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.

Background: Data on long-term outcomes following an acute stroke are sparse. We assessed survival, risk of recurrent stroke and loss in life expectancy following an acute stroke using population-wide data from Australia and New Zealand. Methods: We included all adults with the first stroke hospitalization during 2008 and 2017 at all public and most private hospitals. Patients were followed up to 10 years after the stroke by linkage to each region’s Registry of Deaths and subsequent hospitalizations. Flexible parametric survival modeling was used to estimate all-cause mortality, stroke recurrence, and loss in life expectancy. Competing risk model was used when estimating the risk of stroke recurrence. Results: Three hundred thirteen thousand one hundred sixty-two patients were included (mean age 73.0±14.6 y, 52.0% males) with ischemic stroke (175 547, 56.1%) being the most common, followed by hemorrhagic stroke (77 940, 24.9%) and unspecified stroke (59 675, 19.1%). The overall survival probability was 79.4% at 3 months, 73.0% at 1 year, 52.8% at 5 years, and 36.4% at 10 years. Cumulative incidence of stroke recurrence was 7.8% at 3 months, 11.0% at 1 year, 19.8% at 5 years, and 26.8% at 10 years. Hemorrhagic stroke was associated with greater mortality (hazard ratio, 2.02 [95% CI, 1.99–2.04]) and recurrent stroke (hazard ratio, 1.63 [95% CI, 1.59–1.67]) compared with ischemic stroke. Female sex (hazard ratio, 1.10 [95% CI, 1.09–1.11]) and increasing age (≥85 years versus 18–54 years: hazard ratio, 7.36 [95% CI, 7.15–7.57]) were also associated with increased mortality. Several risk factors including atherosclerotic coronary and noncoronary vascular disease, cardiac arrhythmia, and diabetes were associated with increased risk of mortality and recurrent stroke. Compared with the general population, an acute stroke was associated with a loss of 5.5 years of life expectancy, or 32.7% of the predicted life expectancy, and was pronounced in patients with a hemorrhagic stroke (7.4 years and 38.5% of predicted life expectancy lost). Conclusions: In this population-wide study, death and recurrence of stroke were common after an acute stroke and an acute stroke was associated with considerable loss in life expectancy. Further improvements in treatment and secondary prevention of stroke are needed to reduce these risks.

Aims: Recent US studies report rising rates of mortality and in-hospital complications following catheter ablation of atrial fibrillation (AF), but whether this is a global phenomenon is uncertain. The aim of this study was to examine trends in 30-day mortality and complications following AF ablation in Australia and New Zealand (ANZ) from 2008 to 2017. Methods and results: We identified 37 243 AF (mean age 62.4 ± 11.5 years, 29.6% females, 94.5% elective procedures) ablations using national hospitalization data. The primary outcome was occurrence of any complication, including all-cause mortality, within 30 days of discharge. Trends were evaluated using logistic regression adjusting for changes in patient characteristics. The annual number of ablations increased from 1359 (2008) to 5115 (2017). Patients’ age and rates of heart failure (9.8–10.6%), diabetes (6.8–12.4%), and chronic kidney disease (2.2–4.1%) also increased over time. From 2008 to 2017, the overall rate of complications declined from 7.51% to 5.04% [adjusted odds ratio (aOR) 0.96 (95% confidence interval, CI, 0.94–0.97)/year]. Rates of pericardial effusion [1.69–0.70%, aOR 0.93 (0.89–0.97)], bleeding [4.49–2.74%, aOR 0.94 (0.92–0.96)], and vascular injury [0.52–0.16%, aOR 0.91 (0.85–0.98)] declined, but rates of acute kidney injury [0.15–0.68%, aOR 1.16 (1.08–1.25)] and infection [0.15–0.57%, aOR 1.07 (1.01–1.14)] increased over time. The overall 30-day mortality rate was low (0.11%) and unchanged [0.00–0.16%, aOR 0.99 (0.88–1.11)]. Conclusion: Despite a five-fold increase in AF ablations and the rising risk profile of patients, complications following AF ablation declined by 30% from 2008 to 2017 in ANZ. Procedure-related death was uncommon and occurred in less than 1 in 850 patients.

Objective To assess long term survival and patient characteristics associated with survival following acute myocardial infarction (AMI) in Australia and New Zealand. Design Cohort study. Setting...

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. 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. 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.

Population studies that provide unbiased estimates of gender differences in risk of complications following catheter ablation of atrial fibrillation (AF) are sparse. We sought to evaluate the association of female gender and risk of complications following AF ablation in a nationwide cohort. We identified 35 211 patients (29.5% females) undergoing AF ablations from 2008 to 2017 using national hospitalization data from Australia and New Zealand. The primary outcome was any procedural complication occurring up to 30-days after discharge. Logistic regression was used to adjust for differences in baseline characteristics between sexes. Compared with males, females were older (mean age 64.9 vs. 61.2 years), had higher rates of hypertension (14.0% vs. 11.6%) and haematological disorders (5.3% vs. 3.8%) and experienced a higher rate of procedural complications (6.96% vs. 5.41%) (all P < 0.001). This gender disparity remained significant after adjustment [odds ratio (OR) 1.25 (95% confidence interval 1.14–1.38), P < 0.001] and was driven by an increased risk of vascular injury [OR 1.86 (1.23–2.82), P = 0.003], pericarditis [OR 1.86 (1.16–2.67), P = 0.008], pericardial effusion [OR 1.71 (1.35–2.17), P < 0.001), and bleeding [OR 1.30 (1.15–1.46), P < 0.001]. Notably, the gender difference persisted over time [OR for the most recent period 1.19 (1.003-1.422), P = 0.046] despite a declining complication rate in both men and women. Females undergoing AF ablations experienced a 25% higher risk of procedural complications compared with males, a disparity that has persisted over time despite a falling complication rate. Efforts to reduce this gender disparity should focus on reducing the incidence of pericardial effusion, pericarditis, vascular injury, and bleeding.