Effect of MRI-Guided Fibrosis Ablation vs Conventional Catheter Ablation on Atrial Arrhythmia Recurrence in Patients With Persistent Atrial Fibrillation: The DECAAF II Randomized Clinical Trial.

Importance: Ablation of persistent atrial fibrillation (AF) remains a challenge. Left atrial fibrosis plays an important role in the pathophysiology of AF and has been associated with poor procedural outcomes. Objective: To investigate the efficacy and adverse events of targeting atrial fibrosis detected on magnetic resonance imaging (MRI) in reducing atrial arrhythmia recurrence in persistent AF. Design, Setting, and Participants: The Efficacy of Delayed Enhancement-MRI-Guided Fibrosis Ablation vs Conventional Catheter Ablation of Atrial Fibrillation trial was an investigator-initiated, multicenter, randomized clinical trial involving 44 academic and nonacademic centers in 10 countries. A total of 843 patients with symptomatic or asymptomatic persistent AF and undergoing AF ablation were enrolled from July 2016 to January 2020, with follow-up through February 19, 2021. Interventions: Patients with persistent AF were randomly assigned to pulmonary vein isolation (PVI) plus MRI-guided atrial fibrosis ablation (421 patients) or PVI alone (422 patients). Delayed-enhancement MRI was performed in both groups before the ablation procedure to assess baseline atrial fibrosis and at 3 months postablation to assess for ablation scar. Main Outcomes and Measures: The primary end point was time to first atrial arrhythmia recurrence after a 90-day blanking period postablation. The primary safety composite outcome was defined by the occurrence of 1 or more of the following events within 30 days postablation: stroke, PV stenosis, bleeding, heart failure, or death. Results: Among 843 patients who were randomized (mean age 62.7 years; 178 [21.1%] women), 815 (96.9%) completed the 90-day blanking period and contributed to the efficacy analyses. There was no significant difference in atrial arrhythmia recurrence between groups (fibrosis-guided ablation plus PVI patients, 175 [43.0%] vs PVI-only patients, 188 [46.1%]; hazard ratio [HR], 0.95 [95% CI, 0.77-1.17]; P = .63). Patients in the fibrosis-guided ablation plus PVI group experienced a higher rate of safety outcomes (9 [2.2%] vs 0 in PVI group; P = .001). Six patients (1.5%) in the fibrosis-guided ablation plus PVI group had an ischemic stroke compared with none in PVI-only group. Two deaths occurred in the fibrosis-guided ablation plus PVI group, and the first one was possibly related to the procedure. Conclusions and Relevance: Among patients with persistent AF, MRI-guided fibrosis ablation plus PVI, compared with PVI catheter ablation only, resulted in no significant difference in atrial arrhythmia recurrence. Findings do not support the use of MRI-guided fibrosis ablation for the treatment of persistent AF. Trial Registration: ClinicalTrials.gov Identifier: NCT02529319.

Atrial fibrosis progression in patients with no history of atrial fibrillation.

BACKGROUND: Unexpected high levels of atrial fibrosis are found in individuals with no history of atrial fibrillation (AF). The temporal behavior of atrial fibrosis in this population is still unknown. We sought to investigate the progression and predictors of atrial fibrosis in non-AF individuals. METHODS: Non-AF individuals at baseline who underwent late gadolinium enhancement magnetic resonance imaging (LGE-MRI) for assessment of left atrial (LA) fibrosis at least twice were retrospectively included in this study. The incidence of AF was assessed using review of medical records. RESULTS: In 42 non-AF patients (15 females, 65.9 ± 8.6 years old), all patients had a detectable level of LA fibrosis at baseline, ranging from 4.5% to 28.8%, with a mean of 12.9 ± 5.9%. LA fibrosis in the second LGE-MRI was significantly higher in all patients compared to the first measurement (mean value of 12.9 ± 5.9% vs. 17.34 ± 6.8%; p < .05). Congestive heart failure was a significant clinical predictor of atrial fibrosis progression. The seven patients (16.6%) who developed new-onset AF during follow-up showed a significantly higher degree of LA fibrosis on their second MRI, compared to individuals who stayed in sinus rhythm (20.5 ± 6.9% vs. 16.7 ± 6.7%, p < .05). CONCLUSION: Atrial fibrotic remodeling is a dynamic process that is progressively increasing in non-AF patients, accentuated by congestive heart failure. The higher extent of LA remodeling observed in patients who developed AF could highlight either the fact that AF is an expression of a highly dynamic left atrial substrate, or that remodeling processes are accelerated by AF.

Efficacy of LGE-MRI-guided fibrosis ablation versus conventional catheter ablation of atrial fibrillation: The DECAAF II trial: Study design.

INTRODUCTION: Success rates of catheter ablation in persistent atrial fibrillation (AF) remain suboptimal. A better and more targeted ablation strategy is urgently needed to optimize outcomes of AF treatment. We sought to assess the safety and efficacy of targeting atrial fibrosis during ablation of persistent AF patients in improving procedural outcomes. METHODS: The DECAAF II trial (ClinicalTrials. gov identifier number NCT02529319) is a prospective, randomized, multicenter trial of patients with persistent AF. Patients with persistent AF undergoing a first-time ablation procedure were randomized in a 1:1 fashion to receive conventional pulmonary vein isolation (PVI) ablation (Group 1) or PVI + fibrosis-guided ablation (Group 2). Left atrial fibrosis and ablation induced scarring were defined by late gadolinium enhancement magnetic resonance imaging at baseline and at 3-12 months postablation, respectively. The primary endpoint is the recurrence of atrial arrhythmia postablation, including atrial fibrillation, atrial flutter, or atrial tachycardia after the 90-day postablation blanking period. Patients were followed for a period of 12-18 months with a smartphone ECG Device (ECG Check Device, Cardiac Designs Inc.). With an anticipated enrollment of 900 patients, this study has an 80% power to detect a 26% reduction in the hazard ratio of the primary endpoint. RESULTS AND CONCLUSION: The DECAAF II trial is the first prospective, randomized, multicenter trial of patients with persistent AF using imaging defined atrial fibrosis as a treatment target. The trial will help define an optimal approach to catheter ablation of persistent AF, further our understanding of influencers of ablation lesion formation, and refine selection criteria for ablation based on atrial myopathy burden.

Atrial fibrosis in embolic stroke of undetermined source: A multicenter study.

BACKGROUND AND PURPOSE: Left atrial (LA) cardiac disease is a suspected cause of embolic stroke of undetermined source (ESUS). We tested the hypothesis that LA fibrosis, quantified using late-gadolinium-enhancement magnetic resonance imaging (LGE-MRI), predicts recurrent stroke or atrial fibrillation (AF) in patients with ESUS. METHODS: We compared atrial fibrosis in healthy controls and patients with lacunar stroke, ESUS, and known AF with or without prior stroke. We followed patients with ESUS prospectively for the primary outcome of recurrent ischemic stroke, incident AF, or both. RESULTS: We enrolled 203 patients from three centers: 103 patients without AF (35 healthy controls, 15 with lacunar strokes, 53 with ESUS) and 100 patients with AF (50 with and 50 without prior stroke). Patients with ESUS had significantly higher atrial fibrosis (15.0 ± 6.2%) compared to healthy controls (8.1 ± 7.9%; <0.0001) and compared to lacunar stroke patients (10.8 ± 8.4; p = 0.02), but had comparable fibrosis to patients with AF with (17.9 ± 11.4%) or without prior stroke (16.6 ± 9.2%; p = NS for both). Over a mean follow-up of 19 months, nine of 53 patients (16.9%) with ESUS experienced the combined primary outcome, which included six patients (11.3%) with recurrent ischemic stroke and five patients with incident AF (9.4%). Patients with ESUS with fibrosis ≥12% had a higher proportion of the combined outcome: 25.0% vs. 4.8%; p = 0.039. CONCLUSIONS: Patients with ESUS demonstrate atrial fibrosis comparable to that seen in AF. Atrial fibrosis ≥12% was associated with recurrent stroke, incident AF or both. This subgroup of ESUS patients may benefit from anticoagulation for secondary prevention of ischemic stroke.

Propensity-matched comparison of antiplatelet versus anticoagulant after left atrial appendage closure with the Watchman.

BACKGROUND: Optimal antithrombotic therapy following left atrial appendage closure (LAAC) with the Watchman occluder remains uncertain. This study retrospectively compared clinical outcomes of a 3-month dual antiplatelet therapy (DAPT group) and a protocol of anticoagulation plus aspirin for 45 days followed by DAPT for 6 months (ACT group) after LAAC with the Watchman device. METHODS: Of two Watchman registries (Coburg and Lichtenfels hospitals, Germany), 220 and 304 consecutive patients with successful LAAC were included. Patients in Coburg hospital received DAPT while they received ACT in Lichtenfels. After a 1:1 propensity score matching, 174 (DAPT) versus 174 (ACT) patients were compared by use of the primary efficacy endpoint of thromboembolic events and cardiovascular/unexplained death, the primary safety endpoint of nonprocedural related major bleeding events at follow-up, and the combined hazard endpoint, a composite of all above-mentioned hazards. RESULTS: The mean age 77.5 ± 7.2 (DAPT) versus 77.3 ± 7.1 (ACT) years, CHA2 DS2 -VASc score 4.6 ± 1.5 versus 4.7 ± 1.6, and HAS-BLED score 3.3 ± 0.8 versus 3.3 ± 0.8 were similar. After 12 months, the clinical efficacy (13/174, 7.4% [DAPT] vs 11/174, 6.3% [ACT]; hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.38-1.86; P = .66) and safety (6/174, 3.4% vs 8/174, 4.5%; HR, 0.86; 95% CI, 0.29-2.56; P = .79) as well as the combined hazard endpoint (18/174, 10.3% vs 18/174, 10.3%; HR,1.01; 95% CI, 0.53-1.95; P = .97) were comparable. CONCLUSIONS: This study suggests comparable efficacy and safety of 3-month DAPT versus 6 weeks ACT plus aspirin following LAAC with the Watchman.

Age and sex differences in atrial fibrosis among patients with atrial fibrillation.

Aim: Age and female sex are associated with a higher risk of stroke in atrial fibrillation (AF). We sought to determine whether advancing age and female sex are associated with higher atrial fibrosis. Methods and results: We conducted an observational cohort study of patients with AF enrolled in the University of Utah AF Database and a non-AF control group who underwent late-gadolinium enhancement magnetic resonance imaging (LGE-MRI) for atrial fibrosis quantification. Participants with contra-indications for contrast MRI scanning were excluded. Nine hundred and eight consecutive men and women with AF and 15 non-AF controls were included in this study. Left atrial fibrosis increased with age in both men and women with AF. Women with AF (n = 316) were older than men (n = 592): mean age 68.7±11.6 vs. 64.9±11.7 years; P < 0.01, and had higher left atrial fibrosis compared with men 17.5 ± 10.1% vs. 15.3 ± 8.9%; P < 0.001. Women also had a higher prevalence of prior stroke compared with men (15.8% vs. 6.5%; P < 0.001). Age and sex relationships with atrial fibrosis remained significant in multivariate analysis. Compared with the non-AF control group, patients with AF had significantly higher atrial fibrosis: 16.0 ± 9.4 vs. 5.5 ± 5.8%; P < 0.001. Conclusions: Advancing age and female sex are associated with a higher burden of atrial fibrosis in patients with AF. Women with a prior history of stroke also have higher fibrosis compared with both women and men without history of stroke. Advanced fibrosis may explain the female and age association with stroke in AF.

Improvement in estimated glomerular filtration rate in patients with chronic kidney disease undergoing catheter ablation for atrial fibrillation.

INTRODUCTION: Chronic kidney disease (CKD) and atrial fibrillation (AF) often coexist. We studied the association of CKD with atrial fibrosis and the effect of AF ablation on kidney function. METHODS: AF patients who had a pre- and postablation serum creatinine and who completed a late gadolinium enhancement cardiac magnetic resonance imaging (MRI; LGE-MRI) prior to ablation were included. Estimated glomerular filtration rate (eGFR) was calculated and CKD was staged using the National Kidney Foundation guidelines. Patients with eGFR <30 mL/min/1.73 m(2) were excluded. LGE-MRI was used to quantify atrial fibrosis. Patients were followed for recurrence and change in eGFR. RESULTS: A total of 392 patients were included in the study. A total of 118 (30.2%) had CKD stage 1, 198 (50.4%) CKD stage 2, 56 (14.3%) CKD stage 3A, and 20 (5.1%) CKD stage 3B. Patients with advanced CKD were more likely to be male and to have cardiovascular disease. Atrial fibrosis was not significant different between included CKD stages: 15.8 ± 8.8%, 16.6 ± 12.1%, 17.1 ± 10.4%, and 16.5 ± 8.4% for CKD stage 1, 2, 3A, and 3B, respectively (P = 0.476). At a median of 115 days following ablation, eGFR increased significantly in CKD stage 2 (74 ± 9 to 80 ± 23; P = 0.04), 3A (53 ± 5 to 69 ± 24; P < 0.001), and 3B (40 ± 4 to 71 ± 28; P < 0.01) and decreased in CKD stage 1 (109 ± 18 to 82 ± 28; P < 0.001). Arrhythmia recurrence was associated with atrial fibrosis (hazard ratio [HR] = 1.04, P < 0.01) and persistent AF (HR = 1.5; P = 0.04) but not with CKD stage (HR = 0.98; P = 0.89). CONCLUSIONS: Restoring sinus rhythm with ablation leads to significant improvement of renal function in patients with chronic kidney disease.

MRI Assessment of Ablation-Induced Scarring in Atrial Fibrillation: Analysis from the DECAAF Study.

BACKGROUND: There is limited knowledge on the extent and location of scarring that results from catheter ablation and its role in suppressing atrial fibrillation (AF). We examined the effect of atrial fibrosis and ablation-induced scarring on catheter ablation outcomes in AF. METHODS: We conducted a prospective multicenter study that enrolled 329 AF patients presenting for catheter ablation. Delayed enhancement magnetic resonance imaging (DE-MRI) of the left atrium was obtained preablation. Scarring was evaluated in 177 patients with a DE-MRI scan obtained 90 days postablation. We evaluated residual fibrosis, defined as preablation atrial fibrosis not covered by ablation scar. The primary outcome was freedom from recurrent atrial arrhythmia. RESULTS: In the analysis cohort of 177 patients, preablation fibrosis was 18.7 ± 8.7% of the atrial wall. Ablation aimed at pulmonary vein (PV) isolation was performed in 163 patients (92.1%). Ablation-induced scar averaged 10.6 ± 4.4% of the atrial wall. Scarring completely encircled all 4 PVs only in 12 patients (7.3%). Residual fibrosis was calculated at 15.8 ± 8.0%. At 325 days follow-up, 35% of patients experienced recurrent arrhythmia. Multivariable Cox proportional hazards models demonstrated that baseline atrial fibrosis (HR and 95% CIs) (1.09 [1.06-1.12], P < 0.001) and residual fibrosis (1.09 [1.05-1.13], P < 0.001) were associated with atrial arrhythmia recurrence, while PV encirclement and overall scar were not. CONCLUSIONS: Catheter ablation of AF targeting PVs rarely achieves permanent encircling scar in the intended areas. Overall atrial fibrosis present at baseline and residual fibrosis uncovered by ablation scar are associated with recurrent arrhythmia.

Lesion formation after pulmonary vein isolation using the advance cryoballoon and the standard cryoballoon: lessons learned from late gadolinium enhancement magnetic resonance imaging.

AIMS: To compare ablation lesion formation after pulmonary vein isolation (PVI) using the standard cryoballoon (CB-S) vs. the re-designed cryoballoon Arctic Front Advance (CB-A) using late gadolinium enhancement magnetic resonance imaging (LGE-MRI) 3 months post-ablation. METHODS AND RESULTS: Thirty-six consecutive patients with paroxysmal or short-lasting persistent atrial fibrillation (AF) were evaluated prospectively after PVI using the CB-S in the first 18 patients and the CB-A in the subsequent 18 patients. All patients underwent LGE-MRI and a 7-day Holter electrocardiogram monitoring 3 months after ablation. Fifty-six per cent of the patients were male (mean age 63.0 ± 9.1 years). Fifty-six per cent in the first group and 89% in the second group were free of AF recurrence 3 months after ablation (P = 0.025). Three months after ablation, LGE-MRI of the left atrium showed complete circular lesions in 35% of PVs in the first group and in 32% of PVs in the second group (n.s.). The left PVs showed a significantly higher proportion of PV segments with complete ablation lesions compared with the right PVs (83 vs. 34%; P < 0.001). CONCLUSION: Cardiac MRI is able to visualize induced ablation lesions after PVI and might be suitable to quantify ablation lesion amount. Ablation lesion formation did not differ significantly in patients treated with the CB-S vs. the CB-A, despite a significantly lower rate of AF recurrence after 3 months in the CB-A group. Left PVs showed a significantly higher amount of ablation lesions compared with the right PVs. Larger and randomized studies are needed to understand the relationship between representable tissue lesions and success rates.

Association of atrial tissue fibrosis identified by delayed enhancement MRI and atrial fibrillation catheter ablation: the DECAAF study.

IMPORTANCE: Left atrial fibrosis is prominent in patients with atrial fibrillation (AF). Extensive atrial tissue fibrosis identified by delayed enhancement magnetic resonance imaging (MRI) has been associated with poor outcomes of AF catheter ablation. OBJECTIVE: To characterize the feasibility of atrial tissue fibrosis estimation by delayed enhancement MRI and its association with subsequent AF ablation outcome. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, prospective, observational cohort study of patients diagnosed with paroxysmal and persistent AF (undergoing their first catheter ablation) conducted between August 2010 and August 2011 at 15 centers in the United States, Europe, and Australia. Delayed enhancement MRI images were obtained up to 30 days before ablation. MAIN OUTCOMES AND MEASURES: Fibrosis quantification was performed at a core laboratory blinded to the participating center, ablation approach, and procedure outcome. Fibrosis blinded to the treating physicians was categorized as stage 1 (<10% of the atrial wall), 2 (≥10%-<20%), 3 (≥20%-<30%), and 4 (≥30%). Patients were followed up for recurrent arrhythmia per current guidelines using electrocardiography or ambulatory monitor recording and results were analyzed at a core laboratory. Cumulative incidence of recurrence was estimated by stage at days 325 and 475 after a 90-day blanking period (standard time allowed for arrhythmias related to ablation-induced inflammation to subside) and the risk of recurrence was estimated (adjusting for 10 demographic and clinical covariates). RESULTS: Atrial tissue fibrosis estimation by delayed enhancement MRI was successfully quantified in 272 of 329 enrolled patients (57 patients [17%] were excluded due to poor MRI quality). There were 260 patients who were followed up after the blanking period (mean [SD] age of 59.1 [10.7] years, 31.5% female, 64.6% with paroxysmal AF). For recurrent arrhythmia, the unadjusted overall hazard ratio per 1% increase in left atrial fibrosis was 1.06 (95% CI, 1.03-1.08; P < .001). Estimated unadjusted cumulative incidence of recurrent arrhythmia by day 325 for stage 1 fibrosis was 15.3% (95% CI, 7.6%-29.6%); stage 2, 32.6% (95% CI, 24.3%-42.9%); stage 3, 45.9% (95% CI, 35.5%-57.5%); and stage 4, 51.1% (95% CI, 32.8%-72.2%) and by day 475 was 15.3% (95% CI, 7.6%-29.6%), 35.8% (95% CI, 26.2%-47.6%), 45.9% (95% CI, 35.6%-57.5%), and 69.4% (95% CI, 48.6%-87.7%), respectively. Similar results were obtained after covariate adjustment. The addition of fibrosis to a recurrence prediction model that includes traditional clinical covariates resulted in an improved predictive accuracy with the C statistic increasing from 0.65 to 0.69 (risk difference of 0.05; 95% CI, 0.01-0.09). CONCLUSIONS AND RELEVANCE: Among patients with AF undergoing catheter ablation, atrial tissue fibrosis estimated by delayed enhancement MRI was independently associated with likelihood of recurrent arrhythmia. The clinical implications of this association warrant further investigation.

Effects of meditation on health promoting protective factors of persons with cardiovascular disease-a quasi-experimental pilot study with pre-post comparison.

Background: The aim of this pilot study is to determine, in the context of a controlled intervention study, whether the health-promoting personal protective factors of sense of coherence, resilience, and self-compassion are strengthened by the practice of Metta meditation in individuals with cardiovascular disease. The interactions between mind and body play a pivotal role in health and mortality. Lifestyle factors and especially stress also play a decisive role in the development and progression of cardiovascular diseases. With health-promoting personal protective factors, which can be actively formed over the entire lifespan, stressors can be managed more adequately. Methods: Data collection will be conducted as part of a controlled nonrandomized longitudinal pilot intervention study that will enrol individuals with cardiovascular disease (n=29). After the first interview, a 12-week Metta meditation course will start for the intervention group (IG) (n=9), while the control group (CG) (n=20) will receive no intervention. The Minnesota Living with Heart Failure® Questionnaire (MLHFQ), the 13-item Sense of Coherence Scale (SOC-13), the Resilience Scale, the Self-Compassion Scale short form (SCS-sf) German version, the German version of the 10-item Perceived Stress Scale (PSS-10), and the Stress Coping subscale of the Stress and Coping Inventory (SCI) are used at both measurement time (MT) points. In addition, blood pressure parameters are collected. Furthermore, selected literature will be consulted to integrate the evaluated data into existing research findings. Results: The health-promoting personal competencies of sense of coherence, resilience, and self-compassion were not strengthened by the practice of Metta meditation in individuals with cardiovascular disease. However, there was a significant reduction in perceived stress {F[1, 27] =4.351, P=0.047, f=0.402} and improved stress coping skills {F[1, 26] =6.790, P=0.02, f=0.511} in the IG. Furthermore, the frequency of rehospitalization {F[1, 27] =5.607, P=0.03, f=0.456} differed significantly in the pre-post comparison. Conclusions: Due to the insufficient size of the sample, the results are only exploratory in nature and should therefore only be considered preliminary. Also, the correlations between the significant changes in the parameters and Metta meditation cannot be finally assessed. For this purpose, further studies with larger samples are needed.

Direct-to-catheter ablation versus second line catheter ablation for persistent atrial fibrillation: Effect on arrhythmia recurrence, AF burden, early left atrium remodeling and quality of life.

BACKGROUND: Catheter ablation has obtained class 1 indication in ablation of young, healthy patients with symptomatic paroxysmal atrial fibrillation (AF). Anti-arrhythmic drugs (AADs) remain first-line therapy before ablating persistent AF (PersAF). We sought to evaluate the efficacy of a direct-to-catheter ablation approach against catheter ablation post AADs in PersAF. METHODS: In this DECAAF II subanalysis, patients were stratified into two subgroups: 'Direct-to-catheter' group comprising patients who had not received AADs prior to ablation, and'second-line ablation' group, comprising patients who had been on any AAD therapy at any time before ablation. Patients were followed over 18 months. The primary outcome was AF recurrence. Secondary outcomes included AF burden, quality of life (QoL) that assessed by the AFSS and SF-36 scores, and changes in the left atrial volume index (LAVI) assessed by LGE-MRI scans. RESULTS: The analysis included 815 patients, with 279 classified as'direct-to-catheter' group and 536 classified as'Second-line ablation' group. The primary outcome was similar between both groups (44.8% vs 44.4%, p > 0.05), as was AF burden (20% vs 16%, p > 0.05). Early remodeling, reflected by LAVI reduction, was similar between the groups (9.1 [1.6-18.0] in the second-line ablation group and 9.5 [2.5-19.7] in the direct-to-catheter group, p > 0.05). QoL pre/post ablation was also similar (p > 0.05). On multivariate analysis, history of AAD was not predictive of AF recurrence(p > 0.05). CONCLUSION: Prior AAD therapy demonstrated minimal impact on atrial remodeling and QoL improvement, in addition to limited benefit on AF recurrence and burden post-ablation in patients with PersAF. Additional studies are warranted to explore the efficacy of catheter ablation as a first-line therapy in PersAF.

Sex-specific outcomes and left atrial remodeling following catheter ablation of persistent atrial fibrillation: results from the DECAAF II trial.

BACKGROUND: Catheter ablation is recognized as an effective treatment for atrial fibrillation (AF). Despite its effectiveness, significant sex-specific differences have been observed, which influence the outcomes of the procedure. This study explores these differences in a cohort of patients with persistent AF. We aim to assess sex differences in baseline characteristics, symptoms, quality of life, imaging findings, and response to catheter ablation in patients with persistent AF. METHODS: This post hoc analysis of the DECAAF II trial evaluated 815 patients (161 females, 646 males). Between July 2016 and January 2020, participants were enrolled and randomly assigned to receive either personalized ablation targeting left atrial (LA) fibrosis using DE-MRI in conjunction with pulmonary vein isolation (PVI) or PVI alone. In this analysis, we aimed to compare female and male patients in the full cohort in terms of demographics, risk factors, medications, and outcomes such as AF recurrence, AF burden, LA volume reduction assessed by LGE-MRI before and 3 months after ablation, quality of life assessed by the SF-36 score, and safety outcomes. Statistical methods included t-tests, chi-square, and multivariable Cox regression. RESULTS: Females were generally older with more comorbidities and experienced higher rates of arrhythmia recurrence post-ablation (53.3% vs. 40.2%, p < 0.01). Females also showed a higher AF burden (21% vs. 16%, p < 0.01) and a smaller reduction in left atrial volume indexed to body surface area post-ablation compared to male patients (8.36 (9.94) vs 11.35 (13.12), p-value 0.019). Quality of life scores were significantly worse in females both pre- and post-ablation (54 vs. 66 pre-ablation; 69 vs. 81 post-ablation, both p < 0.01), despite similar improvements across sexes. Safety outcomes and procedural parameters were similar between male and female patients. CONCLUSION: The study highlights significant differences in the outcomes of catheter ablation of persistent AF between sexes, with female patients showing worse quality of life, higher recurrence of AF and AF burden after ablation, and worse LA remodeling.

Lesion Delivery and Scar Formation in Catheter Ablation for Atrial Fibrillation The DECAAF II Trial.

BACKGROUND: The DECAAF-II randomized trial showed no difference in AF recurrence with additional delayed enhancement MRI (DE-MRI) fibrosis-targeted ablation to pulmonary vein isolation (PVI) in persistent AF. OBJECTIVES: We evaluated the impact of lesion delivery on ablation-induced scarring and AF recurrence. METHODS: Lesions delivered, targeting fibrotic and non-fibrotic areas identified from pre-ablation DE-MRI, were studied in relation to ablation-induced scarring on 3-months DE-MRI, including their association with arrhythmia recurrence. RESULTS: 593 patients, treated with radiofrequency were analyzed: 293 underwent PVI and 300 underwent additional fibrosis-guided ablation. Lesion analysis showed that 80.9% in the MRI fibrosis-guided group vs 16.5% in the PVI group (p<0.001), had ≥ 40% of baseline fibrosis targeted. MRI assessment of ablation-induced scar showed that 44.8% of fibrosis-guided ablation and 15.5% of PVI had ≥ 40% of their fibrosis covered by scar (P<0.001), demonstrating a significant attenuation from lesions delivered to scar formed. In the overall population, fibrosis coverage with scar was not associated with recurrence (HR 0.90, 95% confidence interval [CI] 0.80-1.01, p = 0.08 per 20% increase). In patients with baseline fibrosis <20%, fibrosis coverage with scar was associated with lower recurrence than PVI (HR 0.85; 95% CI [0.73-0.97]; p=0.03), whereas the association was not significant when baseline fibrosis ≥20% (HR 0.97; [0.80-1.17], p=0.77). Significant center variation was observed in fibrosis targeting and coverage with scarring. CONCLUSIONS: Radiofrequency ablation lesions do not uniformly result in scar formation. Post hoc analysis suggests reduced arrhythmia recurrence when ablation-induced scarring covers fibrotic regions in patients with low baseline fibrosis.

Feasibility and Efficacy of Transcatheter Tricuspid Valve Repair in Patients with Cardiac Implanted Electrical Devices and Trans-Tricuspid Leads.

BACKGROUND: Transcatheter tricuspid valve repair using the edge-to-edge-technique (TEER) has emerged as an alternative therapy in patients with severe tricuspid regurgitation (TR) and high surgical risk. This study aimed to evaluate the feasibility and efficacy of tricuspid valve TEER in patients with cardiac implanted electric devices (CIEDs). METHODS: All patients who underwent tricuspid valve TEER at our center were retrospectively included. Patients were classified according to the presence of CIEDs. Procedure success was defined as implantation of at least one clip and the reduction of TR of at least one grade. Procedure success and intrahospital outcome were compared between the two groups. RESULTS: One-hundred and six consecutive patients underwent tricuspid TEER (age 80.1 ± 6.4 years, male = 42; 39.6%). Among them, 25 patients (23.6%, age 80.6 ± 7.3 years, male = 14; 56%) had CIEDs. Patients with CIEDs had a significantly lower left ventricular ejection fraction (LV-EF) compared to those without CIEDs (47.2 ± 15% vs. 56.2 ± 8.2%, p = 0.004, respectively). Moreover, arterial hypertension was more common in patients with CIEDs (96% vs. 79%, p = 0.048). The success of the procedure did not differ between the non-CIED vs. CIED group (93.8% vs. 92%, p = 0.748). Furthermore, the number and position of implanted clips, the duration of the procedure, the post-procedural pressure gradient across the tricuspid valve, and post-procedural TR severity were comparable between both groups. CONCLUSION: Tricuspid valve TEER is feasible and efficient in patients with CIEDs. The success of the procedure, as well as the intrahospital outcome were comparable between patients with and without CIEDs.

Atrial fibrosis quantified using late gadolinium enhancement MRI is associated with sinus node dysfunction requiring pacemaker implant.

INTRODUCTION: Sinus node dysfunction (SND) commonly manifests with atrial arrhythmias alternating with sinus pauses and sinus bradycardia. The underlying process is thought to be because of atrial fibrosis. We assessed the value of atrial fibrosis, quantified using late gadolinium enhanced-MRI (LGE-MRI), in predicting significant SND requiring pacemaker implant. METHODS: Three hundred forty-four patients with atrial fibrillation (AF) presenting for catheter ablation underwent LGE-MRI. Left atrial (LA) fibrosis was quantified in all patients and right atrial (RA) fibrosis in 134 patients. All patients underwent catheter ablation with pulmonary vein isolation with posterior wall and septal debulking. Patients were followed prospectively for 329 ± 245 days. Ambulatory monitoring was instituted every 3 months. Symptomatic pauses and bradycardia were treated with pacemaker implantation per published guidelines. RESULTS: The average patient age was 65 ± 12 years. The average wall fibrosis was 16.7 ± 11.1% in the LA, and 5.3 ± 6.4% in the RA. RA fibrosis was correlated with LA fibrosis (R(2) = 0.26; P < 0.01). Patients were divided into 4 stages of LA fibrosis (Utah I: <5%, Utah II: 5-20%, Utah III: 20-35%, Utah IV: >35%). Twenty-two patients (mean atrial fibrosis, 23.9%) required pacemaker implantation during follow-up. Univariate and multivariate analysis identified LA fibrosis stage (OR, 2.2) as a significant predictor for pacemaker implantation with an area under the curve of 0.704. CONCLUSIONS: In patients with AF presenting for catheter ablation, LGE-MRI quantification of atrial fibrosis demonstrates preferential LA involvement. Significant atrial fibrosis is associated with clinically significant SND requiring pacemaker implantation.

Predictors of treatment in acute coronary syndromes in the elderly: impact on decision making and clinical outcome after interventional versus conservative treatment.

BACKGROUND: Management of elderly patients with acute coronary syndromes (ACS) is not standardized and physicians discretion for invasive versus conservative strategies lacks sufficient evidence. The purpose of this analysis was, therefore, to evaluate treatment strategies and outcomes of elderly patients with ACS and to highlight reasons for the treatment decision in a consecutive series of elderly patients. METHODS: This is a retrospective analysis of 1,001 elderly patients (>75 years) presenting with ACS. Patients were identified on the basis of their final discharge diagnosis. Baseline data, past medical history, cardiac and noncardiac concomitant diseases, treatment strategy, and adverse outcomes were evaluated, using patient's charts. Various co-variates were used to determine the association or predictive value of these co-variates to the invasive versus conservative management of the subjects. Thirty-day mortality and long-term survival were assessed either directly or in discharged patients via telephone interview with the patients, the patients' relatives or the primary care physicians. RESULTS: A total of 776 (77.5%) patients were treated invasively and 225 (22.5%) conservatively. Logistic regression analysis revealed that patients with advanced age, Killip class > II, pre-existing coronary artery disease, prior stroke, pre-existing renal failure, obesity, non-ST-elevation myocardial infarction, prior ACS, and the presence of supraventricular arrhythmias were significantly more likely to undergo conservative treatment. In-hospital mortality was significantly higher in conservatively treated patients (P < 0.001). CONCLUSION: In this retrospective analysis, we identified age as the main predictor for a conservative treatment strategy in elderly patients, albeit an invasive strategy was associated with a significantly better outcome.

[Cardiac magnetic resonance imaging and the myocardium : Differentiation between vital and nonvital tissue]. / Kardiale Magnetresonanztomographie und Myokard : Differenzierung zwischen vitalem und avitalem Gewebe.

Cardiac magnetic resonance (cMR), a well-established imaging tool, is indispensable in the diagnosis and management of cardiovascular disease. Given its high spatial resolution and ability to characterize tissue, cMR represents the gold standard in determining myocardial viability. Gadolinium-based contrast-enhanced cMR can accurately identify myocardial scars and fibrosis in the ventricle and the atria, and differentiate it from normal myocardium. Gadolinium is an extracellular molecule which has been shown to be safe and beneficial in magnetic resonance imaging (MRI). Due to the larger extracellular space in myocardial scars, there is more uptake (wash-in) and slower elimination (wash-out) of gadolinium in those areas as opposed to normal myocardium. When imaged several minutes after intravenous administration of gadolinium, nonviable myocardial areas appear brighter than viable myocardium. The use of late-gadolinium enhancement (LGE) technique in assessing myocardial viability has been shown to highly correlate with histological examinations. Furthermore, this technique is highly reproducible and has very high intra- and interobserver agreement. Extent of LGE after myocardial infarction predicts the occurrence of adverse cardiovascular events. Moreover, LGE is highly accurate in predicting functional recovery of dysfunctional myocardial segments in patients undergoing revascularization and consequently has a key role in guiding revascularization procedures. In addition, use of LGE in the identification of myocardial fibrosis or myocardial damage in inflammatory myocardial disease helps to differentiate the type of cardiomyopathy and to predict sudden cardiac death among patients with heart failure. The role of LGE-MRI in the field of electrophysiology through recognition of different substrate for arrythmias and guiding the ablation therapy is steadily increasing and has fundamentally changed our understanding of atrial myopathy.

Gender-specific differences in patients who underwent left atrial appendage closure.

Aim: We aimed to study gender-specific differences in patients who underwent left atrial appendage closure (LAAC). Materials & methods: A total of 201 consecutive patients who underwent LAAC were enrolled. The EQ-5D-3L questionnaire was employed before and 3 months post-LAAC to study the quality of life. Results: Women had a higher score for Anxiety/Depression before implantation. Three months after LAAC, both groups showed a significant improvement in mobility, self-care and usual activities. The female gender had a significant improvement in health state 3 months after implantation than their male counterparts. Conclusion: Our data shows an improvement in mobility, self-care, usual activities and the overall health state in all patients after LAAC. This potential improvement, most likely caused by the discontinuation of oral anticoagulants, should be considered an indication for LAAC.

Atrial fibrillation is the most common persistent cardiac arrhythmia that affects millions worldwide with far-reaching sociomedical consequences. Oral anticoagulation is the current gold standard in stroke prevention in patients with atrial fibrillation. Because of bleeding complications, left atrial appendage closure (LAAC), as an alternative therapy, has excellent clinical significance today. We studied the gender-specific differences in the quality of life in patients who underwent LAAC. The results of our study show a significant improvement in the overall health status in women 3 months after LAAC compared with their male counterparts. We believe that the interruption of the oral anticoagulants was the reason for this improvement. For this reason, the LAAC may be considered as a stroke prevention method in this group of patients.

Successful Thrombolysis of Acute Upper Limb Ischemia Using Ekosonic Endovascular System Ultrasound Catheter in a Patient With Atrial Fibrillation.

Acute upper limb ischemia is considered a vascular emergency. These events are mostly thromboembolic and are often detected in patients with atrial fibrillation (AF). Surgical thrombectomy and percutaneous mechanical thrombectomy are the usual methods to treat this medical emergency. In this case, we report the case of a 75-years old woman with a history of AF who initially presented to our center because of syncope resulting from Torsades de pointes due to a known long-QT syndrome. Those episodes were treated adequately from the implanted ICD. In addition to the symptoms of syncope, the patient also noted symptoms of right upper-limb ischemia. Using duplex sonography, we noticed a thrombotic occlusion at the level of the axillary artery. Using femoral access, we performed an antegrade angiography of the axillary artery, which confirmed a fresh thrombotic occlusion. The initially performed thrombus aspiration wasn't successful, and the decision was made to use an ekosonic endovascular system (Ekosonic ™ Endovascular System, Boston Scientific, EKOS) catheter to perform catheter-directed thrombolysis. Locally, 10 mg Actilyse were administrated. Then an EKOS Catheter was delivered to the occlusion area and was placed for 6 h. Symptoms of ischemia were resolved, and the angiographic control showed normal flow in the axillary artery. The patient was discharged without any local deficits of the right hand.