Real-world evidence on the association between cardiac implantable electronic device infection and all-cause mortality.

AIMS: An infection following cardiac implantable electronic device (CIED) procedure is a serious complication, but its association with all-cause mortality is inconsistent across observational studies. To quantify the association between CIED infection and all-cause mortality in a large, contemporary cohort from New South Wales, Australia. METHODS AND RESULTS: This retrospective cohort study used linked hospital and mortality data and included all patients aged >18 years who underwent a CIED procedure between July 2017 and September 2022. Cardiac implantable electronic device infection was defined by the presence of relevant diagnosis codes. Cox regression to estimate adjusted hazard ratios (aHRs) with 95% confidence intervals (CIs) for the association of CIED infection with mortality, at 1-year, and at the end of follow-up, with CIED infection included as a time-dependent variable, and other potential risk factors for mortality included as fixed covariates. We followed 37,750 patients with CIED procedures {36% female, mean age [standard deviation (SD)] 75.8 [12.7] years}, and 487 (1.3%) CIED infections were identified. We observed 5771 (15.3%) deaths during an average follow-up of 25.2 (SD 16.8) months. Compared with no infection group, patients with CIED infection had a higher Kaplan-Meier mortality rate (19.4 vs. 6.8%) and adjusted hazard of mortality (aHR 2.73, 95% CI 2.10-3.54) at 12 months post-procedure. These differences were attenuated but still remained significant at the end of follow-up (aHR 1.83, 95% CI 1.52-2.19). CONCLUSION: In a complete, state-wide cohort of CIED patients, infection was associated with higher risks of both short-term and long-term mortality.

Post-Discharge Antithrombotic Therapy Following Transcatheter Aortic Valve Implantation in Australian Patients.

BACKGROUND: Guidelines recommend antithrombotic therapy for patients following transcatheter aortic valve implantation (TAVI) to reduce the risk of ischaemic events and bioprosthetic valve thrombosis. OBJECTIVE: To describe antithrombotic dispensing within 30 days of discharge for Australian patients receiving TAVI. METHODS: We performed a state-wide retrospective cohort study using linked hospital and medicines dispensing data from January 2013 to December 2018 for all patients receiving TAVI in New South Wales, Australia. We identified patients dispensed oral anticoagulants (vitamin K antagonists [warfarin], direct oral anticoagulants [DOACs]) or clopidogrel within 30 days of discharge. We examined demographic and clinical predictors of antithrombotic dispensing. RESULTS: Our cohort comprised 1,217 patients who underwent TAVI; median age was 84 years and 707 (58.1%) were male. Of these, 808 patients (66.4%) had an antithrombotic dispensed within 30 days of hospital discharge. One-third (33.7%) of these patients were dispensed an anticoagulant (16.1% warfarin; 17.6% DOACs) and two-thirds (66.3%) were dispensed clopidogrel. Patients undergoing TAVI were more likely to be dispensed an antithrombotic medicine within 30-days of hospital discharge if they had been dispensed antithrombotic medicines (RR 1.07; 95% CI 1.03-1.11) or angiotensin-converting-enzyme inhibitors/angiotensin II receptor blockers (RR 1.04; 95% CI 1.00-1.07) in the 6 months prior to admission. Patients with a history of haemorrhage were less likely to be dispensed an antithrombotic medicine within 30 days of hospital discharge (RR 0.93; 95% CI 0.89-0.98). CONCLUSIONS: We observed gaps in best evidence pharmacotherapy for patients post-TAVI, with almost one third of patients not receiving antithrombotic medicines post-discharge. Further research is needed to quantify the impact of emerging clinical guidelines recommending single antiplatelet therapy, on adherence to best-practice care.

Comparison of long-term outcomes of bioprosthetic and mechanical aortic valve replacement in patients younger than 65 years.

OBJECTIVES: The objectives of this study were to compare rates of mortality and reoperations for patients aged younger than 65 years who underwent surgical aortic valve replacement (AVR). AVR with a bioprosthetic valve (BV) is increasing among younger patients, however evidence to inform the choice between BV or mechanical valve is limited. METHODS: We performed a retrospective cohort study using linked hospital and mortality data from Australia, for 3969 AVR patients between 2003 and 2018. We compared outcomes for valves in inverse probability of treatment-weighted cohorts, stratified according to age (18-54 years; 55-64 years). We used weighted Cox regression models to estimate hazard ratios (HRs) and weighted cumulative incidence function for subdistribution hazards, for follow-up intervals: 0 to 10 and >10 to 15 years. RESULTS: Among patients aged 55 to 64 years, there was no difference in mortality at 0 to 10 years. However, at >10 to 15 years, mortality was higher among BV recipients (HR, 1.56; 95% CI, 1.01-2.42). There was no difference among patients aged 18 to 54 years. Reoperation rates for patients aged 55 to 64 years did not differ according to valve type at 0 to 10 years, but were higher for BV than mechanical valve at >10 to 15 years (HR, 2.87; 95% CI, 1.69-4.86). For patients aged 18 to 54 years, reoperation rates were consistently higher for BV at both time intervals (HR, 2.54 [95% CI, 1.03-6.25] and HR, 4.48 [95% CI, 2.15-9.32], respectively). CONCLUSIONS: Patients aged 55 to 64 years who received a BV had a higher risk of mortality beyond 10 years. Rates of reoperations were higher among patients implanted with a BV in the entire cohort. Further investigation of long-term outcomes among patients with a BV is necessary. Continuous long-term monitoring of BV technologies will ensure evidence-based decision-making and regulation.

Age-stratified outcomes of bioprosthetic and mechanical aortic valve replacements in an Australian cohort of 13 377 patients.

OBJECTIVES: To quantify age-stratified outcomes of bioprosthetic valve (BV) and mechanical valve (MV) surgical aortic valve replacement (AVR) in Australian patients. DESIGN: Retrospective cohort study using population-based linked hospital morbidity and mortality data. SETTING: Public and private hospitals. PARTICIPANTS: Patients aged 18 years and over undergoing AVR from 2001 to 2013, stratified by age (18-64 years; 65+ years). MAIN OUTCOME MEASURES: Age-standardized index AVR rates; rates and multivariable-adjusted (age, sex, Charlson Comorbidity Index) incidence rate ratios (IRRs) for reoperation, incident cardiovascular events (hospitalization or death for acute myocardial infarction (AMI), stroke, major hemorrhage or thromboembolism) and mortality (cardiovascular and all-cause). RESULTS: Our cohort comprised 13 377 patients, of whom 3464 (26%) were aged 18-64 years. Annual age-standardized AVR rates increased by 2.7% with BV implants increasing in both age groups. After 5 years of follow-up, patients implanted with BV had lower rates of stroke (IRR: 0.40, 95% CI 0.27 to 0.60) and hemorrhage (IRR: 0.36, 95% CI 0.26 to 0.50). Among patients 65+ years, those implanted with BV had lower rates of AMI, hemorrhage, and cardiovascular and all-cause mortality than those implanted with MV (IRR: 0.71, 95% CI 0.53 to 0.96; IRR: 0.77, 95% CI 0.62 to 0.95; IRR: 0.80, 95% CI 0.69 to 0.92 and IRR: 0.85, 95% CI 0.74 to 0.97, respectively). After 6-10 years of follow-up, reoperation rates among patients 18-64 years were markedly higher in those implanted with BV compared with MV (IRR: 5.48, 95% CI 2.38 to 12.62) and rates of AMI were lower among patients implanted with BV compared with MV (IRR: 0.49, 95% CI 0.26 to 0.94). Among patients 65+ years rates of cardiovascular and all-cause mortality remained significantly lower for patients implanted with BV compared with MV. CONCLUSIONS: This study provides real-world evidence of AVR use and outcomes. Use of BV implants is increasing irrespective of age. Valve choice in younger patients requires thorough evaluation of patient factors influencing both short-term outcomes and longer-term risks of reoperation, stroke and hemorrhage.