Cryoballoon pulmonary vein isolation versus radiofrequency ablation of the pulmonary veins and left atrial posterior wall: Patient-reported outcomes.

BACKGROUND: Data are lacking on patient-reported outcomes (PRO) following cryoballoon ablation (CBA) versus radiofrequency ablation (RFA). We sought to evaluate QoL and clinical outcomes of cryoballoon pulmonary vein isolation only (CRYO-PVI-ONLY) versus RFA with PVI and posterior wall isolation (RF-PVI+PWI) in a large prospective PRO registry. METHODS: Patients who underwent AF ablation (2013-2016) at our institution were enrolled in an automated, prospectively maintained PRO registry. CRYO-PVI-ONLY patients were matched (1:1) with RF-PVI+PWI patients based on age, gender, and type of AF (paroxysmal vs. persistent). QoL and clinical outcomes were assessed using PRO surveys at baseline and at 1-year. The atrial fibrillation symptom severity scale (AFSSS) was the measure for QoL. Additionally, we assessed patient-reported clinical improvement, arrhythmia recurrence, and AF burden (as indicated by AF frequency and duration scores). RESULTS: A total of 296 patients were included (148 in each group, 72% paroxysmal). By PRO, a significant improvement in QoL was observed in the overall study population and was comparable between CRYO-PVI-ONLY and RF-PVI+PWI (baseline median AFSSS of 11.5 and 11; reduced to 2 and 4 at 1 year, respectively; p = 0.44). Similarly, the proportion of patients who reported improvement in their overall QoL and AF related symptoms was high and similar between the study groups [92% (CRYO-PVI-ONLY) vs. 92.8% (RF-PVI+PWI); p = 0.88]. Arrhythmia recurrence was significantly more common in the CRYO-PVI-ONLY group (39.7%) compared to RF-PVI+PWI (27.7 %); p = 0.03. Comparable results were observed in paroxysmal and persistent AF. CONCLUSION: CRYO-PVI-ONLY and RF-PVI+PWI resulted in comparable improvements in patient reported outcomes including QoL and AF burden; with RF-PVI+PWI being more effective at reducing recurrences.

Impact of redo ablation for atrial fibrillation on patient-reported outcomes and quality of life.

INTRODUCTION: Catheter ablation for atrial fibrillation (AF) is frequently used for the purpose of rhythm control and improved quality of life (QoL). Although success rates are high, a significant proportion of patients require redo ablation. Data are scarce on patient-centered outcomes and QoL in patients undergoing redo AF ablation. We aimed to assess QoL and clinical outcomes using a large prospectively maintained patient-reported outcomes (PRO) registry. METHODS: All patients undergoing redo AF ablation (2013-2016) at our center were enrolled in a prospective registry for outcomes and assessed for QoL using automated PRO surveys (baseline, 3 and 6 months after ablation, every 6 months thereafter). Data were collected over 3 years of follow-up. The atrial fibrillation symptom severity scale (AFSSS) was used as the main measure for QoL. Additional variables included patient-reported improvement, AF burden, and AF-related healthcare utilization including emergency room (ER) visits and hospitalizations. RESULTS: A total of 848 patients were included (28% females, mean age 63.8, 51% persistent AF). By automated PRO, significant improvement in QoL was noted (baseline median AFSSS of 12 [5-18] and ranged between 2 and 4 on subsequent assessments; p < .0001), with ≥70%of patients reported remarkable improvement in their AF-related symptoms. The proportion of patients in AF at the time of baseline survey was 36%, and this decreased to <8% across all time points during follow-up (p < .0001). AF burden was significantly reduced (including frequency and duration of episodes; p < .0001), with an associated decrease in healthcare utilization after 6 months from the time of ablation (including ER visits and hospitalizations; p < .0001). The proportion of patients on anticoagulants or antiarrhythmics decreased on follow-up across all time points (p < .0001 for all variables). CONCLUSION: Most patients derive significant QoL benefit from redo AF ablation; with reduction of both AF burden and healthcare utilization.

Impact of obesity on catheter ablation of atrial fibrillation: Patient characteristics, procedural complications, outcomes, and quality of life.

INTRODUCTION: Obesity is a well-known risk factor for atrial fibrillation (AF). We aim to evaluate the effect of baseline obesity on procedural complications, AF recurrence, and symptoms following catheter ablation (CA). METHODS: All consecutive patients undergoing AF ablation (2013-2021) at our center were enrolled in a prospective registry. The study included all consecutive patients with available data on body mass index (BMI). Primary endpoint was AF recurrence based on electrocardiographic documentation. Patients were categorized into five groups according to their baseline BMI. Patients survey at baseline and at follow-up were used to calculate AF symptom severity score (AFSS) as well as AF burden (mean of AF duration score and AF frequency score; scale 0: no AF to 10: continuous and 9 frequencies/durations in between). Patients were scheduled for follow-up visits with 12-lead electrocardiogram at 3, 6, and 12 months after ablation, and every 6 months thereafter. RESULTS: A total of 5841 patients were included (17% normal weight, 34% overweight, 27% Class I, 13% Class II, and 9% Class III obesity). Major procedural complications were low (1.5%) among all BMI subgroups. At 3 years AF recurrence was the highest in Class III obesity patients (48%) followed by Class II (43%), whereas Class I, normal, and overweight had similar results with lower recurrence (35%). In multivariable analyses, Class III obesity (BMI ≥ 40) was independently associated with increased risk for AF recurrence (hazard ratio, 1.30; confidence interval, 1.06-1.60; p = .01), whereas other groups had similar risk in comparison to normal weight. Baseline AFSS was lowest in normal weight, and highest in Obesity-III, median (interquartile range) 10 (5-16) versus 15 (10-21). In all groups, CA resulted in a significant improvement in their AFSS with a similar magnitude among the groups. At follow-up, AF burden was minimal and did not differ significantly between the groups. CONCLUSION: AF ablation is safe with a low complication rate across all BMI groups. Morbid obesity (BMI ≥ 40) was significantly associated with reduced AF ablation success. However, ablation resulted in improvement in QoL including reduction of the AFSS, and AF burden regardless of BMI.

Radiation reduction in a modern catheterization laboratory: A single-center experience.

BACKGROUND: Measures were undertaken at the Cleveland Clinic to reduce radiation exposure to patients and personnel working in the catheterization laboratories. We report our experience with these improved systems over a 7-year period in patients undergoing diagnostic catheterization (DC) and percutaneous coronary interventions (PCIs). METHODS: Patients were categorized into preinitiative (2009-2012) and postinitiative (2013-2019) groups in the DC and PCI cohorts. Propensity score matching was done between the pre- and postinitiative groups for both cohorts based on age, sex, body surface area, total fluoroscopy time, and total acquisition time. The effectiveness of radiation reduction measures was assessed by comparing the total air kerma (Ka,r ), and fluoroscopy- and acquisition-mode air kerma in patients in the two groups. RESULTS: In the DC cohort, there was a significant reduction in Ka,r in the postinitiative group in comparison to the preinitiative group (median, 396 vs. 857 mGy; p < 0.001). In the PCI cohort, Ka,r in the postinitiative group was 1265 mGy, which was significantly lower than the corresponding values in the preinitiative group (1994 mGy; p < 0.001). We also observed a significant reduction in fluoroscopy- and acquisition-based air kerma rates, and air kerma area product in the postinitiative group in comparison to the preinitiative group in both matched and unmatched DC and PCI cohorts after the institution of radiation reduction measures. CONCLUSION: There was a significant and sustained reduction in radiation exposure to patients in the catheterization laboratory with the implementation of advanced protocols. Similar algorithms can be applied in other laboratories to achieve a similar reduction in radiation exposure.

Catheter ablation of ventricular tachycardia in patients with postinfarction left ventricular aneurysm.

BACKGROUND: While ventricular tachycardia (VT) in the setting of postmyocardial infarction left ventricular aneurysms (LVA) is not uncommonly encountered, there is a scarcity of data regarding the safety, efficacy, and outcomes of ablation of VT in this subset of patients. METHODS: Our study included consecutive patients aged 18 years or older with postmyocardial infarction LVA who presented to Mayo Clinic for catheter ablation of VT between 2002 and 2018. RESULTS: Of 34 patients, the mean age was 70.4 ± 9.1 years; 91% were male. Mean LVEF was 29 ± 9.7% and left ventricular end-diastolic dimension was 64.9 ± 6.6 mm. The site of the LVA was apical in 21 patients (62%). Fifteen patients (44%) presented with electrical storm or incessant VT. Nine patients (26%) had a history of intracardiac thrombus. All except for one patient had at least one VT originating from the aneurysm. The mean number of VTs was 2.9 ± 1.7. All patients underwent ablation at the site of the aneurysm. Ablation outside the aneurysm was performed in 13 patients (38%). Low-voltage fractionated potentials and/or late potentials at the aneurysmal site were present in all cases. Complete elimination of all VTs was achieved in 18 (53%), while the elimination of the clinical VT with continued inducibility of nonclinical VTs was achieved in a further 11 patients (32%). Two patients developed cardiac tamponade requiring pericardiocentesis. During a mean follow-up period of 2.3 ± 2.4 years, 11 patients (32%) experienced VT recurrence. Freedom from all-cause mortality at 1-year follow-up was 94%. CONCLUSION: Radiofrequency catheter ablation targeting the aneurysmal site is a feasible and reasonably effective management strategy for clinical VTs in patients with postinfarction LVA.

Utilization and outcomes of transcatheter coil embolization for various coronary artery lesions: Single-center 12-year experience.

OBJECTIVE: Determining the outcomes of transcatheter coil embolization (TCE) for several coronary artery lesions. BACKGROUND: TCE has been used as a treatment modality for various lesions in the coronary circulation. However, data on the efficacy and safety of TCE to treat coronary artery fistula (CAF), left internal mammary artery (LIMA) side-branch, coronary artery perforation (CAP), coronary artery aneurysm (CAA), and coronary artery pseudoaneurysm (CAPA) are limited. METHODS: We conducted a retrospective, descriptive analysis of all TCE devices in coronary lesions at our center from 2007 to 2019. Forty-one studied lesions included 25 CAF, 7 LIMA side-branch, 5 CAP, 2 CAA, and 2 CAPA. Short- and 1-year mortality and hospital readmission were reported, in addition to coil-related complications and procedural success. RESULTS: The utilization rate of TCE in coronary artery lesions at our center was found to be 33.8 per 100,000 percutaneous coronary intervention procedures over 12 years. Successful angiographic closure was achieved in 37 out of 41 (87.8%) cases (88, 100, 60, 100, and 100% of CAF, LIMA side-branch, CAP, CAA, and CAPA, respectively). No adverse events were directly related to TCE among the LIMA, CAA, and CAPA cases, and only one patient with CAF required reintervention at 3 months due to coil migration. CONCLUSIONS: Coil embolization in our institution was safe and effective in treating different coronary circulation abnormalities with a 87.8% overall success rate. Further study on the use of vascular plug devices in cases such as CAF or LIMA side-branch would be beneficial to understand the treatment options better.

Impact of atrial fibrillation on outcomes following MitraClip: A contemporary population-based analysis.

OBJECTIVES: Despite the rising use of MC, the impact of preexisting AF, a common comorbidity, on short-term postprocedural outcomes is poorly defined. We sought to assess outcomes between patients with and without atrial fibrillation (AF) who underwent percutaneous mitral valve repair with MitraClip (MC). METHODS: In this retrospective cohort study, the Nationwide Readmissions Database was queried for patients who underwent MC between 2014-2017. Groups were stratified based on the presence of AF. Multivariable logistic regression analyses were performed to identify the association between AF and in-hospital stroke and mortality. RESULTS: Of the 15,570 patients who underwent MC, 7,740 (49.7%) had AF. AF patients were older (82 vs. 79 years, p < .001) and more comorbid. Patients with AF relative to without AF demonstrated increased rates of in-hospital ischemic (1.3% vs .0.7%, p < .001) and hemorrhagic stroke (0.3% vs. 0.1%, p = .007), longer duration of hospitalization (median 3 vs. 2 days, p < .001), and similar in-hospital mortality (2.8% vs. 2.6%, p = .52). After adjusting for comorbidities, age, sex, hospital procedural volume, and CHA2DS2-VASc, the presence of AF was associated with higher in-hospital stroke (OR = 2.096, 95%CI[1.503-2.921], p < .001) but not in-hospital mortality (OR = 1.012, 95%CI[0.828-1.238], p = .904). AF patients were more likely to be readmitted (16.8% vs.14.1%, p < .001) and die (1.5% vs. 0.9%, p = .005) within 30 days of discharge despite similar incidences of stroke (0.7% vs. 0.6%, p = .53). CONCLUSIONS: The increased risk of in-hospital stroke, 30-day mortality, and longer hospitalization suggest the need for increased preprocedural optimization by means of stroke prevention strategies in those with AF undergoing MC.

Coenzyme Q10 for heart failure.

BACKGROUND: Coenzyme Q10, or ubiquinone, is a non-prescription nutritional supplement. It is a fat-soluble molecule that acts as an electron carrier in mitochondria, and as a coenzyme for mitochondrial enzymes. Coenzyme Q10 deficiency may be associated with a multitude of diseases, including heart failure. The severity of heart failure correlates with the severity of coenzyme Q10 deficiency. Emerging data suggest that the harmful effects of reactive oxygen species are increased in people with heart failure, and coenzyme Q10 may help to reduce these toxic effects because of its antioxidant activity. Coenzyme Q10 may also have a role in stabilising myocardial calcium-dependent ion channels, and in preventing the consumption of metabolites essential for adenosine-5'-triphosphate (ATP) synthesis. Coenzyme Q10, although not a primary recommended treatment, could be beneficial to people with heart failure. Several randomised controlled trials have compared coenzyme Q10 to other therapeutic modalities, but no systematic review of existing randomised trials was conducted prior to the original version of this Cochrane Review, in 2014. OBJECTIVES: To review the safety and efficacy of coenzyme Q10 in heart failure. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, Web of Science, CINAHL Plus, and AMED on 16 October 2020; ClinicalTrials.gov on 16 July 2020, and the ISRCTN Registry on 11 November 2019. We applied no language restrictions. SELECTION CRITERIA: We included randomised controlled trials of either parallel or cross-over design that assessed the beneficial and harmful effects of coenzyme Q10 in people with heart failure. When we identified cross-over studies, we considered data only from the first phase. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods, assessed study risk of bias using the Cochrane 'Risk of bias' tool, and GRADE methods to assess the quality of the evidence. For dichotomous data, we calculated the risk ratio (RR); for continuous data, the mean difference (MD), both with 95% confidence intervals (CI). Where appropriate data were available, we conducted meta-analysis. When meta-analysis was not possible, we wrote a narrative synthesis. We provided a PRISMA flow chart to show the flow of study selection. MAIN RESULTS: We included eleven studies, with 1573 participants, comparing coenzyme Q10 to placebo or conventional therapy (control). In the majority of the studies, sample size was relatively small. There were important differences among studies in daily coenzyme Q10 dose, follow-up period, and the measures of treatment effect. All studies had unclear, or high risk of bias, or both, in one or more bias domains. We were only able to conduct meta-analysis for some of the outcomes. None of the included trials considered quality of life, measured on a validated scale, exercise variables (exercise haemodynamics), or cost-effectiveness. Coenzyme Q10 probably reduces the risk of all-cause mortality more than control (RR 0.58, 95% CI 0.35 to 0.95; 1 study, 420 participants; number needed to treat for an additional beneficial outcome (NNTB) 13.3; moderate-quality evidence). There was low-quality evidence of inconclusive results between the coenzyme Q10 and control groups for the risk of myocardial infarction (RR 1.62, 95% CI 0.27 to 9.59; 1 study, 420 participants), and stroke (RR 0.18, 95% CI 0.02 to 1.48; 1 study, 420 participants). Coenzyme Q10 probably reduces hospitalisation related to heart failure (RR 0.62, 95% CI 0.49 to 0.78; 2 studies, 1061 participants; NNTB 9.7; moderate-quality evidence). Very low-quality evidence suggests that coenzyme Q10 may improve the left ventricular ejection fraction (MD 1.77, 95% CI 0.09 to 3.44; 7 studies, 650 participants), but the results are inconclusive for exercise capacity (MD 48.23, 95% CI -24.75 to 121.20; 3 studies, 91 participants); and the risk of developing adverse events (RR 0.70, 95% CI 0.45 to 1.10; 2 studies, 568 participants). We downgraded the quality of the evidence mainly due to high risk of bias and imprecision. AUTHORS' CONCLUSIONS: The included studies provide moderate-quality evidence that coenzyme Q10 probably reduces all-cause mortality and hospitalisation for heart failure. There is low-quality evidence of inconclusive results as to whether coenzyme Q10 has an effect on the risk of myocardial infarction, or stroke. Because of very low-quality evidence, it is very uncertain whether coenzyme Q10 has an effect on either left ventricular ejection fraction or exercise capacity. There is low-quality evidence that coenzyme Q10 may increase the risk of adverse effects, or have little to no difference. There is currently no convincing evidence to support or refute the use of coenzyme Q10 for heart failure. Future trials are needed to confirm our findings.

Sex Differences in the Progression and Long-Term Outcomes of Native Mild to Moderate Aortic Stenosis.

BACKGROUND: There are limited data on the sex differences in the hemodynamic progression and outcomes of early-stage aortic stenosis (AS). OBJECTIVES: The authors sought to determine sex differences in hemodynamic progression and outcomes of mild to moderate native AS. METHODS: This was a retrospective observational cohort study including patients with mild to moderate native tricuspid AS from the Cleveland Clinic echocardiographic database between 2008 and 2016 and followed until 2018. All-cause mortality, aortic valve replacement (AVR), and disease progression assessed by annualized changes in echocardiographic parameters were analyzed based on sex. RESULTS: The authors included 2,549 patients (mean age, 74 ± 7 years and 42.5% women) followed over a median duration of 5.7 years. There was no difference in all-cause mortality between sexes irrespective of age, baseline disease severity, progression to severe AS, and receipt of AVR. Relative to men, women had similar all-cause mortality but lower risk of AVR (adjusted HR: 0.81 [95% CI: 0.67-0.91]; P = 0.009) at 10 years. On 1:1 propensity-matched analysis, men had a significantly faster disease progression represented by greater increases in the median of annualized change in mean gradient (2.10 vs 1.15 mm Hg/y, respectively, P < 0.001), maximum transvalvular velocity (0.42 vs 0.28 m/s/y), left ventricular end-diastolic diameters (0.15 vs 0.048 mm/m2.7/y) (P = 0.014). Women have significantly higher left ventricular ejection fraction, filling pressures, and left ventricular septum thickness over time on follow-up echocardiograms compared with men. CONCLUSIONS: Women with mild to moderate AS had slower hemodynamic progression of AS, were more likely to have preserved left ventricular ejection fraction and concentric left ventricular hypertrophy in addition to lower incidence of AVR compared with men despite similar mortality. These findings provide further evidence that there are distinct sex-specific longitudinal echocardiographic and clinical profiles in patients with AS.

Ischemic or Coronary Evaluations in Patients With Monomorphic VT Electrical Storm Undergoing VT Ablation.

BACKGROUND: Monomorphic ventricular tachycardia (VT) electrical storm (ES) in patients with coronary artery disease is dependent on scarred myocardium. The role of routine ischemic or coronary evaluations before ablation in patients presenting with monomorphic VT storm, without acute coronary syndrome (ACS), remains unknown. OBJECTIVES: This study sought to assess the impact of ischemic or coronary evaluations on procedural outcomes and post-ablation mortality in monomorphic VT storm patients. METHODS: All patients undergoing VT ablation at the Cleveland Clinic from 2014 to 2020 after presenting with monomorphic VT storm were enrolled in a prospectively maintained registry. The associations among ischemic or coronary evaluations and short-term procedural efficacy, acute outcomes, and mortality during follow-up were assessed. RESULTS: A total of 97 consecutive patients with monomorphic VT storm in the absence of ACS underwent VT ablations. This cohort was characterized by severe LV systolic dysfunction (mean left ventricular ejection fraction 30.3%, 67% with known ischemic cardiomyopathy) with moderately severe heart failure (median NYHA functional class II); 45% of patients underwent ischemic or coronary evaluations via coronary angiography (10%), noninvasive myocardial perfusion (26%), or both (9%). The yield of these evaluations was low: No acute coronary occlusions were identified. There was no association between ischemic evaluation and acute ablation outcomes or mortality during follow-up. Similarly, in a secondary analysis, the yield of ischemic or coronary evaluations in patients with monomorphic VT storm and known coronary disease (regardless of ablation status) was found to be low. CONCLUSIONS: Ischemic evaluations in patients with monomorphic VT storm without ACS may not improve procedural outcomes or mortality after ablation.

Atrial Fibrillation Ablation in Young Adults: Measuring Quality of Life Using Patient-Reported Outcomes Over 5 Years.

BACKGROUND: Ablation is used for both rhythm control and improved quality of life (QoL) in atrial fibrillation (AF). It has been suggested that young adults may experience high recurrence rates after ablation and data remain lacking regarding QoL benefits. We aimed to investigate AF ablation outcomes and QoL benefits in young adults undergoing AF ablation using a large prospectively maintained registry and automated patient-reported outcomes (PRO). METHODS: All patients undergoing AF ablation (2013-2016) at our center were prospectively enrolled. Patients aged 50 years or younger were included. For PROs, QoL measures and symptoms were assessed at baseline, 3 months after ablation, and every 6 months thereafter. The AF severity score served as the main assessment of QoL. RESULTS: A total of 241 young adults (age, 16-50 years) were included (17% female, 40.3% persistent AF). In all, 77.2% of patients remained arrhythmia-free during the first year of follow-up (80% in nonstructural AF and 66% in structural AF). Using PROs, 90% of patients reported improvement in QoL throughout all survey time points up to 5 years postablation (P<0.0001). The baseline median AF severity score was 14 and improved to between 2 and 4 on all follow-up after ablation (P<0.0001). Patients also reported fewer and shorter AF episodes, fewer emergency room visits secondary to AF, and fewer hospitalizations (P<0.0001). CONCLUSIONS: Ablation remains an effective rhythm-control strategy in young adults with AF. Young adults also experience significant improvement in QoL with reduction of the frequency and duration of AF episodes and AF-related healthcare utilization.

Catheter ablation of atrial fibrillation in elderly and very elderly patients: safety, outcomes, and quality of life.

BACKGROUND: Atrial fibrillation (AF) risk increases with age. We aim to assess the efficacy and safety of catheter ablation in the older population. METHODS: All patients undergoing AF ablation (2013-2021) at our institution were enrolled in a prospectively maintained registry. The primary endpoint was AF recurrence. Patients were divided into 3 groups: non-elderly (< 65 years), elderly (65-75 years), and very elderly (> 75 years). Patient surveys at baseline and during follow-up were used to calculate quality of life (QoL) metrics: the AF severity score as well as the AF burden. RESULTS: A total of 7020 patients were included (42% non-elderly, 42% elderly, and 16% very elderly). Periprocedural major complications were low (< 1.5%) and similar in all groups besides pericardial effusion which was more frequent with older age and similar between the elderly and very elderly. At 3 years, AF recurrence for persistent AF (PersAF) was highest in the very elderly group (48%), followed by the elderly group (42%), and was the lowest in the non-elderly group (36%). In paroxysmal AF (PAF), there was no difference in AF recurrence between the elderly and non-elderly, while the very elderly remained associated with a significantly increased risk. Multivariable Cox analysis confirmed these findings (PersAF; elderly: HR = 1.23, P = 0.003; very elderly: HR = 1.44, P < 0.001) (PAF; elderly: HR = 1.04, P = 0.62; very elderly: HR = 1.30, P = 0.01). Catheter ablation resulted in a significant improvement in quality of life, irrespective of age group. CONCLUSION: Catheter ablation in elderly and very elderly patients is safe, efficacious, and associated with QoL benefits. Overall, major complications were minimal and did not differ significantly between age groups, with the exception of pericardial effusions which were higher in the elderly and very elderly compared to non-elderly adults. Very elderly patients had a higher rate of AF recurrence when compared with elderly or non-elderly patients. Nevertheless, ablation resulted in a remarkable improvement in QoL and a reduction of AF burden and AF symptoms with a similar magnitude, irrespective of age.

Short-Term Outcomes Following Left Atrial Appendage Closure in the Very Elderly: A Population-Based Analysis.

Background Data on percutaneous left atrial appendage closure (LAAC) outcomes in the very elderly with atrial fibrillation are limited. We aimed to investigate the clinical characteristics and short-term outcomes of patients 80 years or older following percutaneous LAAC in a large nationwide database. Methods and Results Using the Nationwide Readmissions Database, we identified patients who underwent percutaneous LAAC between January 2016 and December 2018. Patients were categorized based on age (≥80 and <80 years old). The primary outcome was in-hospital mortality. Secondary outcomes were in-hospital end points including periprocedural complications, 30-day outcomes, and all-cause 30-day readmissions. A propensity score-matched model (1:1) was used to adjust for baseline characteristics among the study groups. A total of 13 208 patients were included in this study (43% women, median age in years [interquartile range] 79.5 [73-84]) and matched one-to-one (6604 and 6604 patients were ≥80 and <80 years old, respectively). In-hospital mortality was not statistically different between the study groups and occurred in 21 patients ≥80 years old (0.32%) and in 14 patients <80 years old (0.21%); P=0.236. Rates of in-hospital stroke/transient ischemic attack were higher in patients ≥80 years old compared with those <80 years old (1.22% versus 0.77%; P=0.009). In-hospital bleeding requiring transfusion, vascular complications, systemic embolization, and pericardial effusion/tamponade requiring pericardiocentesis or surgical intervention occurred more frequently in patients ≥80 years old. Furthermore, the elderly group was more likely to be readmitted within 30 days compared with those <80 years old (9.91% versus 8.4%; P=0.004); however, rates of 30-day complications were not statistically different between the study groups. Conclusions In a large nationwide database, patients ≥80 years old undergoing percutaneous LAAC were found to have similar in-hospital mortality but an increased risk of periprocedural complications and 30-day readmission compared with younger patients. Our data suggest that LAAC should be considered on a case-by-case basis in the very elderly, taking into consideration the risks and benefits of this intervention. Further studies are needed to assess long-term LAAC outcomes in this high-risk population.

The burden of severe hypercholesterolemia and familial hypercholesterolemia in a population-based setting in the US.

Background: Contemporary prevalence, awareness, and control of severe hypercholesterolemia (SH) and familial hypercholesterolemia (FH) and the associated atherosclerotic cardiovascular disease risk in the US are unknown. Method: Using electronic health records, we assessed the burden of SH and FH in Olmsted County, Minnesota, US, between 2004 and 2015. We defined SH as low-density lipoprotein cholesterol (LDL-C) level ≥190 mg/dl without secondary causes of hypercholesterolemia and FH as a Dutch Lipid Clinic Network score ≥6. Controls were age- and sex-matched individuals with LDL-C level <190 mg/dl. Results: The age- and sex-adjusted point and period prevalence (age-recursive method) of SH was 4.44% and 8.95%, respectively; 1 in 21 had FH (∼1:233 adults), and 46.2% had a recorded diagnosis. Guideline recommended targets (LDL-C <100 mg/dl and <70 mg/dl in the primary and secondary prevention settings, respectively) were achieved in 33.1% and 21.2% of SH cases, with less women overall achieving the target than men (18.6% vs. 23.7%, p=0.022). After adjustment for conventional risk factors, the hazard ratio for incident coronary heart disease (CHD) in those with SH was 1.21 (1.05-1.39; p=0.010), in those with SH and a family history of CHD was 2.16 (1.57-2.96; p<0.001) and in those with FH was 4.61 (2.66-7.97; p<0.001). The association of SH with CHD was modified by age (p-interaction = 0.015), such that the risk was greater at younger ages. Conclusions: SH was prevalent and an independent risk factor for incident CHD. Awareness and control were low, highlighting a treatment gap (more prominent in women) that needs to be addressed.

Outcomes of Direct Oral Anticoagulants Co-Prescribed with Common Interacting Medications.

Direct oral anticoagulants (DOACs) can potentially interact with multiple prescription medications. We examined the prevalence of co-prescription of DOACs with interacting medications and its impact on outcomes in patients with atrial fibrillation (AF). Patients with AF treated with a DOAC from 2010 to 2017 at the Mayo Clinic and co-prescribed medications that are inhibitors or inducers of the P-glycoprotein and/or Cytochrome P450 3A4 pathways were identified. The outcomes of stroke, transient ischemic attack, or systemic embolism, major bleeding, and minor bleeds were compared between patients with and without an enzyme inducer. Cox proportional hazards model was used to assess the association between interacting medications and outcomes. Of 8,576 patients with AF (mean age 70 ± 12 years, 35% female) prescribed a DOAC (38.6% apixaban, 35.8% rivaroxaban, 25.6% dabigatran), 2,610 (30.4%) were on at least 1 interacting agent: the majority were on an enzyme inhibitor (n = 2,592). Prescribed medications included non-dihydropyridine calcium channel blocker (n = 1,412; 16.5%), antiarrhythmic medication (n = 790; 9.2%), antidepressant (n = 659; 7.7%), antibiotic/antifungal (n = 77; 0.90%), antiepileptics (n = 17; 0.2%) and immunosuppressant medications (n = 19; 0.2%). Patients on an interacting medication were more likely to receive a lower dose of DOAC than indicated by the manufacturer's labeling (15.0% vs 11.4%, p <0.0001). In multivariable analysis, co-prescription of an enzyme inhibitor was not associated with risk of any bleeding (hazard ratio 0.87 [0.71 to 1.05], p = 0.15) or stroke, transient ischemic attack, or systemic embolism (hazard ratio 0.82 [0.51 to 1.31], p = 0.39). In conclusion, DOACs are co-prescribed with medications with potential interactions in 30.4% of patients with AF. Co-prescription of DOACs and these drugs are not associated with increased risk of adverse embolic or bleeding outcomes in our cohort.

Association between haematological parameters and outcomes following transcatheter aortic valve implantation at mid-term follow-up.

BACKGROUND: Patients undergoing transcatheter aortic valve implantation (TAVI) often have multiple comorbidities, such as anaemia and chronic inflammatory disorders. We sought to investigate the association between preoperative and postoperative haematological parameters and clinical outcomes in TAVI patients at mid-term follow-up. METHODS: In the present study, consecutive patients (N=908) who underwent TAVI at the Cleveland Clinic between 2017 and 2019 with available complete blood counts were studied. Data were collected on preoperative and postoperative anaemia and elevations in neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR). Survival analysis was used to study the association of haematologic parameters with all-cause mortality and major adverse cardiac and cerebrovascular events (MACCE). RESULTS: We found that preoperative anaemia and elevated NLR were significantly associated with a higher risk of all-cause mortality (aHR=1.6 (95% CI: 1.1 to 2.0) and 1.4 (95% CI: 1.1 to 1.6), respectively) and MACCE (aHR=1.9 (95% CI: 1.3 to 2.8) and 1.6 (95% CI: 1.1 to 2.4), respectively). While an elevated preoperative PLR was not associated with increased mortality risk, it had a significant association with MACCE risk (aHR: 1.6 (95% CI: 1.1 to 2.4)). Further, postoperative anaemia, elevated NLR and PLR were associated with increased risks of all-cause mortality and MACCE. CONCLUSION: Pathological alterations in haematological parameters were associated with higher risks of post-TAVI mortality and MACCE at mid-term follow-up. Our findings advocate for further incorporating haematological parameters in the preoperative evaluation of TAVI candidates.

Digital Health Applications in Heart Failure: a Critical Appraisal of Literature.

PURPOSE OF THE REVIEW: Despite advancements in the diagnostic and therapeutic armamentarium, heart failure (HF) remains a major public health concern in the USA and worldwide. Digital health applications hold promise to bridge this gap and improve HF care. This review will provide the reader with a concise overview of the current digital health applications in HF, the main challenges to its use, and discuss the future of digital health for promoting care for HF patients. RECENT FINDINGS: Emerging evidence continues to support the potential role of digital health across the continuum of HF disease process including primary prevention, early detection, disease management, and reducing associated morbidity. There is also increasing emphasis on the need to pursue rigorous investigations to validate these promising claims, with some successful stories that have changed clinical practices. SUMMARY: Digital health technologies have emerged as potentially useful tools to complement HF care in both research and clinical realms. As digital technologies continue to play an increasing role in transforming healthcare delivery, creating the framework for its effective use would be necessary to ensure that digital health applications consistently improve outcomes and enhance care for HF patients.

Contemporary narrative review on left atrial strain mechanics in echocardiography: cardiomyopathy, valvular heart disease and beyond.

Left atrial (LA) strain mechanics refer to the measurement of LA myocardial deformation expressed as a percentage, and have been gathering interest over the last decade with expanding research supporting their utility in multiple cardiovascular disorders. Measured through advanced dynamic imaging techniques which include tissue Doppler imaging (TDI) and two-dimensional (2D) speckle tracking echocardiography (STE), LA strain mechanics are affected by left ventricular diastolic dysfunction prior to the onset of functional and structural changes in the left ventricle (LV). There is a need for practising cardiologists to become more familiar with the clinical utility of LA strain mechanics. In this article, we begin by reviewing the physiologic function of the LA, using this as a basis for understanding LA strain mechanics. The focus of this review article is to provide a contemporary update on the utility of LA strain mechanics in a range of cardiovascular disorders, including atrial fibrillation (AF), hypertrophic cardiomyopathy (HCM), valvular pathologies, coronary artery disease (CAD) as well as systemic diseases, such as hypertension (HTN), obesity and diabetes mellitus (DM). This article also highlights the current limitations in more widespread clinical applications of LA strain mechanics, as well as outlining the future perspectives on the clinical applications of LA strain mechanics.

Cost-effectiveness of cascade genetic testing for familial hypercholesterolemia in the United States: A simulation analysis.

Objective There is no coordinated cascade testing program for familial hypercholesterolemia (FH) in the U.S. We evaluated the contemporary cost-effectiveness of cascade genetic testing relatives of FH probands with a pathogenic variant. Methods A simulation model was created to simulate multiple family trees starting with progenitor individuals carrying a pathogenic variant for FH who were followed through several generations. This approach allowed us to examine a family tree that had grown sufficiently to have large numbers of relatives across multiple degrees of relatedness. The model estimated costs and life years gained (LYG) when cascade genetic testing was implemented for relatives of FH probands identified through standard care who were at or older than designated age thresholds (5, 10, 15, 20, 25, 30, 35, 40). Costs were valued in 2018 U.S. dollars. Future costs and LYG projected by the model were discounted at an annual rate of 3%. Results For 1st degree relatives, cascade testing at every age threshold resulted in a positive number of average LYG per person, though this number decreased as testing was started at higher age thresholds. Testing was not cost-effective if initiated at an age threshold of 40 and older but was cost-effective at younger age thresholds, with a discounted cost per LYG per person of less than $50,000. For 2nd degree relatives, testing was cost-effective with a screening age threshold of 10 but no longer cost-effective at a threshold of 15 or higher. In more distant relatives, cascade genetic testing was not beneficial or cost-effective. Conclusions Based on our simulation model, cascade genetic testing for FH in the U.S. is cost-effective if started before age 40 in 1st degree relatives and before age 15 in 2nd degree relatives.

Inappropriate Dosing of Direct Oral Anticoagulants in Patients with Atrial Fibrillation.

Direct Oral Anticoagulants (DOACs) require dose adjustment based on specific patient characteristics, making them prone to incorrect dosing. The current study aimed to evaluate the prevalence of inappropriate DOAC dosing, its predictors, and corresponding outcomes in a single-center cohort of atrial fibrillation (AF) patients. We reviewed all patients with AF treated at Mayo Clinic with a DOAC (Apixaban, Rivaroxaban, or Dabigatran) between 2010 and 2017. Outcomes examined were ischemic stroke /transient ischemic attack (TIA)/embolism and bleeding. 8,576 patients (mean age 69.5 ± 11.9 years, 35.1 % female, CHA2DS2-VASc 3.0±1.8) received a DOAC (38.6% apixaban, 35.8% rivaroxaban, 25.6% dabigatran). DOAC dosing was inappropriate in 1,273 (14.8%) with 1071 (12.4%) receiving an inappropriately low dose, and 202(2.4%) an inappropriately high dose. Patients prescribed inappropriate doses were older (72.4 ± 11.7 vs 69.0 ± 11.8, p <0.0001), more likely to be female (43.1% vs 33.7%, p <0.0001), had a higher CHA2DS2-VASc score (3.4 ± 1.8 vs 2.9 ± 1.8, p <0.0001) and a greater Charlson co-morbidity index (3.5 ± 3.3 vs 2.9 ± 3.2, p<0.0001). Over 1.2 ±1.6 years (median 0.5 years) follow up; there was no significant difference in the incidence of stroke and/or TIA and/or embolism and bleeding between patients who were inappropriately dosed versus appropriately dosed. In conclusion, DOAC dosing was not in compliance with current recommendations in 15% of AF patients. Patients at higher risk of stroke and/or TIA based on older age, female gender, and higher CHA2DS2-VASc score were more likely to be underdosed, but there was no significant difference in outcomes including stroke/TIA/embolism and bleeding.