Single Center Experience Research Articles

Safety and Efficacy of 177Lu-DOTATATE in Children and Young Adult Population: A Single-Center Experience.

This single-center retrospective study explores the safety and efficacy of 177Lu-DOTATATE in children and young adult population with metastatic/inoperable neuroendocrine tumors (NETs). This study is a retrospective analysis of all children and young adult patients (≤29 years) with advanced inoperable/metastatic epithelial or nonepithelial NETs who were administered a median of 4 cycles of 177Lu-DOTATATE therapy and low-dose oral capecitabine as a radiosensitizer every 8-12 weeks, except 2 patients who received CAPTEM chemotherapy. The radiological response was assessed using RECIST 1.1 on interim and end-of-treatment 68Ga-DOTANOC PET/CT. The primary endpoint was objective response rate, whereas disease control rate, toxicity profile, progression-free survival, and overall survival were secondary endpoints. Nineteen biopsy-proven NET patients (median age, 22 ± 10 years) with 8 of them adolescents (10-18 years) and the remaining young adults (19-29 years) were included. Fourteen patients had gastroenteropancreatic neuroendocrine tumor (pancreas being most common primary site), whereas the rest had non-gastroenteropancreatic neuroendocrine tumor. A total of 65 cycles of 177Lu-DOTATATE (range, 1-6 cycles) were administered with a median cumulative activity of 600 mCi (range, 100-1000 mCi). The objective response rate and disease control rate were 41% and 94%, respectively. Grade 1 and 2 adverse events were observed in 14 (74%) and 5 (26%) of 19 patients, respectively. In a total of 8 events (42%), 4 events each of disease progression and death occurred during a median follow-up of 80.1 months with an estimated 5-year progression-free survival and overall survival of 54% (95% confidence interval, 30-78) and 63% (95% confidence interval, 39-87), respectively. 177Lu-DOTATATE appears safe and effective in children and young adults with metastatic/inoperable NETs. Large prospective trials are required to validate these results.

Pediatric renal transplantation: a single center experience.

The rising prevalence of global end-stage renal disease (ESRD) is a significant health concern, especially among children. Although renal replacement therapy is available, children with ESRD are at an increased risk of mortality. Kidney transplantation is the preferred modality of treatment and surpasses renal replacement therapy in terms of survival. However, pediatric renal transplantation could prove difficult due to factors like smaller recipients and donor-recipient mismatches leading to higher complications. A retrospective single-group case series study was conducted on children with ESRD who were planned to undergo kidney transplantation from living donors between 2015 and 2021. The data was collected from two centers in the city of Sulaymaniyah. The study comprised a predominantly male patient population, with a total of 39 individuals (n = 39) and 13 female patients. The donors were mostly males between 25-40 years old. The majority of participants were 15-18 years old. In majority of the patients Thymoglobulin was the immunosuppressive agent used in induction. The most common etiology for renal failure was reflux nephropathy and artery anastomosis was performed to the external iliac artery in the majority of patients. Only 9 patients had complications following the transplantation and 3 patients had an episode of acute rejection. Renal transplantation is the preferred treatment of renal failure in pediatric patients in the city of Sulaymaniyah. The most common etiology for pediatric renal failure was reflux nephropathy which was different from the findings of North American Pediatric Renal Trials and Collaborative Studies.

Temporal trends with the Evolut family of self-expanding transcatheter heart valves: A single-center experience.

The Evolut self-expanding valve (SEV) systems (Medtronic), were designed to accommodate varying valve sizes and reduce paravalvular leak (PVL) while maintaining a low delivery profile. These systems have evolved between product generations, alongside valve deployment techniques changing over time. This study aimed to examine whether these changes impacted clinical outcomes. EPROMPT is a prospective, investigator-initiated, postmarketing registry of consecutive patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) using the Evolut PRO/PRO+SEV system. A total of 300 patients were divided into three consecutive cohorts of 100 patients according to implantation date (January to October 2018, November 2018 to July 2020, and August 2020 to November 2021). Procedural and clinical outcomes over these time periods were compared. Valve Academic Research Consortium (VARC)-2 device implantation success improved over time (70.0% vs. 78.0% vs. 88.8%, p = 0.01), with a similar trend for VARC-3 device success (94.7% vs. 81.7% vs. 96.8%, p < 0.001). PVL (all degrees) frequency was likewise reduced over time (31.0% vs. 17.0% vs. 19.2%, p = 0.04). Furthermore, a trend was noticed toward shorter procedure times and shorter length of stay. However, postprocedural pacemaker implantation rates did not significantly differ (15.2% vs. 21.1% vs. 14.0%, p = 0.43). During a 3-year period, we demonstrated better TAVR outcomes with newer SEV iterations, alongside changes in implantation techniques, which might result in better procedural and clinical outcomes. However, we did not see a significant change in peri-procedural pacemaker rates for SEV.

Real-world effectiveness, safety and immunogenicity of ocrelizumab in turkish multiple sclerosis patients: a single-center experience for 4-year follow-up.

The aim of this study was to evaluate postmarketing ocrelizumab safety and effectiveness in a real-world population with multiple sclerosis (MS) and matching these parameters among MS disease types. This was a retrospective, single-center study with MS patients treated with ocrelizumab. Demographic, clinical characteristics and immunological data were analyzed, including annualized relapse rate (ARR), relapse-free rate, Expanded Disability Status Scale (EDSS), complete blood count parameters, immunoglobulin (Ig) levels, liver function tests (LFT), hepatitis markers and adverse events in the 4-year follow-up. A total of 96 patients, 22 with relapsing-remitting MS (RRMS), 54 with secondary progressive MS (SPMS), and 20 with primary progressive MS (PPMS) who were treated with at least two doses of ocrelizumab between January 2018 and September 2023 were included in the study. Sixty-five (68%) were women and 31 (32%) were men. The mean age was 48.4 ± 11.1years (20-70years). Ninety-three patients were evaluated in the first year, 65 in the second year, 39 in the third year and 24 in the fourth year of treatment. 96% of patients were relapse-free rate in the first year, 91% in the second year, 85% in the third year and 75% in the fourth year. Eighty-six percent of patients were progression free in the 1st year of treatment, 71% in the 2nd year, in 64% in the 3rd year, and in 62% in the 4th year. During the follow-up of the cases, EDSS remained stable in 77% of RRMS patients, improved in 14%, and worsened in 9%; while EDSS remained stable in 65% of SPMS patients with attacks, it improved in 9% and worsened in 26%; while EDSS remained stable in 60% of PPMS patients, worsening was observed in 40%. There is a significant decrease in IgM and IgG values during the follow-up of ocrelizumab therapy (p < 0.001, p = 0.014). There is no significant difference in IgA, lymphocyte and neutrophil values (p = 0.713, p = 0.086, p = 0.999). No significant relationship was found between low serum IgM levels and the risk of developing infection (p > 0.05). Liver function tests was found to be within normal limits in 94% of the patients over a 4-year period. No hepatitis B, C or A infection, hepatitis B reactivation, tuberculosis, HIV infection, malignancy or drug related death occurred during 4-years follow-up. The most common side effect during ocrelizumab treatment is urinary tract infection (29%); others were upper respiratory tract infections (13%), numbness/tingling of the face, trunk, or extremities (8%), insomnia (6%), headache (5%), and soft tissue infections (cellulitis and dental abscess, 2%). Our results show that ocrelizumab reduces the frequency of attacks and prevent the disease progression in RRMS patients, and reducing the disease progression by primarily stabilizing EDSS scores in SPMS with attacks and PPMS. It is thought that the relatively high rates of urinary tract infection detected in this study may be related with advanced stage of the disease. The absence of hepatitis B reactivation, chronic infection or malignancy in the 4-year follow-up of our cases supports the long-term safety of ocrelizumab treatment. Ocrelizumab may be preferred as an effective and reliable treatment of different types of MS due to non-serious side effects.

Single-center experience of patients with plasma cell leukemia in the era of new therapeutics.

Plasma cell leukemia (PCL) can occur de novo as primary PCL (pPCL), or in patients with prior diagnosis of multiple myeloma (MM) as secondary PCL (sPCL). In 2021, the diagnostic criteria have been revised, establishing a new cut-off of ≥ 5 % plasma cells in the peripheral blood. Lacking specific clinical trials, PCL is treated similarly to MM, however outcome for patients with PCL remains poor. Here, we report outcomes for patients with pPCL and sPCL in the era of novel agents. We performed a retrospective analysis and identified 19 patients (11 pPCL, 8 sPCL) who have been treated for PCL between 2010 and 2022 at University Hospital Essen. Patients with pPCL had a median overall survival (OS) of 37.8 months (95% CI: [15.4; 52.3] months) from diagnosis, with a median time to next treatment (TTNT) of 18.4 [2.0; 22.9] months. All patients were treated with a proteasome- inhibitor (PI)-based induction therapy and the majority was consolidated with an autologous stem cell transplantation (SCT). Five of these patients received a tandem transplantation. Patients with sPCL had a median OS of only 1.5 months after diagnosis of PCL. Only one patient achieved a remission with daratumumab and subsequent allogenic SCT. With our study, we add evidence for a PI-based induction therapy followed by a consolidating autologous stem cell transplantation for patients with pPCL and give further evidence that a tandem transplant concept might be beneficial. The diagnosis of sPCL remains devasting and needs new therapeutic approaches.

Expecting factors for inadequate glycemic control in children and adolescents with type 1 diabetes mellitus: a single center experience

Expecting factors for inadequate glycemic control in children and adolescents with type 1 diabetes mellitus: a single center experience

Open surgery with a lateral neck approach in cases of foreign body impaction that penetrating the neck through the esophagus: a single-center experience

BackgroundBecause the cases are quite scarce, we aimed to review cases of foreign body impaction penetrating the neck through the esophagus to analyze the characteristics of these cases. The open surgery skills of the surgeon, the treatment procedure and the surgeons’ experience in the rare diseases were analyzed.MethodsWe collected and analyzed all cases from 2015–2020 in our hospital. Surgical skills and procedures for fasting and anti-infection treatment were reviewed retrospectively. Follow-up was telephone communication.ResultsOur series included 15 cases. Tenderness in the pre-cervical site was a physical sign for screening. Thirteen cases underwent a lateral neck open surgery with the incision including the left side of neck and only two cases were incised from the right side of the neck. Pus was found 3 days after the impaction in one case, the shortest time observed in our series. The esophageal laceration was only sutured primarily in 5 cases (33.33%) among all fifteen cases. After sufficient drainage (average more than 9 days), antibiotic treatment and fasting (normally 2–3 weeks), patients gradually began to switch to solid foods from fluids after complete blood counts and confirmations from esophageal radiography result. No severe complications occurred, and all the patients have no swallowing dis-function and recovered well.ConclusionSurgery should be performed as soon as possible after impaction. Lateral neck approach surgery and the therapeutic procedure described in this article are safe and effective treatments.

Prognostic factors in Kaposi sarcoma, single centre experience.

Kaposi sarcoma (KS) is a multicentric vascular and lymphatic neoplasm caused by human herpesvirus 8 (HHV-8). It generally concerns the elderly and immunosuppressed population. Four major clinical types of KS have been described. The most common subtype is Classical KS (CKS). Our retrospective study aimed to better define prognostic subgroups among patients with CKS, which is the most common in our country. Between 2014 and 2020, 43 patients with CKS were treated with local excision, radiotherapy and chemotherapy. Reviewed information included demographics, clinical features, laboratory findings, treatment responses and overall survival. During the follow-up, eight patients (18.6%) died of CKS. The complete response rate was 46.5%, partial response and stable disease 51.2%, and progressive disease 2.3% of all patients. Gender, haemoglobin level at diagnosis, and disseminated involvement were prognostic factors affecting survival in all patients. We confirmed that male gender, low haemoglobin levels, and disseminated involvement are associated with poor prognosis in CKS patients. It is the only Turkish study in which prognostic analysis was performed for this rare cancer.

Management of Pulmonary Vascular Disease Associated with Congenital Left to Right Shunts: A Single Center Experience.

To describe the course and outcomes of children under 18 with left-to-right (LR) shunts and pulmonary arterial hypertension (PAH) undergoing one of two management approaches: PAH treatment prior to LR shunt repair (Treat First) and LR shunt repair first, with or without subsequent PAH treatment (Repair First). Retrospective single center study, conducted from September 2015 to September 2021, of children LR shunts and PAH (defined as indexed pulmonary vascular resistance (PVRi) ≥ 4WU*m2) but without Eisenmenger physiology. Patient characteristics, longitudinal hemodynamics data, PAH management, LR shunt repair, and outcomes were reviewed. Of 768 patients evaluated for LR shunt closure, 51 (6.8%) had LR shunt associated PAH [median age 1.1 (0.37,5) years, median PVRi 6 (5.2,8.7) WU*m2]. Of the "Treat First" group (n=33, 65%), 27 (82%) underwent LR shunt closure and 6 (18%) did not respond to PAH therapy and did not undergo LR shunt closure. In the "Repair First" group (n=18, 35%), 12 (67%) received PAH therapy and 6 (33%) did not. Mortality rates were 6% in "Treat First" and 11% in "Repair First", follow-up of 3.4 and 2.5 years, respectively. After LR shunt closure, there was no significant change in PVRi over a median follow-up of 2 years after surgery (p=0.77). In children with LR shunts and associated PAH, treatment with PAH-targeted therapy before defect repair does not appear to endanger the subjects and may have some benefit. The response to PAH-targeted therapy before shunt closure persists 2-3 years post-closure, providing valuable insights into the long-term management of these patients.

Surgical options in thoracic disc herniation: Evaluating long-term outcomes of 21 cases based on a single-center 10-year experience

Background: Symptomatic thoracic disc herniation (TDH) is a rare pathology that is addressed with relatively challenging surgical approaches, the choice and technical execution of which have been well described in the literature. Interestingly, long-term outcomes, including surgical site pain-related disability, the need for instrumentation, and commonly occurring complications such as cerebrospinal fluid (CSF)-pleural fistula have not been widely addressed. Here, we address the complication profiles and long-term outcomes of different surgical approaches for TDH. Methods: We conducted a retrospective review of 21 consecutive patients who underwent surgery for TDH between 2000 and 2010. We assessed post-operative complications such as CSF-pleural fistulas, as well as long-term outcomes using Frankel grades, the EQ-5D-3L, and the Visual Analog Scale. We also looked at the need for instrumentation postoperatively. Results: 21 consecutive patients (13 females, 8 males) with a mean age of 55.3 years (Standard deviation 8.1) underwent thoracic discectomy for symptomatic TDH. Surgical approaches included posterolateral thoracotomy (52%, n = 11), costotransversectomy (43%, n = 9), and transpedicular (5%, n = 1). Herniations were classified as soft (38%, n = 8), calcified (38%, n = 8), or calcified-transdural (24%, n = 5). Postoperatively, all patients with calcifiedtransdural herniations undergoing posterolateral thoracotomy (100%, n = 5) developed CSF-pleural fistulas, which resolved spontaneously without the need for surgical re-exploration. 89% (n = 16) of patients exhibited sustained improvement in Frankel scores. Persistent wound site pain was reported by 50% (n = 7) of patients. Conclusion: Despite favorable neurological outcomes, patients with symptomatic TDHs can experience long-term surgical site pain, and therefore, a move toward minimally invasive exposure in such cases should be considered. Postoperative complications such as CSF-pleural fistulas are unlikely to require surgical intervention and thus can be managed conservatively.

The Incidence of Distant Metastases in Patients with Pleural Mesothelioma Screened for a Multimodal Approach: How Much Staging Do We Really Need?

Pleural mesothelioma (PM) is a very aggressive malignancy with a poor prognosis. Most patients receive systemic treatment only; however, some patients may benefit from multimodality treatment. A precise staging of patients undergoing multimodal treatment is mandatory. We investigated the pattern of metastasis in a cohort of patients screened for multimodal treatment to define the extent of staging examinations. Additionally, we investigated the occurrence of metastasis during follow-up. We investigated a single-center experience of 545 patients newly diagnosed and/or treated with PM between the years 2010 and 2022. Patients who were treated naïvely and had a whole set of imaging of the brain were included and further analyzed. A total of 54% of all patients with cerebral imaging had an available 18FDG-PET CT scan. We also recorded metastasis during treatment follow-up. There were 110 patients who had a whole set of imaging (CT = 89% and MRI = 11%) of the brain, and 54% of all patients with cerebral imaging had an available 18FDG-PET CT scan. We identified four patients with cerebral metastasis at the time of first diagnosis, which means that 5.4% of the cohort had cerebral metastasis and 13.3% of all patients in the subgroup with complete data of 18FDG-PET CT had distant non-cerebral metastasis. During the longitudinal follow-up, we found 11 patients with newly diagnosed metastases after a median time of 1.6 years (range: 2 months to 3.3 years) after first diagnosis without metastases. Distant metastases are more frequent in mesothelioma patients than previously thought. This implies that extensive staging is needed for patients selected for multimodal treatment, including brain imaging and 18FDG-PET CT.

Outpatient management of Post-COVID syndrome – single center experience

BackgroundCOVID patients continue to experience unremitting symptoms that extend far beyond the initial illness. While there is rapid accumulation of data on acute COVID treatment in hospitalized patients, little is known regarding post-COVID management. ObjectivesTo describe our center's experience treating post-COVID sub-syndromes encountered in Post-COVID Lung Clinic. MethodsWe retrospectively reviewed data on 98 post-COVID patients evaluated in our clinic between 07/01/2020–12/31/2022. We encountered three distinct post-COVID subtypes: 1) respiratory complaints associated with increased O2 requirements and abnormal CT findings (post-COVID interstitial lung disease [ILD]), 2) respiratory complaints associated with tachycardia (post-COVID dyspnea-tachycardia syndrome [DTS]). Post-COVID ILD patients (n = 28) received steroids in combination with cell cycle inhibitor (mycophenolate mofetil-MMF). Post-COVID DTS patients (n = 16) were treated with metoprolol. 3) A third, undifferentiated group presented with mild respiratory complaints and normal spirometry (n = 17) and was followed in clinic without initiation of a specific treatment. ResultsIn treated post-COVID ILD patients, mean oxygen requirements at rest (1.96 ± 1.79 L/NC) decreased to 0.89 ± 1.29 L/NC at 6 months follow-up, p = 0.005. In patients with post-COVID DTS, mean heart rate at rest decreased (98 ± 15 bpm to 79 ± 11 bpm) at 6 months follow-up, p = 0.023. 60 % of patients reported an improvement in exertional dyspnea. ConclusionsOur descriptive study presents a single center outpatient COVID-19 clinic experience. We encountered 3 post-COVID sub-syndromes and describe their treatments: post-COVID interstitial lung disease [ILD] treated with a novel regimen of MMF and steroids, post COVID dyspnea-tachycardia syndrome [DTS] treated with metoprolol, and a third subgroup with mild undifferentiated symptoms without specific treatment.

TIMES, ARE THEY A–CHANGING? IMPLANTATION AND FOLLOW–UP EXPERIENCE WITH LEADLESS PACEMAKERS (MICRA) AT PISA UNIVERSITY HOSPITAL

Abstract Background Leadless pacing represents a pivotal advancement in cardiac stimulation. Eliminating traditional pacing leads, leadless devices offer reduced complications, a bailout strategy for many previously challenging cases and streamlined procedures. Purpose This retrospective study aimed to compare, starting from December 1st 2023, newer implants (within the 3 years preceding Dec 1st 2023) and older implants (&amp;gt;3 years before) in a single–center experience with M–TPS (Micra Transcatheter Pacing System) in terms of safety and efficacy, at baseline and in a short–term follow–up (6 months). Methods A comprehensive analysis was conducted on 195 patients who underwent leadless pacemaker implantation at our Center, and that were followed–up for a minimum of 6 months. The cohort was stratified into two groups: recent (n=73) and less recent implants (n=122). Procedural variables, patient demographics, and clinical outcomes were documented. Post–implantation follow–up data include pacing threshold, fluoroscopy time, and other relevant variables. Results Comparison between the two groups revealed significant differences fluoroscopy time. Newer implants demonstrated a reduced fluoroscopy time [8 (IQR 5–12) vs 10 minutes (IQR 7–14)], suggesting potential advancements in technique. No significant differences were observed in other procedural or electrical parameters. Discussion: The comparison between older and newer leadless pacemaker implants reveals reassuring constancy in most parameters, suggesting the reliability of the M–TPS. The reduced fluoroscopy time aligns with the evolving proficiency of implanters and improved procedural efficiency. The dependable consistency observed across various parameters strengthens the confidence in the M–TPS, reinforcing its status as a reliable and effective solution for pacing. Conclusion The implantation and follow–up experience at our center elucidates very few differences between newer and older implants. This nuanced analysis contributes to the ongoing evolution of leadless pacemaker technology, which heralds a transformative era in cardiac care. With several years of implementation, accumulated follow–up data unveils valuable insights into its sustained effectiveness, guiding clinicians in optimizing patient outcomes and solidifying leadless pacing as a breakthrough in the realm of cardiac rhythm management.

Operative and non-operative treatment of injury to solid abdominal organs in adult patients: a single center experience.

In major trauma, lesions of the parenchymatous organs are subject of a controversy as regards the choice between an operative management (OM) in the operating room and a non-operative management (NOM) associated or not with angiography/angioembolization (AG/AE). Retrospective study of all consecutive data of patients coded as "traumatic pathology" in the period between 2011 and 2021. Were enrolled 13740 entries of adult patients with abdominal injuries, including at least: either hepatic or splenic or renal injury of AAST-OIS I. The primary outcome was to establish the rate of efficacy, respectively of OM and NOM. The secondary outcome is to analyze General (CG) and Specific (CS) complications, mean ward and intensive care unit (ICU) hospital stays. One hundred sixty-two patients were included with 89 splenic injuries, 70 hepatic and 50 renal lesions; 35 treated with OM and 127 with NOM±AG/AE. The CGs registered in OM patients are seven (20%); seven SCs (20%); four GCs+SCs (11.4%). The average hospital stay was 24.91 days; mean ICU hospital stay of 10.74; five deaths. The CGs registered are 22 (17%); 12 SCs (9.4%); three GCs+SCs (2.3%). Average hospital stays 18 days; mean ICU hospital stay of 3.15; 6 deaths. Failure of the NOM strategy was recorded in nine patients with a success rate of 92.91%. In OM the presence of numerous high-grade lesions leads to a rapid stabilization. The NOM has reduced the hospital stay and UTI hospitalization in a feasible and safe way in selected CT.

REAL WORLD USAGE OF RANOLAZINE FOR ANTIARRHYTHMIC PURPOSES: SINGLE CENTER EXPERIENCE

Abstract Introduction Ranolazine is a late sodium current blocking drug developed as an antianginal agent, with good preliminary efficacy data even for antiarrhythmic purposes (both at atrial and at ventricular level). Objectives To evaluate patients’ clinical characteristics and antiarrhythmic efficacy of ranolazine in subjects with a history of atrial and/or ventricular arrhythmias, isolated or repetitive. Patients and methods we included patients who received a first prescription of ranolazine for antiarrhythmic purposes in our center from 1/2022 to 11/2023 and evaluated the survival free from major arrhythmic relapses/ablation. Results 93 patients were enrolled (66±13 years, 15% women): 59% with arterial hypertension, 26% diabetics, 46% with post–ischemic dilated heart disease, 32% with primary cardiomyopathy (including 11% with hypertrophic cardiomyopathy, 10% with LMNA, 14% with TTN), 46% with implantable cardioverter defibrillator, 9% with pacemaker. The mean LV ejection fraction was 42 ± 15%, the mean serum creatinine 1 ± 0.3 mg/dL. Half (50%) had a history of atrial arrhythmias in the 6 months before starting the drug, mainly paroxysmal atrial fibrillation (AF), 67% of ventricular arrhythmias (VAs), mainly isolated and repetitive premature ventricular beats (PVB, 47% of the total), but also sustained or treated VAs (n=18, 19%). Overall, 18% of patients had already undergone AF ablation, 13% ventricular tachycardia ablation, 3% cardiac sympathetic denervation. Finally, 95% of patients were on beta–blocker therapy and 28% were on amiodarone. Ranolazine was prescribed at an average initial dose of 535± 150 mg. The majority (54%) of patients (n=50) had a follow–up longer than 3 months (median 9 months, IQR 6–14); in 6% the drug was stopped due to intolerance and the average dose at the last FU was 641 ± 150 mg. Twenty–eight percent of patients with paroxysmal/persistent atrial arrhythmias had relapses, requiring ablation in 6%. Among patients with major VAs, 57% suffered recurrences, but only 19% required ablation (invasive in 2 cases, non–invasive in 1 case). Finally, among the patients with PVBs, none suffered major VAs or required PVB/VA ablation. Conclusions This is the largest available case–series reporting about the real–world usage of ranolazine for antiarrhythmic purposes. Our single center experience supports ranolazine’s good safety and tolerability and shows encouraging efficacy results in terms of clinical stabilization of complex patients.

REAL–WORLD SINGLE CENTER EXPERIENCE WITH THE WEARABLE CARDIOVERTER DEFIBRILLATOR: SEX DIFFERENCES IN RISK STRATIFICATION FOR SUDDEN CARDIAC DEATH

Abstract Background Wearable cardioverter defibrillator (WCD) demonstrated an important role for prevention of sudden cardiac death in patients with advanced heart failure and reduced left ventricular ejection fraction. Although in randomized trial there are no gender difference in WCD use and defibrillator (ICD) implantation rate, real world data in female patients is lacking. Purposes: We aimed to describe the sex differences in WCD use, the rate of cardiac events detected with WCD and the rate of ICD implantation after WCD use in women in a real–world single center experience with reduced left ventricular ejection fraction or prior ventricular tachyarrhythmia. Methods and Results According with the current guidelines indications, between August 2017 and June 2023 ninety–six consecutive patients (mean age 66.0±11.1 years) received a WCD at Piacenza Hospitals and were retrospectively included in this analysis. There were no differences in clinical characteristics between female (18 patients, 18,8%) and male: in particular baseline left ventricular ejection fraction (LV EF) were similar between the two groups (29.5±5.2 vs 27.9±7.9, p=0.23) and no differences were found in the rate of ischaemic cardiopathy (66,6% vs 69,2% p=0.51). After 3–months follow up with WCD use, a similar rate of ventricular arrhythmias were found in the two groups (5.5% vs 3.8%, p=0.48) and no ventricular fibrillation was detected. The WCD usage period and median daily wear time were not different between female and male (55.2±50.6 vs 56.2±34.8 days p=0.53, 21.0±6.4 vs 23.1±1.5 hours p=0.48, respectively). However women presented a better LV EF improvement (12.2±9.7 vs 7.2±6.8, p=0.01), with a significant lower ICD implantation rate at the end of WCD use (55.5% vs 43.8%; p&amp;lt; 0.01). Conclusions In this real word analysis women presented a nice compliance using WCD. In spite of a similar burden of ventricular arrhythmic events, women presented a better LV EF improvement with a significant lower ICD implantation rate.

Therapeutic plasma exchange in critically ill children: A single center experience.

Therapeutic plasma exchange (TPE) is used in a wide spectrum of diseases in critically ill pediatric patients. We aim to review the indications, complications, safety, and outcomes of critically ill children who received TPE. All of the TPE procedures performed in a pediatric intensive care unit providing tertiary care during 19 years (January 2013-January 2023) were evaluated retrospectively. A total of 154 patients underwent 486 TPE sessions. Median age was 6 years (2-12.5) and 35 children had a body weight of <10 kg (22.7%). Number of organ failure was 4 (2-6). Liver diseases were the most common indication for TPE (31.2%) followed by sepsis with multiorgan dysfunction syndrome (27.3%). Overall survival rate was 72.7%. The highest mortality was observed in hemophagocytic lymphohistiocytosis group. Non-survivors had significantly higher number of organ failure (p < 0.001), higher PRISM score (p < 0.001), and higher PELOD score on admission (p < 0.001). Adverse events were observed in 68 (13.9%) sessions. Hypotension (7.8%) and hypocalcemia (5.1%) were the most frequent adverse events. TPE is safe for critically ill pediatric patients with experienced staff. Survival rate may vary depending on the underlying disease. Survival decreases with the increase in the number of failed organs.

Safety and efficacy of peptide receptor radionuclide therapy in neuroendocrine tumors: A single center experience.

Peptide receptor radionucleotide therapy (PRRT) with 177Lu-dotatate is widely used for the treatment of patients with neuroendocrine tumors (NETs). We analyzed data from 104 patients with NETs treated with 177Lu -dotatate at a US academic center between December 2017 and October 2020 to better understand patterns of long-term efficacy, safety, and toxicity in the real-world setting. 177Lu-dotatate (200 mCi) was administered every eight weeks for four doses. The most common sites of primary disease were small intestine NETs (n = 49, 47%), pancreatic NETs (n = 32, 31%), and lung NETs (n = 7, 7%). Twenty-seven percent had Ki-67 <3%, 49% had Ki-67 between 3-20%, and 13.5% had Ki-67 >20%. The cohort had been pretreated with a median of two prior lines of treatment. Forty percent had received prior liver-directed treatment. Seventy-four percent of patients completed all four doses of treatment. The objective response rate was 18%. The median time-to-treatment failure/death was significantly longer for small-bowel NETs when compared to pancreatic NETs (37.3 months vs. 13.2 months, p = 0.001). In a multivariate model, Ki-67, primary site, and liver tumor burden ≥50% were found to independently predict time-to-treatment failure/death. Around 40% of patients experienced adverse events of ≥grade 3 severity. Treatment-related adverse events leading to discontinuation of therapy happened in 10% of patients. Preexisting mesenteric/peritoneal disease was present in 33 patients; seven of these patients developed bowel-related toxicities including two grade 5 events. We also report two cases of delayed-onset minimal change nephrotic syndrome, which occurred 14 and 27 months after the last dose of PRRT. Lastly, we describe six patients who developed rapid tumor progression in the liver leading to terminal liver failure within 7.3 months from the start of PRRT, and identify potential risk factors associated with this occurrence, which will need further study.

A comparative analysis of surgically excised hereditary and sporadic pheochromocytomas: Insights from a single-center experience.

Pheochromocytoma is a tumor that usually originating from adrenal medullary chromaffin cells and producing one or more catecholamines, can manifest as hereditary or sporadic. While the majority pheochromocytomas are sporadic, hereditary forms are often associated with genetic syndromes such as von Hippel-Lindau, multiple endocrine neoplasia type 2, and neurofibromatosis type 1. This study aims to analyze data from our series of surgically excited pheochromocytoma patients and compare the characteristics between hereditary and sporadic cases. We retrospectively evaluated 33 diagnosed pheochromocytoma patients, documenting clinical features, surgical complications, and tumor characteristics in both hereditary and sporadic cases. Among the patients, 21% (7 individuals) had hereditary pheochromocytoma, while 79% (26 individuals) had sporadic cases. During diagnosis, hereditary pheochromocytoma patients exhibited a significantly lower mean age compared to the sporadic group (26.4 ± 9.9 years vs. 50.4 ± 14.0 years; p < 0.001). The maximum tumor size was also lower in hereditary cases compared to sporadic cases (p = 0.004). Adrenal tumor localization analysis showed that 63.6% were right-sided, 24.2% were left-sided, and 12.1% were bilateral. Laboratory analysis revealed significantly higher urinary norepinephrine levels in hereditary pheochromocytoma patients (p = 0.021). Our findings suggest that hereditary pheochromocytoma cases are characterized by a younger age at diagnosis, smaller tumor size, and a higher prevalence of multiple bilateral adrenal adenomas. We recommend genetic testing for all pheochromocytoma patients, particularly those with early-onset disease and bilateral adrenal tumors.

Enhanced adherence counselling outcomes among people living with HIV with virological failure: Single-centre experience in Pune, India.

World Health Organization has recommended enhanced adherence counselling (EAC) for people living with HIV (PLHIV) with virological failure. This study aimed to assess the outcomes of EAC and its associated factors among PLHIV with virological failure. Data collected between March 2020 and February 2022 on viral load (VL) testing at antiretroviral therapy (ART) centre in Pune, India were reviewed. PLHIV with viral load ≥1000 copies/ml followed by three EAC sessions and a repeat viral load test were included. Multivariate logistic regression analysis was used to assess the factors associated with virological suppression (<1000 copies/ml). Of 170 PLHIV, 81 (47.6%) showed virological suppression. Being literate (p = 0.027), females (p = 0.021), on second-line ART regimen (p = 0.020), and with EAC initiation within a month (p = 0.016) were significantly associated with virological suppression. No association was found between reported barriers to treatment adherence and virological suppression. Early initiation of EAC is crucial for virological suppression among PLHIV with high viral load. It is important to highlight the significance of treatment adherence among individuals on first-line ART regimen. The use of effective visual tools during EAC sessions may help in achieving virological suppression among those with low literacy.