Catheter-related and clinical complications associated with QDOT MICROTM Ablation Catheter.

INTRODUCTION: The QDOT MICROTM Ablation Catheter is a next-generation ablation catheter that allows for high-power ablation up to 90 watts. METHODS: We aimed to assess AE associated with the QDOT MICROTM catheter using the MAUDE database. A MAUDE database search was conducted on May 25, 2024, to capture all AEs (since FDA approval) associated with this ablation catheter. RESULTS: A total of 302 AEs from November 23, 2022, to April 30, 2024, were reported including 148 (49%) catheter-related issues and 154 (51%) clinical complications. Among the catheter-related issues, physical catheter damage (74.3%, n = 110) was most common, followed by communication or display issue (10.8%, n = 16), irrigation issue (9.5%, n = 14), signal issue or artifact (3.4%, n = 5), and inaccurate temperature measurement (2.0%, n = 3). Regarding clinical complications, the most common AE was pericardial effusion (43.5%, n = 67), followed by char formation (11.7%, n = 18), catheter thrombosis (7.1%, n = 11), stroke (7.1%, n = 11), pericarditis (7.1%, n = 11), esophageal complications (6.5%, n = 10), phrenic nerve palsy (3.9%, n = 6), cardiac arrest (3.9%, n = 6), significant AV block (3.9%, n = 6), pulmonary vein stenosis (3.2%, n = 5), coronary artery spasm (1.3%, n = 2), and pulmonary embolism (0.6%, n = 1). There were 11 deaths (five related to esophageal complications, five related to cardiac arrest, and one related to pericardial effusion with cardiac tamponade). CONCLUSION: As high-power ablation strategy with novel ablation catheters is becoming more widely utilized, operators must be aware of potential catheter-related issues and clinical complications that may arise. More data are needed to further evaluate risks of these complications to improve the catheter's safety and efficacy.

The diagnostic yield for computed tomography pulmonary angiography in patients with anticoagulation.

BACKGROUND: Patients who present to the emergency department (ED) for suspected pulmonary embolism (PE) are often on active oral anticoagulation (AC). However, the diagnostic yield of computed tomography pulmonary angiography (CTPA) in screening for PE in patients who present on AC has not been well characterized. We aim to investigate the diagnostic yield of CTPA in diagnosing PE depending on AC status. METHODS: We reviewed and analyzed the electronic medical records of patients who underwent CTPA for PE at a university hospital ED from June 1, 2019, to March 25, 2022. Primary outcome was the incidence of PE on CTPA depending on baseline AC status and indication for AC. RESULTS: Of 2,846 patients, 242 were on AC for a history of venous thromboembolism (VTE), 210 were on AC for other indications, and 2,394 were not on AC. The incidence of PE on CTPA was significantly lower in patients on AC for other indications (5.7%) when compared to patients on AC for prior VTE (24.3%) and patients not on AC at presentation (9.8%) (P<0.001). In multivariable analysis among the whole cohort, AC was associated with a positive CTPA (odds ratio [OR] 0.26, 95% confidence interval [CI]: 0.15-0.45, P<0.001). CONCLUSION: The incidence of PE among patients undergoing CTPA in the ED is lower in patients previously on AC for indications other than VTE when compared to those not on AC or those on AC for history of VTE. AC status and indication for AC may affect pre-test probability of a positive CTPA, and AC status therefore warrants consideration as part of future diagnostic algorithms among patients with suspected PE.

Urate-lowering therapy is associated with a reduced risk of arrhythmias: a systematic review and meta-analysis.

Objective: While urate-lowering therapy (ULT) is linked to increased cardioprotective benefits on primary prevention of cardiovascular events such myocardial infarction or heart failure, little is known regarding their effects on arrhythmia risk. The purpose of this study was to investigate the relationship between incident arrhythmias and ULT. Methods: We searched MEDLINE and Embase from inception to May 2023. Included studies were randomized controlled trials and cohort studies that compared the risk of cardiac arrhythmias among ULT users with non-ULT users. Results: A total of 12,420 patients from five studies were analyzed, comprising 7,359 subjects in the ULT group and 5,061 subjects in the non-ULT group. Our results showed that ULT users had significant reductions in the risk of arrhythmias (pooled relative risk [RR] 0.82, 95% confidence interval [CI] 0.74~0.92, p<0.001, I2=0.0%) compared to non-ULT users. Subgroup analysis did not show that ULT users had a significant reduced risk of atrial fibrillation (pooled RR 0.76, 95% CI 0.54~1.05, p=0.096 with I2=15.4%) compared to non-ULT users. Conclusion: ULT is associated with lower risk of overall arrhythmias. Further studies are warranted to confirm our findings.

New-generation electronic appliances and cardiac implantable electronic devices: a systematic literature review of mechanisms and in vivo studies.

INTRODUCTION: Cardiac implantable electronic device (CIED) functions are susceptible to electromagnetic interference (EMI) from electromagnetic fields (EMF). Data on EMI risks from new-generation electronic appliances (EA) are limited. OBJECTIVE: We performed a systematic literature review on the mechanisms of EMI, current evidence, and recently published trials evaluating the effect of EMF on CIEDs from electric vehicles (EV), smartphone, and smartwatch technology and summarize its safety data. METHODS: Electronic databases, including PubMed and EMBASE, were searched for in vivo studies evaluating EMF strength and incidence between CIEDs and commercial EVs, new-generation smartphones, and new-generation smartwatches. RESULTS: A total of ten studies (three on EVs, five on smartphones, one on smartphones, one on smartphones and smartwatches) were included in our systematic review. There was no report of EMI incidence associated with EVs or smartwatches. Magnet-containing smartphones (iPhone 12) can cause EMI when placed directly over CIEDs - thereby triggering the magnet mode; otherwise, no report of EMI was observed with other positions or smartphone models. CONCLUSION: Current evidence suggests CIED recipients are safe from general interaction with EVs/HEVs, smartphones, and smartwatches. Strictly, results may only be applied to commercial brands or models tested in the published studies. There is limited data on EMI risk from EVs wireless charging and smartphones with MagSafe technology.

Temporal Trends in Substance Use and Cardiovascular Disease-Related Mortality in the United States.

BACKGROUND: There are limited data on substance use (SU) and cardiovascular disease (CVD)-related mortality trends in the United States. We aimed to evaluate SU+CVD-related deaths in the United States using the Centers for Disease Control and Prevention Wide-Ranging, Online Data for Epidemiologic Research database. METHODS AND RESULTS: The Multiple Cause-of-Death Public Use record death certificates were used to identify deaths related to both SU and CVD. Crude, age-adjusted mortality rates, annual percent change, and average annual percent changes with a 95% CI were analyzed. Between 1999 and 2019, there were 636 572 SU+CVD-related deaths (75.6% men, 70.6% non-Hispanic White individuals, 65% related to alcohol). Age-adjusted mortality rates per 100 000 population were pronounced in men (22.5 [95% CI, 22.6-22.6]), American Indian or Alaska Native individuals (37.7 [95% CI, 37.0-38.4]), nonmetropolitan/rural areas (15.2 [95% CI, 15.1-15.3]), and alcohol-related death (9.09 [95% CI, 9.07 to 9.12]). The overall SU+CVD-related age-adjusted mortality rates increased from 9.9 (95% CI, 9.8-10.1) in 1999 to 21.4 (95% CI, 21.2-21.6) in 2019 with an average annual percent change of 4.0 (95% CI, 3.7-4.3). Increases in SU+CVD-related average annual percent change were noted across all subgroups and were pronounced among women (4.8% [95% CI, 4.5-5.1]), American Indian or Alaska Native individuals, younger individuals, nonmetropolitan areas, and cannabis and psychostimulant users. CONCLUSIONS: There was a prominent increase in SU+CVD-related mortality in the United States between 1999 and 2019. Women, non-Hispanic American Indian or Alaska Native individuals, younger individuals, nonmetropolitan area residents, and users of cannabis and psychostimulants had pronounced increases in SU+CVD mortality.

Periodontal disease and risk of atrial fibrillation or atrial flutter: A systematic review and meta-analysis.

Background: We conducted a study to evaluate the risk of atrial fibrillation (AF) and atrial flutter (AFL) in periodontal disease (PD) patients. Methods: Cohort studies that evaluate the risk of AF or AFL in PD patients were included. The risk was expressed in the pooled odd ratio (OR) with 95% confidence interval (CI). Results: A total of four cohort studies were included. We found that patients with PD have a significantly higher risk of AF/AFL compared to those without PD with the pooled OR of 1.33 (95% CI 1.29-1.38; p = 0.357, I 2 = 3.0%). Conclusions: PD increases the risk of AF and AFL.

Intravenous Iron for Heart Failure: Updated Systematic Review and Meta-Analysis.

While the administration of intravenous (IV) iron to those with heart failure has been implicated to be associated with a possible reduction in hospitalizations and improvement in symptoms, a recent large multicenter trial only showed modest benefits in reducing hospitalization, necessitating the updated systematic review. We conducted a systematic review and meta-analysis, searching the MEDLINE and EMBASE database until January 9, 2023. Outcomes included total heart failure hospitalizations, first heart failure hospitalization, six-minute walk test (6MWT) distance, and incidence of infection. There were 13 studies with 3410 participants (1,790 with IV iron). Pooled analysis that reported the incidence of cardiovascular death showed that patients with IV iron did not have significantly lower odds of cardiovascular death or first heart failure hospitalization. In contrast, those who received IV iron had significantly lower total heart failure hospitalization (pooled odds ratio (OR) 0.63, 95% confidence interval (CI) 0.44-0.90, I2 59.0%, P = .017) and a composite of cardiovascular death and first heart failure hospitalization (pooled OR 0.55, 95% CI 0.47-0.64, I2 0%, P = .656). While the efficacy is modest, IV iron therapy could be associated with reduced hospitalization for heart failure without significant adverse events.

Racial and Ethnic Disparities in Patients Who Underwent Leadless Pacemaker Implantation.

Evidence regarding racial disparities in leadless pacemaker (LP) utilization and outcomes is limited. We aimed to explore ethnicity-based disparities in LP utilization and clinical outcomes of patients who underwent LP implantation. All consecutive patients who underwent LP between January 2019 and January 2023 at our institution were included. Charts were reviewed for baseline characteristics and clinical outcomes. The primary outcomes were procedure-related complications, cardiac rehospitalization, worsening heart failure (HF) or HF hospitalization, and all-cause mortality. All statistical analyses were performed using SPSS Statistics 22 (IBM Corp., Armonk, NY). The p <0.05 was considered statistically significant. A total of 196 adult patients underwent LP implantation during the study period (48% Caucasians, 36.2% Hispanic, 8.2% Asians, and 7.7% African-American). The groups were balanced with respect to baseline demographics, clinical characteristics, and procedure-related complications. During the median follow-up of 104 days (interquartile range 24 to 382), no statistically significant differences were observed in worsening HF or HF hospitalization or all-cause mortality among the ethnic groups. After multivariable logistic regression, Asian individuals had higher odds of cardiac readmissions (odds ratio 4.1, 95% confidence interval 1.4 to 12.3, p = 0.01). Patients from racial and ethnic minorities face significant inequities in arrhythmia care, including patients who have undergone LP implantation. Awareness and a system-based approach (understanding cultural preferences, effective application of evidence-based guidelines, and population-based policies) are crucial to lessen disparities in health care among minorities.

The missing vector - TactiFlex sensor enabled ablation catheter.

New ablation catheters have continuously developed to improve the safety and efficacy of ablation procedures. The TactiFlex Ablation Catheter Sensor Enabled (Abbott, Minneapolis, MN) is a novel open-irrigation radiofrequency ablation catheter that has contact force-sensing technology and flexible tip, allowing real-time contact force assessment with directionality. This case report reported a loss of contact force vector and directionality with the TactiFlex SE ablation catheter during de novo atrial fibrillation (AF) ablation.

Adverse events associated with amplatzer left atrial appendage occlusion delivery system: A Food and Drug Administration MAUDE database study.

BACKGROUND: Dual occlusive closure mechanism (disc and lobe type), Amulet device (Abbott; a second-generation device that has replaced Amplatzer Cardiac Plug) was approved by the Food and Drug Administration (FDA) in August 2021 for percutaneous left atrial appendage occlusion (LAAO). However, real-world safety data on the delivery system (Amplatzer Cardiac Plug and Amplatzer Amulet device) are lacking. OBJECTIVE: We sought to assess the type of adverse events associated with the Amplatzer LAAO delivery system using the FDA Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: A MAUDE database search was conducted on March 31, 2023, for reports received between February 2013 and March 2023 to capture all adverse events. RESULTS: A total of 59 adverse events were reported, of which 58 were sheath-related events, and one was a wire-related event. The most commonly encountered issue was air embolism (19%, 11 events), followed by sheath thrombosis (13.8%, eight events, two of which were also associated with device thrombosis), kinked sheath (10.3%, six events), and sheath deformation (8.6%, five events). Patient-related adverse events included pericardial effusion requiring pericardiocentesis (22.4%, 13 events), vascular complications (20.7%, 12 events), and device dislodgement (5.2%, three events). CONCLUSION: LAAO-related adverse events are increasingly being reported using the Amplatzer LAAO delivery sheath. It is anticipated that improvements in device technology, the advent of steerable sheaths, and operator experience will minimize these complications.

The risk of new heart failure associated with protease inhibitor: Systematic scoping review.

BACKGROUND: Protease inhibitors (PIs) have contributed to the long-term survival of persons with human immunodeficiency virus (PHIV). While there is a concern linking protease inhibitors to an increased risk of heart failure (HF), the evidence linking protease inhibitors and heart failure has been uncertain. METHODS: Following the PRISMA Extension for Scoping Reviews, we searched MEDLINE and EMBASE for peer-reviewed articles using keywords including "protease inhibitor," "heart failure," and "human immunodeficiency virus" from their inception to December 21, 2022. RESULTS: Five articles, including three observational studies and two randomized controlled trials, were included in the review. While protease inhibitors seem to be associated with atherosclerotic cardiovascular disease through their effects on metabolic markers, there is scarce evidence suggesting a direct association between protease inhibitors and heart failure. Although one study showed a possible correlation between protease inhibitor use and lower left ventricular ejection fraction and increased heart failure admission, the results were subject to confounders, and participants had poor medication adherence. CONCLUSION: Although current data are conflicting, there could be an association between PIs and HF in PHIV. Future prospective studies are warranted to evaluate the incidence of heart failure stratified on the generation of PIs and with adjustment for other metabolic risk factors.

High sensitivity C reactive protein levels and atrial fibrillation recurrence after catheter ablation for atrial fibrillation: A systematic review and meta-analysis.

Background: Atrial fibrillation (AF) recurrence after AF ablation is not uncommon. High sensitivity C reactive protein (hs-CRP) is a widely used inflammatory marker with a potential property to predict AF recurrence. We conducted a systematic review and a meta-analysis to find an association between hs-CRP levels and AF recurrence after ablation. Methods: We searched PubMed, Embase, and Wiley-Cochrane Library from inception to January 2022 for studies that reported hs-CRP levels in patients who underwent AF ablation. Weighted mean difference (WMD) was used to evaluate the difference between hs-CRP levels in post-ablation AF recurrent and non-recurrent group. Also, the difference between hs-CRP levels in pre- and post-ablation was determined. Results: We identified 10 studies, and a total of 789 patients were included (299 recurrent vs. 490 non-recurrent patients). The mean age was 57.7 years (76.4% male). There was no difference in baseline hs-CRP levels between AF recurrent and non-recurrent group (WMD = 0.05, 95% CI = -0.04 to 0.15, p = 0.045). However, higher hs-CRP levels post-ablation were found in AF recurrent group (WMD = 0.09, 95% CI = 0.03-0.15, p < 0.001). Conclusion: There is no significant difference in baseline hs-CRP levels between AF recurrent and non-recurrent patients after AF ablation. However, higher post-ablation hs-CRP level was found in AF recurrent group. High Sensitivity C reactive protein may play a role as a predictor of AF recurrence.

Myocardial Contraction Fraction is not a Predictor of Clinical Outcomes in Acute Systolic Heart Failure: A Brief Report.

Introduction: The utility of myocardial contraction fraction (MCF), a volumetric measure of myocardial shortening, has not been well evaluated in patients with systolic heart failure (SHF). Materials and Methods: A single-center, retrospective cohort study of all adults admitted with acute SHF from 2013 to 2018 at an academic medical center. A chart review was performed to identify key echocardiographic transthoracic echocardiogram (TTE), laboratory, and demographic characteristics. MCF was calculated based on M-mode measurements of estimated stroke volume and myocardial volume based on admission TTE. The primary outcome was 30-day combined all-cause readmission/mortality and 365-day all-cause mortality. Results: A total of 1282 patients were analyzed. The 30-day composite outcome occurred in 310 patients (24.2%), and all-cause death at 365 days occurred in 375 patients (29.3%). There was a weak correlation between the visually estimated ejection fraction (EF) and MCF (r = 0.356, P < 0.001). Neither MCF nor EF was associated with either component of the primary outcome. Other parameters on TTE that were associated with higher risk of primary outcome were higher tricuspid regurgitation (TR) velocity, larger left atrial (LA) diameter, and moderate or greater TR and mitral regurgitation (MR). Conclusion: Echocardiographic predictors of postdischarge adverse events among patients hospitalized with acute SHF include higher TR velocity, larger LA diameter, and at least moderate MR or TR. MCF does not correlate well with visually assessed EF among patients with acute SHF, and neither MCF nor EF provides prognostic information in this population.

High-risk phenotypes of arrhythmic mitral valve prolapse: a systematic review and meta-analysis.

BACKGROUND: Mitral valve prolapse (MVP) is associated with aggravated risk of ventricular tachycardia (VT), ventricular fibrillation (VF) and sudden cardiac death (SCD). There is a lack of specific guideline recommendation regarding risk stratification and management, despite multiple proposed high-risk phenotypes. We performed systematic review and meta-analysis to evaluate high-risk phenotypes for malignant arrhythmias in patients with MVP. METHODS: We comprehensively searched the databases of MEDLINE, SCOPUS, and EMBASE from inception to April 2023. Included studies were cohort and case-control comparing between MVP patients with and without VT, VF, cardiac arrest, ICD placement, or SCD. Data from each study were combined using the random-effects. Pooled odds ratios (OR) and 95% confidence intervals (CI) were calculated. RESULTS: Nine studies from 1985 to 2023 were included involving 2,279 patients with MVP. We found that T-wave inversion (OR 2.52; 95% CI: 1.90-3.33; p < 0.001), bileaflet involvement (OR 2.28; 95% CI: 1.69-3.09; p < 0.001), late gadolinium enhancement (OR 17.05; 95% CI: 3.41-85.22; p < 0.001), mitral annular disjunction (OR 3.71; 95% CI: 1.63-8.41; p < 0.002), and history of syncope (OR 6.96; 95% CI: 1.05-46.01; p = 0.044), but not female (OR 0.96; 95% CI: 0.46-2.01; p = 0.911), redundant leaflets (OR 4.30; 95% CI: 0.81-22.84; p = 0.087), or moderate-to-severe mitral regurgitation (OR 1.24; 95% CI: 0.65-2.37; p = 0.505), were associated with those events. CONCLUSION: Bileaflet prolapse, T-wave inversion, mitral annular disjunction, late gadolinium enhancement, and history of syncope are high-risk phenotypes among population with MVP. Further research is needed to validate the risk stratification model and justify the role of primary prophylaxis against malignant arrhythmias.