Long-term outcomes after hospitalization for atrial fibrillation or flutter.

BACKGROUND AND AIMS: Atrial fibrillation (AF) and flutter are common causes of hospitalizations but contemporary long-term outcomes following these episodes are uncertain. This study assessed outcomes up to 10 years after an acute AF or flutter hospitalization. METHODS: Patients hospitalized acutely with a primary diagnosis of AF or flutter from 2008-17 from all public and most private hospitals in Australia and New Zealand were included. Kaplan-Meier methods and flexible parametric survival modelling were used to estimate survival and loss in life expectancy, respectively. Competing risk model accounting for death was used when estimating incidence of non-fatal outcomes. RESULTS: A total of 260 492 adults (mean age 70.5 ± 14.4 years, 49.6% female) were followed up for 1 068 009 person-years (PY), during which 69 167 died (incidence rate 6.5/100 PY) with 91.2% survival at 1 year, 72.7% at 5 years, and 55.2% at 10 years. Estimated loss in life expectancy was 2.6 years, or 16.8% of expected life expectancy. Re-hospitalizations for heart failure (2.9/100 PY), stroke (1.7/100 PY), and myocardial infarction (1.1/100 PY) were common with respective cumulative incidences of 16.8%, 11.0%, and 7.1% by 10 years. Re-hospitalization for AF or flutter occurred in 21.3% by 1 year, 35.3% by 5 years, and 41.2% by 10 years (11.6/100 PY). The cumulative incidence of patients undergoing catheter ablation of AF was 6.5% at 10 years (1.2/100 PY). CONCLUSIONS: Patients hospitalized for AF or flutter had high death rates with an average 2.6-year loss in life expectancy. Moreover, re-hospitalizations for AF or flutter and related outcomes such as heart failure and stroke were common with catheter ablation used infrequently for treatment, which warrant further actions.

Pulsed Field Ablation of Atrial Fibrillation: An Initial Australian Single-Centre Experience.

BACKGROUND: Pulsed field ablation (PFA) is a newer ablation energy source with the potential to reduce complications and improve efficacy compared to conventional thermal atrial fibrillation (AF) ablation. This study aimed to present an initial single-centre Australian experience of PFA for AF ablation. METHODS: Initial consecutive patients undergoing PFA for paroxysmal or persistent AF at a single centre were included. Baseline patient characteristics, procedural data and clinical outcomes were collected prospectively at the time of the procedure. Patients were followed up at 3 months and 6-monthly thereafter. RESULTS: In total, 100 PFA procedures were performed in 97 patients under general anaesthesia. All pulmonary veins (403 of 403) were successfully isolated acutely. Median follow-up was 218 days (range, 16-343 days), and the Kaplan-Meier estimate for freedom from atrial arrhythmias at 180 days was 87% (95% confidence interval 79%-95%). Median procedure time was 74 minutes (range, 48-134 minutes). Median fluoroscopy dose-area product was 345 µGym2 (interquartile range, 169-685 µGym2). Two (2%) pseudoaneurysm vascular access complications occurred. There were no cases of thromboembolic complications, stroke, phrenic nerve palsy, pulmonary vein stenosis, atrio-oesophageal fistula, or pericardial tamponade. CONCLUSIONS: Pulsed field ablation can be performed safely and efficiently, with encouraging efficacy in early follow-up. Further data and clinical trials will be required to assess the comparative utility of PFA in contemporary AF ablation practice.

Consecutive Experience with Left Bundle Branch Area Pacing in a High-Volume Australian Centre.

INTRODUCTION: Left-bundle branch area pacing (LBBAP) is a relatively new technique for conduction system pacing. Australian safety and efficacy data is currently lacking. We aim to evaluate the learning curve, medium-term safety, and lead performance in a high-volume Australian setting. METHODS: We performed a retrospective cohort study of 200 consecutive LBBAP procedures performed by a single operator at two centres between January 2019 and May 2020. Left bundle branch area pacing was performed predominantly via left subclavian access using a 69 cm Medtronic SelectSecure 3830 pacing lead and a preformed non-steerable C315-His sheath. Procedural success was defined as evidence of left septal or left bundle branch area capture as evidenced by a right bundle branch block-like paced morphology. Procedural characteristics, and follow-up (including lead performance) data were collected. Procedural efficiency over time, as well as safety data, were collected. RESULTS: Median age was 78.26 years (interquartile range [IQR] 71-85), 37% were female. Atrial fibrillation was present in 22%. The left ventricular ejection fraction <50% in 24%, atrioventricular (AV) block was present in 43.5%, left bundle branch block in 22.5% and right bundle branch block in 24.5%. Acute procedural success was 91.5%. Implant threshold was 0.6V @ 0.5 ms, and 0.75V @ 0.5 ms at 11.9 months of follow-up. The QRS was significant reduced (baseline 134 ms vs implant 114 ms, p<0.001) There was a reduction in procedural time and X-ray dose over the course of the study. There were no complications specific to LBBAP. CONCLUSION: LBBAP appears to be a safe and effective pacing strategy. The QRS duration was significantly reduced compared to baseline. There appears to be an early learning curve with LBBAP.

Sex differences in time to primary percutaneous coronary intervention and outcomes in patients presenting with ST-segment elevation myocardial infarction.

OBJECTIVES: We assessed sex differences in treatment and outcomes in ST-segment elevation myocardial infarction (STEMI) patients treated with primary percutaneous coronary intervention (PCI). BACKGROUND: Historically, delays to timely reperfusion and poorer outcomes have been described in women who suffer STEMI. However, whether these sex discrepancies still exist with contemporary STEMI treatment remains to be evaluated. METHODS: Consecutive STEMI patients treated with primary PCI patients over a 10-year period (January 1, 2010 to December 31, 2019) from a tertiary referral center were assessed. Comparisons were performed between patient's sex. Primary outcomes were 30-day and 1-year mortality. Secondary outcomes were STEMI performance measures. RESULTS: Most patients (n = 950; 76%) were male. Females were on average older (66.8 vs. 61.4 years males; p < 0.001). Prehospital treatment delays did not differ between sexes (54 min [IQR: 44-65] females vs. 52 min [IQR: 43-62] males; p = 0.061). STEMI performance measures (door-to-balloon, first medical contact-to-balloon [FMCTB]) differed significantly with longer median durations in females and fewer females achieving FMCTB < 90 min (28% females vs. 39% males; p < 0.001). Women also experienced greater rates of initial radial arterial access failure (11.3% vs. 3.1%; p < 0.001). However, there were no significant sex differences in crude or adjusted mortality between sexes at 30-days (3.6% male vs. 5.1% female; p = 0.241, adjusted OR: 1.1, 95% CI: 0.5-2.2, p = 0.82) or at 1-year (4.8% male vs. 6.8% female; p = 0.190, adjusted OR: 1.0, (95% CI: 0.5-1.8; p = 0.96). CONCLUSION: Small discrepancies between sexes in measures of timely reperfusion for STEMI still exist. No significant sex differences were observed in either 30-day or 1-year mortality.

Clinical Outcomes in Pre-Hospital Activation and Direct Cardiac Catheterisation Laboratory Transfer of STEMI for Primary PCI.

INTRODUCTION: Pre-hospital activation and direct cardiac catheterisation laboratory (CCL) transfer of ST segment elevation myocardial infarction (STEMI) has previously been shown to improve door-to-balloon (DTB) times yet there is limited outcome data in the Australian context. We aimed to assess the impact of pre-hospital activation on STEMI performance measures and mortality. METHODS: Prospective cohort study of consecutive ambulance transported STEMI patients treated with primary percutaneous coronary intervention (PCI) patients over a 10-year period (1 January 2008-31 December 2017) at The Prince Charles Hospital, a large quaternary referral centre in Brisbane, Queensland Australia. Comparisons were performed between patients who underwent pre-hospital CCL activation and patients who did not. STEMI performance measures, 30-day and 1-year mortality were examined. RESULTS: Amongst 1,009 patients included (mean age: 62.8 yrs±12.6), pre-hospital activation increased over time (26.6% in 2008 to 75.0% in 2017, p<0.001). Median DTB time (35 mins vs 76 mins p<0.001) and percentage meeting targets (DTB<60 mins 92% vs 27%, p<0.001) improved significantly with pre-hospital activation. Pre-hospital activation was associated with significantly lower 30-day (1.0% vs 3.5%, p=0.007) and 1-year (1.2% vs 7.7%, p<0.001) mortality. After adjusting for confounders and mediators, we observed a strong total effect of pre-hospital activation on 1-year mortality (OR 5.3, 95%CI 2.2-12.4, p<0.001) compared to patients who did not have pre-hospital activation. False positive rates were 3.7% with pre-hospital activation. CONCLUSION: In patients who underwent primary PCI for STEMI, pre-hospital activation and direct CCL transfer is associated with low false positive rates, significantly reduced time to reperfusion and lower 30-day and 1-year mortality.

Ventricular Ectopy in the Context of Left Ventricular Systolic Dysfunction: Risk Factors and Outcomes Following Catheter Ablation.

BACKGROUND: Ectopy-mediated cardiomyopathy (EMC) is a potentially reversible form of left ventricular systolic dysfunction. Various risk factors for the development of EMC have been proposed in the literature. We aim to assess medium term outcomes of focal ventricular arrhythmia (VA) ablation in the setting of cardiomyopathy (CMP) and to validate published risk factors for EMC. METHODS: Medium term recovery of left ventricular (LV) function and freedom from VA recurrence was assessed and compared between patients undergoing focal VA ablation in the setting of CMP and a control group with normal LV function. Univariate and multivariate analyses for CMP risk factors were performed and compared against prior published risk factors. RESULTS: Of 152 patients who underwent 170 focal VA ablation procedures, 54 (36%) had CMP and the remaining 98 patients had normal LV systolic function. At medium term follow-up, 85% of patients with CMP were free of VA recurrence and median left ventricular ejection fraction (LVEF) had improved from 40 to 52%. Age, male gender, premature ventricular complex (PVC) burden, non- right ventricular outflow tract (RVOT) sites of origin, PVC QRS duration and PVC minimum coupling interval were predictive of CMP on univariate analysis, but only gender persisted on multivariate analysis. CONCLUSIONS: Medium term outcome in patients undergoing focal VA in the setting of CMP are satisfactory with improvement in LV function achievable in most patients. Prior risk factors described in the literature are variable and inconsistent, likely reflecting heterogeneous study populations.

Current Device Therapies for Sudden Cardiac Death Prevention - the ICD, Subcutaneous ICD and Wearable ICD.

Defibrillator technology for sudden cardiac death (SCD) prevention now includes the transvenous implantable cardiac defibrillator (ICD), subcutaneous ICD (S-ICD) and wearable cardioverter defibrillator (WCD). ICD use improves survival in patients who survived previous sudden cardiac arrest (SCA) due to ventricular tachycardia (VT)/ventricular fibrillation (VF), as well as in patients who experienced haemodynamically significant VT. It is also currently indicated for primary prevention in ischaemic/non-ischaemic cardiomyopathies, certain congenital heart disease conditions and inherited channelopathies. In this review article, we hope to present an updated review on ICD use for SCD prevention, with a focus on contemporary issues affecting ICD selection. These include: the role of primary prevention ICD in patients with non-ischaemic cardiomyopathy (NICM) in light of the 2016 DANISH (Danish Study to Assess the Efficacy of ICDs in Patients with Non-Ischemic Systolic Heart Failure on Mortality) trial; the role of defibrillator component (CRT-D) in patients receiving cardiac resynchronisation therapy (CRT-P); and the emerging role of cardiac magnetic resonance imaging (cMRI) in particular, the presence of late gadolinium enhancement (LGE), as an important SCD risk predictor. The current use of S-ICD and WCD, including clinical indications, evidence for efficacy and limitations, will also be discussed.

Leadless Permanent Pacing: A Single Centre Australian Experience.

BACKGROUND: To describe the performance and clinical outcomes of consecutive patients having a leadless pacemaker (LP) implanted at a single institution. METHODS: Clinical data and device parameters were prospectively collected on all patients undergoing LP implantation from November 2015 to April 2018. RESULTS: A total of 79 patients (52 male), median age of 78 years, was included. Leadless pacemaker implantation was successful in 76 patients (96%). Implantation failed in two patients due to excessive venous tortuosity and due to inadequate sensing in another. Seventy-three (73) patients (96%) had chronic atrial fibrillation and all had a Class I or II indication for pacing. Procedure time was 29minutes (IQR 21-43) and fluoroscopy time was 8minutes (IQR 5-13). The median R wave at implant was 11.2mV (IQR 6.9-15.0). The median capture threshold at 0.24ms was 0.5V (IQR 0.4-0.9) and impedance was 754Ω (IQR 680-880). Intraprocedural acute dislodgement occurred in one patient following cutting of the tether but successful snaring and reimplantation was performed. During a median follow-up of 355days (range 9-905), overall electrical performance has been excellent. No patients have been readmitted for device revision or complications. Five (5) patients (7%) died during follow-up from unrelated causes. CONCLUSIONS: Leadless pacemakers can be implanted safely and effectively in the majority of patients. Device electrical performance was excellent over a median follow-up of 12 months.

Catheter ablation of papillary muscle arrhythmias: Implications of mitral valve prolapse and systolic dysfunction.

BACKGROUND: The left ventricular (LV) papillary muscles are important components of the mitral valve apparatus. Catheter ablation of ventricular arrhythmias from these sites is challenging. We aim to describe the association between LV papillary muscle ventricular arrhythmias (VAs) and mitral valve prolapse (MVP), and to determine the outcomes of ablation in these patients with a focus on those with MVP and cardiomyopathy. METHODS: A total of 152 patients underwent 170 consecutive procedures for ablation of focal VAs. MVP and cardiomyopathy were diagnosed by echocardiography. Outcomes following ablation were assessed in three groups: (1) LV papillary muscle VAs versus other sites, (2) LV papillary muscle VAs by the presence of MVP, and (3) LV papillary muscle VAs in the setting of cardiomyopathy. RESULTS: Nine of 23 (39%) patients undergoing ablation of LV papillary muscle VAs had MVP compared to none of 129 (0%) patients at other sites (P < 0.001). In the former group, acute procedural success was achieved in 60% and 80% of those with and without MVP, respectively (P = 0.28). Medium-term outcomes were comparable (P = 0.75). In patients with cardiomyopathy, the median LV ejection fraction improved from 40% to 54% following ablation (P = 0.007). CONCLUSIONS: Although MVP is strongly associated with LV papillary muscle VAs, MVP does not adversely affect the acute or medium-term outcomes of ablation. Systolic function can improve following ablation in patients with ectopy-mediated cardiomyopathy due to papillary muscle VAs.

Ultra-low radiation dose during electrophysiology procedures using optimized new generation fluoroscopy technology.

BACKGROUND: Electrophysiology procedures require fluoroscopic guidance, with the associated potentially adverse effects of ionizing radiation. Newer fluoroscopy systems have more features that enable dose-reduction strategies. This study aimed to investigate any reduction in radiation dose between an older fluoroscopy system (Philips Integris H5000, Philips Healthcare, Einhoven, Netherlands) and one of the latest systems (Siemens Artis Q, Siemens Healthcare, Erlangen, Germany), optimized with dose-reduction strategies. METHODS: Radiation dose measures were collected over a 2-year period in a single electrophysiology laboratory. Procedures were separated into seven groups: devices, biventricular devices, electrophysiology studies, standard radiofrequency ablation, complex atrial ablation, ablation for ventricular arrhythmias, and pulmonary vein isolation. In the first year, an older fluoroscopy system was used, and in the second year, a new system, with dose reduction strategies. Comparisons were also made to the literature with regard to radiation dose levels. RESULTS: Patient characteristics, fluoroscopy times, number of digital acquisitions, procedural times, and procedural success were largely similar between the old and new system across procedure groups. Overall dose area product (DAP) was reduced by 91% (5.0 [2.0-17.0] to 0.45 [0.16-2.61] Gycm2 [P > 0.001]) with the new system and was lower across all groups. DAP readings with the new system are some of the lowest published in the literature in all groups. CONCLUSION: An optimized contemporary digital fluoroscopy system, with low radiation dose configuration and continued good procedural practice, can result in ultra-low radiation levels for all electrophysiology procedures, without compromising procedural time or procedural success.

Excess Bed Days and Hospitalization Costs Associated With 30-Day Complications Following Catheter Ablation of Atrial Fibrillation.

BACKGROUND: The incidence and type of complications following catheter ablation of atrial fibrillation have been extensively examined, but the impact associated with these complications on the length of stay and hospitalization costs is unknown. METHODS AND RESULTS: This cohort study included 20 117 adult patients (mean age 62.6±11.4 years, 30.3% women, median length of stay 1 day [interquartile range 1-2 days]) undergoing atrial fibrillation ablation in financial years 2011 to 2017 in Australia with available cost data from the National Hospital Cost Data Collection, which determines government reimbursement of health services provided. The primary outcome was the costs associated with complications occurring up to 30 days postdischarge adjusted for inflation to 2021 Australian dollars. We used generalized linear models to estimate the increase in length of stay and cost associated with complications, adjusting for patient characteristics. Within 30 days of hospital discharge, 1151 (5.72%) patients experienced a complication with bleeding (3.35%) and pericardial effusion (0.75%) being the most common. On average, the occurrence of a complication was associated with an adjusted 3.3 (95% CI, 3.1-3.6) excess bed days of hospital care (totaling 3851 days), and a $7812 (95% CI, $6754-$8870) increase in hospitalization cost (totaling $9.0 million). Most of the total excess cost was attributable to bleeding ($3.8 million, 41.9% of total excess cost) and pericardial effusion ($1.6 million, 18.2%). CONCLUSIONS: Complications following atrial fibrillation ablation were associated with significant increase in length of stay and hospitalization costs, most of which were attributable to bleeding and pericardial effusion. Strategies to improve procedural safety and reduce health care costs should focus on these complications.

Longitudinal risk of death, hospitalizations for atrial fibrillation, and cardiovascular events following catheter ablation of atrial fibrillation: a cohort study.

AIMS: Population studies reporting contemporary long-term outcomes following catheter ablation of atrial fibrillation (AF) are sparse.We evaluated long-term clinical outcomes following AF ablation and examined variation in outcomes by age, sex, and the presence of heart failure. METHODS AND RESULTS: We identified 30 601 unique patients (mean age 62.7 ± 11.8 years, 30.0% female) undergoing AF ablation from 2008 to 2017 in Australia and New Zealand using nationwide hospitalization data. The primary outcomes were all-cause mortality and rehospitalizations for AF or flutter, repeat AF ablation, and cardioversion. Secondary outcomes were rehospitalizations for other cardiovascular events. During 124 858.7 person-years of follow-up, 1900 patients died (incidence rate 1.5/100 person-years) with a survival probability of 93.0% (95% confidence interval (CI) 92.6-93.4%) by 5 years and 84.0% (95% CI 82.4-85.5%) by 10 years. Rehospitalizations for AF or flutter (13.3/100 person-years), repeat ablation (5.9/100 person-years), and cardioversion (4.5/100 person-years) were common, with respective cumulative incidence of 49.4% (95% CI 48.4-50.4%), 28.1% (95% CI 27.2-29.0%), and 24.4% (95% CI 21.5-27.5%) at 10 years post-ablation. Rehospitalizations for stroke (0.7/100 person-years), heart failure (1.1/100 person-years), acute myocardial infarction (0.4/100 person-years), syncope (0.6/100 person-years), other arrhythmias (2.5/100 person-years), and new cardiac device implantation (2.0/100 person-years) occurred less frequently. Elderly patients and those with comorbid heart failure had worse survival but were less likely to undergo repeat ablation, while long-term outcomes were comparable between the sexes. CONCLUSION: Patients undergoing AF ablations had good long-term survival, a low incidence of rehospitalizations for stroke or heart failure, and about half remained free of rehospitalizations for AF or flutter, including for repeat AF ablation, or cardioversion.

Freedom from atrial arrhythmia and other clinical outcomes at 5 years and beyond after catheter ablation of atrial fibrillation: a systematic review and meta-analysis.

AIMS: Catheter ablation of atrial fibrillation (AF) is now a mainstream procedure although long-term outcomes are uncertain. We performed a systematic review and meta-analysis of procedural outcomes at 5 years and beyond. METHODS AND RESULTS: We searched PubMed and Embase and after the screening, identified 73 studies (67 159 patients) reporting freedom from atrial arrhythmia, all-cause death, stroke, and major bleeding at ≥5 years after AF ablation. The pooled mean age was 59.7y, 71.5% male, 62.2% paroxysmal AF, and radiofrequency was used in 78.1% of studies. Pooled incidence of freedom from atrial arrhythmia at 5 years was 50.6% (95%CI 45.5-55.7%) after a single ablation and 69.7% [95%CI (confidence interval) 63.8-75.3%) after multiple procedures. The incidence was higher among patients with paroxysmal compared with non-paroxysmal AF after single (59.7% vs. 33.3%, p = 0.002) and multiple (80.8% vs. 60.6%, p < 0.001) ablations but was comparable between radiofrequency and cryoablation. Pooled incidences of other outcomes were 6.0% (95%CI 3.2-9.7%) for death, 2.4% (95%CI 1.4-3.7%) for stroke, and 1.2% (95%CI 0.8-2.0%) for major bleeding at 5 years. Beyond 5 years, freedom from arrhythmia recurrence remained largely stable (52.3% and 64.7% after single and multiple procedures at 10 years), while the risk of stroke and bleeding increased over time. CONCLUSION: Nearly 70% of patients having multiple ablations remained free from atrial arrhythmia at 5 years, with the incidence slightly decreasing beyond this period. Risk of death, stroke, and major bleeding at 5 years were low but increased over time, emphasizing the importance of long-term thromboembolism prevention and bleeding risk management.

Prehospital Activation of the Cardiac Catheterization Laboratory in ST-Segment-Elevation Myocardial Infarction for Primary Percutaneous Coronary Intervention.

Background Prehospital activation of the cardiac catheter laboratory is associated with significant improvements in ST-segment-elevation myocardial infarction (STEMI) performance measures. However, there are equivocal data, particularly within Australia, regarding its influence on mortality. We assessed the association of prehospital activation on performance measures and mortality in patients with STEMI treated with primary percutaneous coronary intervention from the Queensland Cardiac Outcomes Registry (QCOR). Methods and Results Consecutive ambulance-transported patients with STEMI treated with primary percutaneous coronary intervention were analyzed from January 1, 2017 to December 31, 2020 from the QCOR. The total and direct effects of prehospital activation on the primary outcomes (30-day and 1-year cardiovascular mortality) were estimated using logistic regression analyses. Secondary outcomes were STEMI performance measures. Among 2498 patients (mean age: 62.2±12.4 years; 79.2% male), 73% underwent prehospital activation. Median door-to-balloon time (34 minutes [26-46] versus 86 minutes [68-113]; P<0.001), first-electrocardiograph-to-balloon time (83.5 minutes [72-98] versus 109 minutes [81-139]; P<0.001), and proportion of patients meeting STEMI targets (door-to-balloon <60 minutes 90% versus 16%; P<0.001), electrocardiograph-to-balloon time <90 minutes (62% versus 33%; P<0.001) were significantly improved with prehospital activation. Prehospital activation was associated with significantly lower 30-day (1.6% versus 6.6%; P<0.001) and 1-year cardiovascular mortality (2.9% versus 9.5%; P<0.001). After adjustment, no prehospital activation was strongly associated with increased 30-day (odds ratio [OR], 3.6 [95% CI, 2.2-6.0], P<0.001) and 1-year cardiovascular mortality (OR, 3.0 [95% CI, 2.0-4.6]; P<0.001). Conclusions Prehospital activation of cardiac catheterization laboratory for primary percutaneous coronary intervention was associated with significantly shorter time to reperfusion, achievement of STEMI performance measures, and lower 30-day and 1-year cardiovascular mortality.

Phenotypic variability within the desminopathies: A case series of three patients.

The DES gene encodes desmin, a key intermediate filament of skeletal, cardiac and smooth muscle. Pathogenic DES variants produce a range of skeletal and cardiac muscle disorders collectively known as the desminopathies. We report three desminopathy cases which highlight the phenotypic heterogeneity of this disorder and discuss various factors that may contribute to the clinical differences seen between patients with different desmin variants and also between family members with the same variant.

Safety and Efficacy of Leadless Pacemakers: A Systematic Review and Meta-Analysis.

Background Leadless pacemaker is a novel technology, and evidence supporting its use is uncertain. We performed a systematic review and meta-analysis to examine the safety and efficacy of leadless pacemakers implanted in the right ventricle. Methods and Results We searched PubMed and Embase for studies published before June 6, 2020. The primary safety outcome was major complications, whereas the primary efficacy end point was acceptable pacing capture threshold (≤2 V). Pooled estimates were calculated using the Freedman-Tukey double arcsine transformation. Of 1281 records screened, we identified 36 observational studies of Nanostim and Micra leadless pacemakers, with most (69.4%) reporting outcomes for the Micra. For Micra, the pooled incidence of complications at 90 days (n=1608) was 0.46% (95% CI, 0.08%-1.05%) and at 1 year (n=3194) was 1.77% (95% CI, 0.76%-3.07%). In 5 studies with up to 1-year follow-up, Micra was associated with 51% lower odds of complications compared with transvenous pacemakers (3.30% versus 7.43%; odds ratio [OR], 0.49; 95% CI, 0.34-0.70). At 1 year, 98.96% (95% CI, 97.26%-99.94%) of 1376 patients implanted with Micra had good pacing capture thresholds. For Nanostim, the reported complication incidence ranged from 6.06% to 23.54% at 90 days and 5.33% to 6.67% at 1 year, with 90% to 100% having good pacing capture thresholds at 1 year (pooled result not estimated because of the low number of studies). Conclusions Most studies report outcomes for the Micra, which is associated with a low risk of complications and good electrical performance up to 1-year after implantation. Further data from randomized controlled trials are needed to support the widespread adoption of these devices in clinical practice.

First-in-Human Chronic Implant Experience of the Substernal Extravascular Implantable Cardioverter-Defibrillator.

OBJECTIVES: The aim of this study was to evaluate the safety and performance of an extravascular (EV) implantable cardioverter-defibrillator (ICD). BACKGROUND: Limitations of existing transvenous and subcutaneous ICD systems include lead reliability and morbidity issues associated with ICD lead implantation in the vasculature or lack of pacing therapies (e.g., antitachycardia pacing) in subcutaneous systems. The EV defibrillator uses a novel substernal lead placement to address these limitations. METHODS: This was a prospective, nonrandomized, chronic pilot study conducted at 4 centers in Australia and New Zealand. Participants were 21 patients referred for ICD implantation. Patients received EV ICD systems. Data collection included major systemic and procedural adverse events, defibrillation testing at implantation, and sensing and pacing thresholds. RESULTS: Among 20 patients who underwent successful implantation, the median defibrillation threshold was 15 J, and 90% passed defibrillation testing with a ≥10-J safety margin. Mean R-wave amplitude was 3.4 ± 2.0 mV, mean ventricular fibrillation amplitude was 2.8 ± 1.7 mV, and pacing was successful in 95% at ≤10 V. There were no intraprocedural complications. Two patients have undergone elective chronic system removal since hospital discharge. In the 15 patients presently implanted, the systems are stable in long-term follow-up. CONCLUSIONS: This first-in-human evaluation of an EV ICD demonstrated the feasibility of substernal lead placement, defibrillation, and pacing with a chronically implanted system. There were no acute major complications, and pacing, defibrillation, and sensing performance at implantation were successful in most patients. (Extravascular ICD Pilot Study [EV ICD]; NCT03608670).

Analgesic patches and defibrillators: a cautionary tale.

Implantable cardioverter defibrillator (ICD) insertions have increased significantly over the last decade. Transdermal patches are increasingly used for drug delivery. Skin burns associated with metal containing transdermal patches have been reported with magnetic resonance imaging and external cardiac defibrillation. However, there are no reports of dermal injury secondary to an ICD shock and a transdermal drug delivery patch. We report the first known case of a patient who suffered a dermal burn following a defibrillation due to a transdermal patch being positioned over the ICD.

Spontaneous transformation of a concealed to manifest posteroseptal accessory pathway requiring epicardial ablation.

Concealed accessory pathways (APs) are considered benign as they can only sustain orthodromic atrioventricular re-entrant tachycardia (ORT). We describe a unique case of a concealed posteroseptal AP where longitudinal surveillance following repeated failed ablation attempts due to abnormal coronary sinus (CS) anatomy revealed spontaneous development of manifest pre-excitation. The pathway was ultimately ablated via the percutaneous epicardial approach. The potential for development of Wolff-Parkinson-White (WPW) syndrome in patients with concealed APs has implications for ongoing surveillance in these patients.