Real-world Single-center Experience Research Articles

P262 PREDICTORS OF ICD IMPLANTATION: THE ROLE OF THE WEARABLE CARDIOVERTER DEFIBRILLATOR

Abstract Background Previous studies established a role for the wearable cardioverter defibrillator (WCD) In patients with transient risk of sudden cardiac death ( SCD) . In clinical trials, nearly 40% of patients received implantable cardioverter–defibrillator (ICD) implantation at the end of WCD use. It’ unknown if WCD can be usefull in final ICD implantation indication. Objectives We aimed to describe the clinical predictors of ICD implantation rate at the end of WCD use in a real–world single center experience. Methods and results Between August 2017 and June 2022, 60 consecutive patients receiving a WCD at Piacenza Hospitals were retrospectively included in this analysis: : mean age 66.9±11.9 years, 56.6% with ischaemic cardiomyopathy, 38.3% with dilated cardiomyopathy, 5% after implantable cardioverter–defibrillator explant. A total of 34 participants (56.6%) received implantable cardioverter–defibrillator (ICD) implantation at the end of WCD use. We evaluated clinical features related to ICD implantation rate with Chi Square test and Student’s t test. Female sex was related with no ICD implantation ( ICD 5,9% vs no ICD 23,1%, p= 0,03), whilst Low ejection fraction at beginning of evaluation was related with ICD implantation ( ICD 27.1±9.3 vs no ICD 33.1±11.9, p=0,03). Although in our population there weren’t shock of WCD, the strongest clinical predictor was arrhythmic event recordered at WCD monitoring both non sustained ventricular tachicardia, sustained ventricular tachicardia and supraventricular tachicardia ( ICD 20 vs no ICD 0, p < 0,01). Age ( ICD 66.6±11.9 vs NO ICD 67.4±11.9, p=0,7) and etiology of cardiopathy both ischemic and non ischemic ( ICD 52% vs no ICD 53,8%, P=0.5) were not factors associated with ICD implantation. Conclusion In our study the rate of ICD implantation after wearing time of WCD is consistent but slightly major to European registries. Arrhythmic Event recordered at WCD monitoring is related with ICD implantation, so WCD, when it is used, may be a further help in final ICD implantation.

P10 REAL–WORLD SINGLE CENTER EXPERIENCE WITH THE WEARABLE CARDIOVERTER DEFIBRILLATOR: SEX DIFFERENCES IN RISK STRATIFICATION FOR SUDDEN CARDIAC DEATH

Abstract Background Previous studies established a role for the wearable cardioverter defibrillator (WCD) in patients with transient risk os sudden cardiac death (SCD). The WEARIT–II Registry highlighted an higher burden of ventricular and atrial arrhythmic events in women than in men, in spite of a similar ICD implantation rates. Objectives We aimed to describe the sex differences in WCD use and compliance. Moreover we reviewed the rate of cardiac events detected with WCD and the rate of ICD implantation in women in a real–world single center experience. Methods and results Between August 2017 and June 2022, 60 consecutive patients receiving a WCD at Piacenza Hospitals were retrospectively included in this analysis: mean age 66.9±11.9 years, 56.6% with ischaemic cardiomyopathy, 38.3% with dilated cardiomyopathy, 5% after implantable cardioverter–defibrillator explant. 8 patients were women (13.3%). Women and men presented similar clinical characteristics. Median WCD usage period and median daily wear time were not different between women and men (49.6±25.3 vs 51.8±32.8 days, 23.6±0.3 vs 23.1±1.7 hours, respectively). No ventricular fibrillation was detected in the monitoring period. Non–sustained ventricular tachycardia and atrial arrhythmias were similar between women and men. However, ICD implantation rate at the end of WCD use was significantly lower in women than and men (25% vs 61.5%; p< 0.01). Conclusions In this real word analysis WCD was underused in women despite a nice compliance. A similar burden of ventricular and atrial arrhythmic events were detected, with a lower ICD implantation rate at the end of WCD use in women than in men.

Wearable cardioverter defibrillator shortens the length of stay: a single center real-world experience

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): ZOLL France supported with an unrestricted grant. Background The wearable cardioverter defibrillator (WCD) has been proven to have efficacy in treating sudden cardiac death (SCD) in patients soon after acute myocardial infarction (AMI) and left ventricular ejection fraction (LVEF) ≤35%. However, data regarding hospitalization rate and length of stay among these patients have not yet been evaluated. Purpose WCD can shorten hospital stays (total length, time in intensive care unit (ICU) and in cardiac intensive care unit (CICU)) of patients post-AMI, with severe reduced LVEF. Methods We performed a single center, retrospective observational study of patients prescribed WCD upon hospital discharge, from June 2016 to June 2022. We selected patients referred for management of SCD, post-AMI, with age over 18 years and LVEF ≤35%. Patients who already had ICD or CRT-D (or who had previously received it) were excluded from the analysis. Patients with the same characteristics, and who were discharged from the hospital without WCD or ICD served as a control group. Clinical characteristics were obtained from hospital electronic and WCD specific database. The clinical characteristics and length of index hospitalization of two groups were compared. An initial propensity score analysis was performed, then a weighted regression models for total hospitalization, days in ICU, and days in CICU were conducted. Results 101 patients in the WCD group and 29 in the control group were enrolled in the analysis (Figure 1). The two groups showed similar clinical characteristics (Table 1), even if patients in the WCD group had lower LVEF (p <0.001), more cardiogenic shocks (p = 0.045) and higher NT-proBNP values (p = 0.033). After a propensity score analysis and a weighted regression model, LVEF emerged as independent variable for WCD use (odds ratio (OR) 0.755, confidence interval (CI) 95% 0.654 – 0.872, p <0.001). Left ventricular thrombosis also affected the use of WCD (OR 5.574, CI 95% 1.139 – 27.267, p = 0.0339). In a weighted regression model, WCD significantly influenced the days spent in CICU (p<0.001), and those in ICU even without statistical significance (p = 0.251). Even after excluding all patients undergoing extracorporeal membrane oxygenation (ECMO) or heart transplantation, WCD reduced days spent in CICU (p<0.001). Furthermore, when excluding from the analysis all patients with very long hospitalizations (> 30 days), WCD patients showed significantly shorter total hospitalization (p=0.005) and days spent in CICU (p<0.001), compared with control group. Conclusions At the propensity score analysis, WCD reduce CICU length of stay for patients post-AMI with LVEF ≤35%. The association between WCD use and hospitalization is more relevant for days spent in CICU, but there is also a positive trend for the days spent in ICU. The study has the limitation of a retrospective analysis and can only serve as hypothesis-generating research, which will be verified with further randomized clinical trial.

C-33 | Clinical Outcomes After Percutaneous Mechanical Thrombectomy in Acute Pulmonary Embolism: A Real-World Single Center Experience

C-33 | Clinical Outcomes After Percutaneous Mechanical Thrombectomy in Acute Pulmonary Embolism: A Real-World Single Center Experience

248P Systemic treatment strategies following progression on CDK4/6 inhibitors in advanced breast cancer: A single-center real-world experience

248P Systemic treatment strategies following progression on CDK4/6 inhibitors in advanced breast cancer: A single-center real-world experience

17 - Molecular profiling of lung adenocarcinoma using a genomic laboratory hub approach: a single centre real-world experience

17 - Molecular profiling of lung adenocarcinoma using a genomic laboratory hub approach: a single centre real-world experience

Exploiting SMART pass filter deactivation detection to minimize inappropriate subcutaneous implantable cardioverter defibrillator therapies: a real-world single-centre experience and management guide.

The SMART Pass™ (SP) algorithm is a high-pass filter that aims to reduce inappropriate therapy (IT) in subcutaneous internal cardiac defibrillator (S-ICD), but SP can deactivate due to low amplitude sensed R waves or asystole. The association between IT and SP deactivation and management strategies were evaluated, hypothesizing SP deactivation increases the risk of IT and device re-programming, or lead/generator re-positioning could reduce this risk. Retrospective single-centre audit of Emblem™ S-ICD devices implanted 2016 to 2020 utilizing health records and remote monitoring data. Cox regression models evaluated associations between SP deactivation and IT. A total of 348 patients (27 ± 16.6 months follow-up) were studied: 73% primary prevention. Thirty-eight patients (11.8%) received 83 shocks with 27 patients (7.8%) receiving a total of 44 IT. Causes of IT were oversensing (98%) and aberrantly conducted atrial fibrillation (2%). SP deactivation occurred in 32 of 348 patients (9%) and was significantly associated with increased risk of IT (hazard ratio 5.36, 95% CI 2.37-12.13). SP deactivation was due to low amplitude R waves (94%), associated with a higher defibrillation threshold at implant and presence of arrhythmogenic right ventricular cardiomyopathy. No further IT occurred 16 ± 15.5 months after corrective interventions, with changing the sensing vector being successful in 59% of cases. To reduce the risk of IT, the cause of the SP deactivation should be investigated, and appropriate reprogramming, device, or lead modifications made. Utilizing the alert for SP deactivation and electrograms could pro-actively prevent IT.

Endovascular thrombectomy for distal vessel occlusion stroke: Single-center experience.

The safety and efficacy of endovascular thrombectomy (EVT) in distal vessel occlusion (DVO) are not well described. We aimed to evaluate the technical feasibility and safety of EVT in patients with DVO. We performed a retrospective analysis of consecutive DVOs (defined as M3/M4, A1/A2, and P1/P2 occlusion) who underwent EVT within 24 h since last known well. The primary efficacy outcome was successful reperfusion (mTICI ≥ 2B). Secondary outcomes included successful recanalization with ≤3 passes. The safety outcome measures included the rate of subarachnoid hemorrhage (SAH), all intracerebral hemorrhage (ICH), and symptomatic ICH (sICH). A total of 72 patients with DVO was identified: 39 (54%) with M3/M4, 13 (18%) with A1/A2, and 20 (28%) with P1/P2 occlusions. Admission NIHSS score median (IQR) was 12 (11), and 90% of the patients had baseline mRS ≤ 2. Thirty-six percent of the patients received intravenous thrombolytic therapy. Successful recanalization was achieved in 90% of the patients. The median number of passes was 2, with successful recanalization achieved with ≤3 passes in 83% of the patients. ICH was seen in 16% of the patients, including three SAHs. However, only one patient (1.4%) had sICH. Among 48 patients in whom 90-day outcome data were available, 33 (53.2%) had favorable clinical outcome (mRS ≤ 3). In a multivariable logistic regression, only baseline NIHSS was identified as an independent predictor of poor outcome. This single-center real-world experience demonstrates that EVT in patients with DVO stroke is safe and feasible and may lead to improved clinical outcome.

Efficacy and Safety of Nintedanib in Patients with Connective Tissue Disease-Interstitial Lung Disease (CTD-ILD): A Real-World Single Center Experience.

Connective Tissue Disease-Interstitial Lung Disease (CTD-ILD) is a severe and fatal manifestation of systemic autoimmune disorders. Therapies rely on immunomodulators but their efficacy in ILD progression remains uncertain. Nintedanib, an antifibrotic agent that slows pulmonary function decline, has been approved for CTD-ILD treatment. The aim of this study was to assess the effectiveness and safety of nintedanib in CTD-ILD patients in a real-world data setting. A single-center, retrospective, and descriptive analysis of CTD-ILD patients treated with nintedanib from June 2019 to November 2022 was performed. The assessment of nintedanib treatment's efficacy was judged solely on the evolution of pulmonary function tests (PFTs), which were evaluated before and after treatment. Twenty-one patients (67% females, median age 64 years (IQR = 9) with CTD-ILD (systemic sclerosis n = 9, rheumatoid arthritis n = 5, dermatomyositis n = 4, juvenile rheumatoid arthritis n = 1, undifferentiated CTD n = 1, interstitial pneumonia with autoimmune features n = 1), 18 of whom were on concomitant immunosuppressives, had a median follow-up period of 10 months (IQR = 5). PFTs before and after treatment did not significantly differ. The mean FVC% difference was +0.9 (sd = 7.6) and the mean DLco% difference was +3.4 (sd = 12.6), suggesting numerical improvement of PFTs. The average percentage change was -0.3% and +7.6% for FVC% and DLco%, respectively, indicating stabilization of lung function. Our real-world data across a broad spectrum of CTD-ILD suggest that nintedanib could be beneficial in combination with immunosuppressives in slowing the rate of lung function decline.

P699 Ustekinumab therapy after biologic failure in patients with Crohn’s Disease – A real-world single centre experience

Abstract Background Patients with Crohn’s disease (CD) often require multiple biological therapies due to loss of response. Anti-TNF drugs are generally used as first-line biologics followed by a switch of class. Ustekinumab (UST), an IL-12/23p40 antagonist is used often after anti-TNF failure. The aim of the study was to report on the outcomes of UST therapy with a median follow-up period of nearly 24 months. Methods All CD patients who commenced UST therapy were identified from EMR at a tertiary referral centre between January 2017 and December 2021. All relevant demographic and clinical data were collected. Data on clinical response (defined as a downgrade in disease activity based on clinician assessment & biochemical parameters), steroid-free duration, and long-term response to UST at 52 and 104 weeks were recorded. The response was assessed clinically and supported by biomarkers, cross-sectional imaging, colonoscopic data, and sustained maintenance of UST. The statistical analysis was carried out using the IBM® SPSS® Statistics software package Version: 28.0.0.0 Results A total of 147 CD patients (M=65, 44%; median age 38years) were included in the analysis with a median follow-up period of 24 months (range 5-67 months). 82 (56%) patients had stricturing (B2), penetrating (B3) and perianal phenotype at baseline, and 50 (34%) had undergone the previous resection/s. 109 (75%) had documented moderate to severe disease activity and 139 (95%) patients were exposed to at least one biologic prior to treatment with UST. A total of 34 (23%) patients were on concomitant thiopurines at the start of treatment. Among 147 patients in our cohort, 143 (97%) showed clinical response to UST and remained on treatment at the end of the follow-up period. The distribution of patients as per disease activity at baseline, 52 and 104 weeks is illustrated in Figure 1. An improvement in haemoglobin levels was observed post-therapy with UST, which was statistically significant at 104 weeks (p<0.001), with a corresponding significant reduction in faecal calprotectin levels (median reduction from 976 mcg/g ◊ 333 mcg at 104w; p<0.001). Only 13(8.8%) patients had side effects that were directly attributed to UST therapy. Conclusion UST is an effective therapeutic option in patients with CD who have failed previous biologic therapy. In our cohort with a large proportion of patients with complicated and refractory disease, clinical response was observed regardless of their previous exposure status to biologics, and disease phenotype. UST appears to be well tolerated with a reasonable safety profile. The consistent response rates even after prolonged treatment periods mean that clinicians could safely continue UST for longer durations, where options are limited.

Real world single center experience with saphenous vein grafts interventions: should filters be filtered out?

Percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) can be challenging due to no reflow phenomenon from distal embolization of debris and microvascular vasoconstriction, resulting in myocardial injury post-procedure. Guidelines promote the use of distal embolic protection devices (EPD) to protect the distal arterial bed during SVG PCI. However, this approach has shown less-than-optimal results in many studies. We report our data using the Borgess protocol [prophylactic intracoronary (IC) nicardipine injection and direct stenting], as an alternative to EPDs in a large series of SVG interventions. This is a retrospective, cohort study of our single center experience with SVG interventions between 2017 and 2021. The primary outcome of the study was major adverse cardiovascular events (MACE) [a composite of death, emergent coronary artery bypass graft surgery (CABG), myocardial infarction (MI), and target vessel revascularization (TVR)] at 30 days post-procedure. There were 424 consecutive SVG interventions performed during the study period, and 76% of cases presented with acute coronary syndrome. Full adherence to the Borgess protocol was observed in 36% of cases; IC nicardipine was utilized in 72% of cases. MACE rate was 3.5% at 30 days driven primarily by MI (2.6%). The Borgess protocol approach to vein graft interventions proved good outcomes when compared to SVG PCI in randomized trials utilizing EPDs. Our study is limited by the retrospective nature and single center experience.

Safety and efficacy of transitioning inflammatory bowel disease patients from intravenous to subcutaneous infliximab: a single-center real-world experience.

A new subcutaneous (SC) formulation exists for infliximab (CT-P13 SC). The aim of this study was to assess the durability of clinical and endoscopic responses after a switch from intravenous (IV) to SC infliximab. Patients were transitioned on maintenance infliximab, including those with dose-optimized therapy. The primary outcome was clinical, biochemical and overall remission at 6 months, as defined by a Harvey-Bradshaw Index <5 for Crohn's disease or a partial Mayo score <3 for ulcerative colitis, C-reactive protein less than 10 mg/L, and fecal calprotectin less than 100 μg/g. Forty patients were switched from IV to SC infliximab. Twenty-seven (68%) had a diagnosis of Crohn's disease and 13 (33%) had ulcerative colitis. Twenty-three (58%) were on 5 mg/kg of IV infliximab every 8 weeks and 15 (38%) 5 mg/kg every 6 weeks. There were 2 patients (4%) on 10 mg/kg every 6 weeks. At the time of their switch, 37 (93%) patients were in clinical remission, 25 (76%) were in biochemical remission, and 25 (76%) were in both biochemical and clinical remission. At 6 months the proportion of patients in clinical remission decreased from 93% to 82%, with an overall relapse rate of 11%. Treatment persistence at 6 months was 77.5%. Switching patients from IV infliximab to 120 mg fortnightly SC injections is a safe and effective option for the treatment of inflammatory bowel disease, including for those patients on dose-escalated infliximab or with active disease at the time of switch.

LDL reduction in subcutaneous evolocumab after 30 days: Real-world single-center experience

LDL reduction in subcutaneous evolocumab after 30 days: Real-world single-center experience

Lipid lowering with inclisiran: a real-world single-centre experience

ObjectiveThe reduction in circulating low-density lipoprotein cholesterol (LDL-c) is the primary aim of lipid-lowering therapies as a method of atherosclerotic cardiovascular disease risk reduction. Inclisiran is a new and potent...

Impact of Age of Onset on Survival after Hepatectomy for Patients with Colorectal Cancer Liver Metastasis: A Real-World Single-Center Experience.

The incidence of early-onset CRC is increasing. However, the effect of age of onset on the long-term outcome of colorectal cancer liver metastasis (CRLM) remains unclear. This study aimed to evaluate the association between the age of onset and the oncological outcome of CRLM patients and to investigate whether the prognostic role of RAS mutation is altered with age. We retrospectively investigated consecutive patients at our institution who underwent initial liver resection between 2006 and 2020. The inverse probability of treatment weighting (IPTW) method was used to balance the confounders among early- (≤45 years; EOCRLM), intermediate- (46-70 years; IOCRLM), and late-onset (>70 years; LOCRLM) groups. The prognostic role of RAS was assessed based on age group. A total of 1189 patients were enrolled: 162 in the EOCRLM group, 930 in the IOCRLM group, and 97 in the LOCRLM group. No difference in disease-free survival (DFS) was found between the three groups. However, EOCRLM were more likely to develop extrahepatic and extrapulmonary metastasis and had significantly lower five-year OS rates than IOCRLM. After IPTW, EOCRLM remained a negative prognostic predictor. RAS mutations were significantly associated with worse survival than wild-type RAS in EOCRLM and IOCRLM. However, RAS mutation did not predict the prognosis of patients with LOCRLM. Patients with EOCRLM had a significantly lower OS than IOCRLM patients and age influences the prognostic power of RAS status. These findings may be helpful for doctors to guide the clinical treatments and develop follow-up strategies.

201P Immunotherapy in advanced mismatch repair deficiency endometrial cancer: A real-world single center experience

Mismatch repair (MMR) deficiency is seen in 15-30% of patients with endometrial cancer (EC). Single agent immune checkpoint inhibitors (ICI) have been approved for treatment with advanced endometrial cancer based on the high response rates and the long duration of response. There is very limited data of MMR deficient EC patients treated with ICI from India.

140P Lenvatinib + everolimus in mRCC that has progressed on immunotherapy: A real-world single center experience

The 1st line treatment of metastatic renal cell carcinoma (mRCC) is either immuno-oncology drug (IO) with IO or IO + vascular endothelial growth factor - tyrosine kinase inhibitors (VEGF-TKIs). At progression, the 2nd line options are lenvatinib + everolimus (L+E) or cabozantinib which is based on older data from 1st line TKI era. The best treatment for patients who progress on 1st line IO combination is not clear. In this study, we report the efficacy and safety of (L+E) in patients with mRCC who progressed on IO + TKI combination.

Evaluation of non-breath-hold, ultra-fast, low-dose high-pitch (flash) CT scan as a practical alternative to standard spiral scan for pre-TAVI patients: a real-world single-center experience

Abstract Introduction and aim Aortic annulus dimensions change during the cardiac cycle. A retrospective ECG-gated (Spiral) scan is the default technique for pre TAVR evaluation since it includes systolic phases considered optimal for aortic annulus assessment. Ultra-fast, Low-Dose High-Pitch (FLASH) offers faster, potentially low radiation and low contrast dose scans. However, it lacks the ability to time data acquisition to the systole. Therefore, measurements derived from FLASH scan are considered suboptimal for reporting. The effect of this potential annular measurement difference on procedural success and safety was not evaluated. Therefore, we aimed to assess the feasibility and safety of FLASH vs. Spiral scan before TAVI. Methods We conducted a retrospective, single-center study. 409 patients underwent CT-TAVI scan with either FLASH or SPIRAL acquisition. Baseline characteristics, CT study, procedural and f/u data were acquired from the EMR. Outcomes defined by Valve Academic Research Consortium3 (VARC-2) endpoint definitions included in-hospital mortality, bleeding, vascular complications, acute kidney injury (AKI), conduction disorders, mechanical complications, and prosthetic aortic valve regurgitation. Composite endpoints such as device success were also examined. Results Of the 409 patients, 55.7% underwent FLASH scans. The median age was 80 years, and males accounted for 55%. The FLASH-protocol patients had higher rate of chronic kidney disease, their CT-measured aortic annulus area and diameter were smaller, and they were exposed to a smaller amount of contrast agent and radiation than the SPIRAL group. There was no statistically significant difference in primary clinical and safety endpoints between the two groups, including mechanical complications (such as annular rupture and valve malposition) and conduction disorders. Conclusions FLASH CT scan is a pragmatic and safe approach that potentially may replace spiral scan for the evaluation before TAVI procedure in the appropriate patients. Funding Acknowledgement Type of funding sources: None.

EP08.02-124 Lorlatinib Treatment Related Adverse Events: Single Centre Real-World Experience in ALK and ROS1-driven NSCLC

Lorlatinib is an ALK and ROS1 targeted next-generation tyrosine kinase inhibitor (TKI). Real-world treatment related adverse event (TRAE) data are limited. We reviewed TRAEs and therapeutic efficacy for advanced non-small-cell lung cancer (NSCLC) patients receiving lorlatinib at our centre.

Efficacy and safety of palbociclib in treatment of HR-positive advanced breast cancer patients: A single center real-world experience.

e13035 Background: With an estimated 2.3 million new cases (11.7% of all cases), female breast cancer is the leading cause of cancer globally as of 2020. Metastatic or advanced breast cancer is an incurable disease with a 5-year overall survival rate of 28.1%. Palbociclib, a cyclin-dependent kinase 4/6 inhibitor combined with an aromatase inhibitor, is approved to treat HR+/HER2- metastatic breast cancer (MBC). The present single-arm study evaluates the real world experience of efficacy and safety of Palbociclib-Letrozole for the treatment of HR+/HER2- MBC in the Indian population. Methods: MBC patients with or without prior chemotherapy and hormone therapy were treated with Palbociclib 125 mg once daily (3/1 schedule) plus Letrozole 2.5 mg once daily. The efficacy was recorded as objective response or disease control rate based on the response as per the RECIST criteria. The study also reports the incidence and severity of adverse events during the treatment duration. The tolerability was assessed per Common Terminology Criteria for Adverse Events (CTCAE) v.4.0 and coded using Medical Dictionary for Regulatory Activities (MedDRA) v.21.0. Results: A total of 102 patients were treated from 2017 to 2020 at the tertiary cancer center. The efficacy response is captured as per the investigator's assessment of the disease response. The response is as captured for 100/102 patients (two patients lost to follow-up) and are represented in Table. About 17% (23/100) patients achieved an objective response, while 54% (57/100) showed disease control. The tolerability was assessed as treatment-related side-effects (adverse events (AEs) and severe adverse events (SAEs)) as reported by the treating oncologist. Overall, 61 adverse events were observed in 40/102 (39.22%). The most-reported AE, neutropenia, was reported in 13 patients, followed by chest pain and breathlessness. Conclusions: In the present study, Palbociclib + Letrozole reported good clinical response at the end of treatment duration with a manageable tolerability profile in the Indian population.