Renal Denervation for Treating Hypertension: Current Scientific and Clinical Evidence

Initial studies of catheter-based renal denervation (RDN) for uncontrolled HTN using radiofrequency ablation in the main renal arteries showed that RDN was effective in lowering office blood pressure (BP). However, the first randomized sham-controlled trial, SYMPLICITY-HTN-3, did not show significantly lower office or 24-h ambulatory systolic BP compared with sham treatment. Subsequent studies in both animals and humans demonstrated the potential importance of more distal and branch renal artery radiofrequency ablation, and a second-generation multielectrode system became available. Two recent randomized sham-controlled trials in patients not taking antihypertensive drugs (SPYRAL HTN-OFF MED) or continuing to take drugs (SPYRAL HTN-ON MED) performed RDN with the second-generation radiofrequency ablation system using an ablation protocol that included treatment of the distal renal artery as well as the branch renal arteries. These studies showed that RDN significantly reduced office and 24-h ambulatory BP compared with sham treatment. Another recent randomized sham-controlled trial in patients not receiving medications showed that RDN with catheter-based ultrasound (RADIANCE-HTN SOLO) applied in just the main renal arteries significantly lowered daytime ambulatory and office BP compared with sham treatment. These trials have renewed clinical and scientific interest in defining the appropriate role of RDN in hypertension treatment. In addition, other important issues will need to be addressed in the future such as the development of tests to determine the extent of RDN at the time of the procedure and the potential of renal nerve fibers to regain their patency at some later stage following the ablation procedure.     

Structural Cardiac Remodeling in Atrial Fibrillation

ObjectivesThis study sought to evaluate preablation computed tomography angiography (CTA) for atrial and epicardial features to predict atrial fibrillation (AF) recurrence after ablation.BackgroundStructural atrial remodeling is a process associated with occurrence or persistence of AF. Different anatomical imaging features have been proposed to influence atrial remodeling both negatively and positively as substrate for AF.MethodsPatients with nonvalvular AF underwent cardiac CTA before pulmonary vein isolation at 2 high-volume centers. Left atrial (LA) and right atrial volumes, LA wall thickness (LAWT), and epicardial adipose tissue volume and attenuation were evaluated. Additional subanalyses of electroanatomical maps were made. Follow-up was performed for at least 12 months, including subanalysis of repeated cardiac CTA studies. Interrater variability was assessed.ResultsOf 732 patients, 270 (36.9%) had AF recurrence after a mean of 7 months. CT analysis revealed larger indexed LA volume (47.3 mL/m² vs 43.6 mL/m²; P = 0.0001) and higher mean anterior (1.91 mm vs 1.65 mm; P < 0.0001) and posterior (1.61 mm vs 1.39 mm; P = 0.001) LAWT in patients with AF recurrence. Epicardial adipose tissue volume in patients with AF recurrence was higher (144.5 mm³ vs 128.5 mm³; P < 0.0001) and further progressed significantly in a subset of 85 patients after 2 years (+11.8 mm² vs −3.5 mm²; P = 0.041). Attenuation levels were lower, indicating a higher lipid component associated with AF recurrence (−69.1 HU vs −67.5 HU; P = 0.001). A total of 103 atrial voltage maps were highly predictive of AF recurrence and showed good discriminatory power for patients with low voltage >50% and LAWT (1.55 ± 0.5 mm vs 1.81 ± 0.6 mm; P = 0.032). Net reclassification improvement (NRI) showed a significant incremental benefit (NRI = 0.279; P < 0.0001) when adding LAWT to established risk models.ConclusionsAtrial wall thickness, epicardial fat volume, and attenuation are associated with AF recurrence in patients undergoing ablation therapy.     

Recurrence of Atrial Fibrillation After Catheter Ablation or Antiarrhythmic Drug Therapy in the CABANA Trial

BackgroundThe CABANA (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) trial randomized 2,204 patients with atrial fibrillation (AF) to catheter ablation or drug therapy. Analysis by intention-to-treat showed a nonsignificant 14% relative reduction in the primary outcome of death, disabling stroke, serious bleeding, or cardiac arrest.ObjectivesThe purpose of this study was to assess recurrence of AF in the CABANA trial.MethodsThe authors prospectively studied CABANA patients using a proprietary electrocardiogram recording monitor for symptom-activated and 24-h AF auto detection. The AF recurrence endpoint was any post–90-day blanking atrial tachyarrhythmias lasting 30 s or longer. Biannual 96-h Holter monitoring was used to assess AF burden. Patients who used the CABANA monitors and provided 90-day post-blanking recordings qualified for this analysis (n = 1,240; 56% of CABANA population). Treatment comparisons were performed using a modified intention-to-treat approach.ResultsMedian age of the 1,240 patients was 68 years, 34.4% were women, and AF was paroxysmal in 43.0%. Over 60 months of follow-up, first recurrence of any symptomatic or asymptomatic AF (hazard ratio: 0.52; 95% confidence interval: 0.45 to 0.60; p < 0.001) or first symptomatic-only AF (hazard ratio: 0.49; 95% confidence interval: 0.39 to 0.61; p < 0.001) were both significantly reduced in the catheter ablation group. Baseline Holter AF burden in both treatment groups was 48%. At 12 months, AF burden in ablation patients averaged 6.3%, and in drug-therapy patients, 14.4%. AF burden was significantly less in catheter ablation compared with drug-therapy patients across the 5-year follow-up (p < 0.001). These findings were not sensitive to the baseline pattern of AF.ConclusionsCatheter ablation was effective in reducing recurrence of any AF by 48% and symptomatic AF by 51% compared with drug therapy over 5 years of follow-up. Furthermore, AF burden was also significantly reduced in catheter ablation patients, regardless of their baseline AF type. (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial [CABANA]; NCT00911508)     

Pacemaker Implantation After Mitral Valve Surgery With Atrial Fibrillation Ablation

BackgroundThe incidence of permanent pacemaker (PPM) implantation is higher following mitral valve surgery (MVS) with ablation for atrial fibrillation (AF) compared with MVS alone.ObjectivesThis study identified risk factors and outcomes associated with PPM implantation in a randomized trial that evaluated ablation for AF in patients who underwent MVS.MethodsA total of 243 patients with AF and without previous PPM placement were randomly assigned to MVS alone (n = 117) or MVS + ablation (n = 126). Patients in the ablation group were further randomized to pulmonary vein isolation (PVI) (n = 62) or the biatrial maze procedure (n = 64). Using competing risk models, this study examined the association among PPM and baseline and operative risk factors, and the effect of PPM on time to discharge, readmissions, and 1-year mortality.ResultsThirty-five patients received a PPM within the first year (14.4%), 29 (83%) underwent implantation during the index hospitalization. The frequency of PPM implantation was 7.7% in patients randomized to MVS alone, 16.1% in MVS + PVI, and 25% in MVS + biatrial maze. The indications for PPM were similar among patients who underwent MVS with and without ablation. Ablation, multivalve surgery, and New York Heart Association functional (NYHA) functional class III/IV were independent risk factors for PPM implantation. Length of stay post-surgery was longer in patients who received PPMs, but it was not significant when adjusted for randomization assignment (MVS vs. ablation) and age (hazard ratio [HR]: 0.81; 95% confidence interval [CI]: 0.61 to 1.08; p = 0.14). PPM implantation did not increase 30-day readmission rate (HR: 1.43; 95% CI: 0.50 to 4.05; p = 0.50). The need for PPM was associated with a higher risk of 1-year mortality (HR: 3.21; 95% CI: 1.01 to 10.17; p = 0.05) after adjustment for randomization assignment, age, and NYHA functional class.ConclusionsAF ablation, multivalve surgery, and NYHA functional class III/IV were associated with an increased risk for permanent pacing. PPM implantation following MVS was associated with a significant increase in 1-year mortality. (Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery; NCT00903370)     

The impact of malnutrition on atrial fibrillation recurrence post ablation

Background and aimsBoth malnutrition and atrial fibrillation (AF) are the major health problems in modern society. Only a few studies focused on the relationship between malnutrition and recurrence of atrial arrhythmias post AF ablation (AF recurrence), which used body mass index (BMI) as nutrition assessment tool. However, BMI can't credibly reflect body composition and has limitation in patients with water-sodium retention. In this study, we used controlling nutritional status score (CONUT score) and geriatric nutritional risk index (GNRI) to identify the malnutrition patients and explored the effect of malnutrition on AF recurrence.Methods and resultsThis retrospective study included 246 patients who underwent AF ablation. During a median 11-month follow-up, 77 patients (31.3%) experienced AF recurrence. The recurrence group had higher CONUT score (2.3 ± 1.5 vs. 0.9 ± 1.0, P < 0.001) and lower GNRI (99.9 ± 7.6 vs. 103.9 ± 5.6, P < 0.001). After balancing the traditional risk factors, both CONUT score (OR: 2.614, 95%CI: 1.831–3.731, P < 0.001) and GNRI (OR: 0.884, 95%CI: 0.828–0.944, P < 0.001) were the independent predictors for AF recurrence. Pre-ablation CONUT score ≥1 and GNRI≥95.66 are indicative of AF recurrence. Adding CONUT score or GNRI to the base prediction model for AF recurrence significantly improved the discrimination and calibration. However, adding BMI to the base prediction model did not improve the model performance.ConclusionsCONUT score and GNRI are ideal tools to evaluate the nutrition status of AF patients. Undernourished patients are more likely to suffer from AF recurrence. Improving nutrition status may be a potential target for reducing the postoperative recurrence rate.     

Atrial Fibrillation and Transcatheter Repair of Functional Mitral Regurgitation: Evidence From a Meta-Regression

ObjectivesThe aim of this study was to assess the impact of atrial fibrillation (AF) on mortality and efficacy in patients with functional mitral regurgitation (FMR) undergoing MitraClip implantation.BackgroundAF is a common arrhythmia in patients with severe FMR undergoing transcatheter mitral valve repair with the MitraClip device. Although AF has been consistently shown to be associated with poor outcomes after mitral valve surgery, the impact of AF on outcomes of MitraClip placement in patients with FMR has not been well studied.MethodsProspective, retrospective registries, observational studies, and randomized controlled trials on MitraClip reporting AF and FMR as one of the variables from inception until January 2019 were included.ResultsOf the initial 1,694 studies, 15 studies met the inclusion criteria. From a total of 5,184 patients, 2,105 patients were identified to have FMR and AF. All-cause 30-day mortality in patients with FMR was 3.7% (95% confidence interval: 2.87 to 4.66) and 1-year mortality was 17.9% (95% confidence interval: 16.01 to 19.71). The meta-regression analysis studying the impact of AF among patients with FMR treated with the MitraClip demonstrated no difference in mortality at 30 days but demonstrated significantly increased mortality at 1 year (95% confidence interval: 0.0006 to 0.0027) (p = 0.004). AF did not influence procedural success.ConclusionsThis meta-regression identifies AF as an independent negative predictor of long-term mortality after MitraClip implantation in patients with FMR. The mechanism of worse outcomes in patients with AF requires further study.     

Prevalence of Left Atrial Thrombus in Anticoagulated Patients With Atrial Fibrillation

BackgroundThe prevalence of left atrial (LA) thrombus in patients with atrial fibrillation (AF) or atrial flutter (AFL) on guideline-directed anticoagulation is not well known, yet this may inform transesophageal echocardiogram (TEE) use before cardioversion or catheter ablation.ObjectivesThe purpose of this study was to quantify LA thrombus prevalence among patients with AF/AFL on guideline-directed anticoagulation and to identify high-risk subgroups.MethodsEMBASE, MEDLINE, and CENTRAL were systematically searched from inception to July 2020 for studies reporting on LA thrombus prevalence among patients with AF/AFL undergoing TEE following at least 3 weeks of continuous therapeutic oral anticoagulation with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs). Meta-analysis was performed using random effects models.ResultsThirty-five studies describing 14,653 patients were identified. The mean-weighted LA thrombus prevalence was 2.73% (95% confidence interval [CI]: 1.95% to 3.80%). LA thrombus prevalence was similar for VKA- and DOAC-treated patients (2.80%; 95% CI: 1.86% to 4.21% vs. 3.12%; 95% CI: 1.92% to 5.03%; p = 0.674). Patients with nonparoxysmal AF/AFL had a 4-fold higher LA thrombus prevalence compared with paroxysmal patients (4.81%; 95% CI: 3.35% to 6.86% vs. 1.03%; 95% CI: 0.52% to 2.03%; p < 0.001). LA thrombus prevalence was higher among patients undergoing cardioversion versus ablation (5.55%; 95% CI: 3.15% to 9.58% vs. 1.65%; 95% CI: 1.07% to 2.53%; p < 0.001). Patients with CHA₂DS₂-VASc scores ≥3 had a higher LA thrombus prevalence compared with patients with scores ≤2 (6.31%; 95% CI: 3.72% to 10.49% vs. 1.06%; 95% CI: 0.45% to 2.49%; p < 0.001).ConclusionsLA thrombus prevalence is high in subgroups of anticoagulated patients with AF/AFL, who may benefit from routine pre-procedural TEE use before cardioversion or catheter ablation.     

Oral Anticoagulation for Patients With Atrial Fibrillation on Long-Term Dialysis

BackgroundPatients on long-term dialysis are at increased risk of bleeding. Although oral anticoagulants (OACs) are recommended for atrial fibrillation (AF) to reduce the risk of stroke, randomized trials have excluded these populations. As such, the net clinical benefit of OACs among patients on dialysis is unknown.ObjectivesThis study aimed to investigate the efficacy and safety of OACs in patients with AF on long-term dialysis.MethodsMEDLINE and EMBASE were searched through June 10, 2019, for studies that investigated the efficacy and safety of different OAC strategies in patients with AF on long-term dialysis. The efficacy outcomes were ischemic stroke and/or systemic thromboembolism, all-cause mortality, and the safety outcome was major bleeding.ResultsThis study identified 16 eligible observational studies (N = 71,877) regarding patients on long-term dialysis who had AF. Only 2 of 16 studies investigated direct OACs. Outcomes for dabigatran and rivaroxaban were limited to major bleeding events. Compared with no anticoagulants, apixaban and warfarin were not associated with a significant decrease in stroke and/or systemic thromboembolism (apixaban 5 mg, hazard ratio [HR]: 0.59; 95% confidence interval [CI]: 0.30 to 1.17; apixaban 2.5 mg, HR: 1.00; 95% CI: 0.52 to 1.93; warfarin, HR: 0.91; 95% CI: 0.72 to 1.16). Apixaban 5 mg was associated with a significantly lower risk of mortality (vs. warfarin, HR: 0.65; 95% CI: 0.45 to 0.93; vs. apixaban 2.5 mg, HR: 0.62; 95% CI: 0.42 to 0.90; vs. no anticoagulant, HR: 0.61; 95% CI: 0.41 to 0.90). Warfarin was associated with a significantly higher risk of major bleeding than apixaban 5 min/2.5 mg and no anticoagulant (vs. apixaban 5 mg, HR: 1.41; 95% CI: 1.07 to 1.88; vs. apixaban 2.5 mg, HR: 1.40; 95% CI: 1.07 to 1.82; vs. no anticoagulant, HR: 1.31; 95% CI: 1.15 to 1.50). Dabigatran and rivaroxaban were also associated with significantly higher risk of major bleeding than apixaban and no anticoagulant.ConclusionsThis meta-analysis showed that OACs were not associated with a reduced risk of thromboembolism in patients with AF on long-term dialysis. Warfarin, dabigatran, and rivaroxaban were associated with significantly higher bleeding risk compared with apixaban and no anticoagulant. The benefit-to-risk ratio of OACs in patients with AF on long-term dialysis warrants validation in randomized clinical trials.     

Atrial Fibrillation: JACC Council Perspectives

Atrial fibrillation (AF) is an increasingly prevalent arrhythmia; its pathophysiology and progression are well studied. Stroke and bleeding risk models have been created and validated. Decision tools for stroke prophylaxis are evolving, with better options at hand. Utilization of various diagnostic tools offer insight into AF burden and thromboembolic risk. Rate control, rhythm control, and stroke prophylaxis are the cornerstones of AF therapy. Although antiarrhythmic drugs are useful, AF ablation has become a primary therapeutic strategy. Pulmonary vein isolation is the cornerstone of AF ablation, and methods to improve ablation safety and efficacy continue to progress. Ablation of nonpulmonary vein sites is increasingly being recognized as an important strategy for treating nonparoxysmal AF. Several new ablation techniques and technologies and stroke prophylaxis are being explored. This is a contemporary review on the prevalence, pathophysiology, risk prediction, prophylaxis, treatment options, new insights for optimizing treatment outcomes, and emerging concepts of AF.     

Mobile Health Technology to Improve Care for Patients With Atrial Fibrillation

BackgroundCurrent management of patients with atrial fibrillation (AF) is limited by low detection of AF, non-adherence to guidelines, and lack of consideration of patients’ preferences, thus highlighting the need for a more holistic and integrated approach to AF management.ObjectiveThe objective of this study was to determine whether a mobile health (mHealth) technology-supported AF integrated management strategy would reduce AF-related adverse events, compared with usual care.MethodsThis is a cluster randomized trial of patients with AF older than 18 years of age who were enrolled in 40 cities in China. Recruitment began on June 1, 2018 and follow-up ended on August 16, 2019. Patients with AF were randomized to receive usual care, or integrated care based on a mobile AF Application (mAFA) incorporating the ABC (Atrial Fibrillation Better Care) Pathway: A, Avoid stroke; B, Better symptom management; and C, Cardiovascular and other comorbidity risk reduction. The primary composite outcome was a composite of stroke/thromboembolism, all-cause death, and rehospitalization. Rehospitalization alone was a secondary outcome. Cardiovascular events were assessed using Cox proportional hazard modeling after adjusting for baseline risk.ResultsThere were 1,646 patients allocated to mAFA intervention (mean age, 67.0 years; 38.0% female) with mean follow-up of 262 days, whereas 1,678 patients were allocated to usual care (mean age, 70.0 years; 38.0% female) with mean follow-up of 291 days. Rates of the composite outcome of ‘ischemic stroke/systemic thromboembolism, death, and rehospitalization’ were lower with the mAFA intervention compared with usual care (1.9% vs. 6.0%; hazard ratio [HR]: 0.39; 95% confidence interval [CI]: 0.22 to 0.67; p < 0.001). Rates of rehospitalization were lower with the mAFA intervention (1.2% vs. 4.5%; HR: 0.32; 95% CI: 0.17 to 0.60; p < 0.001). Subgroup analyses by sex, age, AF type, risk score, and comorbidities demonstrated consistently lower HRs for the composite outcome for patients receiving the mAFA intervention compared with usual care (all p < 0.05).ConclusionsAn integrated care approach to holistic AF care, supported by mHealth technology, reduces the risks of rehospitalization and clinical adverse events. (Mobile Health [mHealth] technology integrating atrial fibrillation screening and ABC management approach trial; ChiCTR-OOC-17014138).     

El tejido adiposo epicárdico no es un predictor independiente de recurrencia de fibrilación auricular tras ablación con catéter

Introduction and objectivesPrevious studies have suggested that epicardial adipose tissue (EAT) could exert a paracrine effect in the myocardium. However, few studies have assessed its role in the risk of atrial fibrillation (AF) recurrence. This study aimed to evaluate the association between EAT volume, and its attenuation, with the risk of AF recurrence after AF ablation.MethodsA total of 350 consecutive patients who underwent AF ablation were included. The median age was 57 [IQR 48-65] years and 21% had persistent AF. Epicardial fat was quantified by multidetector computed tomography using Syngo.via Frontier-Cardiac Risk Assessment software, measuring pericardial fat volume (PATV), EAT volume, and attenuation of EAT posterior to the left atrium. AF recurrence was defined as any documented episode of AF, atrial flutter, or atrial tachycardia more than 3 months after the procedure.ResultsAfter a median follow-up of 34 [range, 12-57] months, 114 patients (33%) had AF recurrence. Univariable Cox regression showed that patients with an EAT volume ≥ 80 mL had an increased risk of AF recurrence (HR, 1.65; 95%CI, 1.14-2.39; P = .007). However, after multivariable adjustment, EAT volume did not remain an independent predictor of AF recurrence (HR, 1.24; 95%CI, 0.83-1.87; P = .3). Similar results were observed with PATV. Patients with lower attenuation of EAT did not have a higher risk of AF recurrence (log-rank test, P = .75).ConclusionsEAT parameters including the evaluation of EAT volume, PATV and EAT attenuation were not independent predictors of AF recurrence after catheter ablation.     

Prediction of AF in Heart Failure With Preserved Ejection Fraction: Incremental Value of Left Atrial Strain

ObjectivesThis study sought to identify the factors associated with incident atrial fibrillation (AF) in a well-characterized heart failure with preserved ejection fraction (HFpEF) population, with special focus on left atrial (LA) strain.BackgroundAF is associated with HFpEF, with adverse consequences. Effective risk evaluation might allow the initiation of protective strategies.MethodsClinical evaluation and echocardiography, including measurements of peak atrial longitudinal strain (PALS), peak atrial contraction strain (PACS), and LA volume index (LAVI), were obtained in 170 patients with symptomatic HFpEF (mean age, 65 ± 8 years), free of baseline AF. AF was identified by standard 12-lead electrocardiogram, review of relevant medical records (including Holter documentation), and surveillance with a portable single-lead electrocardiogram device over 2 weeks. Results were validated in the 103 patients with HFpEF from the Karolinska-Rennes (KaRen) study.ResultsOver a median follow-up of 49 months, incident AF was identified in 39 patients (23%). Patients who developed AF were older; had higher clinical risk scores, brain natriuretic peptide, creatinine, LAVI, and LV mass; lower LA strain and exercise capacity; and more impaired LV diastolic function. PACS, PALS, and LAVI were the most predictive parameters for AF (area under receiver-operating characteristic curve: 0.76 for PACS, 0.71 for PALS, and 0.72 for LAVI). Nested Cox regression models showed that the predictive value of PACS and PALS was independent from and incremental to clinical data, LAVI, and E/e’ ratio. Classification and regression trees analysis identified PACS ≤12.7%, PALS ≤29.4%, and LAVI >34.3 ml/m² as discriminatory nodes for AF, with a 33-fold greater hazard of AF (p < 0.001) in patients categorized as high risk. The classification and regression trees algorithm discriminated high and low AF risk in the validation cohort.ConclusionsPACS and PALS provide incremental predictive information about incident AF in HFpEF. The inclusion of these LA strain components to the diagnostic algorithm may help guide screening and further monitoring for AF risk in this population.     

Long-Term Outcomes After Atrial Septal Defect Transcatheter Closure by Age and Against Population Controls

ObjectivesThe long-term outcomes after transcatheter closure of atrial septal defects (ASD) in adults are reported and compared between age groups and against population control patients.BackgroundASD is the second most common lesion in congenital heart disease. Comprehensive data on long-term outcomes after ASD closure are limited.MethodsThis retrospective cohort study enrolled adult patients with secundum ASD closure between 1998 and 2016. Information from a detailed clinical registry was linked to population-based administrative databases to capture outcomes. The population control cohort was matched using important prognostic characteristics.ResultsThe cohort included 1,390 ASD patients of whom 32% were <40 years of age, 45% were 40 to 60 years of age, and 23% were >60 years of age at closure. The median follow-up was 10.6 years (interquartile range: 6.2 to 14.0 years). New-onset atrial fibrillation (AF) was the most frequent outcome overall (14.9%). The incidence of adverse cardiac and cerebrovascular events was higher in the >60 years of age group than in the younger groups. In adjusted analysis, patients >60 years of age continued exhibiting higher risk of all-cause (hazard ratio [HR]: 8.54; 95% confidence interval [CI]: 93.40 to 21.43) and cardiovascular (CV)-specific mortality compared with the <40 years of age group. The risk of new-onset AF (HR: 3.73; 95% CI: 2.79 to 4.98) and any AF hospitalization (HR: 1.55; 95% CI: 1.28 to 1.89) was higher in the ASD than in the control population, whereas there was no difference in all-cause and CV-specific mortality.ConclusionsAs expected, rates of adverse events post-ASD closure are higher in older age groups, but long-term mortality was comparable to that of a population control cohort. The high rates of AF necessitate future investigations.     

Evaluation of Multimodality LAA Leak Closure Methods Following Incomplete Occlusion: The LAA Leak Study

BackgroundIncomplete left atrial appendage (LAA) closure is an evolving topic of clinical significance and thromboembolic potential, with recent long-term studies suggesting lower cutoffs for relevant leak size.ObjectivesThe aim of this prospective observational study was to assess 3 different closure techniques for persistent peridevice leaks after incomplete LAA closure and compare their efficacy and safety outcomes.MethodsWe studied 160 patients (mean age 72 ± 9 years; 71% men) who underwent 1 of the 3 available modalities (detachable embolization coils, vascular plugs or septal occluders, and radiofrequency ablation) for residual central or eccentric leak closure. Both acute postprocedural success (closure or <1-mm leak at the end of the procedure) and closure at 1-year follow-up transesophageal echocardiography imaging were evaluated.ResultsOf 160 patients, 0.6%, 41.3%, and 58.1% had mild (1-2 mm), moderate (3-5 mm), and severe (≥5 mm) leaks, respectively. Baseline LAA closure type was 72.5% Watchman FLX, 16.3% Lariat, 5.6% surgical ligation, 1.9% AtriClip, and 1.9% Amulet. Successful closure (0- or <1-mm leak) was seen in 100% of patients in all cohorts following intervention, with overall complete closure (0-1 mm) or mild or minimal leaks (1-2 mm) on 1-year follow-up transesophageal echocardiography seen in 100% of the atrial septal occluder or vascular plug cohort, 85.9% of the coil cohort, and 83.3% of the radiofrequency ablation cohort (P < 0.001). Two patients (1.3%) experienced cardiac tamponade, and there were no deaths or other complications.ConclusionsPeridevice leaks can safely and effectively be closed using 3 different modalities depending on size and location.     

Stroke Complicating Infective Endocarditis After Transcatheter Aortic Valve Replacement

BackgroundStroke is one of the most common and potentially disabling complications of infective endocarditis (IE). However, scarce data exist about stroke complicating IE after transcatheter aortic valve replacement (TAVR).ObjectivesThe purpose of this study was to determine the incidence, risk factors, clinical characteristics, management, and outcomes of patients with definite IE after TAVR complicated by stroke during index IE hospitalization.MethodsData from the Infectious Endocarditis after TAVR International Registry (including 569 patients who developed definite IE following TAVR from 59 centers in 11 countries) was analyzed. Patients were divided into two groups according to stroke occurrence during IE admission (stroke [S-IE] vs. no stroke [NS-IE]).ResultsA total of 57 (10%) patients had a stroke during IE hospitalization, with no differences in causative microorganism between groups. S-IE patients exhibited higher rates of acute renal failure, systemic embolization, and persistent bacteremia (p < 0.05 for all). Previous stroke before IE, residual aortic regurgitation ≥moderate after TAVR, balloon-expandable valves, IE within 30 days after TAVR, and vegetation size >8 mm were associated with a higher risk of stroke during the index IE hospitalization (p < 0.05 for all). Stroke rate in patients with no risk factors was 3.1% and increased up to 60% in the presence of >3 risk factors. S-IE patients had higher rates of in-hospital mortality (54.4% vs. 28.7%; p < 0.001) and overall mortality at 1 year (66.3% vs. 45.6%; p < 0.001). Surgical treatment was not associated with improved outcomes in S-IE patients (in-hospital mortality: 46.2% in surgical vs. 58.1% in no surgical treatment; p = 0.47).ConclusionsStroke occurred in 1 of 10 patients with IE post-TAVR. A history of stroke, short time between TAVR and IE, vegetation size, valve prosthesis type, and residual aortic regurgitation determined an increased risk. The occurrence of stroke was associated with increased in-hospital and 1-year mortality rates, and surgical treatment failed to improve clinical outcomes.     

A novel prognostic tool to predict mortality in patients with atrial fibrillation: The BASIC-AF risk score

BackgroundThis study sought to develop and validate a risk score to predict mortality in patients with atrial fibrillation (AF) after a hospitalization for cardiac reasons.MethodsThe new risk score was derived from a prospective cohort of hospitalized patients with concurrent AF. The outcome measures were all-cause and cardiovascular mortality. Random forest was used for variable selection. A risk points model with predictor variables was developed by weighted Cox regression coefficients and was internally validated by bootstrapping.ResultsIn total, 1130 patients with AF were included. During a median follow-up of 2 years, 346 (30.6%) patients died and 250 patients had a cardiovascular cause of death. N-terminal pro-B-type natriuretic peptide and high-sensitivity troponin-T were the most important predictors of mortality, followed by indexed left atrial volume, history and type of heart failure, age, history of diabetes mellitus, and intraventricular conduction delay, all forming the BASIC-AF risk score (Biomarkers, Age, ultraSound, Intraventricular conduction delay, and Clinical history). The score had good discrimination for all-cause (c-index = 0.85 and 95% CI 0.82–0.88) and cardiovascular death (c-index = 0.84 and 95% CI 0.81-0.87). The predicted probability of mortality varied more than 50-fold across deciles and adjusted well to observed mortality rates. A decision curve analysis revealed a significant net benefit of using the BASIC-AF risk score to predict the risk of death, when compared with other existing risk schemes.ConclusionsWe developed and internally validated a well-performing novel risk score for predicting death in patients with AF. The BASIC-AF risk score included routinely assessed parameters, selected through machine-learning algorithms, and may assist in tailored risk stratification and management of these patients.     

Atrial fibrillation,cancer and anticancer drugs

Active cancer is associated with an increased risk of atrial fibrillation (AF), which varies depending on the pre-existing substrate (particularly in older patients), the cancer type and stage, and the anticancer therapeutics being taken. To date, studies have not been able to identify the individual contribution of each factor. During anticancer drug therapy, AF may occur with a frequency of ≈ 15–20% according to several factors, including the patient's baseline cardiovascular toxicity risk and the AF-detection strategies used. Many anticancer drugs have been associated with AF or AF reporting, both in terms of incident and recurrent AF, but robust data are lacking. Only bruton tyrosine kinase inhibitor associated AF (mainly ibrutinib) has a high level of evidence, with a ≈ 3–4-fold higher risk of AF. AF in patients with active cancer is associated with a twofold higher risk of systemic thromboembolism or stroke, and the “TBIP” (Thromboembolic risk, Bleeding risk, drug–drug Interactions, Patient preferences) structured approach must be used to evaluate the need for anticoagulation therapy. AF in patients with active cancer is also associated with a sixfold higher risk of heart failure, and optimal symptom control must be targeted, usually with rate-control drugs (beta-blockers), but a rhythm-control strategy may be proposed in patients remaining symptomatic despite optimal rate-control. AF is generally manageable, with the continuation of anticancer drugs (including ibrutinib); interruption of cancer drugs must be avoided whenever possible and weighed against the risk of cancer progression.     

Left Atrial Late Gadolinium Enhancement is Associated With Incident Atrial Fibrillation as Detected by Continuous Monitoring With Implantable Loop Recorders

ObjectivesThe authors hypothesized that left atrial (LA) fibrosis was associated with incident atrial fibrillation (AF) as detected by continuous long-term monitoring in an at-risk population.BackgroundLA late gadolinium enhancement (LGE) measured with cardiac magnetic resonance is emerging as a marker of atrial fibrosis and has been associated with worse outcomes in AF ablation procedures; however, the prognostic value of LA LGE for incident AF remains unknown.MethodsCardiac magnetic resonance, including measurement of left ventricular and LA volumes and function, as well as left ventricular extracellular volume fraction and LA LGE, was acquired in 68 patients aged at least 70 years with risk factors for stroke. All included patients received an implantable loop recorder and were continuously monitored for previously unknown AF. Incident AF was adjudicated by senior cardiologists.ResultsPatients were monitored for AF with an implantable loop recorder during a median of 41 (interquartile range: 7) months. AF episodes lasting ≥6 min were detected in 32 patients (47%), and 16 patients (24%) experienced AF episodes lasting ≥5.5 h. In Cox regression analyses adjusted for sex, age, and comorbidities, we found that LA volumes and function and LA LGE were independently associated with incident AF. For LA LGE, the hazard ratios for time to AF episodes lasting ≥6 min and ≥5.5 h were 1.40 (95% CI: 1.03 to 1.89) per 10 cm² increase (p = 0.03) and 1.63 (95% CI: 1.11 to 2.40) per 10 cm² increase (p = 0.01), respectively. LA LGE was significantly associated with high burden of AF. The addition of LA LGE to a multivariable risk prediction model for incident AF significantly increased the predictive value.ConclusionsExtent of LA fibrosis measured by LA LGE was significantly associated with incident AF detected by implantable loop recorder. (Atrial Fibrillation Detected by Continuous ECG Monitoring [LOOP]; NCT02036450)     

Stable Clinical Outcomes When a Stroke Thrombectomy Program Is Started in an Experienced Cardiology Cath Lab

ObjectivesThis study analyzed the learning curve effect when a new stroke thrombectomy program was initiated in a cardiac cath lab in close cooperation with neurologists and radiologists.BackgroundMechanical thrombectomy has proven to be the best treatment option for ischemic stroke patients, but this method is not widely available.MethodsAn endovascular treatment program for acute ischemic strokes was established in the cardiac cath lab of a tertiary university hospital in 2012. The decision to perform catheter-based thrombectomy was made by a neurologist and was based on acute stroke clinical symptoms and computed tomography angiographic findings. Patients with a large vessel occlusion of either anterior or posterior circulation were enrolled. The primary endpoint was the functional neurological outcome (Modified Rankin Scale [mRS] score) of the patient at 3 months. A total of 333 patients were enrolled between October 2012 and December 2019.ResultsThe clinical (mRS) outcomes did not vary significantly across years 2012 to 2019 (mRS 0 to 2 was achieved in 47.9% of patients). Symptomatic intracerebral hemorrhage occurred in 19 patients (5.7%). Embolization in a new vascular territory occurred in 6 patients (1.8%).ConclusionsWhen a catheter-based thrombectomy program was initiated in an experienced cardiac cath lab in close cooperation between cardiologists, neurologists, and radiologists, outcomes were comparable to those of neuroradiology centers. The desired clinical results were achieved from the onset of the program, without any signs of a learning curve effect. These findings support the potential role of interventional cardiac cath labs in the treatment of acute stroke in regions where this therapy is not readily available due to the lack of neurointerventionalists.     

Impact of Pre-Existing and New-Onset Atrial Fibrillation on Outcomes After Transcatheter Aortic Valve Replacement

ObjectivesThis study sought to evaluate impact of new-onset and pre-existing atrial fibrillation (AF) on transcatheter aortic valve replacement (TAVR) long-term outcomes compared with patients without AF.BackgroundPre-existing and new-onset AF in patients undergoing TAVR are associated with poor outcomes.MethodsThe study identified 72,660 patients ≥65 years of age who underwent nonapical TAVR between 2014 and 2016 using Medicare inpatient claims. History of AF was defined by diagnoses on claims during the 3 years preceding the TAVR, and new-onset AF was defined as occurrence of AF during the TAVR admission or within 30 days after TAVR in a patient without prior history of AF. Outcomes included all-cause mortality, and readmission for bleeding, stroke, and heart failure (HF).ResultsOverall, 40.7% had pre-existing AF (n = 29,563) and 6.8% experienced new-onset AF (n = 2,948) after TAVR. Mean age was 81.3, 82.4, and 83.8 years in patients with no AF, pre-existing, and new-onset AF, respectively. Pre-existing AF patients had the highest burden of comorbidities. After follow-up of 73,732 person-years, mortality was higher with new-onset AF compared with pre-existing and no AF (29.7, 22.6, and 12.8 per 100 person-years, respectively; p < 0.001). After adjusting for patient characteristics and hospital TAVR volume, new-onset AF remained associated with higher mortality compared with no AF (adjusted hazard ratio: 2.068, 95% confidence interval [CI]: 1.92 to 2.20; p < 0.01) and pre-existing AF (adjusted hazard ratio: 1.35; 95% CI: 1.26 to 1.45; p < 0.01). In competing risk analysis, new-onset AF was associated with higher risk of bleeding (subdistribution hazard ratio [sHR]: 1.66; 95% CI: 1.48 to 1.86; p < 0.01), stroke (sHR: 1.92; 95% CI: 1.63 to 2.26; p < 0.01), and HF (sHR: 1.98; 95% CI: 1.81 to 2.16; p < 0.01) compared with pre-existing AF.ConclusionsIn patients undergoing TAVR, new-onset AF is associated with increased risk of mortality and bleeding, stroke, and HF hospitalizations compared with pre-existing AF or no AF.