Primary Prevention Indication Research Articles

Anxiety and depression in patients with an implantable cardioverter defibrillator does personality and icd expectations play a role?

Abstract Background The implantable cardioverter defibrillator (ICD) is the treatment of choice for the prevention of sudden cardiac death. Given that 22.6% of patients with an ICD develop anxiety and 15.4% depression (1), it is paramount to identify factors contributing to their distress. Anxiety may lead to depression if untreated and both have been associated with risk of morbidity and mortality. Purpose To examine if Type D personality and expectations to ICD therapy are associated with anxiety and depression in ICD patients at 12 months follow-up. Methods Patients with a first-time ICD or cardiac resynchronization therapy device (CRT-D) participating in the national Danish ACQUIRE-ICD trial completed the Type D Scale (2), the EXPECT-ICD Scale containing both negative and positive expectations at baseline, the Generalized Anxiety Disorder scale (GAD-7), and the Patient Health Questionnaire (PHQ-9) to determine anxiety and depression, respectively, both at baseline and 12 months follow-up. Results Of the 478 patients participating in the study, the mean age was 60.2 ± 11.2, 397 (83.1%) were male and 81 (16.9%) women. Of all patients, 255 (53.3%) had a primary prevention indication for the ICD and 223 (46.7%) a secondary prevention indication, while 441 (92.3%) were in NYHA Class I-II and 37 (7.7%) in NYHA class III-IV at the time of implant. With respect to personality, 73 patients (15.3%) had a Type D personality. Mean scores on Positive expectations towards ICD implantation were 12.8 ± 3.18, and mean scores on negative expectations were 5.37 ± 3.30. In the multivariate, adjusted analysis for depression, Type D personality was independently associated with 12 months depression scores, over and above the impact of baseline depressive symptoms (B = 2.43, 95% CI [1.42, 3.43], p < .001). ICD expectations were not significantly associated with 12 months depression scores. In the multivariate, adjusted analysis for anxiety, Type D personality was independently associated with 12 months anxiety scores, over and above the impact of baseline anxiety symptoms (B = 1.90, 95% CI [1.07, 2.73], p <.001). ICD expectations were not significantly associated with 12 months depression scores. Conclusion In a large Danish national cohort of ICD patients, depressive symptoms at baseline and Type D personality were associated with increased depressive symptoms at 12 months follow-up. Neither positive nor negative ICD expectations were associated with depressive symptoms at 12 months follow-up, adjusting for other variables. Similar results were found for anxiety symptoms. Anxiety symptoms at baseline and Type D personality were associated with increased anxiety at 12 months follow-up, adjusting for all other variables, including ICD expectations. It may be worthwhile to screen cardiac patients for this personality type in clinical practice.

Effects of tele-yoga on physical and psychological outcomes in patients living with ICD, a randomised controlled trial

Abstract Background Patients with long-term illness, including those living with an implantable cardioverter defibrillator (ICD), often suffer from symptoms of anxiety and depression, decreased health-related quality-of-life (HRQOL), and impaired functional capacity. Yoga, being a mind-body intervention, may improve all these outcomes. Purpose To determine effects of tele-yoga on exercise capacity and patient-reported outcome measures. Methods A single-blind (evaluator blinded) parallel two-arm RCT with 1:1 distribution. Participants were recruited from four hospitals in Sweden. Inclusion criteria: >18 years, admitted to a cardiology or intensive care units >48 hours during the last 36 months due to ICD implantation or ventricular arrhythmias, heart failure, or conditions in need of intensive care and now clinically stable. The participants were randomised to a control group receiving individual exercise advice or to the intervention group (tele-yoga). The intervention included performing live-streamed group-yoga for 60 min twice/week for 3 months and practicing yoga individually for a minimum of 10 min/day using an app. The group-sessions with approximately 10 participants were led by certified Mediyoga-instructors via the virtual video-platform ZOOM. The yoga form was Kundalini adapted to individuals with health conditions (Mediyoga). Two standardised yoga-programmes including different postures, breathing exercises and meditations were rotated. The primary endpoint of the study after 3 months was a combined endpoint consisting of change in functional capacity measured by 6-min walk test (6MWT), HRQOL (EQ-5D index/VAS) and symptoms of anxiety and depression (HADS). The used cut offs for change were 30 meters for 6MWT, a score >11 for EQ-5D VAS and ≥8 for anxiety/depression in HADS. Secondary endpoints included separate analysis of functional capacity, HRQOL and symptoms of anxiety/depression. Results In total, 311 participants were randomized to tele-yoga (n=156) and control (n=155), mean age 65.8 years, 30% women, 38% living with an ICD (whereof 62% had a primary preventive indication). Median attendance to yoga-sessions was 20 sessions for 12 weeks and 74% of the study participants were adherent to >16 tele-yoga sessions. There were no adverse events reported during yoga sessions or app usage. In this sub-group analysis involving the ICD cohort (n=118), there was a significant improvement in favour of the tele-yoga group in the combined primary endpoint (p=.011). When analysing them separately, there was a significant improvement in 6MWT (p=.002), but not in HRQOL in EQ-5D VAS or symptoms of anxiety and depression. No adverse events were reported during yoga sessions or app usage. Conclusion Digitally delivered mind-body training such as tele-yoga showed a significant improvement in the combined endpoint consisting of physical function, HRQOL and mental health. Tele-yoga may be a promising new form of rehabilitation for patients living with ICD.

Long QT syndrome: importance of reassessing arrhythmic risk after treatment initiation.

Risk scores are proposed for genetic arrhythmias. Having proposed in 2010 one such score (M-FACT) for the long QT syndrome (LQTS), this study aims to test whether adherence to its suggestions would be appropriate. LQT1/2/3 and genotype-negative patients without aborted cardiac arrest (ACA) before diagnosis or cardiac events (CEs) below age 1 were included in the study, focusing on an M-FACT score ≥2 (intermediate/high risk), either at presentation (static) or during follow-up (dynamic), previously associated with 40% risk of implantable cardioverter defibrillator (ICD) shocks within 4 years. Overall, 946 patients (26 ± 19 years at diagnosis, 51% female) were included. Beta-blocker (βB) therapy in 94% of them reduced the rate of those with a QTc ≥500 ms from 18% to 12% (P < .001). During 7 ± 6 years of follow-up, none died; 4% had CEs, including 0.4% with ACA. A static M-FACT ≥2 was present in 110 patients, of whom 106 received βBs. In 49/106 patients with persistent dynamic M-FACT ≥2, further therapeutic optimization (left cardiac sympathetic denervation in 55%, mexiletine in 31%, and ICD at 27%) resulted in just 7 (14%) patients with CEs (no ACA), with no CEs in the remaining 57. Additionally, 32 patients developed a dynamic M-FACT ≥2 but, after therapeutic optimization, only 3 (9%) had CEs. According to an M-FACT score ≥2, a total of 142 patients should have received an ICD, but only 22/142 (15%) were implanted, with shocks reported in 3. Beta-blockers often shorten QTc, thus changing risk scores and ICD indications for primary prevention. Yearly risk reassessment with therapy optimization leads to fewer ICD implants (3%) without increasing life-threatening events.

Clinical guidelines for prevention and treatment of CAT in Japan and other countries.

Cancer-associated thrombosis (CAT) is an important prognostic factor for an increasing number of cancer patients. Understanding of CAT among cancer care providers has grown in recent years, and guidelines for the prevention and treatment of CAT have been published in Japan and around the world. In this article, we introduce these major guidelines and discuss differences we identified between the Japanese guidelines and those of other countries, with a focus on problems and issues. Insurance coverage of low-molecular-weight heparin and indications for primary prevention with direct oral anticoagulants in particular require urgent consideration.

Mortality Benefit Among Primary Prevention Implantable Cardioverter-Defibrillator Recipients on Contemporary Heart Failure Treatment

BackgroundPast clinical trials have shown the benefit of implantable cardioverter-defibrillators (ICDs) for reducing sudden cardiac death in at-risk patients. However, heart failure management and ICD technology have changed since these trials were first published. An updated assessment of ICD mortality benefit is needed. ObjectivesThe purpose of this study was to compare mortality rates between patients with a primary prevention (PP) indication for an ICD who did or did not receive an ICD using a contemporary, real-world data set. MethodsData was obtained from a large electronic health record data set covering patients in the United States from 2012 through 2020 who had a PP indication for an ICD and survived at least 1-year postindication. ResultsA total of 25,296 patients were identified as having a PP indication for ICD implantation, of which 2,118 (8.4%) were treated with an ICD within a year. Treated patients were younger than nontreated patients (age 63.4 years vs 66.1 years) with a smaller proportion of women (25.0% vs 36.7%). After 4-to-1 propensity matching, treated patients had similar clinical characteristics to nontreated patients. A Cox proportional hazard model estimated a 24.3% lower risk of all-cause mortality in patients when treated vs not treated with an ICD (HR: 0.757; 95% CI: 0.678-0.835; P <0.001). There was no detectable difference in ICD benefit between patients with ischemic and nonischemic heart disease (P = 0.50). ConclusionsICD treatment of patients with a PP indication is associated with improved mortality even in the context of evolving adjunctive HF treatment, consistent with earlier landmark trials.

Prognostic value of noninvasive programmed stimulation in primary prevention implantable cardioverter‐defibrillator recipients

AbstractBackgroundImplantable cardioverter‐defibrillator (ICD) offers an opportunity to study inducibility of ventricular tachycardia (VT) or ventricular fibrillation (VF) by performing noninvasive programmed ventricular stimulation (NIPS). Whether NIPS can predict future arrhythmic events or mortality in patients with primary prevention ICD, has not yet been examined.MethodsFrom the NIPS‐ICD study (ClinicalTrials ID: NCT02373306) 41 consecutive patients (34 males, age 64 ± 11 years, 76% ischemic cardiomyopathy [ICM]) had ICD for primary prevention indication. Patients underwent NIPS using a standardized protocol of up to three premature extrastimuli at 600, 500 and 400 ms drive cycle lengths. NIPS was classified as positive if sustained VT or VF was induced. The study endpoint was occurrence of sustained VT/VF during the follow‐up.ResultsAt baseline NIPS, VT/VF was induced in 8 (20%) ICM patients. During the 5‐year follow‐up, the VT/VF occurred in 7 (17%) patients, all with ICM. The difference between NIPS‐inducible versus NIPS‐noninducible patients regarding VT/VF occurrence did not meet statistical significance (38% vs. 12%, log rank test p = .11). After a 5‐year follow‐up, the mortality rate was significantly higher in patients who had VT/VF induced at NIPS versus no VT/VF at NIPS (38% vs. 12%, p = .043). The occurrence of a composite endpoint consisting of VT/VF recurrence or death in patients with ICM was also most frequent in the NIPS‐inducible group (75% vs. 35%, p = .037).ConclusionsInducibility of VT/VF during NIPS in ICM patients with primary prevention ICD is associated with higher mortality and higher incidence of composite endpoint consisting of death or VT/VF during a long‐term observation.

Recommended and observed statin use among US adults with and without cancer.

Patients with cancer are at increased cardiovascular (CV) risk. We aimed to compare the recommended and observed statin use among individuals with and without cancer. Using three 2-year cycles from the National Health and Nutrition Examination Survey (2013-18), we analysed data from 17 050 US adults. We compared the prevalence of Class 1 statin recommendations and use between individuals with and without cancer, overall, and among different demographic groups. Individuals with a history of cancer were older and had a higher burden of comorbidities. Stratified by age groups, they were more likely to have a secondary prevention indication compared with individuals without cancer but not a primary prevention indication for statin. Among individuals with an indication for statin therapy, the prevalence of statin use was higher in the cancer group compared with those without cancer (60.8% vs. 47.8%, P < 0.001), regardless of sex, type of indication (primary vs. secondary prevention), and education level. However, the higher prevalence of statin use in the cancer group was noted among younger individuals, ethnic minorities, and those with lower family income. Our finding highlights the importance of optimization of CV health in patients with cancer, as individuals with cancer were more likely to have a Class 1 indication for statin treatment when compared with individuals without cancer. Important differences in statin use among cohorts based on sex, age, ethnicity, and socioeconomic status were identified, which may provide a framework through which CV risk factor control can be targeted in this population. Higher statin use in cancer patients: Among those with Class 1 recommendation to take statins, 60.8% of cancer patients were using them, compared with 47.8% of non-cancer individuals, indicating a greater adherence to heart health recommendations in the cancer group. Demographic variations in statin use: The study found notable differences in statin use among younger individuals, ethnic minorities, and those with lower income within the cancer patient group, suggesting disparities in how these subgroups manage their cardiovascular health.

Mortality benefit of implantable cardioverter-defibrillators for primary prevention of sudden cardiac death: a real-world analysis

Abstract Background Nearly 1,000 people suffer an out-of-hospital sudden cardiac arrest daily in the United States, with only 10% surviving when treated by emergency medical services. Implantable cardioverter-defibrillators (ICDs) are a proven first-line treatment in limiting sudden cardiac death, but the evidence has become dated. We sought to assess the survival benefit of ICDs in a contemporary population. Purpose Using a real-world database, we aimed to determine the current impact of ICDs on mortality in primary prevention patients. Methods Data were obtained from a de-identified electronic health record database. We included patients that met ICD primary prevention indication (PPI) implantation criteria between 2012 and 2019, had one year of available data before the PPI, and survived for at least one year post-PPI. Patients were split into 2 groups based on ICD implant status (implanted vs not implanted) within one year after PPI. The primary endpoint was the overall mortality rate, beginning at one-year post-PPI. Propensity matching was performed to account for baseline differences between patients that did and did not receive an ICD, and all-cause mortality rates were compared using the Kaplan-Meier method and Cox proportional hazard model. Results A total of 25,296 patients were identified as having a PPI for ICD implantation, of which 2,118 (8.4%) were implanted with an ICD within a year. Implanted patients were younger than non-implanted patients (63.4 vs 66.1 years) and had a smaller proportion of females (25.0% vs 36.7%). After 4 to 1 propensity matching, patients who did not have an ICD implanted had a mean age of 63.6 years and were 25.1% female. In the matched cohort, the 5-year all-cause mortality rate was 37.6% (CI: 33.2%-41.7%) in PPI patients who received an ICD and 44.9% (CI: 42.8%-47.0%) in those that did not receive an ICD. A Cox proportional hazard model revealed a 25.3% lower risk of all-cause mortality in PPI patients implanted with an ICD compared to PPI patients without an ICD (HR: 0.747; CI: 0.670-0.834; p&amp;lt;0.001 [Figure 1]). Conclusion In a large cohort of PPI patients that survived at least one year after indication, those implanted with an ICD during that year had a 25.3% lower risk of all-cause mortality than similar patients who did not receive an ICD, consistent with landmark trials. Thus, ICD implantation continues to be associated with a reduction in all-cause mortality in PPI patients at risk for sudden cardiac death.

Intermuscular placement and defibrillation with the extravascular ICD: a single-centre experience

Abstract Background Extravascular (EV) implantable cardiac defibrillators (ICD) with substernal lead have recently proved to be a safe and effective alternative to conventional transvenous (TV) and subcutaneous defibrillators (S-ICD), owing to the possibility to deliver antitachycardia and asystole pacing while saving intravascular hardware. The proposed implantation technique for EV-ICDs is a subcutaneous pocket along the mid axillary line, although an intermuscular ICD placement can potentially reduce the risk of pocket complications, device migration and improve patient comfort and aesthetic outcomes. Purpose exploring the safety and feasibility of extravascular ICDs implantation with a substernal coil and an intermuscular generator placement. Methods Seventeen patients with a class I or IIa ICD indication either for primary (14/17) or secondary (3/17) prevention underwent EV-ICD implantation in our centre as part of the EV ICD Pivotal Study from May 2021 to November 2022. Access and tunnelling along the retrosternal space were performed based on current standard recommendations for EV-ICDs implantation. An intermuscular pocket for generator placement was obtained between the latissimus dorsi and the serratus anterior muscles beyond the left mid-axillary line. Results Mean age, BMI, NYHA class and left ventricular ejection fraction (LVEF) were respectively 53±9yrs, 25.3 ±6 kg/m2, 2 ±0.7, and 39±14%. The main aetiology was non ischemic cardiomyopathy (12/17), including 3 arrhythmogenic cardiomyopathy patients and one with hypertrophic cardiomyopathy. The implantation was successful in 16 (6 females) out of 17 patients, with one implant failure due to inadequate sensing (0,5 mV); the median sensing amplitude was 2,3 mV (min = 1,3 mV; max = 5,8 mV), with R1R2 being the final sensing vector chosen for 14/16 and R2-Can for 2/16. Defibrillation Testing (DFT) was performed in all patients: a 15 J shock terminated induced ventricular fibrillation (VF) in 12/16 patients, 20 J terminated VF in 3, a single patient had VF terminated at 30 J. No patient had infection or skin erosion or complained pain/discomfort at the pocket site along an 18±4 months follow-up. Only 1/16 patients had ventricular tachycardia at follow-up, successfully treated by the device. Conclusions Intermuscular placement of the EV ICD may be a feasible and reliable alternative to a subcutaneous one in terms of defibrillation efficacy, enabling patient comfort and aesthetic acceptance in thin-habit or young patients. Additional long-term data and larger patient cohorts are required to confirm its advantage compared to the subcutaneous placement.

Changes in study enrollment of patients with non-ischemic cardiomyopathy receiving an ICD for primary prevention: Insights from the APPRAISE ATP study

Abstract Introduction The DANISH study called into question the effectiveness of the ICD in patients (pts) with non-ischemic cardiomyopathy (NIC) and resulted in a downgrade in ESC guidelines from Class I to Class IIA. The effect of these findings on implantation of ICDs in NIC pts in clinical studies has not been well established. Methods Two clinical studies were analyzed before and after the publication of DANISH: MADIT-RIT (2009-2012) and APPRAISE ATP (2017-present). These two studies enrolled globally and implanted ICDs in pts with primary prevention (PP) indications. The proportion of pts with NIC were analyzed between the two studies, both globally and by region: North America (NA) and European Union (EU). In addition, the APPRAISE ATP study was divided into halves to determine if any changes were observed whilst the study was in progress. Continuous variables were analyzed with a t-test and categorical variables were analyzed with a Chi-square test. Due to small numbers, implanted pts outside NA and the EU were not entered into the analysis. Results Demographics for the NIC subgroups are shown in the table below [MADIT-RIT (n=284) and APPRAISE ATP (n=1084)]. When compared to MADIT-RIT, pts in APPRAISE ATP were significantly older, had a higher mean LVEF, and greater prevalence of AF and diabetes. Globally, the proportion of pts with NIC who received ICDs was unchanged between the current APPRAISE ATP study and MADIT-RIT 10 years previously (38.1% vs 39.3%, p=0.91). When analyzed by geography, there was no change in North America (38.0% vs 41.6%, p=0.27). In Europe, however, there was a drop in enrollment of NIC ICD pts from 38.6% in MADIT-RIT to 29.1% in APPRAISE ATP. This decline was 24.6% in relative terms and approached, but did not achieve, statistical significance (p=0.074). Implant rates in NIC ICD pts were stable overall when comparing the first half of APPRAISE ATP to its second half. Rates were also stable across both halves in NA and while implant rates of NIC ICD pts appeared to rebound in the second half in the EU, that late increase was not statistically significant. Conclusions The results of the DANISH study appear to have had a limited global impact on enrollment of NIC pts requiring implant of a PP ICD into the APPRAISE ICD clinical study. Whilst there was no change in North America before and after DANISH, there is a signal in the data that investigators in the EU may have restricted implants initially but eventually relaxed as time progressed. Further investigation is needed to confirm whether physicians in general practice have altered their referral patterns.

The Pacemaker and Implantable Cardioverter-Defibrillator Registry of the Italian Association of Arrhythmology and Cardiac Pacing - Report 2022

The Pacemaker (PM) and Implantable Cardioverter-Defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the voluntary Italian collaborating centers. For the year 2022 main data about national PM and ICD implantation activity were obtained on the basis of European Cards and subsequently analyzed to create a standard report. PM Registry: data about 17 800 PM implantations were collected (14 191 first implants and 3609 replacements). The number of collaborating centers was 152. Median age of treated patients was 81 years (75 quartile I; 86 quartile III). Main ECG indications included atrioventricular conduction disorders in 46.0% of first PM implants, sick sinus syndrome in 17.7%, atrial fibrillation plus bradycardia in 7.7%, other unspecified ECG and electrophysiological abnormalities in 43.0%. For first PM implants, pacing in DDDR mode was reported in 42.2%, followed by DDD mode (20.6%), VVIR mode (25.1%), VVI mode (11.1%) and finally VDD-VDDR (5.1%). Median value of longevity of explanted PMs was 8.3 years. ICD Registry: data about 5210 ICD implantations were obtained (3656 first implants and 1554 replacements). The number of collaborating centers was 301. Median age of treated patients was 72 years (63 quartile I; 79 quartile III). Primary prevention indication was reported in 72.4% of first implants, secondary prevention in 27.6% (cardiac arrest in 4.6% of records). A single-chamber ICD was used in 30.3% of first implants, dual-chamber ICD in 30.0% and biventricular ICD in 39.7%. Median value of longevity of explanted ICDs was 7.0 years. In the calendar year 2022, the Italian PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The ICD Registry documented a large use of prophylactic and biventricular ICDs, reflecting a favorable adherence in clinical practice to trials and guidelines. The ICD longevity and the number of recalls demonstrated a favorable trend.

Long-Term Clinical Outcomes of Implantable Cardioverter Defibrillator Recipients in New Zealand: A Subanalysis by Sex, Age Group, and Ethnicity

The long-term clinical outcomes of implantable cardioverter defibrillator (ICD) recipients across New Zealand are unknown. This study provides a detailed subanalysis of long-term clinical outcomes of ICD recipients by sex, age group, and ethnicity. All patients with an ICD implant between 2010 and 2019 were identified using the National Minimum Dataset, which collects all public hospital admissions in New Zealand using International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD10-AM) procedure coding. There were 4,261 patients with a mean follow-up of 4.85±2.76 years. The median age was 62 years and 78.9% were male. The all-cause mortality was higher in males compared with females (23.1% vs 17.2%; p<0.001). There was no significant difference by primary and secondary prevention indication ICD in each sex group. Heart failure (HF) hospitalisation was higher in males compared with females (29.4% vs 26.6%; p=0.009). All-cause mortality was highest in the age group of ≥80 years and lowest in those <40 years (44.1% vs 8.4%, p<0.001). HF hospitalisation was highest in the age group of 70–79 years and lowest in the age group <40 years (36.5% vs 16.1%; p<0.001). All-cause mortality was highest in Māori and lowest in Asians (26.7% vs 15.9%; p<0.001). Heart failure hospitalisation was highest in Māori and lowest in Europeans (36.1% vs 26.3%; p<0.001). In New Zealand, all-cause mortality and HF hospitalisation was highest in males and Māori ICD recipients. These disparities in clinical outcomes warrant further investigation.

Subcutaneous implantable cardioverter-defibrillator therapy in Poland: Results of the Polish S-ICD Registry.

The use of a subcutaneous implantable cardioverter-defibrillator (S-ICD) has been expanding in Poland since 2014. The Polish Registry of S-ICD Implantations was held by the Heart Rhythm Section of the Polish Cardiac Society between May 2020 and September 2022 to monitor the implementation of that therapy in Poland. To investigate and present the state-of-the-art of S-ICD implantation in Poland. Implanting centers reported clinical data of patients undergoing S-ICD implantations and replacements, including: age, gender, height, weight, underlying disease, history of pacemaker and defibrillator implantations, indications for S-ICD, electrocardiographical parameters, procedural techniques, and complications. 440 patients undergoing S-ICD implantation (411) or replacement (29) were reported by 16 centers. Most patients were in New York Heart Association class II (218 patients, 53%) or I (150 patients, 36.5%). Left ventricular ejection fraction was 10-80%, median (IQR) 33% (25%‒55%). Primary prevention indications were present in 273 patients (66.4%). Non-ischemic cardiomyopathy was reported in 194 patients (47.2%). The main reason for the choice of S-ICD were: young age (309, 75.2%), risk of infective complications (46, 11.2%), prior infective endocarditis (36, 8.8%), hemodialysis (23, 5.6%), and immunosuppressive therapy (7, 1.7%). Electrocardiographic screening was performed in 90% of patients. The rate of adverse events was low (1.7%). No surgical complications were observed. Qualification for S-ICD in Poland was slightly different when compared to the rest of Europe. The implantation technique was mostly consistent with the current guidelines. S-ICD implantation was safe, and the complication rate was low.

PCSK9 inhibitors and incidence of arrhythmias in clinical practice: a phase IV multicentric study

Abstract Funding Acknowledgements Type of funding sources: None. Background PCSK9 inhibitors (PCSK9i) are a novel drug class indicated for the treatment of dyslipidaemia. PCSK9i have been shown to remarkably reduce cardiovascular events in patients at high risk, but little data is currently available regarding the incidence of atrial fibrillation, no reports exist on ventricular events or other cardiac arrhythmias, and is not documented if this drug class is safe regarding arrhythmias as a potential side effect. Purpose To study the incidence of arrhythmias in patients before and after treatment with PCSK9i. Methods All consecutive patients starting treatment with PCSK9 inhibitors, either evolocumab or alirocumab, were consecutively enrolled in two high-volume Italian arrhythmia centres. All patients were treated according to ESC guidelines for primary and secondary prevention. All patients failed to achieve the recommended LDL goals with standard treatment before the introduction of PCSK9i. Patients with familial hypercholesterolemia were excluded. All arrhythmic endpoints were collected in a one-year time frame before and after the first dose of PCSK9i. Results 191 patients were enrolled (mean age 63±15 years, 76.6% males) and followed up for one year. 13.2% were labelled as "statin-intolerant" and were treated only with ezetimibe, all the others had PCSK9i prescription on top of both statin and ezetimibe. The recommended LDL threshold was reached in 45.1% of patients at very high-risk and 76.7% at high-risk. 14.9% of all patients had a history of PACs and 15.6% had a history of PVCs. 7.8% had a previous diagnosis of atrial fibrillation, 2.1% of TRNAV and 6.4% of sustained ventricular arrhythmias. These 6.4% all had an ICD implanted for secondary prevention, while another 0.9% had a primary prevention indication. The total number of PACs in 24 hours decreased from 1260 to 800, although the difference was not statistically significant (p=0.058). Similar results were noted for PVCs (from 271 to 195 in 24 hours; p=0.089). The one-year incidence was 6.1% for atrial fibrillation, 2.3% for TRNAV and 3.8% for sustained ventricular arrhythmias, with no difference between the year before (all p=NS). Of all patients with an ICD and a history of appropriate ICD therapies (n=11, 5.7%) only one experienced appropriate therapies in the year after PCSK9i started. Conclusions The treatment with PCSK9 inhibitors does not significantly modify the risk of supraventricular or ventricular arrhythmias in patients with non-familial hypercholesterolemia. Preliminary data support the safety of this class of drug also regarding arrhythmic events.

Impact of gender on the utilization of cardiac implantable devices and outcome: results from the German DEVICE registry

Abstract Funding Acknowledgements Type of funding sources: None. Background Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) are widely used in patients with life-threatening cardiac arrhythmias or systolic heart failure. Real world data regarding gender impact on ICD and CRT implantation and outcome is scarce. Purpose To investigate the impact of gender-specific differences on cardiac devices implantation and outcomes. Methods The German DEVICE registry is a nationwide prospective multicentre database of ICD and CRT devices implantation. A total of 5451 patients were prospectively enrolled in 44 centres between March 2007 and February 2014 and were monitored for a median of 17 months. Results A minority of patients in this registry was female 1050 (19.3%; mean age 64.4 ± 14.6 years; median BMI 27.2) while men represented 80.7% (mean age 65.5 ± 12.4 years; median BMI 26.8). Female patients were less likely to have a LVEF &amp;lt;35% (70.6% vs. 77.7%; p&amp;lt;0.0001) and more likely to have a LVEF &amp;gt;55% (13.3% vs. 6.6%; p&amp;lt;0.0001). Moreover, women were less likely to have coronary artery disease (42.3% vs. 64.7%; p&amp;lt;0.0001), history of myocardial infarction, percutaneous coronary intervention, and coronary artery bypass graft (p&amp;lt;0.0001 for all). The rate of CRTs was significantly higher in women than in men (33.4% vs. 28.7%; p=0.0036). In terms of secondary prevention implantations, women were more likely to have history of ventricular fibrillation (VF; 50.7% vs. 37.2%; p&amp;lt;0.0001) but less likely to have history of ventricular tachycardia (VT; 34.5% vs. 47.5%; p&amp;lt;0.0001). The rates of major periprocedural complications and in-hospital complications were higher in women (3.3% vs. 1.7%; p=0.002 and 5.6% vs. 3.7%; p=0.0208). The Kaplan-Meier estimated 1-year all-cause mortality was 5.4% for women and 7.4% for men, while the overall mortality during follow-up was 10% for women and 14% for men (p=0.0004), with no gender differences in terms of death cause. Significantly less women received device shocks (14.2% vs. 17.5%; p=0.0260), while more women needed device revision during follow-up (10.9 % vs. 8.2%; p=0.0246). Similar rates of primary and secondary prevention indication were noted for female and male patients (p=0.9717). There was no difference between the groups regarding the need of postprocedural system revision (p=0.7884), as well as in-hospital death, cardiac death, or sudden cardiac death. The non-fatal complications during follow-up were comparable for men and women. Moreover, similar rates and durations of all cause and cardiac rehospitalizations were found (p=0.1644 and p= 0.1816). Conclusion In this real-life patient cohort only a minority of female patients were enrolled. Female patients were more likely to undergo CRT implantation and had a higher risk for acute major periprocedural complications and in-hospital complications but a lower overall mortality in 1-year follow-up. However, the differences in baseline characteristics should be considered as potential confounders.

Prevention of febrile neutropenia in oncological patients: real-world data

Aim. To assess the effect of febrile neutropenia (FN) prophylaxis with granulocyte colony-stimulating factors (G-CSF) in real-world cancer patients.&#x0D; Materials and methods. We conducted a statistical analysis of anonymized medical records collected in the Webiomed platform. Before analysis, the cards were validated by clinical experts. Electronic records were extracted according to two principles: mentioning D70 in the diagnosis or mentioning a chemotherapy regimen associated with a high risk of FN (20%), requiring the primary prevention of neutropenia. Thus, we obtained two datasets comprising 47.085 (590 patients) and 30.523 (398 patients) records, respectively.&#x0D; Results. Based on the analysis results, the most common risk factors for FN development were highly hematologically toxic chemotherapy regimens and elderly age about 50% in the adult population. In both datasets, the number of female patients prevailed (63.7% in dataset 1, 91.2% in dataset 2), so the most common was breast cancer. Less common were cervical cancer, digestive cancer, and lung cancer. Despite the indications for primary prevention of FN, for safety and importance of achieving the planned dose intensity, it was administered in 18.3% of patients in dataset 1 and 2.3% in dataset 2. No FN or G-CSF-related adverse events were reported in patients who received adequate primary prevention.&#x0D; Conclusion. Some issues related to G-CSF administration in cancer patients were identified. We identified the insufficient provision of patients with primary prevention of FN, which negatively affects survival rates and reduces adherence to antitumor therapy. Real-world data demonstrate the efficacy and safety of FN prevention and planned dose intensity maintance in cytotoxic therapy regimens.

PO-01-048 FACTORS INFLUENCING SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SCREENING SUCCESS IN PAEDIATRIC POPULATION: A TERTIARY HOSPITAL EXPERIENCE

Implantable cardioverter defibrillators (ICD), used to reduce risk from life threatening ventricular arrhythmia, are important treatments. Subcutaneous ICD (SICD) offers a lower risk of endocarditis, lead fracture and vascular complication. Screening is essential to identify the appropriate candidates and reduce inappropriate shocks, however there are limited data available in the paediatric population. To assess the incidence and associated characteristics of SICD screen failure, and the incidence of inappropriate shocks in a paediatric population. All patients screened for SICD from June 2016 to November 2022 were included. Screening failures were identified from supine, standing and exercise in both left and right sternal positions. Those who passed at least two vectors in all conditions were offered an SICD. The incidence of inappropriate shocks on follow up was assessed. From 74 screened patients (baseline characteristics Table 1), 58 (78%) passed supine and standing and 51(69%) on exercise screening. 59 (67%) had Hypertrophic Cardiomyopathy (HCM), 17 (23%) Inherited arrhythmias (IA) and 8 (11%) Other Cardiomyopathies (OC). Overall, 60(81%) had a primary prevention indication. Of the 45 (61%) who passed screening on the left supine, all passed when standing and 43 (96%) passed on exercise. Those screened on the right, 18 (55%) passed supine, 16(88%) of these passed standing and 14(87%) passed on exercise. Those that failed were younger and had HCM (passed vs failed, age 14±2.6 vs 12±3.7, p=0.009, HCM 56% vs 87%, p=0.008). IA patients were more likely to pass (pass vs failed, 35% vs 8%, p=0.02). Weight, height and BMI did not impact on the failure rate (Table 1). Overall, 40 (78%) had an SICD implanted with a mean follow up 21±15 months. Four patients had inappropriate shocks; One for air in the header and three for T wave oversensing. Those who had T wave oversensing had left sided lead implants, two had HCM and one had AI. In this population the screen failure rate for SICD was high, particularly in younger patients with HCM. The addition of exercise further excluded patients however, the number was small. There was no link between weight, height and BMI and screen failure. The incidence of inappropriate shocks was low.Tabled 1Table 1 – Characteristics of patients who passed and failed Subcutaneous Internal Cardioverter Defibrillator ScreeningCharacteristicsPassed (n=51)Failed (n=23)p-valueAge, years mean (SD)14 ± 2.612 ±3.7p=0.009Sex F(%)17 (34)6 (26)p=0.6Weight kg, mean (SD)57 ±16.953 ±(22)p=0.34Height cm mean (SD)156 ±29.6155 ±17.8p=0.88BMI kg/m2 mean (SD)23 ± 10.421 ± 5.5p=0.39HCM n (%)29 (56)20 (87)p=0.008Inherited n (%)15 (29)2 (8)p=0.02Other Cardiomyopathy n (%)7 (14)1 (4)p=0.26 Open table in a new tab

Subcutaneous versus transvenous cardioverter-defibrillators: 6-month follow-up

Objective: To evaluate the effectiveness and safety of subcutaneous implantable cardioverter-defibrillators versus transvenous implantable cardioverter-defibrillators during 6-month follow-up.Methods: The prospective research successively included 95 patients with indications for primary prevention of sudden cardiac death. The patients were divided into 2 groups: group 1 — 52 patients with subcutaneous implantable cardioverter-defibrillators, group 2 — 43 patients with transvenous implantable cardioverter-defibrillators. The patients were followed up for 6 months. All episodes of applied shock therapy, complications, patients changes in the condition and quality of life were analyzed.Results: The groups were initially comparable in terms of gender, age, etiology of the disease, and severity of the condition. Male patients prevailed (subcutaneous implantable cardioverter-defibrillators — 90.3%, transvenous implantable cardioverter-defibrillators — 93.0%), the mean age for subcutaneous devices was 56 [49;62] years and 60 [54;65] years for transvenous implantable cardioverter-defibrillators. All patients had chronic heart failure. The median LV EF for subcutaneous implantable cardioverter-defibrillator and transvenous implantable cardioverter-defibrillator was 29% [26;32] and 30% [27;32], respectively, EDV — 220 mL [187;278] and 202 mL [186;248], ESV — 151 mL [126;188] and 145 mL [122;184]. The number of complications recorded during the 6-month follow-up was slightly higher in patients who were implanted with subcutaneous implantable cardioverter-defibrillator (subcutaneous implantable cardioverter-defibrillators — 7.6%, transvenous implantable cardioverter-defibrillators — 2.3%, p = 0.249). The incidence of inadequate shocks in the groups was comparable (7.7% for subcutaneous implantable cardioverter-defibrillators, 6.9% for transvenous implantable cardioverter-defibrillators, p = 0.882). The percentage of using adequate shock therapy was higher in the transvenous implantable cardioverter-defibrillator group, 18.6% versus 5.7% in the subcutaneous implantable cardioverter-defibrillator group (p = 0.051). Implantation of the devices (both subcutaneous and transvenous) improved quality of life according to the results of questionnaires (Minnesota and EQ-5D questionnaires) before implantation and after 6 months of follow-up (p &lt; 0.001 in both groups).Conclusion: This research demonstrates comparable results for the effectiveness and safety of subcutaneous implantable cardioverter-defibrillators compared with transvenous implantable cardioverter-defibrillators in patients with the need for primary prevention of sudden cardiac death within 6 months. Received 6 October 2022. Revised 28 February 2023. Accepted 1 March 2023. Funding: The study did not have sponsorship. Conflict of interest: The authors declare no conflict of interest. Contribution of the authorsConception and study design: A.V. Vereshchagina, T.M. Uskach, O.V. SapelnikovData collection and analysis: A.V. Vereshchagina, V.A. Amanatova, I.R. GrishinStatistical analysis: A.V. Vereshchagina, V.A. AmanatovaDrafting the article: A.V. Vereshchagina, T.M. UskachCritical revision of the article: A.V. Vereshchagina, T.M. Uskach, O.V. SapelnikovFinal approval of the version to be published: A.V. Vereshchagina, T.M. Uskach, O.V. Sapelnikov, V.A. Amanatova, I.R. Grishin

The Pacemaker and Implantable Cardioverter-Defibrillator Registry of the Italian Association of Arrhythmology and Cardiac Pacing - Report 2021

The Pacemaker (PM) and Implantable Cardioverter-Defibrillator (ICD) Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) collects information about demographics, clinical characteristics, main indications for PM/ICD therapy and device types from the voluntary Italian collaborating centers. For the year 2021 main data about national PM and ICD implantation activity were obtained on the basis of European Cards and subsequently analyzed to create a standard report. PM Registry: data about 18 631 PM implantations were collected (15879 first implants and 2752 replacements). The number of collaborating centers was 121. Median age of treated patients was 82 years (76 quartile I; 87 quartile III). Main ECG indications included atrioventricular conduction disorders in 26.8% of first PM implants, sick sinus syndrome in 12.2%, atrial fibrillation plus bradycardia in 9.6%, other unspecified ECG and electrophysiological abnormalities in 43.0%. For first PM implants, pacing in DDDR mode was reported in 46.5%, followed by DDD mode (20.6%), VVIR mode (15.0%), VVI mode (9.0%) and finally VDD-VDDR (5.8%). Median value of longevity of explanted PMs was 8.9 years. ICD Registry: data about 6878 ICD implantations were obtained (4708 first implants and 2170 replacements). The number of collaborating centers was 345. Median age of treated patients was 72 years (70 quartile I; 75 quartile III). Primary prevention indication was reported in 86.3% of first implants, secondary prevention in 13.7% (cardiac arrest in 4.4% of records). A single-chamber ICD was used in 32.1% of first implants, dual-chamber ICD in 30.3% and biventricular ICD in 37.6%. Median value of longevity of explanted ICDs was 6.9 years. In the calendar year 2021, the Italian PM Registry showed stable electrocardiographic and symptom indications, with an important prevalence of dual-chamber pacing. The ICD Registry documented a large use of prophylactic and biventricular ICDs, reflecting a favorable adherence in the clinical practice to trials and guidelines. The ICD longevity and the number of recalls demonstrated a favorable trend. In order to increase and optimize the cooperation of Italian PM and ICD implanting centers, the online data entry (https://www.aiac.it/riprid) should be adopted at large scale.

Abstract TP203: Annual Population Burden Of Major Adverse Event From Statin Overuse In Acute Cerebral Ischemia Patients Without Indications

Background: Statin agents play a major role in secondary prevention after acute cerebral ischemia (ACI) events but are not indicated in all ischemic stroke and TIA patients. National guidelines recommend statins for patients: 1) with ACI of large or small vessel atherosclerotic origin; and 2) without these stroke mechanisms, but co-existing CAD or primary prevention indications. The potential adverse effects of statin overuse in the remaining ACI patients has not been well delineated. Methods: Per PRISMA guidelines, we performed systematic meta-analyses of: 1) statin RCTs to determine absolute risk increases for 6 major adverse events; and 2) large clinical series to determine the proportion of ACI events due to large or small vessel atherosclerotic disease and the proportion of remaining patients with CAD/primary prevention statin indications. Results: For adverse effects, data was available from 63 RCTs enrolling 155,107 patients. Statin therapy increased the risk of occurrence of 6 conditions: diabetes, myalgia, myopathy, liver disease, renal insufficiency, and eye disease. Across 16 large series enrolling 16,161 patients, rate of ACI due to large and small artery atherosclerosis was 45.9% (LAA 19.3%, SVD 17.9%), rate of remaining patients with CAD/primary prevention statin indications 24.0%, and rate of patients without statin indication 30.0%. Data synthesis indicated that, in the US, were all ACI without statin indications treated with statins, a total of 8902 patients would develop needless adverse events each year, most commonly diabetes, myopathy, and eye disease (Table). Conclusion: Nearly one-third of acute cerebral ischemia patients do not have an indication for statins and statin overuse in these patients could annually lead to nearly 9000 needless adverse events, including diabetes, myopathy, and eye disease. These findings emphasize the importance of adhering to guideline indications for the start of statin therapy in acute cerebral ischemia.