Heart

BackgroundPatients undergoing cardiac surgery face an increased risk of infective endocarditis (IE), a risk that may be further exacerbated by implantation of cardiac implantable electronic devices (CIED). This study aimed to assess the risk of IE after CIED implantation within 30 days of cardiac surgery and identify associated risk factors. MethodsAll patients in Sweden, with no previous CIED, who underwent first-time cardiac surgery between 2006 and 2020 were included in this nationwide registry-based study. Cox proportional hazards models adjusted for demographic and clinical covariates were used to estimate the association between CIED implantation and the risk of IE. ResultsOut of 73,367 patients, 2,302 (3.1%) received a CIED within 30 days. Over a median follow-up of 6.5 years (interquartile range, 3.2-10.1 years), 1,556 patients (2.1%) developed IE. CIED implantation was associated with an increased IE risk (adjusted Hazard ratio (aHR) 1.46; 95% confidence interval (CI) 1.20-1.77). Patients with IE had a significantly higher risk of mortality compared to those without IE (aHR 1.80; 95% CI 1.67-1.94; p<0.001). The type of cardiac surgery influenced IE risk, with valvular surgeries showing a higher incidence than coronary artery bypass grafting. Risk factors independently associated with IE included male sex, age at surgery, diabetes mellitus, and peripheral vascular disease. ConclusionsCIED implantation within 30 days after cardiac surgery is associated with an increased long-term risk of IE and subsequent mortality. The type of surgery and patient comorbidities influence the risk. CLINICAL PERSPECTIVE What is new?O_LIIn this large nationwide registry study, cardiac implantable electronic devices (CIEDs) placed within 30 days after cardiac surgery were associated with a substantial and persistent risk of infective endocarditis. C_LIO_LIThe risk of infective endocarditis was influenced by the type of cardiac surgery and patient-specific factors, rather than the timing of device implantation. C_LI What are the clinical implications?O_LIAmong post-cardiac surgery patients at elevated risk for infective endocarditis (e.g., those undergoing valvular procedures) who require a CIED, selecting devices associated with lower infection risk--such as leadless pacemakers or non-transvenous ICDs--may be a preferable strategy when appropriate. C_LIO_LIThe optimal timing of CIED implantation after cardiac surgery remains uncertain. When delaying implantation, the rationale should center on allowing for potential recovery of conduction abnormalities, rather than attempting to mitigate the risk of device-related infection. C_LI

BackgroundThe Covid-19 pandemic has affected human behaviour and burdened health systems and has thus had an impact on other health outcomes. ObjectiveThis paper studies whether there was a decrease in cardiac surgery operations in Greece during the first wave of the Covid-19 pandemic. Data and MethodsWe used data from 7 major hospitals that geographically cover about half the country and more than half the population, including a mix of public, private, military and childrens hospitals. We used a difference-in-differences econometric approach to compare trends in cardiac surgery before and after the pandemic in 2020, to the same months in 2019, controlling for seasonality and unemployment, and using hospital fixed effects. ResultsWe found that during the first wave of the pandemic and the associated lockdown, there were 35-56% fewer cardiac surgery operations compared to what we would have expected in the absence of the pandemic. ConclusionsThere was a steep decline in Cardiac surgery operations in Greece during the first wave of the Covid-19 pandemic. Possible reasons may include people not seeking medical attention to avoid the risk of catching Covid-19; fewer referrals; and working from home, thus not being exposed to a stressful work environment or commute.

BackgroundCardiac rehabilitation (CR) uptake for heart failure (HF) in the UK remains low at around 15%, with evidence of disparities based on sex, ethnicity, socioeconomic status, availability of staffing and financial constraints. We analysed data from the Pumping Marvellous Foundation online home CR programme to understand who accesses this service and whether inequities persist, to help guide strategies to achieve equitable rehabilitation delivery. MethodsThe PMF online home CR platform was launched in August 2024 along with an educational booklet available for order (at no cost) by HF or CR teams. We analysed anonymised data (n=673) of registrants from August 2024 to July 2025. Variables analysed included demographics, ethnicity, deprivation index, HF type based on ejection fraction, referral source, time since diagnosis and prior CR participation. We also analysed CR booklet orders and assessed correlation with HF admissions as per national HF audit data. Descriptive statistics summarised distributions. Results673 participants (median age 62 years; IQR 18 to 90 years, 12% aged >76 years) registered for the online CR classes from August 2024 to July 2025. The majority (63%) were women, and 6% were from minority ethnic communities. 35% of registrants had either mildly reduced (HFmrEF) or preserved (HFpEF) ejection fraction. 30% of referrals were from HF or CR teams, 29% obtained information via social media, and around 25% obtained information directly from PMF groups. There were also direct referrals from GPs (4%) and around 10% obtained referral information via Google search or YouTube. Analysis of the time since HF diagnosis demonstrated late entry to CR: 343 (51%) registered >12 months post-diagnosis, 88 (13%) within 3 months, and 130 (19%) within 6 to 12 months. Only 38 (6%) reported any prior CR participation. We also correlated CR booklet orders from hospitals with National HF Audit HF admissions. Within the limitations of the spread of the scatter, there was a general positive relationship: hospitals with more HF admissions tended to order more booklets. 33% of registrants came from the top 20 most deprived cities in England. ConclusionsBy providing free lifetime access to online cardiac rehabilitation, widening the access of cardiac rehab to more women and people without access to standard cardiac rehabilitation (due to staffing, cost constraints, accessibility issues) and reaching areas with socio-economic deprivation, the PMF online cardiac rehab platform can help to increase CR uptake and reduce the inequity in access to CR in the UK.

BackgroundAlthough morbidity and mortality from COVID-19 have been widely reported, the indirect effects of the pandemic beyond 2020 on other major diseases and health service activity have not been well described. MethodsAnalyses used national administrative electronic hospital records in England, Scotland and Wales for 2016-2021. Admissions and procedures during the pandemic (2020-2021) related to six major cardiovascular conditions (acute coronary syndrome, heart failure, stroke/transient ischaemic attack, peripheral arterial disease, aortic aneurysm, and venous thromboembolism) were compared to the annual average in the pre-pandemic period (2016-2019). Differences were assessed by time period and urgency of care. ResultsIn 2020, there were 31,064 (-6%) fewer hospital admissions (14,506 [-4%] fewer emergencies, 16,560 [-23%] fewer elective admissions) compared to 2016-2019 for the six major cardiovascular diseases combined. The proportional reduction in admissions was similar in all three countries. Overall, hospital admissions returned to pre-pandemic levels in 2021. Elective admissions remained substantially below expected levels for almost all conditions in all three countries (-10,996 [-15%] fewer admissions). However, these reductions were offset by higher than expected total emergency admissions (+25,878 [+6%] higher admissions), notably for heart failure and stroke in England, and for venous thromboembolism in all three countries. Analyses for procedures showed similar temporal variations to admissions. ConclusionThis study highlights increasing emergency cardiovascular admissions as a result of the pandemic, in the context of a substantial and sustained reduction in elective admissions and procedures. This is likely to increase further the demands on cardiovascular services over the coming years. Key QuestionWhat is the impact in 2020 and 2021 of the COVID-19 pandemic on hospital admissions and procedures for six major cardiovascular diseases in England, Scotland and Wales? Key FindingIn 2020, there were 6% fewer hospital admissions (emergency: -4%, elective: -23%) compared to 2016-2019 for six major cardiovascular diseases, across three UK countries. Overall, admissions returned to pre-pandemic levels in 2021, but elective admissions remained below expected levels. Take-home MessageThere was increasing emergency cardiovascular admissions as a result of the pandemic, with substantial and sustained reduction in elective admissions and procedures. This is likely to increase further the demands on cardiovascular services over the coming years.

BackgroundThere is no consensus on a risk threshold for sudden cardiac death (SCD) that could be used in practical design and evaluation of prediction models and decisions regarding implantable cardioverter-defibrillator (ICD) therapy. MethodsBaseline assumptions for a simulation framework were derived from previous randomized controlled trials (n=18) to identify minimal SCD risk threshold that would translate to mortality benefit by ICD therapy also considering the effect of competing non-sudden mortality. ICD efficacy to prevent SCDs and other data for simulations were estimated using inverse-variance weighted meta-analysis of included trials. Number needed to treat (NNT) was evaluated over a five-year horizon ([&le;]21 defined as clinically relevant). ResultsCorrelation analysis confirmed annual SCD incidence in trial populations as the key factor associating with ICD therapy effectiveness to reduce mortality (Pearsons r=0.653, p<0.01). In a simulation assuming 5% annual non-sudden mortality (pooled estimate of included RCTs) and a 56% (48-62%) efficacy for ICDs to reduce SCDs or similar events, 3% annual SCD risk ({approx}12% over five years) emerged as the lowest practical threshold even after controlling for excess (overlapping) mortality among those saved successfully from SCD by ICD therapy. The theoretical minimum threshold for annual SCD risk is 2.0%, 2.5% and 3.5% for populations with the annual incidence of non-sudden deaths 2%, 5% and 10% (assuming no overlapping mortality). ConclusionsEven under substantial competing risk, a 3% annual SCD threshold appears an optimal minimum threshold for identifying patients most likely to benefit from ICD therapy if severe mortality overlap is not observed. Key QuestionsWhat is the minimal risk threshold after which ICD therapy will likely lead to meaningful reduction in overall mortality. This information is needed in practical design of clinical trials and evaluation and development of prediction models Key FindingAnalysis of the data extracted from previous randomized controlled trials revealed that annual SCD risk should be at least 3% in most scenarios (with the annual incidence of non-sudden mortality [&le;]5%) for ICD therapy to be effective. Take-home MessagePrimary prevention SCD and risk models targeted to identify high-risk individual should aim for identifying patients with 3% or higher annual risk for SCD.

ObjectivesTo examine short-term primary causes of death after percutaneous coronary intervention (PCI) in a national cohort before and during COVID-19. BackgroundPublic reporting of PCI outcomes is a performance metric and a requirement in many healthcare systems. There are inconsistent data on the causes of death after PCI, and what proportion of these are attributable to cardiac causes. MethodsAll patients undergoing PCI in England between 1st January 2017 and 10th May 2020 were retrospectively analysed (n=273,141), according to their outcome from the date of PCI; no death and in-hospital, post-discharge, and 30-day death. ResultsThe overall rates of in-hospital and 30-day death were 1.9% and 2.8%, respectively. The rate of 30-day death declined between 2017 (2.9%) and February 2020 (2.5%), mainly due to lower in-hospital death (2.1% vs. 1.5%), before rising again from 1st March 2020 (3.2%) due to higher rates of post-discharge mortality. Only 59.6% of 30-day deaths were due to cardiac causes, the most common being acute coronary syndrome, cardiogenic shock and heart failure, and this persisted throughout the study period. 10.4% of 30-day deaths after 1st March 2020 were due to confirmed COVID-19. ConclusionsIn this nationwide study, we show that 40% of 30-day deaths are due to non-cardiac causes. Non-cardiac deaths have increased even more from the start of the COVID-19 pandemic, with one in ten deaths from March 2020 being COVID-19 related. These findings raise a question of whether public reporting of PCI outcomes should be cause-specific.

BackgroundDirect current cardioversion is frequently used to return patients with atrial fibrillation (AF) to sinus rhythm. Chest pressure during cardioversion may improve the efficacy of cardioversion through decreasing transthoracic impedance and increasing cardiac energy delivery. We aimed to assess the efficacy and safety of upfront chest pressure during direct current cardioversion for atrial fibrillation with anterior-posterior pad positioning. Design, Setting and ParticipantsThis was a multi-center, investigator-initiated, patient and analysis blinded, randomised clinical trial. Recruitment occurred from 2021 to 2023. Follow-up was until hospital discharge. Recruitment occurred across three centers in New South Wales, Australia. Inclusion criteria were age [&ge;]18, referred for cardioversion for AF, and anticoagulation for three weeks or transoesophageal echocardiography excluding left atrial appendage thrombus. Exclusion criteria were other arrhythmias requiring cardioversion, such as atrial flutter and atrial tachycardia. Intervention and OutcomesThe intervention arm received chest pressure during cardioversion from the first shock. The primary efficacy outcome was total joules required per patient encounter. Secondary efficacy outcomes included first shock success, transthoracic impedance, cardioversion success and sinus rhythm at 30 minutes post cardioversion. Results311 patients were randomised, 153 to control and 158 to intervention. There was no difference in total joules applied per encounter in the control arm versus intervention arm (356.4 {+/-} 301 vs 413.8 {+/-} 347, P=0.25). There was no difference in first shock success, total shocks provided, average impedance and cardioversion success. Conclusions and RelevanceThis study does not support the routine application of chest pressure for direct current cardioversion in atrial fibrillation. Reducing the complexity of cardioversion will improve the efficiency of the procedure for patients and healthcare systems. FundingNone to disclose Trial RegistrationACTRN12620001028998

BackgroundAim of this study was to test if oral anticoagulant (OAC) use in patients with heart failure (HF), accompanied by atrial fibrillation (AF), leads to a favorable outcome. Further, the specific impact of non-vitamin K oral anticoagulants (NOACs) is analyzed. MethodsAnonymous data from all patients with a health insurance at the largest entity which covers approximately 30% of the German population. Patients with a claims record for hospitalization with the main diagnosis of HF and AF from the years 2017 to 2019 were included. A hospital stay in the previous year was an exclusion criterion. Mortality and readmission for all-cause and stroke/intracranial bleeding (ICB) were analyzed 91-365 days after the index hospitalization. Kaplan-Meier survival curves and multivariable Cox regression models were used to evaluate the impact of medication on outcome. Results180,316 cases were included [81 years (IQR 76 to 86), 55.6% female, CHA2DS2-VASc score [&ge;] 2 (96.81%)]. In 80.6%, OACs were prescribed (vitamin K antagonists (VKA): 21.7%; direct factor Xa inhibitors (FXaI): 60.0%; direct thrombin inhibitors (DTI): 3.4%; with multiple prescriptions per patient included). The mortality rate was 19.1%, readmission rate was 29.9% and stroke/ICB occurred in 1.9%. Risk of death was lower with the any OAC (HR 0.77, 95% CI 0.75 to 0.79) but without significant differences in OAC type (VKA: HR 0.73, 95% CI 0.71 to 0.76; FXaI: HR 0.77, 95% CI 0.75 to 0.78; DTI: HR 0.71, 95% CI 0.66 to 0.77). The total readmission rate (HR 0.97, 95% CI 0.94 to 0.99) and readmission for stroke/ICB (HR 0.71, 95% CI 0.65 to 0.77) was lower with OAC. ConclusionsRoutine data confirm the positive effect of OACs in HF-AF. There are no additional benefits regarding mortality with the use of NOACs. Clinical PerspectiveO_ST_ABSWhat is new?C_ST_ABSO_LIThis routine data analysis on a study population of 180,316 indicates a decreasing mortality rate, 91 to 365 days after index hospital stay, in patients with HF complicated by AF in case oral anticoagulants (OACs) were prescribed. C_LIO_LISecondly, the findings imply no additional benefits of new OACs (NOACs) compared to vitamin K antagonists. C_LI What are the clinical implications?O_LIOur study highlights the benefits of a permanent oral anticoagulation therapy in patients with heart failure (HF) complicated by atrial fibrillation (AF). C_LIO_LIFor patients with HF and AF, the results indicate room for personalizationin choosing the specific OAC type for anticoagulation as NOACs show no survival benefit over vitamin K antagonists. C_LI

BackgroundPatients with atrial fibrillation (AF) have a high rate of all-cause mortality that is only partially attributable to vascular outcomes. While the competing risk of death may affect expected anticoagulant benefit, guidelines do not account for it. We sought to determine if using a competing risks framework materially affects the guideline-endorsed estimate of absolute risk reduction attributable to anticoagulants. MethodsWe conducted a secondary analysis of 12 RCTs that randomized patients with AF to oral anticoagulants or either placebo or antiplatelets. For each participant, we estimated the absolute risk reduction (ARR) of anticoagulants to prevent stroke or systemic embolism using two methods. First, we estimated the ARR using a guideline-endorsed model (CHA2DS2-VASc) and then again using a Competing Risk Model that uses the same inputs as CHA2DS2-VASc but accounts for the competing risk of death and allows for non-linear growth in benefit over time. We compared the absolute and relative differences in estimated benefit and whether the differences in estimated benefit varied by life expectancy. Results7933 participants had a median life expectancy of 8 years (IQR 6, 12), determined by comorbidity-adjusted life tables. 43% were randomized to oral anticoagulation (median age 73 years, 36% women). The guideline-endorsed CHA2DS2-VASc model estimated a larger ARR than the Competing Risk Model (median ARR at 3 years, 6.9% vs. 5.2%). ARR differences varied by life expectancies: for those with life expectancies in the highest decile, 3-year ARR difference (CHA2DS2-VASc model - Competing Risk Model 3-year risk) was -1.2% (42% relative underestimation); for those with life expectancies in the lowest decile, 3-year ARR difference was 5.9% (91% relative overestimation). ConclusionAnticoagulants were exceptionally effective at reduced stroke risk. However, anticoagulant benefits were misestimated with CHA2DS2-VASc, which does not account for the competing risk of death nor decelerating treatment benefit over time. Overestimation was most pronounced in patients with the lowest life expectancy and when benefit was estimated over a multi-year horizon.

BackgroundInternational guidelines recommend the use of a vitamin K antagonist (VKA, e.g. warfarin) for the first three months after mitral repair as a Class IIa recommendation with Level of Evidence C. High rates of atrial fibrillation, thrombogenicity of the non-endothelialised repair components, and high rates of antiplatelet resistance are cited as rationale. However, surveys of practice indicate that surgeon compliance is low, suggesting uncertainty of the evidence. We sought to establish the best current evidence by conducting a systematic review as a precursor to a randomised trial. MethodsWe included prospective randomised and retrospective observational studies of adult patients undergoing mitral valve repair with no other indications for anticoagulation. Studies had to compare a VKA to a non-vitamin K antagonist oral anticoagulants (NOAC), anti-platelet or placebo/null treatment ("Other"). Outcomes had to include thromboembolic complications, major bleeding or mortality within three months. The Cochrane Register, Medline, Embase and Clinical Trials Registries were checked. Risk of Bias assessments were conducted using the ROBINS-I tool as part of the GRADE Pro methodology. Quantitative synthesis was agreed following review of the methodology and a random effects model using the Mantel-Haenszel method employed. ResultsThere were no randomised controlled trials comparing VKA to other treatment strategies. Six observational studies comprising 5291 patients (2925 receiving VKA, 807 antiplatelet, 104 NOAC and 1455 null treatment) were included. Four studies reporting early thromboembolic risk found that the use of a VKA may not be associated with a reduction in risk (relative risk [RR] 0.54, 95% CI 0.13 - 2.35, p=0.41, I2 = 68%, overall certainty of evidence = very low). Three studies reporting late thromboembolism also showed that use of VKA may not be associated with risk reduction (RR 0.84, 95% CI 0.57 - 1.24, p=0.37, I2 = 23%). Two studies reported on early risks of major bleeding and found VKA treatment had very uncertain effects (RR 0.60, 95% CI 0.36 - 1.02, p=0.06, I2=0%, certainty of evidence = very low). Late bleeding reported by four studies was uncertain but seemed to show no risk reduction with VKA (RR 0.97, 95% CI 0.37 - 2.52, p=0.95, I2=73%). Three studies found an unclear effect of VKA use on early mortality (RR 0.39, 95% CI 0.10 - 1.51, p=0.17, I2=35%, certainty of evidence = low). Two studies comparing VKA with antiplatelets and no thromboprophylaxis respectively, showed there may be risk reduction in late mortality (RR 0.72, 95% CI 0.59 - 0.87, p=0.0006, I2=0%, certainty of evidence = very low), although this effect was weighted by a single study. ConclusionThere is insufficient good quality evidence to inform anticoagulation, anti-platelet or null treatment practices following mitral valve repair. A high-quality trial is therefore required in this setting, with particular methodological focus on aspects found to increase risk of bias in current studies. FundingThere was no funding for this systematic review. RegistrationThe review protocol was published in PROSPERO (CRD42021271198).

ImportanceTransparency and data sharing are valuable practices in research, contributing to improved precision and flexibility in cumulative evidence; and ultimately expanding the research ecosystem by addressing one of the philosophical research norms that implies that knowledge belongs to society. ObjectivesThe objective of the Reproducibility Policies In Cardiology Journals (REPLICA) study was to estimate the proportions of policies and guidance for reproducibility and transparency practices among Cardiology journals, as well as to determine details of completeness of reporting and data sharing conditions whenever disclosed. DesignCross-sectional analysis. SettingCross-sectional study through analyses of journals deposited in the National Library of Medicine (NLM) Catalog tagged with the "Cardiology" and "Vascular Diseases" entry terms. Eligibility CriteriaCardiology journals from the NLM Catalog database that published at least one randomized clinical trial in 2018. Journals that published articles in English, Spanish, French, or Portuguese and were available in MEDLINE/PubMed were eligible for inclusion. ExposuresThe exposures were mainly related to journals characteristics such as publisher operations characteristics (e.g., journal access only by subscription), indexation in the DOAJPlus, requirement for registration for RCTs, and others. Main outcomes and measuresWe prespecified a primary composite outcome composed of data-sharing policy or guidance. Secondary outcomes were proportions of reporting guidelines within the journals instructions for the authors section (e.g., CONSORT), and also other components of sharing practices. ResultsWe assessed 148 journals. Of them, 74 (50.0%, 95%CI 41.9% to 58.1%) presented policy or guidance for data sharing. We found guidance for data sharing in 68 journals (47.5% 95%CI 39.4% to 55.8%). Notably, among them, only two mentioned sharing individual participant data (IPD). Regarding guidelines for article reporting, we identified that 132 journals displayed guidance for authors, in which 27 (20.45%, 95%CI 14.34% to 28.29%) had CONSORT and EQUATOR Network guidance content. Conclusion and relevanceIn summary, we found a mild proportion of policies and guidance for data-sharing. Moreover, transparency practices inclined to RCTs are suboptimal, as mirrored by the very low prevalence of IPD data-sharing policy and guidance as well as specific reporting guidelines instructions for RCTs. Key PointsO_ST_ABSQuestionC_ST_ABSWhat is the proportion of journals displaying policies and guidance about data sharing in cardiology journals? FindingsWe found a low prevalence of policy and guidance for data sharing in Cardiology journals, as well as transparency and reproducibility practices; details, individual participant data sharing, registration, and completeness of reporting, for example. MeaningJournals play a role in driving reproducibility and transparency among scientific areas. Stakeholders involved in the editorial processes should be open to understand the valuable impact of data-sharing practices and learn how to implement such mechanisms, that being the case.

BackgroundPermanent pacemaker implantation (PPI) is required in up to 30% of patients following transcatheter aortic valve replacement (TAVR), mainly due to conduction disturbances. While transvenous pacemakers (TVPM) have traditionally been used, leadless pacemakers (LLPM) could improve outcomes and reduce complications, especially in high-risk populations. MethodsWe conducted a retrospective, observational, propensity-matched cohort study using the TriNetX Global Collaborative Network. Patients who underwent TAVR followed by single chamber PPI within 30 days were identified and divided into two groups: LLPM and TVPM. Those with pre-existing pacemakers or concomitant cardiac surgery were excluded. Propensity score matching (1:1) was performed on demographic, clinical, laboratory, echocardiographic, and medication variables. Clinical outcomes such as all-cause mortality, heart failure, atrial fibrillation, procedural and device-related complications during follow-up were assessed. Kaplan-Meier analyses and Cox proportional hazards models were used. ResultsAmong 1,425 identified patients (469 LLPM, 956 TVPM), 367 matched pairs were analyzed. At 5-year follow-up, there was no significant difference in all-cause mortality (27.2% LLPM vs. 29.4% TVPM; HR 1.07, 95% CI 0.81-1.40; p=0.637). LLPM was associated with a significantly lower incidence of heart failure (16.1% vs. 25.6%; HR 0.61, 95% CI 0.44-0.84; p=0.002). Atrial fibrillation during follow-up was lower in the LLPM group (18.0% vs. 25.6%; HR 0.69, 95% CI 0.50-0.95; p=0.018). Procedure and device-related complication rates were low and similar between groups. ConclusionsIn this large real-world cohort, LLPM was associated with a reduced risk of heart failure and atrial fibrillation compared to TVPM, without differences in overall mortality or safety. These data support considering leadless pacing in selected post-TAVR patients, although prospective randomized studies are required to confirm these findings. Clinical PerspectiveO_ST_ABSWhat Is KnownC_ST_ABSO_LIPermanent pacemaker implantation is frequent after transcatheter aortic valve replacement (TAVR) and may negatively impact outcomes through device related complications, pacing-induced dyssynchrony and tricuspid interference. C_LIO_LILeadless pacemakers eliminate transvenous leads and pockets, reducing the risk of lead-related and infectious complications. C_LI What the Study AddsO_LIIn this large real-world propensity-matched analysis, leadless pacemakers were associated with fewer heart failure and atrial fibrillation events compared with transvenous devices, without differences in mortality or procedural safety. C_LIO_LIThese findings support the use of leadless pacing as a safe and potentially morbidity-sparing option in selected post-TAVR patients. C_LI

ObjectivesTo provide a contemporary nationally representative assessment of atrial fibrillation (AF) and atrial flutter (AFL) expenditures in the United States. BackgroundAF prevalence is rising over time and management is evolving. However, there has been no contemporary national assessment of expenditures of AF. MethodsUsing Medical Expenditure Panel Survey (MEPS) 2016-2021 data, we identified individuals with AF or AFL using International Classification of Disease (ICD)-10 codes and reported total and categorized expenditures. Using two-part and gamma regression models, respectively, we estimated the incremental expenditures with AF for the entire population and for individuals with common coexisting comorbidities. Among individuals with AF, we identified characteristics associated with higher expenditures. ResultsOf a weighted surveyed population of 248,067,064 adults, 3,564,763 (1.4%) had AF. Mean age was 71.9 {+/-} 10.6 years and 45.7% were female. Mean unadjusted annual total healthcare expenditure for individuals with AF was $25,451 {+/-} $1,100 compared with $9,254 {+/-} $82 for individuals without AF. The highest spending categories were inpatient visits ($7,975 {+/-} $733) and prescriptions ($6,505 {+/-} $372). AF expenditures increased over the study period by 11.1%. After adjustment, the incremental annual expenditure attributable to AF was $6,188 per person. Incremental expenditures with AF were highest for those with cancer ($11,967, 95% CI $4,410 - $19,525), while AF did not significantly increase expenditures in HF (-$2,756, 95% CI -$10,048 - $4,535). Modified Charlson Comorbidity Index of 1 or [&ge;]2, uninsured status, cancer, poor income level, ASCVD, COPD, and later survey year were associated with higher expenditures. ConclusionAF is associated with substantial healthcare expenditures which are increasing over time. With changes in screening and management, expenditures need periodic reassessments. CONDENSED ABSTRACTO_ST_ABSIntroductionC_ST_ABSAF prevalence is rising, but contemporary national expenditure assessments are lacking. MethodsTwo-part and gamma regression models of MEPS 2016-2021 data (all-payer cross-sectional US survey) estimated AF effect on healthcare expenditures. ResultsOf 248,067,064 adults, 1.4% had AF, with mean age 72.1 years and 45.7% female. Mean unadjusted annual expenditure was $25,451 {+/-} $1,100 ($9,254 {+/-} $82 without AF). Incremental adjusted annual expenditure attributable to AF was $6,188. Modified CCI of 1 or [&ge;]2, uninsured status, cancer, poor income level, ASCVD, COPD, and later survey year were associated with higher expenditure. DiscussionAF expenditures are substantial and increasing.

IntroductionAtrial fibrillation-related stroke is a leading cause of morbidity and mortality. Options for prevention include left atrial appendage closure devices or oral anticoagulation. However, it remains unclear which option may be superior overall. MethodsWe conducted a systematic review and network meta-analysis of all clinical trials comparing the WATCHMAN, Amplatzer Amulet (Amulet), and/or OACs. The primary outcomes of interest were any stroke and all-cause death. Safety outcomes included any thromboembolism, device embolization, and pericardial effusion. We calculated risk ratios and heterogeneity statistics for each comparison, and calculated the probability of intervention superiority where at least one comparison was significant. ResultsThere were 441 articles identified from the search, from which 5 eligible RCTs were identified (n=1,811). Compared to OACs (all warfarin), risk of stroke was non-significantly decreased with WATCHMAN (RR=0.90, 95% CI: 0.48, 1.72, I2=13.4%), but risk with Amulet was non-significantly lower than WATCHMAN (RR=0.95, 95% CI: 0.50, 1.81). However, observed risk of all-cause death was significantly lower with Amulet than OAC (RR=0.53, 95% CI: 0.33, 0.85, I2=0%) and trended towards significance versus WATCHMAN (RR=0.74, 95% CI: 0.55, 1.02, p=0.06). The P-score was 0.982, signifying a >98% probability Amulet was superior to all alternatives. Risk of thromboembolism was non-significantly increased with WATCHMAN (RR=2.04, 95% CI: 0.23, 18.4) and Amulet (RR=1.54, 95% CI: 0.11, 22.1), with head-to-head comparison favoring Amulet (RR=0.76, 95% CI: 0.17, 3.38, I2=0%). Versus WATCHMAN, device embolization risk was non-significantly elevated with Amulet (RR= 2.38, 95% CI: 0.67, 8.43, I2=0%). Finally, risk of pericardial effusion was significantly elevated with Amulet versus OACs (RR=27.0, 95% CI: 3.48, 210) and versus WATCHMAN (RR=2.11, 95% CI: 1.41, 3.17, I2=0%). The inverse P-score for Amulet (0.9995) indicated a very high probability Amulet was inferior to alternatives. ConclusionWhile risk of some adverse events was greater with Amulet, we estimated >98% probability Amulet is superior to alternatives in risk of death. Pooled patient-level analyses are warranted.

Background and aimsEvidence of the impact of frailty on oral anticoagulant (OAC) prescription in older people with atrial fibrillation (AF) is conflicting. This study aimed to examine the prevalence of frailty in hospitalised older patients with AF and its relationship with OAC prescription during admission. The secondary aim was to examine the association between frailty and rate/rhythm control medication prescriptions. MethodsThis retrospective observational study included adults aged [&ge;]65 with AF admitted to six hospitals in Australia in 2022. Frailty was defined by a Frailty Index [&ge;]0.25. Logistic regression models were applied to examine the association between frailty and the prescriptions of OAC, rate-control and rhythm-control drugs during hospitalisation. Results are presented as odds ratios and 95% confidence intervals (CI). ResultsThere were 685 patients, with a mean age of 82.6(SD 8.3), 49.8% female and 42.8% identified as frail. Overall, 75.6% were prescribed OAC (67.9% in the frail versus 81.4% in the non-frail, p<0.001), 37.7% received rate-control drugs (42.0% in the frail versus 34.4% in the non-frail, p=0.044), 27.3% received rhythm-control drugs (22.9% in the frail versus 30.6% in the non-frail, p=0.024). The adjusted odds ratios of frailty on prescriptions were 0.58 (95% CI 0.39-0.86) for OAC, 1.75 (95%CI 1.22-2.52) for rate-control drugs, and 0.83 (95%CI 0.55-1.24) for rhythm-control drugs. ConclusionsThe study revealed a high prevalence of frailty in older inpatients with AF. Frailty was associated with reduced likelihood of prescription of OAC during admission and increased likelihood of prescribing rate-control medications, with no independent impact on rhythm-control therapy. Further studies are needed to understand these prescribing patterns.

BackgroundIn the last two decades, many new interventions have been introduced with the ultimate goal of improving overall postoperative outcomes after cardiac operations in adults. We aimed to assess how often randomized controlled trials (RCTs) in adult cardiac surgery found significant mortality benefits for newer interventions versus older ones, whether observed treatment effect estimates changed over time and whether RCTs and non-randomized observational studies gave similar results. MethodsWe searched journals likely to publish systematic reviews on adult cardiac surgery for meta-analyses of mortality outcomes and that included at least one RCT, with or without observational studies. Relative treatment effect sizes were evaluated overall, over time, and per study design. Results73 meta-analysis comparisons (824 study outcomes on mortality, 519 from RCTs, 305 from observational studies) were eligible. The median mortality effect size was 1.00, IQR 0.54-1.30 (1.00 among RCTs, 0.91 among observational studies, p=0.039). 4 RCTs and 6 observational studies reached p<0.005 favoring newer interventions. 2/73 meta-analyses reached p<0.005 favoring the newer interventions. Effect size for experimental interventions relative to controls did not change over time overall (p=0.64) or for RCTs (p=0.30), and there was a trend for increase in observational studies (p=0.027). In 34 meta-analyses with both RCTs (n=95) and observational studies (n=305), the median relative summary effect (summary effect in observational studies divided by summary effect in RCTs) was 0.87 (IQR, 0.55-1.29); meta-analysis of the relative summary effects yielded a summary of 0.93 (95% CI, 0.74-1.18). ConclusionsThe vast majority of newer interventions had no mortality differences over older ones both overall and in RCTs in particular, while benefits for newer interventions were reported more frequently in observational studies.

AimsTo determine national estimates for the percentage of all readmissions with demographic features, length of stay, cost analysis, comorbidities, overall and gender-specific mortality and complications of transcutaneous Tricuspid replacement/repair [TTVR] vs. open surgical tricuspid valve replacement/repair [Open TVR]. MethodsData was extrapolated from the NRD databases 2015-19. Of the 75,266,750 (unweighted) cases recorded in the 2015 - 2019 dataset, 429 had one or more of the percutaneous approach codes as per the ICD-10 data set, and 10077 had one or more of the open approach codes. ResultsOverall, the number of cases performed each year through open TVR was higher than TTVR, but there was an increased trend towards the TTVR every passing year. TTVR was performed more in females and advanced age groups than open TVR. The length of stay and cost was lower in the TTVR group than in open TVR. Patients undergoing TTVR had more underlying comorbidities like CHF, HTN, and uncomplicated DM. Overall mortality was 3.49 % in TTVR vs. 6.09% in open TVR. Gender-specific analysis demonstrated higher female mortality in the open TVR compared to TTVR (5.45% vs. 3.03 %). Male mortality was statistically insignificant between the two groups (6.8%% vs. 4.3%, p-value 0.15%). Patients with TTVR had lower rates of complications than open TVR, except for arrhythmias, which were higher in TTVR. Patients undergoing open TVR required more intracardiac support, such as IABP and Impella, than TTVR. ConclusionTranscatheter tricuspid valve replacement/repair is an emerging alternative to open surgical repair/replacement in patients with tricuspid valve diseases, especially tricuspid regurgitation. Despite having more underlying comorbidities, the TTVR group had lower in- hospital mortality, hospital cost, length of stay, and fewer complications than open TVR.

BackgroundHeart valve disease can result in high morbidity and impairment of quality of life (QOL) both before and after intervention. However, there are few descriptions of the QOL of people with heart valve disease across the disease course. AimsWe aimed to describe the QOL of people living with heart valve disease through qualitative interviews. MethodsSemi-structured interviews were conducted in people with heart valve disease, their family members, and clinical experts. A simple thematic analysis was used to summarise their perceptions of QOL. ResultsWe interviewed 34 people with heart valve disease: seven with aortic stenosis, seven with rheumatic heart disease involving the mitral valve, nine with mitral regurgitation, and 11 with valve replacement/repair (mean age 66, 56% female). Three family members and five clinical experts were also interviewed. A key contributor to QOL was fatigue: most participants experienced fatigue, even mild fatigue impaired QOL directly, and severe fatigue had devastating effects on quality of life. Physical limitations impaired QOL due to the loss of normal activity rather than objective physical limitation. Symptoms of heart valve disease impaired QOL directly, but the indirect effects of valve disease inspiring worry that reduced confidence and activity led to greater impairment. ConclusionsFatigue both before and after valve intervention is a contributor to QOL and requires further assessment. Research is recommended into whether fatigue is a specific enough symptom to warrant valvular intervention in heart valve disease.

ObjectiveThe aim of this study was to compare antithrombotic regimens following transcatheter aortic valve implantation (TAVI) in patients requiring long-term oral anticoagulation (OAC). MethodsWe systematically searched PubMed, Embase, and Cochrane databases for interventional and observational studies comparing OAC to OAC plus single antiplatelet therapy (SAPT). ResultsFive studies were included (four registry-based and one randomized controlled trial), comprising a total of 1318 patients. Our meta-analysis revealed lower rates of severe bleeding (pooled odds ratio [OR] 0.46 [0.31, 0.69], P<0.01, I2=0%) and major bleeding (pooled OR 0.46 [0.27,0.79], P<0.01, I2=0%) for the OAC group than for the OAC-plus-SAPT group. There was a nonsignificant trend towards reduced life-threatening bleeding events in the OAC group (pooled OR 0.54 [0.27,1.08], P=0.08, I2=11%). There was no difference between groups in the risks of stroke (pooled OR 1.02 [0.58,1.80], P=0.58, I2= 0%) or all-cause mortality (pooled OR 1.04 [0.75,1.42], P=0.83, I2= 0%) after TAVI. ConclusionsOur pooled analysis suggests that for patients with an indication for long-term OAC after TAVI, double anti-thrombotic therapy, compared to OAC alone, increased the risk of bleeding without reducing cerebrovascular events and all-cause mortality. Key questionsO_LIWhat is already known about this subject? Transcatheter Aortic Valve Implantation (TAVI) is a landmark techinique in interventional cardiology with growing clinical experience and continuous refinement of procedural techniques and devices. Nevertheless, the post-TAVI antithrombotic regimen guidelines are largely based on expert opinions and followed variably across the globe. C_LIO_LIWhat does this study add? Our pooled analysis suggests that for patients with an indication for long-term anticoagulation after TAVI, double anti-thrombotic therapy, compared to OAC alone, increased the risk of bleeding without reducing cerebrovascular events and all-cause mortality. C_LIO_LIHow might this impact on clinical practice? Our finding may prove insightful for future recommendations regarding the conundrum of the best antithrombotic strategy, particularly for patients with AF. C_LI

BackgroundIncidence and recurrence of atrial fibrillation (AF) is associated with several lifestyle risk factors. Lifestyle and risk factor modification (LRFM) clinics could have a role in comprehensively addressing AF from a holistic patient-centred approach to improve clinical outcomes. MethodsWe performed a systematic review and meta-analysis of randomised controlled trials (RCTs) evaluating the role of LRFM clinics compared with usual care (UC) in patients with AF. The primary endpoint was atrial arrhythmia recurrence. Secondary endpoints were AF and heart failure (HF) related hospitalisation, cardiovascular death, stroke or transient ischaemic attack (TIA), and quality-of-life (QOL). ResultsA total of eleven RCTs with a total of 3364 patients were included (five RCTs performed in the context of AF ablation). Mean age was 58-73 years, 30% were female and 18% had persistent AF. Duration of follow-up ranged from 3-24 months. LRFM clinics significantly reduced the primary endpoint of arrhythmia recurrence compared with UC after catheter ablation (OR 0.34, 95% CI 0.23-0.51, p<0.001, I2=0%). LRFM clinics also reduced AF-related hospitalisation (OR 0.70, 95%CI 0.51-0.98, p=0.04, I2=21%) and improved QOL (mean improvement on Short Form 36 Questionnaire 8.90, 95% CI 7.6.91-10.90, p<0.001). There was no difference between LRFM clinics and UC for HF-related hospitalisation (p=0.16), cardiovascular deaths (p=0.79) or stroke/TIA (p=0.83). ConclusionIn this meta-analysis of RCTs, LRFM clinics reduced AF recurrence after ablation, reduced AF-related hospitalisation and improved QOL. This study supports a comprehensive multidisciplinary lifestyle risk modification model of care to improve clinical outcomes in patients with AF.