POEM in our center from Apr 2015 to Feb 2022 and evaluate their post-operative GERD and residual chest pain. Results Before POEM, 126 cases (54.8%) had chest pain. Residual chest pain 2 months after POEM was observed in 28 patients (23.1%). 78.2% had complete remission of chest pain after 1 year. Severe GERD (LA Grade C or D) 2 months and 1 year after POEM was observed in 5.1%, 8.2%, respectively. All of them except one patient were improved by PPIs. On univariable analysis, younger patients and pre-treatment were at risk for residual chest pain (p=0.02, p=0.04, respectively). Higher BMI was risk for severe GERD after 2 months (p=0.02), however it was not associate with that after 1 year (p=0.04). Conclusion Younger age and pre-treatment were at risk for residual chest pain after POEM and post-operative severe GERD was related to higher BMI, however almost all of them was controlled by PPIs. The number of cases was small, so it is necessary to accumulate more cases.

Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies.

Psoriatic arthritis (PsA) is a chronic inflammatory disease requiring long-term treatment. Bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated tolerability and sustained clinical efficacy for up to 1year for patients with PsA. Here, we report the longer-‍term safety and efficacy of bimekizumab up to 2years. BE OPTIMAL (biologic disease-modifying antirheumatic drug [bDMARD]-naïve) and BE COMPLETE (prior inadequate response/intolerance to tumor necrosis factor inhibitors [TNFi-IR]) assessed subcutaneous bimekizumab 160mg every 4weeks in patients with PsA. BE OPTIMAL included a reference arm (adalimumab 40mg every 2weeks); patients switched to bimekizumab at week 52 with no washout between treatments. BE OPTIMAL week 52 and BE COMPLETE week 16 completers were eligible for the BE VITAL open-label extension. Efficacy outcomes are reported to week 104/100 (BE OPTIMAL/BE COMPLETE). A total of 710/852 (83.3%) bDMARD-naïve and 322/400 (80.5%) TNFi-IR patients completed week 104/100. Up to 104weeks, patients treated with bimekizumab in BE OPTIMAL and BE COMPLETE had treatment-emergent adverse event incidence rates (exposure-adjusted incidence rate/100 patient-years) of 179.9 (95% CI 166.9, 193.7) and 100.3 (89.2, ‍112.4), respectively. The proportion of patients achieving efficacy outcomes (≥ 50% improvement from baseline in American College of Rheumatology [ACR] response criteria, 100% improvement from baseline in Psorisis Area and Severity Index [PASI], minimal disease activity [MDA]) was sustained in all patients from week 52 to week 104/100. Bimekizumab was well tolerated for up to 2years of treatment and no new safety signals were observed. Sustained clinical efficacy was observed up to 2years in bDMARD-naïve and TNFi-IR patients with active PsA. Patients switching from adalimumab to bimekizumab demonstrated further improvement in skin and nail symptoms, and sustained efficacy in joint symptoms. BE OPTIMAL (NCT03895203), BE COMPLETE (NCT03896581), BE VITAL (NCT04009499).