A case report of vaping-associated sudden cardiac arrest in a young healthy patient.

Introduction and importance: While vaping has increased significantly among young individuals, the effects of vape aerosol constituents on cardiac electrophysiological dynamics remain unknown. Case presentation: A 22-year-old female with a history of energy vaping presented with cardiac arrest. Found to have no pulse, CPR was started and an initial rhythm of ventricular tachycardia was obtained. Shock was administered with a follow-up rhythm of ventricular fibrillation. She was emergently defibrillated and entered atrial fibrillation with rapid ventricular response. Toxicology and troponins were all negative. Left heart catheterization and cardiac MRI were unremarkable. She was discharged with an external defibrillation vest and a tentative plan for outpatient electrophysiology study in the setting of negative work-up for cardiopulmonary arrest. Clinical discussion: Vaping-induced sudden cardiac arrest may be attributed to a reduction in cardiac repolarization reserve. Exposure to vegetable glycerin and propylene glycol, substances present in nearly all vape products, have been found to incite arrhythmias and disrupt cardiac conduction in animals. Acrolein, an aldehyde byproduct of glycerin, has also been found to induce arrhythmias due to autonomic dysfunction. Increased intracellular calcium concentration and free radical damage, which occur as a result of inhaling particulate matter generated from e-cigarettes, further propagates the risk of arrhythmia. Conclusion: The effects of inhaling vape aerosols remain not fully understood. While there is a perceived notion that nicotine-free aerosols may be harmless, that remains unclear. Further studies are needed to evaluate proarrhythmogenic effects and autonomic dysfunction from the various chemical substances present in vape aerosols.

Percutaneous Coronary Intervention Versus Optimal Medical Therapy for Severe Ischemic Left Ventricular Systolic Dysfunction.

Coronary artery disease is the most common cause of heart failure, which is the leading cause of cardiovascular-related death worldwide. There are insufficient data to make strong recommendations for percutaneous coronary intervention (PCI) in patients with severe ischemic left ventricular systolic dysfunction (LVSD). In that context, we performed a meta-analysis to compare the outcomes of PCI with those of optimal medical therapy alone in patients with severe ischemic LVSD. A systematic search was conducted in PubMed, EMBASE, and ClinicalTrials.gov from inception to December 2023. Our outcome of interest was all-cause mortality in patients undergoing PCI vs medical therapy. We used random effects models to aggregate data and to calculate pooled incidence and relative risk with 95% CIs. Four studies including 2 randomized controlled trials with 2080 patients (PCI, 1082; optimal medical therapy, 998) were included. All-cause mortality did not differ significantly between the groups: 168 patients (15.5%) in the PCI group vs 200 patients (20.0%) in the optimal medical therapy group (relative risk, 0.88; 95% CI, 0.75-1.09; P=.25). In conclusion, the available evidence indicates that PCI does not improve all-cause mortality in patients with severe LVSD without lifestyle-limiting anginal symptoms. Further data are needed to identify subgroups of patients better served by each modality.

Impact of anemia on outcomes and resource utilization in patients with myocardial infarction: A national database analysis.

BACKGROUND: Although anemia is common in patients with myocardial infarction (MI), management remains controversial. We quantified the association of anemia with in-hospital outcomes and resource utilization in patients admitted with MI using a large national database. METHODS: All hospitalizations with a primary diagnosis code for acute MI in the National Inpatient Sample (NIS) between 2014 and 2018 were identified. Among these hospitalizations, patients with anemia were identified using a secondary diagnosis code. Data on demographic and clinical variables were collected. Outcomes of interest included in-hospital adverse events, length of stay (LOS), and total cost. Multivariable logistic regression and generalized linear models were used to evaluate the relationship between anemia and outcomes. RESULTS: Among 1,113,181 MI hospitalizations, 254,816 (22.8%) included concomitant anemia. Anemic patients were older and more likely to be women. After adjustment for demographics and comorbidities, anemia was associated with higher mortality (7.1 vs. 4.3%; odds ratio 1.09; 95% confidence interval [CI] 1.07-1.12, p < 0.001). Anemia was also associated with a mean of 2.71 days longer LOS (average marginal effects [AME] 2.71; 95% CI 2.68-2.73, p < 0.05), and $ 9703 mean higher total costs (AME $9703, 95% CI $9577-$9829, p < 0.05). Anemic patients who received blood transfusions had higher mortality as compared with those who did not (8.2% vs. 7.0, p < 0.001). CONCLUSION: In MI patients, anemia was associated with higher in-hospital mortality, adverse events, total cost, and length of stay. Transfusion was associated with increased mortality, and its role in MI requires further research.

Clinical Protocol for Selecting Intracardiac or Transesophageal Echocardiography-Guided Left Atrial Appendage Occlusion.

Intracardiac echocardiography (ICE) has emerged as an alternative to transesophageal echo (TEE) to guide left atrial appendage occlusion (LAAO). We established a protocol to select patients appropriate for ICE guidance. Patients who underwent LAAO with the Watchman or Watchman FLX device (Boston Scientific, Marlborough, Massachusetts) from January 2018 to March 2022 at a large United States center were included. The novel protocol prospectively selected TEE or ICE guidance beginning in January 2020; previous LAAO procedures were retrospectively included. ICE was selected for patients with uninterrupted anticoagulation and appropriate LAA anatomy, renal function, and moderate sedation tolerance. In-hospital outcomes with successful implantation without conversion to TEE guidance, no peridevice leak, and no procedural complications were compared. Composite 1-year outcome included freedom from peridevice leak, device-related thrombus, stroke, and all-cause mortality. A total of 234 patients were included; the mean age was 76.1 ± 8.3 years old, and 42.3% were female. ICE guidance was used for 63 procedures; TEE guidance was used for 171 procedures. For the composite outcome, ICE-guided LAAO was superior to TEE-guided LAAO (risk difference 0.102, 96.8% vs 86.5%, 95% confidence interval 0.003 to 0.203, p = 0.029). In comparison to the TEE-guided group, ICE-guided procedures were shorter (89.1 ± 26.3 vs 99.8 ± 30.0 min, p = 0.0087) with less general anesthesia (26.6% vs 98.8%, p <0.0001). One-year composite adverse outcomes did not differ significantly (80.7% vs 88.9%, p = 0.17). In conclusion, the protocol to select appropriate patients for ICE versus TEE guidance for LAAO is safe and effective. Larger studies are indicated to validate this approach to improve outcomes, shorten procedures, and avoid general anesthesia.

In-hospital safety outcomes of left atrial appendage occlusion in octogenarians and nonagenarians.

AIMS: Data on safety outcomes of left atrial appendage occlusion (LAAO) in elderly patients are limited. This study aimed to compare the outcomes of LAAO between octogenarians (age 80-89) and nonagenarians (age ≥90) vs. younger patients (age ≤79). METHODS AND RESULTS: We conducted a retrospective cohort study using the National Inpatient Sample database to identify patients hospitalized for LAAO from 2016 to 2020 and to compare in-hospital safety outcomes in octogenarians and nonagenarians vs. younger patients. The primary outcome was a composite of in-hospital all-cause mortality or stroke. Secondary outcomes included procedural complications, length of stay (LOS), and total costs. Outcomes were determined using logistic regression models. Among 84 140 patients hospitalized for LAAO, 32.9% were octogenarians, 2.8% were nonagenarians, and 64.3% were ≤79 years of age. Over the study period, the volume of LAAO increased in all age groups (all Ptrend < 0.01). After adjustment for clinical and demographic factors, octogenarians and nonagenarians had similar odds of in-hospital all-cause mortality or stroke [adjusted odds ratio (aOR) 1.41, 95% confidence interval (CI) 0.93-2.13 for octogenarians; aOR 1.69, 95% CI 0.67-3.92 for nonagenarians], cardiac tamponade, acute kidney injury, major bleeding, and blood transfusion, in addition to similar LOS and total costs compared with younger patients (all P > 0.05). However, octogenarians and nonagenarians had higher odds of vascular complications compared with younger patients (aOR 1.47, 95% CI 1.08-1.99 for octogenarians; aOR 1.60, 95% CI 1.18-2.97 for nonagenarians). CONCLUSION: Octogenarians and nonagenarians undergoing LAAO have a similar safety profile compared with clinically similar younger patients except for higher odds of vascular complications.

Approval, Evidence, and "Off-Label" Device Utilization: The Patent Foramen Ovale Closure Story.

BACKGROUND: Following regulatory approval, medical devices may be used "off-label." Patent foramen ovale (PFO) closure is indicated to reduce recurrent stroke but has been proposed for other indications, including migraine, transient ischemic attack, and diving decompression illness. We sought to evaluate PFO closure rates and indications relative to the timing of regulatory approval and publication of key randomized trials. METHODS: We performed a retrospective cohort study using the OptumLabs Data Warehouse of US commercial insurance enrollees from 2006 to 2019. We quantified PFO closure among individuals with ≥2 years of preprocedure coverage to establish indications, classified hierarchically as stroke/systemic embolism, migraine, transient ischemia attack, or other. RESULTS: We identified 5315 patients undergoing PFO closure (51.8% female, 29.2%≥60 years old), which increased from 4.75 per 100 000 person-years in 2006 to 6.60 per 100 000 person-years in 2019. Patients aged ≥60 years accounted for 29.2% of closures. Procedure volumes corresponded weakly with supportive clinical publications and device approval. Among patients with PFO closure, 58.6% underwent closure for stroke/systemic embolism, 10.2% for transient ischemia attack, 8.8% for migraine, and 22.4% for other indications; 17.6% of patients had atrial fibrillation at baseline; and 11.9% developed atrial fibrillation postprocedure. Those aged ≥60 years and male were less likely to undergo closure for migraine than stroke/systemic embolism. CONCLUSIONS: From 2006 to 2019, PFO closure use was consistently low and corresponded weakly with clinical trial publications and regulatory status. Nearly half of patients underwent PFO closure for indications unapproved by the Food and Drug Administration. Regulators and payers should coordinate mechanisms to promote utilization for approved indications to ensure patient safety and should facilitate clinical trials for other possible indications.

Safety and Efficacy of Combining Left Atrial Appendage Occlusion With Another Cardiac Procedure.

BACKGROUND: Clinical outcomes of left atrial appendage occlusion (LAAO) combined with other cardiac procedures have not been previously examined. OBJECTIVES: This study sought to evaluate the safety and efficacy of combining LAAO with other cardiac procedures vs isolated LAAO. METHODS: We conducted a retrospective cohort study using the 2016 to 2020 National Inpatient Sample database to compare patients undergoing LAAO combined with another cardiac procedure vs isolated LAAO. Outcomes included risk-adjusted major adverse cardiovascular events (MACEs), in-hospital mortality, major complications, length of stay (LOS), and total costs. RESULTS: The total cohort included 88,910 weighted encounters, of which 1,225 (1.4%) involved concomitant cardiac procedures. After risk adjustment, patients in the concomitant procedure group had similar odds of MACEs (adjusted OR: 1.82; 95% CI: 0.94-2.74); in-hospital mortality; and complications including stroke, acute kidney injury, major bleeding, blood transfusion, and vascular injury. They also had similar LOS (1 day vs 1 day; P = 0.32) and higher costs ($44,723 vs $32,364; P < 0.01) compared with isolated LAAO but shorter LOS (1 day vs 2 days; P < 0.01) and lower costs ($51,552 vs $63,170; P = 0.04) compared with LAAO with sequential procedures. In subgroup analyses, concomitant atrial fibrillation/atrial flutter ablation had higher adjusted odds of heart block (P < 0.01), and concomitant transcatheter aortic valve replacement had higher adjusted odds of stroke (P = 0.02) and vascular injury (P < 0.01). CONCLUSIONS: In this retrospective observational study, combining LAAO with another cardiac intervention appeared to be associated with similar MACEs and LOS. However, certain complications appeared to be more frequent, and the cost was higher with combined procedures.

An Endovascular- Versus a Surgery-First Revascularization Strategy for Chronic Limb-Threatening Ischemia: A Meta-Analysis of Randomized Controlled Trials.

Timely revascularization is essential for limb salvage and to reduce mortality in patients with chronic limb-threatening ischemia (CLTI). In patients who are candidates for endovascular therapy and surgical bypass, the optimal revascularization strategy remains uncertain. Recently published randomized controlled trials (RCTs) have presented conflicting results. We conducted a trial-level meta-analysis to compare the outcomes between endovascular-first and surgery-first strategies for revascularization. PubMed, Web of Science, and the Cochrane Library were searched to identify RCTs comparing the outcomes of endovascular-first versus surgery-first strategies for revascularization in patients with CLTI. Data were pooled for major outcomes and their aggregate risk ratios (RRs) with 95% confidence intervals were calculated using a random-effects model. Kaplan-Meier curves for amputation-free survival and overall survival time were plotted using the pooled aggregated data from published curves, with their corresponding hazard ratios (HRs) and 95% confidence intervals reported for up to 5 years of follow-up. A total of 3 RCTs with 2,627 patients (1,312 endovascular-first and 1,315 surgery-first) were included in the meta-analysis. Of these, 1,864 patients (70.9%) were men and 347 (13.2%) were older than 80 years. Comparing the endovascular-first and surgery-first approaches, there was no significant difference in the overall (HR 0.92 [0.83 to 1.01], p = 0.09) or amputation-free survival (HR 0.98 [0.92 to 1.03], p = 0.42), reintervention (RR 1.24 [0.74 to 2.07], p = 0.41), major amputation, (RR 1.16 [0.87 to 1.54], p = 0.31), or therapeutic crossover (RR 0.92 [0.37 to 2.26], p = 0.85). In conclusion, data from available RCTs suggest that there is no difference in clinical outcomes between endovascular-first and surgery-first revascularization strategies for CLTI. A planned patient-level meta-analysis may provide further insight.

Short duration of dual antiplatelet therapy following complex percutaneous coronary intervention: A systematic review and meta-analysis.

INTRODUCTION AND AIM: The optimal composition and duration of antiplatelet therapy after complex percutaneous coronary intervention (PCI) remains unclear. We conducted a meta-analysis to compare 1-3 months of dual antiplatelet therapy (DAPT) followed by monotherapy vs. 12 months of DAPT. METHOD: MEDLINE/PubMed, EMBASE, and Cochrane Central Register of Controlled Trials were queried for studies comparing 1-3 months of DAPT followed by monotherapy vs. 12 months of DAPT in the outcomes of complex PCI from inception through January 2023. Outcomes of interest included major bleeding, all-cause mortality, cardiovascular mortality, myocardial infarction (MI), stent thrombosis, target vessel revascularization, and stroke. RESULTS: Compared to 12 months, 1-3 months of dual antiplatelet therapy had a weak association with less major bleeding (OR 0.67; 95 % CI, 0.44-1.00; p = 0.05; I2 = 28 %). There were no significant differences between the shorter and longer antiplatelet therapy in terms of all-cause mortality (OR 0.83; 95 % CI, 0.59-1.16; p = 0.21; I2 = 17 %), cardiovascular mortality (OR 0.87; 95 % CI, 0.53-0.42; p = 0.50; I2 = 0), MI (OR 0.97; 95 % CI, 0.69-1.35; p = 0.82; I2 = 32 %), stent thrombosis (OR 1.17, 95 % CI, 0.77-1.76; p = 0.38; I2 = 0 %), target vessel revascularization (OR 1.05, 95 % CI, 0.58-1.89; p = 0.82; I2 = 64 %), or stroke (OR 1.10, 95 % CI, 0.55-2.17; p = 0.37; I2 = 7 %);. CONCLUSION: Among patients undergoing complex PCI, DAPT for 1-3 months may be associated with less major bleeding but similar rates of cardiovascular events (death, MI, stroke, stent thrombosis, and revascularization) compared to DAPT for 12 months.

Catheter-directed thrombolysis versus thrombectomy for submassive and massive pulmonary embolism: A systematic review and meta-analysis.

INTRODUCTION: Controversy surrounds the optimal therapy for submassive and massive pulmonary embolism (PE). We conducted a systematic review and meta-analysis to compare the outcomes of catheter-directed thrombolysis (CDT) versus surgical and catheter-based thrombectomy in patients with submassive and massive PE. METHODS: We searched PubMed, EMBASE, Cochrane, and Google Scholar for studies comparing outcomes of CDT versus thrombectomy in submassive and massive PE. Studies were identified and data were extracted by two independent reviewers. A random effects model was used to calculate risk ratios (RRs) with 95 % confidence intervals (CIs). Outcomes included in-hospital mortality, procedural complications, hospital and intensive care unit (ICU) length of stay (LOS), 30-day readmissions, and right ventricle/left ventricle (RV/LV) ratio improvement. RESULTS: Eight observational studies with 1403 patients were included, of whom 50.0 % received CDT. Compared to thrombectomy, CDT was associated with significantly lower in-hospital mortality (RR 0.62; 95 % CI 0.43-0.89; p = 0.01) and similar rates of major bleeding (p = 0.61), blood transfusion (p = 0.41), stroke (p = 0.41), and atrial fibrillation (p = 0.71). The hospital and ICU LOS, 30-day readmissions, and degree of RV/LV ratio improvement were similar between the two strategies (all p > 0.1). In subgroup analyses, in-hospital mortality was similar between CDT and catheter-based thrombectomy (p = 0.48) but lower with CDT compared with surgical thrombectomy (p = 0.01). CONCLUSIONS: In patients with submassive and massive PE, CDT was associated with similar in-hospital mortality compared to catheter-based thrombectomy, but lower in-hospital mortality compared to surgical thrombectomy. Procedural complications, LOS, 30-day readmissions, and RV/LV ratio improvement were similar between CDT and any thrombectomy. Randomized controlled trials are indicated to confirm our findings.

Safety and Efficacy of Cangrelor in Acute Coronary Syndromes: A Systematic Review and Network Meta-Analysis.

INTRODUCTION: Cangrelor is a potent intravenous non-thienopyridine P2Y12 inhibitor. We conducted a network meta-analysis to study the efficacy and safety of cangrelor as compared with the oral P2Y12 inhibition, clopidogrel, or placebo in acute coronary syndromes. METHODS: This meta-analysis followed the Cochrane collaboration guidelines and the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) protocols. Outcomes of interest included all-cause mortality, myocardial infarction, stent thrombosis, target vessel revascularization, major bleeding, minor bleeding, and the need for blood transfusion. RESULTS: The analysis was comprised of 6 studies including 26,444 patients treated with cangrelor, clopidogrel, or placebo. There were no statistically significant differences in the incidence of all-cause mortality, myocardial infarction, stent thrombosis, target vessel revascularization, or major bleeding. Cangrelor was associated with a higher risk of minor bleeding than clopidogrel or placebo, with no difference in requiring blood transfusion. CONCLUSION: Cangrelor has comparable outcomes to clopidogrel in patients with acute coronary syndromes and can be used as a reliable alternative in this population.

Restrictive or Liberal Transfusion Strategy in Myocardial Infarction and Anemia.

BACKGROUND: A strategy of administering a transfusion only when the hemoglobin level falls below 7 or 8 g per deciliter has been widely adopted. However, patients with acute myocardial infarction may benefit from a higher hemoglobin level. METHODS: In this phase 3, interventional trial, we randomly assigned patients with myocardial infarction and a hemoglobin level of less than 10 g per deciliter to a restrictive transfusion strategy (hemoglobin cutoff for transfusion, 7 or 8 g per deciliter) or a liberal transfusion strategy (hemoglobin cutoff, <10 g per deciliter). The primary outcome was a composite of myocardial infarction or death at 30 days. RESULTS: A total of 3504 patients were included in the primary analysis. The mean (±SD) number of red-cell units that were transfused was 0.7±1.6 in the restrictive-strategy group and 2.5±2.3 in the liberal-strategy group. The mean hemoglobin level was 1.3 to 1.6 g per deciliter lower in the restrictive-strategy group than in the liberal-strategy group on days 1 to 3 after randomization. A primary-outcome event occurred in 295 of 1749 patients (16.9%) in the restrictive-strategy group and in 255 of 1755 patients (14.5%) in the liberal-strategy group (risk ratio modeled with multiple imputation for incomplete follow-up, 1.15; 95% confidence interval [CI], 0.99 to 1.34; P = 0.07). Death occurred in 9.9% of the patients with the restrictive strategy and in 8.3% of the patients with the liberal strategy (risk ratio, 1.19; 95% CI, 0.96 to 1.47); myocardial infarction occurred in 8.5% and 7.2% of the patients, respectively (risk ratio, 1.19; 95% CI, 0.94 to 1.49). CONCLUSIONS: In patients with acute myocardial infarction and anemia, a liberal transfusion strategy did not significantly reduce the risk of recurrent myocardial infarction or death at 30 days. However, potential harms of a restrictive transfusion strategy cannot be excluded. (Funded by the National Heart, Lung, and Blood Institute and others; MINT ClinicalTrials.gov number, NCT02981407.).

Early Utilization of Mechanical Circulatory Support in Acute Myocardial Infarction Complicated by Cardiogenic Shock: The National Cardiogenic Shock Initiative.

BACKGROUND: Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is associated with significant morbidity and mortality. Mechanical circulatory support (MCS) devices increase systemic blood pressure and end organ perfusion while reducing cardiac filling pressures. METHODS AND RESULTS: The National Cardiogenic Shock Initiative (NCT03677180) is a single-arm, multicenter study. The purpose of this study was to assess the feasibility and effectiveness of utilizing early MCS with Impella in patients presenting with AMI-CS. The primary end point was in-hospital mortality. A total of 406 patients were enrolled at 80 sites between 2016 and 2020. Average age was 64±12 years, 24% were female, 17% had a witnessed out-of-hospital cardiac arrest, 27% had in-hospital cardiac arrest, and 9% were under active cardiopulmonary resuscitation during MCS implantation. Patients presented with a mean systolic blood pressure of 77.2±19.2 mm Hg, 85% of patients were on vasopressors or inotropes, mean lactate was 4.8±3.9 mmol/L and cardiac power output was 0.67±0.29 watts. At 24 hours, mean systolic blood pressure improved to 103.9±17.8 mm Hg, lactate to 2.7±2.8 mmol/L, and cardiac power output to 1.0±1.3 watts. Procedural survival, survival to discharge, survival to 30 days, and survival to 1 year were 99%, 71%, 68%, and 53%, respectively. CONCLUSIONS: Early use of MCS in AMI-CS is feasible across varying health care settings and resulted in improvements to early hemodynamics and perfusion. Survival rates to hospital discharge were high. Given the encouraging results from our analysis, randomized clinical trials are warranted to assess the role of utilizing early MCS, using a standardized, multidisciplinary approach.

The Emerging Role of Intracardiac Echocardiography (ICE) in Left Atrial Appendage Closure (LAAC).

PURPOSE OF REVIEW: Intracardiac echocardiography (ICE) has emerged as a powerful imaging tool to guide percutaneous left atrial appendage closure (LAAC). Herein, we review an imaging protocol for ICE-guided LAAC and discuss the evidence for its use. RECENT FINDINGS: Standardized imaging protocols have been proposed but have not been fully validated. ICE imaging yields similar procedural and clinical outcomes when compared to transesophageal echocardiography (TEE) to guide LAAC. Despite benefits of avoiding general anesthesia, TEE, and multiple physicians for LAAC procedures, ICE imaging remains under-utilized. Novel ICE catheters with 3D imaging capabilities may improve accuracy and efficiency of LAAC device implantation. ICE guidance is feasible, safe, and effective for LAAC. As the field evolves, further studies will be necessary to assess this technological advancement in imaging guidance.

Meta-Analysis of the Outcomes of Peri-Device Leak After Left Atrial Appendage Closure.

Left atrial appendage closure (LAAC) reduces the risk of thromboembolic stroke in atrial fibrillation. Peri-device leak (PDL) after LAAC may affect the subsequent risk of thromboembolism. We conducted a systematic review and meta-analysis to evaluate the effect of PDL after LAAC. We searched PubMed/Medline, Embase, and Google Scholar for studies reporting outcomes of PDL after LAAC from inception through October 2022. The primary outcome was the composite of stroke, transient ischemic attack (TIA), or systemic embolism (SE). Secondary outcomes included all-cause and cardiovascular mortality, ischemic stroke, TIA, and device-related thrombus. Outcomes were pooled using random-effects models. We used I2 statistics to assess statistical heterogeneity; I2 >50% considered significant heterogeneity. This study included 54,279 patients from 11 studies (6 observational, 2 nonrandomized controlled trials [non-RCTs] primary results, 2 RCT post hoc analyses, and 1 analysis combining 2 RCTs data). PDL was associated with a significant increase in the composite outcome of stroke, TIA, or SE (odds ratio 1.63, 95% confidence interval 1.06 to 2.52, p = 0.03, I2 = 43%) as compared with cases with no PDL. There were no significant differences in all-cause or cardiovascular mortality, ischemic stroke, TIA, or device-related thrombus. In conclusion, PDL after LAAC is associated with an increased risk of thromboembolism (composite stroke, TIA, or SE) without impacting mortality.

Infective Endocarditis Risk with Melody versus Sapien Valves Following Transcatheter Pulmonary Valve Implantation: A Systematic Review and Meta-Analysis of Prospective Cohort Studies.

BACKGROUND: Transcatheter pulmonary valve implantation (TPVI) is an effective non-surgical treatment method for patients with right ventricle outflow tract dysfunction. The Medtronic Melody and the Edwards Sapien are the two valves approved for use in TPVI. Since TPVI patients are typically younger, even a modest annual incidence of infective endocarditis (IE) is significant. Several previous studies have shown a growing risk of IE after TPVI. There is uncertainty regarding the overall incidence of IE and differences in the risk of IE between the valves. METHODS: A systematic search was conducted in the MEDLINE, EMBASE, PubMed, and Cochrane databases from inception to 1 January 2023 using the search terms 'pulmonary valve implantation', 'TPVI', or 'PPVI'. The primary outcome was the pooled incidence of IE following TPVI in Melody and Sapien valves and the difference in incidence between Sapien and Melody valves. Fixed effect and random effect models were used depending on the valve. Meta-regression with random effects was conducted to test the difference in the incidence of IE between the two valves. RESULTS: A total of 22 studies (including 10 Melody valve studies, 8 Sapien valve studies, and 4 studies that included both valves (572 patients that used the Sapien valve and 1395 patients that used the Melody valve)) were used for the final analysis. Zero IE incidence following TPVI was reported by eight studies (66.7%) that utilized Sapien valves compared to two studies (14.3%) that utilized Melody valves. The pooled incidence of IE following TPVI with Sapien valves was 2.1% (95% CI: 0.9% to 5.13%) compared to 8.5% (95% CI: 4.8% to 15.2%) following TPVI with Melody valves. Results of meta-regression indicated that the Sapien valve had a 79.6% (95% CI: 24.2% to 94.4%, p = 0.019; R2 = 34.4) lower risk of IE incidence compared to the Melody valve. CONCLUSIONS: The risk of IE following TPVI differs significantly. A prudent valve choice in favor of Sapien valves to lower the risk of post-TPVI endocarditis may be beneficial.