Single-center Prospective Study Research Articles

Prospective evaluation of patients with non-cirrhotic portal hypertension: A single centre study.

Non-cirrhotic portal hypertension (NCPH) is a spectrum of liver diseases, including porto-sinusoidal vascular disorder, with portal hypertension (PH) in the absence of cirrhosis. The natural history and diagnostic approach to NCPH are not well understood. We aimed to evaluate disease progression and outcomes in NCPH. Patients with or at risk for NCPH were enrolled in a single centre prospective study; two groups were formed based on the presence of specific features of PH, such as varices, collaterals, portal hypertensive gastropathy or portal hypertensive bleeding. All participants underwent a baseline liver biopsy. Liver stiffness measurement (LSM), and imaging were repeated every 6-12 months. Fifteen patients without specific features of PH (Group I), and 35 patients with specific features (Group II) were enrolled. The median follow-up time was 50 months. Group II had higher hepatic venous pressure gradients, non-invasive measures of PH and a lower platelet count (PLT) when compared to Group I. Rates of survival and decompensation were similar in both groups. Patients with PLT ≤100 K/mcL had lower survival compared to those with PLT >100 K/mcL. Patients with LSM ≥10 kPa had lower survival and survival without decompensation when compared to patients with LSM <10 kPa. Patients irrespective of specific features of PH had similar survival or survival without decompensation. Patients without specific features are at risk for disease progression and should be monitored closely. Thrombocytopenia and increased LSM are associated with severe forms of liver disease, which are strongly associated with outcomes.

Clinical value of serum tumor markers in assessing the efficacy of neoadjuvant chemotherapy in advanced ovarian cancer: single-center prospective clinical study

ObjectiveThis study aimed to assess the clinical importance of various biomarkers, including NLR, CEA, CA199, CA125, CA153, and HE4, through dynamic testing to evaluate the effectiveness of neoadjuvant chemotherapy (NACT) for individuals facing advanced ovarian cancer. This provides valuable information for tailoring treatment plans to individual patients, thereby leading to a more personalized and effective management of individuals facing ovarian cancer.MethodsThe levels of NLR, CA125, CA199, CEA, CA153, and HE4 were detected before chemotherapy and after 3 courses of chemotherapy. Patients were categorized into ineffective and effective groups according to the effectiveness of NACT. To evaluate the factors influencing NACT’s effectiveness in individuals facing advanced ovarian cancer, receiver operating characteristic (ROC) curves, predictive modeling, and multifactorial regression analysis were employed.ResultsIn the effective group, the patients’ age, maximum tumor diameter, and CEA and HE4 levels of the patients were significantly higher compared to those in the ineffective group (P &amp;lt;.05). Additionally, the difference in HE4 levels before and after treatment between the effective and ineffective groups was statistically significant (P&amp;lt;.05). Multifactorial analysis showed that age and maximum tumor diameter were independent risk factors impacting the effectiveness of NACT in individuals facing advanced ovarian cancer (P&amp;lt;.05). The ROC curve for predicting the effectiveness of NACT in individuals facing advanced ovarian cancer showed a sensitivity of 93.3% for NLR and a specificity of 92.3% for CA199. HE4 emerged as the most reliable predictor, demonstrating a specificity of 84.6% and a sensitivity of 75.3%. The area under the curve of the combined CA125 and HE4 assays for predicting the ineffectiveness of NACT in individuals facing advanced ovarian cancer was 0.825, showcasing a specificity of 74.2% and a sensitivity of 84.6%.ConclusionThe predictive capacity for the effectiveness of NACT in individuals facing advanced ovarian cancer is notably high when considering the sensitivity of NLR and the specificity of CA199. Additionally, the combination of CA125 and HE4 assays can obtain a better predictive effect, which can accurately select patients suitable for NACT, determine the appropriate timing of the interval debulking surgery (IDS) surgery, and achieve a satisfactory tumor reduction effect.

Association of NOTCH3 Variant Risk Category With 2-Year Clinical and Radiologic Small Vessel Disease Progression in Patients With CADASIL.

Pathogenic variants in NOTCH3 are the main cause of hereditary cerebral small vessel disease (SVD). SVD-associated NOTCH3 variants have recently been categorized into high risk (HR), moderate risk (MR), or low risk (LR) for developing early-onset severe SVD. The most severe NOTCH3-associated SVD phenotype is also known as cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL). We aimed to investigate whether NOTCH3 variant risk category is associated with 2-year progression rate of SVD clinical and neuroimaging outcomes in CADASIL. A single-center prospective 2-year follow-up study was performed of patients with CADASIL. Clinical outcomes were incident stroke, disability (modified Rankin Scale), and executive function (Trail Making Test B given A t-scores). Neuroimaging outcomes were mean skeletonized mean diffusivity (MSMD), normalized white matter hyperintensity volume (nWMHv), normalized lacune volume (nLV), and brain parenchymal fraction (BPF). Cox regression and mixed-effect models, adjusted for age, sex, and cardiovascular risk factors, were used to study 2-year changes in outcomes and differences in disease progression between patients with HR-NOTCH3 and MR-NOTCH3 variants. One hundred sixty-two patients with HR (n = 90), MR (n = 67), and LR (n = 5) NOTCH3 variants were included. For the entire cohort, there was 2-year mean progression for MSMD (β = 0.20, 95% CI 0.17-0.23, p = 7.0 × 10-24), nLV (β = 0.13, 95% CI 0.080-0.19, p = 2.1 × 10-6), nWMHv (β = 0.092, 95% CI 0.075-0.11, p = 8.8 × 10-20), and BPF (β = -0.22, 95% CI -0.26 to -0.19, p = 3.2 × 10-22), as well as an increase in disability (p = 0.002) and decline of executive function (β = -0.15, 95% CI -0.30 to -3.4 × 10-5, p = 0.05). The HR-NOTCH3 group had a higher probability of 2-year incident stroke (hazard ratio 4.3, 95% CI 1.4-13.5, p = 0.011), and a higher increase in MSMD (β = 0.074, 95% CI 0.013-0.14, p = 0.017) and nLV (β = 0.14, 95% CI 0.034-0.24, p = 0.0089) than the MR-NOTCH3 group. Subgroup analyses showed significant 2-year progression of MSMD in young (n = 17, β = 0.014, 95% CI 0.0093-0.019, p = 1.4 × 10-5) and premanifest (n = 24, β = 0.012, 95% CI 0.0082-0.016, p = 1.1 × 10-6) individuals. In a trial-sensitive time span of 2 years, we found that patients with HR-NOTCH3 variants have a significantly faster progression of major clinical and neuroimaging outcomes, compared with patients with MR-NOTCH3 variants. This has important implications for clinical trial design and disease prediction and monitoring in the clinic. Moreover, we show that MSMD is a promising outcome measure for trials enrolling premanifest individuals.

Efficacy and Safety Evaluation of 177Lu-FAP-2286 in the Treatment of Advanced Lung Cancer

Purpose The aim of this study was to evaluate the efficacy and safety of peptide-targeted radionuclide therapy (PTRT) with 177Lu-FAP-2286 in advanced lung cancer. Patients and Methods This single-center prospective study included 9 patients diagnosed with advanced lung cancer. These patients met the inclusion criteria and received PTRT with 177Lu-FAP-2286. Short-term efficacy was assessed using RECIST 1.1 and PERCIST 1.0 criteria. Long-term efficacy was evaluated through overall survival, progression-free survival (PFS), overall response rate, EORTC QLQ-C30 v3.0, Eastern Cooperative Oncology Group, and Karnofsky Performance Status. Toxicity response was assessed using CTCAE v5.0. Results The results based on RECIST 1.1 and PERCIST 1.0 criteria were comparable, with 44% of patients showing a partial metabolic response, 33.3% with stable metabolic disease, and 22.22% with progressive metabolic disease. The highest metabolic response after treatment reached 66.89%, and the overall response rate could reach 77.78%. In the long-term efficacy assessment, the median overall survival and PFS were 10 months and 6 months, respectively. The 2 patients with the lowest PFS (3 months) started PTRT relatively late. EORTC QLQ-C30 v3.0, Eastern Cooperative Oncology Group, and Karnofsky Performance Status scores showed that the overall health status, symptom response, and quality of life of patients improved after 177Lu-FAP-2286 treatment. The most noticeable improvements in clinical symptoms were dyspnea and cancer-related pain. No grade III/IV toxicity events were observed during follow-up period, and fibrinogen decreased significantly after treatment. Conclusions 177Lu-FAP-2286 has the potential to be a viable PTRT option for patients with advanced lung cancer.

Validation of bidirectional cavotricuspid isthmus block using electrocardiographic imaging

Abstract Background The validation of bidirectional cavotricuspid isthmus (CTI) block following catheter ablation for typical atrial flutter (AFL) involves endocavitary manoeuvres using multiple catheters. The diagnostic capacity of electrocardiographic imaging (ECGi) as a non-invasive tool to confirm bidirectional CTI block may simplify the procedure but its benefit has not been investigated so far. Purpose To evaluate the diagnostic capacities of a novel imageless ECGi system in detecting bidirectional CTI block during AFL catheter ablation. Methods A total of 34 patients were consecutively included in a prospective single-centre study. Atrial activation maps were derived from a novel imageless ECGi system when pacing the septal and lateral aspects of the CTI, gauging the technology's capacities to detect bidirectional block by measuring transisthmic intervals (TII) and observing wave-front collision patterns. TII reflects the time taken for electrical activation to cross the CTI during pacing and we measured both the absolute value and the increase relative to its baseline value. The bidirectional CTI block was assessed by endocavitary manoeuvres using a multipole catheter as the gold-standard. We conducted a blind assessment of the diagnostic capacities of ECGi over endocavitary manoeuvres considering maps from the septal and lateral pacing to determine clockwise and counterclockwise CTI block, respectively. Results Our study established clear benchmarks for diagnosing CTI block using ECGi (Figure 1). Regarding the assessment of clockwise CTI block, the presence of a wave-front collision pattern at the CTI yielded a positive predictive value (PPV) of 91% and negative predictive value (NPV) of 69%. Furthermore, ROC analysis pinpointed 100 ms and 30 ms as the optimal threshold for TII absolute value (PPV=89%, NPV =78%) and TII increase from baseline (PPV=91%, NPV =65%), respectively. Taking together, the combination of these three parameters offered high diagnostic capacities (PPV=87%, NPV=90%). Regarding counterclockwise CTI block, the TII absolute value alone was a reliable predictor, with a threshold derived from ROC analysis of 115 ms providing a PPV of 77% and a NPV of 83% (Graphical abstract). Conclusion These results highlight the efficacy of ECGi in CTI block assessment, promising a streamlined and accurate diagnostic approach (Graphical abstract). The use of a single ablation catheter coupled with ECGi to assess the bidirectional CTI block offers a simplified and efficient alternative to traditional dual catheter techniques.ECGi-based CTI block assessment methodGraphical abstract

Effectiveness of a novel integrated dilator-needle transseptal crossing device in atrial fibrillation cryoballoon ablation procedures

Abstract Background In cryoballoon ablation (CBA) procedures, left atrial (LA) access is generally achieved using a standard sheath and needle system that is exchanged for the cryoballoon delivery sheath and dilator over a long wire. Sheath exchange has been related with air embolic events in CBA procedures. A novel integrated dilator-needle system, that can be combined with the cryoballoon delivery sheath allowing direct LA transseptal access, was recently introduced. Figure. Objective The purpose of this study is to evaluate the efficacy and safety of this new integrated transseptal access tool compared with the traditional approach in CBA procedures. Methods In this prospective single-center study, consecutive patients who underwent AF CBA procedures were randomly assigned 1:1 to undergo traditional transseptal access (t-TSA) or integrated transseptal access (i-TSA). Patients with foramen ovale or interatrial communication, detected on transesophageal echocardiogram prior to the procedure, were excluded. Transseptal access time was defined as time from superior vena cava to LA insertion of the cryoballoon delivery sheath, after sheath exchange (t-TSA) or directly (i-TSA). Results We evaluated 82 patients (63 males, mean age 59 ± 10 years) indicated to CBA of atrial fibrillation, 42 patients underwent t-TSA and 40 i-TSA. The baseline characteristics of the study population were comparable between groups. Table. Mean CBS transseptal access time was 5 min 6 sec ± 2 min 5 sec in the t-TSA group and 3 min 5 sec ± 2 min 23 sec in the i-TSA group, P &amp;lt; 0.001. Challenging interatrial septa were noted in 3 patients: 1 in t-TSA (1 aneurysmal/elastic) and 2 in i-TSA group (1 lipomatous hypertrophy, and 1 abnormally thickened/fibrotic). No acute complications related to transseptal access were noted in both cohorts. The CBA procedure time and fluoroscopy time were lower in the i-TSA group. Table. There were 1 temporary phrenic nerve injury and 1 vascular complication, both in the t-TSA group. Importantly, no signs of clinical air embolism were noted in both groups. Conclusion This is the first randomized study comparing the traditional approach and the use of a new integrated dilator-needle system. Transseptal crossing in CBA procedures using this integrated tool enables a safe and more efficient workflow, reducing time for transseptal access and avoiding sheath exchange.FigureTable

Low-dose dexmedetomidine sedation in patients undergoing electrophysiological study and ablation of supraventricular tachycardias in a same day setting

Abstract Background Catheter ablation for supraventricular tachycardias (SVT) can frequently cause patient discomfort, anxiety or pain. Through the years different drugs have been employed to provide an optimal sedation without interfere with inducibility of tachyarrhythmia. Moreover, the increasing number of patients with this clinical condition and the growing demand of catheter ablation, makes same day discharge mandatory. For this purpose, drugs that guarantee minimal sedation and reduce adverse events should be used. Dexedetomidine (DEX) is a selective alpha-2 agonist with analgesic and sedating effect without significant respiratory depression. Its electrophysiological effects include the sinus node and atrioventricular (AV) node depression and an increased atrial refractoriness. Albeit there is a reduction of side effects of most commonly used sedation drugs, data on the efficacy and safety profile of DEX during SVT ablation of adult patients are unclear and conflicting. Purpose The aim of this study was to assess whether optimal sedation and patient’s comfort can be achieved with a low-dose DEX without interfering with electrophysiological parameters during catheter ablation of SVT in adult population. Methods This is a single-center prospective study. Study population consisted of patients undergoing mapping and catheter ablation of SVT from January to September 2023 divided into DEX group (periprocedural infusion of Dexedetomidine 0.07-0.11 mcg/kg/h without loading dose) and non-DEX group (midazolam 1-2 mg periprocedural). Clinical and procedural data were recorded for all patients, as well as all measurements taken during electrophysiological study. Results The study population was predominantly female (60%) with a mean age of 56 ± 13.7 years. Hypotension occurred in only one patient, in the DEX group. No cases of desaturation were observed in both groups. Most of the induced tachyarrhythmias were the slow-fast type of atrioventricular nodal reentrant tachycardia (75%), whereas atrioventricular reentrant tachycardia and atrial tachycardia were less common (7.1% and 7.1%). No significant differences were recorded in relation to AV node refractoriness, atrial refractoriness, anterograde and retrograde conduction. (Table 1) Isoproterenol was required to induce tachyarrhythmia in both groups. Arrhythmia inducibility and aberrancy in tachycardia was not significantly influenced by DEX. The jump phenomenon was recorded more frequently in the DEX group (86.4% vs. 46.7%; p=0.004). The mean duration of the procedure did not differ between the two groups. All patients were discharged on the same day after 3 hours of observation. Conclusions The use of low-dose Dexedetomidine was succesful in improving periprocedural patient comfort, without reducing tachyarrhythmia inducibility or major electrophysiological parameters.

Physiologist-led management of heart failure patients using cardiac implantable electronic device diagnostics during COVID-19: a 2-year UK perspective

Abstract Background/ Introduction The COVID-19 pandemic prompted greater use of remote monitoring capabilities of cardiac implantable electronic devices (CIED). The HeartLogic Index incorporated within certain Boston Scientific CIEDs uses device-derived physiological parameters to generate a score which may be predictive of worsening heart failure (HF). We aimed to define the utility of a novel service, led by cardiac physiologists acting autonomously upon HeartLogic Index alerts, to guide HF patient care during the pandemic. Purpose To assess the utility of a physiologist-led HF service, using CIED diagnostics combined with clinical assessment, to improve HF management. Methods In a single-centre prospective study, 153 Boston Scientific CRT/ICD patients were reviewed over a 2-year period using the integrated HeartLogic algorithm. In response to a HeartLogic alert indicating worsening HF, the patient was contacted by a cardiac physiologist using a structured telephone triage to assess HF symptoms. In those deemed as being at risk of decompensated HF based on clinical assessment, an intervention was made e.g. face-to-face physiologist-led clinical assessment, consultant review, medication optimisation. Results During the 2-year audit, 748 alerts were received from 60 patients, the majority of which had a HF implant indication (n=42). Twenty-one patients within the study population required an intervention due to worsening HF. Following intervention, there were no further hospitalisations within this group. Five hospitalisations were documented during the audit, only 3 of which were HF related. Of these HF hospitalisations, one patient denied HF symptoms at the time of telephone contact, one had a HF decompensation due to deteriorating renal failure and the final patient had a disconnected remote monitor. During the 2-year audit, there were a total of 13 deaths, 3 of which were classified as caused by HF. Conclusion A physiologist-led service may be of clinical utility within this complex patient population, with the audit results demonstrating favourable outcomes with a low rate of mortality and HF hospitalisations. The addition of this service can act to streamline the time from patient presentation to HF review, and therefore improve patient care.

GR.1 Standardized approach to direct first pass aspiration technique for endovascular thrombectomy: description and initial experience with CANADAPT

Background: Endovascular thrombectomy (EVT) is standard of care for acute ischemic stroke. There is growing evidence that A Direct Aspiration first Pass Technique (ADAPT) is a safe, efficient and effective approach for EVT, offering several advantages. This study describes initial institutional experience in the use of a standardized aspiration only technique: CANADAPT. Methods: Single center prospective cohort study was performed on patients treated for large/medium vessel ischemic stroke. A sequential stepwise aspiration only technique was applied, CANADAPT, consisting of three maneuvers, A, B and C. The reperfusion success rate, number of passes, use of rescue technique, complication rate and procedural cost was determined. Results: 22 patients were included representing M1 (77%), M1/2 (9%), carotid-T (9%) and basilar (5%) occlusions. First pass recanalization was achieved in 50% of patients. A further 4 patients had successful reperfusion with a second pass (total 68% success). 7 patients had stent rescue technique (SOLUMBRA). Of these, 5 patients (22% of total) had successful reperfusion. The cost per procedure was $6,630 ± 1069 for CANADAPT, and $13,530 ± 2706 for SOLUMBRA. Conclusions: CANADAPT represents a standardized approach to aspiration only thrombectomy. This study demonstrates the safety, efficiency and efficacy of this technique in EVT.

Chronic inflammatory cardiomyopathy and its overlap with arrhythmogenic cardiomyopathy: long-term follow-up of a prospective single-centre cohort study

Abstract Background Chronic Inflammatory Cardiomyopathy (infl-CMP) may overlap with Arrhythmogenic Cardiomyopathy (ACM), a group of conditions with similar ventricular arrhythmic phenotypes and key imaging, electrocardiographic, histopathological, and genetic features. Purpose This single-centre cohort study aimed to assess the role of pathogenic genetic variants of ACM in long-term follow-up of patients with infl-CMP and ventricular arrhythmic phenotype. Methods In this prospective, single-centre study, 24 consecutive patients with suspected infl-CMP and ventricular arrhythmic phenotype were enrolled at our tertiary referral hospital between 2017 and 2022. Baseline demographic and clinical characteristics of the patients were collected. All patients underwent extensive workup, including electrocardiography, echocardiography, cardiac magnetic resonance, and genetic counselling and testing. Endomyocardial biopsy was performed if a definite diagnosis had not been reached after non-invasive diagnostic workup. Patients were classified according to phenotype as ACM (either definite or borderline), as indicated by the 2010 Padua Criteria, and genetically classified as genotype-positive or genotype-negative according to the presence of pathogenic variants for ACM. Long-term follow-up was performed to assess cardiovascular morbidity and mortality. The primary outcome was the occurrence of in-hospital admission for sustained ventricular tachyarrhythmias. Results At admission, 5 (21%) patients presented with syncope, 19 (79%) with high ventricular burden (&amp;gt;25% premature ventricular contractions) or with sustained ventricular tachyarrhythmias. After complete diagnostic work-up, 17 patients (71%) received a diagnosis of either definite or borderline ACM, while the remaining 7 patients (29%) received a diagnosis of infl-CMP. In 18 patients (75.0%), an endomyocardial biopsy was required as part of the diagnostic workup. In our population, the frequency of pathogenic ACM variants was 41% (8 variants in ACM patients and 2 variants in infl-CMP); in particular, pathogenic genetic variants coexisted in 2 patients (1 in the ACM group: PKP2 and KCNE1 mutations; 1 in the infl-CMP group: DSG2 and TMEM43 mutations). At a mean follow-up of 4.37 (SD ±1.77) years, the primary outcome occurred in 8 patients (33%), all identified as borderline or definite ACM (X²=4.94, p=0.026). Notably, sustained ventricular tachyarrhythmias occurred in 25% of genotype-negative and 50% of genotype-positive patients (X²=1.50, p=0.220). Conclusions Criteria-driven diagnosis of ACM was significantly associated with the occurrence of sustained ventricular tachyarrhythmias at long-term follow up. The presence of pathogenic genetic variants of ACM did not clearly stratify the ventricular arrhythmic risk as a single factor in our cohort of patients with ventricular arrhythmic phenotype.

Abnormal vascular thickness and stiffness in young adults with type 1 diabetes: new insights from cutting-edge ultrasound modalities

BackgroundCardiovascular disease (CVD) remains the leading cause of morbidity and mortality in patients with Type 1 Diabetes (T1D). Early markers of CVD include increased carotid intima-media thickness (CIMT) and pulse wave velocity (PWV), but these existing ultrasound technologies show limited spatial and temporal resolution in young adults. The purpose of this study is to evaluate the utility of high-resolution ultrasound modalities, including high frequency ultrasound CIMT (hfCIMT) and ultrafast ultrasound PWV (ufPWV), in young adults with Type 1 Diabetes.MethodsThis is a prospective single-center observational cohort study including 39 participants with T1D and 25 age and sex matched controls. All participants underwent hfCIMT and ufPWV measurements. hfCIMT and ufPWV measures of T1D were compared with controls and associations with age, sex, BMI, A1c, blood pressure, and lipids were studied.ResultsMean age was 24.1 years old in both groups. T1D had a greater body mass index (27.7 [5.7] vs 23.1 [3.2] kg/m2), LDL Cholesterol, and estimated GFR, and had a mean A1c of 7.4 [1.0] % (57 mmol/mol) and diabetes duration of 16.1 [3.7] years with 56% using insulin pumps. In T1D, hfCIMT was significantly increased as compared to controls (0.435 ± 0.06 mm vs 0.379 ± 0.06 mm respectively, p < 0.01). ufPWV measures were significantly increased in T1D (systolic foot PWV: 5.29 ± 0.23 m/s vs 5.50 ± 0.37 m/s, p < 0.01; dicrotic notch PWV = 7.54 ± 0.46 m/s vs 7.92 ± 0.41 m/s, p < 0.01). Further, there was an impact of A1c-measured glycemia on hfCIMT, but this relationship was not seen with ufPWV. No significant statistical correlations between hfCIMT and ufPWV measures in either T1D or healthy controls were observed.ConclusionYoung adults with T1D present with differences in arterial thickness and stiffness when compared with controls. Use of novel high-resolution ultrasound measures describe important relationships between early structural and vascular pathophysiologic changes and are promising tools to evaluate pre-clinical CVD risk in youth with T1D.Trial Registration: ISRCTN91419926.

Value of basal HV Interval prior TAVR as predictor of permanent pacemaker implantation

Abstract Background/Introduction Transfemoral aortic valve replacement (TAVR) is an effective and safe treatment for severe aortic stenosis (SAoS) even in low risk patients (1,2). As population ages, the volume of TAVR procedure increases and although improvements in technology and technique, new onset persistent disturbances in the electrocardiogram (ECG) are present up to 34,8% of patients at hospital discharge(3) and the secondary need of permanent pacemaker implantation (PPM) remains high, being of 4-24% with balloon-expanding valves (BEV) and 14.7-26.7% with self-expanding valves (SEV)(3). According to ESC guidelines, an electrophyisiologic study (EPS) centered in HV interval measure with a cutoff of ≥70ms is a useful tool to assess the risk of progression to high auriculoventricular block (HAVB) in specific groups with persistent ECG abnormalities to consider PPM(4-5), but this only applies in post TAVR scenario. Measuring HV interval at the intervention day prior procedure could help optimize and assess risk for PPM post TAVR. Purpose To measure basal HV interval prior TAVR and correlate it to risk of PPM implantation before discharge and 30 days after discharge. Methods Single-center prospective cohort study, patients with SAoS scheduled for TAVR, sinus rhythm at intervention day, without PPM or history of PPM indication were included. At time of TAVR, a tetrapolar catheter was placed at the septal aspect of tricuspid valve. A mobile polygraph was used to measure ECG parameters and HV interval before TAVR. Then, tetrapolar catheter was advanced to ventricle to perform rapid stimulation as part of habitual valve implantation protocol. After procedure, a rhythm monitorization for &amp;gt;48-72 hrs, was made to decide, PPM, HV interval measure or clinical daily ECG vigilance with posterior discharge was performed. A 30-day post discharge follow up was expected. Results 38 patients were enrolled, median age 83.5 ± 5.5 years, 23 females (60,5%). 37 patients had SEV implanted and 1 patient had BEV implanted. Median HV interval was 54.4ms. 18 patients (47.4%) had a mild abnormal HV interval, of whom 11 had a narrow QRS. Post TAVR procedure, 15 patients (39.5%) persisted with "de novo" LBB at discharge. 5 women and 7 men, had PPM implanted before discharge. 1 woman was implanted 6 days after discharge due to HAVB (66ms HV interval prior TAVR). In a multivariate analysis including sex, age, PR, QRS and HV interval &amp;gt;55ms, the RR (IC 95% 1.9-70.3) risk of PPM was 13.42 folds higher (p=0.008). At a bivariate quantitative HV analysis, a higher HV period persisted significantly related to PPM outcome (p=0.001). Conclusions In our study population, a pre-existing mild to moderate prolongation of HV interval prior TAVR substantially elevates the risk of requiring PPM before discharge. 61.1% of these basal mild prolongation HV interval patients had a narrow QRS prior TAVR.HV measure prior TAVR in narrow QRSTable 1

Posterior wall isolation in patients with persistent atrial fibrillation: a single center comparative study between ablation index and very high power short duration radiofrequency ablation protocol

Abstract Background Circumferential pulmonary veins ablation (CPVA) with posterior wall isolation (PWI) using radiofrequency catheter ablation (RFCA) is gaining increasing interest in terms of safety and efficacy. Purpose To compare procedural data and efficacy between two radiofrequency ablation protocols for the treatment of persistent atrial fibrillation (PersAF): very high power-short duration (vHPSD) ablation using a novel temperature-controlled ablation catheter and Ablation Index (AI) guided RFCA using traditional contact-force catheter. Methods This single center prospective study enrolled 75 consecutive patients (Group 1) with symptomatic PersAF undergoing RFCA using a novel contact-force catheter optimized for temperature-controlled ablation with microelectrodes and 6 thermocouples for real-time temperature monitoring during ablation. The vHPSD algorithm modulates power to maintain target temperature during these lesions (90 Watts, 4 s) in the posterior wall. RF delivery in anterior regions was performed in a temperature guided setting (1-45W, 45°C) to achieve a 500-550 AI. These patients were compared to 75 propensity matched patients (Group 2) undergoing PersAF ablation with traditional AI-guided ablation. Procedural data were compared between the two groups (Table 1). Procedural outcome was considered as loop recorder documented atrial arrhythmias recurrences and compared between the two groups. Results Seventy-five patients (69% male, 63.1±11.2 years old) underwent ablation with vHPSD protocol (Group 1). CPVA and PWI was achieved in all patients with total procedure and fluoroscopy times of 67.5±28.8 min and 4.5±2.8 min, respectively. After 12-month median follow-up, 57/75 patients (76%) were free from AF. Seventy-five propensity matched patients (69% male, 60.7±9.9 years old) have undergone ablation with standard contact-force catheter. CPVA and PWI was achieved in all patients with total procedure and fluoroscopy times of 81.99±20.5 min and 5.7±2.1 min, respectively. After 12-month median follow-up, 55/75 patients (73%) were free from AF. Procedural and fluoroscopy times were significantly lower in in Group 1 than in Group 2 (Table 1). AF recurrencies were comparable between the two groups as assessed with survival analysis (Figure 1, log-rank 0.509). There were no deaths or other severe periprocedural complications. Conclusions PWI on top of CPVA is effective in limiting arrhythmic recurrences following RFCA of PersAF. Compared to standard AI guided ablation, vHPSD protocol significantly reduces procedural time and fluoroscopy exposure. Clinical outcomes between the two protocols are similar.Figure 1

Effect of implantable cardioverter defibrillator intracardiac electrogram morphology changes on hospitalization and life quality

Abstract Background Implantable Cardioverter Defibrillators (ICD) are standard therapy for patients at risk of life-threatening ventricular tachyarrhythmias. ICDs use morphology discrimination to compare ventricular electrogram during tachycardia with reference template during baseline rhythm. Baseline morphology match score (MMS) changes may predict arrhythmic events, but usefulness as a parameter for heart failure (HF) is still unknown. Methods The prospective single-center study included consecutive 88 patients undergoing device control at cardiology department from July 2022 to May 2023. Inclusion criteria were patients implanted with ICD or CRT for at least 3 months; the exclusion criteria were defined as communication barriers (n=1), depleted device battery during checks (n=1), total AV block (n=3), and auto-template activation (n=4). The data were analysed for changes in the baseline (MMS) relationship with demographic, clinical characteristics, quality of life (QOL), and hospitalisation with HF. Results We analyzed 79 patients with a mean age 64,9 13,6 and an average MMS of 98 1,8 morphology. During follow-up there were 12 (15%) patients hospitalized due to HF. ROC curve analysis showed that a MMS ≤ 97% had 73% sensitivity and 59% specificity for hospitalization (p: 0,033 Area 0.695). No significant differences were observed in demographics between the two groups. Although there was no significant difference in EF and BNP levels, patients with MMS &amp;lt;97% had lower QOL scores and more hospitalizations for heart failure (HF). Conclusion EGM baseline MMS changes in ICD were associated with hospitalization for HF and QOL, apart from arrhythmia detection indications. It may be a follow-up parameter for HF, in addition to the current device algorithms.Graphical AbstractTable 1

Left bundle branch vs biventricular pacing for cardiac resynchronization therapy

Abstract Background/Introduction Left bundle branch pacing (LBBP) has emerged as a predominant conduction system pacing technique for reducing QRS duration in patients with intrinsic left bundle branch block (LBBB). It represents a potentially optimal alternative to cardiac resynchronization therapy (CRT) through biventricular pacing (BiVP). Purpose This study aims to compare the efficacy of LBBP-CRT with BiVP-CRT in patients experiencing heart failure with reduced left ventricular ejection fraction. Methods This single-center prospective study involved patients with heart failure and reduced ventricular ejection fraction, encompassing both ischemic and nonischemic cardiomyopathy. LBBP-CRT was employed when BiVP was unsuccessful for any reason, with LBBP-CRT implanted during the same procedure. After 3 and 6 months of preplanned follow-up, comparisons were made between the New York Heart Association (NYHA) functional class and QRS duration in the BiVP-CRT and LBBP-CRT groups. Results Sixty consecutive patients were included in the study (39 males, mean age 64.1 ± 10.6 years, LVEF 29.6% ± 5.6%). All patients completed follow-up, with 32 receiving LBBP-CRT and 28 receiving BiVP-CRT. All 32 LBBP-CRT patients achieved LBB capture, with 14 undergoing selective LBBP and 18 undergoing nonselective LBBP. The LBBP-CRT group exhibited shorter procedure and x-ray exposure times ((11.95 ± 5.77 vs 18.66 ± 10.12). The LBBP lead demonstrated a lower LBB capture threshold at implantation (0.7 ± 0.26 V vs. 1.1 ± 0.40 V; p= 0.039) compared to the CS LV lead in the BiVP-CRT group. Pacing parameters remained stable at the 6-month follow-up (0.72 ± 0.20 V vs. 1.1 ± 0.57 V; p=0.07). During the 3 and 6-month follow-up, pacing parameters remained stable in both groups. Only one patient in the LBBP-CRT group experienced dislodgment of the CS LV lead two days after the procedure, while no patients in the LBBP-CRT group had lead dislodgment. QRS duration significantly shortened in LBBP (171.6 ± 14.3 ms to 131.5 ± 12.5 ms; p=0.047) and remained not significantly shortened in BiVP (174.7 ± 14.1 ms to 150.6 ± 12.9 ms; p=0.06). Both LBBP and BiVP demonstrated improvement in NYHA functional class at the 3 and 6-month follow-up, with statistically significant differences observed between the two groups (change in NYHA functional class from baseline to 6 months -1.2 ± 0.1 vs -0.94 ± 0.11 p=0.047). Throughout the 6-month follow-up, neither the LBBP-CRT nor BiVP-CRT groups experienced rehospitalizations for heart failure, ventricular arrhythmia events, or all-cause death. Conclusions In this series, LBBP-CRT exhibited improvements in NYHA functional class and significantly shortened QRS duration when compared to BiVP-CRT in patients with reduced left ventricular ejection fraction and LBBB.

#862 Prevalence and surrogate predictors of acute kidney injury in tropical infections in eastern India

Abstract Background and Aims Acute kidney injury (AKI) in tropical countries is strikingly different from the other countries with a temperate climate. The epidemiology of AKI is largely influenced by environmental factors and climatic conditions and differ significantly its outcome and the surrogate predictors are not much studied. 1. To observe the spectrum and estimate the prevalence of AKI in tropical infections. 2. To evaluate the outcome and surrogate predictor of tropical AKI. Method This was a tertiary level single centre prospective observational study. All patients admitted with tropical infections associated AKI (KDIGO) were enrolled in two years and underwent complete history taking, clinical examinations and necessary laboratory investigations according to situations.. All patients were followed up more than 6 month. All data recorded were analysed in suitable statistical tool. Univariate analysis is followed by multivariate analysis was done for predictors followed by hazards ratio and Neglekers test. Results Out of 132 patients with Tropical AKI M:F was 1.5:1. Mean age was 42.3 ± 14.4 year, About 35.6% had Malaria,31.1% Dengue, 17% Scrub typhus, 10.4% Leptospira, and 5.9% patients had Typhoid fever. Malaria was the most common causative factor followed by Dengue. study reflecting the high dengue incidence occurring in the months of August, September, October &amp; November. Among Malaria AKI (MAKI) 43.75% (21) had Falciparum malaria, 50% (24) had Vivax malaria and 6.25% (3) had dual infection. Out of 132 patients with Tropical AKI about 60% totally recovered at the time of discharge. 40% patients had Shock. Among them 60% Dengue AKI, 33.3% Malarial AKI 5 (21.7%) Scrub typhus, 4 (28.6%) Leptospira AKI &amp; 3 (37%) Typhoid AKI patients had Shock. About 23% patients required RRT. Among them 8 (25%) patients died, 5 (15.6%) patients had CKD progression compared to non-RRT group where only 3 (2.9%) patients died, and 2 (1.94%) patients had progression to CKD. Total 11 (8.1%) patients died during hospital stay and only 7 (6.2%) patients had progressed to CKD. The mean Hospital stay was 5.51 ± 3.8 days. S hock at presentation, requirement of ICU support ( in form of ionotropic and ventilatory support), Need of RRT, prolong hospital stay, late referral was the bad prognostic predictor in terms of death. Though not statistically significant, presence of anaemia, hyponatraemia, deranged liver function &amp; hypoalbuminemia were more in patients who died compared to survival group. Limitations: Small enrolments. non inclusion of all cause including snake bite, less biopsy in this study. Conclusion There are wide spectrum of tropical AKI with high mortality and morbidity. A greater awareness and early intervention is necessary for prompt diagnosis, treatment and favourable outcome.

#2590 Electrolyte abnormalities in HIV patients with CKD

Abstract Background and Aims Individuals with HIV infection and CKD are prone to various water &amp; electrolyte disorders with previous studies showing prevalence of 70%. Many of these disturbances remain clinically silent until they reach an advanced stage, emphasizing the need for a high level of clinical suspicion and awareness, as they contribute to both morbidity and mortality. The prevalence of CKD in HIV patients has been increasing, yet data on electrolyte disturbances is sparse. The study we conducted aims to determine electrolyte imbalances in this population. Method Prospective observational single center study for a period of 2 years including HIV seropositive patients &amp;gt;18 years of age who were screened for CKD as per KDIGO definition (eGFR &amp;lt; 60 ml/min/1.73 m2 or significant proteinuria &amp;gt; 300 mg/day for more than 3 months). Demographic features, laboratory investigations for serum electrolytes including Sodium, Potassium, Phosphorous &amp; Calcium levels were done at baseline with follow up at 3, 6 &amp; 12 months. Results Out of 695 HIV patients screened, 56 who had CKD were included in our study. The average age was 53.8 ± 11.3 years, including 41 males (73.2%). Median creatinine at baseline was 1 (1.3) mg/dL, &amp; median eGFR was 59 (24.82) ml/min/1.73 m2 (Table 1). Commonest abnormality at baseline was hyponatremia (53.6%), and only 8.9% had severe hyponatremia (&amp;lt;125 mmol/L). Other abnormalities prevalent were hypocalcemia (35.7%) and hypophosphatemia (46.4%). Follow up details are presented in Table 2. Conclusion CKD was prevalent in 56 (8%) of our patients. Dyselectrolytemias were seen in 91% of study population. Hyponatremia (89.2%) was the commonest electrolyte imbalance followed by Hypophosphatemia (62.5%) &amp; Hypocalcemia (57.1%). Notably, our study identified a significantly higher incidence of hypocalcemia, and hypophosphatemia compared to other studies.

#1813 Safety and efficacy of reducing hemodialysis fluid flow rate—contribution to planetary health

Abstract Background and Aims Historically, increasing dialysate flow rates (Qd) have been recommended to improve hemodialysis (HD) efficiency. For decades, Qd has routinely been set to a fixed rate of 500 ml/min. A standard HD treatment uses on average around 500 L of water [1], resulting in a consumption of 78 000 L per patient and year with an additional estimated 10 000 L for post-dilution hemodiafiltration. This corresponds to the annual water consumption of 1.5 persons in developed countries and considerably more in developing countries. We investigated the effect of reducing dialysate flow rates on HD safety and efficacy. Method This is a prospective single-center non-blinded observational study. We investigated the effect of a 1:1 adjustment of online Qd to blood flow rate by adjusting autoflow (AF) settings of the dialysis monitor to a calculation factor of 1.0 with a lower Qd limit of 350 ml/min (AF 1.0 mode). We examined the effect on dialysis efficacy, metabolic markers, and anemia in routine biochemical analyses, and calculated energy, water, and waste savings in 116 stable chronic HD patients. Data were compared with previous turnover in energy, waste, and water, as well as with clinical results prior to the mentioned modifications. Results After 12 months of HD treatment with AF 1.0 mode we observed reductions of 10% in electricity consumption, 19% in raw water consumption, and 24% in dialysate concentrate consumption. Conversely, we did not observe deteriorations in treatment quality or dialysis dose (Table 1), nor phosphate or hemoglobin. Conclusion Long-term HD treatment with reduced dialysate fluid flow rates led to substantially improved water and carbon footprints with potential effects on planetary health and economic savings, while dialysis quality remained unchanged.

#1370 Frailty prevalence and short-term outcomes among younger end-stage renal disease patients on maintenance hemodialysis

Abstract Background and Aims Frailty is a medical condition of reduced function and health, or a state of heightened risk for catastrophic decline in vitality and function which is evident among end-stage renal disease (ESRD) patients. There has been only limited data regarding its occurrence in the younger age group since most of the published frailty studies involved the elderly as their study population. It is important to identify who among the younger hemodialysis patients are frail, since frailty is related to a higher risk of hospitalization and mortality. This study aims to estimate the prevalence of frailty among younger ESRD patients on maintenance hemodialysis using the Edmonton Frail Scale (EFS) and its association with short-term outcomes: hospital consultations, use of emergency room services, hospitalizations, and mortality. Method A prospective single-center cohort study was conducted. All ESRD patients aged 18-64 years old on maintenance hemodialysis on an outpatient basis were included. Data collection included the patients’ demographic data, underlying diseases, comorbid conditions, body mass index, and recent laboratory results. The EFS was administered during the first month of the study, and patients were then monitored for consultations, use of emergency room services, hospitalizations, and mortality in the succeeding months until the end of the study period. Results Out of 166 ESRD patients, 94 belong to the younger age group and 87 patients were included: 33 (37.9%) were frail, 21 (24.1%) were vulnerable, and 33 (37.9%) were fit. Chronic Glomerulonephritis was the leading cause of ESRD in the younger population, and Diabetic Nephropathy was the primary cause among those categorized as frail. Hypertension was the predominant comorbid condition across all categories. Frail patients had the greatest number of hospital consultations (54%) and had frequent utilization of emergency room services. They also exhibited the highest number of hospitalizations consisting 69% of the total admissions across all categories. All deaths in this study came from the patients categorized as frail. Conclusion Frailty is prevalent among younger ESRD patients on maintenance hemodialysis and is associated with increased risk for hospital consultation, use of emergency room services, hospitalization, and mortality.

#1351 Assessment of safety and efficacy of expanded hemodialysis in comparison to HDF

Abstract Background and Aims In end-stage kidney disease, solutes with a wide spectrum of molecular weight, called uremic toxins, are retained due to impaired kidney cleansing capacity. Particularly, the retention of toxins in the middle molecular weight range 15–45 kDa might negatively affects multiple organ systems and metabolic pathways. The removal of such large uraemic toxins is still a challenge. HDF has produced some results although large convective volume, optimal vascular access to increase the blood flow rate and strict water quality management are required. Medium Cut-Off, high Retention Onset membrane have been recently developed introducing the concept therapy called “expanded haemodialysis” (HDx). Furthermore, vitamin E-coated membrane has potential beneficial effects on inflammation and oxidative stress. Method A prospective longitudinal single-center study was conducted for 3 months among 18 chronic haemodialysis patients. Patients were randomly assigned into either HDF with high flux membrane or HDx with Theranova or ViE-X membrane. The primary goal was to assess albumin loss among the three types of dialyzers. Secondary goals included assessment of depurative efficacy for uraemic toxins and clinical outcomes. Throughout the treatment, a proportional part of the dialysis fluid was collected to quantify albumin loss. Blood samples were taken before and after dialysis session in order to calculate the Removal Ratio and at two different intradialytic timepoints from arterial and venous line of the circuit in order to calculate instantaneous clearance. Results Mean albumin loss was significantly higher in patients undergoing HDx with Theranova membrane (ANOVA, p&amp;lt;0.001) without any difference in serum albumin concentration among the three groups. Instantaneous clearance of small and middle molecules was significantly higher in patients undergoing HDF, but we didn't find differences in removal ratio. Reduction of Erythropoietin resistance index was observed in patients treated with ViE-X membrane but it was related to their lower dialysis vintage. Conclusion HDx with Theranova membrane was associated with higher albumin loss without any effect on pre-dialysis serum albumin. Moreover, patients treated Theranova membrane, in the presence lower Qb, lower convective dose and lower instantaneous clearance reached same dialysis efficacy compared to HDF.