Rate Of Device-related Complications Research Articles

Abstract 14643: Benefits and Risks of Single- vs. Dual- Chamber Implantable Cardioverter Defibrillators for Primary Prevention of Sudden Cardiac Death

Introduction: Implantable cardioverter defibrillator (ICD) is the more effective and safer treatment for the primary prevention of sudden cardiac death. It remains unclear whether dual-chamber ICD offers the clinical benefits over single-chamber ICD without increasing complications. Hypothesis: The study aimed to evaluate the benefits and risks of dual-chamber ICD compared with single-chamber ICD for primary prevention of sudden cardiac death in clinical practice. Methods: Using the Korean National Health Insurance Service database from January 2008 to December 2019, we include patients with primary prevention ICD and no documented indication for pacing. The propensity score matching method was used to balance covariates across single- and dual-chamber ICDs. Primary outcomes were all-cause mortality, hospitalization of heart failure, and hospitalization of cardiovascular cause. Results: Among 1,929 patients, 1,098 (56.9%) received a single-chamber ICD and 831 (43.1%) received a dual-chamber ICD. In 752 pairs of patients after propensity matching baseline characteristics were balanced between the 2 groups (median age 62 years; male 72%). Over a mean follow-up of 2.7±2.4 years, 1- and 5-year all-cause mortality (5.5% vs. 5.6%, P=0.910; 19.4% vs. 19.3%, P=0.948), 1- and 5-year hospitalization for cardiovascular cause (14.9% vs. 14.9%, P=1.000; 23.9% vs. 22.6%, P=0.542), and 1- and 5-year hospitalization for heart failure (10.8% vs. 8.6%, P=0.163; 16.8% vs. 14.0%, P=0.133) were similar in both groups. However, cardiac tamponade in the rates of device-related complications was 0.1% in the single-chamber ICD vs. 1.1% in dual-chamber ICD groups (P=0.013). Conclusions: In the real-world population receiving a primary prevention ICD, dual-chamber ICD was associated with higher rates of cardiac tamponade than single-chamber ICD. One and five-year rates of all-cause mortality and hospitalization did not differ significantly between the two groups.

Peri-procedural and mid-term follow-up age-related differences in leadless pacemaker implantation: Insights from a multicenter European registry

BackgroundAge-related differences on leadless pacemaker (LP) are poorly described. Aim of this study was to compare clinical indications, periprocedural and mid-term device-associated outcomes in a large real-world cohort of LP patients, stratified by age at implantation. MethodsTwo cohorts of younger and older patients (≤50 and > 50 years old) were retrieved from the iLEAPER registry. The primary outcome was to compare the underlying indication why a LP was preferred over a transvenous PM across the two cohorts. Rates of peri-procedural and mid-term follow-up major complications as well as LP electrical performance were deemed secondary outcomes. Results1154 patients were enrolled, with younger patients representing 6.2% of the entire cohort. Infective and vascular concerns were the most frequent characteristics that led to a LP implantation in the older cohort (45.8% vs 67.7%, p < 0.001; 4.2% vs 16.4%, p = 0.006), while patient preference was the leading cause to choose a LP in the younger (47.2% vs 5.6%, p < 0.001). Median overall procedural (52 [40–70] vs 50 [40–65] mins) and fluoroscopy time were similar in both groups. 4.3% of patients experienced periprocedural complications, without differences among groups. Threshold values were higher in the younger, both at discharge and at last follow-up (0.63 [0.5–0.9] vs 0.5 [0.38–0-7] V, p = 0.004). ConclusionWhen considering LP indications, patient preference was more common in younger, while infective and vascular concerns were more frequent in the older cohort. Rates of device-related complications did not differ significantly. Younger patients tended to have a slightly higher pacing threshold at mid-term follow-up.

S-ICD in heart failure patients: real-world data from a multicenter, european analysis

Abstract Funding Acknowledgements Type of funding sources: None. Background Data on patients with heart failure (HF) and subcutaneous implantable cardioverter defibrillator (S-ICD) are very scarce and limited to a single prospective analysis from the UNTOUCHED trial. Purpose Aim of this study was to assess clinical outcomes of the S-ICD in HF patients, comparing them with a no-HF population, in a real-world analysis from the largest European retrospective S-ICD registry (ELISIR registry). Methods All consecutive patients undergoing S-ICD implantation at 20 European institutions enrolled in the ELISIR registry were used for the current analysis. According to European Guidelines, the registry population was classified into two groups: the HF cohort (further classified as HF with reduced and mid-range ejection fraction – HFrEF and HFmrEF) vs the no-HF group. The primary outcome of the study was the inappropriate shock (IS) rate across the two cohorts. As secondary outcomes, appropriate shocks, cardiovascular mortality and device-related complications during follow-up were assessed. Results A total of 1409 patients from the ELISIR registry were included in this analysis; HF patients represented 57.3% of the entire cohort (n=701, 86.9% HFrEF; n=106,13.1% HFmrEF). As expected, the HF cohort showed significantly higher rates of cardiovascular risk factors and comorbidities when compared to the no-HF cohort. Over a median follow-up of approximately 2 years, a total of 133 inappropriate shocks were observed in the entire cohort, without significant differences among the two groups (9.2% vs 9.8%, p=0.689). 133 complex ventricular arrhythmias were adequately recognized and treated in the overall cohort, showing similar rates of appropriate shocks (9.2% vs 9.8%, p=0.689). Inappropriate and effective shocks-free survival has been represented in Figure 1, showing Kaplan-Meier estimates comparing HF vs no-HF patients, also stratified by left ventricular ejection fraction (LVEF). The impact of baseline and procedural characteristics on the primary outcome was tested through univariable and multivariable Cox regression analysis in HF patients; at multivariate analysis, only age (HR=0.974 [0.955–0.992], p=0.005), LVEF (HR=0.954 [0.926-0.984], p=0.003), ARVC (HR=3.364 [1.206-9.384], p=0.020) and smart pass algorithm "on" (HR=0.321 [0.184-0.560], p&amp;lt;0.001) remained associated with inappropriate shocks (Figure 2). A low number of patients (n=76) experienced device-related complications, more frequently in the HF cohort (6.2% vs 3.8%, p=0.031) with no significant differences regarding any specific outcome of interest: lead infection (1.1% vs 0.7%, p=0.381), pocket infection (1.9% vs 0.8%, p=0.107), pocket hematoma (3.2% vs 2.8%, p=0.668). Conclusion The rate of inappropriate shocks seems to be comparable in both HF and non-HF patients implanted with S-ICD. However, the rate of device-related complications was slightly more frequent in HF patients.

Age-related differences and associated outcomes of S-ICD: insights from a large, european, multicenter, real-world registry

Abstract Funding Acknowledgements Type of funding sources: None. Background Young patients often represent the most suitable candidates for an entirely subcutaenous implantable cardioverter defibrillator (S-ICD) system, since they have to face a lifetime of device therapy and they rarely have a pre-existing or concurrent pacing or cardiac resynchronization therapy (CRT) indication. Moreover, S-ICD offers lower rate and a safer management of lead and major procedure-related complications. To date, a few limited case series and experiences with S-ICD in teenagers and young adults have shown that the S-ICD system is safe and feasible in this population, with a rate of inappropriate shocks (IS) comparable to transvenous (TV) ICD, but focused analysis on a large scale are currently lacking in this setting. Purpose The aim of the current study was to compare the age-related differences observed in patient selection, baseline characteristics, and device long-term associated outcomes in a large real world cohort of S-ICD recipients. The primary outcome of the study was defined as the comparisons of the IS rate observed during the entirety of follow up in the teenagers/young adult vs the adult populations. Rate of complications, freedom from sustained ventricular arrhythmic events, overall and cardiovascular mortality were also assessed in the two cohorts and assessed as secondary outcomes. Methods All S-ICD recipients in the ELISIR project were enrolled in the current study. Patients were classified into teenagers + young adults (≤ 30 years old) vs adults (&amp;gt; 30 years old), depending from patient age at device implantation (Figure 1). Rates of device-related complications and IS were compared between the cohorts. Results A total of 1349 patients were extracted from the ELISIR project. Teenagers and young adults represented 12.4% of the registry (n=56 teenagers; n=112 young adults). Patients were followed-up for a median of 23.1 [12.6–37.9] months. Overall, 117 (8.7%) patients experienced inappropriate S-ICD shocks and 100 (7.4%) device related complications were observed, with no age-related differences. IS resulted more frequent in the teenager and young adult cohort (14.3% vs 7.9%; p=0.006). Figure 2 reports Kaplan Meier curves for the occurrence of IS. At univariate analysis, young age was associated with IS, but after correcting for differences in arrhythmic substrate, this association resulted non-significant (aHR: 1.428 [0.883–2.331]; p=0.146). The use of SMART pass algorithm was instead associated to a strong reduction in IS (aHR 0.367 [0.245–0.548]; p&amp;lt;0.001). Conclusion The use of S-ICD in teenagers/young adults resulted safe and effective. Indeed, the rate of complications between teenagers/young adults and adults was not significantly different. Although a higher rate of IS was observed in the teenagers/young adults, when accounting for differences in baseline substrate and comorbidities, young age did not result associated with an increased risk of IS.

Sex and Race Disparities in Hypertrophic Cardiomyopathy: Unequal Implantable Cardioverter-Defibrillator Use During Hospitalization

ObjectiveTo evaluate if there are sex and race disparities in use of implantable cardioverter-defibrillator (ICD) devices for prevention of sudden cardiac death in patients with hypertrophic cardiomyopathy (HCM). Patients and MethodsUsing the National Inpatient Sample from January 2003 through December 2014, we identified all adult admissions with a diagnosis of HCM and an ICD implantation. Race was classified as White versus non-White. Trends in ICD use, predictors of ICD implantation, device-related complications, hospitalization costs, and lengths of stay were evaluated. ResultsAmong a total of 23,535 adult hospitalizations for HCM, ICD implantation was performed in 3954 (16.8%) admissions. Over the study period, there was an overall increasing trend in ICD use (11.6% in 2003 to 17.0% in 2014, P<.001). Compared with admissions not receiving an ICD, those receiving an ICD had shorter median lengths of in-hospital stay but higher hospitalization costs (P<.001). Compared with men and White race, female sex (odds ratio, 0.72; 95% CI, 0.66 to 0.78; P<.001) and non-White race (odds ratio, 0.87; 95% CI, 0.79 to 0.96; P<.001) were associated with lower adjusted odds of receiving an ICD. Women and non-White hospitalizations had higher rates of device related complications, longer lengths of in-hospital stay, and higher hospitalization costs compared with men and White race, respectively (all P<.01). ConclusionAmong HCM hospitalizations, ICD devices are underused in women and racial minorities independent of demographics, hospital characteristics, and comorbidities. Women and racial minorities also had higher rates of complications and greater resource use compared with men and those belonging to the White race, respectively.

Device-related complications after Impella mechanical circulatory support implantation: an IMP-IT observational multicentre registry substudy.

To report the incidence, the predictors and clinical impact of device-related complications (DRCs) in the IMP-IT (IMPella Mechanical Circulatory Support Device in Italy) registry. Impella is percutaneous left ventricular assist devices, which provides mechanical circulatory support both in cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI). The IMP-IT registry is a multicentre registry evaluating the trends in use and clinical outcomes of Impella in Italy. A total of 406 patients have been included in this registry: 56.4% in the setting of CS, while 43.6% patients in the setting of HR-PCI. DRCs were defined as a composite endpoint of access-site bleeding, limb ischaemia, vascular complication requiring treatment, haemolysis, aortic injury, and left ventricular perforation. DRC incidence in the overall population was 25.6%, with significantly higher rate in the CS (37.1%) than in the HR-PCI (10.7%) group. The most frequent complication was haemolysis (11.8%), which occurred almost exclusively in CS population. Access-site bleeding was observed in 9.6% of the overall population, with no significant difference between the two groups. Limb ischaemia was observed in 8.3% of the overall population, with significantly higher rate in the CS group. CS and right ventricular dysfunction appear as the strongest independent predictors of DRC. One-year mortality in patients with DRC appears higher than in patients with no DRC. However, DRC was not confirmed as an independent predictor of 1-year mortality at multivariate analysis. In the IMP-IT registry, the rate of DRC was 25.6%, with CS being the strongest independent predictor. DRC was not found as an independent predictor of 1-year mortality.

Anxiety and depression in inherited channelopathy patients with implantable cardioverter-defibrillators.

BackgroundImplantable cardioverter-defibrillators (ICDs) are an effective treatment in some patients with inherited heart disease, including inherited channelopathies, yet they have also been shown to impact patients’ psychological health.ObjectiveWe sought to improve understanding of the level of anxiety and depression as well as device acceptance among inherited channelopathy patients with an ICD.MethodsEligible patients seen at Johns Hopkins Hospital were sent a survey, which included the Hospital Anxiety and Depression Scale (HADS), Cardiac Anxiety Questionnaire (CAQ), and the Florida Patient Acceptance Survey (FPAS). Student t tests and χ2 tests were used to identify associations with abnormal anxiety and depression scores.ResultsAmong eligible patients (n = 65), 32 individuals (49%) completed the survey. The rate of device-related complications was 34%, and 41% of patients experienced 1 or more ICD shocks. Twelve patients (38%) had an abnormal HADS anxiety subscore and 5 patients (16%) had an abnormal HADS depression subscore (score ≥ 8). Secondary-prevention ICDs were associated with an abnormal HADS anxiety subscore (P = .03). Experiencing ICD shock(s), device complications, age, sex, and family history of sudden cardiac death were not statistically associated with anxiety or depression. Overall, respondents demonstrated high device acceptance by FPAS (79.9 ± 2.9, maximum total score 100) and moderately high cardiac-specific anxiety by CAQ total score (1.53 ± 0.12).ConclusionA high prevalence of generalized anxiety was identified among inherited channelopathy patients with ICDs. High device acceptance and lack of association with ICD shocks or complications indicate that further research is necessary to understand this increased incidence.

807 Comparison of 30-Day Outcomes Between Balloon-Expandable and Self-Expanding Transcatheter Heart Valves in Patients With Moderate or Severe Device Landing Zone Calcification

Patients undergoing TAVI who have a significant volume of calcium at the device landing zone (DLZ) have been shown to have a high risk of death, annular rupture and paravalvular leak. Self-expanding (SE) valves have predominantly been used in this patient cohort due to a perceived reduced risk of annular rupture. A recently published propensity-matched cohort study of the French TAVI registry suggested that balloon expanding valves have lower rates of device related complications. A retrospective study comparing 30-day TAVI outcomes between balloon-expandable (BE) and SE valves in patients with moderate or severe device landing zone calcification (DLZC) as defined by SCCT guidelines. The endpoint was a composite of death, stroke, >mild PVL, urgent surgery, annular rupture or second valve deployed. A total of 120 patients (Mean age 82.3±9.2 with 46.7% female) with moderate or severe DLZC were included. 16.7% (20) patients were treated with SE valves. 35% (7/20) of SE valves were post dilated. BE valves had a lower 30-composite endpoint (BE 10% vs SE 45%, p<0.0001). 27 of the 120 patients (22.5%) had severe DLZC. In severe DLZC, the composite endpoint in both groups increased: BE valves 15.8% (3/19); SE valves 50% (4/8). No difference in pacemaker rates was observed. This is the first comparison of TAVI valves in moderate or severely calcified device landing zones. Balloon expandable valves were found to provide a lower rate of early valve related complications than self-expanding valves. This supports recent registry findings however, randomised data is needed.

Facilitation of Surgical Innovation: Is It Possible to Speed the Introduction of New Technology While Simultaneously Improving Patient Safety?

To review efficiency metrics and patient safety data before and after implementation of a structured review process for surgical innovations. Surgical innovation ranges from minor incremental improvement to radical experimentation. Although innovation paradigms have been described, these are not widely adopted or enforced in the surgical community. A Continuous Quality Improvement Team (CQIT) of surgical quality officers and perioperative nurses was organized to perform structured reviews of proposed new surgical devices and procedures at a large quaternary cancer care center. The CQIT process was placed to precede an established Value Analysis Team business evaluation. Pre- and post-CQIT implementation metrics of approval process efficiency and patient safety data were compared. Seven novel procedures were also vetted by the CQIT. Forty-six product requests were evaluated after CQIT implementation. Compared with 34 products evaluated prior to CQIT establishment, the total mean evaluation time decreased from 124 to 51 days (P= 0.007). For new devices requiring intraoperative trial, the time between product proposal and trial decreased from a mean of 260 to 99 days (P= 0.014). The rate of device-related complications in the pre-CQIT group was 10% compared with 0% post-CQIT. Two devices, which administratively bypassed CQIT review, had both minor and major complications, including a mortality. Five novel procedures approved by CQIT with simulation were performed without complications. Using novel algorithms, the addition of a dedicated team of surgical quality officers to the surgical innovation evaluation process improved both the efficiency and the safety associated with introducing new devices and procedures into practice.

P5735Feasibility and safety of Impella mechanical circulatory support in different clinical scenarios: a single-centre experience

Abstract Background The Impella (Abiomed, Danvers, MA) mechanical circulatory support is a catheter-based axial-flow pump. It reduces left ventricular (LV) stroke work and myocardial oxygen demand while increasing systemic and coronary perfusion in the setting of cardiogenic shock (CS), and it provides hemodynamic support during high-risk percutaneous coronary intervention (PCI). Purpose To evaluate the outcomes of Impella-supported patients in the context of CS and protected-PCI. Methods This single-center registry includes all patients implanted with Impella device at our institution between February 2013 and June 2018. Indications for Impella support were CS (hypotension despite adequate filling status with signs of hypoperfusion) and protected-PCI (prophylactic hemodynamic support during non-emergent high-risk PCI). Results A total of 145 patients were implanted with Impella: 130 (89.7%) for CS and 15 (10.3%) for protected-PCI. Among CS patients, mean age was 61.6±12.9, 79.2% males. The prevalence of chronic heart failure (HF) was 26.1%, prior myocardial infarction (MI) 29% and myocardial revascularization 36.6%, chronic kidney disease (CKD) 18.3%. Among protected PCI patients, mean age was 73.4±8.7 years, 86.7% males. The prevalence of HF was 85.7%, prior MI 42.9%, myocardial revascularization 35.7%, CKD 57.1%. In CS group, the indications for Impella implantation were myocarditis in 8 (6.2%) patients, acute coronary syndromes in 77 (59.2%), periprocedural ventricular tachycardia ablation CS in 10 (7.7%), decompensated heart failure in 26.9%. Out of hospital cardiac arrest occurred in 35 (30.4%) patients, INTERMACS I class in 70 (59.3%), mean arterial pressure was 65.4±18.4 mmHg, serum lactate 6.7±5.5 mmol/l, at least 1 inotropic agent use in 73 (66.4%), mean LV EF 21.4±11,7%, right ventricular dysfunction in 53 (48.6%). The rate of device-related complications was not negligible in CS group: 18 (14.5%) patients had limb ischemia and vascular surgery was required in 14, 17 (14.3%) had access-site bleeding. A total of 42 (33.3%) had haemolysis, and 67 (56.8%) acute kidney injury (AKI), half of whom requiring renal replacement therapy. Escalation to other therapies was necessary in 43 cases. Conversely, in the protected-PCI group a low rate of AKI (n=4, 28.6%) and acute limb ischemia (n=1, 7.1%) was observed, whereas no cases of haemolysis nor need of escalation therapy were recorded. Mean Impella support was 135.5±167.21 days for CS group, 60.6±80 for protected-PCI group. Survival at 30 days was 60.33% for CS group and 92.9% for protected-PCI group. One-year all-cause death was 50% for CS group and 13.3% for protected-PCI group. Conclusion Mechanical circulatory support with Impella is associated with good outcomes and reasonable rates of complications in the protected-PCI group, whereas less favorable results were observed in CS population probably due to the greater severity of clinical presentation.

Body mass index and outcomes of cardiac resynchronization with implantable cardioverter-defibrillator therapy in older patients with heart failure.

To assess the association of body mass index (BMI) with heart failure (HF) outcomes after cardiac resynchronization therapy with defibrillator (CRT-D) implantation. Medicare beneficiaries with HF aged ≥ 65 years (n=18 922) undergoing first-time CRT-D from the National Cardiovascular Data Registry (NCDR) Implantable Cardioverter-Defibrillator Registry between 2010 and 2013, were followed for 3 years post-implantation. Survival curves and covariate adjusted hazard ratio (aHR) or odds ratio were used to assess the risks for death, readmission, and device-related complications by BMI status. Of 18 922 HF patients receiving CRT-D, 5265 (27.8%) were normal weight, 6896 (37%) were overweight, 6318 (33.4%) were obese, and 353 (1.8%) were underweight. Compared to those of normal weight (BMI 18.5-24.9 kg/m2 ), underweight patients had a higher 3-year post-device implantation risk of death [aHR: 1.34 (95% confidence interval 1.09-1.65); P < 0.001] and of readmission [sub-aHR: 1.25 (1.09-1.42); P < 0.001]. The corresponding 3-year aHRs for death were 0.83 (0.77-0.89) for overweight, 0.74 (0.67-0.82) for obesity class I (BMI 30-34.9 kg/m2 ), 0.78 (0.68-0.90) for obesity class II (BMI 35-39.9 kg/m2 ), and 0.75 (0.60-0.93) for obesity class III (BMI ≥ 40 kg/m2 , P for all categories < 0.001). Individuals with class III obesity had a higher risk of readmission [sub-aHR: 1.17 (1.06-1.30)]. There were no differences in rates of device-related complications within 90 days across BMI categories. Most elderly patients with HF receiving CRT-D were overweight or obese. While being underweight was associated with greater risks of death and hospitalization, overweight and obese patients were at lower risk of death after CRT-D.

Surgical growth guidance with non-fused anchoring segments in early-onset scoliosis.

Surgical treatment of early-onset scoliosis (EOS) requires a balance between maintained curve correction and the capacity for spinal and thoracic growth. Spinal fusion creates irreversible conditions that prevent the implementation of further treatment methods. Our hypothesis was that non-fused anchors in growth guidance show a comparable outcome as the technique described in the literature, which involves spondylodesis of the anchoring segments. This retrospective study analysed 148 surgeries in 22 EOS patients (11 female, 11 male) over a 15-year period. Patients underwent surgery with non-fused anchors and growth guidance techniques. Scoliosis, kyphosis, growth and anchoring segments were measured. For the latter, a new measuring technique was developed. Complications were recorded and classified. The mean Cobb angle reduced from 73.5 ± 24.4° to 28.4 ± 16.2° (60.2 ± 22.9%, p < 0.001) at the last follow-up. Spinal growth T1-S1 and T1-T12 were 41.1 ± 23.3mm and 24.9 ± 16.6mm (p < 0.001), respectively. Growth at the cranial and caudal anchoring segment was 1.5mm/segment/year and 1.9mm/segment/year, respectively. A total of 63 complications were documented in 20 patients, with 40 requiring unplanned revision surgery. Definitive spondylodesis was performed in three patients. Patients demonstrated a significant spinal growth including the anchoring segments. A comparable correction in Cobb angle and the type of complications was noted, although the rate of device-related complications was higher. No permanent impairment was reported. The rate of device-related complications is acceptable and outweighed by the significant degree of growth preservation and more flexible and individualised treatment strategy for patients with EOS. These slides can be retrieved under Electronic Supplementary Material.

First-in-Man Experience With the ClearLumen Thrombectomy System as an Adjunctive Therapy in Primary Percutaneous Coronary Interventions.

To describe the first-in-man experience with the ClearLumen Thrombectomy System (Walk Vascular, Irvine, CA) and report on its safety, feasibility and efficacy when used as an adjunctive therapy during primary PCI. Thrombus aspiration (TA) aims to improve microvascular perfusion but currently available devices are not optimal. Prospective, single-centre, non-randomized, safety, and efficacy trial. Patients with acute STEMI were enrolled and the investigational device was used for thrombus aspiration. Safety was evaluated as the overall rate of device related complications while efficacy as the rate of successful device deployment and culprit vessel reperfusion. The composite endpoint based on the achievement of at least two of the following three criteria-TIMI flow 3 and/or myocardial blush grade ≥2 at completion of the case and ST-resolution >70% at 90 minutes after vessel reperfusion-was also evaluated. Over a 3 months period 20 patients were enrolled in the study. Culprit lesion was successfully reached with the investigational device in 19 patients (95%). The pre-specified combined endpoint was met in 16 out of 19 patients (84.2%). Three patients not meeting the combined end point had procedure related, non TA associated, adverse event. Only 2 minor procedural adverse event occurred after thrombus aspiration. This first-in-man experience with the ClearLumen Thrombectomy System demonstrates initial promising results on safety and efficacy when used as an adjunctive therapy during primary PCI.

73 Elderly Patients do not appear to be at Increased Risk of Pacemaker and Complex Device Related Complications

Introduction Pacemaker and complex device implantation is becoming increasingly common as indications expand and are better recognised. As the population ages, increasingly complex procedures are performed in district general hospitals in older, frailer patients. Historic benchmark pacing studies included younger patients and underestimate contemporary rates of device related complications. We reviewed complication rates across all pacing procedures in a high-volume district general hospital and compared rates across age ranges. Methods All pacing procedures between January 2013 and April 2014 were retrospectively identified from the NICOR database. Procedural reports and pacing checks for all new implants, lead revisions, generator changes and system upgrades for all implantable device types were reviewed. Complications were recorded and classified as major or minor (Table 1). Complication rates were compared across age ranges, by sex and procedural priority. Results 775 procedures were reviewed. The overall complication rate was 10.7%. This comprised of a rate of 8.4% for major complications vs.2.3% for minor complications. 356 (46%) of patients were >80. Complication rates were not influenced by patient age (p = 0.8), sex (p = 0.1) or procedural priority (p = 0.6) (Table 2). A trend was seen for increasing complication rate corresponding to the complexity of the device and number of leads implanted (Figure 1). Lead displacement was the commonest complication although re-intervention did not translate into a high rate of infection or wound problems as all other complications occurred with a frequency of Conclusions Complication rates from implantable cardiac device procedures were not insignificant but are comparable in a high volume district hospital to other contemporary data. Older patients made up a high proportion of patients undergoing pacing procedures but did not have a higher complication rate. The major complication was lead displacement and there was a corresponding increase in complications with increasing complexity of the device and the number of leads implanted.

Drug-Induced Brugada Syndrome in Children: Clinical Features, Device-Based Management, and Long-Term Follow-Up

The goal of this study was to investigate the clinical features, management, and long-term follow-up of children with drug-induced Brugada syndrome (BS). Patients with BS <12 years of age with a spontaneous type I electrocardiogram have a higher risk of arrhythmic events. Data on drug-induced BS in patients <12 years of age are lacking. Among 505 patients with ajmaline-induced BS, subjects ≤12 years of age at the time of diagnosis were considered as children and eligible for this study. Forty children (60% male; age 8 ± 2.8 years) were included. Twenty-four children (60%) had a family history of sudden death. Two (5%) had a previous episode of aborted sudden death, and 8 (20%) had syncope. Children experienced more frequent episodes of sinus node dysfunction (SND) compared with older subjects (7.5% vs. 1.5%; p = 0.04) and had a comparable incidence of atrial tachyarrhythmias. Children more frequently experienced episodes of ajmaline-induced sustained ventricular arrhythmias (VAs) compared with older patients (10.0% vs. 1.3%; p = 0.005). Twelve children (30%) received an implantable cardioverter-defibrillator (ICD). After a mean follow-up time of 83 ± 51 months, none of the children died suddenly. Spontaneous sustained VAs were documented in 1 child (2%). Among children with ICD, 1 (8%) experienced an appropriate shock, 4 (33%) had inappropriate ICD shocks, and 4 (33%) experienced device-related complications. Drug-induced BS is associated with atrial arrhythmias and SND. Children are at higher risk of ajmaline-induced VAs. The rate of device-related complications, leading to lead replacement or inappropriate shocks, is considerable and even higher than with appropriate interventions. Based on these findings, the optimal management of BS in childhood should remain individualized, taking into consideration the patient's clinical history and family's wishes.