Risk assessment of esophageal ulceration following left atrial radiofrequency linear ablation.

INTRODUCTION: Esophageal safety following radiofrequency (RF) left atrial (LA) linear ablation has not been established. To determine the esophageal safety profile of LA linear RF lesions, we performed systematic esophagogastroduodenoscopy in all patients with intraesophageal temperature rise (ITR) ≥ 38.5°C. METHODS AND RESULTS: Between December 2021 and July 2023, a total of 200 consecutive patients with atrial tachyarrhythmia (ATA) underwent linear ablation with posterior dome (roof or floor) or posterior mitral isthmus line transection. Patients with ITR ≥ 38.5°C were scheduled for esophageal endoscopy ~3 weeks after ablation. Patient and ATA characteristics, procedural parameters, endoscopy findings and ablation lesion data were collected and analyzed. One hundred thirty-three out of 200 (67%) patients showed ITR ≥ 38.5°C during LA linear ablation. ITR (with maximal temperature of 45.7°C) was more frequently observed during floor line ablation (82% of cases). ITR was less observed during roof line ablation (34%) and posterior mitral isthmus ablation (4%). Endoscopy, performed in 115 patients after 24 ± 10 days, showed esophageal ulceration in four patients (two patients Kansas City classification [KCC] 2a and two patients KCC 2b). No patient showed esophageal perforation or fistula. CONCLUSION: Temperature rise during LA linear ablation is frequent and ulceration risk exists, particularly when floor line is performed. Safety measures are needed to avoid potential severe complications like esophageal perforation and fistula.

Procedural performance and outcome after pulsed field ablation for pulmonary vein isolation: comparison with a reference radiofrequency database.

Aims: Pulsed field ablation (PFA) is a promising ablation technique for pulmonary vein isolation (PVI) with appealing advantages over radiofrequency (RF) including speed, tissue selectivity, and the promise of enhanced durability. In this study, we determine the procedural performance, efficacy, safety, and durability of PFA and compare its performance with a dataset of optimized RF ablation. Methods and results: After propensity score matching, we compared 161 patients who received optimized RF-guided PVI in the PowerPlus study (CLOSE protocol) with 161 patients undergoing PFA-guided PVI for paroxysmal or persistent atrial fibrillation (AF; pentaspline basket catheter). The median age was 65 years with 78% paroxysmal AF in the PFA group (comparable characteristics in the RF group). Pulsed field ablation-guided PVI was obtained in all patients with a procedure time of 47 min (vs. 71 min in RF, P < 0.0001) and a fluoroscopy time of 15 min (vs. 11 min in RF, P < 0.0001). One serious adverse event [transient ischaemic attack] occurred in a patient with thrombocytosis (0.6 vs. 0% in RF). During the 6-month follow-up, 24 and 27 patients experienced a recurrence with 20 and 11 repeat procedures in the PFA and the RF groups, respectively (P = 0.6 and 0.09). High-density mapping revealed a status of 4 isolated veins in 7/20 patients in the PFA group and in 2/11 patients in the RF group (35 vs. 18%, P = 0.3). Conclusion: Pulsed field ablation fulfils the promise of offering a short and safe PVI procedure, even when compared with optimized RF in experienced hands. Pulmonary vein reconnection is the dominant cause of recurrence and tempers the expectation of a high durability rate with PFA.

Early atrial fibrillation recurrence post catheter ablation: Analysis from insertable cardiac monitor in the era of optimized radiofrequency ablation.

BACKGROUND: Early recurrence of atrial tachyarrhythmia (ERAT) is associated with ablation-induced proarrhythmogenic inflammation; however, existing studies used intermittent monitoring or nonoptimized radiofrequency (RF) applications (noncontiguous or without ablation index target value). OBJECTIVE: The purpose of this study was to investigate the relationship between ERAT and late recurrence based on insertable cardiac monitor (ICM) data. METHODS: We compiled data from Close-To-Cure and Close Maze studies, which enrolled patients who underwent RF ablation for paroxysmal or persistent atrial fibrillation (AF). All patients were implanted with an ICM 2-3 months before ablation. RESULTS: We studied 165 patients (104 with paroxysmal AF, 61 with persistent AF). Over the 1-year follow-up period, 41 of the patients experienced late recurrence. The risk of late recurrence was higher in patients experiencing ERAT (hazard ratio [HR] 6.2; 95% confidence interval [CI] 3.0-13.0), with negative and positive predictive values of 90.5% and 45.7%, respectively. Median burden of AF during the blanking period was significantly higher in patients with late recurrence (7.9% [0.0%-99.6%]) compared to those without recurrence (0.0% [0.0%-6.0]; P <.001). For each 1% increase in AF burden during the blanking period, late recurrence increased by 4.6% (HR 1.046; 95% CI 1.035-1.059). The best tradeoff for predicting AF from ERAT occurrence was AF burden of 0.6% and last ERAT at 64 days. CONCLUSION: In patients ablated for paroxysmal and persistent AF with a durable RF lesion set and implanted with a continuous monitoring device, postablation early AF recurrence and burden significantly predict late recurrence. The post-AF ablation blanking period should be reduced to 2 months.

No Effect of Continued Antiarrhythmic Drug Treatment on Top of Optimized Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation: Results From the POWDER-AF2 Trial.

BACKGROUND: In patients with persistent atrial fibrillation (PersAF), catheter ablation aiming for pulmonary vein isolation (PVI) is associated with moderate clinical effectiveness. We investigated the benefit of continuing previously ineffective class 1C or 3 antiarrhythmic drug therapy (ADT) in the setting of a standardized PVI-only ablation strategy. METHODS: In this multicenter, randomized controlled study, patients with PersAF (≥7 days and <12 months) despite ADT were prospectively randomized 1:1 to PVI with ADT continued versus discontinued beyond the blanking period (ADT ON versus ADT OFF). Standardized catheter ablation was performed aiming for durable isolation with stable, contiguous, and optimized radio frequency applications encircling the pulmonary veins (CLOSE protocol). Clinical visits and 1-to-7-day Holter were performed at 3, 6, and 12 months. The primary end point was any documented atrial tachyarrhythmia lasting >30 seconds beyond 3 months. Prospectively defined secondary end points included repeat ablations, unscheduled arrhythmia-related visits, and quality of life among groups. RESULTS: Of 200 PersAF patients, 98 were assigned to ADT OFF and 102 to ADT ON. The longest atrial fibrillation episode qualifying for PersAF was 28 (10-90) versus 30 (11-90) days. Clinical characteristics and procedural characteristics were similar. Recurrence of atrial tachyarrhythmia was comparable in both groups (20% OFF versus 21.2% ON). No differences were observed in repeat ablations and unscheduled arrhythmia-related visits. Marked improvement in quality of life was observed in both groups. CONCLUSIONS: In patients with PersAF, there is no benefit in continuing previously ineffective ADT beyond the blanking period after catheter ablation. The high success rate of PVI-only might be explained by the high rate of durable isolation after optimized PVI and the early stage of PersAF (POWDER-AF2). REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03437356.

Safety of the Radiofrequency Balloon for Pulmonary Vein Isolation: A Focus on Lesion Metric Analysis of Posterior Electrodes.

Previous clinical studies on pulmonary vein isolation (PVI) with radiofrequency balloons (RFB) reported safe and effective procedures for a 20 s RF delivery via posterior electrodes. Recent recommendations from the manufacturer suggest reducing the application time to 15 s on the posterior wall (PW) when facing the esophagus region. Here, we retrospectively assess whether 15 s of RF delivery time on posterior electrodes is safe while still ensuring lesion metrics of sufficient quality. This retrospective study included 133 patients with paroxysmal and persistent atrial fibrillation who underwent PVI using an RFB (Heliostar, Biosense Webster, Inc., Irvine, CA, USA) at two European centers. The ablation protocol was set for an RF duration of 20 s/60 s for the posterior/anterior electrodes. A multielectrode temperature probe was systematically used. In the case of an esophageal temperature rise (ETR) above 42 °C (ETR+), an endoscopic evaluation was performed. All posterior electrode lesion metric dynamics (temperature (T) and impedance (Z)) were collected from the RFB generator and analyzed offline. In total, 2435 posterior electrode applications were analyzed. With an RF delivery of 19.8 (19.7-19.8) s, the median impedance drop was 18.4 (12.2-25.2) Ω, while the temperature rise was 11.1 (7.1-14.9) °C. Accordingly, impedance (84.6 (79.3-90.2) Ω) and temperature plateaus (38 (35.3-41.1) °C) were reached at 13.9 (10.6-16) s and 16.4 (12.6-18.5) s, respectively. Overall, 99.6% and 95.8% of electrodes reached 90% (16.6 Ω) and 95% (17.5 Ω) of their impedance drops within 15 s of RF delivery, while 97.2% and 92.8% achieved 90% (34.2 °C) and 95% (36.1 °C) of their temperature rise to reach the plateaus within 15 s of RF delivery. An ETR >42 °C occurred in 37 (30.1%) patients after 17.7 ± 2.3 s of RF delivery. In the ETR+ group, the impedance drop and temperature rise on the posterior electrodes were higher compared to patients where ETR was <42 °C. Two asymptomatic thermal esophageal injuries were observed. In conclusion, 15 s of RF delivery on the posterior electrodes provides a good balance between safety, with no esophageal temperature rise, and efficacy with high-profile lesion metrics.

Outcomes of pulmonary vein isolation with radiofrequency balloon vs. cryoballoon ablation: a multi-centric study.

AIMS: Cryoballoon (CB) ablation is the mainstay of single-shot pulmonary vein isolation (PVI). A radiofrequency balloon (RFB) catheter has recently emerged as an alternative. However, these two technologies have not been compared. This study aims to evaluate the freedom from atrial tachyarrhythmias (ATas) at 1 year: procedural characteristics, efficacy, and safety of the novel RFB compared with CB for PVI in patients with paroxysmal atrial fibrillation (AF). METHODS AND RESULTS: This prospective multi-centre study included consecutive patients with symptomatic drug-resistant paroxysmal AF who underwent PVI with RFB or CB between July 2021 and January 2022 from three European centres. A total of 375 consecutive patients were included, 125 in the RFB group and 250 in the CB. Both groups had comparable clinical characteristics. At 12.33 ± 4.91 months, ATas-free rates were 83.20% and 82.00% in the RFB and CB groups, respectively (P > 0.05). Compared with the CB group, the RFB group showed a shorter procedure time [59.91 (45.80-77.12) vs. 77.0 (35.13-122.71) min (P < 0.001)], dwell time [19.59 (14.41-30.24) vs. 27.03 (17.11-57.21) min (P = 0.04)], time to isolation, and thermal energy delivery in all pulmonary veins (P < 0.001). First-pass isolation was comparable. No major complications occurred in either group, with no stroke, atrio-oesophageal fistula, or permanent phrenic nerve injury. Transient phrenic nerve palsy occurred more frequently with CB than RFB (7.20% vs. 3.20%; P = 0.02). Oesophageal temperature rise occurred in 21 (16.8%) patients in the RFB group, and gastroscopy showed erythema in two of them with complete recovery after 30 days. CONCLUSIONS: The RFB appears to have a safety and efficacy profile similar to that of the CB for PVI. Shorter procedural times appear to be driven by shorter left atrial dwell and thermal delivery times.

Impact of Catheter Ablation on Arrhythmia Burden in Patients With Shock-Resistant Persistent Atrial Fibrillation.

BACKGROUND: Persistent shock-resistant atrial fibrillation (AF) is a challenging entity, with modest results from catheter ablation according to conventional survival analysis. OBJECTIVES: The aim of this study was to determine the effect of catheter ablation on atrial tachyarrhythmia (ATA) burden in persistent AF patients undergoing first-time ablation with the use of an implantable cardiac monitor (ICM). METHODS: Patients with drug-resistant ongoing persistent AF and at least 1 previous failed cardioversion were implanted with an ICM 2 months before the procedure. All patients underwent pulmonary vein isolation with or without additional substrate ablation depending on the presence of self-terminating AF on ICM and left atrium size. Median AF burden before and after ablation, off antiarrhythmic medication, was determined from ICM recordings after review by 2 independent investigators. RESULTS: Sixty patients were recruited (mean age 66 ± 9 years, 70% male). Mean left atrial diameter was 48 ± 6 mm and median CHA2DS2VASc score was 2. Ten patients (17%) unexpectedly demonstrated self-terminating AF before ablation. The median burden of ATA before ablation was 100% (95% CI: 19.6%-100%), decreasing to 0% (95% CI: 0%-95.8%) after ablation during the post-blanking follow-up period (median reduction 100%; 95% CI: 4%-100%; P < 0.001). Twenty-seven patients (45%) experienced recurrent ATA during 12-month follow-up. In these patients, median burden before ablation was 100% (95% CI: 26.9%-100%), decreasing to 11.4% (95% CI: 0.35%-99.7%) after ablation (P < 0.001). Quality of life improved significantly from baseline, driven by lack of recurrence. CONCLUSIONS: Patient-tailored catheter ablation results in a significant reduction in ATA burden (off antiarrhythmic medication) in shock-resistant persistent AF patients using ICMs implanted 2-months pre-procedure. These data suggest that conventional arrhythmia-free survival analysis does not capture the true impact of catheter ablation in this challenging cohort.

Assessing the Novel Myval Balloon-Expandable Valve with the Evolut Valve: A Propensity-Matched Study.

BACKGROUND: The Myval balloon-expandable (BE) valve has shown encouraging early clinical data in terms of safety and efficacy. Comparative data with other well-established contemporary valves are nonetheless still scarce. This study aims to compare the performance of the Myval BE valve with the Evolut self-expanding (SE) valve. METHODS: In this retrospective single-center study, 223 patients with symptomatic severe aortic stenosis (AS) were included and treated with the Myval BE valve (n = 120) or with the Evolut SE valve (n = 103). Then, 91 pairs were compared after matching. Clinical outcomes were evaluated at 30 days and 1 year. Echocardiographic follow-up was performed at 30 days. RESULTS: Procedural complications were rare in both groups. At the 30-day follow-up, no significant difference in cardiac death (Myval: 1% vs. Evolut: 2%, p = 0.56), stroke (2% vs. 4%, p = 0.41) and myocardial infarction (1% vs. 3%, p = 0.31) was observed. A permanent pacemaker implantation (PPI) was significantly less needed in the Myval group (4% vs. 15%, p = 0.01). At 1 year, cardiac death (2% vs. 4%, p = 0.41) and the stroke rate (7% vs. 5%, p = 0.76) were similar. Moderate-severe paravalvular leakage (PVL) was also comparable in both groups (1% vs. 4%, p = 0.17). CONCLUSION: Safety and efficacy outcomes were comparable between the two valves, except for a higher PPI rate for the Evolut SE valve. Up to 1-year follow-up, clinical outcomes showed acceptable rates of stroke and cardiac death with both valves. Valve hemodynamics were excellent with a low rate of moderate-severe PVL in both groups.

Very High-Power Ablation for Contiguous Pulmonary Vein Isolation: Results From the Randomized POWER PLUS Trial.

BACKGROUND: Very high-power, short-duration (90-W/4-second) ablation for pulmonary vein isolation (PVI) may reduce procedural times. However, shorter applications with higher power may impact lesion quality. OBJECTIVES: In this multicenter, randomized controlled trial, the authors compared procedural efficiency, efficacy, and safety of PVI using 90-W/4-second ablation to 35/50-W ablation. METHODS: Patients with paroxysmal or persistent atrial fibrillation undergoing first-time PVI were randomized to pulmonary vein encirclement with contiguous applications using very high-power, short-duration applications (90 W over 4 seconds) or 35/50-W applications (titrated up to ablation index >550 anteriorly and >400 posteriorly). Prospective endpoints were procedural efficiency (procedure time and first-pass isolation), safety (including esophageal endoscopic evaluation), and 6-month effectiveness using repetitive Holter monitoring. RESULTS: A total of 180 patients were randomized, 90 to the 90-W group (mean age: 64.2 ± 8.9 years) and 90 to the 35/50-W group (mean age: 62.3 ± 10.8 years). Procedural time was shorter in the 90-W group vs the 35/50-W group (70 [IQR: 60-80] minutes vs 75 [IQR: 65-88.3] minutes; P = 0.009). A nonsignificant trend towards lower rates of first-pass isolation was seen in the 90-W group (83.9% vs 90%; P = 0.0852). No major complications were observed in both groups with esophageal injury occurring in 1 patient per group. At 6 months, 17% of patients in the 90-W group vs 15% in the 35/50-W group experienced recurrent arrhythmia (P = 0.681). CONCLUSIONS: Contiguous ablation using very high-power, short-duration applications results in a significant but modest reduction in procedure time with similar safety and 6-month efficacy vs a conventional approach. A hybrid approach combining both ablation modalities might be the most optimal strategy. (POWER PLUS [Very High Power Ablation in Patients With Atrial Fibrillation Schedule for a First Pulmonary Vein Isolation]; NCT04784013).

Vein of Marshall Ethanol Infusion as First Step for Mitral Isthmus Linear Ablation.

OBJECTIVES: In this study, the authors sought to investigate the added value of vein of Marshall ethanol infusion (VOMEt) as first step in facilitating radiofrequency (RF)-guided mitral isthmus (MI) block. BACKGROUND: Achieving MI block with the use of RF ablation is challenging. METHODS: Seventy patients planned for MI ablation were randomized 1:1 to VOMEt as a first step preceding RF (endocardial and epicardial, VOMFIRST group) vs RF ablation as a first step preceding VOMEt (RFFIRST group). The study end point was incidence of MI block after RF ablation and after the 2 steps. RESULTS: In VOMFIRST, VOMEt was successful in 30/35 patients (86%) resulting in a low-voltage area of 12 ± 7.4 cm2 and MI block in 2/35 patients (6%). VOMFIRST, compared with RFFIRST, was associated with higher incidence of MI block after endocardial (46% vs 11%; P < 0.001) and epicardial ablation (94% vs 43%; P < 0.001), with fewer endocardial applications (4 vs 11 vs 4; P < 0.001) and similar epicardial applications (7 vs 8; P = 0.68). Incidence of MI block after the 2 steps was 94% vs 63% (P = 0.001) in VOMFIRST vs RFFIRST, respectively. Additional touch-up RF ablation in both groups resulted in final MI block in all but 1 patient (99%). CONCLUSIONS: VOMEt as a first step in RF-guided MI line ablation significantly reduced the number of RF applications needed to achieve MI block, even if the sequence of the ablation steps did not affect the final incidence of block. (Evaluation of Vein of Marshall Ethanol Infusion During Left Atrial Linear Ablation in Patients With Persistent Atrial Fibrillation [MARSHALINE]; NCT04124328).

Clinical validation of a 13-lead electrocardiogram derived from a self-applicable 3-lead recording for diagnosis of myocardial supply ischaemia and common non-ischaemic electrocardiogram abnormalities at rest.

Aims: In this study, we compare the diagnostic accuracy of a standard 12-lead electrocardiogram (ECG) with a novel 13-lead ECG derived from a self-applicable 3-lead ECG recorded with the right exploratory left foot (RELF) device. The 13th lead is a novel age and sex orthonormalized computed ST (ASO-ST) lead to increase the sensitivity for detecting ischaemia during acute coronary artery occlusion. Methods and results: A database of simultaneously recorded 12-lead ECGs and RELF recordings from 110 patients undergoing coronary angioplasty and 30 healthy subjects was used. Five cardiologists scored the learning data set and five other cardiologists scored the validation data set. In addition, the presence of non-ischaemic ECG abnormalities was compared. The accuracy for detection of myocardial supply ischaemia with the derived 12 leads was comparable with that of the standard 12-lead ECG (P = 0.126). By adding the ASO-ST lead, the accuracy increased to 77.4% [95% confidence interval (CI): 72.4-82.3; P < 0.001], which was attributed to a higher sensitivity of 81.9% (95% CI: 74.8-89.1) for the RELF 13-lead ECG compared with a sensitivity of 76.8% (95% CI: 71.9-81.7; P < 0.001) for the 12-lead ECG. There was no significant difference in the diagnosis of non-ischaemic ECG abnormalities, except for Q-waves that were more frequently detected on the standard ECG compared with the derived ECG (25.9 vs. 13.8%; P < 0.001). Conclusion: A self-applicable and easy-to-use 3-lead RELF device can compute a 12-lead ECG plus an ischaemia-specific 13th lead that is, compared with the standard 12-lead ECG, more accurate for the visual diagnosis of myocardial supply ischaemia by cardiologists.

Personalized assessment of the cumulative complication risk of the atrial fibrillation ablation track: The AF-TRACK calculator.

Background: Atrial fibrillation (AF) ablation strategy is associated with a non-negligible risk of complications and often requires repeat procedures (AF ablation track), implying repetitive exposure to procedural risk. Objective: The purpose of this study was to develop and validate a model to estimate individualized cumulative risk of complications in patients undergoing the AF ablation track (Atrial Fibrillation TRAck Complication risK [AF-TRACK] calculator). Methods: The model was derived from a multicenter cohort including 3762 AF ablation procedures in 2943 patients. A first regression model was fitted to predict the propensity for repeat ablation. The AF-TRACK calculator computed the risk of AF ablation track complications, considering the propensity for repeat ablation. Internal (cross-validation) and external (independent cohort) validation were assessed for discrimination capacity (area under the curve [AUC]) and goodness of fit (Hosmer-Lemeshow [HL] test). Results: Complications (N = 111) occurred in 3.7% of patients (2.9% of procedures). Predictors included female sex, heart failure, sleep apnea syndrome, and repeat procedures. The model showed fair discrimination capacity to predict complications (AUC 0.61 [0.55-0.67]) and likelihood of repeat procedure (AUC 0.62 [0.60-0.64]), with good calibration (HL χ2 12.5; P = .13). The model maintained adequate discrimination capacity (AUC 0.67 [0.57-0.77]) and calibration (HL χ2 5.6; P = .23) in the external validation cohort. The validated model was used to create the Web-based AF-TRACK calculator. Conclusion: The proposed risk model provides individualized estimates of the cumulative risk of complications of undergoing the AF ablation track. The AF-TRACK calculator is a validated, easy-to-use, Web-based clinical tool to calibrate the risk-to-benefit ratio of this treatment strategy.

Evaluation of Directed Graph-Mapping in Complex Atrial Tachycardias.

OBJECTIVES: Directed graph-mapping (DGM) is a novel operator-independent automatic tool that can be applied to the identification of the atrial tachycardia (AT) mechanism. In the present study, for the first time, DGM was applied in complex AT cases, and diagnostic accuracy was evaluated. BACKGROUND: Catheter ablation of ATs still represents a challenge, as the identification of the correct mechanism can be difficult. New algorithms for high-density activation mapping (HDAM) render an easier acquisition of more detailed maps; however, understanding of the mechanism and, thus, identification of the ablation targets, especially in complex cases, remains strongly operator-dependent. METHODS: HDAMs acquired with the latest algorithm (COHERENT version 7, Biosense Webster, Irvine, California) were interpreted offline by 4 expert electrophysiologists, and the acquired electrode recordings with corresponding local activation times (LATs) were analyzed by DGM (also offline). Entrainment maneuvers (EM) were performed to understand the correct mechanism, which was then confirmed by successful ablation (13 cases were centrifugal, 10 cases were localized re-entry, 22 cases were macro-re-entry, and 6 were double-loops). In total, 51 ATs were retrospectively analyzed. We compared the diagnoses made by DGM were compared with those of the experts and with additional EM results. RESULTS: In total, 51 ATs were retrospectively analyzed. Experts diagnosed the correct AT mechanism and location in 33 cases versus DGM in 38 cases. Diagnostic accuracy varied according to different AT mechanisms. The 13 centrifugal activation patterns were always correctly identified by both methods; 2 of 10 localized reentries were identified by the experts, whereas DGM diagnosed 7 of 10. For the macro-re-entries, 12 of 22 were correctly identified using HDAM versus 13 of 22 for DGM. Finally, 6 of 6 double-loops were correctly identified by the experts, versus 5 of 6 for DGM. CONCLUSIONS: Even in complex cases, DGM provides an automatic, fast, and operator-independent tool to identify the AT mechanism and location and could be a valuable addition to current mapping technologies.

Predictors of recurrence after durable pulmonary vein isolation for paroxysmal atrial fibrillation.

AIMS: Catheter ablation of paroxysmal atrial fibrillation (AF) reduces AF recurrence, AF burden, and improves quality of life. Data on clinical and procedural predictors of arrhythmia recurrence are scarce and are flawed by the high rate of pulmonary vein reconnection evidenced during repeat procedures after pulmonary vein isolation (PVI). In this study, we identified clinical and procedural predictors for AF recurrence 1 year after CLOSE-guided PVI, as this strategy has been associated with an increased PVI durability. METHODS AND RESULTS: Patients with paroxysmal AF, who received CLOSE-guided PVI and who participated in a prospective trial in our centre, were included in this study. Uni- and multivariate models were plotted to find clinical and procedural predictors for AF recurrence within 1 year. Three hundred twenty-five patients with a mean age of 63 years (CHA2DS2VASc 1 [1-3], left atrium diameter 41 ± 6 mm) were included. About 60.9% were male individuals. After 1 year, AF recurrence occurred in 10.5% of patients. In a binary logistic regression analysis, the diagnosis-to-ablation time (DAT) was found to be the strongest predictor of AF recurrence (P = 0.011). Diagnosis-to-ablation time ≥1 year was associated with a nearly two-fold increased risk for developing AF recurrence. CONCLUSION: The DAT is the most important predictor of arrhythmia recurrence in low-risk patients treated with durable pulmonary vein isolation for paroxysmal AF. Whether reducing the DAT could improve long-term outcomes should be investigated in another trial.

Diagnostic and Prognostic Value of Several Color Doppler Jet Grading Methods in Patients With Mitral Regurgitation.

Color Doppler is a widely used ultrasound imaging method for assessing mitral regurgitation (MR) in clinical practice. Nevertheless, color Doppler-based grading of the MR jet has been rarely considered in clinical studies. We investigated the diagnostic and prognostic value of several color Doppler MR jet grading methods and compared them with quantitative grading of MR. The MR color Doppler jet was assessed in 476 MR patients using an 'integrated' eyeballing approach by quantifying the color Doppler jet area, jet area/left atrium area and jet length and using quantitative methods. Clinical endpoints were scored as major adverse clinical events, including cardiovascular death, heart failure hospitalization and mitral valve intervention. When assessed by three echocardiographers, there was a moderate inter-observer agreement for eyeballing color Doppler grade of MR (intraclass correlation coefficient 0.69, p < 0.001). The intra-observer agreement was good for all color Doppler approaches. In primary MR, eyeballing color Doppler correlated well with (in)direct measures of MR severity, with a negative predictive value of 91% when using a grade 2 color Doppler as cut-off. In secondary MR, eyeballing color Doppler grade and jet length were predictors of clinical outcome in Cox proportional hazards analysis (p = 0.003), independent of pulmonary pressures, atrial and ventricular volumes. Overall, the integrated eyeballing approach performed better than color Doppler quantification of the MR jet area and length. In conclusion, this study shows that color Doppler grading of the distal MR jet performs well in predicting events in primary and secondary MR, compared to quantitative grading methods.

D-dimer blood concentrations to exclude left atrial thrombus in patients with atrial fibrillation.

OBJECTIVE: Left atrial (LA) thrombus is routinely excluded by transoesophageal echocardiography (TOE) before cardioversion for non-valvular atrial fibrillation (AF). In the D-dimer blood concentrations to exclude LA thrombus in patients with AF study, two D-dimer cut-offs were compared to exclude LA thrombus prior to cardioversion. One was fixed to 500 ng/mL (DD500), based on clinical practice where such values are commonly accepted to exclude a thrombus. The other cut-off was adjusted to 10 times the patient's age (DDAge), based on the cut-off used to exclude pulmonary embolism. METHODS: 142 consecutive patients with non-valvular AF aged 69.7±11.4 years (52% with paroxysmal AF) referred for precardioversion TOE to exclude LA thrombus were prospectively enrolled. D-dimers were measured at the time of TOE by an ELISA test. RESULTS: LA thrombus was excluded with TOE in 129 (91%) and confirmed in 13 (9%) patients. D-dimers were significantly lower in patients without LA thrombus (729±611 vs 2376±1081 ng/L; p<0.05). DDAge indicated absence of LA thrombus with higher specificity than DD500 (66.4% vs 50.4%; p<0.05). Both cut-offs were able to identify all 13 patients with LA thrombus (false negative 0%). Patients with D-dimers

Prospective Randomized Evaluation of High Power During CLOSE-Guided Pulmonary Vein Isolation: The POWER-AF Study.

BACKGROUND: CLOSE-guided atrial fibrillation (AF) ablation is based on contiguous (intertag distance ≤6 mm), optimized (Ablation Index >550 anteriorly and >400 posteriorly) point-by-point radiofrequency lesions. The optimal radiofrequency power remains unknown. METHODS: The POWER-AF study is a prospective, randomized controlled monocentric study including patients with paroxysmal AF, planned for first CLOSE-guided pulmonary vein isolation using a contact force radiofrequency catheter (Thermocool SmartTouch, Biosense Webster, Inc, Irvine, CA). A total of 100 patients were randomized into 2 groups (1:1). The control group received AF ablation using the standard CLOSE protocol (35 W), whereas in the experimental group, pulmonary vein isolation was performed using high power (45 W). Endoscopic evaluation was performed in patients with intraesophageal temperature rise >38.5 °C. RESULTS: The resulting sample size was 96 (48+48) patients. In the high power group, shorter procedure time (80 versus 102 minutes, P<0.001), shorter total radiofrequency application time (16 versus 26 minutes, P<0.001), and radiofrequency time per application (26 versus 37 s anteriorly, P<0.001 and 13 versus 17 s posteriorly, P<0.001) were observed. Endoscopic evaluation (performed in 19/48 versus 25/48 patients respectively, P=0.31) showed an ulcerative perforation in a high power group patient (treated by endoscopic stenting and normalization after ≈4 months) and a superficial ulcerative lesion in a control group patient (conservative treatment). Both occurred following excessive Ablation Index applications (up to 460 and 480, respectively) with excessive contact force (30 g on average, with peaks up to 50 g). Six-months AF recurrence was not significantly different (10% in high power versus 8% in control, P=0.74). CONCLUSIONS: This randomized controlled study shows that a 45 W radiofrequency power CLOSE protocol in patients with paroxysmal AF significantly increases the global procedural efficiency with similar midterm efficacy. However, our study showed a narrower safety margin and a limited increased efficiency at the posterior wall using high power. This advocates against the use of high power in the region neighboring the esophagus.

Outcome of degenerative nonprolapse mitral regurgitation using the average pixel intensity method.

BACKGROUND: Primary mitral valve regurgitation (MR) is a comprehensive term that mostly comprises mitral valve prolapse (MVP), while other causes of degenerative MR are often not considered. We describe the echocardiographic characteristics of degenerative nonprolapse mitral regurgitation (DMR) and assess the outcome at medium-term follow-up using the novel average pixel intensity (API) method. METHODS: Of 126 patients with any nonprolapse DMR were consecutively included. MR was graded according to all guideline-recommended parameters and with the API method. MR flow dynamics in DMR were compared to MVP-MR and functional MR (FMR). RESULTS: DMR is associated with moderate-to-severe calcifications of the mitral valve apparatus, and a low event rate was observed at a mean follow-up of 27 months. The API grading method had a higher feasibility (94%) compared to proximal isovelocity surface area (PISA) (60%) method and vena contracta width (VCW) (71%) for assessing MR. The API method was predictive for events. The API method also provides insights into DMR flow dynamics: A triphasic pattern was observed with a midsystolic nadir for both API and PISA-EROA, which is similar to the dynamic flow pattern described in FMR, but distinct from holosystolic MVP-MR. Compared to FMR and MVP-MR patients, DMR is less severe and patients with DMR are generally older than MVP-MR patients. CONCLUSIONS: DMR is a distinct MR pathology and conveys a relatively low event rate. MR grading was feasible with the API method, and flow dynamics demonstrated a similar triphasic pattern compared to FMR but distinct from holosystolic MVP-MR.

Efficacy and safety of ablation index-guided catheter ablation for atrial fibrillation: an updated meta-analysis.

AIMS: Despite recent advances in catheter ablation for atrial fibrillation (AF), pulmonary vein reconnection (PVR), and AF recurrence remain significantly high. Ablation index (AI) is a new method incorporating contact force, time, and power that should optimize procedural outcomes. We aimed to evaluate the efficacy and safety of AI-guided catheter ablation compared to a non-AI-guided approach. METHODS AND RESULTS: A systematic search was performed on MEDLINE (via PubMED), EMBASE, COCHRANE, and European Society of Cardiology (ESC) databases (from inception to 1 July 2019). We included only studies that compared AI-guided with non-AI-guided catheter ablation of AF. Eleven studies reporting on 2306 patients were identified. Median follow-up period was 12 months. Ablation index-guided ablation had a significant shorter procedural time (141.0 vs. 152.8 min, P = 0.01; I2 = 90%), ablation time (21.8 vs. 32.0 min, P < 0.00001; I2 = 0%), achieved first-pass isolation more frequently [odds ratio (OR) = 0.09, 95%CI 0.04-0.21; 93.4% vs. 62.9%, P < 0.001; I2 = 58%] and was less frequently associated with acute PVR (OR = 0.37, 95%CI 0.18-0.75; 18.0% vs 35.0%; P = 0.006; I2 = 0%). Importantly, atrial arrhythmia relapse post-blanking was significantly lower in AI compared to non-AI catheter ablation (OR = 0.41, 95%CI 0.25-0.66; 11.8% vs. 24.9%, P = 0.0003; I2 = 35%). Finally, there was no difference in complication rate between AI and non-AI ablation, with the number of cardiac tamponade events in the AI group less being numerically lower (OR = 0.69, 95%CI 0.30-1.60, 1.6% vs. 2.5%, P = 0.39; I2 = 0%). CONCLUSIONS: These data suggest that AI-guided catheter ablation is associated with increased efficacy of AF ablation, while preserving a comparable safety profile to non-AI catheter ablation.