Atrioesophageal Fistula Rates Before and After Adoption of Active Esophageal Cooling During Atrial Fibrillation Ablation.

BACKGROUND: Active esophageal cooling reduces the incidence of endoscopically identified severe esophageal lesions during radiofrequency (RF) catheter ablation of the left atrium for the treatment of atrial fibrillation. A formal analysis of the atrioesophageal fistula (AEF) rate with active esophageal cooling has not previously been performed. OBJECTIVES: The authors aimed to compare AEF rates before and after the adoption of active esophageal cooling. METHODS: This institutional review board (IRB)-approved study was a prospective analysis of retrospective data, designed before collecting and analyzing the real-world data. The number of AEFs occurring in equivalent time frames before and after adoption of cooling using a dedicated esophageal cooling device (ensoETM, Attune Medical) were quantified across 25 prespecified hospital systems. AEF rates were then compared using generalized estimating equations robust to cluster correlation. RESULTS: A total of 14,224 patients received active esophageal cooling during RF ablation across the 25 hospital systems, which included a total of 30 separate hospitals. In the time frames before adoption of active cooling, a total of 10,962 patients received primarily luminal esophageal temperature (LET) monitoring during their RF ablations. In the preadoption cohort, a total of 16 AEFs occurred, for an AEF rate of 0.146%, in line with other published estimates for procedures using LET monitoring. In the postadoption cohort, no AEFs were found in the prespecified sites, yielding an AEF rate of 0% (P < 0.0001). CONCLUSIONS: Adoption of active esophageal cooling during RF ablation of the left atrium for the treatment of atrial fibrillation was associated with a significant reduction in AEF rate.

Forward-Solution Noninvasive Computational Arrhythmia Mapping: The VMAP Study.

BACKGROUND: The accuracy of noninvasive arrhythmia source localization using a forward-solution computational mapping system has not yet been evaluated in blinded, multicenter analysis. This study tested the hypothesis that a computational mapping system incorporating a comprehensive arrhythmia simulation library would provide accurate localization of the site-of-origin for atrial and ventricular arrhythmias and pacing using 12-lead ECG data when compared with the gold standard of invasive electrophysiology study and ablation. METHODS: The VMAP study (Vectorcardiographic Mapping of Arrhythmogenic Probability) was a blinded, multicenter evaluation with final data analysis performed by an independent core laboratory. Eligible episodes included atrial and ventricular: tachycardia, fibrillation, pacing, premature atrial and ventricular complexes, and orthodromic atrioventricular reentrant tachycardia. Mapping system results were compared with the gold standard site of successful ablation or pacing during electrophysiology study and ablation. Mapping time was assessed from time-stamped logs. Prespecified performance goals were used for statistical comparisons. RESULTS: A total of 255 episodes from 225 patients were enrolled from 4 centers. Regional accuracy for ventricular tachycardia and premature ventricular complexes in patients without significant structural heart disease (n=75, primary end point) was 98.7% (95% CI, 96.0%-100%; P<0.001 to reject predefined H0 <0.80). Regional accuracy for all episodes (secondary end point 1) was 96.9% (95% CI, 94.7%-99.0%; P<0.001 to reject predefined H0 <0.75). Accuracy for the exact or neighboring segment for all episodes (secondary end point 2) was 97.3% (95% CI, 95.2%-99.3%; P<0.001 to reject predefined H0 <0.70). Median spatial accuracy was 15 mm (n=255, interquartile range, 7-25 mm). The mapping process was completed in a median of 0.8 minutes (interquartile range, 0.4-1.4 minutes). CONCLUSIONS: Computational ECG mapping using a forward-solution approach exceeded prespecified accuracy goals for arrhythmia and pacing localization. Spatial accuracy analysis demonstrated clinically actionable results. This rapid, noninvasive mapping technology may facilitate catheter-based and noninvasive targeted arrhythmia therapies. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04559061.

Correlation between sinus rhythm deceleration zones and critical sites for localized reentrant atrial flutter: A retrospective multicenter analysis.

Background: Atypical left atrial flutter (AFL) may be macroreentrant or spatially localized. The relationship between the critical isthmus (CI) for localized reentry with sinus rhythm (SR) conduction slowing has not been systematically examined. Objective: To examine the correlation between CI sites for localized AFL (L-AFL) and deceleration zones (DZ) identified by isochronal late activation mapping (ILAM) during baseline rhythm. Methods: Patients with localized AFL who underwent high-density activation mapping of both SR and AFL were retrospectively analyzed. L-AFL was defined as reentry restricted to 2 wall segments of the left atrium. CI was defined by activation mapping and sites of successful termination during ablation. DZ, defined as >3 isochrones within 1 cm radius during baseline rhythm, were correlated to the locations of the CI. Results: Thirty-one consecutive patients that underwent detailed sinus rhythm and AFL high-density activation maps were analyzed at 3 centers. A mean 4060 ± 3275 and 6209 ± 8656 points were collected in ILAM and AFL activation maps, respectively. At least 1 DZ (1.7 ± 0.77) was identified in all patients. ILAM showed 3.27 ± 0.52 isochrones per DZ (168 ± 32 ms), and co-localized to CI sites at a distance of 6.7 ± 3 mm. A total of 34% ± 14% of the AFL cycle length was contained within 0.5 cm of the DZ. Conclusions: In patients with L-AFL, CI co-localized with DZ during baseline rhythm, suggesting that DZ mapping during SR may yield candidate targets for ablation as an adjunct to pulmonary vein isolation to prevent a subtype of AFL.

Computational ECG mapping and respiratory gating to optimize stereotactic ablative radiotherapy workflow for refractory ventricular tachycardia.

BACKGROUND: Stereotactic ablative radiotherapy (SAbR) is an emerging therapy for refractory ventricular tachycardia (VT). However, the current workflow is complicated, and the precision and safety in patients with significant cardiorespiratory motion and VT targets near the stomach may be suboptimal. OBJECTIVE: We hypothesized that automated 12-lead electrocardiogram (ECG) mapping and respiratory-gated therapy may improve the ease and precision of SAbR planning and facilitate safe radiation delivery in patients with refractory VT. METHODS: Consecutive patients with refractory VT were studied at 2 hospitals. VT exit sites were localized using a 3-D computational ECG algorithm noninvasively and compared to available prior invasive mapping. Radiotherapy (25 Gy) was delivered at end-expiration when cardiac respiratory motion was ≥0.6 cm or targets were ≤2 cm from the stomach. RESULTS: In 6 patients (ejection fraction 29% ± 13%), 4.2 ± 2.3 VT morphologies per patient were mapped. Overall, 7 out of 7 computational ECG mappings (100%) colocalized to the identical cardiac segment when prior invasive electrophysiology study was available. Respiratory gating was associated with smaller planning target volumes compared to nongated volumes (71 ± 7 vs 153 ± 35 cc, P < .01). In 2 patients with inferior wall VT targets close to the stomach (6 mm proximity) or significant respiratory motion (22 mm excursion), no GI complications were observed at 9- and 12-month follow-up. Implantable cardioverter-defibrillator shocks decreased from 23 ± 12 shocks/patient to 0.67 ± 1.0 (P < .001) post-SAbR at 6.0 ± 4.9 months follow-up. CONCLUSIONS: A workflow including computational ECG mapping and protocol-guided respiratory gating is feasible, is safe, and may improve the ease of SAbR planning. Studies to validate this workflow in larger populations are required.

Open-window mapping of accessory pathways utilizing high-density mapping.

PURPOSE: Accessory pathway (AP) mapping is currently based on point-by-point mapping and identifying if a local electrogram's origin is atrial, pathway, or ventricular, which is time-consuming and prone to insufficient mapping. We sought to determine the feasibility of automated and high-density mapping to define AP location using open-window mapping (OWM), which does not rely on defining the electrogram's origin but simply detects the sharpest local signal at each point. METHODS: We enrolled 23 consecutive patients undergoing catheter ablation for atrioventricular reentrant tachycardia. High-density mapping was performed using OWM and ablation was performed. The successful site of ablation was determined by the loss of pathway function. RESULTS: OWM was 100% effective at identifying the successful site of ablation (average mapping time 7.3 ± 4.3 min.) Permanent AP elimination was achieved using a mean radiofrequency energy time of 18.5 ± 24.5 s/patient. Transiently successful ablations were 4.0 ± 1.8 mm from permanently successful sites and had lower contact force (5.1 ± 2.5 g vs. 11.7 ± 9.0 g; P = 0.041). Unsuccessful sites had similar contact force to permanently successful sites (12.2 ± 9.2 g vs. 11.7 ± 9.0 g; P = 0.856) but were 6.4 ± 2.0 mm away from successful sites. CONCLUSION: A novel technique of high-density, automated, and open-window mapping (OWM) effectively localizes APs without the need to differentiate the signal's site of origin. These findings suggest that OWM can be used to rapidly and successfully map and ablate APs. Both distances from the pathway and contact force were shown to be important for pathway ablation.

Long-term mode and timing of premature ventricular complex recurrence following successful catheter ablation.

PURPOSE: Catheter ablation of premature ventricular contractions (PVCs) is highly successful and has become the hallmark treatment for symptomatic or highly prevalent cases. However, few studies exist that evaluate the outcomes of ablation and likely mechanisms of PVC recurrence beyond 1 year of follow-up. METHODS: This study is a retrospective analysis of patients who underwent catheter ablation for symptomatic PVCs with acute procedural success and had clinical follow-up ≥ 12 months. RESULTS: Forty-four patients (24 women; age 53.5 ± 4.8 years) following acutely successful PVC ablation with long-term follow-up were studied. At a mean of 36 ± 6 months, overall long-term ablation success was 75% (33/44 patients). Notably, recurrence of the targeted PVC focus was low (6.8%, 3/44 patients); the majority of recurrences were from a new source location (18.2%, 8/44 patients). The time course for targeted versus de novo PVC recurrences was significantly different: recurrence of a PVC similar to the targeted PVC morphology occurred at a mean of 5.0 ± 2.0 months, while recurrence of a PVC different from the index case occurred at a mean of 35.8 ± 17.1 months (p = 0.01). Non-ischemic cardiomyopathy was associated with increased risk of PVC recurrence (odds ratio [OR] 14.50 (95% confidence interval [CI] 1.92-109.33, p = 0.01)) and was a significant negative prognostic factor in multivariate analysis for PVC recurrence survival (hazard ratio [HR] 4.63, 95% CI 1.03-20.74, p = 0.04). CONCLUSIONS: The majority of long-term PVC recurrences occur late in follow-up, at locations remote from the targeted PVC source or sources. Such sites may represent ongoing substrate evolution; additional work is required to determine the precise substrate alterations which promote such arrhythmogenic changes.

Mechanistic targets for the ablation of atrial fibrillation.

The mechanisms responsible for sustaining atrial fibrillation are a key debate in cardiovascular pathophysiology, and directly influence the approach to therapy including ablation Clinical and basic studies have split AF mechanisms into two basic camps: 'spatially distributed disorganization' and 'localized sources'. Recent data suggest that these mechanisms can also be separated by the method for mapping - with nearly all traditional electrogram analyses showing spatially distributed disorganization and nearly all optical mapping studies showing localized sources We will review this dichotomy in light of these recently identified differences in mapping, and in the context of recent clinical studies in which localized ablation has been shown to impact AF, also lending support to the localized source hypothesis. We will conclude with other concepts on mechanism-based ablation and areas of ongoing research that must be addressed to continue improving our knowledge and treatment of AF.

Reasons for and predictors of acute hospitalization versus elective outpatient implantable cardioverter-defibrillator implantation and subsequent differential clinical outcomes.

BACKGROUND: Implantable cardioverter-defibrillator (ICD) implantation is often an elective outpatient procedure, but previous studies have shown that approximately 30% are performed during acute hospitalizations. PURPOSE: This study aims to identify predictors of acute hospitalization versus elective outpatient ICD implantation and evaluate differential clinical outcomes. METHODS: We studied 327 first-time ICD recipients between 2011 and 2015. All patients receiving a primary prevention ICD were optimized on guideline directed medical therapy (GDMT) prior to consideration for device implantation. Using multivariate logistic regression, we examined predictors of ICD implantation during acute hospitalization. Cox proportional hazard regression was used adjusting for patient characteristics to examine associations with clinical outcomes including complications, device therapy, heart failure re-admission, and death. RESULTS: Of all patients, 132 (40.3%) underwent ICD implantation during acute hospitalization, most frequently performed for secondary prevention (n = 76, 57.6%). The most common reason for acute hospitalization ICD implantation in primary prevention patients was an indication for pacing (n = 20, 35.7%). In multivariable adjusted models, secondary prevention indication, non-single chamber device, NYHA class IV symptoms, lower diastolic blood pressure, higher BUN, and lower hemoglobin were significant predictors of ICD implantation during an acute hospitalization. In univariate analysis, acute hospitalization ICD implantation was associated with a higher risk of heart failure re-admission (HR = 1.6, 95% CI 1.1-2.4) and mortality (HR = 3.0, 95% CI 1.1-8.0) but no difference in risk of ICD therapy (HR = 1.4, 95% CI 0.9-2.3) or adverse events (HR = 1.1, 95% CI 0.6-2.1). After multivariable adjustment for potential confounders, all outcomes were no different between acute hospitalization versus elective outpatient ICD recipients. CONCLUSIONS: Among first-time ICD recipients, specific clinical characteristics predicted acute hospitalization ICD implantation. After adjustment for potential confounders, acute hospitalization ICD implantation was not associated with increased risk of morbidity or mortality.

Recurrent Post-Ablation Paroxysmal Atrial Fibrillation Shares Substrates With Persistent Atrial Fibrillation : An 11-Center Study.

INTRODUCTION: The role of atrial fibrillation (AF) substrates is unclear in patients with paroxysmal AF (PAF) that recurs after pulmonary vein isolation (PVI). We hypothesized that patients with recurrent post-ablation (redo) PAF despite PVI have electrical substrates marked by rotors and focal sources, and structural substrates that resemble persistent AF more than patients with (de novo) PAF at first ablation. METHODS: In 175 patients at 11 centers, we compared AF substrates in both atria using 64 pole-basket catheters and phase mapping, and indices of anatomical remodeling between patients with de novo or redo PAF and first ablation for persistent AF. RESULTS: Sources were seen in all patients. More patients with de novo PAF (78.0%) had sources near PVs than patients with redo PAF (47.4%, p=0.005) or persistent AF (46.9%, p=0.001). The total number of sources per patient (p=0.444), and number of non-PV sources (p=0.701) were similar between groups, indicating that redo PAF patients had residual non-PV sources after elimination of PV sources by prior PVI. Structurally, left atrial size did not separate de novo from redo PAF (49.5±9.5 vs. 49.0±7.1mm, p=0.956) but was larger in patients with persistent AF (55.2±8.4mm, p=0.001). CONCLUSIONS: Patients with paroxysmal AF despite prior PVI show electrical substrates that resemble persistent AF more closely than patients with paroxysmal AF at first ablation. Notably, these subgroups of paroxysmal AF are indistinguishable by structural indices. These data motivate studies of trigger versus substrate mechanisms for patients with recurrent paroxysmal AF after PVI.

Multicentre safety of adding Focal Impulse and Rotor Modulation (FIRM) to conventional ablation for atrial fibrillation.

AIMS: Focal Impulse and Rotor Modulation (FIRM) uses 64-electrode basket catheters to identify atrial fibrillation (AF)-sustaining sites for ablation, with promising results in many studies. Accordingly, new basket designs are being tested by several groups. We set out to determine the procedural safety of adding basket mapping and map-guided ablation to conventional pulmonary vein isolation (PVI). METHODS AND RESULTS: We collected 30 day procedural safety data in five US centres for consecutive patients undergoing FIRM plus PVI (FIRM-PVI) compared with contemporaneous controls undergoing PVI without FIRM. A total of 625 cases were included in this analysis: 325 FIRM-PVI and 300 PVI-controls. FIRM-PVI patients were more likely than PVI-controls to be male (83% vs. 66%, P < 0.001) and have long-standing persistent AF (26% vs. 13%, P < 0.001) reflecting patients referred for FIRM. Total ablation time was greater for FIRM-PVI (62 ± 22 min) vs. PVI-controls (52 ± 18 min, P = 0.03). The complication rate for FIRM-PVI procedures (4.3%) was similar to controls (4.0%, P = 1) for both major and minor complications; no deaths were reported. The rate of complications potentially attributable to the basket catheter was small and did not differ between basket types (Constellation 2.8% vs. FIRMap 1.8%, P = 0.7) or between cases in which basket catheters were and were not used (P = 0.5). Complication rates did not differ between centres (P = 0.6). CONCLUSIONS: Procedural complications from the use of the basket catheters for AF mapping are low, and thus procedural safety appears similar between FIRM-PVI and PVI-controls in a large multicentre cohort. Future studies are required to determine the optimal approach to maximize the efficacy of FIRM-guided ablation.

Compatibility of Radiofrequency Surgical Sponge Detection Technology with Cardiac Implantable Electronic Devices and Temporary Pacemakers.

BACKGROUND: Radiofrequency (RF) technology has improved detection of retained surgical sponges with a reported 100% sensitivity and specificity. However, the potential for interactions of the RF signals emitted by the detection system with cardiac implantable electronic devices (CIEDs) or temporary pacemakers may limit its use in those patients with these devices. This study investigated whether RF detection technology causes interference or clinically significant changes in the programmed settings of implanted pacemakers and defibrillators or temporary epicardial pacemakers. METHODS: Fifty patients who were scheduled either for CIED removal or placement of a temporary epicardial pacemaker (at the time of open heart surgery) were recruited for this study. Device settings and measurements from separate interrogations before and after scanning with the RF detection system were compared. For the temporary pacemakers, we observed for any changes in hemodynamics or signs of pacing interference. RESULTS: Twenty (40%) pacemakers, 20 (40%) implantable cardioverter defibrillators, and 10 (20%) temporary pacemakers were analyzed in this study. During scanning, no signal interference was detected in any permanent device, and there were no significant changes in programmed settings after scanning with the RF detection system. However, pacing inhibition was detected with temporary pacing systems when programmed to a synchronous mode (DDD). CONCLUSIONS: RF detection technology can be safely used to scan for retained surgical sponges in patients with permanent CIEDs and temporary pacemakers set to asynchronous mode.

Cardiac Device Implant Skin Closure with a Novel Adjustable, Coaptive Tape-Based Device.

BACKGROUND: The purpose of this study was to compare a unique zip-type adjustable coaptive tape-based skin closure device to traditional subcuticular sutures in three domains: time, cosmesis, and wound closure-related outcomes in cardiac implantable electronic device (CIED) procedures. METHODS: A total of 40 patients were enrolled in a prospective randomized controlled trial to assess time to wound closure, as well as cosmesis and wound closure-related outcomes. RESULTS: The adjustable coaptive tape-based skin closure device had shorter overall closure time (78 ± 6.6 seconds vs 216 ± 21.5 seconds; P < 0.001) and mean closure time per centimeter (18.0 ± 2.0 s/cm vs 50.1 ± 6.7 s/cm; P < 0.001) versus sutures, with less intersurgeon and interpatient variability with the use of adjustable coaptive device versus sutures (P < 0.001). There was no difference between groups in postoperative pain or scar cosmesis during the follow-up period. Neither group had any closure-related adverse events. CONCLUSIONS: The adjustable coaptive tape-based skin closure device demonstrated shorter closure times with less variability when compared to sutures. It is a safe and acceptable alternative to sutures for skin closure following CIED implantation.

Ventricular fibrillation: triggers, mechanisms and therapies.

Ventricular fibrillation (VF) is a common, life-threatening arrhythmia responsible for significant morbidity and mortality. Due to challenges in safely mapping VF, a comprehensive understanding of its mechanisms remains elusive. Recent findings have provided new insights into mechanisms that sustain early VF. Notably, the central role of electrical rotors and catheter-based ablation of VF rotor substrate have been recently reported. In this article, we will review data regarding four stages of VF: initiation, transition, maintenance and evolution. We will discuss the particular mechanisms for each stage and therapies targeting these mechanisms. We also examine inherited arrhythmia syndromes, including the mechanisms and therapies specific to each. We hope that the overview of VF outlined in this work will assist other investigators in designing future therapies to interrupt this life-threatening arrhythmia.