Personalized pulmonary vein isolation with very high-power short-duration lesions guided by left atrial wall thickness: the QDOT-by-LAWT randomized trial.

AIMS: Pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) using very high-power short-duration (vHPSD) radiofrequency (RF) ablation proved to be safe and effective. However, vHPSD applications result in shallower lesions that might not be always transmural. Multidetector computed tomography-derived left atrial wall thickness (LAWT) maps could enable a thickness-guided switching from vHPSD to the standard-power ablation mode. The aim of this randomized trial was to compare the safety, the efficacy, and the efficiency of a LAWT-guided vHPSD PVI approach with those of the CLOSE protocol for PAF ablation (NCT04298177). METHODS AND RESULTS: Consecutive patients referred for first-time PAF ablation were randomized on a 1:1 basis. In the QDOT-by-LAWT arm, for LAWT ≤2.5 mm, vHPSD ablation was performed; for points with LAWT > 2.5 mm, standard-power RF ablation titrating ablation index (AI) according to the local LAWT was performed. In the CLOSE arm, LAWT information was not available to the operator; ablation was performed according to the CLOSE study settings: AI ≥400 at the posterior wall and ≥550 at the anterior wall. A total of 162 patients were included. In the QDOT-by-LAWT group, a significant reduction in procedure time (40 vs. 70 min; P < 0.001) and RF time (6.6 vs. 25.7 min; P < 0.001) was observed. No difference was observed between the groups regarding complication rate (P = 0.99) and first-pass isolation (P = 0.99). At 12-month follow-up, no significant differences occurred in atrial arrhythmia-free survival between groups (P = 0.88). CONCLUSION: LAWT-guided PVI combining vHPSD and standard-power ablation is not inferior to the CLOSE protocol in terms of 1-year atrial arrhythmia-free survival and demonstrated a reduction in procedural and RF times.

Scar architecture affects the electrophysiological characteristics of induced ventricular arrhythmias in hypertrophic cardiomyopathy.

AIMS: Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) detects myocardial scarring, a risk factor for ventricular arrhythmias (VAs) in hypertrophic cardiomyopathy (HCM). The LGE-CMR distinguishes core, borderzone (BZ) fibrosis, and BZ channels, crucial components of re-entry circuits. We studied how scar architecture affects inducibility and electrophysiological traits of VA in HCM. METHODS AND RESULTS: We correlated scar composition with programmed ventricular stimulation-inducible VA features using LGE intensity maps. Thirty consecutive patients were enrolled. Thirteen (43%) were non-inducible, 6 (20%) had inducible non-sustained, and 11 (37%) had inducible sustained mono (MMVT)- or polymorphic VT/VF (PVT/VF). Of 17 induced VA, 13 (76%) were MMVT that either ended spontaneously, persisted as sustained monomorphic, or degenerated into PVT/VF. Twenty-seven patients (90%) had LGE. Of these, 17 (57%) had non-sustained or sustained inducible VA. Scar mass significantly increased (P = 0.002) from non-inducible to inducible non-sustained and sustained VA patients in both the BZ and core components. Borderzone channels were found in 23%, 67%, and 91% of non-inducible, inducible non-sustained, and inducible sustained VA patients (P = 0.003). All 13 patients induced with MMVT or monomorphic-initiated PVT/VF had LGE. The origin of 10/13 of these VTs matched scar location, with 8/10 of these LGE regions showing BZ channels. During follow-up (20 months, interquartile range: 7-37), one patient with BZ channels and inducible PVT had an ICD shock for VF. CONCLUSION: Scar architecture determines inducibility and electrophysiological traits of VA in HCM. Larger studies should explore the role of complex LGE patterns in refining risk assessment in HCM patients.

Assessing left atrial intramyocardial fat infiltration from computerized tomography angiography in patients with atrial fibrillation.

AIMS: Epicardial adipose tissue might promote atrial fibrillation (AF) in several ways, including infiltrating the underlying atrial myocardium. However, the role of this potential mechanism has been poorly investigated. The aim of this study is to evaluate the presence of left atrial (LA) infiltrated adipose tissue (inFAT) by analysing multi-detector computer tomography (MDCT)-derived three-dimensional (3D) fat infiltration maps and to compare the extent of LA inFAT between patients without AF history, with paroxysmal, and with persistent AF. METHODS AND RESULTS: Sixty consecutive patients with AF diagnosis (30 persistent and 30 paroxysmal) were enrolled and compared with 20 age-matched control; MDCT-derived images were post-processed to obtain 3D LA inFAT maps for all patients. Volume (mL) and mean signal intensities [(Hounsfield Units (HU)] of inFAT (HU -194; -5), dense inFAT (HU -194; -50), and fat-myocardial admixture (HU -50; -5) were automatically computed by the software. inFAT volume was significantly different across the three groups (P = 0.009), with post-hoc pairwise comparisons showing a significant increase in inFAT volume in persistent AF compared to controls (P = 0.006). Dense inFAT retained a significant difference also after correcting for body mass index (P = 0.028). In addition, more negative inFAT radiodensity values were found in AF patients. Regional distribution analysis showed a significantly higher regional distribution of LA inFAT at left and right superior pulmonary vein antra in AF patients. CONCLUSION: Persistent forms of AF are associated with greater degree of LA intramyocardial adipose infiltration, independently of body mass index. Compared to controls, AF patients present higher LA inFAT volume at left and right superior pulmonary vein antra.

Clinical impact of aging on outcomes of cardioneuroablation for reflex syncope or functional bradycardia: Results from the cardionEuroabLation: patiEnt selection, imaGe integrAtioN and outComEs-The ELEGANCE multicenter study.

BACKGROUND: Cardioneuroablation (CNA) is a novel treatment for reflex syncope. The effect of aging on CNA efficacy is not fully understood. OBJECTIVE: The purpose of this study was to assess the impact of aging on candidacy and efficacy of CNA for treating vasovagal syncope (VVS), carotid sinus syndrome (CSS), and functional bradyarrhythmia. METHODS: The ELEGANCE (cardionEuroabLation: patiEnt selection, imaGe integrAtioN and outComEs) multicenter study assessed CNA in patients with reflex syncope or severe functional bradyarrhythmia. Patients underwent pre-CNA Holter electrocardiography (ECG), head-up tilt testing (HUT), and electrophysiological study. CNA candidacy and efficacy was assessed in 14 young (18-40 years), 26 middle-aged (41-60 years), and 20 older (>60 years) patients. RESULTS: Sixty patients (37 men; mean age 51 ± 16 years) underwent CNA. The majority (80%) had VVS, 8% had CSS, and 12% had functional bradycardia/atrioventricular block. Pre-CNA Holter ECG, HUT, and electrophysiological findings did not differ across age groups. Acute CNA success was 93%, without differences between age groups (P = .42). Post-CNA HUT response was negative in 53%, vasodepressor in 38%, cardioinhibitory in 7%, and mixed in 2%, without differences across age groups (P = .59). At follow-up (8 months, interquartile range 4-15), 53 patients (88%) were free of symptoms. Kaplan-Meier curves did not show differences in event-free survival between age groups (P = .29). The negative predictive value of a negative HUT was 91.7%. CONCLUSION: CNA is a viable treatment for reflex syncope and functional bradyarrhythmia in all ages, and is highly effective in mixed VVS. HUT is a key step in postablation clinical assessment.

Safety and performance of MR-conditional pacing systems with automated MRI mode at 1.5 and 3 Tesla.

OBJECTIVES: To evaluate at 1.5 and 3 T MRI the safety and performance of trademarked ENO®, TEO®, or OTO® pacing systems with automated MRI Mode and the image quality of non-enhanced MR examinations. METHODS: A total of 267 implanted patients underwent MRI examination (brain, cardiac, shoulder, cervical spine) at 1.5 (n = 126) or 3 T (n = 141). MRI-related device complications, lead electrical performances stability at 1-month post-MRI, proper functioning of the automated MRI mode and image quality were evaluated. RESULTS: Freedom from MRI-related complications at 1 month post-MRI was 100% in both 1.5 and 3 T arms (both p < 0.0001). The stability of pacing capture threshold was respectively at 1.5 and 3 T (atrial:: 98.9% (p = 0.001) and 100% (p < 0.0001); ventricular: both 100% (p < 0001)). The stability of sensing was respectively at 1.5 and 3 T (atrial: 100% (p = 0.0001) and 96.9% (p = 0.01); ventricular: 100% (p < 0.0001) and 99.1% (p = 0.0001)). All devices switched automatically to the programmed asynchronous mode in the MRI environment and to initially programmed mode after the MRI exam. While all MR examinations were assessed as interpretable, artifacts deteriorated a subset of examinations including mostly cardiac and shoulder ones. CONCLUSION: This study demonstrates the safety and electrical stability of ENO®, TEO®, or OTO® pacing systems at 1 month post-MRI at 1.5 and 3 T. Even if artifacts were noticed in a subset of examinations, overall interpretability was preserved. CLINICAL RELEVANCE STATEMENT: ENO®, TEO®, and OTO® pacing systems switch to MR-mode when detecting magnetic field and switch back on conventional mode after MRI. Their safety and electrical stability at 1 month post MRI were shown at 1.5 and 3 T. Overall interpretability was preserved. KEY POINTS: • Patients implanted with an MRI conditional cardiac pacemaker can be safely scanned under 1.5 or 3 Tesla MRI with preserved interpretability. • Electrical parameters of the MRI conditional pacing system remain stable after a 1.5 or 3 Tesla MRI scan. • The automated MRI mode enabled the automatic switch to asynchronous mode in the MRI environment and to initial settings after the MRI scan in all patients.

Personalized pulmonary vein antrum isolation guided by left atrial wall thickness for persistent atrial fibrillation.

AIMS: Pulmonary vein (PV) antrum isolation proved to be effective for treating persistent atrial fibrillation (PeAF). We sought to investigate the results of a personalized approach aimed at adapting the ablation index (AI) to the local left atrial wall thickness (LAWT) in a cohort of consecutive patients with PeAF. METHODS AND RESULTS: Consecutive patients referred for PeAF first ablation were prospectively enrolled. The LAWT three-dimensional maps were obtained from pre-procedure multidetector computed tomography and integrated into the navigation system. Ablation index was titrated according to the local LAWT, and the ablation line was personalized to avoid the thickest regions while encircling the PV antrum. A total of 121 patients (69.4% male, age 64.5 ± 9.5 years) were included. Procedure time was 57 min (IQR 50-67), fluoroscopy time was 43 s (IQR 20-71), and radiofrequency (RF) time was 16.5 min (IQR 14.3-18.4). The median AI tailored to the local LAWT was 387 (IQR 360-410) for the anterior wall and 335 (IQR 300-375) for the posterior wall. First-pass PV antrum isolation was obtained in 103 (85%) of the right PVs and 103 (85%) of the left PVs. Median LAWT values were higher for PVs without first-pass isolation as compared to the whole cohort (P = 0.02 for left PVs and P = 0.03 for right PVs). Recurrence-free survival was 79% at 12 month follow-up. CONCLUSION: In this prospective study, LAWT-guided PV antrum isolation for PeAF was effective and efficient, requiring low procedure, fluoroscopy, and RF time. A randomized trial comparing the LAWT-guided ablation with the standard of practice is in progress (ClinicalTrials.gov, NCT05396534).

Outcomes of cavotricuspid isthmus-dependent flutter ablation: randomized study comparing single vs. multiple catheter procedures-the SIMPLE study.

BACKGROUND: Catheter ablation is recommended as first-line therapy for patients with symptomatic typical AFl. Although the conventional multi-catheter approach is the standard of care for cavotricuspid isthmus (CTI) ablation, a single-catheter approach was recently described as a feasible alternative. The present study sought to compare safety, efficacy, and efficiency of single vs. multi-catheter approach for atrial flutter (AFl) ablation. METHODS: In this randomized multi-center study, consecutive patients referred for AFl ablation (n = 253) were enrolled and randomized to multiple vs. single-catheter approach for CTI ablation. In the single-catheter arm, PR interval (PRI) on the surface ECG was used to prove CTI block. Procedural and follow-up data were collected and compared between the two arms. RESULTS: 128 and 125 patients were assigned to the single-catheter and to the multi-catheter arms, respectively. In the single-catheter arm, procedure time was significantly shorter (37 ± 25 vs. 48 ± 27 minutes, p = 0.002) and required less fluoroscopy time (430 ± 461 vs. 712 ± 628 seconds, p < 0.001) and less radiofrequency time (428 ± 316 vs. 643 ± 519 seconds, p < 0.001), achieving a higher first-pass CTI block rate (55 (45%) vs. 37 (31%), p = 0.044), compared with the multi-catheter arm. After a median follow-up of 12 months, 11 (4%) patients experienced AFl recurrences (5 (4%) in the single-catheter arm and 6 (5%) in the multi-catheter arm, p = 0.99). No differences were found in arrhythmia-free survival between arms (log-rank = 0.71). CONCLUSIONS: The single-catheter approach for typical AFl ablation is not inferior to the conventional multiple-catheter approach, reducing procedure, fluoroscopy, and radiofrequency time.

STereotactic Arrhythmia Radioablation (STAR): the Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary consortium (STOPSTORM.eu) and review of current patterns of STAR practice in Europe.

The EU Horizon 2020 Framework-funded Standardized Treatment and Outcome Platform for Stereotactic Therapy Of Re-entrant tachycardia by a Multidisciplinary (STOPSTORM) consortium has been established as a large research network for investigating STereotactic Arrhythmia Radioablation (STAR) for ventricular tachycardia (VT). The aim is to provide a pooled treatment database to evaluate patterns of practice and outcomes of STAR and finally to harmonize STAR within Europe. The consortium comprises 31 clinical and research institutions. The project is divided into nine work packages (WPs): (i) observational cohort; (ii) standardization and harmonization of target delineation; (iii) harmonized prospective cohort; (iv) quality assurance (QA); (v) analysis and evaluation; (vi, ix) ethics and regulations; and (vii, viii) project coordination and dissemination. To provide a review of current clinical STAR practice in Europe, a comprehensive questionnaire was performed at project start. The STOPSTORM Institutions' experience in VT catheter ablation (83% ≥ 20 ann.) and stereotactic body radiotherapy (59% > 200 ann.) was adequate, and 84 STAR treatments were performed until project launch, while 8/22 centres already recruited VT patients in national clinical trials. The majority currently base their target definition on mapping during VT (96%) and/or pace mapping (75%), reduced voltage areas (63%), or late ventricular potentials (75%) during sinus rhythm. The majority currently apply a single-fraction dose of 25 Gy while planning techniques and dose prescription methods vary greatly. The current clinical STAR practice in the STOPSTORM consortium highlights potential areas of optimization and harmonization for substrate mapping, target delineation, motion management, dosimetry, and QA, which will be addressed in the various WPs.

A hybrid clinical and electrocardiographic score to predict the origin of outflow tract ventricular arrhythmias.

BACKGROUND: To predict the outflow tract ventricular arrhythmias (OTVA) site of origin (SOO) before the ablation procedure has important practical implications. The present study sought to prospectively evaluate the accuracy of a clinical and electrocardiographic hybrid algorithm (HA) for the prediction of OTVAs-SOO, and at the same time to develop and to prospectively validate a new score with improved discriminatory capacity. METHODS: In this multicenter study, we prospectively enrolled consecutive patients referred for OTVA ablation (N = 202), and we divided them in a derivation sample and a validation cohort. Surface ECGs during OTVA were analyzed to compare previous published ECG-only criteria and to develop a new score. RESULTS: In the derivation sample (N = 105), the correct prediction rate of HA and ECG-only criteria ranged from 74 to 89%. R-wave amplitude in V3 was the best ECG parameter for discriminating LVOT origin in V3 precordial transition (V3PT) patients, and was incorporated to the novel weighted hybrid score (WHS). WHS correctly classified 99 (94.2%) patients, presenting 90% sensitivity and 96% specificity (AUC 0.97) in the entire population; WHS mantained a 87% sensitivity and 91% specificity (AUC 0.95) in patients with V3PT subgroup. The high discriminatory capacity was confirmed in the validation sample (N = 97): the WHS exhibited an AUC (0.93), and a WHS ≥ 2 allowed a correct prediction of LVOT origin in 87 (90.0%) cases, yielding a sensitivity of 87% and specificity of 90%; moreover, the V3PT subgroup showed an AUC of 0.92, and a punctuation ≥ 2 predicted an LVOT origin with a sensitivity of 94% and specificity of 78%. CONCLUSIONS: The novel hybrid score has proved to accurately anticipate the OTVA's origin, even in those with a V3 precordial transition. A Weighted hybrid score. B Typical examples of the use of the weighted hybrid score. C ROC analysis of WHS and previous ECG criteria for prediction of LVOT origin in the derivation cohort. D ROC analysis of WHS and previous ECG criteria for prediction of LVOT origin in the V3 precordial transition OTVA subgroup.

Long-term outcomes of extended DAPT in a real-life cohort of consecutive STEMI patients.

INTRODUCTION AND OBJECTIVES: Dual antiplatelet therapy (DAPT) duration after ST-segment elevation myocardial infarction (STEMI) remains a matter of debate. METHODS: We analyzed the effect of DAPT on 5-year all-cause mortality, cardiovascular mortality, and cardiovascular readmission or mortality in a cohort of 1-year survivor STEMI patients. RESULTS: A total of 3107 patients with the diagnosis of STEMI were included: 93% of them were discharged on DAPT, a therapy that persisted in 275 high-risk patients at 5 years. Cardiovascular mortality in patients on single antiplatelet therapy vs DAPT at 5 years was 1.4% vs 3.6% (P <.01), respectively, whereas noncardiovascular mortality was 3.3% vs 5.8% (P=.049) at 5 years. Cardiovascular readmission or mortality in patients with single antiplatelet therapy vs DAPT was 11.4% vs 46.5% (P <.001). Extended DAPT was independently associated with worse 5-year all-cause mortality (HR, 2.16; 95%CI, 1.40-3.33), cardiovascular mortality (HR, 2.83; 95%CI, 1.37-5.84), and cardiovascular readmission or mortality (HR, 5.20; 95%CI, 3.96-6.82). These findings were confirmed in propensity score matching and inverse probability weighting analyses. CONCLUSIONS: Our results suggest the hypothesis that, in 1-year STEMI survivors, extending DAPT up to 5 years in high-risk patients does not improve their long-term prognosis.

Preventive substrate ablation in chronic post-myocardial infarction patients with high-risk scar characteristics for ventricular arrhythmias: rationale and design of PREVENT-VT study.

BACKGROUND: Recent studies showed that an early strategy for ventricular tachycardia (VT) ablation resulted in reduction of VT episodes or mortality. Cardiac magnetic resonance (CMR)-derived border zone channel (BZC) mass has proved to be a strong non-invasive predictor of VT in post-myocardial infarction (MI). CMR-guided VT substrate ablation proved to be safe and effective for reducing sudden cardiac death (SCD) and VA occurrence. METHODS: PREVENT-VT is a prospective, randomized, multicenter, and controlled trial designed to evaluate the safety and efficacy of prophylactic CMR-guided VT substrate ablation in chronic post-MI patients with CMR-derived arrhythmogenic scar characteristics. Chronic post-MI patients with late gadolinium enhancement (LGE) CMR will be evaluated. CMR images will be post-processed and the BZC mass measured: patients with a BZC mass > 5.15 g will be eligible. Consecutive patients will be enrolled at 3 centers and randomized on a 1:1 basis to undergo a VT substrate ablation (ABLATE arm) or optimal medical treatment (OMT arm). Primary prevention ICD will be implanted following guideline recommendations, while non-ICD candidates will be implanted with an implantable cardiac monitor (ICM). The primary endpoint is a composite outcome of sudden cardiac death (SCD) or sustained monomorphic VT, either treated by an ICD or documented with ICM. Secondary endpoints are procedural safety and efficiency outcomes of CMR-guided ablation. DISCUSSION: In some patients, the first VA episode causes SCD or severe neurological damage. The aim of the PREVENT-VT is to evaluate whether primary preventive substrate ablation may be a safe and effective prophylactic therapy for reducing SCD and VA occurrence in patients with previous MI and high-risk scar characteristics based on CMR. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04675073, registered on January 1, 2021.

An intensive, structured, mobile devices-based healthcare intervention to optimize the lipid-lowering therapy improves lipid control after an acute coronary syndrome.

Aims: Despite the evidence, lipid-lowering treatment (LLT) in secondary prevention remains insufficient, and a low percentage of patients achieve the recommended LDL cholesterol (LDLc) levels by the guidelines. We aimed to evaluate the efficacy of an intensive, mobile devices-based healthcare lipid-lowering intervention after hospital discharge in patients hospitalized for acute coronary syndrome (ACS). Methods and results: Ambiespective register in which a mobile devices-based healthcare intervention including periodic follow-up, serial lipid level controls, and optimization of lipid-lowering therapy, if appropriate, was assessed in terms of serum lipid-level control at 12 weeks after discharge. A total of 497 patients, of which 462 (93%) correctly adhered to the optimization protocol, were included in the analysis. At the end of the optimization period, 327 (70.7%) patients had LDLc levels ≤ 70 mg/dL. 40% of patients in the LDLc ≤ 70 mg/dL group were upgraded to very-high intensity lipid-lowering ability therapy vs. 60.7% in the LDLc > 70 mg/dL group, p < 0.001. Overall, 38.5% of patients had at least a change in their LLT. Side effects were relatively infrequent (10.7%). At 1-year follow-up, LDLc levels were measured by the primary care physician in 342 (68.8%) of the whole cohort of 497 patients. In this group, 71.1% of patients had LDLc levels ≤ 70 mg/dL. Conclusion: An intensive, structured, mobile devices-based healthcare intervention after an ACS is associated with more than 70% of patients reaching the LDLc levels recommended by the clinical guidelines. In patients with LDLc measured at 1-year follow-up, 71.1% had LDLc levels ≤ 70 mg/dL.

Relationship between the posterior atrial wall and the esophagus: esophageal position and temperature measurement during atrial fibrillation ablation (AWESOME-AF). A randomized controlled trial.

BACKGROUND: Pulmonary vein isolation (PVI) implies unavoidable ablation lesions to the left atrial posterior wall, which is closely related to the esophagus, leading to several potential complications. This study evaluates the usefulness of the esophageal fingerprint in avoiding temperature rises during paroxysmal atrial fibrillation (PAF) ablation. METHODS: Isodistance maps of the atrio-esophageal relationship (esophageal fingerprint) were derived from the preprocedural computerized tomography. Patients were randomized (1:1) into two groups: (1) PRINT group, the PVI line was modified according to the esophageal fingerprint; (2) CONTROL group, standard PVI with operator blinded to the fingerprint. The primary endpoint was temperature rise detected by intraluminal esophageal temperature probe monitoring. Ablation settings were as specified on the Ablate BY-LAW study protocol. RESULTS: Sixty consecutive patients referred for paroxysmal AF ablation were randomized (42 (70%) men, mean age 60 ± 11 years). Temperature rise (> 39.1 °C) occurred in 5 (16%) patients in the PRINT group vs. 17 (56%) in the CONTROL group (p < 0.01). Three AF recurrences were documented at a mean follow-up of 12 ± 3 months (one (3%) in the PRINT group and 2 (6.6%) in the CONTROL group, p = 0.4). CONCLUSION: The esophageal fingerprint allows for a reliable identification of the esophageal position and its use for PVI line deployment results in less frequent esophageal temperature rises when compared to the standard approach. Further studies are needed to evaluate the impact of PVI line modification to avoid esophageal heating on long-term outcomes. The development of new imaging-derived tools could ultimately improve patient safety (NCT04394923).

Real-world cost-effectiveness analysis of NOACs versus VKA for stroke prevention in Spain.

AIMS: A Markov model was adapted to assess the real-world cost-effectiveness of rivaroxaban, dabigatran and apixaban. Each of these non-vitamin K antagonist oral anticoagulants was compared with vitamin K antagonist for stroke prevention in patients with non-valvular atrial fibrillation in Spain. METHODS: All inputs were derived from real-world studies: baseline patient characteristics, clinical event rates, as well as persistence rates for the vitamin K antagonist treatment option. A meta-analysis of real-world studies provided treatment effect and persistence data for rivaroxaban, dabigatran and apixaban, each compared with vitamin K antagonist therapy. The model considered 3-month cycles over a lifetime horizon. The model outcomes included different costs, quality-adjusted life years and life-years gained. Sensitivity analyses were performed to test the robustness of the model. RESULTS: When compared with vitamin K antagonist, rivaroxaban incurred incremental costs of €77 and resulted in incremental quality-adjusted life years of 0.08. The incremental cost per quality-adjusted life year was €952. For the same comparison, the incremental cost per quality-adjusted life year for dabigatran was €4,612. Finally, compared with vitamin K antagonist, the incremental cost per quality-adjusted life year for apixaban was €32,015. The sensitivity analyses confirmed the robustness of the base case results. The probabilities to be cost-effective versus vitamin K antagonist were 94%, 86% and 35%, respectively, for rivaroxaban, dabigatran and apixaban, considering a willingness-to-pay threshold of €22,000 per quality-adjusted life year gained, based on a cost-effectiveness study of the Spanish National Health System. CONCLUSION: These results suggest that rivaroxaban and dabigatran are cost-effective versus vitamin K antagonist for stroke prevention in non-valvular atrial fibrillation, from the Spanish National Health System perspective.

Cardiac Tomography and Cardiac Magnetic Resonance to Predict the Absence of Intracardiac Thrombus in Anticoagulated Patients Undergoing Atrial Fibrillation Ablation.

Background: Pulmonary veins isolation (PVI) is a standard treatment for recurrent atrial fibrillation (AF). Uninterrupted anticoagulation for a minimum of 3 weeks before ablation and exclusion of left atrial (LA) thrombus with transesophageal echography (TEE) immediately before or during the procedure minimize peri-procedural risk. We aimed to demonstrate the utility of cardiac tomography (CT) and cardiac magnetic resonance (CMR) to rule out LA thrombus prior to PVI. Methods: Patients undergoing PVI for recurrent AF were retrospectively evaluated. Only patients that started anticoagulation at least 3 weeks prior to the CT/CMR and subsequently uninterrupted until the ablation procedure were selected. An intracardiac echo (ICE) catheter was used in all patients to evaluate LA thrombus. The results of CT/CMR were compared to ICE imaging. Results: We included 272 consecutive patients averaging 54.5 years (71% male; 30% persistent AF). Average CHA2DS2VASC score was 0.9 ± 0.83 and mean LA diameter was 42 ± 5.7 mm, 111 (41%) patients were on Acenocumarol and 161 (59%) were on direct oral anticoagulants. Anticoagulation was started 227 ± 392 days before the CT/CMR, and 291 ± 416 days before the ablation procedure. CT/CMR diagnosed intracardiac thrombus in two cases, both in the LA appendage. A new CT/CMR revealed resolution of thrombus after six additional months of uninterrupted anticoagulation. No macroscopic thrombus was observed in any patients with ICE (negative predictive value of 100%; p < 0.01). Conclusions: CT and MRI are excellent surrogates to TEE and ICE to rule out intracardiac thrombus in patients adequately anticoagulated prior AF ablation. This is true even for delayed procedures as long as anticoagulation is uninterrupted.